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CINCOR PHARMA, INC.

Date Filed : Dec 17, 2021

S-11d501326ds1.htmS-1S-1
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As filed with the Securities and Exchange Commission on December 17, 2021.

Registration No. 333-            

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIESACT OF 1933

 

 

CinCor Pharma, Inc.

(Exactname of registrant as specified in its charter)

 

Delaware 2834 36-4931245
(State or other jurisdiction of
incorporation or organization)
 (Primary Standard Industrial
Classification Code Number)
 (I.R.S. Employer
Identification No.)

200 Clarendon Street, 6th Floor

Boston, MA 02116

(844) 531-1834

(Address, including zip code, and telephone number, including area code, of registrant’sprincipal executive offices)

 

 

Marc de Garidel

ChiefExecutive Officer

CinCor Pharma, Inc.

200 Clarendon Street, 6th Floor

Boston, MA 02116

(844) 531-1834

(Name, address, including zip code, and telephone number, including area code, of agent forservice)

 

 

Copies to:

 

Ryan Sansom

Divakar Gupta

Courtney T.Thorne

Cooley LLP

500 Boylston Street

Boston,MA 02116

(617) 937-2300

 

Lisa Firenze

Ryan S. Brewer

WilmerCutler Pickering Hale & Dorr LLP

7 World Trade Center

250 Greenwich Street

NewYork, NY 10007

(212) 230-8800

 

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement isdeclared effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuousbasis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  ☐

If this Form isfiled to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statementfor the same offering.  ☐

If this Form is a post-effective amendment filed pursuant toRule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the followingbox and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and“emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

  

Accelerated filer

 

Non-accelerated filer

 

  

Smaller reporting company

 

   

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to usethe extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.  ☐

 

 

CALCULATION OF REGISTRATION FEE

 

 

Title of Each Class of
Securities To Be Registered
 Proposed Maximum
Aggregate
Offering Price(1)
 Amount of
Registration Fee(2)

Common stock, $0.00001 par value per share

 $100,000,000 $9,270

 

 

(1)

Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under theSecurities Act of 1933, as amended. Includes the offering price of additional shares that the underwriters have the option to purchase.

(2)

Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price.

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary todelay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until theRegistration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

 

 


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The information in this preliminary prospectus is not complete andmay be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities nor does it seek an offer to buythese securities in any jurisdiction where the offer or sale is not permitted.

 

SUBJECT TO COMPLETION DATED     , 2022

PRELIMINARY PROSPECTUS

            Shares

 

 

LOGO

CinCor Pharma, Inc.

COMMON STOCK

 

 

CinCor Pharma,Inc. is offering                  shares of common stock. This is our initial public offering and no public market exists for our common stock. We anticipate that theinitial public offering price will be between $                 and $                pershare.

 

 

We have applied to list our common stock on the Nasdaq Global Market under the trading symbol “CINC.”

 

 

We are an “emerging growth company” as defined under U.S. federal securities laws and, as such, will be subject to reducedpublic company reporting requirements for this prospectus and future filings. See “Prospectus Summary—Implications of Being an Emerging Growth Company and a Smaller Reporting Company.” Investing in our common stock involves risks. See“Risk Factors” beginning on page 14 of this prospectus.

 

 

 

     

Per Share

     

Total

 

Initial Public Offering Price

     $              $         

Underwriting Discounts andCommissions(1)

     $                  $             

Proceeds, before expenses, to us

     $                      $                 

 

(1)

We refer you to “Underwriting” for additional information regarding total underwritercompensation.

 

 

At our request, the underwriters have reserved up to 5% of the shares offered by this prospectus, for sale at the initial public offeringprice in a directed share program, to our directors, officers, employees and business associates and other parties related to us. See the section titled “Underwriters—Directed Share Program.”

We have granted the underwriters an option for a period of 30 days to purchase up to anadditional                shares of our common stock.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities ordetermined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The underwritersexpect to deliver the shares of common stock against payment in New York, New York on or about                , 2022.

 

 

Joint Book-Running Managers

 

MORGAN STANLEY JEFFERIES      EVERCORE ISI

 

Lead Manager

 

OPPENHEIMER & CO.

The date of this prospectus is                , 2022


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TABLE OF CONTENTS

 

 

 

 

Neither we nor the underwriters have authorized anyone to provide any information or to make any representations other thanthose contained in this prospectus or in any free writing prospectuses we have prepared. We and the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may provide you. Weare offering to sell, and seeking offers to buy, shares of common stock only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of thetime of delivery of this prospectus or of any sale of the common stock.

For investors outside of the United States: wehave not, and the underwriters have not, done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than the United States. Persons outside ofthe United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of common stock and the distribution of this prospectus outside of the United States.

All trademarks, trade names and service marks appearing in this prospectus are the property of their respective owners.Solely for convenience, the trademarks and trade names in this prospectus may be referred to without the ® and symbols, but suchreferences should not be construed as any indicator that their respective owners will not assert their rights thereto.

 

 

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PROSPECTUS SUMMARY

This summary highlights, and is qualified in its entirety by, information contained elsewhere in this prospectus. Thissummary does not contain all of the information you should consider before investing in our common stock. You should read this entire prospectus carefully, especially the sections titled “Risk Factors” and “Management’sDiscussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes appearing elsewhere in this prospectus, before making an investment decision. As used in this prospectus, unless thecontext otherwise requires, references to “we,” “us,” “our,” “the company,” and “CinCor” and similar references in this prospectus refer to CinCor Pharma, Inc.

OVERVIEW

We are a clinical-stage biopharmaceutical company focused on developing our lead clinical candidate, CIN-107, for the treatment of hypertension and other cardio-renal diseases. CIN-107 is a highly selective, oral small molecule inhibitor of aldosterone synthase, the enzymeresponsible for the synthesis of aldosterone in the adrenal gland. CIN-107 has been designed to use a differentiated mechanism of action, direct inhibition of aldosterone synthase production, with the goal of providing an improved treatment forpatients suffering from hypertension, or high blood pressure. Despite the widespread availability of multiple antihypertensive agents, there remains a significant unmet medical need as more than half of the 108 million hypertensive patients in theUnited States do not achieve blood pressure control. We are evaluating the efficacy and safety profile of CIN-107 as a potential treatment for the broader hypertensive population, including differentsubpopulations of hypertensive patients who have not achieved blood pressure control despite treatment. We are conducting a Phase 2 clinical trial, which we refer to as our BrigHtn trial, of CIN-107 inpatients whose blood pressure is not controlled despite treatment with three antihypertensive agents, including a diuretic, which is referred to as treatment resistant hypertension, or rHTN, and have recently initiated a separate Phase 2 clinicaltrial, which we refer to as our HALO trial, in patients with elevated aldosterone levels whose blood pressure is not controlled despite treatment with one antihypertensive agent, which is referred to as uncontrolled hypertension, or uHTN. Inaddition to hypertension, we are developing CIN-107 for the treatment of primary aldosteronism, or PA, and exploring its utility in ameliorating complications of chronic kidney disease, or CKD. Earlier this year, we initiated a Phase 2 clinicaltrial of CIN-107 in patients with confirmed PA, which we refer to as our spark-PA trial, and plan to initiate a Phase 2 clinical trial in patients with CKD who have uncontrolled blood pressure in the firsthalf of 2022.

In August 2021, we conducted a review of blinded, preliminary safety data from our ongoing BrigHtn trialand reviewed data of 124 patients who had either completed 12 weeks of treatment or withdrew from the trial. The purpose of this blinded data review was to enable an assessment of the overall management and conduct of the trial, without unblindingany individual patient data. Due to the preliminary and blinded nature of the data, this interim data set was not subject to the standard quality control measures typically associated with final clinical trial results. The mean systolic bloodpressure, or SBP, at baseline was 147 mm Hg and, following 12 weeks, SBP levels declined to a mean of 132 mm Hg for the 124 patients included in the review, including patients in the placebo cohort. Due to the blinded nature of the BrigHtn trial, wecurrently do not know if participants receiving CIN-107 experienced any decrease in blood pressure, or if the decreases in blood pressure, if any, differed from participants receiving a placebo. In addition, the BrigHtn trial is ongoing, and we willnot know whether treatment with CIN-107 lowers blood pressure in a clinically meaningful manner until all clinical trials we intend to complete prior to submitting a request for marketing authorization have been conducted and the U.S. Food and DrugAdministration, or the FDA, makes its efficacy determination. Furthermore, this preliminary data is not subject to the same quality control measures as final data, which creates a risk that the final results could be materially different from thepreliminary results observed in this blinded data review. We expect to announce top-line data from the final results of this trial in the second half of 2022.

Aldosterone is a steroid hormone synthesized in the adrenal gland that regulates water and salt balance in the human body. Itcauses retention of water and salt by the kidney, a genomic effect that contributes to the pathogenesis of hypertension. In addition to this genomic effect, aldosterone induces certain indirect,

 

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non-genomic effects, including pro-inflammatory and pro-fibrotic effects,increases in oxidative stress, as well as cardiac muscle cell hypertrophy and remodeling. Increasing evidence shows a correlation between these non-genomic effects of aldosterone and a worsening of patientoutcomes, particularly in patients who have heart disease or kidney disease. Given these potentially deleterious effects of aldosterone, inhibiting its effects is a well understood mechanism of action for the treatment of hypertension and othercardio-renal diseases, such as PA and CKD.

Hypertension is one of the world’s leading causes of mortality. Accordingto the United States Centers for Disease Control and Prevention, or the U.S. CDC, approximately 500,000 people still die every year in the United States with uncontrolled blood pressure listed as a primary or secondary cause of death. Despitedecades of understanding the importance of controlling hypertension and the widespread availability of multiple approved therapies, only 43.7% of the 108 million U.S. adults with hypertension achieve blood pressure levels of less than 140/90 mm Hg,despite the recommended target blood pressure goal being less than 130/80 mm Hg. Although the evidence for the benefits of reducing blood pressure is overwhelming and has been consistently supported by the medical community’s recommendations todrive blood pressure to lower levels, the current standard-of-care has not meaningfully changed in more than a decade, with no new classes of antihypertensive agentsapproved during that period.

There are multiplestandard-of-care antihypertensive agents currently available, including angiotensin converting enzyme, or ACE, inhibitors and angiotensin receptor blockers, or ARBs,which are designed to inhibit the production of aldosterone at different points along the renin angiotensin-aldosterone system, or RAAS, axis, as well as mineralocorticoid receptor antagonists, or MRAs, which block the effects of aldosterone at themineralocorticoid receptor. Despite the widespread availability and use of these antihypertensive agents, many of which are available as generic products, each class of drugs currently available is associated with significant limitations. Forexample, a significant proportion of patients taking ACE inhibitors and ARBs for prolonged periods of time experience aldosterone breakthrough, where plasma aldosterone levels return to or exceed baseline levels. In addition, the extent ofaldosterone reduction achieved with ACE inhibitors and ARBs is less than what could be achieved with aldosterone synthase inhibitors that directly inhibit aldosterone synthesis. In the case of MRAs, blocking the effects of aldosterone at themineralocorticoid receptor level often leads to increases in aldosterone synthesis, which ultimately requires higher doses of the MRA agent to compensate for these effects. The MRAs that are currently available, particularly spironolactone, are alsoassociated with multiple side effects that prevent their widespread use, including a variety of anti-androgenic effects such as breast tenderness and enlargement in men, decreased libido in men and menstrual irregularities in women. In addition,spironolactone treatment can lead to potentially harmful increases in blood potassium levels. Given both the importance of reducing aldosterone and the limitations of currently available therapies, we believe thatCIN-107 has the potential to have a significant impact on the treatment paradigm for hypertension and other cardio-renal diseases.

 

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OUR PIPELINE

We are developing CIN-107 for the treatment of multiple diseases where aldosteroneplays a significant role in disease pathophysiology, including hypertension and PA. We are also exploring its utility in ameliorating complications of CKD. To support the advancement of this “pipeline-in-a-product” opportunity, we are currently conducting and plan to initiate additional Phase 2 clinical trials ofCIN-107 for different indications and patient populations. The following table summarizes our CIN-107 pipeline across multiple indications.

 

 

LOGO

*

We plan to initiate a Phase 2 clinical trial to evaluate the efficacy and safety of CIN-107 in patients withCKD who have uncontrolled blood pressure. As we explore the utility of CIN-107 in treating hypertension in patient with CKD, we will evaluate the best path for maximizing the value of CIN-107, including as a monotherapy or in combination with othertreatments for the treatment of CKD.

 

CIN-107 Overview

Directly inhibiting aldosterone synthesis has long been a goal intherapeutic drug development as the relationship between elevated levels of aldosterone and the progression of multiple diseases is well understood. However, the challenge has been developing a molecule with the ability to safely inhibit aldosteroneproduction without negatively impacting cortisol synthesis. The major enzymes responsible for the synthesis of aldosterone and cortisol share approximately 93% amino acid sequence similarity, and therefore, a highly selective aldosterone synthesisinhibitor is required. Multiple programs in development by others have been discontinued over the past several years due to, what we believe is, their product candidates’ lack of selectivity, which resulted in the simultaneous inhibition ofboth aldosterone and cortisol. Off-target suppression of cortisol leads to compromised stress and immunologic responses, adverse impact on metabolic functions and increased risk of mortality.

CIN-107 was designed with high selectivity to specifically overcome this challenge. Inparticular, CIN-107 selectively targets aldosterone synthase, which is encoded by the CYP11B2 gene. Importantly, it has low affinity for 11ß-hydroxylase, the enzyme responsible for cortisol synthesis,which is encoded by the CYP11B1 gene. In multiple preclinical in vivo studies, CIN-107 significantly lowered aldosterone levels without affecting cortisol levels, across a wide range of doses. Similarobservations were made in multiple Phase 1 clinical trials in healthy volunteers. We observed a dose-dependent reduction of plasma aldosterone levels with patients receiving a 10 mg dose demonstrating an approximately 85% to 90% reduction inthe single ascending dose trial, and with patients receiving a 1.5 mg to 5 mg dose range demonstrating a 65% to 71% reduction in the multiple ascending

 

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dose trial. These reductions were compared to baseline levels measured the day prior to initial dosing and were not observed in individuals receiving a placebo. Importantly, no effects oncortisol levels were observed at doses up to 360 mg, the highest dose evaluated. In the multiple ascending dose trial, for doses up to 5 mg once-daily administered for 10 days, there was no observed suppression of cortisol synthesis.

To date, multiple Phase 1 clinical trials of CIN-107 have been conducted in healthyvolunteers to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CIN-107. CIN-107 was well tolerated in healthy volunteers across all Phase 1clinical trials conducted to date, with no serious adverse events, or SAEs, or treatment-emergent adverse events, or TEAEs, leading to treatment withdrawal associated with CIN-107.

In addition, a Phase 1 clinical trial was conducted in subjects with varying degrees of renal function. In this trial, one SAEnot related to CIN-107 was observed.

Based on the preclinical and clinical data available to date, we are developing CIN-107 in multiple diseases where aldosterone plays a significant role in disease pathophysiology, including hypertension and PA. We are also exploring its utility in ameliorating complications of CKD.

Hypertension

The first indication we are pursuing for CIN-107 is hypertension, with an initial focuson the subpopulation of patients with rHTN. Hypertension, which is defined by the American College of Cardiology and the American Heart Association as resting blood pressure above 130/80 mm Hg, is generally acknowledged to be the mostcommon preventable risk factor for premature death worldwide. Though often asymptomatic, hypertension significantly increases the risk of heart disease, stroke and kidney disease, amongst other diseases. It is estimated that as much as 20% ofthe global population suffers from hypertension, and the U.S. CDC estimated that as many as 108 million Americans could be hypertensive. Patients who fail to maintain blood pressure levels of 130/80 mm Hg or less, despite being compliant withat least three antihypertensive agents, of which one is a diuretic, are considered to have rHTN. The rHTN patient population represents an estimated 17% to 20% of the total hypertensive population in the United States, or approximately 12-15 million individuals. For these patients, treatment options are limited and the current standard-of-care is to introduce an MRAagent to their antihypertensive regimen.

We are currently conducting our BrigHtn trial, in hypertensive patients whofailed to achieve blood pressure control on three antihypertensive agents, including a diuretic, at their maximally tolerated doses. In addition, we recently initiated our HALO trial in hypertensive patients with elevated aldosterone levels who havefailed to achieve blood pressure control on one antihypertensive agent.

Primary Aldosteronism (PA)

PA is a hormonal disorder that is caused by the autonomous production of aldosterone by the adrenal gland and often leads tohypertension that can be difficult to treat. Although previously considered a rare disease, PA is now understood to be one of the more common causes of secondary hypertension, accounting for 5% to 10% of all hypertensive patients and approximately20% to 30% of patients with rHTN, or approximately 5 to 11 million individuals in the United States. Compared to primary hypertension, PA causes more end-organ damage and is associated with higher risks ofcardiovascular morbidity and mortality, and can result in heart failure or stroke. Therefore, it is now increasingly recognized that it is important to diagnose these patients early in their disease progression. However, PA continues to beunderdiagnosed due to the complexity of the current diagnostic guidelines recommended by the Endocrine Society and the inherent variability in plasma aldosterone measurements.

The overall treatment goal in patients with PA is to prevent the morbidity and mortality associated with hypertension,hypokalemia, renal toxicity and cardiovascular damage. In addition to antihypertensive agents, such as ACE inhibitors and ARBs, PA patients are often treated with an MRA agent, such as spironolactone, or in some rare cases, by surgical resection ofthe adrenal gland. However, MRAs, including spironolactone, are associated with multiple adverse effects, including a variety of anti-androgenic effects.

 

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In light of the pharmacokinetics and pharmacodynamics profile observed inPhase 1 trials, we are evaluating the potential of CIN-107 as a treatment for PA in our recently initiated Phase 2 clinical trial in patients with confirmed PA.

Chronic Kidney Disease (CKD)

CKD is a condition characterized by a gradual degradation of renal function over time as measured by glomerular filtrationrate, or GFR, which measures how much blood the kidneys filter each minute, and by proteinuria levels. According to the CDC, CKD afflicts approximately 15% of the U.S. adult population, or approximately 37 million people. Hypertension, diabetesand glomerulonephritis, or inflammation of the tiny filters in the kidneys, are considered to be the leading contributing factors to the development and progression of CKD. CKD has no cure, and currently available therapeutic options are designed todelay the onset of the more severe manifestations of the disease, most notably kidney failure. Patients with early-stage CKD are recommended to undertake dietary and lifestyle changes in order to improve overall health and reduce renal stress. Giventhe role of hypertension in CKD, many of the therapeutics prescribed to treat hypertension are also used for the treatment of CKD.

Aldosterone plays a significant role in the pathogenesis of CKD through its hypertensive effect and its non-genomic effects, which are known to enhance oxidative stress and promote inflammation and fibrosis. All of these deleterious effects are known to exert pressure on kidney function, especially over the multi-yearcourse of disease progression. Multiple third-party studies and meta-analyses have demonstrated that inhibiting the effect of aldosterone reduces proteinuria, as measured by the level of albumin in the urine, and ultimately delays the progression ofCKD. Reductions in systemic aldosterone levels are associated with a blood pressure lowering effect, as well as a direct effect on the progression of CKD. We plan to initiate a Phase 2 clinical trial to evaluate the efficacy and safety of CIN-107 in patients with CKD who have uncontrolled blood pressure in the first half of 2022. As we explore the utility of CIN-107 in ameliorating the complications of CKD, we will evaluate the best path formaximizing the value of CIN-107, including as a monotherapy or in combination with other treatments.

OUR STRATEGY

Our strategy is focused on developing and commercializing CIN-107 for the treatment ofmultiple cardio-renal diseases in which aldosterone is known to play a significant role in the disease pathophysiology, including hypertension and PA. We are also exploring its utility in ameliorating complications of CKD. Key elements of ourstrategy include the following:

 

  

Advance CIN-107 through clinical development for the treatment ofrHTN. We are currently conducting our BrigHtn trial in patients with rHTN, and expect topline data in the second half of 2022. While we expect the FDA to provide a label for hypertension broadly, ifCIN-107 is approved, we plan to focus our initial commercial efforts on patients with rHTN, which represents a patient population of approximately 12-15 millionindividuals in the United States who have limited treatment options and significant unmet medical need.

 

  

Expand the hypertension opportunity for CIN-107 to include patientswith uHTN and use as an earlier line of therapy. Despite the widespread availability of multiple, generic antihypertensive agents, which are often used in combination, an overwhelming number of patients are considered to have uHTN because theycontinue to fail to reach target blood pressure goals. There is growing evidence in scientific literature demonstrating that elevated aldosterone levels play a direct role in the pathogenesis of hypertension in the broader hypertensive population.Therefore, we believe a highly selective aldosterone synthase inhibitor, like CIN-107, that is designed to specifically target aldosterone production may address one of the primary underlying causes ofhypertension, thereby

 

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allowing more patients to achieve their target blood pressure goal with fewer antihypertensive agents. We believe CIN-107 may provide clinical benefit forpatients at an earlier point in their course of treatment than currently available treatments, as opposed to waiting until the patient fails to achieve blood pressure control with three or more antihypertensive agents. To evaluate the potential of CIN-107 as an earlier line of therapy and in a broader patient population, we recently initiated our HALO trial in patients with elevated aldosterone levels who failed to achieve blood pressure control on oneantihypertensive agent.

 

  

Leverage the clinical development of CIN-107 in hypertension, ifsuccessful, to efficiently develop CIN-107 for the treatment of PA. PA results from the autonomous production of excess aldosterone and affects approximately 5-10%of the total hypertensive population in the United States. This population is associated with worse outcomes and higher risks of cardiovascular events than the general hypertensive population. Therefore, it is important to identify these patients atan early stage of their disease progression in order to control their blood pressure and reduce the secondary effects of the disease. However, PA is currently underdiagnosed due to the complexity of the diagnostic guidelines and the inherentvariability in plasma aldosterone measurements. We initiated our spark-PA trial to evaluate the potential of CIN-107 as a treatment for hypertension in patients with PAearlier this year. Based on recent literature, we are using the measurement of 24-hour urine aldosterone levels in addition to plasma aldosterone levels to assess aldosterone status in patients participatingin the trial. We believe the adoption of a 24-hour urine aldosterone measurement could improve PA diagnosis rates and provide an improved approach to identifying the patients who are most likely to benefitfrom treatment with CIN-107.

 

  

Develop CIN-107 as a potentially differentiated treatment for CKDby modifying disease progression. Multiple third-party clinical trials and meta-analyses have demonstrated that blocking the effect of aldosterone reduces proteinuria and delays the progression of CKD. Long-term use of current standard-of-care agents for CKD are associated with aldosterone breakthrough, where patients experience aldosterone levels reverting back to or exceeding baseline, and canlead to poor patient outcomes. Based on the results of our preclinical and Phase 1 clinical trials of CIN-107, we plan to initiate a Phase 2 clinical trial to evaluate the efficacy and safety of CIN-107 inpatients with CKD who have uncontrolled blood pressure in the first half of 2022.

 

  

Opportunistically evaluate strategic partnerships to maximize the value ofCIN-107. We acquired the exclusive worldwide rights to CIN-107 from F. Hoffmann-La Roche Ltd and Hoffmann La-Roche Inc., whom we collectively refer to in this prospectus as Roche. As we advance the development of CIN-107 across multiple diseases and continue to generate additionalnon-clinical and clinical data, we will evaluate the best path for maximizing the value of CIN-107, including in combination with other treatments for certainindications, such as CKD. For certain geographies, we may opportunistically enter into strategic partnerships to accelerate the development and maximize the commercial potential of CIN-107. In addition, thereare several diseases where aldosterone plays a significant role, such as heart failure, that we do not currently plan to pursue on our own, but may seek to opportunistically partner with one or more third parties in order to further expand thecommercial potential of CIN-107.

OUR CORPORATE HISTORY AND TEAM

We were incorporated in March 2018 as a subsidiary of CinRx Pharma, LLC, or CinRx, a biotechnology company focused ondeveloping novel therapeutics. In May 2019, we entered into an agreement with Roche for an exclusive, worldwide, royalty-bearing license to certain Roche technology to research, develop, manufacture, and commercialize a novel aldosterone synthaseinhibitor compound, CIN-107, for any and all diseases and conditions. In connection with the closing of our Series A preferred stock financing and the execution of ourin-licensing transaction with Roche, we were spun out as an independent company. For further information,

 

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please see the section titled “Certain Relationships and Related Party Transactions—CinRx Pharma, LLC” elsewhere in this prospectus.

Our co-founders and senior management team have extensive leadership and scientificexperience in cardiovascular and specialty drug discovery and development. Our Chief Executive Officer, Marc de Garidel, has over 35 years of leadership experience in the biopharmaceutical industry and is currently the chairman of the board ofdirectors of Ipsen S.A. Prior to joining us, Mr. de Garidel served as chief executive officer of Corvidia Therapeutics, which was sold to Novo Nordisk in July 2020 for up to $2.1 billion, and prior to that, he served as chief executive officerof Ipsen S.A. Our Executive Vice President, Chief Financial Officer and Chief Business Development Officer, Mary Theresa Coelho, M.B.A., has an accomplished track record as a leader across finance, business development and operations for publicbiopharmaceutical and other publicly traded and private companies. Our Executive Vice President, Clinical Development, Mason Freeman, M.D., has been deeply involved in the development of multiple, novel medicines that are now approved for commercialsale in the United States to treat lipid disorders, heart failure, hyperkalemia, Cushing’s disease, and diabetes. Our Chief Operating Officer and co-founder, Catherine Pearce, M.B.A., D.H.Sc., has over 20years of clinical and business development experience, and previously held the position of vice president of research at Teva Pharmaceuticals. Since our inception, we have raised an aggregate of approximately $192.9 million from leading lifesciences investors, including General Atlantic, Sofinnova Investments, Sofinnova Partners and 5AM Ventures.

RISKS ASSOCIATED WITH OURBUSINESS

 

  

We have incurred significant operating losses since our inception. We expect to incur substantial operatinglosses for the foreseeable future and may never achieve or maintain profitability.

 

  

We have a limited operating history and no history of commercializing products, which may make it difficultfor you to evaluate the success of our business to date and to assess our future viability.

 

  

Even if this offering is successful, we will require substantial additional funding to finance our operations.If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate our development of CIN-107 or other operations.

 

  

Our history of recurring losses and anticipated expenditures raises substantial doubts about our ability tocontinue as a going concern. Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations.

 

  

Our business is entirely dependent on the success of one clinical development program, CIN-107, for which we are currently pursuing clinical development in various clinical trials. Our future success is substantially dependent on the successful clinical development and regulatory approval of CIN-107. If we are not able to obtain required regulatory approvals for CIN-107 or any future product candidates, we will not be able to commercialize CIN-107 or any future product candidates and our ability to generate revenue will be adversely affected.

 

  

Interim, “top-line” and preliminary data from our clinical trials that we announce or publish fromtime to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

 

  

We may not be successful in our efforts to expand our pipeline beyondCIN-107 for hypertension, PA and CKD.

 

  

Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinicaltrials and we cannot assure you that any ongoing, planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals.

 

  

Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and couldbe delayed, made more difficult or rendered impossible by multiple factors outside our control. We may find it difficult to enroll patients in our Phase 2 clinical trial of CIN-107 in PA.

 

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We have, and intend to continue to, rely on third parties to conduct, supervise and monitor our existingclinical trials and potential future clinical trials for product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.

 

  

We have, and intend to continue to, rely on third parties to produce clinical and commercial supplies of CIN-107 and any future product candidates.

 

  

We have delivered notice to terminate our Management Services Agreement with CinRx, a related party we haverelied on to provide us with services since our inception, and we may not be able to effectively replace those services.

 

  

Our business, operations and clinical development timelines and plans may be adversely affected by theevolving and ongoing COVID-19 pandemic.

 

  

We may face substantial competition, which may result in others developing or commercializing drugs before ormore successfully than us.

 

  

Even if we complete the necessary preclinical studies and clinical trials, the regulatory approval process isexpensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of CIN-107 or any future product candidates. If we or any future collaborators are not able toobtain, or if there are delays in obtaining, required regulatory approvals, we or they will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.

 

  

Our success depends in part on our ability to protect our intellectual property. It is difficult and costly toprotect our proprietary rights and technology, and we may not be able to ensure their protection.

CORPORATEINFORMATION

We were incorporated under the laws of the State of Delaware in March 2018 as a subsidiary of CinRx andspun out as an independent company in May 2019. Our principal executive offices are located at 200 Clarendon Street, 6th Floor, Boston, Massachusetts 02116 and our telephone number is (844) 531-1834. Ourwebsite address is www.cincor.com. The information contained on, or accessible through, our website is not incorporated by reference into this prospectus, and you should not consider any information contained in, or that can be accessed through, ourwebsite as part of this prospectus or in deciding whether to purchase our common stock. We have included our website in this prospectus solely as an inactive textual reference.

 

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THE OFFERING

 

Common stock offered by us

  

                shares.

Common stock to be outstanding immediately after this
offering

  


                 shares(or                  shares if the underwriters exercise in full their option to purchase additional shares).

Option to purchase additional shares offered by us

  

We have granted the underwriters an option for a period of 30 days to purchase upto         additional shares of common stock.

Directed Share Program

  

At our request, the underwriters have reserved upto        % of the shares offered by this prospectus, for sale at the initial public offering price through a directed share program to certain of our directors, officers, employees and business associates andother parties related to us. If purchased by these persons, these shares will be subject to a 180-day lock- up restriction.

 

The number of shares available for sale to the general public will be reduced to the extent that such persons purchasesuch reserved shares. Any reserved shares not so purchased will be offered by the underwriters to the general public on the same basis as the other shares offered by this prospectus. Morgan Stanley & Co. LLC will administer our directed shareprogram. See the sections titled “Certain Relationships and Related Party Transactions” and “Underwriting—Directed Share Program.”

Use of proceeds

  

We estimate that the net proceeds from this offering will be approximately$             million, or approximately $             million if the underwriters exercise in full their option topurchase additional shares of common stock, assuming an initial public offering price of $         per share, which is the midpoint of the price range set forth on the cover page of this prospectus,after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

We intend to use the net proceeds from this offering as follows:

 

•   approximately $            million to fund the clinical development of CIN-107 for the treatment of hypertension through the completion of our ongoing Phase 2BrigHtn clinical trial, our ongoing Phase 2 HALO clinical trial and initial preparations for our planned Phase 3 clinical trials in

 

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hypertension, as well as initial preparations for commercialization, if approved;

 

•   approximately$             million to fund clinical development of CIN-107 for the treatment of PA through the completion of our ongoing Phase 2 spark-PA clinicaltrial;

 

•   approximately $            million to fund the clinical development of CIN-107 to explore its utility in ameliorating complications of CKD through the completion ofour planned Phase 2 clinical trial; and

 

•   the remaining proceeds for working capital and general corporate purposes.

 

See the section titled “Use ofProceeds” beginning for additional information.

Risk factors

  

You should read the section titled “Risk Factors” for a discussion of factors you shouldconsider carefully, together with all the other information included in this prospectus, before deciding to invest in our common stock.

Proposed Nasdaq Global Market symbol

  

“CINC”

The number of shares of our common stock to be outstanding after this offering is basedon                shares of our common stock outstanding as of September 30, 2021, after giving effect to (i) the automatic conversion of all outstandingshares of our preferred stock, including 2,013,749 shares of our Series B preferred stock issued in a subsequent closing on October 5, 2021, into an aggregateof                shares of common stock upon the closing of this offering; and (ii) the automatic net exercise of the three outstanding warrants held by RocheFinance Ltd., or the Roche Warrants, for an aggregate of                shares of our common stock immediately prior to the effectiveness of the registration statementof which this prospectus forms a part (assuming an initial public offering price of $                per share, which is the midpoint of the price range listed on thecover page of this prospectus) and excludes:

 

  

5,057,647 shares of our common stock issuable upon the exercise of options under our 2019 Stock Option Plan,or the 2019 Plan, outstanding as of September 30, 2021, at a weighted-average exercise price of $1.34 per share;

 

  

            shares of our common stock issuableupon the exercise of options under the 2019 Plan granted subsequent to September 30, 2021, at a weighted-average exercise price of $    per share;

 

  

            shares of our common stock reservedfor future issuance under the 2019 Plan, which shares will cease to be available for issuance at the time our 2022 Equity Incentive Plan, or the 2022 Plan, becomes effective and will be added to, and become available for issuance under, the 2022Plan;

 

  

            shares of our common stock reservedfor future issuance under the 2022 Plan, which will become effective in connection with this offering, as well as any automatic increases in the number of shares of common stock reserved for future issuance under the 2022 Plan; and

 

  

            shares of our common stock reservedfor future issuance under our 2022 Employee Stock Purchase Plan, or the ESPP, which will become effective in connection with this offering, as well as any automatic increases in the number of shares of common stock reserved for future issuance underthe ESPP.

 

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Unless otherwise indicated, all information contained in this prospectus,including the number of shares of common stock that will be outstanding after this offering, assumes or gives effect to:

 

  

the automatic conversion of all outstanding shares of our preferred stock, including 2,013,749 shares of ourSeries B preferred stock issued in a subsequent closing on October 5, 2021, into an aggregate of    shares of our common stock, which will occur upon the closing of this offering;

 

  

a                 -for-                stock split of our common stock effected prior to the closing of thisoffering;

 

  

the filing and effectiveness of our amended and restated certificate of incorporation and the adoption of ouramended and restated bylaws upon the closing of this offering;

 

  

the automatic net exercise of the Roche Warrants into an aggregateof                shares of our common stock immediately prior to the effectiveness of the registration statement of which this prospectus forms a part (assuming aninitial public offering price of $                per share, which is the midpoint of the price range listed on the cover page of this prospectus);

 

  

no exercise of the outstanding options referred to above after September 30, 2021;

 

  

no exercise by the underwriters of their option to purchase additional shares of our common stock; and

 

  

no purchase of shares through our directed share program described under “Underwriting—DirectedShare Program.”

 

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SUMMARY FINANCIAL DATA

The following tables set forth our summary financial data for the periods indicated. We have derived the statements ofoperations and comprehensive loss data for the years ended December 31, 2019 and 2020 from our audited financial statements included elsewhere in this prospectus. The condensed statements of operations and comprehensive loss data for the ninemonths ended September 30, 2020 and 2021 and the condensed balance sheet data as of September 30, 2021, have been derived from our unaudited condensed financial statements included elsewhere in this prospectus and have been prepared on thesame basis as the audited financial statements. In the opinion of management, the unaudited data reflects all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the financial information in thoseunaudited condensed financial statements. Our historical results are not necessarily indicative of the results that should be expected in the future and our operating results for the nine months ended September 30, 2021, are not necessarilyindicative of the results that may be expected for the full year ended December 31, 2021, or any other interim periods or any future year or period.

You should read the following summary financial data together with our financial statements and the related notes theretoincluded elsewhere in this prospectus and the section of this prospectus titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The summary financial data in this section are not intended toreplace our financial statements and are qualified in their entirety by our financial statements and related notes included elsewhere in this prospectus.

 

   Year Ended  Nine Months Ended 
   December 31,
2019
  December 31,
2020
  September 30,
2020
  September 30,
2021
 
   (in thousands, except share and per share data) 

Statement of Operations and Comprehensive Loss Data:

    

Operating expenses:

     

Research and development

  $3,926  $17,952  $12,829  $10,131 

General and administrative

   1,211   3,173   2,783   7,147 
  

 

 

  

 

 

  

 

 

  

 

 

 

Total operating expenses

   5,137   21,125   15,612   17,278 
  

 

 

  

 

 

  

 

 

  

 

 

 

Loss from operations

   5,137   21,125   15,612   17,278 
  

 

 

  

 

 

   

Other (income) expense:

     

Interest income

   (101  (37  (30  (8

Change in fair value of warrant derivative liabilities

   —     1,210   907   3,756 
  

 

 

  

 

 

  

 

 

  

 

 

 

Total other (income) expense

   (101  1,173   877   3,748 
  

 

 

  

 

 

  

 

 

  

 

 

 

Net loss

   5,035  $22,298   16,489   21,026 
  

 

 

  

 

 

  

 

 

  

 

 

 

Net loss per share, basic anddiluted(1)

  $1.18  $5.25  $3.88  $4.12 
  

 

 

  

 

 

  

 

 

  

 

 

 

Shares used to compute net loss per share, basic and diluted(1)

   4,250,000   4,250,000   4,250,000   5,106,876 
  

 

 

  

 

 

  

 

 

  

 

 

 

Pro forma net loss per share, basic and diluted

   $    $  
   

 

 

   

 

 

 

Weighted average shares used to compute pro forma net loss per share, basic anddiluted

     
   

 

 

   

 

 

 

 

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(1)

See Note 8 of the notes to our audited financial statements and Note 8 of the notes to our unauditedcondensed financial statements appearing at the end of this prospectus for further details on the calculation of basic and diluted net loss per share attributable to common stockholders.

 

   AS OF SEPTEMBER 30, 2021 
   ACTUAL  PRO
FORMA(1)
   PROFORMA
AS ADJUSTED(2) 
 
      (in thousands) 

Balance Sheet Data:

     

Cash and cash equivalents

  $141,708  $                $              

Working capital(3)

   135,720    

Total assets

   147,264    

Redeemable convertible preferred stock

   180,526        

Accumulated deficit

   (48,360   

Total stockholders’ (deficit) equity

   (48,806   

 

(1)

The pro forma column reflects the conversion of all of the outstanding preferred shares into an aggregate ofshares of common stock upon completion of this offering.

(2)

The pro forma as adjusted column reflects (i) the pro forma adjustments set forth above, (ii) theissuance and sale of 2,013,749 shares of our Series B preferred stock in a subsequent closing on October 5, 2021, (iii) the sale of                shares of commonstock in this offering at the initial public offering price of $                per share, after deducting underwriting fees and commissions and estimated offeringexpenses payable by us, and (iv) the automatic net exercise of the Roche Warrants into an aggregate of                shares of our common stock immediately priorto the effectiveness of the registration statement of which this prospectus forms a part (assuming an initial public offering price of $                per share, whichis the midpoint of the price range listed on the cover page of this prospectus).

(3)

We define working capital as current assets less current liabilities.

The pro forma as adjusted information discussed above is illustrative only and will depend on the actual initial publicoffering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed initial public offering price of$                per share, the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease each of cash and cash equivalents,working capital, total assets and total stockholders’ (deficit) equity by $                million, assuming that the number of shares of common stock offered byus, as set forth on the cover page of this prospectus, remains the same, and after deducting underwriting discounts and commissions. We may also increase or decrease the number of shares of common stock we are offering. Each increase or decrease of1.0 million in the number of shares of common stock offered by us would increase or decrease each of cash and cash equivalents, working capital, total assets and total stockholders’ (deficit) equity by$                million, assuming that the assumed initial public offering price remains the same, and after deducting underwriting discounts and commissions.

 

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RISK FACTORS

Investing in our shares of common stock involves a high degree of risk. You should carefully consider the risks describedbelow, as well as the other information in this prospectus, including our financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whetherto invest in our common stock. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and prospects. In such an event, the market price of our common stock coulddecline and you may lose all or part of your investment.

Risks Related to Our Financial Position and Capital Needs

We have incurred significant operating losses since our inception. We expect to incur substantial operating losses for the foreseeablefuture and may never achieve or maintain profitability.

Investment in biopharmaceutical product development ishighly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and becomecommercially viable. We have no products approved for commercial sale and have not generated any revenue from product sales to date, and we will continue to incur significant research and development and other expenses related to our clinicaldevelopment and ongoing operations. Since inception in 2018, we have incurred significant operating losses. Our net loss was $5.0 million and $22.3 million for the years ended December 31, 2019 and 2020, respectively, and $16.5 million and$21.0 million for the nine months ended September 30, 2020 and 2021, respectively. As of September 30, 2021, we had an accumulated deficit of $48.3 million. We expect to continue to incur significant expenses and increasing operatinglosses for the foreseeable future. Since our inception, we have focused primarily on raising capital, organizing and staffing our company, business planning, and acquiring and progressing our lead product candidate,CIN-107, through clinical development after in-licensing the compound from F. Hoffmann-La Roche Ltd and Hoffmann La-Roche Inc., whom we collectively refer to in this prospectus as Roche, in 2019. It could be several years, if ever, before we have a commercialized drug. The net losses we incur may fluctuate significantly fromquarter to quarter and year to year. We anticipate that our expenses will increase substantially if, and as, we:

 

  

continue our ongoing and planned development of CIN-107, including ourPhase 2 clinical trials evaluating the effects of CIN-107 on treatment-resistant hypertension, or rHTN, uncontrolled hypertension, or uHTN, and primary aldosteronism, or PA;

 

  

initiate clinical trials for CIN-107 for any additional cardio-renalindications we may pursue, including our planned Phase 2 clinical trial exploring the utility of CIN-107 in ameliorating complications of chronic kidney diseases, or CKD;

 

  

seek marketing approvals for CIN-107 for the treatment ofhypertension, PA and any future product candidates that successfully complete clinical trials;

 

  

maintain, protect and expand our intellectual property portfolio;

 

  

hire additional clinical, regulatory and scientific personnel;

 

  

add operational, financial and management information systems and personnel, including personnel to supportour product development and planned future commercialization efforts;

 

  

incur additional legal, accounting and other expenses associated with operating as a public company;

 

  

establish a sales, marketing, manufacturing and distribution capability to commercialize CIN-107 or any future product candidate for which we may obtain marketing approval; and

 

  

build a portfolio of product candidates through development, or the acquisition or in-license of drugs, product candidates or technologies.

 

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To become and remain profitable, we must succeed in developing andeventually commercializing drugs that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing clinical trials of CIN-107 for the treatmentof hypertension, PA and any future indications, or product candidates that way may pursue, obtaining regulatory approval, procuring commercial-scale manufacturing, marketing and selling CIN-107 and any futureproducts for which we may obtain regulatory approval, as well as discovering or acquiring and then developing additional product candidates. We are only in the preliminary stages of some of these activities. We may never succeed in these activitiesand, even if we do, may never generate revenues that are significant enough to achieve profitability.

Because of thenumerous risks and uncertainties associated with drug development, we are unable to accurately predict the timing or amount of expenses or when, or if, we will be able to achieve profitability.

Our expenses could increase beyond our expectations if we are required by the U.S. Food and Drug Administration, or the FDA,the European Medicines Agency, or EMA, or other regulatory authorities to perform studies in addition to those we currently expect, or if there are any delays in the initiation and completion of our clinical trials or the development of CIN-107 or any future product candidates.

Even if we do achieve profitability, we maynot be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and developmentefforts, expand our business or continue our operations. A decline in the value of our common stock could also cause you to lose all or part of your investment.

We have a limited operating history and no history of commercializing products, which may make it difficult for you to evaluate thesuccess of our business to date and to assess our future viability.

We are a clinical-stage company founded in2018 and spun-out as a separate company from CinRx Pharma, LLC, or CinRx, in 2019. Our operations to date have been largely focused on raising capital, organizing and staffing our company, business planning,and acquiring and progressing our lead product candidate, CIN-107, through clinical development after in-licensing the compound from Roche in 2019. As an organization,we have not yet demonstrated an ability to successfully complete clinical development, obtain regulatory approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activitiesnecessary for successful commercialization. Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in clinical development, especially clinical-stagebiopharmaceutical companies such as ours. Any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializingpharmaceutical products.

We may encounter additional and unforeseen expenses, difficulties, complications, delays andother known or unknown factors in achieving our business objectives. We may also face additional costs of building out internal accounting, legal, compliance and other operational and administrative functions, including as a result of ourtermination of the management services agreement with CinRx, or the Management Services Agreement. For further information on our termination of the Management Services Agreement, please see “We delivered notice to terminate our ManagementServices Agreement with CinRx, a related party we have relied on to provide us with services since our inception, and we may not be able to effectively replace those services.” elsewhere in this section. We will need to transition at some pointfrom a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition.

Additionally, we expect our financial condition and operating results to continue to fluctuate from quarter to quarter andyear to year due to a variety of factors, many of which are beyond our control. Accordingly, you should not rely upon the results of any quarterly or annual periods as indications of future operating performance.

 

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Even if this offering is successful, we will require substantial additional funding tofinance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate our development of CIN-107 or other operations.

Based on our research and development plans, we expect that the net proceeds from this offering, together with our existingcash and cash equivalents, will be sufficient to fund our operations through the                . However, we will need to obtain substantial additional funding inconnection with our continuing operations and planned activities. Our future capital requirements will depend on many factors, including:

 

  

the timing, progress and results of our ongoing and planned clinical trials ofCIN-107 for the treatment of hypertension, PA and any additional cardio-renal indications;

 

  

the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials of CIN-107 for additional indications or any future product candidates that we may pursue;

 

  

our ability to establish collaborations on favorable terms, if at all;

 

  

the costs, timing and outcome of the regulatory review of CIN-107 andany future product candidates;

 

  

the costs and timing of future commercialization activities, including product manufacturing, marketing, salesand distribution, for CIN-107 and any future product candidates for which we receive marketing approval;

 

  

the revenue, if any, received from commercial sales of CIN-107 and anyfuture product candidates for which we receive marketing approval;

 

  

the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing ourintellectual property rights and defending any intellectual property-related claims;

 

  

the extent to which we acquire or in-license other product candidatesand technologies; and

 

  

the costs of operating as a public company.

Conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years tocomplete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. In addition, CIN-107 and any future product candidates, if approved, may notachieve commercial success. Our commercial revenues, if any, will be derived from sales of drugs that we do not expect to be commercially available for several years, if at all. Accordingly, we will need to continue to rely on additional financingto achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if webelieve we have sufficient funds for our current or future operating plans. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or altogether terminate our research and development programs orfuture commercialization efforts. We may also need to seek collaborators for CIN-107 and any future product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorablethan might otherwise be available or relinquish or license on unfavorable terms our rights to CIN-107 and any future product candidates in markets where we otherwise would seek to pursue development orcommercialization ourselves. Any of the above events could significantly harm our business, prospects, financial condition, and results of operations and cause the price of our common stock to decline. Further, our ability to raise additionalcapital may be adversely impacted by potential worsening global economic conditions and the continued disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic. If we are unable to raise sufficient additional capital, we could be forced to curtail our planned operations and the pursuit of our growth strategy.

 

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Our history of recurring losses and anticipated expenditures raises substantial doubtsabout our ability to continue as a going concern. Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations.

We have incurred operating losses to date and it is possible we may never generate a profit. Our financial statements includedelsewhere in this prospectus have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. If we are unable to raise sufficient capital in this offeringor otherwise as and when needed, our business, financial condition and results of operations will be materially and adversely affected, and we will need to significantly modify our operational plans to continue as a going concern. If we are unableto continue as a going concern, we may have to liquidate our assets, and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. Our lack of cashresources and our potential inability to continue as a going concern may materially adversely affect our share price and our ability to raise new capital, enter into critical contractual relations with third parties and otherwise execute ourdevelopment strategy.

Raising additional capital may cause dilution to our stockholders, including purchasers of shares of ourcommon stock in this offering, restrict our operations or require us to relinquish rights to CIN-107 or any future product candidates.

We expect our expenses to increase in connection with our planned operations. Until such time, if ever, as we can generatesubstantial revenue from CIN-107 or any future product candidates, we expect to finance our cash needs through public or private equity or debt financings, third-party funding, marketing and distributionarrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. We do not have any committed external source of funds. To the extent that we raise additional capital through thesale of equity or convertible debt securities, your ownership interest may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Debt and equity financings, ifavailable, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as redeeming our shares, making investments, incurring additional debt, making capital expenditures, declaring dividends orplacing limitations on our ability to acquire, sell or license intellectual property rights. In addition, securing financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount oftheir attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development ofCIN-107 or any future product candidates.

If we raise additional capital throughfuture collaborations, strategic alliances or third-party licensing arrangements, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates, or grant licenses on termsthat may not be favorable to us. If we are unable to raise additional capital when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts, or grant rights to develop and market CIN-107 or any future product candidates that we would otherwise develop and market ourselves.

Risks Related to theClinical Development of CIN-107 or Future Product Candidates

Our business is entirelydependent on the success of one clinical development program, CIN-107, for which we are currently pursuing clinical development in various clinical trials. Our future success is substantially dependent on thesuccessful clinical development and regulatory approval of CIN-107. If we are not able to obtain required regulatory approvals for CIN-107 or any future productcandidates, we will not be able to commercialize CIN-107 or any future product candidates and our ability to generate revenue will be adversely affected.

CIN-107 is currently our only product candidate and we have not licensed, acquired, orinvented any other product candidates for preclinical or clinical evaluation. This may make an investment in our company riskier

 

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than similar companies that have multiple product candidates in active development and that therefore may be able to better sustain a failure of a lead candidate. The success of our business,including our ability to finance our company and generate any revenue in the future, will, at this point, depend entirely on the successful development, regulatory approval and commercialization of CIN-107,which may never occur. Neither we nor any future collaborator is permitted to market any drug product candidates in the United States or abroad until we receive regulatory approval from the FDA or applicable foreign regulatory agency. The timerequired to obtain approval or other marketing authorizations by the FDA and comparable foreign regulatory authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors,including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinicaldevelopment and may vary among jurisdictions.

Prior to obtaining approval to commercializeCIN-107 and any other product candidate in the United States or abroad, we must demonstrate with substantial evidence from well controlled clinical trials, and to the satisfaction of the FDA or comparableforeign regulatory authorities, that such product candidates are safe and effective for their intended uses. Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe the nonclinical or clinicaldata for CIN-107 is promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities. The FDA may also require us to conduct additional nonclinical studies, includinghuman factor studies, or clinical trials for CIN-107 either prior to or post-approval, or it may object to elements of our clinical development program. In addition, the FDA typically refers applications fornovel drugs, like CIN-107 and potentially any future product candidates, to an advisory committee composed of outside experts. The FDA is not bound by the recommendation of the advisory committee, but itconsiders such recommendation when making its decision.

Of the large number of products in development, only a smallpercentage successfully complete the FDA or comparable foreign regulatory authorities’ approval processes and are commercialized. The lengthy approval or marketing authorization process as well as the unpredictability of future clinical trialresults may result in our failing to obtain regulatory approval or marketing authorization to market CIN-107 or any future product candidates, which would significantly harm our business, financial condition,results of operations and prospects.

We have invested a significant portion of our time and financial resources in thedevelopment of CIN-107. Our business is dependent on our ability to successfully complete development of, obtain regulatory approval for, and, if approved, successfully commercialize CIN-107 and any future product candidates in a timely manner.

Even if we eventuallycomplete clinical testing and receive approval of a new drug application, or NDA, or foreign marketing application for CIN-107 and any future product candidates, the FDA or the comparable foreign regulatoryauthorities may grant approval or other marketing authorization contingent on the performance of costly additional clinical trials, including post-market clinical trials. The FDA or the comparable foreign regulatory authorities also may approve orauthorize for marketing a product candidate for a more limited indication or patient population that we originally request, and the FDA or comparable foreign regulatory authorities may not approve or authorize the labeling that we believe isnecessary or desirable for the successful commercialization of CIN-107 or any future product candidate. Any delay in obtaining, or inability to obtain, applicable regulatory approval or other marketingauthorization would delay or prevent commercialization of that product candidate and would materially adversely impact our business and prospects.

In addition, the FDA and comparable foreign regulatory authorities may change their policies, adopt additional regulations orrevise existing regulations or take other actions, which may prevent or delay approval of our future products under development on a timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delay ourability to obtain approvals, increase the costs of compliance or restrict our ability to maintain any marketing authorizations we may have obtained.

 

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Interim, “top-line” and preliminarydata from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publish interim, “top-line” or preliminary datafrom our clinical trials. Interim data from ongoing clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. For example, the onlyPhase 2 clinical data we have is from the preliminary safety data review of 124 patients who had either completed 12 weeks of treatment in, or withdrew from, our ongoing BrigHtn trial, which represents a small sample size relative to ourtargeted enrollment for the overall clinical trial, may not be indicative of the clinical trial’s final results. Preliminary or “top-line” data also remain subject to that audit and verificationprocedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Differencesbetween preliminary or interim data and final data could significantly harm our business prospects and may cause the trading price of our common stock to fluctuate significantly.

Additionally, we may utilize an “open-label” clinical trial design. For example, our HALO trial includes a four week“open-label” extension during which patients will continue to receive doses of CIN-107 but discontinue background antihypertensive therapy. An “open-label” clinical trial is one where both the patient and investigator knowwhether the patient is receiving the investigational product candidate or either an existing approved drug or placebo. Most open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels.Open label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a“patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an “investigator bias” wherethose assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. The results from an openlabel trial may not be predictive of future clinical trial results with CIN-107 or any future product candidates for which we include an open-label clinical trial when studied in a controlled environment with a placebo or active control.

We may not be successful in our efforts to expand our pipeline beyond CIN-107 for hypertension,PA and CKD.

We intend to advance the development of CIN-107 acrossmultiple cardio-renal indications and progress these indications through clinical development. We may not be able to expand the scope of cardio-renal indications for CIN-107 beyond hypertension, PA and CKD, orleverage our expertise and experience with hypertension and PA to other cardio-renal indications. We may not be able to develop CIN-107 for other indications in a manner that is safe and effective. Even if weare successful in continuing to expand CIN-107 to other indications and further build our pipeline, the potential indications that we identify may not be suitable for clinical development, including as aresult of safety, tolerability, efficacy or other characteristics that indicate that they are unlikely to receive marketing approval, achieve market acceptance or obtain reimbursements from third-party payors. If we do not successfully execute onour strategy of expanding our product pipeline, it could significantly harm our financial position and adversely affect the trading price of our common stock.

Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials and we cannotassure you that any ongoing, planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals.

Success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the sameresults or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. Preclinical tests and Phase 1 and Phase 2 clinical trials are primarily designed to test safety, to study

 

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pharmacokinetics and pharmacodynamics and to understand the side effects of product candidates at various doses and schedules. Success in preclinical studies and earlier clinical trials does notensure that later efficacy trials will be successful, nor does it predict final results. For example, we have not completed a Phase 2 or Phase 3 clinical trial evaluating the safety and efficacy of CIN-107 inany indication. CIN-107 and any future product candidates may fail to show the desired safety and efficacy in clinical development despite positive results in preclinical studies or having successfullyadvanced through earlier clinical trials.

In addition, the design of a clinical trial can determine whether its resultswill support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. As an organization, we have limited experience designing clinical trials and may be unable to designand execute a clinical trial to support regulatory approval. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinicaltesting and earlier clinical trials. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejectionsas a result of many factors, including changes in regulatory policy during the period of our product candidate development. Any such delays could negatively impact our business, financial condition, results of operations and prospects.

We may encounter substantial delays or difficulties in our clinical trials.

We may not commercialize, market, promote or sell any product candidate without obtaining marketing approval from the FDA orcomparable foreign regulatory authorities, and we may never receive such approvals. It is impossible to predict when or if CIN-107 or any future product candidates will prove effective or safe in humans andwill receive regulatory approval. Before obtaining marketing approval from regulatory authorities for the sale of CIN-107 or any future product candidate, we must complete preclinical development and thenconduct extensive clinical trials to demonstrate the safety and efficacy of our product candidate in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failureof one or more clinical trials can occur at any stage of testing. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performedsatisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products.

We may experience numerous unforeseen events prior to, during, or as a result of, clinical trials that could delay or preventour ability to receive marketing approval or commercialize CIN-107 and any future product candidates, including:

 

  

delays in reaching a consensus with regulatory authorities on design or implementation of our clinical trials;

 

  

regulators or institutional review boards, or IRBs, may not authorize us or our investigators to commence aclinical trial or conduct a clinical trial at a prospective trial site;

 

  

delays in reaching agreement on acceptable terms with prospective clinical research organizations, or CROs,and clinical trial sites;

 

  

the number of patients required for clinical trials of CIN-107 or anyfuture product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, patients may drop out of these clinical trials at a higher rate than we anticipate or fail to return for post-treatmentfollow-up or we may fail to recruit suitable patients to participate in a trial;

 

  

clinical trials of CIN-107 or any future product candidates mayproduce negative or inconclusive results;

 

  

imposition of a clinical hold by regulatory authorities as a result of a serious adverse event, concerns witha CIN-107 or any future product candidates or after an inspection of our clinical trial operations, trial sites or manufacturing facilities;

 

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occurrence of serious adverse events associated with CIN-107 or anyfuture product candidate that are viewed to outweigh its potential benefits;

 

  

changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;

 

  

interruptions resulting from public health emergencies, including those related to the COVID-19 pandemic; or

 

  

we may decide, or regulators may require us, to conduct additional clinical trials or abandon productdevelopment programs.

Any inability to successfully complete preclinical and clinical development couldresult in additional costs to us or impair our ability to generate revenue from future drug sales or other sources. In addition, if we make manufacturing or formulation changes to our product candidates, we may need to conduct additional testing tobridge our modified product candidate to earlier versions. Clinical trial delays could shorten any periods during which we may have the exclusive right to commercialize our product candidates, if approved, or allow our competitors to bring competingdrugs to market before we do, which could impair our ability to successfully commercialize CIN-107 or any future product candidates and may harm our business, financial condition, results of operations andprospects.

Additionally, if the results of our clinical trials are inconclusive or if there are safety concerns orserious adverse events associated with our product candidates, we may:

 

  

be delayed in obtaining marketing approval, if at all;

 

  

obtain approval for indications or patient populations that are not as broad as intended or desired;

 

  

obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;

 

  

be subject to additional post-marketing testing requirements;

 

  

be required to perform additional clinical trials to support approval or be subject to additionalpost-marketing testing requirements;

 

  

have regulatory authorities withdraw, or suspend, their approval of the drug or impose restrictions on itsdistribution in the form of a modified risk evaluation and mitigation strategy, or REMS;

 

  

be subject to the addition of labeling statements, such as warnings or contraindications;

 

  

be sued; or

 

  

experience damage to our reputation.

Our product development costs will also increase if we experience delays in testing or obtaining marketing approvals. We donot know whether any of our preclinical studies or clinical trials will begin as planned, need to be restructured or be completed on schedule, if at all.

Further, we, the FDA or an IRB may suspend our clinical trials at any time if it appears that we or our collaborators arefailing to conduct a trial in accordance with regulatory requirements, including the FDA’s current Good Clinical Practice, or GCP, regulations, that we are exposing participants to unacceptable health risks, or if the FDA finds deficiencies inour investigational new drug applications, or INDs, or the conduct of these trials. Therefore, we cannot predict with any certainty the schedule for commencement and completion of future clinical trials. If we experience delays in the commencementor completion of our clinical trials, or if we terminate a clinical trial prior to completion, the commercial prospects of CIN-107 or any future product

 

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candidates could be negatively impacted, and our ability to generate revenues from CIN-107 or any future product candidates may be delayed.

Clinical trials are very expensive, time consuming and difficult to design and implement.

CIN-107 and any future product candidates we may decide to pursue will require clinicaltesting before we are prepared to submit an NDA for regulatory approval. We cannot predict with any certainty if or when we might submit an NDA for regulatory approval for CIN-107 or any future productcandidate or whether any such NDA will be approved by the FDA. Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. For instance, the FDA may not agreewith our proposed endpoints for any future clinical trial of CIN-107 or any future product candidates, which may delay the commencement of our clinical trials. The clinical trial process is also timeconsuming. We estimate that the successful completion of clinical trials for CIN-107 and any future product candidates will take several years to complete. Furthermore, failure can occur at any stage, and wecould encounter problems that cause us to abandon or repeat clinical trials.

Certain of the indications we seek to treat are oftenunderdiagnosed and it may be difficult to identify and enroll patients with these indications. If we experience delays or difficulties in the enrollment and/or maintenance of patients in clinical trials, our receipt of necessary regulatory approvalscould be delayed or prevented.

Successful and timely completion of clinical trials will require that we enroll asufficient number of patients. Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors, including the size and nature of the patient population and competition for patients with other trials. Certain ofthe indications we are pursuing are often underdiagnosed, which may further limit the number of patients available to participate in our clinical trials. For example, despite being one of the more common causes of secondary hypertension, PAcontinues to be underdiagnosed due to the complexity of the current diagnostic guidelines recommended by the Endocrine Society.

Clinical trials may be subject to delays as a result of patient enrollment taking longer than anticipated or patientwithdrawal. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA, EMA or foreignregulatory authorities. We cannot predict how successful we will be at enrolling subjects in future clinical trials. Subject enrollment is affected by other factors including:

 

  

the eligibility criteria for the trial in question;

 

  

the size of the patient population and process for identifying patients;

 

  

the perceived risks and benefits of the product candidate in the trial;

 

  

the availability of competing commercially available therapies and other competing therapeuticcandidates’ clinical trials;

 

  

the willingness of patients to be enrolled in our clinical trials;

 

  

the efforts to facilitate timely enrollment in clinical trials;

 

  

potential disruptions caused by the COVID-19 pandemic, includingdifficulties in initiating clinical sites, enrolling and retaining participants, diversion of healthcare resources away from clinical trials, travel or quarantine policies that may be implemented, and other factors;

 

  

the patient referral practices of physicians;

 

  

the ability to monitor patients adequately during and after treatment; and

 

  

the proximity and availability of clinical trial sites for prospective patients.

 

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Our inability to enroll a sufficient number of patients for clinical trialswould result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays in these clinical trials may result in increased development costs for our product candidates, which would cause the valueof our company to decline and limit our ability to obtain additional financing. Furthermore, we currently rely and expect to rely in the future on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and wewill have limited influence over their performance.

Furthermore, even if we are able to enroll a sufficient number ofpatients for our clinical trials, we may have difficulty maintaining enrollment of such patients in our clinical trials.

Enrollmentand retention of patients in clinical trials is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control. We may find it difficult to enroll patients in ourPhase 2 spark-PA clinical trial of CIN-107 in PA.

Identifying andqualifying patients to participate in our clinical trials is critical to our success. If the actual number of patients with rHTN, uHTN, PA, CKD, or any other indications that we may pursue for CIN-107 orfuture product candidates, is smaller than we anticipate, we may encounter difficulties in enrolling patients in our clinical trials, thereby delaying or preventing development and approval of CIN-107 and anyfuture product candidates. Furthermore, certain of the indications we are pursuing may be underdiagnosed, which may further limit the number of patients available to participate in our clinical trials. For example, despite being one of the morecommon causes of secondary hypertension, PA continues to be underdiagnosed due to the complexity of the current diagnostic guidelines recommended by the Endocrine Society. Even once enrolled we may be unable to retain a sufficient number of patientsto complete any of our trials. Patient enrollment and retention in clinical trials depends on many factors, including the size of the patient population, the nature of the trial protocol, the existing body of safety and efficacy data, the number andnature of competing treatments and ongoing clinical trials of competing therapies for the same indication, the proximity of patients to clinical sites, the experience and capabilities of the clinical sites to recruit the correct patients, and theeligibility criteria for the trial. Patient enrollment may also continue to be affected by the ongoing COVID-19 pandemic, which could be due to the prioritization of hospitalization resources toward thispandemic, exposure of healthcare providers to COVID-19 and difficulties for patients to access clinical trial sites and comply with clinical trial protocols.

Furthermore, our efforts to build relationships with patient communities may not succeed, which could result in delays inpatient enrollment in our clinical trials. In addition, any negative results we may report in clinical trials of CIN-107 and any future product candidate may make it difficult or impossible to recruit andretain patients in other clinical trials of that same product candidate. Delays or failures in planned patient enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to developCIN-107 or any future product candidates or could render further development impossible. In addition, we expect to rely on CROs and clinical trial sites to ensure proper and timely conduct of our futureclinical trials and, while we intend to enter into agreements governing their services, we will be limited in our ability to compel their actual performance.

Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.

As product candidates proceed through preclinical studies to late-stage clinical trials towards potential approval andcommercialization, it is common that various aspects of the development activities, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Any of these changes could cause CIN-107 or any future product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the materials manufactured using altered processes.Such changes may also require additional testing, including comparability testing to bridge earlier clinical data obtained from CIN-107 produced under earlier manufacturing methods or formulations, andregulatory authorities may disagree on the interpretation of results from this testing. This could delay completion

 

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of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of CIN-107 or any future product candidates and jeopardize our ability to commence sales and generate revenue.

Our business, operations and clinical development timelines and plans may be adversely affected by the evolving and ongoing COVID-19 pandemic.

Our business and operations may be adversely affected by theeffects of the recent and evolving COVID-19 virus, which was declared by the World Health Organization as a global pandemic. The COVID-19 pandemic has resulted in traveland other restrictions in order to reduce the spread of the disease, including public health directives and orders in the United States and the European Union that, among other things and for various periods of time, directed individuals to shelterat their places of residence, directed businesses and governmental agencies to cease non-essential operations at physical locations, prohibited certain non-essentialgatherings and events and ordered cessation of non-essential travel. Future remote work policies and similar government orders or other restrictions on the conduct of business operations related to the COVID-19 pandemic may negatively impact productivity and may disrupt our ongoing research and development activities and our clinical programs and timelines, the magnitude of which will depend, in part, on thelength and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. Further, such orders also may impact the availability or cost of materials, which would disrupt our supply chain andmanufacturing efforts and could affect our ability to conduct ongoing and planned clinical trials and preparatory activities.

Although our current and planned clinical trials have not been impacted by theCOVID-19 pandemic to date, we may experience related disruptions in the future that could severely impact our clinical trials, including:

 

  

delays, difficulties or a suspension in clinical site initiation, including difficulties in recruitingclinical site investigators and clinical site staff;

 

  

interruptions in our ability to manufacture and deliver drug supply for trials;

 

  

diversion of healthcare resources away from the conduct of clinical trials, including the diversion ofhospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

 

  

changes in local regulations as part of a response to the COVID-19pandemic that may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;

 

  

interruption of key clinical trial activities, such as clinical trial site monitoring, and the ability orwillingness of subjects to travel to trial sites due to limitations on travel imposed or recommended by federal or state governments, employers and others;

 

  

limitations in employee resources that would otherwise be focused on the conduct of our clinical trials,including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

 

  

delays in necessary interactions with local regulators, ethics committees and other important agencies andcontractors due to limitations in employee resources or forced furlough of government employees; and

 

  

refusal of the FDA to accept data from clinical trials in these affected geographies.

The spread of COVID-19, which has caused a broad impact globally, may materiallyaffect us economically. While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, it could result in significant disruption of global financialmarkets, reducing our ability to access capital, which could in the future negatively affect our liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 could materiallyaffect our business and the value of our common stock.

 

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The COVID-19 pandemic continues torapidly evolve. The extent to which the COVID-19 pandemic impacts our business and operations, including our clinical development and regulatory efforts, will depend on future developments that are highlyuncertain and cannot be predicted with confidence at the time of this prospectus, such as the duration of the outbreak, the duration and effect of business disruptions and the short-term effects and ultimate effectiveness of the travel restrictions,quarantines, social distancing requirements and business closures in the United States and other countries to contain and treat the disease and the availability, timing and effectiveness of a vaccine, both domestically and globally.Accordingly, we do not yet know the full extent of potential delays or impacts on our business, our clinical and regulatory activities, healthcare systems or the global economy as a whole. However, these impacts could adversely affect our business,financial condition, results of operations and growth prospects.

In addition, to the extent the ongoing COVID-19 pandemic adversely affects our business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties described in this “Risk Factors” section.

CIN-107 or any future product candidate may cause undesirable side effects or have otherproperties that could delay or prevent their regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval.

During the conduct of clinical trials, patients report changes in their health, including illnesses, injuries and discomforts,to their doctor. Often, it is not possible to determine whether or not the product candidate being studied caused these conditions. Regulatory authorities may draw different conclusions or require additional testing to confirm these determinations,if they occur. For example, patients participating in our clinical trials have reported urinary tract infection, fatigue, hyperkalemia, headache, renal impairment, hyponatremia, nausea, and dizziness.

In addition, it is possible that as we test CIN-107 or any future product candidatesin larger, longer and more extensive clinical trials on larger more diverse groups of patients, or as use of CIN-107 or any future product candidates becomes more widespread if they receive regulatoryapproval, illnesses, injuries, discomforts and other adverse events that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by subjects or patients. Many times, sideeffects are only detectable after investigational drugs are tested in large-scale pivotal trials, which we as an organization have never conducted, or in some cases, after they are made available to patients on a commercial scale after approval. Anyadverse effects encountered in our preclinical studies or clinical trials, whether or not drug-related, could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Ifadditional clinical experience indicates that CIN-107 or any future product candidates have side effects or causes serious or life-threatening side effects, the development of the product candidate may fail orbe delayed, or, if the product candidate has received regulatory approval, such approval may be revoked, which would harm our business, prospects, operating results and financial condition.

As an organization, we have never completed pivotal clinical trials, and we may be unable to do so forCIN-107 or any product candidates we may develop.

We will need tosuccessfully complete pivotal clinical trials in order to obtain the approval of the FDA and other regulatory agencies to market CIN-107 or any future product candidates. Carrying out later-stage clinicaltrials and the submission of a successful NDA is a complicated process. As an organization, we have not previously completed any later stage or pivotal clinical trials and have limited experience in preparing, submitting and prosecuting regulatoryfilings. Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to NDA submission and approval of CIN-107 for treatment resistanthypertension. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop. Failure to commence or complete, or delays in, our planned clinicaltrials could prevent us from or delay us in commercializing CIN-107.

 

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We may explore strategic collaborations that may never materialize, or we may berequired to relinquish important rights to and control over the development of CIN-107 or any future product candidate to any future collaborators.

We intend to periodically explore a variety of possible strategic collaborations in an effort to gain access to additionalproduct candidates or resources. At the current time, we cannot predict what form such a strategic collaboration might take. We are likely to face significant competition in seeking appropriate strategic collaborators, and strategic collaborationscan be complicated and time consuming to negotiate and document. We may not be able to negotiate strategic collaborations on acceptable terms, or at all. We are unable to predict when, if ever, we will enter into any strategic collaborations becauseof the numerous risks and uncertainties associated with establishing them.

Future collaborations could subject us to anumber of risks, including:

 

  

we may be required to undertake the expenditure of substantial operational, financial and managementresources;

 

  

we may be required to issue equity securities that would dilute our stockholders’ percentage ownership ofour company;

 

  

we may be required to assume substantial actual or contingent liabilities;

 

  

we may not be able to control the amount and timing of resources that our strategic collaborators devote tothe development or commercialization of our product candidates;

 

  

strategic collaborators may select indications or design clinical trials in a way that may be less successfulthan if we were doing so;

 

  

strategic collaborators may delay clinical trials, provide insufficient funding, terminate a clinical trial orabandon a product candidate, repeat or conduct new clinical trials or require a new version of a product candidate for clinical testing;

 

  

strategic collaborators may not pursue further development of products resulting from the strategiccollaboration arrangement or may elect to discontinue research and development programs;

 

  

strategic collaborators may not commit adequate resources to the marketing and distribution of CIN-107 or any future product candidates, limiting our potential revenues from these products;

 

  

disputes may arise between us and our strategic collaborators that result in the delay or termination of theresearch or development of CIN-107 or any future product candidates or that result in costly litigation or arbitration that diverts management’s attention and consumes resources;

 

  

strategic collaborators may experience financial difficulties;

 

  

strategic collaborators may not properly maintain or defend our intellectual property rights or may use ourproprietary information in a manner that could jeopardize or invalidate our proprietary information or expose us to potential litigation;

 

  

business combinations or significant changes in a strategic collaborator’s business strategy mayadversely affect a strategic collaborator’s willingness or ability to complete its obligations under any arrangement;

 

  

strategic collaborators could decide to move forward with a competing product candidate developed eitherindependently or in collaboration with others, including our competitors; and

 

  

strategic collaborators could terminate the arrangement or allow it to expire, which would delay thedevelopment and may increase the cost of developing our product candidates.

 

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Risks Related to Our Dependence on Third Parties

We have, and intend to continue to, rely on third parties to conduct, supervise and monitor our existing clinical trials and potentialfuture clinical trials for product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.

We have engaged CROs to conduct all three of our Phase 2 clinical trials in patients with rHTN, uHTN and PA, and we expect toengage CROs for future clinical trials of CIN-107 and any future product candidates. We expect to continue to rely on third parties, including clinical data management organizations, medical institutions andclinical investigators, to conduct those clinical trials, and we do not currently have the ability to independently conduct any clinical trials ourselves. Any of these third parties may terminate their engagements with us, some in the event of anuncured material breach and some at any time for convenience. If any of our relationships with these third parties terminate, we may not be able to timely enter into arrangements with alternative third parties or to do so on commercially reasonableterms, if at all. Switching or adding CROs involves substantial cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact ourability to meet our desired clinical development timelines. Though we intend to carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future or that these delays orchallenges will not have a material adverse impact on our business, financial condition and prospects. Further, the performance of our CROs may also be interrupted by the ongoing COVID-19 pandemic, includingdue to travel or quarantine policies, heightened exposure of CRO staff who are healthcare providers to COVID-19 or prioritization of resources toward the COVID-19pandemic.

We rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials, and weexpect to have limited influence over their actual performance. We rely upon CROs to monitor and manage data for our clinical programs. We expect to control only certain aspects of the activities of our CROs. Nevertheless, we will be responsible forensuring that each of our preclinical studies and clinical trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the CROs does not relieve us of our regulatoryresponsibilities.

We and our CROs are required to comply with the good laboratory practices, or GLPs, and GCPs, which areregulations and guidelines enforced by the FDA and comparable foreign regulatory authorities in the form of International Conference on Harmonization guidelines for CIN-107 or any future product candidatesthat are in preclinical and clinical development. The regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and clinical trial sites. Although we rely on CROs to conduct GCP-compliant clinical trials, we remain responsible for ensuring that each of our GLP preclinical studies and clinical trials is conducted in accordance with its investigational plan and protocol and applicablelaws and regulations, and our reliance on the CROs does not relieve us of our regulatory responsibilities. If we or our CROs fail to comply with GCPs, the clinical data generated in our clinical trials may be deemed unreliable, and the FDA orcomparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. Accordingly, if our CROs fail to comply with these regulations or fail to recruit a sufficient number ofsubjects, we may be required to repeat clinical trials, which would delay the regulatory approval process. We are also required to register certain clinical trials and post the results of completed clinical trials on a government-sponsored database,ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Our reliance on third parties to conduct clinical trials will result in less direct control over the management of datadeveloped through clinical trials than would be the case if we were relying entirely upon our own staff. Communicating with CROs and other third parties can be challenging, potentially leading to mistakes as well as difficulties in coordinatingactivities. Such parties may:

 

  

have staffing difficulties;

 

  

fail to comply with contractual obligations;

 

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experience regulatory compliance issues;

 

  

experience business disruptions from public health emergencies, such as theCOVID-19 pandemic, and accompanying shelter in place orders; or

 

  

undergo changes in priorities or become financially distressed.

These factors may materially adversely affect the willingness or ability of third parties to conduct our clinical trials andmay subject us to unexpected cost increases that are beyond our control. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, fail to comply with regulatory requirements, or if thequality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for any other reasons, our clinical trials may be extended, delayed or terminated, and we maynot be able to obtain regulatory approval for, or successfully commercialize, any product candidate that we develop. As a result, our financial results and the commercial prospects for any product candidate that we develop would be harmed, our costscould increase, and our ability to generate revenue could be delayed.

While we will have agreements governing theiractivities, our CROs will not be our employees, and we will not control whether or not they devote sufficient time and resources to our clinical programs. These CROs may also have relationships with other commercial entities, including ourcompetitors, for whom they may also be conducting clinical trials, or other drug development activities. If these CROs, do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance withregulatory requirements or our stated protocols, we may not be able to obtain, or may be delayed in obtaining, regulatory approvals for CIN-107 or any future product candidates. If that occurs, we will not beable to, or may be delayed in our efforts to, successfully commercialize CIN-107 or any future product candidates. In such an event, our financial results and the commercial prospects for CIN-107 or any future product candidates that we seek to develop could be harmed, our costs could increase and our ability to generate revenues could be delayed, impaired or foreclosed.

In addition, quarantines, shelter-in-place,and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could occur, related to the COVID-19 pandemic or other infectiousdiseases could impact personnel at our CROs, which could disrupt our clinical timelines, which could have a material adverse impact on our business, prospects, financial condition, and results of operations.

We face the risk of potential unauthorized disclosure or misappropriation of our intellectual property by CROs, which mayreduce our trade secret protection and allow our potential competitors to access and exploit our proprietary technology.

In addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from timeto time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA. The FDA may conclude that a financial relationship between us and a principalinvestigator has created a conflict of interest or otherwise affected interpretation of the trial. The FDA may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itselfmay be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA and may ultimately lead to the denial of marketing approval of CIN-107 and any futureproduct candidates.

We have, and intend to continue to, rely on third parties to produce clinical and commercial supplies of CIN-107 and any future product candidates.

We do not own or operate facilitiesfor drug manufacturing, storage and distribution, or testing. We are, and will continue to be, dependent on third parties to manufacture the clinical supplies of CIN-107 and any future

 

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product candidates. The facilities used by our CMOs to manufacture CIN-107 and any future product candidates must be approved by the FDA pursuant toinspections that will be conducted after we submit our NDA to the FDA. We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with the regulatory requirements, known ascGMPs for manufacture of active drug substances and finished product candidates. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others,we will not be able to secure and/or maintain regulatory approval for CIN-107 or any future product candidates. In addition, we have no control over the ability of our contract manufacturers to maintainadequate quality control, quality assurance and qualified personnel. We intend to use multiple third parties to produce, store and distribute clinical and commercial supply of our drug product and drug substance. As such, we will need to demonstrateto the FDA that the drug product and drug substance from these contract manufacturers are comparable, which may include conducting additional equivalence studies. If the FDA or a comparable foreign regulatory authority does not approve thesefacilities for the manufacture of CIN-107 or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop,obtain regulatory approval for or market CIN-107, if approved. Any significant delay in the supply of a product candidate, or the raw material components thereof, for an ongoing clinical trial due to the needto replace a third-party manufacturer could considerably delay completion of our clinical trials, product testing and potential regulatory approval of CIN-107 or any future product candidates.

Further, we also will rely on third-party manufacturers to supply us with sufficient quantities of CIN-107 and any future product candidates, if approved, for commercialization. We do not yet have a commercial supply agreement for commercial quantities of drug substance or drug product. If we are not able to meetmarket demand for any approved product, it would negatively affect our ability to generate revenue, harm our reputation, and could have a material and adverse effect on our business and financial condition. Increasing the scale of productioninherently creates increased risk of manufacturing errors, and we may not be able to adequately inspect every device that is produced, and it is possible that individual devices may fail to perform as designed. Manufacturing errors could negativelyimpact market acceptance of any of CIN-107 or any future product candidates that receive approval, result in negative press coverage, or increase our liability.

Further, our reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured CIN-107 ourselves, including:

 

  

inability to meet our product specifications and quality requirements consistently;

 

  

delay or inability to procure or expand sufficient manufacturing capacity;

 

  

issues related to scale-up of manufacturing;

 

  

costs and validation of new equipment and facilities required forscale-up;

 

  

our third-party manufacturers may not be able to execute our manufacturing procedures and other logisticalsupport requirements appropriately;

 

  

our third-party manufacturers may fail to comply with cGMP-compliance and other inspections by the FDA orother comparable regulatory authorities;

 

  

our inability to negotiate manufacturing agreements with third parties under commercially reasonable terms, ifat all;

 

  

breach, termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time thatis costly or damaging to us;

 

  

our third-party manufacturers may not devote sufficient resources to our product candidate;

 

  

we may not own, or may have to share, the intellectual property rights to any improvements made by ourthird-party manufacturers in the manufacturing process for our product candidate;

 

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operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to ourbusiness or operations, including the bankruptcy of the manufacturer or supplier; and

 

  

carrier disruptions or increased costs that are beyond our control.

In addition, if we enter into a strategic collaboration with a third party for the commercialization of CIN-107 or any future product candidate, we will not be able to control the amount of time or resources that they devote to such efforts. If any strategic collaborator does not commit adequate resources to themarketing and distribution of CIN-107 or any future product candidate, it could limit our potential revenues.

Any of these events could lead to clinical trial delays, failure to obtain regulatory approval or affect our ability tosuccessfully commercialize CIN-107 or any future product candidates once approved. Some of these events could be the basis for FDA action, including injunction, request for recall, seizure, or total or partialsuspension of production.

We are subject to a multitude of manufacturing risks, any of which could substantially increase ourcosts, delay our programs or limit supply of CIN-107.

Developing commercially viable manufacturing processes for CIN-107 is a difficult and uncertain task and requires significant expertise and capital investment. We are still in the early stages of developing and implementing manufacturing processes for CIN-107. Our abilityto consistently and reliably manufacture CIN-107 is essential to our success, and there are risks associated with scaling to the level required for advanced clinical trials or commercialization, including costoverruns, potential problems with process scale-up, process reproducibility, stability issues, consistency and timely availability of reagents or raw materials. Furthermore, we have significantdependence on CMOs for our manufacturing processes, which adds additional risks to our manufacturing capabilities. Additionally, we do not yet have sufficient information to reliably estimate the cost of the commercial manufacturing and processingof our product candidate, and the actual cost to manufacture and process our product candidate could materially and adversely affect the commercial viability of our product candidate. As a result, we may never be able to develop a commerciallyviable product.

The process of successfully manufacturing products for clinical testing and commercialization may beparticularly challenging, even if such products otherwise prove to be safe and effective. The manufacture of our product candidates involves complex processes. Some of these processes require specialized equipment and highly skilled and trainedpersonnel. For example, one of the raw materials we use in the manufacture of our clinical supply requires the use of a high pressure reactor which is a very specialized piece of equipment, and limits our choice of a supplier or suppliers.

Any adverse developments affecting manufacturing operations for our product candidate may result in lot failures, inventoryshortages, shipment delays, product withdrawals or recalls or other interruptions in supply which could delay the development of our product candidate. If we are unable to obtain sufficient supply of our product candidate, whether due to productionshortages or other supply interruptions resulting from the ongoing COVID-19 pandemic or otherwise, our clinical trials or regulatory approval may be delayed. We may also have to write off inventory, incurother charges and expenses for supply of product that fails to meet specifications, undertake costly remediation efforts, or seek more costly manufacturing alternatives. In addition, parts of the supply chain may have long lead times or may comefrom a small number of suppliers. If we are not able to appropriately manage our supply chain our ability to successfully produce our product candidate could be delayed or harmed. Inability to meet the demand for our product candidate could damageour reputation and the reputation of our product candidate among physicians, healthcare payors, patients or the medical community that supports our product candidate development efforts, including hospitals and outpatient clinics.

Furthermore, the manufacturing facilities in which our product candidate will be made could be adversely affected byearthquakes and other natural disasters, equipment failures, labor shortages, power failures, health epidemics such as the COVID-19 pandemic and numerous other factors. If any of these events were to occur andimpact our manufacturing facilities, our business would be materially and adversely affected.

 

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We have delivered notice to terminate our Management Services Agreement with CinRx, arelated party we have relied on to provide us with services since our inception, and we may not be able to effectively replace those services.

We were spun out of CinRx in May 2019. Since our spinout from CinRx, we have relied on the services provided by CinRx pursuantto the terms of the Management Services Agreement, as described in “Certain Relationships and Related Party Transactions—CinRx Pharma, LLC.” With the support of August J. Troendle, M.D., M.B.A., we provided notice to terminate theManagement Services Agreement on November 4, 2021. Pursuant to the terms of the Master Services Agreement, the termination shall become effective no later than February 2, 2022.

In the past months we have made several new hires, including Mary Theresa Coelho, M.B.A. as our Executive Vice President,Chief Financial Officer and Chief Business Development Officer and Mason Freeman, M.D. as our Executive Vice President, Clinical Development. However, these employees are new to our company, and there can be no guarantee that we will be able toeffectively replace the services provided by CinRx. We have no history of operating our business without the services provided by CinRx pursuant to the terms of the Management Services Agreement, and the termination of our relationship with CinRx,including our relationship with Jonathan Isaacsohn, M.D., FACC, who previously held the titles of Chief Executive Officer, Chief Scientific Officer and served as a member of our board of directors, could make it difficult for us to operate ourbusiness, including the management of our clinical trials and associated timelines. Any failure by us to successfully integrate our new employees and effectively replace the services CinRx previously provided to us under the Management ServicesAgreement could materially harm our business, financial condition and results of operations.

Additionally, if we do nothave adequate financial resources or personnel and systems in place by the time the Management Services Agreement is fully terminated, which will become effective no later than February 2, 2022, we may not be successful in effectively orefficiently assuming these services from CinRx, which could disrupt our business and have a material adverse effect on our financial condition and results of operations. Even if we are able to successfully assume these services, there may beincreased transition and other costs or reduced efficiency levels of when compared with the services we previously received from CinRx.

We have engaged Medpace Holdings, Inc., a related party, to assist us with certain of our clinical trials which may expose us tosignificant regulatory risks. If there are any data integrity issues, we may be required to repeat such studies or required to contract with other CROs, and our clinical development plans will be significantly delayed.

Dr. Troendle a former member of our board of directors, is the president, chief executive officer and chairman of the board ofdirectors of Medpace Holdings, Inc., or Medpace, and Jonathan Isaacsohn, M.D., FACC, our former Chief Scientific Officer and former member of our board of directors, is an officer of Medpace. We have engaged Medpace to provide us with certainclinical trial related services pursuant to a master services agreement, as described in “Certain Relationships and Related Party Transactions—Medpace Holdings, Inc.” Relying on a related party CRO to assist us with our clinicaldevelopment plans and with the development of data that is used as the basis to support regulatory approval can expose us to significant regulatory risks.

If we are unable to continue receiving clinical trial services from Medpace on acceptable terms, or should we or Medpace ceaseto continue to work together for any reason, a transition to an alternative CRO could result in delays and increased costs, and may impact our clinical development timelines during such a transition period, any of which could have a material adverseeffect on our business, financial condition and results of operations.

 

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We may seek collaborations with third parties for the development or commercializationof CIN-107 and any future product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.

We may seek third-party collaborators for the development and commercialization ofCIN-107 or any future product candidates, including for the commercialization of any of our product candidates that are approved for marketing outside the United States. Our likely collaborators for any sucharrangements include regional and national pharmaceutical companies and biotechnology companies. If we enter into any additional such arrangements with any third parties, we will likely have limited control over the amount and timing of resourcesthat our collaborators dedicate to the development or commercialization of our product candidates. Our ability to generate revenue from these arrangements will depend on our collaborators’ abilities to successfully perform the functionsassigned to them in these arrangements.

Collaborations involving our product candidates would pose the following risks tous:

 

  

collaborators have significant discretion in determining the efforts and resources that they will apply tothese collaborations;

 

  

collaborators may not perform their obligations as expected;

 

  

collaborators may not pursue development and commercialization of any product candidates that achieveregulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as anacquisition, that divert resources or create competing priorities;

 

  

collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop aclinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

 

  

collaborators could independently develop, or develop with third parties, products that compete directly orindirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

 

  

we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;

 

  

product candidates discovered in collaboration with us may be viewed by our collaborators as competitive withtheir own product candidates or drugs, which may cause collaborators to cease to devote resources to the commercialization of our product candidates;

 

  

a collaborator with marketing and distribution rights to one or more of our product candidates that achieveregulatory approval may not commit sufficient resources to the marketing and distribution of such products;

 

  

disagreements with collaborators, including disagreements over proprietary rights, contract interpretation orthe preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result inlitigation or arbitration, any of which would be time-consuming and expensive;

 

  

collaborators may not properly maintain or defend our or their intellectual property rights or may use our ortheir proprietary information in such a way as to invite litigation that could jeopardize or invalidate such intellectual property or proprietary information or expose us to potential litigation;

 

  

collaborators may infringe the intellectual property rights of third parties, which may expose us tolitigation and potential liability; and

 

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collaborations may be terminated for the convenience of the collaborator and, if terminated, we could berequired to raise additional capital to pursue further development or commercialization of the applicable product candidates.

Collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manneror at all. If any future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program could be delayed, diminished or terminated.

We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for anycollaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for the subject product candidate, the costs and complexitiesof manufacturing and delivering such product candidate to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership withoutregard to the merits of the challenge and industry and market conditions generally. The collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such acollaboration could be more attractive than the one with us for our product candidate. Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations amonglarge pharmaceutical companies that have resulted in a reduced number of potential future collaborators.

We may not beable to negotiate additional collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of such product candidate, reduce or delay its development program or one or more of ourother development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect toincrease our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not beable to further develop our product candidates or bring them to market and generate revenue.

Risks Related to the Commercialization of CIN-107 or Future Product Candidates

If we are unable to establish sales and marketingcapabilities or enter into agreements with third parties to market and sell CIN-107 or any future product candidates, we may not be successful in commercializing CIN-107or any future product candidates, if and when they are approved.

To successfully commercialize CIN-107 or any future product candidate that may result from our development programs, we will need to build out our sales and marketing capabilities, either on our own or with others. The establishment anddevelopment of our own commercial team or the establishment of a contract field force to market any product candidate we may develop will be expensive and time-consuming and could delay any drug launch. Moreover, we cannot be certain that we will beable to successfully develop this capability. We may seek to enter into collaborations with other entities to use their established marketing and distribution capabilities, but we may be unable to enter into such agreements on favorable terms, if atall. If any current or future collaborators do not commit sufficient resources to commercialize CIN-107, or we are unable to develop the necessary capabilities on our own, we may be unable to generatesufficient revenue to sustain our business. We may compete with many companies that currently have extensive, experienced and well-funded marketing and sales operations to recruit, hire, train and retain marketing and sales personnel. We will likelyalso face competition if we seek third parties to assist us with the sales and marketing efforts of CIN-107 and any future product candidates. Without an internal team or the support of a third party toperform marketing and sales functions, we may be unable to compete successfully against these more established companies.

 

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Even if CIN-107 or any future productcandidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.

Even if CIN-107 or any future product candidates receive marketing approval, they mayfail to gain market acceptance by physicians, patients, third-party payors and others in the medical community. If such product candidates do not achieve an adequate level of acceptance, we may not generate significant drug revenue and may notbecome profitable. The degree of market acceptance of CIN-107 or any future product candidates, if approved for commercial sale, will depend on a number of factors, including but not limited to:

 

  

the convenience and ease of administration compared to alternative treatments and therapies;

 

  

the willingness of the target patient population to try new therapies and of physicians to prescribe thesetherapies;

 

  

the efficacy and potential advantages compared to alternative treatments and therapies;

 

  

the effectiveness of sales and marketing efforts;

 

  

the prevalence and severity of any side effects;

 

  

the strength of our relationships with patient communities;

 

  

the cost of treatment in relation to alternative treatments and therapies, including any similar generictreatments;

 

  

our ability to offer such drug for sale at competitive prices;

 

  

the strength of marketing and distribution support;

 

  

the availability of third-party coverage and adequate reimbursement;

 

  

any restrictions on the use of the drug together with other medications; and

 

  

the awareness and support from key opinion leaders in cardiology.

Our efforts to educate physicians, patients, third-party payors and others in the medical community on the benefits of CIN-107 or any future product candidates may require significant resources and may never be successful. Because we expect sales of CIN-107 or any future product candidates, ifapproved, to generate substantially all of our revenues for the foreseeable future, the failure of these product candidates to find market acceptance would harm our business.

If the market opportunities for CIN-107 are smaller than we estimate, our business may suffer.

Our eligible patient population may differ significantly from the actual market addressable by CIN-107. Our projections of both the number of people who have these conditions, as well as the subset of people with these diseases who have the potential to benefit from treatment with CIN-107, are based on our beliefs and estimates. These estimates have been derived from a variety of sources, including the scientific literature, insurance claims databases or market research, and may prove to beincorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The number of patients may turn out to be lower than expected. Furthermore, certain of the indications we are pursuing may be underdiagnosed, whichmay further limit the eligible patient population. For example, PA continues to be underdiagnosed despite being one of the more common causes of secondary hypertension due to the complexity of the current diagnostic guidelines recommended by theEndocrine Society. Likewise, the potentially addressable patient population for CIN-107 may be limited or may not be amenable to treatment with CIN-107, and new patientsmay become increasingly difficult to identify or access. If the market opportunities for CIN-107 are smaller than we estimate, our business and results of operations could be adversely affected.

 

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We may face substantial competition, which may result in others developing orcommercializing drugs before or more successfully than us.

The development and commercialization of new drugs ishighly competitive. We may face competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. Potential competitors also include academic institutions, government agencies and other publicand private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

In particular, we face competition from companies in the pharmaceutical, biotechnology and other related markets that arepursuing the development of treatments for hypertension, PA and CKD. Our competitors include Mineralys Therapeutics, Damian Pharma AG, Idorsia Ltd., Quantum Genomics, Ionis Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., Sihuan Pharmaceuticaland KBP BioSciences. More established companies may have a competitive advantage over us due to their greater size, resources and institutional experience. In particular, these companies have greater experience and expertise in securingreimbursement, government contracts and relationships with key opinion leaders, conducting testing and clinical trials, obtaining and maintaining regulatory approvals and distribution relationships to market products and marketing approved drugs.These companies also have significantly greater research and marketing capabilities than we do. If we are not able to compete effectively against existing and potential competitors, our business and financial condition may be harmed.

As a result of these factors, our competitors may obtain regulatory approval of their drugs before we are able to, which maylimit our ability to develop or commercialize CIN-107 and any future product candidates. Our competitors may also develop therapies that are safer, more effective, more widely accepted or less expensive thanours, and may also be more successful than we in manufacturing and marketing their drugs. These advantages could render CIN-107 obsolete or non-competitive before we canrecover the costs of such product candidates’ development and commercialization.

Mergers and acquisitions in thepharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and early-stage companies may also prove to be significant competitors, particularly throughcollaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and subject registrationfor clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

If we commercialize CIN-107 or any future product candidates outside of the United States, a variety of risks associated with international operations could harm our business.

We intend to seek approval to market CIN-107 outside of the United States, and may doso for future product candidates. If we market approved products outside of the United States, we expect that we will be subject to additional risks in commercialization including:

 

  

different regulatory requirements for approval of therapies in foreign countries;

 

  

reduced protection for intellectual property rights;

 

  

unexpected changes in tariffs, trade barriers and regulatory requirements;

 

  

economic weakness, including inflation, or political instability in particular foreign economies and markets;

 

  

compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

 

  

foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, andother obligations incident to doing business in another country;

 

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foreign reimbursement, pricing and insurance regimes;

 

  

workforce uncertainty in countries where labor unrest is more common than in the United States;

 

  

production shortages resulting from any events affecting raw material supply or manufacturing capabilitiesabroad; and

 

  

business interruptions resulting from pandemics and public health emergencies, including those related to COVID-19 pandemic, geopolitical actions, including war and terrorism or natural disasters including earthquakes, typhoons, floods and fires.

We have no prior experience in these areas. In addition, there are complex regulatory, tax, labor and other legal requirementsimposed by many of the individual countries in and outside of Europe with which we will need to comply. Many biopharmaceutical companies have found the process of marketing their own products in foreign countries to be very challenging.

Healthcare insurance coverage and adequate reimbursement may not be available for CIN-107 or anyfuture product candidates, which could make it difficult for us to gain market acceptance.

Market acceptance andsales of CIN-107 or any product candidates that we commercialize, if approved, will depend in part on the extent to which reimbursement for these drugs and related treatments will be available from third-partypayors, including government health administration authorities, managed care organizations and other private health insurers. Third-party payors decide for which therapies reimbursement is available, and establish reimbursement levels. While nouniform policy for coverage and reimbursement exists in the United States, third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding theextent of coverage and amount of reimbursement to be provided for any product candidates that we develop will be made on a payor-by-payor basis. Therefore, onepayor’s determination to provide coverage for a drug does not assure that other payors will also provide coverage, and adequate reimbursement, for the drug. Additionally, a third-party payor’s decision to provide coverage for a therapydoes not imply that an adequate reimbursement rate will be approved. Each payor determines whether or not it will provide coverage for a therapy, what amount it will pay the manufacturer for the therapy, and on what tier of its formulary it will beplaced. The position on a payor’s list of covered drugs, or formulary, generally determines the co-payment that a patient will need to make to obtain the therapy and can strongly influence the adoption ofsuch therapy by patients and physicians. Patients who are prescribed treatments for their conditions and providers prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patientsare unlikely to use our products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products.

Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particularmedications. Increasingly, third-party payors are requiring that drug manufacturers provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. Further, such payors are increasinglychallenging the price, examining the medical necessity, and reviewing the cost effectiveness of medical product candidates. There may be especially significant delays in obtaining coverage and reimbursement for newly approved drugs. Third-partypayors may limit coverage to specific product candidates on a formulary, which might not include all FDA-approved drugs for a particular indication. We may need to conduct expensive pharmaco-economic studiesto demonstrate the medical necessity and cost effectiveness of our products. Nonetheless, CIN-107 or any future product candidates may not be considered medically necessary or cost effective. We cannot be surethat coverage and reimbursement will be available for any drug that we commercialize and, if reimbursement is available, what the level of reimbursement will be. Inadequate coverage and reimbursement may impact the demand for, or the price of, anydrug for which we obtain marketing approval. If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize CIN-107 or anyfuture product candidates that we develop.

 

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Outside the United States, the commercialization of therapeutics isgenerally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost containment initiatives in Europe, Canada and other countries has and will continue to put pressure on thepricing and usage of therapeutics such as CIN-107. In many countries, particularly the countries of the European Union, medical product prices are subject to varying price control mechanisms as part ofnational health systems. In these countries, pricing negotiations with governmental authorities can take considerable time after a product receives marketing approval. To obtain reimbursement or pricing approval in some countries, we may be requiredto conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. In general, product prices under such systems are substantially lower than in the United States. Other countries allow companiesto fix their own prices for products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge forCIN-107 or any future product candidates. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient togenerate commercially reasonable revenue and profits.

Product liability lawsuits against us could cause us to incur substantialliabilities and could limit commercialization of CIN-107.

We face aninherent risk of product liability exposure related to the testing of CIN-107 or any future product candidates in clinical trials and may face an even greater risk if we commercialize any product candidatethat we may develop. If we cannot successfully defend ourselves against claims that any such product candidates caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

 

  

decreased demand for any product candidate that we may develop;

 

  

loss of revenue;

 

  

substantial monetary awards to trial participants or patients;

 

  

significant time and costs to defend the related litigation;

 

  

withdrawal of clinical trial participants;

 

  

increased insurance costs;

 

  

the inability to commercialize any product candidate that we may develop; and

 

  

injury to our reputation and significant negative media attention.

Although we maintain product liability insurance coverage with maximum coverage of $5.0 million per incident and an aggregateloss limit of $5.0 million, such insurance may not be adequate to cover all liabilities that we may incur. We anticipate that we will need to increase our insurance coverage each time we commence a clinical trial and if we successfully commercializeany product candidate. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Risks Related to Regulatory Matters

Even if we complete the necessary preclinical studies and clinical trials, the regulatory approval process is expensive, time-consumingand uncertain and may prevent us from obtaining approvals for the commercialization of CIN-107 or any future product candidates. If we or any future collaborators are not able to obtain, or if there are delaysin obtaining, required regulatory approvals, we or they will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.

The activities associated with its development and commercialization, including its design, testing, manufacture, safety,efficacy, record keeping, labeling, storage, approval, advertising, promotion, sale and

 

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distribution, export and import, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable regulatory authorities in other countries.Failure to obtain marketing approval for CIN-107 or any future product candidates will prevent us from commercializing them. We have not received approval to market any product candidates from regulatoryauthorities in any jurisdiction. We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party CROs to assist us in this process.

Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information,including manufacturing information, to the various regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. CIN-107 or any future productcandidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.

The process of obtaining marketing approvals, both in the United States and abroad, is expensive, may take many years ifadditional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Changes in marketing approvalpolicies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. TheFDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinical, clinical orother studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of CIN-107 or any future product candidates. Anymarketing approval we or our collaborators ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

Finally, disruptions at the FDA and other agencies may prolong the time necessary for new drugs to be reviewed and/or approvedby necessary government agencies, which would adversely affect our business. For example, over the last several years, the United States government has shut down several times and certain regulatory agencies, such as the FDA, have had to furloughcritical employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect onour business.

Accordingly, if we or any future collaborators experience delays in obtaining approval or if we or theyfail to obtain approval of CIN-107 or any future product candidates, the commercial prospects for them may be harmed, and our ability to generate revenues will be materially impaired.

Even if we obtain regulatory approval for CIN-107 or any future product candidates, they willremain subject to ongoing regulatory oversight.

Even if we obtain regulatory approvals for CIN-107 or any future product candidates, such approvals will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping andsubmission of safety and other post-market information. Any regulatory approvals that we receive for CIN-107 or any future product candidates may also be subject to a REMS, limitations on the approvedindicated uses for which the drug may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 trials, and surveillance to monitor the quality, safety and efficacy of thedrug. Such regulatory requirements may differ from country to country depending on where we have received regulatory approval.

In addition, drug manufacturers and their facilities are subject to payment of user fees and continual review and periodicinspections by the FDA and other regulatory authorities for compliance with cGMP requirements

 

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and adherence to commitments made in the NDA or foreign marketing application. If we, or a regulatory authority, discover previously unknown problems with a drug, such as adverse events ofunanticipated severity or frequency, or problems with the facility where the drug is manufactured or if a regulatory authority disagrees with the promotion, marketing or labeling of that drug, a regulatory authority may impose restrictions relativeto that drug, the manufacturing facility or us, including requesting a recall or requiring withdrawal of the drug from the market or suspension of manufacturing.

CIN-107 or any future product candidates could be subject to restrictions or withdrawal from themarket, and we may be subject to substantial penalties, if we or our collaborators fail to comply with regulatory requirements or if we or they experience unanticipated problems with such product candidates, when and if it is approved.

CIN-107 or any future product candidate for which we or our collaborators obtainmarketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatoryauthorities. These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to quality control and manufacturing, quality assurance andcorresponding maintenance of records and documents, and requirements regarding the distribution of samples to physicians and recordkeeping. Even if marketing approval of a product candidate is granted, the approval may be subject to limitations onthe indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the medicine, including the requirement toimplement a risk evaluation and mitigation strategy.

The FDA and other agencies, including the Department of Justice, orthe DOJ, closely regulate and monitor the post-approval marketing and promotion of products to ensure that they are marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling. The FDAand DOJ impose stringent restrictions on manufacturers’ communications regarding off-label use and if we do not market our products for their approved indications, we may be subject to enforcement actionfor off-label marketing. Violations of the FDCA and other statutes, including the False Claims Act, relating to the promotion and advertising of prescription drugs may lead to investigations and enforcementactions alleging violations of federal and state healthcare fraud and abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously unknown adverse events or other problems with our products, manufacturers ormanufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

 

  

restrictions on such products, manufacturers or manufacturing processes;

 

  

restrictions on the labeling or marketing of a product;

 

  

restrictions on distribution or use of a product;

 

  

requirements to conduct post-marketing studies or clinical trials;

 

  

warning letters or untitled letters;

 

  

withdrawal of the products from the market;

 

  

refusal to approve pending applications or supplements to approved applications that we submit;

 

  

recall of products;

 

  

damage to relationships with any potential collaborators;

 

  

unfavorable press coverage and damage to our reputation;

 

  

fines, restitution or disgorgement of profits or revenues;

 

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suspension or withdrawal of marketing approvals;

 

  

refusal to permit the import or export of our products;

 

  

product seizure;

 

  

injunctions or the imposition of civil or criminal penalties; and

 

  

litigation involving patients using our products.

Non-compliance with European Union requirements regarding safety monitoring orpharmacovigilance, and with requirements related to the development of products for the pediatric population, can also result in significant financial penalties. Similarly, failure to comply with the European Union’s requirements regarding theprotection of personal information can also lead to significant penalties and sanctions.

Failure to obtain marketing approval inforeign jurisdictions would prevent CIN-107 or any future product candidate product candidates from being marketed in such jurisdictions.

In order to market and sell our medicines in the European Union and many other jurisdictions, we or our third-partycollaborators must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differsubstantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the United States,a product must be approved for reimbursement before the product can be approved for sale in that country. We or any future third-party collaborators may not obtain approvals from regulatory authorities outside the United States on a timely basis, ifat all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in othercountries or jurisdictions or by the FDA. We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize CIN-107 or any future product candidate in any market.

Additionally, we could face heightened risks with respect to seeking marketing approval in the United Kingdom, should wechoose to do so, as a result of the recent withdrawal of the United Kingdom from the European Union, commonly referred to as Brexit. Pursuant to the formal withdrawal arrangements agreed between the United Kingdom and the European Union, the UnitedKingdom withdrew from the European Union, effective December 31, 2020. On December 24, 2020, the United Kingdom and European Union entered into a Trade and Cooperation Agreement. The agreement sets out certain procedures for approval andrecognition of medical products in each jurisdiction. Since the regulatory framework for pharmaceutical products in the United Kingdom covering the quality, safety, and efficacy of pharmaceutical products, clinical trials, marketing authorization,commercial sales, and distribution of pharmaceutical products is derived from European Union directives and regulations, Brexit could materially impact the future regulatory regime that applies to products and the approval of product candidates inthe United Kingdom. Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, would prevent us from commercializing any product candidates in the United Kingdom and/or the European Union andrestrict our ability to generate revenue and achieve and sustain profitability. If any of these outcomes occur, we may be forced to restrict or delay efforts to seek regulatory approval in the United Kingdom and/or European Union for any productcandidates, which could significantly and materially harm our business

Our relationships with customers, physicians, andthird-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If we are unable to comply, orhave not fully complied, with such laws, we could face substantial penalties.

Healthcare providers, physicians andthird-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing

 

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approval. Our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors subject us to various federal and state fraudand abuse laws, data privacy and security laws, transparency laws and other healthcare laws that may constrain the business or financial arrangements and relationships through which we research, sell, market, and distribute our products, if weobtain marketing approval. We will also be subject to healthcare regulation and enforcement by the U.S. federal government and the states and any other countries in which we conduct our business, including our research, and the sales, marketing anddistribution of CIN-107 or any future products once they have obtained marketing authorization. For additional information on the healthcare laws and regulations that we may be subject to, see“Business—Government Regulation and Product Approval.”

Ensuring that our business arrangements with thirdparties comply with applicable healthcare laws and regulations will likely be costly. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case lawinvolving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil,criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we becomesubject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm and the curtailment or restructuring of ouroperations.

If the physicians or other providers or entities with whom we expect to do business are found not to be incompliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. Even if resolved in our favor, litigation or other legal proceedingsrelating to healthcare laws and regulations may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results ofhearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedingscould substantially increase our operating losses and reduce the resources available for development, manufacturing, sales, marketing or distribution activities. Uncertainties resulting from the initiation and continuation of litigation or otherproceedings relating to applicable healthcare laws and regulations could have a material adverse effect on our ability to compete in the marketplace.

Healthcare legislative reform measures may have a negative impact on our business and results of operations.

In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatorychanges and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates forwhich we obtain marketing approval. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, onJune 17, 2021 the United States Supreme Court dismissed a challenge on procedural grounds that argued the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, orcollectively the PPACA, is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Thus, the PPACA will remain in effect in its current form.

Further, in the United States there has been heightened governmental scrutiny over the manner in which manufacturers setprices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost ofprescription drugs under government payor programs, and review the relationship

 

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between pricing and manufacturer patient programs. At the federal level, the Trump administration used several means to propose or implement drug pricing reform, including through federal budgetproposals, executive orders, and policy initiatives. It is unclear whether the Biden administration will work to reverse these measures or pursue similar policy initiatives. Nonetheless, we expect that additional U.S. federal healthcare reformmeasures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for CIN-107 orany future product candidates or additional pricing pressures.

We cannot predict the likelihood, nature or extent ofgovernment regulation that may arise from future legislation or administrative action in the United States or any other jurisdiction. If we or any third parties we may engage are slow or unable to adapt to changes in existing or new requirements orpolicies, or if we or such third parties are not able to maintain regulatory compliance, CIN-107 or any future product candidates we may develop may lose any regulatory approval that may have been obtained andwe may not achieve or sustain profitability. For additional information on the healthcare reform, see “Business—Government Regulation and Product Approval.”

The prices of prescription pharmaceuticals in the United States and foreign jurisdictions is subject to considerable legislative andexecutive actions and could impact the prices we obtain for our products, if and when licensed.

The prices ofprescription pharmaceuticals have also been the subject of considerable discussion in the United States. To date, there have been several recent U.S. congressional inquiries, as well as proposed and enacted state and federal legislation designed to,among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for products.To those ends, President Trump issued several executive orders intended to lower the costs of prescription drug products. Certain of these orders are reflected in recently promulgated regulations, including an interim final rule implementingPresident Trump’s most favored nation model, but such final rule is currently subject to a nationwide preliminary injunction. It remains to be seen whether these orders and resulting regulations will remain in force during the BidenAdministration. Further, on September 24, 2020, the Trump Administration finalized a rulemaking allowing states or certain other non-federal government entities to submit importation program proposals tothe FDA for review and approval. Applicants are required to demonstrate that their importation plans pose no additional risk to public health and safety and will result in significant cost savings for consumers. The FDA has issued draft guidancethat would allow manufacturers to import their own FDA-approved drugs that are authorized for sale in other countries (multi-market approved products).

At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designedto control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designedto encourage importation from other countries and bulk purchasing. In addition, regional health care organizations and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers willbe included in their prescription drug and other health care programs. These measures could reduce the ultimate demand for CIN-107 or any future product candidates, once approved, or put pressure on our product pricing. We expect that additionalstate and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for CIN-107 orany future product candidates or additional pricing pressures.

In markets outside of the United States, reimbursement andhealthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. In some countries, particularly the countries of the European Union, the pricing of prescriptionpharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take

 

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considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial thatcompares the cost-effectiveness of CIN-107 or any future product candidates to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our businesscould be harmed, possibly materially.

Even if we obtain and maintain approval for CIN-107or any future product candidates from the FDA, we may never obtain approval of CIN-107 or any future product candidates outside of the United States, which would limit our market opportunities and could harmour business.

Approval of a product candidate in the United States by the FDA does not ensure approval of suchproduct candidate by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. Sales of CIN-107 or any future product candidates outside of the United States will be subject to foreign regulatory requirements governing clinical trials and marketing approval. Even if the FDA grants marketing approvalfor a product candidate, comparable foreign regulatory authorities also must approve the manufacturing and marketing of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements andadministrative review periods different from, and more onerous than, those in the United States, including additional preclinical studies or clinical trials. In many countries outside the United States, a product candidate must be approved forreimbursement before it can be approved for sale in that country. In some cases, the price that we intend to charge for any product candidates, if approved, is also subject to approval. Obtaining approval forCIN-107 or any future product candidates in the European Union from the European Commission following the opinion of the European Medicines Agency, if we choose to submit a marketing authorization applicationthere, would be a lengthy and expensive process. Even if a product candidate is approved, the FDA or the European Commission, as the case may be, may limit the indications for which the drug may be marketed, require extensive warnings on the druglabeling or require expensive and time-consuming additional clinical trials or reporting as conditions of approval. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays,difficulties and costs for us and could delay or prevent the introduction of CIN-107 or any future product candidates in certain countries.

Further, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries. Also,regulatory approval for CIN-107 may be withdrawn. If we fail to comply with the regulatory requirements, our target market will be reduced and our ability to realize the full market potential of CIN-107 or any future product candidates will be harmed and our business, financial condition, results of operations and prospects could be harmed.

We, any future collaborators and our service providers may be subject to a variety of privacy and data security laws and contractualobligations, which could increase compliance costs and our failure to comply with them could subject us to potentially significant fines or penalties and otherwise harm our business.

We may maintain a large quantity of sensitive information, including confidential business, patient health and other personallyidentifiable information in connection with our preclinical studies, and we may be subject to laws, orders, regulations, or regulatory guidance governing the privacy and security of such information. The regulatory framework for privacy, informationsecurity, data protection and data processing worldwide is, and is likely to remain, uncertain for the foreseeable future, and it is possible that these or other actual or alleged obligations may be interpreted and applied in a manner that isinconsistent from one jurisdiction to another and may conflict with other rules or our practices. Any significant change in data protection laws or data protection obligations could increase our costs and could require us to modify our products oroperations, possibly in a material manner, and may limit our ability to develop CIN-107 or any future product candidates.

In the United States, there are numerous federal and state privacy and data security laws and regulations governing thecollection, use, disclosure and protection of personal information, including federal and state

 

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health information privacy laws, security breach notification laws and consumer protection laws. Each of these laws is subject to varying interpretations and constantly evolving. By way ofexample, HIPAA imposes privacy and security requirements and breach reporting obligations with respect to individually identifiable health information upon “covered entities” (health plans, health care clearinghouses and certain healthcare providers), and their respective business associates, individuals or entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity, and their coveredsubcontractors. HIPAA mandates the reporting of certain breaches of health information to the U.S. Department of Health and Human Services, or HHS, affected individuals and if the breach is large enough, the media. Entities that are found to be inviolation of HIPAA as the result of a breach of unsecured protected health information, a complaint about privacy practices or an audit by HHS, may be subject to significant civil, criminal and administrative fines and penalties and/or additionalreporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance. When HIPAA is not applicable, failing totake appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act, or FTCA, 15 U.S.C § 45(a). TheFederal Trade Commission, or FTC, expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business and the cost ofavailable tools to improve security and reduce vulnerabilities. Individually identifiable health information is considered sensitive data that may merit stronger safeguards.

In addition, and when applicable, certain state laws govern the privacy and security of health and other personal information,some of which are more stringent than HIPAA. For example, the California Consumer Privacy Act, or CCPA, which went into effect on January 1, 2020, gives California residents expanded rights to access and delete their personal information, optout of certain personal information sharing, and receive detailed information about how their personal information is used. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expectedto increase data breach litigation. If applicable to our operations, the CCPA may increase our compliance costs and potential liability. Some observers have noted that the CCPA could mark the beginning of a trend toward more stringent privacylegislation in the United States, which could increase our potential liability and adversely affect our business.

In theEuropean Union, in May 2018, a new privacy regime, the General Data Protection Regulation, the GDPR, took effect in the European Economic Area, or the EEA. We may elect to conduct other Phase 1 or Phase 2 clinical trials for CIN-107 in countriesoutside of the United States, including in the European Union, which could subject us to European data protection laws, including GDPR. We may also elect to do so for future product candidates. When applicable, the GDPR governs the collection, use,disclosure, transfer or other processing of personal data of European persons. Among other things, the GDPR may impose new requirements regarding the security of personal data. We may be subject to new requirements related to the notification ofdata processing obligations, the lawful bases on which personal data can be processed, expanded definitions of personal data, informed consent practices, and notices for clinical trial subjects and investigators. In addition, the GDPR may increasethe scrutiny of transfers of personal data from clinical trial sites located in the EEA to the United States and other jurisdictions that the European Commission does not recognize as having “adequate” data protection laws, and imposessubstantial fines for breaches and violations (up to the greater of €20 million or 4% of our consolidated annual worldwide gross revenue). The GDPR also confers a private right of action on data subjects and consumer associations to lodgecomplaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR. Further, the United Kingdom’s decision to leave the European Union has created uncertainty with regard todata protection regulation in the United Kingdom. In particular, while the Data Protection Act of 2018, which “implements” and complements the GDPR, achieved Royal Assent on May 23, 2018 and is now effective in the United Kingdom, therelationship between the United Kingdom and the European Union in relation to certain aspects of data protection law remains unclear, for example, how data transfers between EU member states and the United Kingdom will be treated and the role of theUnited Kingdom’s Information Commissioner’s Office with respect to the European Union. Compliance with these and any other applicable privacy and data security laws and regulations is a

 

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rigorous and time-intensive process, and we may be required to put in place additional mechanisms ensuring compliance with new data protection rules. If we fail to comply with any applicable lawsor regulations, we may face significant fines and penalties that could adversely affect our business, financial condition and results of operations.

We strive to comply with applicable data protection laws to the extent possible, but we may at times fail, or may be perceivedto have failed, to do so. Data protection laws and data protection worldwide are, and are likely to remain, uncertain for the foreseeable future, and our actual or perceived failure to address or comply with these laws could: increase our complianceand operational costs; limit our ability to produce our products; expose us to regulatory scrutiny, actions, investigations, fines and penalties; result in reputational harm; result in litigation and liability, including class action litigation;cause to incur significant costs, expenses and fees (including attorney fees); cause a material adverse impact to business operations or financial results, and; otherwise result in other material harm to our business. In addition, any such failureor perceived failure could result in public statements against us by consumer advocacy groups, the media or others, which may cause us material reputational harm.

We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.

We are subject to the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, the U.S. domestic bribery statutecontained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and possibly other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities. Anti-corruption laws are interpreted broadlyand prohibit companies and their employees, agents, third-party intermediaries, joint venture partners and collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or benefits to recipients in thepublic or private sector. We may have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. In addition, we may engage third-partyintermediaries to promote our clinical research activities abroad and/or to obtain necessary permits, licenses, and other regulatory approvals. We can be held liable for the corrupt or other illegal activities of these third-party intermediaries,our employees, representatives, contractors, partners, and agents, even if we do not explicitly authorize or have actual knowledge of such activities.

Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem.The FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals inconnection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

We cannot ensure that our employees and third-party intermediaries will comply with such anti-corruption laws. Noncompliancewith anti-corruption and anti-money laundering laws could subject us to whistleblower complaints, investigations, sanctions, settlements, prosecution, other enforcement actions, disgorgement of profits, significant fines, damages, other civil andcriminal penalties or injunctions, suspension and/or debarment from contracting with certain persons, the loss of export privileges, reputational harm, adverse media coverage, and other collateral consequences. If any subpoenas, investigations, orother enforcement actions are launched, or governmental or other sanctions are imposed, or if we do not prevail in any possible civil or criminal litigation, our business, results of operations and financial condition could be materially harmed. Inaddition, responding to any action will likely result in a materially significant diversion of management’s attention and resources and significant defense and compliance costs and other professional fees. In certain cases, enforcementauthorities may even cause us to appoint an independent compliance monitor which can result in added costs and administrative burdens.

 

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Further, the provision of benefits or advantages to physicians to induce orencourage the prescription, recommendation, endorsement, purchase, supply, order, or use of medicinal products is prohibited in the European Union. The provision of benefits or advantages to physicians is also governed by the national anti-briberylaws of European Union Member States, such as the UK Bribery Act 2010. Infringement of these laws could result in substantial fines and imprisonment. Payments made to physicians in certain European Union Member States must be publicly disclosed.Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization, and/or the regulatory authorities of the individual European UnionMember States. These requirements are provided in the national laws, industry codes, or professional codes of conduct applicable in the European Union Member States. Failure to comply with these requirements could result in reputational risk, publicreprimands, administrative penalties, fines, or imprisonment.

Our business involves the use of hazardous materials and we and ourthird-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.

Our research and development activities and our third-party manufacturers’ and suppliers’ activities involve thecontrolled storage, use and disposal of hazardous materials owned by us, including the components of CIN-107 and any future product candidates and other hazardous compounds. We and our manufacturers andsuppliers are subject to laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at our and ourmanufacturers’ facilities pending their use and disposal. We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization efforts, research and development efforts and business operations, environmentaldamage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. Although we believethat the safety procedures utilized by our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminatethe risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail ouruse of certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot becertain of our future compliance. We do not currently carry hazardous waste insurance coverage.

We may seek and fail to obtainBreakthrough Therapy Designation or Fast Track Designation from the FDA for CIN-107 for the treatment of PA or future product candidates. Even if granted for any of our current or future product candidates,these programs may not lead to a faster development, regulatory review or approval process, and such designations do not increase the likelihood that any of our product candidates will receive marketing approval in the United States.

We may seek a Breakthrough Therapy Designation for CIN-107 for the treatment of PA orone or more of our or future product candidates. A breakthrough therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminaryclinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs thathave been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed inineffective control regimens. Product candidates designated as breakthrough therapies by the FDA may also be eligible for priority review and accelerated approval. Designation as a breakthrough therapy is within the discretion of the FDA.Accordingly, even if we believe one of our current or future product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In any event,

 

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the receipt of a Breakthrough Therapy Designation for CIN-107 or a future product candidate may not result in a faster development process, review orapproval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if CIN-107 or one or more of our future productcandidates qualify as breakthrough therapies, the FDA may later decide that such product candidates no longer meet the conditions for qualification and rescind the designation or decide that the time period for FDA review or approval will not beshortened.

We may also seek Fast Track Designation for CIN-107 for the treatmentof PA or for future product candidates. If a product candidate is intended for the treatment of a serious or life-threatening condition and preclinical or clinical data demonstrate the potential to address an unmet medical need for this condition,the product sponsor may apply for Fast Track Designation. The sponsor of a product candidate with Fast Track Designation has opportunities for more frequent interactions with the applicable FDA review team during product development and, once an NDAis submitted, the product candidate may be eligible for priority review. Such product candidate may also be eligible for rolling review, where the FDA may consider to review sections of the NDA on a rolling basis before the complete application issubmitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission ofthe first section of the NDA. The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular current or future product candidate is eligible for this designation, we cannot assure you that the FDA woulddecide to grant it. Even if we do receive Fast Track Designation for CIN-107 for the treatment of PA or future product candidates, we may not experience a faster development process, review or approvalcompared to conventional FDA procedures. The FDA may rescind Fast Track Designation if it believes that the designation is no longer supported by data from our clinical development program. Fast Track Designation alone does not guaranteequalification for the FDA’s priority review procedures.

We are subject to U.S. export and import controls, and sanctions lawsand regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We could face criminal liability and other serious consequences for violations, which could harm our business.

We are subject to export control and import laws and regulations, including the U.S. Export AdministrationRegulations, U.S. Customs regulations, and various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls. Compliance with applicable regulatory requirements regarding theexport of our products may create delays in the introduction of our products in international markets or, in some cases, prevent the export of our products to some countries altogether. Furthermore, U.S. export control laws and economic sanctionsprohibit the shipment of certain products and services to countries, governments, and persons targeted by U.S. sanctions.

Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties,imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences

Risks Related to Intellectual Property Matters

Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietaryrights and technology, and we may not be able to ensure their protection.

Our commercial success will depend inlarge part on obtaining and maintaining patent protection of our proprietary technologies and CIN-107 or any future product candidates, their respective components, formulations, combination therapies, methodsused to manufacture them, methods of treatment, and any other proprietary technologies we develop, as well as successfully defending these patents against third-party challenges. Our ability to stop unauthorized third parties from making, using,selling, offering to sell or importing

 

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CIN-107 and any future product candidates is dependent upon the extent to which we have rights under valid and enforceable patents that cover theseactivities. If we are unable to secure and maintain patent protection for any product or technology we develop, or if the scope of the patent protection secured is not sufficiently broad, our competitors could develop and commercialize products andtechnology similar or identical to ours, and our ability to commercialize any product candidates may be adversely affected.

The patenting process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirablepatent applications at a reasonable cost or in a timely manner. In addition, we may not pursue or obtain patent protection in all relevant markets. It is also possible that we will fail to identify patentable aspects of our research and developmentoutput before it is too late to obtain patent protection. Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that welicense from third parties and are reliant on our licensors.

The strength of patents in the biotechnology andpharmaceutical field involves complex legal and scientific questions and can be uncertain. The patent applications that we own or in-license may fail to result in issued patents with claims that cover CIN-107 or any future product candidates or uses thereof in the United States or in other foreign countries. Even if the patents do issue, third parties may challenge the validity, enforceability or scope thereof,which may result in such patents being narrowed, invalidated or held unenforceable. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property or prevent others from designingaround our issued patent claims. If the breadth or strength of protection provided by the patent applications we hold with respect to CIN-107 or any future product candidates is threatened, it could dissuadecompanies from collaborating with us to develop, and threaten our ability to commercialize, CIN-107 or any future product candidates. Further, if we encounter delays in our clinical trials, the period of timeduring which we could market CIN-107 or any future product candidates under patent protection would be reduced.

Because patent applications in the United States and most other countries are confidential for a period of time after filing,we cannot be certain that we or our licensor was the first to file any patent applications related to CIN-107 or any future product candidates. Furthermore, publications of discoveries in the scientificliterature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all.

We may be required to disclaim part or all of the term of certain patents or all of the term of certain patent applications.There may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim. There also may be prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim,which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim. No assurance can be given that if challenged, our patents would be declared by a court to be valid or enforceable or that even if found valid andenforceable, a competitor’s technology or product would be found by a court to infringe our patents. We may analyze the claims of issued patents or pending patent applications of our competitors that we believe are relevant to our commercialactivities, and consider that we are free to operate in relation to CIN-107 or any future product candidates, but our competitors may achieve issued claims, including in patents we consider to be unrelated,which block our commercial efforts or may potentially result in CIN-107 or our future product candidates infringing such claims. The possibility exists that others will develop products which have the sameeffect as our products on an independent basis which do not infringe our patents or other intellectual property rights, or will design around the claims of patents that we have had issued that cover our products.

Recent or future patent reform legislation could increase the uncertainties and costs surrounding the prosecution of ourpatent applications and the enforcement or defense of our issued patents. Under the Leahy-Smith America Invents Act, or America Invents Act, enacted in 2013, the United States moved from a “first to invent” to a “first-to-file” system. Under a “first-to-file” system, assuming the otherrequirements for

 

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patentability are met, the first inventor to file a patent application generally will be entitled to a patent on the invention regardless of whether another inventor had made the inventionearlier. A third party that files a patent application in the U.S. Patent and Trademark Office, or the USPTO, after March 2013, but before us, could therefore be awarded a patent covering an invention of ours even if we had made the invention beforeit was made by such third party. This will require us to be cognizant of the time from invention to filing of a patent application. Because patent applications in the United States and most other countries are confidential for a period of time afterfiling or until issuance, we cannot be certain that we were the first to either (i) file any patent application related to CIN-107, any future product candidates or other proprietary technologies we may develop or (ii) invent any of theinventions claimed in our patent applications.

The America Invents Act includes a number of other significant changes toU.S. patent law, including provisions that affect the way patent applications are prosecuted, redefine prior art and establish a new post-grant review system. These include allowing third party submission of prior art to the USPTO during patentprosecution and additional procedures to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. Because of a lower evidentiary standard in USPTOproceedings compared to the evidentiary standard in United States federal district courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO post-grant proceeding sufficient for the USPTO to hold aclaim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a federal district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims thatwould not have been invalidated if first challenged by the third party as a defendant in a federal district court action. Therefore, the America Invents Act and its implementation could increase the uncertainties and costs surrounding theprosecution of our patent applications and the enforcement or defense of patents issuing from those patent applications, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

The effects of these changes are uncertain as the USPTO recently developed new regulations and procedures in connectionwith the America Invents Act and many of the substantive changes to patent law, including the “first-to-file” provisions, became effective in March 2013. Inaddition, the courts have yet to address many of these provisions and the applicability of the act and new regulations on specific patents discussed herein have not been determined and would need to be reviewed. However, the America Invents Act andits implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business andfinancial condition.

The degree of future protection for our proprietary rights is uncertain because legal means affordonly limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. For example:

 

  

others may be able to make or use compounds that are similar to the compositions of CIN-107 or any future product candidates but that are not covered by the claims of our patents;

 

  

we or our licensors, as the case may be, might not have been the first to file patent applications for theseinventions;

 

  

others may independently develop similar or alternative technologies or duplicate any of our technologies;

 

  

it is possible that our patent applications will not result in issued patents;

 

  

it is possible that there are prior public disclosures that could invalidate our or our licensors’patents, as the case may be, or parts of our or their patents;

 

  

it is possible that others may circumvent our owned or in-licensedpatents by, for example, developing similar or alternative technologies or products in a non-infringing manner;

 

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it is possible that there are unpublished applications or patent applications maintained in secrecy that maylater issue with claims covering our products or technology similar to ours;

 

  

the laws of foreign countries may not protect our or our licensors’, as the case may be, proprietaryrights to the same extent as the laws of the United States;

 

  

the claims of our owned or in-licensed issued patents or patentapplications, if and when issued, may not cover CIN-107 or any future product candidates;

 

  

our owned or in-licensed issued patents may not provide us with anycompetitive advantages, may be narrowed in scope, or be held invalid or unenforceable as a result of legal challenges by third parties;

 

  

the inventors of our owned or in-licensed patents or patentapplications may become involved with competitors, develop products or processes which design around our patents, or become hostile to us or the patents or patent applications on which they are named as inventors;

 

  

it is possible that our owned or in-licensed patents or patentapplications omit individual(s) that should be listed as inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid orunenforceable;

 

  

we have engaged in scientific collaborations in the past, and will continue to do so in the future. Suchcollaborators may develop adjacent or competing products to ours that are outside the scope of our patents;

 

  

we may not develop additional proprietary technologies for which we can obtain patent protection;

 

  

it is possible that product candidates we develop may be covered by third parties’ patents or otherexclusive rights; or

 

  

the patents of others may have an adverse effect on our business.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment andother requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, feepayment and other similar provisions during the patent application process. In addition, periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and/or applications will have to be paid to the USPTO andvarious government patent agencies outside of the United States over the lifetime of our owned patents and/or applications and any patent rights we may own or license in the future. We rely on outside counsel to pay these fees due to non-U.S. patent agencies. The USPTO and various non-U.S. government patent agencies require compliance with several procedural, documentary, fee payment and other similarprovisions during the patent application process. We engage reputable law firms and other professionals to help us comply. Non-compliance events that could result in abandonment or lapse of a patent or patentapplication include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we failto maintain the patents and patent applications covering our products or technologies, we may not be able to stop a competitor from marketing products that are the same as or similar to CIN-107 or any futureproduct candidates, which would have a material adverse effect on our business. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. There are situations, however, inwhich non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, potentialcompetitors might be able to enter the market and this circumstance could harm our business.

 

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Patent terms may be inadequate to protect our competitive position on CIN-107 or any future product candidates for an adequate amount of time.

Giventhe amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

Patents have a limited term. In most countries, including the United States, the expiration of a patent is generally 20 yearsafter its first effective non-provisional filing date. However, depending upon the timing, duration and specifics of FDA marketing approval of CIN-107, the back-up compound to CIN-107, or any future product candidates, one or more of any U.S. patents we may be issued or have licensed may be eligible for limited patent termrestoration under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments.

The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost duringproduct development and the FDA regulatory review process. The Hatch-Waxman Act allows a maximum of one patent to be extended per FDA-approved product as compensation for the patent term lost during the FDAregulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only those claims covering such approved drug product, a method for using it or a methodfor manufacturing it may be extended. Patent term extension may also be available in certain foreign countries upon regulatory approval of CIN-107 or any future product candidates. However, we may not begranted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or thescope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or restoration or the term of any such extension is less than we request, our competitors may obtain approval of competing productsfollowing our patent expiration, and our competitive position, business, financial condition, results of operations, and prospects could be harmed, possibly materially.

If there are delays in obtaining regulatory approvals or other additional delays, the period of time during which we canmarket CIN-107 or any future product candidates under patent protection could be further reduced. Given the amount of time required for the development, testing and regulatory review of new product candidates,patents protecting such product candidates might expire before or shortly after such product candidates are commercialized. Once the patent term has expired, we may be open to competition from similar or generic products. The launch of a genericversion of one of our products in particular would be likely to result in an immediate and substantial reduction in the demand for that product, which could have a material adverse effect on our business, financial condition, results of operationsand prospects.

We expect to seek extensions of patent terms in the United States and, if available, in other countrieswhere we are prosecuting patents. However, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions areavailable, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. If this occurs, our competitors may be able to take advantage of our investment in development and clinical trials by referencing ourclinical and preclinical data and launch their drug earlier than might otherwise be the case, which could result in material harm to our business.

 

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Intellectual property rights do not necessarily address all potential threats to ourbusiness.

The degree of future protection afforded by our intellectual property rights is uncertain becauseintellectual property rights have limitations and may not adequately protect our business. The following examples are illustrative:

 

  

others may be able to make compounds or formulations that are similar toCIN-107 or any future product candidates but that are not covered by the claims of any patents, should they issue, that we own or license;

 

  

we or any strategic partners might not have been the first to make the inventions covered by the issuedpatents or pending patent applications that we own or license;

 

  

we might not have been the first to file patent applications covering certain of our inventions;

 

  

others may independently develop similar or alternative technologies or duplicate any of our technologieswithout infringing our intellectual property rights;

 

  

it is possible that our patent applications will not lead to issued patents;

 

  

issued patents that we own or license may not provide us with any competitive advantages, or may be heldinvalid or unenforceable as a result of legal challenges;

 

  

our competitors might conduct research and development activities in the United States and other countriesthat provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights and then use the information learned from such activities to develop competitivedrugs for sale in our major commercial markets;

 

  

we may not develop additional proprietary technologies that are patentable;

 

  

the patents of others may have an adverse effect on our business; and

 

  

we may choose not to file for patent protection in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such intellectual property.

Should any of these events occur, they could have a material adverse effect on our business, financial condition, results ofoperations and prospects.

We may become involved in lawsuits to protect or enforce our patents or other intellectual propertyrights, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our issued patents,future trademarks, copyrights or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming and divert the time and attention of our managementand scientific personnel. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents, trademarks, copyrights or other intellectual property. In addition,in a patent infringement proceeding, there is a risk that a court will decide that a patent of ours is invalid or unenforceable, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue.Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertioncould be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may raise claims challenging the validity or enforceabilityof a patent before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, derivationproceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of or amendment to our patents in

 

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such a way that they no longer cover CIN-107, any future product candidates or other proprietary technologies we may develop. The outcome following legal assertions of invalidity andunenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we or our licensing partners and the patent examiner were unaware during prosecution. If athird party were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on CIN-107, any future product candidates or other proprietary technologies we may develop.

There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’sclaims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our patents do not cover the invention. An adverse outcome in a litigation or proceeding involving our patentscould limit our ability to assert our patents against those parties or other competitors, and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Similarly, if we assert trademarkinfringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we couldultimately be forced to cease use of such trademarks.

In any infringement litigation, any award of monetary damages wereceive may not be commercially valuable. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised bydisclosure during litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it couldhave a substantial adverse effect on the price of our common stock. Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before theyare concluded. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Evenif we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings. Accordingly, despiteour efforts, we may not be able to prevent third parties from infringing, misappropriating or successfully challenging our intellectual property rights. Uncertainties resulting from the initiation and continuation of patent litigation or otherproceedings could have a negative impact on our ability to compete in the marketplace.

Third parties may initiate legal proceedingsalleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.

Our commercial success depends, in part, upon our ability and the ability of future collaborators, if any, to develop,manufacture, market and sell CIN-107 or any future product candidates and use our proprietary technologies without infringing the proprietary rights and intellectual property of third parties. Thebiotechnology and pharmaceutical industries are characterized by extensive and complex litigation regarding patents and other intellectual property rights. We may in the future become party to, or be threatened with, adversarial proceedings orlitigation regarding intellectual property rights with respect to CIN-107 or any future product candidates and technology, including interference proceedings, postgrant review and inter partes reviewbefore the USPTO. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future, regardless of their merit. There is a risk that third parties may choose to engage in litigation withus to enforce or to otherwise assert their patent rights against us. Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could havea negative impact on our ability to commercialize our current and any future product candidates. In order to successfully challenge the validity of any such U.S. patent in federal district court, we would need to overcome a presumption of validity.As this burden is a high one requiring us to present clear and

 

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convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. If we arefound to infringe a third party’s valid and enforceable intellectual property rights, we could be required to obtain a license from such third party to continue developing, manufacturing and marketing our product candidate(s) and technology.However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors andother third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. We could be forced, including by court order, to cease developing, manufacturing and commercializing theinfringing technology or product candidate. In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right. Afinding of infringement could prevent us from manufacturing and commercializing CIN-107 or any future product candidates or force us to cease some or all of our business operations, which could materially harmour business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business, financial condition, results of operations and prospects.

We may in the future pursue invalidity proceedings with respect to third-party patents. The outcome following legal assertionsof invalidity is unpredictable. Even if resolved in our favor, these legal proceedings may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. Such proceedings couldsubstantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such proceedingsadequately. Some of these third parties may be able to sustain the costs of such proceedings more effectively than we can because of their greater financial resources. If we do not prevail in the patent proceedings, the third parties may assert aclaim of patent infringement directed at CIN-107 or any future product candidates.

We maybe subject to claims challenging the inventorship of our patents and other intellectual property.

We may besubject to claims that former employees, collaborators or other third parties have an interest in our patent rights, trade secrets, or other intellectual property as an inventor or co-inventor. For example, wemay have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing CIN-107, any future product candidates or other proprietary technologies we may develop. Litigation may be necessary to defendagainst these and other claims challenging inventorship or our patent rights, trade secrets or other intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual propertyrights, such as exclusive ownership of, or right to use, intellectual property that is important to CIN-107, any future product candidates or other proprietary technologies we may develop. Even if we are successful in defending against such claims,litigation could result in substantial costs and be a distraction to our management and other employees. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may need to license intellectual property from third parties, and such licenses may not be available or may not be available oncommercially reasonable terms.

A third party may hold intellectual property rights, including patent rights, thatare important or necessary to the development of CIN-107 or any future product candidates. It may be necessary for us to use the patented or proprietary technology of third parties to commercialize CIN-107 or any future product candidates, in which case we would be required to obtain a license from these third parties. Such a license may not be available on commercially reasonable terms, or at all, and wecould be forced to accept unfavorable contractual terms. If we are unable to obtain such licenses on commercially reasonable terms, our business could be harmed.

The growth of our business may depend in part on our ability to acquire, in-license oruse third-party proprietary rights. For example, CIN-107 or any future product candidates may require specific formulations to

 

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work effectively and efficiently, we may develop product candidates containing our compounds and pre-existing pharmaceutical compounds, or we may berequired by the FDA or comparable foreign regulatory authorities to provide a companion diagnostic test or tests with CIN-107 or any future product candidates, any of which could require us to obtain rights touse intellectual property held by third parties. In addition, with respect to any patents we may co-own with third parties, we may require licenses to suchco-owner’s interest to such patents. We may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectualproperty rights from third parties that we identify as necessary or important to our business operations. In addition, we may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. Were that to happen, we mayneed to cease use of the compositions or methods covered by those third-party intellectual property rights, and may need to seek to develop alternative approaches that do not infringe on those intellectual property rights, which may entailadditional costs and development delays, even if we were able to develop such alternatives, which may not be feasible. Even if we are able to obtain a license, it may be non-exclusive, which means that ourcompetitors may also receive access to the same technologies licensed to us. In that event, we may be required to expend significant time and resources to develop or license replacement technology.

We rely on intellectual property licensed from third parties. We face risks with respect to such reliance, including the risk that wecould lose these rights that are important to our business if we fail to comply with our obligations under these licenses.

We rely on a license agreement with Roche, or the Roche Agreement, pursuant to which we received exclusive, worldwide,royalty-bearing license under certain patents and specified know-how owned or controlled by Roche and Roche’s interest in joint patents and covering certain specified small molecule aldosterone synthaseinhibitors, including our product candidate, CIN-107. The Roche Agreement imposes diligence, milestone payment, royalty payment and other obligations on us. We may in the futurein-license additional third-party intellectual property rights on which we may similarly rely. Such licenses may impose diligence, milestone payment, royalty payment and other obligations on us. Anytermination of the Roche Agreement or any future licenses could result in the loss of significant rights and could harm our ability to commercialize CIN-107 or any future product candidates. See“Business—License Agreement with Roche” for additional information regarding the Roche Agreement.

Disputesmay also arise between us and our licensors regarding intellectual property subject to a license agreement, including:

 

  

the scope of rights granted under the license agreement and other interpretation-related issues;

 

  

whether and the extent to which our technology and processes infringe on intellectual property of the licensorthat is not subject to the licensing agreement;

 

  

our right to sublicense patent and other rights to third parties under collaborative developmentrelationships;

 

  

our diligence obligations with respect to the use of the licensed technology in relation to our developmentand commercialization of CIN-107 or any future product candidates, and what activities satisfy those diligence obligations; and

 

  

the ownership of inventions and know-how resulting from the jointcreation or use of intellectual property by our licensors and us and our partners.

If disputes overintellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.

We are generally also subject to all of the same risks with respect to protection of intellectual property that we license, aswe are for intellectual property that we own, which are described below. If we or our licensors fail to adequately protect this intellectual property, our ability to commercialize products could suffer.

 

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Our current and any potential future licensors might conclude that we havematerially breached our license agreements and might therefore terminate the relevant license agreements, thereby removing our ability to develop and commercialize products and technology covered by such license agreements. If any of our current orfuture inbound license agreements are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors would have the freedom to seek regulatory approval of, and to market, products that are covered by such licenseagreements and underlying patents, which might be identical to our products or product candidates. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations and growth prospects. Ourbusiness also would suffer if any current or future licensors fail to abide by the terms of the license or fail to enforce licensed patents against infringing third parties, if the licensed patents or other rights are found to be invalid orunenforceable, or if we are unable to enter into necessary licenses on acceptable terms. Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless oftheir merit, that we are infringing or otherwise violating the licensor’s rights.

Any licensor of ours may haverelied on third-party consultants or collaborators or on funds from third parties, such as the United States government, such that such licensor is not the sole and exclusive owners of the patents wein-licensed. If other third parties have ownership rights or other rights to our in-licensed patents, they may be able to license such patents to our competitors, andour competitors could market competing products and technology. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

In addition, while we cannot currently determine the amount of the royalty obligations we would be required to pay on sales offuture products, if any, the amounts may be significant. The amount of our future royalty obligations will depend on the technology and intellectual property we use in products that we successfully develop and commercialize, if any. Therefore, evenif we successfully develop and commercialize products, we may be unable to achieve or maintain profitability.

We may be subject toclaims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.

Many of our employees, consultants or advisors are currently, or were previously, employed at other biotechnology orpharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of othersin their work for us, we may be subject to claims that these individuals or we have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer.Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defendingagainst such claims, litigation could result in substantial costs and be a distraction to management.

In addition, we mayin the future be subject to claims by our former employees or consultants asserting an ownership right in our patents or patent applications, as a result of the work they performed on our behalf. Although it is our policy to require our employeesand contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives ordevelops intellectual property that we regard as our own, and we cannot be certain that our agreements with such parties will be upheld in the face of a potential challenge or that they will not be breached, for which we may not have an adequateremedy. The assignment of intellectual property rights may not be self-executing or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determinethe ownership of what we regard as our intellectual property. Such claims are likely to be expensive to pursue and there can be no assurance that we would prevail in any event. Failure to secure

 

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ownership of intellectual property could have a material adverse effect on our business, financial conditions, results of operations and prospects.

Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, therebyimpairing our ability to protect our future product candidates.

The United States enacted and implemented wideranging patent reform legislation in 2013. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners incertain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on actions by theU.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to enforce patents that we have licensed or that we might obtainin the future. Similarly, changes in patent law and regulations in other countries or jurisdictions, changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations mayweaken our ability to obtain new patents or to enforce patents that we have licensed or that we may obtain in the future.

We maynot be able to protect our intellectual property rights throughout the world, which could negatively impact our business.

Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitivelyexpensive, and our intellectual property rights in some countries outside the United States could be less extensive than those in the United States. In some cases, we may not be able to obtain patent protection for certain technology outside theUnited States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States, even in jurisdictions where we do pursue patent protection. Consequently,we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, even in jurisdictions where we do pursue patent protection or from selling or importing products made using our inventions in andinto the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territorieswhere we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent themfrom competing.

Many companies have encountered significant problems in protecting and defending intellectual propertyrights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, which could make it difficult for us to stop theinfringement of our patents, if pursued and obtained, or marketing of competing products in violation of our proprietary rights generally. In addition, some jurisdictions, such as Europe, Japan and China, may have a higher standard for patentabilitythan in the United States, including, for example, the requirement of claims having literal support in the original patent filing and the limitation on using supporting data that is not in the original patent filing. Under those heightenedpatentability requirements, we may not be able to obtain sufficient patent protection in certain jurisdictions even though the same or similar patent protection can be secured in the United States and other jurisdictions.

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts andattention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may notprevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain asignificant commercial advantage from the intellectual property that we develop or license.

 

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Many countries have compulsory licensing laws under which a patent owner maybe compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which couldmaterially diminish the value of such patent. If we are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results ofoperations and prospects may be adversely affected.

Reliance on third parties requires us to share our proprietary information,which increases the possibility that such information will be misappropriated or disclosed.

We rely on thirdparties to develop and manufacture CIN-107, and we intend to continue to rely on third parties for the development or commercialization of CIN-107 or any future productcandidate. Since we must, at times, share proprietary information with these parties, we seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, consultingagreements or other similar agreements with our advisors, employees, third-party contractors and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to useor disclose our confidential information. Despite the contractual provisions employed when working with third parties, the need to share confidential information increases the risk that such information become known by our competitors, isinadvertently incorporated into the technology of others, or is disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how, a competitor’sdiscovery of our know-how or other unauthorized use or disclosure could have an adverse effect on our business and results of operations.

In addition, these agreements typically restrict the ability of our advisors, employees, third-party contractors andconsultants to publish data potentially relating to our know-how. Despite our efforts to protect our know-how, we may not be able to prevent the unauthorized disclosureor use of our technical know-how by the parties to these agreements. Moreover, we cannot guarantee that we have entered into such agreements with each party that may have or have had access to our confidentialinformation or proprietary technology and processes. Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our proprietary technologies will be effective. If any of thecollaborators, scientific advisors, employees, contractors and consultants who are parties to these agreements breaches or violates the terms of any of these agreements, we may not have adequate remedies for any such breach or violation. Moreover,if confidential information that is licensed or disclosed to us by our partners, collaborators, or others is inadvertently disclosed or subject to a breach or violation, we may be exposed to liability to the owner of that confidential information.Enforcing a claim that a third-party illegally obtained and is using our proprietary information, like patent litigation, is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimesless willing to protect proprietary information.

Any trademarks we may obtain may be infringed or successfully challenged,resulting in harm to our business.

We expect to rely on trademarks as one means to distinguish any of CIN-107 or any future product candidates that are approved for marketing from the products of our competitors. We have sought U.S. federal trademark registration of our house mark CinCor, which has not yet beengranted. We have not yet selected trademarks for CIN-107 or any future product candidate and have not yet begun the process of applying to register trademarks forCIN-107 or any other product candidate. The pending application for our house mark CinCor, and for any subsequent trademarks we apply to register, may not be approved. Third parties may oppose our trademarkapplications or otherwise challenge our use of the trademarks. In the event that our trademarks are challenged, we could be forced to rebrand our products or our company, which could result in loss of brand recognition and could require us to devoteresources to advertising and marketing new brands. Our competitors may infringe our trademarks, and we may not have adequate resources to enforce our trademarks.

 

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In addition, any proprietary name we propose to use with CIN-107 or any future product candidate in the United States must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. The FDA typically conducts a reviewof proposed product names, including an evaluation of the potential for confusion with other product names. If the FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in aneffort to identify a suitable proprietary product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA. Furthermore, in many countries, owning and maintaining atrademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark.

We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition amongpotential partners or customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to marketconfusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Overthe long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. Our efforts to enforce or protect our proprietaryrights related to trademarks, trade names, domain name or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results ofoperations and prospects.

If we are unable to protect the confidentiality of our proprietary information, our business andcompetitive position would be harmed.

In addition to seeking patent and trademark protection for CIN-107, we also rely on confidentiality agreements to protect our unpatented know-how, technology and other proprietary information, to maintain our competitive position.Trade secrets and know-how can be difficult to protect. In particular, the trade secrets and know-how in connection with our development programs and other proprietarytechnology we may develop may over time be disseminated within the industry through independent development, the publication of journal articles describing the methodology and the movement of personnel with scientific positions in academic andindustry.

We seek to protect our proprietary information, in part, by entering intonon-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants,advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietaryinformation. Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective. In addition, we may not be able to obtainadequate remedies for any such breaches. Enforcing a claim that a party illegally disclosed or misappropriated proprietary information is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside andoutside the United States are less willing or are unwilling to protect trade secrets.

We may be subject to claims thatthird parties have an ownership interest in our trade secrets. For example, we may have disputes arise from conflicting obligations of our employees, consultants or others who are involved in developingCIN-107 or any future product candidate. Litigation may be necessary to defend against these and other claims challenging ownership of our trade secrets. If we fail in defending any such claims, in addition topaying monetary damages, we may lose valuable trade secret rights, such as exclusive ownership of, or right to use, trade secrets that are important to CIN-107, any future product candidates or other proprietary technologies we may develop. Such anoutcome could have a materially adverse effect on our business. Even if

 

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we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to our management and other employees.

Moreover, our competitors may independently develop knowledge, methods and know-howequivalent to our proprietary information. Competitors could purchase our products and replicate some or all of the competitive advantages we derive from our development efforts for technologies on which we do not have patent protection. If any ofour proprietary information were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If anyof our proprietary information were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.

We also seek to preserve the integrity and confidentiality of our data and other confidential information by maintainingphysical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached and detecting thedisclosure or misappropriation of confidential information and enforcing a claim that a party illegally disclosed or misappropriated confidential information is difficult, expensive and time-consuming, and the outcome is unpredictable. Further, wemay not be able to obtain adequate remedies for any breach. In addition, our confidential information may otherwise become known or be independently discovered by competitors, in which case we would have no right to prevent them, or those to whomthey communicate it, from using that technology or information to compete with us, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Risks Related to Our Business Operations, Employee Matters and Managing Growth

Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

We are highly dependent on the research and development, clinical and business expertise of Marc de Garidel, our ChiefExecutive Officer, as well as other members of our senior management, scientific and clinical team. Although we have entered into employment agreements with our executive officers, each of them may currently terminate their employment with us at anytime and will continue to be able to do so after the closing of this offering. We currently maintain “key person” life insurance for Mr. de Garidel. The loss of the services of any of these persons could impede the achievement of ourresearch, development and commercialization objectives.

Recruiting and retaining qualified scientific and clinicalpersonnel and, if we progress the development of CIN-107, commercialization, manufacturing and sales and marketing personnel, will be critical to our success. The loss of the services of our executive officersor other key employees could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and keyemployees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercializeCIN-107. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerouspharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.

We have in the past hired part-time employees or used consultants, and anticipate we will continue to do so in the future. Asa result, certain of our employees, officers, directors or consultants may not devote all of their time to our business, and may from time to time serve as employees, officers, directors and consultants of other companies. In addition, we rely onconsultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may

 

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have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to retain and recruit qualified scientists and advisors, orif any of our key executives, key employees or key consultants discontinues his or her employment or consulting relationship with us, it may delay our growth strategy, development efforts or otherwise harm our business.

We expect to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.

As of November 15, 2021, we had 10 full-time employees and no part-time employees. As the clinical development of CIN-107 progresses and as we move towards submission of a NDA, we expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of research, drugdevelopment, regulatory affairs and, if CIN-107 or any future product candidates receives marketing approval, we may add sales, marketing and distribution functions. To manage our anticipated future growth, wemust continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience ofour management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead tosignificant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

In preparation for this offering, we identified a material weakness in our internal control over financial reporting. If we identifyadditional material weaknesses in the future or if we otherwise fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial statements in a timely manner, which mayadversely affect our business, investor confidence in our company and the market value of our common stock.

Although we are not yet subject to the certification or attestation requirements of Section 404 of the Sarbanes-Oxley Act, inthe course of reviewing our annual financial statements for this offering, management and our independent registered public accounting firm identified a material weakness in our internal control over financial reporting with respect to theaccumulation, tracking, and disclosure of our outstanding common stock that was deemed to be remediated as of the date of this filing. As a result, there were adjustments to the disclosure of common stock and resulting impact on our net loss pershare required in our 2020 and 2019 financial statements and the material weakness was remediated.

A material weakness isa deficiency, or a combination of control deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not beprevented or detected on a timely basis.

We have hired experienced accounting and finance personnel, including MaryTheresa Coelho, M.B.A. as our Executive Vice President, Chief Financial Officer and Chief Business Development Officer, and insourced our accounting function, as of the date of this filing. However, there can be no assurance that we will not havematerial weaknesses in the future. If we fail to meet the demands that will be placed upon us as a public company, including the requirements of the Sarbanes-Oxley Act, we may be unable to accurately report our financial results, or report themwithin the timeframes required by law or Nasdaq. Failure to comply with Section 404 could also potentially subject us to sanctions or investigations by the SEC or other regulatory authorities. There is no assurance that we will be able to remediatea material weakness in a timely manner, or at all, or that in the future, additional material weaknesses will not exist or otherwise be discovered. If other material weaknesses or other deficiencies occur, our ability to accurately and timely reportour financial position could be impaired, which could result in late filings of our required reports under the Exchange Act, restatements of our financial statements, a decline in the price of our common stock, suspension or delisting of our commonstock from Nasdaq, and could adversely affect our reputation, results of operations and financial condition.

 

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Our internal computer systems, or those of our collaborators or other contractors orconsultants, may fail or suffer security breaches, which could result in a significant disruption of our product development programs and our ability to operate our business effectively.

Our internal computer systems and those of our current and future collaborators, contractors or consultants may be vulnerableto damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Cyberattacks are increasing in their frequency, sophistication and intensity, and have become increasinglydifficult to detect. Cyberattacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affectservice reliability and threaten the confidentiality, integrity and availability of information. Cyberattacks also could include phishing attempts or e-mail fraud to cause payments or information to betransmitted to an unintended recipient.

Despite our efforts to ensure the security, privacy, integrity, confidentiality,availability, and authenticity information technology networks and systems, processing and information, we may not be able to anticipate or to implement effective preventive and remedial measures against all data security and privacy threats. Therecovery systems, security protocols, network protection mechanisms and other security measures that we have integrated into our systems, networks and physical facilities, which are designed to protect against, detect and minimize security breaches,may not be adequate to prevent or detect service interruption, system failure data loss or theft, or other material adverse consequences. No security solution, strategy, or measures can address all possible security threats or block all methods ofpenetrating a network or otherwise perpetrating a security incident. The risk of unauthorized circumvention of our security measures or those of our third-party providers, clients and partners has been heightened by advances in computer and softwarecapabilities and the increasing sophistication of hackers who employ complex techniques, including without limitation, the theft or misuse of personal and financial information, counterfeiting, “phishing” or social engineering incidents,ransomware, extortion, publicly announcing security breaches, account takeover attacks, denial or degradation of service attacks, malware, fraudulent payment and identity theft. Because the techniques used by hackers change frequently, we may beunable to anticipate these techniques or implement adequate preventive measures. Our applications, systems, networks, software and physical facilities could have material vulnerabilities, be breached or personal or confidential information could beotherwise compromised due to employee error or malfeasance, if, for example, third parties attempt to fraudulently induce our personnel or our customers to disclose information or user names and/or passwords, or otherwise compromise the security ofour networks, systems and/or physical facilities. Third parties may also exploit vulnerabilities in, or obtain unauthorized access to, platforms, software, applications, systems, networks, sensitive information, and/or physical facilities utilizedby our vendors. Improper access to our systems or databases could result in the theft, publication, deletion or modification of personal information, confidential or proprietary information, financial information and other information. An actual orperceived breach of our security systems or those of our third-party service providers may require notification under applicable data privacy regulations or contractual obligations, or for customer relations or publicity purposes, which could resultin reputational harm, costly litigation (including class action litigation), material contract breaches, liability, settlement costs, loss of sales, regulatory scrutiny, actions or investigations, a loss of confidence in our business, systems andprocessing, a diversion of management’s time and attention, and significant fines, penalties, assessments, fees and expenses.

The costs to respond to a security breach and/or to mitigate any security vulnerabilities that may be identified could besignificant, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service, negative publicity, and other harm to our business and our competitive position. Wecould be required to fundamentally change our business activities and practices in response to a security breach or related regulatory actions or litigation, which could have an adverse effect on our business.

We may have contractual and other legal obligations to notify relevant stakeholders of security breaches. Most jurisdictionshave enacted laws requiring companies to notify individuals, regulatory authorities, and others of security breaches involving certain types of data. In addition, our agreements with certain customers and

 

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partners may require us to notify them in the event of a security breach. Such mandatory disclosures are costly, could lead to negative publicity, may cause our customers to lose confidence inthe effectiveness of our security measures and require us to expend significant capital and other resources to respond to and/or alleviate problems caused by the actual or perceived security breach, and may cause us to breach customer contracts. Ouragreements with certain customers, our representations, or industry standards, may require us to use industry-standard or reasonable measures to safeguard sensitive personal information or confidential information. A security breach could lead toclaims by our customers, or other relevant stakeholders that we have failed to comply with such legal or contractual obligations. As a result, we could be subject to legal action or our customers could end their relationships with us. There can beno assurance that any limitations of liability in our contracts would be enforceable or adequate or would otherwise protect us from liabilities or damages.

While we have not to our knowledge experienced any significant system failure, accident or security breach to date, if such anevent were to occur and cause interruptions in our operations, it could result in a disruption of our development programs and our business operations. For example, the loss of clinical trial data from completed or future clinical trials by us orour CROs could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Additionally, any such event that leads to unauthorized access, use or disclosure of personal information,including personal information regarding our patients or employees, could harm our reputation, cause us not to comply with federal and/or state breach notification laws and foreign law equivalents or otherwise subject us to liability under laws andregulations that protect the privacy and security of personal information. Security breaches and other unauthorized access can be difficult to detect, and any delay in identifying them may lead to increased harm of the type described above. While wehave implemented security measures designed to protect our information technology systems and infrastructure, such measures may not prevent service interruptions or security breaches that could adversely affect our business. To the extent that anydisruption or security breach were to result in a loss of, or damage to, our data or applications, or unauthorized disclosure of confidential or proprietary information, we could incur liability, our competitive position could be harmed and thefurther development and commercialization of CIN-107 or any future product candidates could be delayed.

We may be unable in the future to detect, anticipate, measure or prevent threats or techniques used to detect or exploitvulnerabilities in our (or our third parties’) information technology, services, processing, communications or software, or cause security breaches, because such threats and techniques change frequently, are often sophisticated in nature, andmay not be detected until after an incident has occurred. In addition, security researchers and other individuals have in the past and will continue in the future to actively search for and exploit actual and potential vulnerabilities in our (or ourthird parties’) information technology, services, communications or software. We cannot be certain that we will be able to address any such vulnerabilities, in whole or part, and there may be delays in developing and deploying patches and otherremedial measures to adequately address vulnerabilities, and taking such remedial steps could adversely impact or disrupt our operations.

We may not have adequate insurance coverage for security incidents or breaches, including fines, judgments, settlements,penalties, costs, attorney fees and other impacts that arise out of incidents or breaches. If the impacts of a security incident or breach, or the successful assertion of one or more large claims against us that exceeds our available insurancecoverage, or results in changes to our insurance policies (including premium increases or the imposition of large deductible or co-insurance requirements), it could have an adverse effect on our business. In addition, we cannot be sure that ourexisting insurance coverage, cyber coverage and coverage for errors and omissions will continue to be available on acceptable terms or that our insurers will not deny coverage as to all or part of any future claim or loss. Our risks are likely toincrease as we continue to expand, grow our customer base, and process, store, and transmit increasingly large amounts of proprietary and sensitive data.

 

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Our employees, principal investigators, consultants and commercial partners may engagein misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.

We are exposed to the risk of fraud or other misconduct by our employees, principal investigators, consultants and commercialpartners. Misconduct by these parties could include intentional failures to comply with FDA regulations or the regulations applicable in other jurisdictions, provide accurate information to the FDA and other regulatory authorities, comply withhealthcare fraud and abuse laws and regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcareindustry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing andpromotion, sales commission, customer incentive programs and other business arrangements. Such misconduct also could involve the improper use of information obtained in the course of clinical trials or interactions with the FDA or other regulatoryauthorities, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not beeffective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are institutedagainst us and we are not successful in defending ourselves or asserting our rights, those actions could result in significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating ingovernment funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm and the curtailment or restructuring of our operations, any of which could have a negative impact on our business, financial condition, resultsof operations and prospects.

We have had a number of related party transactions with our current and former affiliates, which mayresult in a conflict of interest involving certain of our current and former management and directors.

Historically, we have engaged in a number and variety of transactions with our current and former affiliates, including CinRxand Medpace. While we believe that these transactions were made on terms that were not less favorable to us than those obtainable on an arm’s length basis, there was no independent determination of that fact. In the future, we may continue toenter into transactions with our former affiliates, and some of these transactions may be significant. Related party transactions present difficult conflicts of interest, could result in disadvantages to our company and may impair investorconfidence, which could materially and adversely affect us. Related party transactions could also cause us to become materially dependent on related parties in the ongoing conduct of our business, and related parties may be motivated by personalinterests to pursue courses of action that are not necessarily in the best interests of our company and our stockholders. For further information please see the section titled “Certain Relationships and Related Party Transactions”elsewhere in this prospectus.

Risks Related to This Offering and Ownership of Our Common Stock

No public market for our common stock currently exists, and a public market may not develop or be liquid enough for you to sell yourshares quickly or at market price.

Prior to this offering, there has not been a public market for our commonstock. If an active trading market for our common stock does not develop following this offering, you may not be able to sell your shares quickly or at the market price. An inactive market may also impair our ability to raise capital to continue tofund operations by selling shares of our common stock and may impair our ability to acquire other companies or technologies by using shares of our common stock as consideration. The initial public offering price of our common stock will bedetermined by negotiations between us and representatives of the underwriters and may not be indicative of the market prices of our common stock that will prevail in the trading market.

 

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The market price of shares of our common stock may be volatile and fluctuatesubstantially, which could result in substantial losses for purchasers of shares of our common stock in this offering.

The market price of shares of our common stock is likely to be volatile. The stock market in general and the market forbiopharmaceutical and pharmaceutical companies in particular, has experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, you may not be able to sell yourcommon stock at or above the initial public offering price. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this prospectus, the market price for shares of our common stock may be influenced by thefollowing:

 

  

the commencement, enrollment or results of our planned or future clinical trials of CIN-107 and any future product candidates or those of our competitors;

 

  

the success of competitive drugs or therapies;

 

  

regulatory or legal developments in the United States and other countries;

 

  

the success of competitive products or technologies;

 

  

developments or disputes concerning patent applications, issued patents or other proprietary rights;

 

  

the recruitment or departure of key personnel;

 

  

the level of expenses related to CIN-107 and any future productcandidates or clinical development programs;

 

  

the results of our efforts to discover, develop, acquire or in-licenseadditional product candidates;

 

  

actual or anticipated changes in estimates as to financial results, development timelines or recommendationsby securities analysts;

 

  

our inability to obtain or delays in obtaining adequate drug supply for any approved drug or inability to doso at acceptable prices;

 

  

disputes or other developments relating to proprietary rights, including patents, litigation matters and ourability to obtain patent protection for our technologies;

 

  

significant lawsuits, including patent or stockholder litigation;

 

  

variations in our financial results or those of companies that are perceived to be similar to us;

 

  

changes in the structure of healthcare payment systems, including coverage and adequate reimbursement for anyapproved drug;

 

  

market conditions in the pharmaceutical and biotechnology sectors;

 

  

general economic, political, and market conditions and overall fluctuations in the financial markets in theUnited States and abroad, including those related to the COVID-19 pandemic; and

 

  

investors’ general perception of us and our business.

These and other market and industry factors may cause the market price and demand for shares of our common stock to fluctuatesubstantially, regardless of our actual operating performance, which may limit or prevent investors from selling their shares at or above the price paid for the shares and may otherwise negatively affect the liquidity of our common stock. Inaddition, the stock market in general, and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies,including very recently in connection with the ongoing COVID-19 pandemic, which has resulted in decreased stock prices for many companies notwithstanding the lack of a fundamental change in their underlyingbusiness models or prospects. Broad market and industry factors, including potentially worsening economic conditions and other adverse effects or developments relating to the ongoing COVID-19 pandemic, maynegatively affect the market price of our

 

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common stock, regardless of our actual operating performance. The realization of any of the above risks or any of a broad range of other risks, including those described in this section, couldhave a significant and material adverse impact on the market price of our common stock.

In addition, in the past,companies that have experienced volatility in the trading price of their shares have been the subject of securities class action litigation. Any lawsuit to which we are a party, with or without merit, may result in an unfavorable judgment. We alsomay decide to settle lawsuits on unfavorable terms. Any such negative outcome could result in payments of substantial damages or fines, damage to our reputation or adverse changes to our business practices. Defending against litigation is costly andtime-consuming, and could divert our management’s attention and our resources. Furthermore, during the course of litigation, there could be negative public announcements of the results of hearings, motions or other interim proceedings ordevelopments, which could have a negative effect on the market price of our common stock.

Concentration of ownership of shares ofour common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.

Based upon our common stock outstanding as of September 30, 2021, upon the completion of this offering, our executiveofficers, directors and stockholders who owned more than 5% of our outstanding common stock before this offering will, in the aggregate, beneficially own shares representing approximately    % of our outstanding common stock(assuming the number of shares offered by us as set forth on the cover page of this prospectus remains the same and no purchases of shares in this offering by any members of this group, including through our directed share program). If our executiveofficers, directors and stockholders who owned more than 5% of our outstanding common stock acted together, they may be able to significantly influence all matters requiring stockholder approval, including the election and removal of directors andapproval of any merger, consolidation or sale of all or substantially all of our assets. The concentration of voting power and transfer restrictions could delay or prevent an acquisition of our company on terms that other stockholders may desire orresult in the management of our company in ways with which other stockholders disagree.

If you purchase shares of our common stockin this offering, you will suffer immediate dilution of your investment.

The initial public offering price of ourcommon stock will be substantially higher than the net tangible book value per share of our common stock. Therefore, if you purchase shares of our common stock in this offering, you will pay a price per share that substantially exceeds our nettangible book value per share after this offering. Based on an assumed initial public offering price of $                per share, which is the midpoint of the pricerange set forth on the cover page of this prospectus, you will experience immediate dilution of $                per share, representing the difference between our proforma as adjusted net tangible book value per share after this offering and the initial public offering price per share. After this offering, we will also have outstanding options to purchase shares of our common stock with exercise prices lowerthan the initial public offering price. To the extent these outstanding options are exercised, there will be further dilution to investors in this offering. See the section titled “Dilution” for additional information.

We have broad discretion in the use of our cash and cash equivalents, including the net proceeds from this offering, and may use themineffectively, in ways in which you do not agree or in ways that do not increase the value of your investment.

Ourmanagement will have broad discretion in the application of our cash and cash equivalents, including the net proceeds from this offering, and could spend the proceeds in ways that do not improve our results of operations or enhance the value of ourcommon stock. The failure by our management to apply these funds effectively could result in financial losses that could have a negative impact on our business, cause the price of our common stock to decline and delay the development of CIN-107. Pending their use, we may invest our cash

 

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and cash equivalents, including the net proceeds from this offering, in a manner that does not produce income or that loses value. See the section titled “Use of Proceeds” foradditional information.

A significant portion of our total outstanding shares are restricted from immediate resale but may be soldinto the market in the near future, which could cause the market price of our common stock to drop significantly, even if our business is performing well.

Sales of a substantial number of our common stock in the public market could occur at any time, subject to certain restrictionsdescribed below. These sales, or the perception in the market that holders of a large number of shares intend to sell shares, could reduce the market price of our common stock. After this offering, we will have outstanding share of our common stockbased on the number of shares outstanding as of September 30, 2021 assuming no exercise by the underwriters of their option to purchase additional common stock. This includes the shares that we are selling in this offering, which may be resoldin the public market immediately without restriction, unless purchased by our affiliates. The remaining shares are currently restricted as a result of securities laws or lock-up agreements but will be able tobe sold after the offering as described in the sections titled “Shares Eligible for Future Sale” and “Underwriting.” Moreover, upon the completion of this offering, holders of an aggregate of approximately shares of our commonstock will have rights, subject to some conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. We intend to registerall of the shares of our common stock that we may issue under our equity compensation plans. Once we register these shares, they can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and the lock-up agreements described in the section titled “Underwriting.”

Provisions in ourcorporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as aresult.

There are provisions in our certificate of incorporation and bylaws to be in effect upon the closing ofthis offering that may make it difficult for a third party to acquire, or attempt to acquire, control of our company, even if a change of control was considered favorable by you and other stockholders. For example, our board of directors will havethe authority to issue up to              shares of preferred stock. The board of directors can fix the price, rights, preferences, privileges, and restrictions of the preferred stockwithout any further vote or action by our stockholders. The issuance of shares of preferred stock may delay or prevent a change of control transaction. As a result, the market price of our common stock and the voting and other rights of ourstockholders may be adversely affected. An issuance of shares of preferred stock may result in the loss of voting control to other stockholders.

Our charter documents will also contain other provisions that could have an anti-takeover effect, including:

 

  

only one of our three classes of directors will be elected each year;

 

  

stockholders will not be entitled to remove directors other than by a 66 2/3% vote and only for cause;

 

  

stockholders will not be permitted to take actions by written consent;

 

  

stockholders cannot call a special meeting of stockholders; and

 

  

stockholders must give advance notice to nominate directors or submit proposals for consideration atstockholder meetings.

In addition, we are subject to the anti-takeover provisions of Section 203of the Delaware General Corporation Law, which regulates corporate acquisitions by prohibiting Delaware corporations from engaging in specified business combinations with particular stockholders of those companies. These provisions could discouragepotential acquisition proposals and could delay or prevent a change of control transaction. They could

 

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also have the effect of discouraging others from making tender offers for our common stock, including transactions that may be in your best interests. These provisions may also prevent changes inour management or limit the price that investors are willing to pay for our stock.

Because we do not anticipate paying any cashdividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment.

You should not rely on an investment in our common stock to provide dividend income. We have not declared or paid cashdividends on our common stock to date. We currently intend to retain our future earnings, if any, to fund the development and growth of our business. As a result, capital appreciation, if any, of our common stock will be your sole source of gain forthe foreseeable future. Investors seeking cash dividends should not purchase our common stock.

Our amended and restated certificateof incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us and our stockholders, which couldlimit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our amended and restated certificate of incorporation, as will be in effect upon the completion of this offering, will providethat the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

 

  

any derivative claim or cause of action brought on our behalf;

 

  

any claim or cause of action asserting a breach of fiduciary duty;

 

  

any claim or cause of action against us arising under the Delaware General Corporation Law;

 

  

any claim or cause of action arising under or seeking to interpret our amended and restated certificate ofincorporation, or our amended and restated bylaws; and

 

  

any claim or cause of action against us that is governed by the internal affairs doctrine.

The provisions would not apply to suits brought to enforce a duty or liability created by the ExchangeAct. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims. Toprevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated certificate of incorporation will further provide that thefederal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause or causes of action arising under the Securities Act, including all causes of action asserted against any defendant tosuch complaint. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In suchinstance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our amended and restated certificate of incorporation. This may require significant additional costs associated with resolving suchaction in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.

These exclusive forum provisions may result in increased costs for investors to bring a claim. Further, these exclusive forumprovisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officersand other employees. If a court were to find either exclusive-forum provision in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur further significant additional costs associatedwith resolving the dispute in other jurisdictions, all of which could seriously harm our business.

 

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General Risk Factors

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

We have incurred substantial losses during our history and do not expect to become profitable in the near future, and we maynever achieve profitability. To the extent that we continue to generate taxable losses, unused losses will carry forward to offset a portion of future taxable income, if any, until such unused losses expire, if ever. Under Sections 382 and 383 ofthe Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a rollingthree-year period, the corporation’s ability to use its pre-change net operating loss carryforwards (NOLs) and other pre-change tax attributes (such as research anddevelopment tax credits) to offset its post-change income or taxes may be limited. We have not performed an analysis to assess whether an ownership change has occurred. There is also a risk that due to regulatory changes, such as suspensions on theuse of NOLs, or other unforeseen reasons, our existing NOLs could expire or otherwise become unavailable to offset future income tax liabilities. Under the Tax Cuts and Jobs Act, or the TCJA, as modified by the Coronavirus Aid, Relief and EconomicSecurity Act, the CARES Act, NOLs generated in taxable years beginning after December 31, 2017 may be carried forward indefinitely, but the deductibility of such NOLs generally will be limited in taxable years beginning after December 31,2020 to 80% of current year taxable income. The TCJA, as modified by the CARES Act, generally eliminates the ability to carry back any NOLs to prior taxable years for tax years beginning after December 31, 2020. Additionally, state NOLsgenerated in one state cannot be used to offset income generated in another state. For these reasons, even if we attain profitability, we may be unable to use a material portion of our NOLs and other tax attributes.

If we engage in future acquisitions or strategic collaborations, this may increase our capital requirements, dilute our stockholders, cause us to incurdebt or assume contingent liabilities and subject us to other risks.

From time to time, we may evaluate variousacquisitions and strategic collaborations, including licensing or acquiring complementary drugs, intellectual property rights, technologies or businesses, as deemed appropriate to carry out our business plan. Any potential acquisition or strategicpartnership may entail numerous risks,

including:

 

  

increased operating expenses and cash requirements;

 

  

the assumption of additional indebtedness or contingent liabilities;

 

  

assimilation of operations, intellectual property and drugs of an acquired company, including difficultiesassociated with integrating new personnel;

 

  

the diversion of our management’s attention from our existing drug programs and initiatives in pursuingsuch a strategic partnership, merger or acquisition;

 

  

retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain keybusiness relationships;

 

  

risks and uncertainties associated with the other party to such a transaction, including the prospects of thatparty and their existing drugs or product candidates and regulatory approvals; and

 

  

our inability to generate revenue from acquired technology and/or drugs sufficient to meet our objectives inundertaking the acquisition or even to offset the associated acquisition and maintenance costs.

Inaddition, if we engage in future acquisitions or strategic partnerships, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets thatcould result in significant future amortization expense. Moreover, we may not be able to locate suitable acquisition opportunities, and this inability could impair our ability to grow or obtain access to technology or drugs that may be important tothe development of our business.

 

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If research analysts do not publish research or reports, or publish unfavorable research or reports,about us, our business or our market, our share price and trading volume could decline.

The trading market for ourcommon stock will be influenced by the research and reports that industry or financial analysts publish about us or our business. We do not currently have, and may never obtain, research coverage by industry or financial analysts. Equity researchanalysts may elect not to provide research coverage of our common stock after the completion of this offering, and such lack of research coverage may adversely affect the market price of our common stock. In the event we do have equity researchanalyst coverage, we will not have any control over the analysts or the content and opinions included in their reports. The price of our shares could decline if one or more equity research analysts downgrade our shares or issue other unfavorablecommentary or research about us. If one or more equity research analysts ceases coverage of us or fails to publish reports on us regularly, demand for our shares could decrease, which in turn could cause the trading price or trading volume of ourcommon stock to decline.

We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growthcompanies may make our common stock less attractive to investors.

We are an “emerging growth company,”or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and we intend to take advantage of some of the exemptions from reporting requirements that are applicable to other public companies that are not emerging growthcompanies, including:

 

  

being permitted to provide only two years of audited financial statements, in addition to any requiredunaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;

 

  

not being required to comply with the auditor attestation requirements in the assessment of our internalcontrol over financial reporting;

 

  

not being required to comply with any requirement that may be adopted by the Public Company AccountingOversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;

 

  

reduced disclosure obligations regarding executive compensation; and

 

  

not being required to hold a nonbinding advisory vote on executive compensation and stockholder approval ofany golden parachute payments not previously approved.

We cannot predict whether investors will findour common stock less attractive because we will rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our share price may be more volatile.We may take advantage of some or all of these reporting exemptions until we are no longer an EGC. We will remain an EGC until the earlier of (i) five years following the completion of this offering, (ii) the last day of the fiscal year inwhich we have total annual gross revenue of at least $1.07 billion, (iii) the last day of the first fiscal year in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th, and (iv) the date on which we have issued more than $1.0 billion in non-convertible debt duringthe prior three-year period.

Under Section 107(b) of the JOBS Act, EGCs can delay adopting new or revised accountingstandards until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will be subject to the same new or revisedaccounting standards as other public companies that are not EGCs.

 

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We will incur increased costs as a result of operating as a public company, and our management will berequired to devote substantial time to new compliance initiatives.

As a public company, and particularly after weare no longer an EGC, we will incur significant legal, accounting and other expenses that we did not incur as a private company. In addition, the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, and rules subsequently implemented by the SECand The Nasdaq Stock Market LLC, or Nasdaq, have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and otherpersonnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time consuming and costly.For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance.

Pursuant to Section 404 of the Sarbanes-Oxley Act, or Section 404, we will be required to furnish a report by ourmanagement on our internal control over financial reporting, including an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. However, while we remain an EGC, we will not berequired to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we will be engaged in aprocess to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt adetailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement acontinuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that neither we nor our independent registered public accounting firm will be able to conclude within the prescribedtimeframe that our internal control over financial reporting is effective as required by Section 404. This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements that involve substantial risks and uncertainties. The forward-lookingstatements are contained principally in the sections titled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business” andelsewhere in this prospectus. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,”“intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions intended toidentify statements about the future. These statements speak only as of the date of this prospectus and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to bematerially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future eventsand financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements include, without limitation, statements about the following:

 

  

the timing, progress and results of our preclinical studies and clinical trials of CIN-107 and any future product candidates, including statements regarding the timing of our planned IND submissions, initiation and completion of studies or trials and related preparatory work, the period duringwhich the results of the trials will become available and our research and development programs;

 

  

our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

 

  

the timing of any submission of filings for regulatory approval of, and our ability to obtain and maintainregulatory approvals for, CIN-107 and any future product candidates;

 

  

our ability to identify patients with the diseases treated by our product candidate and to enroll thesepatients in our clinical trials;

 

  

our expectations regarding the size of the patient populations, market acceptance and opportunity for andclinical utility of CIN-107 and any future product candidates, if approved for commercial use;

 

  

business disruptions affecting the initiation, patient enrollment, development and operation of our clinicaltrials, including a public health emergency, such as the COVID-19 pandemic;

 

  

our expectations regarding the scope of any approved indication forCIN-107 or any future product candidate;

 

  

our ability to successfully commercialize CIN-107 or any futureproduct candidate, if approved;

 

  

our expectations regarding the potential market size and the rate and degree of market acceptance for CIN-107or any future product candidates that we develop;

 

  

the effects of competition with respect to CIN-107 or any future product candidates, as well as innovations bycurrent and future competitors in our industry;

 

  

our ability to fund our working capital requirements;

 

  

our intellectual property position, including the scope of protection we are able to establish, maintain andenforce for intellectual property rights covering CIN-107;

 

  

our financial performance and our ability to effectively manage our anticipated growth; and

 

  

our ability to obtain additional funding for our operations and our expected use of proceeds from thisoffering.

The foregoing list of forward-looking statements is not exhaustive. You should refer to the“Risk Factors” section of this prospectus for a discussion of important factors that may cause our actual results to differ

 

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materially from those expressed or implied by our forward-looking statements. Other sections of this prospectus may include additional factors that could harm our business and financialperformance. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, wecannot assure you that the forward-looking statements in this prospectus will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as aresult of any new information, future events, changed circumstances or otherwise. You should, however, review the factors and risks and other information we describe in the reports we will file from time to time with the SEC after the date of thisprospectus.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot bepredicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statementcontained in this prospectus, the events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.

You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to theregistration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionarystatements.

 

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MARKET AND INDUSTRY DATA

We are responsible for the disclosure contained in this prospectus. However, this prospectus contains industry, statisticaland market data derived from our own internal estimates and research as well as from industry and general publications and research, surveys and studies conducted by third parties. All of the market data used in this prospectus involve a number ofassumptions and limitations, and the sources of such data cannot guarantee the accuracy or completeness of such information. While we are not aware of any misstatements regarding the third-party information and we believe that each of these studiesand publications is reliable, the industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of important factors, including those described in the section titled “Risk Factors.” These and otherfactors could cause results to differ materially from those expressed in the estimates made by third parties and by us.

 

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USE OF PROCEEDS

We estimate that the net proceeds to us from this offering will be approximately$                million, or approximately $                million if the underwritersexercise in full their option to purchase additional shares from us, in each case after deducting the underwriting discounts and commissions and estimated offering expenses payable by us and based on an assumed initial public offering price of$                per share, which is the midpoint of the price range set forth on the cover page of this prospectus.

Each $1.00 increase or decrease in the assumed initial public offering price of$                per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease the net proceeds to usfrom this offering by approximately $                million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus,remains the same, and after deducting underwriting discounts and commissions payable by us. We may also increase or decrease the number of shares we are offering. Each 1,000,000 share increase or decrease in the number of shares offered by us wouldincrease or decrease the net proceeds to us from this offering by approximately $                million, assuming that the assumed initial public offering price remainsthe same, and after deducting underwriting discounts and commissions payable by us.

We intend to use the net proceeds ofthis offering as follows:

 

  

approximately$                million to fund the clinical development of CIN-107 for the treatment of hypertension through the completion ofour ongoing Phase 2 BrigHtn clinical trial, our ongoing Phase 2 HALO clinical trial and initial preparations for our planned Phase 3 clinical trials in hypertension, as well as initial preparations for commercialization, if approved;

 

  

approximately$                million to fund the clinical development of CIN-107 for the treatment of PA through the completion of ourongoing Phase 2 spark-PA clinical trial;

 

  

approximately$                million to fund the clinical development of CIN-107 to explore its utility in ameliorating complications of CKDthrough the completion of our planned Phase 2 clinical trial; and

 

  

the remaining proceeds for working capital and general corporate purposes.

Based on our planned use of the net proceeds from this offering and our existing cash and cash equivalents, we estimate thatsuch funds will be sufficient to fund our operating expenses and capital expenditure requirements through             . We have based this estimate on assumptions that may prove to bewrong, and we could use our available capital resources sooner than we expect. The expected net proceeds from this offering, together with our existing cash and cash equivalents, will not be sufficient for us to fundCIN-107 through regulatory approval in any indication, and we will need to raise additional capital to complete the development and commercialization, if approved, ofCIN-107 for hypertension as well as any indication expansion opportunities.

Thisexpected use of net proceeds from this offering represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. We may also use a portion of the netproceeds to in-license, acquire or invest in additional businesses, technologies, products or assets. We cannot predict with certainty all of the particular uses for the net proceeds to be received upon thecompletion of this offering or the amounts that we will actually spend on the uses set forth above. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering. See “RiskFactors—Risks Related to This Offering and Ownership of Our Common Stock—We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.”

Pending our use of proceeds from this offering, we plan to invest these net proceeds in a variety of capital preservationinstruments, including short term, interest bearing obligations and investment grade instruments.

 

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DIVIDEND POLICY

We have never declared or paid any dividends on our capital stock. We currently intend to retain all available funds and anyfuture earnings for the operation and expansion of our business and, therefore, we do not anticipate declaring or paying cash dividends in the foreseeable future. The payment of dividends will be at the discretion of our board of directors and willdepend on our results of operations, capital requirements, financial condition, prospects, contractual arrangements, any limitations on payment of dividends present in any future debt agreements and other factors that our board of directors may deemrelevant.

 

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CAPITALIZATION

The following table sets forth our cash and cash equivalents and our capitalization as of September 30, 2021:

 

  

on an actual basis;

 

  

on a pro forma basis to give effect to (i) the conversion of all outstanding shares of our preferredstock, including 2,013,749 shares of our Series B preferred stock issued in a subsequent closing on October 5, 2021, into an aggregate of                shares ofour common stock, as if such conversion had occurred on September 30, 2021 (ii) the automatic net exercise of the three outstanding warrants held by Roche Finance Ltd., or the Roche Warrants, for an aggregate of                 shares of our common stock immediately prior to the effectiveness of the registration statement of which this prospectus forms a part (assuming aninitial public offering price of $                 per share, which is the midpoint of the price range listed on the cover page of this prospectus); and (iii) thefiling and effectiveness of our amended and restated certificate of incorporation upon the closing of this offering; and

 

  

on a pro forma as adjusted basis to give further effect to our issuance and saleof                shares of common stock in this offering at an assumed initial public offering price of$                per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discountsand commissions and estimated offering expenses payable by us.

Our capitalization following the closingof this offering will depend on the actual initial public offering price and other terms of this offering determined at pricing. You should read this information in conjunction with our financial statements and the related notes appearing at the endof this prospectus, the section of this prospectus titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other financial information contained in this prospectus.

 

   As of September 30, 2021 
   Actual  Pro Forma   ProForma
As Adjusted(1)
 
   (in thousands, except share and
per share amounts)
 

Cash and cash equivalents

  $141,708  $                $             
  

 

 

  

 

 

   

 

 

 

Redeemable convertible preferred stock

     

Series A preferred stock, par value $0.00001; 35,714,282 shares authorized, 35,714,282 sharesissued and outstanding, actual, and no shares authorized and outstanding, pro forma and pro forma as adjusted

  $47,173  $    $  

Series B preferred stock, par value $0.00001; 35,716,249 shares authorized, 33,702,500 sharesissued and outstanding, actual, and no shares authorized and outstanding, pro forma and pro forma as adjusted

  $133,353  $    $  

Stockholders’ (deficit) equity:

     

Common stock, $0.00001 par value; 95,000,000 shares authorized;             shares issued and outstanding, actual;              shares authorized, pro forma and pro forma as adjusted;             shares issued and outstanding, pro forma;              shares issued and outstanding, pro forma as adjusted

   1    

Additional paid-in capital

   3,553    

Accumulated deficit

   (48,360   

Total stockholders’ (deficit) equity

   (44,806   
  

 

 

  

 

 

   

 

 

 

Total capitalization

  $277,428  $    $  
  

 

 

  

 

 

   

 

 

 

 

(1)

Each $1.00 increase or decrease in the assumed initial public offering price of$                 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease the pro forma asadjusted amount of each of cash and cash equivalents, additional paid-in capital, total stockholders’ (deficit) equity and total capitalization by$                 million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting

 

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estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million in the number of shares offered by uswould increase or decrease the pro forma as adjusted amount of each of cash and cash equivalents, additional paid-in capital, total stockholders’ (deficit) equity and total capitalization by$                million, assuming no change in the assumed initial public offering price per share and after deducting estimated underwriting discounts and commissionsand estimated offering expenses payable by us.

The number of shares of our common stock outstanding inthe table above excludes:

 

  

5,057,647 shares of our common stock issuable upon the exercise of options under the 2019 Plan, outstanding asof September 30, 2021, at a weighted-average exercise price of $1.34 per share;

 

  

            shares of our common stock issuableupon the exercise of options under the 2019 Plan granted subsequent to September 30, 2021, at a weighted-average exercise price of $    per share;

 

  

            shares of our common stock reservedfor future issuance under the 2019 Plan, which shares will cease to be available for issuance at the time the 2022 Plan, becomes effective and will be added to, and become available for issuance under, the 2022 Plan;

 

  

            shares of our common stock reservedfor future issuance under the 2022 Plan, which will become effective in connection with this offering, as well as any automatic increases in the number of shares of common stock reserved for future issuance under the 2022 Plan; and

 

  

            shares of our common stock reservedfor future issuance under the ESPP, which will become effective in connection with this offering, as well as any automatic increases in the number of shares of common stock reserved for future issuance under the ESPP.

 

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DILUTION

If you invest in our common stock in this offering, your ownership interest will be immediately diluted to the extent of thedifference between the initial public offering price per share and the pro forma as adjusted net tangible book value per share of our common stock after this offering.

As of September 30, 2021, we had a historical net tangible book value (deficit) of $(44,806) million, or $(7.60) pershare of common stock. Our historical net tangible book value (deficit) per share represents total tangible assets less total liabilities and preferred stock, divided by the number of shares of our common stock outstanding as of September 30,2021.

Our pro forma net tangible book value as of September 30, 2021 was$                million, or $                per share of our common stock. Pro formanet tangible book value represents the amount of our total tangible assets less our total liabilities, after giving effect to (i) the conversion of all outstanding shares of our preferred stock, including 2,013,749 shares of our Series Bpreferred stock issued in a subsequent closing on October 5, 2021, into an aggregate of                 shares of our common stock as if such conversion had occurred onSeptember 30, 2021; and (ii) the automatic net exercise of the Roche Warrants for an aggregate of shares of our common stock immediately prior to the effectiveness of the registration statement of which this prospectus forms a part (assuming aninitial public offering price of $                 per share, which is the midpoint of the price range listed on the cover page of this prospectus). Pro forma nettangible book value per share represents pro forma net tangible book value divided by the total number of shares outstanding as of September 30, 2021, after giving effect to those pro forma adjustments.

After giving further effect to the sale of                 shares of common stock in this offering at an assumed initial public offering price of$                 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the estimated underwritingdiscounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of September 30, 2021 would have been$                 million, or $                 per share. This amount represents animmediate increase in pro forma net tangible book value of $                 per share to our existing stockholders and immediate dilution of$                 per share to new investors in this offering. We determine dilution by subtracting the pro forma as adjusted net tangible book value per share afterthis offering from the amount of cash that a new investor paid for a share of common stock in this offering.

Thefollowing table illustrates this dilution:

 

Assumed initial public offering price per share

   $             

Historical net tangible book value (deficit) per share as of September 30, 2021

  $(7.60 

Pro forma decrease in net tangible book value (deficit) per share attributable to the pro formatransactions described above

   
  

 

 

  

Pro forma net tangible book value per share as of September 30, 2021

   

Increase in pro forma as adjusted net tangible book value per share attributable to new investorsparticipating in this offering

   
  

 

 

  

Pro forma as adjusted net tangible book value per share after this offering

   

Dilution per share to new investors participating in this offering

   $  
   

 

 

 

The dilution information discussed above is illustrative only and will change based on theactual initial public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed initial public offering price of$                 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease the pro forma asadjusted net tangible book value per share after this offering by $                , and dilution in pro forma net tangible book value per share to new investors by$                , assuming that the number of shares offered by us, as set forth on the cover page of

 

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this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. An increase of 1,000,000 shares in the numberof shares we are offering would increase the pro forma as adjusted net tangible book value per share after this offering by $                and decrease the dilutionper share to new investors participating in this offering by $                , assuming no change in the assumed initial public offering price per share and afterdeducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. A decrease of 1,000,000 shares in the number of shares we are offering would decrease the pro forma as adjusted net tangible book value pershare after this offering by $                and increase the dilution per share to new investors participating in this offering by$                , assuming no change in the assumed initial public offering price per share and after deducting the estimated underwriting discounts and commissions andestimated offering expenses payable by us.

If the underwriters exercise their option to purchase additional shares of ourcommon stock in full, the pro forma as adjusted net tangible book value after this offering would be $                 per share, the increase in pro forma net tangiblebook value would be $                 per share and the dilution to new investors would be$                 per share, in each case assuming an initial public offering price of$                 per share, which is the midpoint of the price range set forth on the cover page of this prospectus.

The following table summarizes, as of September 30, 2021, on the pro forma as adjusted basis described above, thedifferences between the number of shares purchased from us, the total consideration paid to us in cash and the average price per share that existing stockholders and new investors paid for such shares. This calculation is based on an assumed initialpublic offering price of $                 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting theestimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

   

 

Total Shares

  

 

Total Consideration

  Weighted-
Average
Price Per Share
 
   Number   Percent  Amount   Percent 

Existing stockholders

          $                      $                      

New investors

                      
  

 

 

   

 

 

  

 

 

   

 

 

  

Total

     100  

$            

    100 
  

 

 

   

 

 

  

 

 

   

 

 

  

The foregoing tables and calculations are based on the number of                 shares of our common stock outstanding as of September 30, 2021, after giving effect to (i) the automatic conversion of all outstanding sharesof our preferred stock, including 2,013,749 shares of our Series B preferred stock issued in a subsequent closing on October 5, 2021, into an aggregateof                shares of common stock upon the closing of this offering; and (ii) the automatic net exercise of the Roche Warrants for an aggregateof                shares of our common stock immediately prior to the effectiveness of the registration statement of which this prospectus forms a part (assuming aninitial public offering price of $                per share, which is the midpoint of the price range listed on the cover page of this prospectus), and excludes:

 

  

5,057,647 shares of our common stock issuable upon the exercise of options under the 2019 Plan, outstanding asof September 30, 2021, at a weighted-average exercise price of $1.34 per share;

 

  

            shares of our common stock issuableupon the exercise of options under the 2019 Plan granted subsequent to September 30, 2021, at a weighted-average exercise price of $    per share;

 

  

            shares of our common stock reservedfor future issuance under the 2019 Plan, which shares will cease to be available for issuance at the time the 2022 Plan, becomes effective and will be added to, and become available for issuance under, the 2022 Plan;

 

  

            shares of our common stock reservedfor future issuance under the 2022 Plan, which will become effective in connection with this offering, as well as any automatic increases in the number of shares of common stock reserved for future issuance under the 2022 Plan; and

 

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                shares of ourcommon stock reserved for future issuance under the ESPP, which will become effective in connection with this offering, as well as any automatic increases in the number of shares of common stock reserved for future issuance under the ESPP.

To the extent that stock options are exercised, new stock options are issued under our equity incentiveplan or we issue additional shares of common stock in the future, there will be further dilution to investors participating in this offering. In addition, we may choose to raise additional capital because of market conditions or strategicconsiderations, even if we believe that we have sufficient funds for our current or future operating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result infurther dilution to our stockholders.

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONAND RESULTS OF

OPERATIONS

The following discussion and analysis should be read with our financial statements and related notes included elsewhere inthis prospectus. This discussion and analysis and other parts of this prospectus contain forward-looking statements based upon current beliefs that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives,expectations, intentions and projections. Our actual results and the timing of selected events could differ materially from those described in or implied by these forward-looking statements as a result of several factors, including those set forthunder “Risk Factors” and elsewhere in this prospectus. You should carefully read the “Risk Factors” section of this prospectus to gain an understanding of the important factors that could cause actual results to differ materiallyfrom our forward-looking statements. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”

Overview

We are a clinical-stage biopharmaceutical company focused on developing our lead clinical candidate, CIN-107, for the treatment of hypertension and other cardio-renal diseases. CIN-107 is a highly selective, oral small molecule inhibitor of aldosterone synthase, the enzymeresponsible for the synthesis of aldosterone in the adrenal gland. CIN-107 has been designed to use a differentiated mechanism of action, direct inhibition of aldosterone synthase production, with the goal of providing an improved treatment forpatients suffering from hypertension, or high blood pressure. Despite the widespread availability of multiple antihypertensive agents, there remains a significant unmet medical need as more than half of the 108 million hypertensive patients in theUnited States do not achieve blood pressure control. We are evaluating the efficacy and safety profile of CIN-107 as a potential treatment for a broad hypertensive population, including differentsubpopulations of hypertensive patients who have not achieved blood pressure control despite treatment. We are conducting a Phase 2 clinical trial, which we refer to as our BrigHtn trial, of CIN-107 inpatients whose blood pressure is not controlled despite treatment with three antihypertensive agents, including a diuretic, which is referred to as treatment resistant hypertension, or rHTN, and recently initiated a separate Phase 2 clinical trial,which we refer to as our HALO trial, in patients with elevated aldosterone levels whose blood pressure is not controlled despite treatment with one antihypertensive agent, which is referred to as uncontrolled hypertension, or uHTN. In addition tohypertension, we are developing CIN-107 for the treatment of primary aldosteronism, or PA, and exploring its utility in ameliorating complications of chronic kidney disease, or CKD. Earlier this year, we initiated a Phase 2 clinical trial of CIN-107in patients with confirmed PA, which we refer to as our spark-PA trial, and plan to initiate a Phase 2 clinical trial in patients with CKD who have uncontrolled blood pressure in the first half of 2022.

We were incorporated in March 2018 as a subsidiary of CinRx Pharma, LLC, a biotechnology company focused on developing noveltherapeutics, or CinRx. Since our inception, we have focused primarily on raising capital, organizing and staffing our company, business planning, and acquiring and progressing our lead product candidate,CIN-107, through clinical development after in-licensing the compound from F. Hoffmann-La Roche Ltd and Hoffmann La-Roche Inc., whom we collectively refer to in this prospectus as Roche, in 2019. We spun out as an independent company in 2019 after the closing of our Series A preferred stock financing and the execution of our in-licensing transaction with Roche.

We do not have any product candidates approved forsale and have not generated any revenue from product sales. From inception through September 30, 2021, we have funded our operations primarily through equity financings, and have raised an aggregate of approximately $186 million of gross proceedsfrom the sale of shares of our preferred stock. As of September 30, 2021, we had cash and cash equivalents on hand of $141.7 million. Subsequent to September 30, 2021, we received $8.1 million in aggregate gross proceeds from the sale of2,013,749 shares of our Series B preferred stock.

Since inception, we have incurred significant operating losses.Our net losses were $5.0 million and $22.3 million for the years ended December 31, 2019 and 2020, respectively, and $16.5 million and $21.0

 

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million for the nine months ended September 30, 2020 and 2021, respectively. As of September 30, 2021, we had an accumulated deficit of $48.3 million. We expect to continue to incur significantand increasing expenses and operating losses for the foreseeable future, as we advance CIN-107 through clinical development and seek regulatory approval, pursue indication expansion of CIN-107, maintain and expand our intellectual property portfolio, as well as hire additional personnel, pay for accounting, audit, legal, regulatory and consulting services, and pay costs associated with maintainingcompliance with Nasdaq listing rules and the requirements of the U.S. Securities and Exchange Commission, or SEC, director and officer liability insurance, investor and public relations activities and other expenses associated with operating as apublic company. Our net losses may fluctuate significantly from quarter-to-quarter andyear-to-year, depending on the timing of our preclinical studies, our clinical trials and our expenditures on other research and development activities.

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtainregulatory approval for CIN-107 or any future product candidates, if ever. In addition, if we obtain regulatory approval for CIN-107 or any future product candidates and do not enter into a third-party commercialization partnership, we expect toincur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities. As a result, we will need substantial additional funding to support our continuingoperations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources,such as potential collaboration agreements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Our failure toraise capital or enter into such agreements as, and when, needed, could have a negative effect on our business, results of operations and financial condition. If we are unable to obtain funding, we will be forced to delay, reduce or eliminate someor all of our research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. Although we continue to pursue these plans,there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all.

Impact of COVID-19 on Our Business

We have been actively monitoring the impact of the COVID-19 pandemic on our business.To date, we have not experienced a material financial statement impact or business disruptions, including with our vendors or third parties, as a result of the COVID-19 pandemic. However, we cannot, at thistime, predict the specific extent, duration or full impact that the COVID-19 pandemic will have on our financial statements and operations, including our ongoing and planned preclinical activities and futureclinical trials. The extent of the impact of the COVID-19 pandemic on our business, operations and clinical development timelines and plans remains uncertain and will depend on certain developments, includingthe duration and spread of the pandemic and its impact on our contract research organizations, or CROs, third-party manufacturers, and other third parties with which we do business, as well as its impact on regulatory authorities and our keyscientific and management personnel. To the extent possible, we are conducting business as usual, with necessary or advisable modifications to employee travel. We will continue to actively monitor the rapidly evolving situation related to COVID-19 pandemic and may take further actions that alter our operations, including those that may be required by federal, state or local authorities, or that we determine are in the best interests of our employeesand other third parties with which we do business. If we or any of the third parties with whom we engage were to experience shutdowns or other prolonged business disruptions due to the COVID-19 pandemic, ourability to conduct our business in the manner and on the timelines presently planned could have a material adverse impact on our business, results of operation and financial condition.

Roche License Agreement

Below is a summary of the key terms for our license agreement with Roche. For a more detailed description, see the sectiontitled “Business—License Agreement with Roche” elsewhere in this prospectus as well as Note 4 to our audited financial statements.

 

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In May 2019, following the closing of the initial tranche of our Series Apreferred stock financing, we entered into a license agreement, or the Roche Agreement, with Roche, pursuant to which we obtained an exclusive, worldwide, royalty-bearing license under certain patents and specifiedknow-how owned or controlled by Roche and Roche’s interest in joint patents and covering certain specified small molecule aldosterone synthase inhibitors, or the Roche Technology, to research, develop,register, use, make, import, export, market, distribute, sell (as well as the right to have each of the foregoing done) and otherwise exploit products containing such aldosterone synthase inhibitors, or the Licensed Products, for any and all uses,including the treatment, prevention or diagnosis of any and all diseases and medical conditions in humans and animals.

Pursuant to the Roche Agreement, we paid Roche a one-time, upfront non-refundable license fee of $2.0 million and one $1.0 million milestone payment in connection with the completion of the multiple ascending dose Phase 1 clinical trial of CIN-107. We are required to payRoche an additional $40.0 million in aggregate payments with respect to the first Licensed Product upon the achievement of certain development and regulatory milestone events. Additionally, we are required to pay Roche, on a one-time basis, up to $175.0 million in the aggregate upon the achievement of specified net sales milestones for a Licensed Product. In addition, on a Licensed Product-by-Licensed Product and country-by-country basis, we will be obligated to pay Roche tiered royalties on net sales ofLicensed Products at percentages ranging from the mid single-digits to 10%.

Components of Results of Operations

Revenue

To date, we have not recognized any revenue from any sources, including from product sales, and we do not expect to generateany revenue from the sale of products in the foreseeable future. If our development efforts for CIN-107 or any future product candidate is successful and results in regulatory approval, we may generate revenuein the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.

Researchand Development Expenses

Research and development expenses consist primarily of costs incurred for our researchactivities, including our research and discovery efforts and the development of CIN-107 or any future product candidates. We expense research and development costs as incurred, which include:

 

  

external research and development expenses incurred under arrangements with third parties, such as CROs, aswell as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;

 

  

costs related to acquiring, developing, and manufacturing clinical study material for our preclinical studiesand clinical trials, including fees paid to contract manufacturing organizations, or CMOs;

 

  

laboratory supplies and research materials;

 

  

upfront, milestone and maintenance fees incurred under license, acquisition and other third-party agreements;and

 

  

costs related to compliance with clinical regulatory requirements.

Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasksusing data such as information provided to us by our vendors and clinical sites and analyzing the progress of clinical trials or other services performed. Significant judgment and estimates are made in determining the accrued expense balances at theend of any reporting period.

We track external research and development costs on a program-by-program basis. External costs include fees paid to consultants, contractors and vendors, including CMOs and CROs, in connection with our clinical activities. We currently only have one productdevelopment program, CIN-107.

 

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Research and development activities will continue to be central to ourbusiness model. We anticipate that our research and development expenses will increase for the foreseeable future as we advance our product candidates through clinical trials, as well as acquire new product candidates. We also expect higheremployee-related expenses, including higher stock-based compensation expenses, as well as higher consulting costs as we hire additional resources to support increasing development activity.

The successful development of CIN-107 or any future product candidate is highlyuncertain. We cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete development of CIN-107 or any future product candidate due to theinherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We are also unable to predict when, ifever, material net cash inflows will commence from the sale of CIN-107 or any future product candidate, if they are approved.

The duration, costs and timing of the clinical development of our product candidates will depend on a variety of factors thatinclude, but are not limited to, the following:

 

  

the scope, rate of progress, and expenses of our ongoing research activities as well as any preclinicalstudies and clinical trials and other research and development activities;

 

  

the number and scope of clinical programs we decide to pursue;

 

  

the uncertainties in clinical trial design and patient enrollment rates;

 

  

establishing an appropriate safety and efficacy profile;

 

  

successful enrollment in and completion of clinical trials;

 

  

whether CIN-107 shows safety and efficacy in our clinical trials;

 

  

the timing, receipt and terms of marketing approvals from applicable regulatory authorities;

 

  

making arrangements with third-party CMOs for manufacturing;

 

  

obtaining and maintaining patent and trade secret protection and regulatory exclusivity for CIN-107 and any future product candidate;

 

  

commercializing product candidates, if and when approved, whether alone or in collaboration with others; and

 

  

continued acceptable safety profile of the products following any regulatory approval.

A change in the outcome of any of these variables with respect to the development ofCIN-107 or any future product candidate would significantly change the costs and timing associated with the development of those product candidates. We may never succeed in achieving regulatory approval forany product candidate. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on other product candidates. For example, if the U.S. Food and DrugAdministration, the European Medicines Agency, or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experiencesignificant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.

General and Administrative Expenses

General and administrative expenses consist primarily of compensation and employee-related costs for our finance, humanresources and other administrative personnel, including salaries, benefits and other related costs,

 

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as well as expenses for outside professional services, including legal, accounting and audit services and other consulting fees, rent expense, and other general administrative expenses, andstock-based compensation, to a lesser extent.

We expect our general and administrative expenses will increase in thefuture as we increase our headcount to support our continued research activities and development of our product candidates, potential commercialization efforts, and increased costs associated with being a public company. These increases will likelyinclude additional costs related to the hiring of new personnel, including higher stock-based compensation expenses, and fees to outside consultants, as well as other expenses. We also anticipate that we will incur significantly increasedaccounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company.

Amended and Restated Management Services Agreement with CinRx Pharma

In April 2020, we entered into the Management Services Agreement, with CinRx pursuant to which CinRx provide us with certainprofessional services. The Management Services Agreement has a term of two years, and is automatically renewable for successive one-year periods unless terminated. In exchange for services provided to us underthe Management Services Agreement, we pay CinRx monthly fees for management services calculated based on costs incurred by CinRx in the provision of services to us, plus a reasonable mark-up. As ofDecember 31, 2019 and 2020, $0.8 million and $1.6 million, respectively, and as of the nine months ended September 30, 2020 and 2021, $1.2 million and $1.0 million, respectively, of these fees are included in general and administrative expenseson our statements of operations and comprehensive loss. We provided notice to terminate the Management Services Agreement on November 4, 2021. Pursuant to the terms of the Master Services Agreement, the termination shall become effective no laterthan February 2, 2022. See the section titled “Certain Relationships and Related Party Transactions—CinRx Pharma, LLC” elsewhere in this prospectus for more information.

Interest Income

Interestincome consists primarily of interest income received on our cash and cash equivalents.

Change in Fair Value of Warrant Derivative Liabilities

The change in fair value of warrant derivative liabilities consists of the change in fair value related to the threefreestanding detachable stock purchase warrants issued to Roche in connection with the Roche Agreement, which we collectively refer to as the Roche Warrants. The first Roche Warrant, which was issued in connection with our Series A preferred stockfinancing, is exercisable for 1,400,000 shares of our common stock. The second Roche Warrant, issued in connection with our Series A preferred stock financing, is exercisable for 1,120,476 shares of our common stock. The third Roche Warrant, issuedin connection with our Series B preferred stock financing, is exercisable for 386,271 shares of our common stock. The Roche Warrants are collectively exercisable for 2,906,747 shares of our common stock at an exercise price of $0.01 per share. TheRoche Warrants will automatically net exercise in whole immediately prior to the effectiveness of the registration statement of which this prospectus forms a part.

The grant date fair value of the Roche Warrants are calculated using the Black Scholes valuation model. The valuation modelsused require the input of subjective assumptions, including assumptions about the expected life of the Roche Warrant, share price volatility and as a privately held company, the estimated fair value of our common stock. These assumptions usedrepresent our best estimates at the time of issuance and in subsequent reporting periods, but the estimates involve inherent uncertainties and the application of our judgment.

 

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Results of Operations

Comparison of Years Ended December 31, 2019 and 2020

The following table summarizes our results of operations for each of the years presented:

 

   Year Ended December 31, 
           2019                  2020         

Operating expenses

   

Research and development

  $3,926  $17,952 

General and administrative

   1,211   3,173 
  

 

 

  

 

 

 

Total operating expenses

   5,137   21,125 
  

 

 

  

 

 

 

Loss from operations

   5,137   21,125 

Interest income

   (102  (37

Change in fair value of warrant derivative liabilities

      1,210 
  

 

 

  

 

 

 

Total other (income) expense

   (102  1,173 

Net and comprehensive loss

  $5,035  $22,298 

Research and Development Expenses

Research and development expenses for the year ended December 31, 2020 were $18.0 million, compared to$3.9 million for the year ended December 31, 2019. The increase of $14.1 million, or 362%, was primarily due to the initiation of several Phase 2 clinical trials including our ongoing Phase 2 BrigHtn clinical trial as well as ourPhase 2 spark-PA clinical trial.

General and Administrative Expenses

General and administrative expenses were $3.2 million for the year ended December 31, 2020, compared to$1.2 million for the year ended December 31, 2019. The increase of $2.0 million, or 167%, was the result of increased payroll and personnel related costs under our Management Services Agreement with CinRx, legal and professional feesand other costs associated with operating activities.

Interest Income

Interest income was $37 thousand for the year ended December 31, 2020, compared to $102 thousand for the year endedDecember 31, 2019, reflecting interest earned on cash equivalents. The difference was attributed primarily to lower interest rates compared to the year ended December 31, 2019.

Change in Fair Value of Warrant Derivative Liabilities

The change in the fair value of the warrant derivative liabilities was $1.2 million for the year ended December 31,2020. The Roche Warrants were issued in connection with the Roche Agreement and in connection with our Series A preferred stock financing in 2019, with an additional warrant issued in connection with our Series B preferred stock financing. Based onthe timing of the issuance of the Roche Warrants in 2019, there was no change in fair value of warrant derivative liabilities recognized for the year ended December 31, 2019. We classify these warrants as a liability on our balance sheets which weremeasure to fair value at each reporting date. We recognize changes in the fair value of the warrant derivative liabilities as a component of other (income) expense in our statements of operations and comprehensive loss. We will continue torecognize changes in the fair value of the warrant derivative liabilities until the warrants are exercised, expire or qualify for equity classification.

 

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Comparison of Nine Months Ended September 30, 2020 and 2021

The following table summarizes our results of operations for each of the periods presented:

 

   Nine Months
Ended September 30,
 
   2020  2021 

Research and development

  $12,829  $10,131 

General and administrative

   2,783   7,147 
  

 

 

  

 

 

 

Total operating expenses

   15,612   17,278 
  

 

 

  

 

 

 

Loss from operations

   15,612   17,278 

Interest income

   (30  (8

Change in fair value of warrant derivative liabilities

   907   3,756 
  

 

 

  

 

 

 

Total other expense

   877   3,748 

Net and comprehensive loss

  $16,489  $21,026 

Research and Development Expenses

Research and development expenses for the nine months ended September 30, 2021 were $10.1 million, compared to $12.8 millionfor the nine months ended September 30, 2020. The decrease of $2.7 million, or 21%, was primarily due to the work related to several Phase 2 clinical trials.

General and Administrative Expenses

General and administrative expenses were $7.1 million for the nine months ended September 30, 2021, compared to $2.8 millionfor the nine months ended September 30, 2020. The increase of $4.3 million, or 154%, was the result of increased payroll and personnel-related costs, legal and professional fees and other costs associated with operating activities.

Interest Income

Interest income was $8 thousand for the nine months ended September 30, 2021 and $30 thousand for the nine months endedSeptember 30, 2020, reflecting interest earned on cash equivalents. The difference was attributed primarily to a lower cash balance as well as lower interest rates compared to the nine months ended September 30, 2020.

Change in Fair Value of Warrant Derivative Liabilities

The change in the fair value of the warrant derivative liabilities was $3.8 million for the nine months ended September 30,2021 as compared to $0.9 million for the nine months ended September 30, 2020. The increase of $2.9 million or 322% increase is due to the increase in the fair value of the common stock underlying the Roche Warrants. The Roche Warrants were issuedin connection with the Roche Agreement, in connection with our Series A preferred stock financing in 2019 and in connection with our Series B preferred stock financing in 2021. We classify these warrants as a liability on our balance sheets which weremeasure to fair value at each reporting date. We recognize changes in the fair value of the warrant derivative liabilities as a component of other (income) expense in our condensed statements of operations and comprehensive loss. We will continueto recognize changes in the fair value of the warrant derivative liabilities until the warrants are exercised, expire or qualify for equity classification.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from ouroperations. We have not yet commercialized any product and we do not expect to generate

 

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revenue from sales of any products for several years, if at all. From inception through September 30, 2021, we have funded our operations primarily through equity financings, and have raised anaggregate of approximately $186 million of gross proceeds from the sale of shares of our preferred stock. As of September 30, 2021, we had cash and cash equivalents on hand of $141.7 million. Subsequent to September 30, 2021, we received$8.1 million in aggregate gross proceeds from the sale of 2,013,749 shares of our Series B preferred stock.

Cash Flows

Comparison of Years Ended December 31, 2019 and 2020

The following table summarizes our cash flows for each of the years presented:

 

   Year Ended December 31, 
           2019                  2020         

Net cash used in operating activities

  $(4,430 $(17,396

Net cash provided by investing activities

       

Net cash provided by financing activities

   15,914   31,990 
  

 

 

  

 

 

 

Net increase in cash and cash equivalents

  $11,484  $14,594 
  

 

 

  

 

 

 

Operating Activities

We have historically experienced negative operating cash outflows as we continue clinical development of CIN-107. Our net cash used in operating activities primarily results from our net and comprehensive loss adjusted for non-cash expenses and changes in working capitalcomponents. Our primary uses of cash from operating activities are amounts due to CROs for the conduct of our clinical programs and employee-related expenditures for research and development, and general and administrative activities. Our cash flowsfrom operating activities will continue to be affected by spending to advance and support our clinical development and other operating and general administrative activities.

For the year ended December 31, 2020, net cash used in operating activities was $17.4 million and was primarilyrelated to cash payments for clinical development activities and personnel-related costs under our Management Services Agreement with CinRx, legal and professional fees and other costs associated with operating activities.

For the year ended December 31, 2019, net cash used in operating activities was $4.4 million and was primarilyrelated to cash payments for clinical development activities and certain professional fees and other costs associated with operating activities.

Investing Activities

During the years ended December 31, 2019 and 2020, we had no cash flows from investing activities.

Financing Activities

Net cash provided by financing activities for the year ended December 31, 2020 was $32.0 million, consisting of netproceeds from the issuance of Series A preferred stock in August 2020. Net cash provided by financing activities for the year ended December 31, 2019 was $15.9 million, consisting of net proceeds from the issuance of Series A preferredstock in May 2019.

 

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Comparison of Nine Months Ended September 30, 2020 and 2021

The following table summarizes our cash flows for each of the periods presented:

 

   Nine Months
Ended September 30,
 
   2020  2021 

Net cash used in operating activities

  $(12,320 $(19,822

Net cash provided by investing activities

       

Net cash provided by financing activities

   31,990   135,452 
  

 

 

  

 

 

 

Net increase in cash and cash equivalents

  $19,700  $115,630 
  

 

 

  

 

 

 

Operating Activities

We have historically experienced negative operating cash outflows as we continue clinical development of CIN-107. Our net cashused in operating activities primarily results from our net and comprehensive loss adjusted for non-cash expenses and changes in working capital components. Our primary uses of cash from operating activities are amounts due to CROs for the conductof our clinical programs and employee-related expenditures for research and development, and general and administrative activities. Our cash flows from operating activities will continue to be affected by spending to advance and support our clinicaldevelopment and other operating and general administrative activities.

For the nine months ended September 30, 2021, netcash used in operating activities was $19.8 million and was related to cash payments for clinical development activities and personnel related costs under our Management Services Agreement with CinRx, legal and professional fees and other costsassociated with operating activities.

For the nine months ended September 30, 2020, net cash used in operating activitieswas $12.3 million and was primarily as a result of our net and comprehensive loss of $16.8 million, which includes $0.9 million of non-cash expense related to the change in fair value of warrant derivative liabilities, offset by $2.9 million fromchanges in working capital.

Investing Activities

During the nine months ended September 30, 2020 and 2021, we had no cash flows from investing activities.

Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2021 was $135.0 million, consisting of netproceeds from the issuance of Series B preferred stock in September 2021. Net cash provided by financing activities for the nine months ended September 30, 2020 was $32.0 million, consisting of net proceeds from the issuance of Series A preferredstock in August 2020.

Funding Requirements

As of September 30, 2021, our cash and cash equivalents on hand was $141.7 million. We believe that the net proceeds fromthe October 2021 closing of our Series B financing and this offering, together with our existing cash and cash equivalents, will enable us to fund our operating expenses and capital expenditure requirements through            . We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect.

We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidatesthrough preclinical and clinical development, seek regulatory approval and pursue commercialization of any approved product candidates. We expect that our research and development and general and administrative costs will increase in connection withour planned clinical development activities. In addition, upon the completion of this offering, we expect to incur additional costs associated with operating as a public company.

 

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We have based this estimate on assumptions that may prove to be wrong, andwe could exhaust our capital resources sooner than we expect. If we receive regulatory approval for CIN-107, we expect to incur significant commercialization expenses related to product manufacturing, sales,marketing and distribution, depending on where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.

Our future capital requirements will depend on a number of factors, including:

 

  

the costs of conducting preclinical studies and clinical trials;

 

  

the scope, progress, results and costs of discovery, preclinical development, laboratory testing, and clinicaltrials for product candidates we may develop, if any;

 

  

the costs, timing, and outcome of regulatory review of our product candidates;

 

  

our ability to establish and maintain collaborations on favorable terms, if at all;

 

  

the achievement of milestones or occurrence of other developments that trigger payments under any license orcollaboration agreements we might have at such time;

 

  

the costs and timing of future commercialization activities, including product sales, marketing, manufacturingand distribution, for any of our product candidates for which we receive marketing approval;

 

  

the amount of revenue, if any, received from commercial sales of our product candidates, should any of ourproduct candidates receive marketing approval;

 

  

the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining and enforcing ourintellectual property rights, and defending intellectual property-related claims;

 

  

our headcount growth and associated costs as we expand our business operations and research and developmentactivities;

 

  

the costs of building out internal accounting, legal, compliance and other operational and administrativefunctions, including after any expiration or termination of the Management Services Agreement;

 

  

the timing and size of any milestone payments required under our existing or future arrangements, includingthe Roche Agreement; and

 

  

the costs of operating as a public company.

The net proceeds of this offering, together with our existing cash and cash equivalents, will not be sufficient to completedevelopment of CIN-107 or any other product candidate. Accordingly, we will be required to obtain further funding to achieve our long-term business objectives.

Until such time, if ever, as we can generate substantial revenue, we expect to finance our cash needs through a combination ofpublic or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity orconvertible debt securities, your ownership interests may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect your rights as a common stockholder. Debt financing, if available, mayinvolve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct ourbusiness.

If we raise funds through potential collaborations, strategic alliances or licensing arrangements with thirdparties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us. If we are unable to raise

 

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additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market productcandidates that we would otherwise prefer to develop and market ourselves.

Contractual Obligations and Commitments

License Agreement Obligations

License agreement obligations relate to the Roche Agreement that we entered into with Roche in May 2019. Under the terms of theRoche Agreement, we obtained an exclusive, worldwide, royalty-bearing license to the Roche Technology to research, develop, manufacture, and commercialize to a novel aldosterone synthase inhibitor compound,CIN-107. Pursuant to the Roche Agreement, we paid Roche a one-time, upfront non-refundable license fee of $2.0 million and one$1.0 million milestone payment in connection with the completion of the multiple ascending dose Phase 1 clinical trial of CIN-107. We are required to pay Roche certain tiered development event-based milestone payments, certain sales-based milestonepayments, as well as a royalty from the future sales of Licensed Products. The royalty is tiered based on the combined net sales of each Licensed Product.

As of September 30, 2021, we were unable to estimate the timing or likelihood of achieving these clinical and commercialmilestones or generating future product sales. See the section titled “Business—License Agreement with Roche” elsewhere in this prospectus as well as Note 4 to our audited financial statements appearing elsewhere in this prospectusfor a description of our license agreement with Roche.

Purchase and Other Obligations

In the normal course of business, we enter into contracts with CROs and other third parties for conducting research anddevelopment activities, preclinical studies and clinical trials, research and development supplies and other testing and manufacturing services. The scope of the services under these contracts can be modified and provide for termination on notice,and therefore are cancellable contracts. These payments are not included in the table above as the amount and timing of such payments are not known as of September 30, 2021.

Off-Balance Sheet Arrangements

During periods presented, we did not have any off-balance sheet arrangements as definedby SEC rules.

Critical Accounting Policies and Significant Judgments and Estimates

This management’s discussion and analysis is based on our financial statements, which have been prepared in accordancewith U.S. generally accepted accounting principles. The preparation of the financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and related disclosures. On an ongoingbasis, we evaluate our estimates and assumptions. Our estimates are based on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances. Actual results may differ from theseestimates under different assumptions or conditions.

On an ongoing basis, we evaluate our judgments and estimates inlight of changes in circumstances, facts, and experience. The effects of material revisions in estimates, if any, will be reflected in the financial statements prospectively from the date of change in estimates.

While our accounting policies are described in more detail in the notes to our audited financial statements appearingelsewhere in this prospectus, we believe the following accounting policies used in the preparation of our financial statements require the most significant judgments and estimates. See Note 2 to our audited financial statements included elsewhere inthis prospectus for a description of our other significant accounting policies.

 

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Prepaid and Accrued Research and Development Expenses

As part of the process of preparing our financial statements, we are required to estimate our prepaid and accrued research anddevelopment expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associatedcost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed. We make estimates of our prepaid and accruedresearch and development expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at the time. We confirm the accuracy of estimates with the service providers and make adjustments if necessary.Examples of estimated prepaid and accrued research and development expenses include expenses for:

 

  

CROs in connection with clinical studies;

 

  

investigative sites in connection with clinical studies;

 

  

vendors in connection with preclinical development activities; and

 

  

vendors related to product manufacturing, development and distribution of clinical materials.

We base our expenses related to clinical studies on our estimates of the services received and effortsexpended pursuant to contracts with multiple CROs that conduct and manage clinical studies on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Thescope of services under these contracts can be modified and some of the agreements may be cancelled by either party upon written notice. There may be instances in which payments made to our vendors will exceed the level of services provided andresult in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical study milestones. In accruing service fees, we estimate the timeperiod over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid accordingly.

Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates ofthe status and timing of services performed differ from the actual status and timing of services performed, we may report amounts that are too high or too low in any particular period. To date, there have been no material differences between ourestimates and amounts actually incurred.

Warrant Derivative Instruments including Determination of the Fair Value of UnderlyingCommon Stock

We account for derivatives, specifically freestanding detachable stock purchase warrants, inaccordance with Accounting Standards Codification Topic 815, Derivatives and Hedging. This guidance establishes accounting and reporting principles for derivative instruments, including certain derivative instruments embedded in othercontracts. The Roche Warrants which are discussed previously are valued using the Black Scholes valuation model. The Black Scholes valuation was determined using assumptions that are subjective and require significant judgement and estimationby management, including the fair value of our common stock, as discussed below. Other assumptions include the risk-free rate, expected volatility, term and dividend yield, if applicable. The risk-free rate assumption was based on observed yieldsfrom governmental zero-coupon bonds. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose stock prices are publicly available. The peergroup was developed based on companies in the therapeutics and pharmaceutical industries.

Determination of the Fair Value of Common Stock

As there has been no public market for our common stock to date, the estimated fair value of our common stock has beendetermined by our board of directors as of each reporting date, with input from management,

 

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considering third-party valuations of our common stock as well as our board of directors’ assessment of additional objective and subjective factors that it believed were relevant and whichmay have changed from the date of the most recent third-party valuation to each reporting date. These third-party valuations of our common stock were determined in accordance with the guidelines outlined in the American Institute of Certified PublicAccountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation, or AICPA Practice Aid. The assumptions used in the valuation model were based on future expectations combinedwith management judgment.

In addition to considering the results of these third-party valuations, our board of directorsconsidered various objective and subjective factors to determine the fair value of our common stock as of each reporting date, which may be a date later than the most recent third-party valuation date, including:

 

  

the prices at which we sold preferred stock and the superior rights and preferences of the preferred stockrelative to our common stock at the time of each reporting date;

 

  

the progress of our research and development programs, including the status of ongoing and planned clinicaltrials;

 

  

our stage of development and our business strategy;

 

  

external market conditions affecting the biotechnology industry, and trends within the biotechnology industry;

 

  

our financial position, including cash on hand, and our historical and forecasted performance and operatingresults;

 

  

the lack of an active public market for our common stock and our preferred stock;

 

  

the likelihood of achieving a liquidity event, such as an initial public offering, or IPO, or a sale of ourcompany in light of prevailing market conditions; and

 

  

the analysis of IPOs and the market performance of similar companies in the biopharmaceutical industry.

The assumptions underlying these valuations represent management’s best estimates, which involveinherent uncertainties and the application of management judgment. As a result, if factors or expected outcomes change and we use significantly different assumptions or estimates, our analysis and related statement of operations and comprehensiveloss impact could be materially different.

Following the closing of this offering, the fair value of our common stockwill be determined based on the quoted market price of our common stock.

Emerging Growth Company Status and Smaller Reporting Company Status

We are an “emerging growth company,” or EGC, under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.Section 107 of the JOBS Act provides that an EGC can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an EGC can delay theadoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of the delayed adoption of new or revised accounting standards and, therefore, we will be subject to thesame requirements to adopt new or revised accounting standards as private entities.

As an EGC, we may also take advantageof certain exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an EGC:

 

  

we are presenting only two years of audited financial statements and only two years of relatedManagement’s Discussion and Analysis of Financial Condition and Results of Operations in this prospectus;

 

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we will avail ourselves of the exemption from providing an auditor’s attestation report on our internalcontrol over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;

 

  

we will avail ourselves of the exemption from complying with any requirement that may be adopted by the PublicCompany Accounting Oversight Board, or PCAOB, regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion andanalysis;

 

  

we are providing reduced disclosure about our executive compensation arrangements; and

 

  

we will not require nonbinding advisory votes on executive compensation or stockholder approval of any goldenparachute payments.

We will remain an EGC until the earliest of (i) December 31, 2027, (ii)the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more, (iii) the date on which we have issued more than $1 billion in non-convertible debt duringthe previous rolling three-year period, or (iv) the date on which we are deemed to be a large accelerated filer under the Securities Exchange Act of 1934, as amended, or the Exchange Act.

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to us as a result of this offering is less than $700 million and our annual revenue was less than $100 million during the most recentlycompleted fiscal year. We may continue to be a smaller reporting company after this offering if either (i) the market value of our stock held by non-affiliates is less than $250 million or(ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million.

If we are a smaller reporting company at the time we cease to be an EGC, we may continue to rely on exemptions from certaindisclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to EGCs, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Recently Issued and Adopted Accounting Pronouncements

Other than as disclosed in Note 2 to our audited financial statements appearing elsewhere in this prospectus, we do not expectthat any recently issued accounting standards will have a material impact on our financial statements or will otherwise apply to our operations.

 

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BUSINESS

Overview

We are aclinical-stage biopharmaceutical company focused on developing our lead clinical candidate, CIN-107, for the treatment of hypertension and other cardio-renal diseases.CIN-107 is a highly selective, oral small molecule inhibitor of aldosterone synthase, the enzyme responsible for the synthesis of aldosterone in the adrenal gland. CIN-107 has been designed to usedifferentiated mechanism of action, direct inhibition of aldosterone synthase production, with the goal of providing an improved treatment for patients suffering from hypertension, or high blood pressure. Despite the widespread availability ofmultiple antihypertensive agents, there remains a significant unmet medical need as more than half of the 108 million hypertensive patients in the United States do not achieve blood pressure control. We are evaluating the efficacy and safety profileof CIN-107 as a potential treatment for a broad hypertensive population, including different subpopulations of hypertensive patients who have not achieved blood pressure control despite treatment. We areconducting a Phase 2 clinical trial, which we refer to as our BrigHtn trial, of CIN-107 in patients whose blood pressure is not controlled despite treatment with three antihypertensive agents, including adiuretic, which is referred to as treatment resistant hypertension, or rHTN, and recently initiated a separate Phase 2 clinical trial, which we refer to as our HALO trial, in patients with elevated aldosterone levels whose blood pressure is notcontrolled despite treatment with one antihypertensive agent, which is referred to as uncontrolled hypertension, or uHTN. In addition to hypertension, we are developing CIN-107 for the treatment of primary aldosteronism, or PA, and exploring itsutility in ameliorating complications of chronic kidney disease, or CKD. Earlier this year, we initiated a Phase 2 clinical trial of CIN-107 in patients with confirmed PA, which we refer to as our spark-PAtrial, and plan to initiate a Phase 2 clinical trial in patients with CKD who have uncontrolled blood pressure in the first half of 2022.

In August 2021, we conducted a review of blinded, preliminary safety data from our ongoing BrigHtn trial on 124 patients whohad either completed 12 weeks of treatment or withdrew from the trial. The purpose of this blinded data review was to enable an assessment of the overall management and conduct of the trial, without unblinding any individual patient data. Due to thepreliminary and blinded nature of the data, this interim data set was not subject to the standard quality control measures typically associated with final clinical trial results. The mean systolic blood pressure, or SBP, at baseline was 147 mm Hgand, following 12 weeks, SBP levels declined to a mean of 132 mm Hg for the 124 patients included in the review, including patients in the placebo cohort. Due to the blinded nature of the BrigHtn trial, we currently do not know if participantsreceiving CIN-107 experienced any decrease in blood pressure, or if the decreases in blood pressure, if any, differed from participants receiving a placebo. In addition, the BrigHtn trial is ongoing, and we will not know whether treatment withCIN-107 lowers blood pressure in a clinically meaningful manner until all clinical trials we intend to complete prior to submitting a request for marketing authorization have been conducted and the U.S. Food and Drug Administration, or the FDA,makes its efficacy determination. Furthermore, this preliminary data is not subject to the same quality control measures as final data, which creates a risk that the final results could be materially different from the preliminary results observedin this blinded data review. We expect to announce top-line data from the final results of this trial in the second half of 2022.

Aldosterone is a steroid hormone synthesized in the adrenal gland that regulates water and salt balance in the human body. Itcauses retention of water and salt by the kidney, a genomic effect that contributes to the pathogenesis of hypertension. In addition to this genomic effect, aldosterone induces certain indirect, non-genomiceffects, including pro-inflammatory and pro-fibrotic effects, increases in oxidative stress, as well as cardiac muscle cell hypertrophy and remodeling. Increasingevidence shows a correlation between these non-genomic effects of aldosterone and a worsening of patient outcomes, particularly in patients who have heart disease or kidney disease. Given these potentiallydeleterious effects of aldosterone, inhibiting its effects is a well understood mechanism of action for the treatment of hypertension and other cardio-renal diseases, such as PA and CKD.

 

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Hypertension is one of the world’s leading causes of mortality.According to the United States Centers for Disease Control and Prevention, or the U.S. CDC, approximately 500,000 people still die every year in the United States with uncontrolled blood pressure listed as a primary or secondary cause of death.Despite decades of understanding the importance of controlling hypertension and the widespread availability of multiple approved therapies, only 43.7% of the 108 million U.S. adults with hypertension achieve blood pressure levels of less than 140/90mm Hg, despite the recommended target blood pressure goal being less than 130/80 mm Hg. Although the evidence for the benefits of reducing blood pressure is overwhelming and has consistently supported the medical community’s recommendations todrive blood pressure to lower levels, the current standard-of-care has not meaningfully changed, with no new classes of antihypertensive agents approved in more than adecade.

There are multiplestandard-of-care antihypertensive agents currently available, including angiotensin converting enzyme, or ACE, inhibitors and angiotensin receptor blockers, or ARBs,which are designed to inhibit the production of aldosterone at different points along the renin angiotensin-aldosterone system, or RAAS, axis, as well as mineralocorticoid receptor antagonists, or MRAs, which block the effects of aldosterone at themineralocorticoid receptor. Despite the widespread availability and use of these antihypertensive agents, many of which are available as generic products, each class of drugs currently available is associated with significant limitations, includinglimited efficacy, limited duration of aldosterone lowering effect and multiple side effects. Given both the importance of reducing aldosterone and the limitations of currently available therapies, we believe thatCIN-107 has the potential to have a significant impact on the treatment paradigm for hypertension and other cardio-renal diseases.

Our Pipeline

We aredeveloping CIN-107 for the treatment of multiple diseases where aldosterone plays a significant role in disease pathophysiology, including hypertension and PA. We are also exploring its utility in amelioratingcomplications of CKD. To support the advancement of this “pipeline-in-a-product” opportunity, we are currentlyconducting and plan to initiate additional Phase 2 clinical trials of CIN-107 for different indications and patient populations. The following table summarizes ourCIN-107 pipeline across multiple indications.

 

LOGO

*

We plan to initiate a Phase 2 clinical trial to evaluate the efficacy and safety of CIN-107 in patients withCKD who have uncontrolled blood pressure. As we explore the utility of CIN-107 in treating hypertension in patient with CKD, we will evaluate the best path for maximizing the value of CIN-107, including as a monotherapy or in combination with othertreatments for the treatment of CKD.

 

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Our Corporate History and Team

We were incorporated in March 2018 as a subsidiary of CinRx Pharma, LLC, a biotechnology company focused on developing noveltherapeutics. In May 2019, we entered into an agreement with F. Hoffmann-La Roche Ltd and Hoffmann La-Roche Inc., whom we collectively refer to in this prospectus as Roche, for an exclusive, worldwide, royalty-bearing license to certain Rochetechnology to research, develop, manufacture, and commercialize a novel aldosterone synthase inhibitor compound, CIN-107, for any and all diseases and conditions. In connection with the closing of our Series Apreferred stock financing and the execution of our in-licensing transaction with Roche, we spun out as an independent company. For further information, please see the section titled “Certain Relationshipsand Related Party Transactions—CinRx Pharma, LLC” elsewhere in this prospectus.

Our co-founders and senior management team have extensive leadership and scientific experience in cardiovascular and specialty drug discovery and development. Our Chief Executive Officer, Marc de Garidel, has over 35years of leadership experience in the biopharmaceutical industry and is currently the chairman of the board of directors of Ipsen S.A. Prior to joining us, Mr. de Garidel served as chief executive officer of Corvidia Therapeutics, which was sold toNovo Nordisk in July 2020 for up to $2.1 billion, and prior to that, he served as chief executive officer of Ipsen S.A. Our Executive Vice President, Chief Financial Officer and Chief Business Development Officer, Mary Theresa Coelho, M.B.A.,has an accomplished track record as a leader across finance, business development and operations for public biopharmaceutical and other publicly traded and private companies. Our Executive Vice President, Clinical Development, Mason Freeman, M.D.,has been deeply involved in the development of multiple, novel medicines that are now approved for commercial sale in the United States to treat lipid disorders, heart failure, hyperkalemia, Cushing’s disease, and diabetes. Our Chief OperatingOfficer and co-founder, Catherine Pearce, M.B.A., D.H.Sc., has over 20 years of clinical and business development experience, and previously held the position of vice president of research at TevaPharmaceuticals. Since our inception, we have raised an aggregate of approximately $192.9 million from leading life sciences investors, including General Atlantic, Sofinnova Investments, Sofinnova Partners, and 5AM Ventures.

Our Strategy

Ourstrategy is focused on developing and commercializing CIN-107 for the treatment of multiple cardio-renal diseases in which aldosterone is known to play a significant role in the disease pathophysiology,including hypertension and PA. We are also exploring its utility in ameliorating complications of CKD. Key elements of our strategy include the following:

 

  

Advance CIN-107 through clinical development for the treatment ofhypertension. We are currently conducting our BrigHtn trial in patients with rHTN, and expect topline data in the second half of 2022. While we expect the FDA to provide a label for hypertension broadly, ifCIN-107 is approved, we plan to focus our initial commercial efforts on patients with rHTN, which represents a patient population of approximately 12-15 millionindividuals in the United States who have limited treatment options and significant unmet medical need.

 

  

Expand the hypertension opportunity for CIN-107 to include patientswith uHTN and use as an earlier line of therapy. Despite the widespread availability of multiple, generic antihypertensive agents, which are often used in combination, an overwhelming number of patients are considered to have uHTN because theycontinue to fail to reach target blood pressure goals. There is growing evidence in scientific literature demonstrating that elevated aldosterone levels play a direct role in the pathogenesis of hypertension in the broader hypertensive population.Therefore, we believe a highly selective aldosterone synthase inhibitor, like CIN-107, that is designed to specifically target aldosterone production may address one of the primary underlying causes ofhypertension, thereby allowing more patients to achieve their target blood pressure goal with fewer antihypertensive agents. We believe CIN-107 may provide clinical benefit for patients at an earlier point intheir course of treatment than currently available treatments, as opposed to waiting until the patient fails to achieve blood pressure control with three or more antihypertensive agents. To evaluate the potential of

 

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CIN-107 as an earlier line of therapy and in a broader patient population, we recently initiated our HALO trial in patients with elevated aldosteronelevels who failed to achieve blood pressure control on one antihypertensive agent.

 

  

Leverage the clinical development of CIN-107 in hypertension, ifsuccessful, to efficiently develop CIN-107 for the treatment of PA. PA results from the autonomous production of excess aldosterone and affects approximately 5-10%of the total hypertensive population in the United States. This population is associated with worse outcomes and higher risks of cardiovascular events than the general hypertensive population. Therefore, it is important to identify these patients atan early stage in order to control their blood pressure. However, PA is currently underdiagnosed due to the complexity of the diagnostic guidelines and the inherent variability in plasma aldosterone measurements. We initiated our spark-PA trial earlier this year to evaluate the potential of CIN-107 as a treatment for hypertension in patients with PA. Based on recent literature, we are using themeasurement of 24-hour urine aldosterone levels in addition to plasma aldosterone levels to assess aldosterone status in patients participating in the trial. We believe the adoption of a 24-hour urine aldosterone measurement could improve PA diagnosis rates and provide an improved approach to identifying the patients who are most likely to benefit from treatment withCIN-107.

 

  

Develop CIN-107 as a potentially differentiated treatment for CKDby modifying disease progression. Multiple third-party clinical trials and meta-analyses have demonstrated that blocking the effect of aldosterone reduces proteinuria and delays the progression of CKD. Long-term use of current standard-of-care agents for CKD are associated with aldosterone breakthrough, where patients experience aldosterone levels reverting back to or exceeding baseline, and canlead to poor patient outcomes. Based on the results of our preclinical and Phase 1 clinical trials of CIN-107, we plan to initiate a Phase 2 clinical trial to evaluate the efficacy and safety of CIN-107 inpatients with CKD who have uncontrolled blood pressure in the first half of 2022.

 

  

Opportunistically evaluate strategic partnerships to maximize the value ofCIN-107. We acquired the exclusive worldwide rights to CIN-107 from Roche. As we advance the development of CIN-107 acrossmultiple diseases and continue to generate additional non-clinical and clinical data, we will evaluate the best path for maximizing the value of CIN-107, including incombination with other treatments for certain indications, such as CKD. For certain geographies, we may opportunistically enter into strategic partnerships to accelerate the development and maximize the commercial potential of CIN-107. In addition, there are several diseases where aldosterone plays a significant role, such as heart failure, that we do not currently plan to pursue on our own but may seek to opportunistically partner withone or more third parties in order to further expand the commercial potential of CIN-107.

The Significant Role of Aldosterone in Multiple Cardio-renal Disease Pathogenesis

Aldosterone is a steroid hormone synthesized in the adrenal gland that stimulates the absorption of sodium in the kidneys andregulates water and salt balance in the human body. As shown in the graphic below, aldosterone is one of the three key components of the RAAS, an endocrine system that plays an important role in regulating blood pressure and electrolyte andfluid balance. When blood flow into the kidney is reduced or there is a drop in blood pressure, the RAAS is activated and the kidney secretes renin into blood circulation. Renin converts angiotensinogen, a protein produced by the liver and releasedinto circulation, into angiotensin I. The ACE, which is found predominantly on the surface of vascular endothelial cells of the lungs, subsequently converts angiotensin I into angiotensin II. Angiotensin II stimulates the secretion ofaldosterone from the adrenal cortex. Aldosterone binds to intracellular receptors and activates the mineralocorticoid receptor in the kidney, resulting in increased sodium absorption, which increases the body’s fluid load and thereby increasesblood pressure, accomplishing the original objective set forth by the activation of the RAAS. In the process of sodium absorption, potassium is exchanged and released into the urine. This overall effect of aldosterone on the kidney, which is drivenby the binding of aldosterone to intracellular receptors that then control the transcription of several genes, is referred to as its genomic effect.

 

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The Role of Aldosterone in RAAS

 

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Under normal conditions, the RAAS achieves a physiological equilibrium between the kidneyand the adrenal gland mediated by the effects of renin from the kidney and aldosterone from the adrenal gland. However, when the RAAS is abnormally active, excess levels of aldosterone are produced, leading to increased salt and fluid retention andresulting in increases in circulating blood volume, which contributes to the pathogenesis of hypertension. In certain situations, aldosterone can be produced independent of the activation of the RAAS and secretion of renin. In these cases ofrenin-independent aldosterone production, the level of plasma aldosterone is greater than what is physiologically needed based on the level of plasma renin released by the kidney.

Recent scientific literature has demonstrated that there is a prevalent continuum of renin-independent aldosterone productionthat parallels the severity of hypertension. A study conducted by Dr. Jenifer Brown et al, which was published in the Annals of Internal Medicine in July 2020, evaluated urinary aldosterone excretion rates in patients with confirmedrenin-independent aldosterone production across different stages of hypertension: normal (less than 130/80 mm Hg); stage 1 (130-139/80-89 mm Hg); stage 2 (equal to or greater than 140/90 mm Hg); and rHTN (greater than 130/80 mm Hg), despitetreatment with three or more antihypertensive agents one of which is a diuretic. As shown in the figure below, this study demonstrated a strong correlation between aldosterone levels and severity of hypertension. In addition, this study showedminimal to no differences when aldosterone levels were adjusted for age, body mass index, race, sex, history of diabetes and 24-hour urinary sodium excretion.

 

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Correlation of Renin-Independent Aldosterone Production by Blood Pressure Category

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There are many conditions that lead to renin-independent aldosterone production, including:PA, where there is autonomous secretion of aldosterone by the adrenal gland; body mass index, or BMI, above average levels, particularly male type obesity with excess fat in the abdominal or waist area; sleep apnea syndrome, a sleep disorder inwhich breathing repeatedly stops and starts; and endothelial dysfunction, a type of vascular disease due to constricted blood vessels.

In addition to the genomic effects of aldosterone discussed above, aldosterone induces certain indirect, non-genomic effects that occur without the transcription of any genes, including pro-inflammatory and pro-fibrotic effects, increasesin oxidative stress, as well as cardiac muscle cell hypertrophy and remodeling. Increasing evidence shows a correlation between these non-genomic effects of aldosterone and a worsening of patient outcomes,particularly in patients who have heart disease or kidney disease. For example, scientific literature suggests the non-genomic effects of aldosterone contribute to the progression of CKD. Hypertension is oneof the major causes of CKD, and many patients with CKD from other causes, such as diabetes, also have hypertension. Multiple third-party clinical trials and meta-analyses have demonstrated that reducing aldosterone levels in patients with CKD, andthereby mitigating the non-genomic effects of aldosterone and lowering blood pressure, leads to a reduction in proteinuria and delays the progression of the disease.

Currently Available Treatments Involving Aldosterone Inhibition Relating to RAAS

Given the potentially deleterious effects of aldosterone described above, inhibiting its effects is a well understood mechanismof action for the treatment of hypertension and other cardio-renal diseases, such as PA and CKD. When plasma aldosterone levels are reduced or blocked, the reverse of the natural RAAS process occurs. Instead of the kidney retaining sodium and water,sodium is lost through urine and, in exchange, potassium is retained. This results in a reduction in plasma sodium levels and an increase in plasma potassium levels, which leads to a reduction in blood volume and thus has a blood pressure loweringeffect. Many standard-of-care antihypertensive agents, such as ACE inhibitors, ARBs, which are also known as angiotensin II receptor antagonists, and MRAs, are designedto inhibit the production or effects of aldosterone at different points of the RAAS axis, as shown below. In addition to these currently available antihypertensive agents, there are multiple aldosterone synthase inhibitors, including CIN-107, in clinical development, which are designed to directly inhibit aldosterone synthesis.

 

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Antihypertensive Agents Inhibit the Production or Effects of Aldosterone at DifferentPoints of the RAAS Axis

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Despite the widespread availability and use of antihypertensive agents, each class of drugscurrently available is associated with significant limitations. For example, a significant proportion of patients taking ACE inhibitors and ARBs for prolonged periods of time experience aldosterone breakthrough, where plasma aldosterone levelsreturn to or exceed baseline levels. In addition, the extent of aldosterone reduction achieved with ACE inhibitors and ARBs is less than what could be achieved with aldosterone synthase inhibitors that directly inhibit aldosterone synthesis. In thecase of MRAs, blocking the effects of aldosterone at the mineralocorticoid receptor level often leads to increases in aldosterone synthesis, which ultimately requires higher doses of the MRA agent to compensate for these effects. Furthermore, withthe MRAs that are currently available, particularly spironolactone, there are multiple side effects that prevent their widespread use, including a variety of anti-androgenic effects such as breast tenderness and enlargement in men, decreased libidoin men and menstrual irregularities in woman. In addition, spironolactone treatment can lead to potentially harmful increases in blood potassium levels. Given both the importance of reducing aldosterone and the limitations of currently availabletherapies, we believe that CIN-107 has the potential to have a significant impact on the treatment paradigm for hypertension and other cardio-renal diseases.

CIN-107—A Highly Selective Aldosterone Synthase Inhibitor

Overview

CIN-107 is a highly selective, oral, small molecule inhibitor of aldosterone synthase,the enzyme responsible for the synthesis of aldosterone in the adrenal gland. We are developing CIN-107 for the treatment of multiple diseases where aldosterone plays a significant role, including hypertensionand PA. We are also exploring its utility in ameliorating complications of CKD. A robust Phase 1 clinical development program for CIN-107 has been conducted, with approximately 180 individuals dosed acrossmultiple conducted clinical trials. CIN-107 was shown to be well tolerated in healthy volunteers, with no serious adverse events, or SAEs, or treatment-emergent adverse events, or TEAEs, leading to treatmentwithdrawal associated with CIN-107. In addition, a Phase 1 clinical trial was conducted in subjects with varying degrees of renal function. In this trial, one SAE not related to CIN-107 was observed.

 

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We are currently conducting our BrigHTN trial of CIN-107 in patients withrHTN. In August 2021, we conducted a review of blinded, preliminary safety data from this trial on and reviewed data from 124 patients who had either completed 12 weeks of treatment or withdrew from the trial. The purpose of this blinded data reviewwas to enable an assessment of the overall management and conduct of the trial, without unblinding any individual patient data. Due to the preliminary and blinded nature of the data, this interim data set was not subject to the standard qualitycontrol measures typically associated with final clinical trial results. The mean SBP at baseline was 147 mm Hg and, following 12 weeks, SBP levels declined to a mean of 132 mm Hg for the 124 patients included in the review, including patients inthe placebo cohort. Due to the blinded nature of the BrigHtn trial, we currently do not know if participants receiving CIN-107 experienced any decrease in blood pressure, or if the decreases in blood pressure, if any, differed from participantsreceiving a placebo. In addition, the BrigHtn trial is ongoing, and we will not know whether treatment with CIN-107 lowers blood pressure in a clinically meaningful manner until all clinical trials we intend to complete prior to submitting a requestfor marketing authorization have been conducted and the FDA makes its efficacy determination. Furthermore, this preliminary data is not subject to the same quality control measures as final data, which creates a risk that the final results could bematerially different from the preliminary results observed in this blinded data review.

In addition to rHTN, we initiatedour spark-PA trial of CIN-107 in patients with PA earlier this year. We also recently initiated our HALO trial in patients with elevated aldosterone levels with uHTN andplan to initiate a separate Phase 2 clinical trial in patients with CKD who have uncontrolled blood pressure in the first half of 2022.

Mechanism of Action of CIN-107

Directly inhibiting aldosterone synthesis has long been a goal in therapeutic drug development as the relationship betweenelevated levels of aldosterone and the progression of multiple diseases is well understood. However, the challenge has been developing a molecule with the ability to safely inhibit aldosterone production without negatively impacting cortisolsynthesis. The major enzymes responsible for the synthesis of aldosterone and cortisol share approximately 93% amino acid sequence similarity, and therefore, a highly selective aldosterone synthesis inhibitor is required. Multiple programs indevelopment by others have been discontinued over the past several years due to, what we believe is, their product candidates’ lack of selectivity, which resulted in the simultaneous inhibition of both aldosterone and cortisol. Off-target suppression of cortisol leads to compromised stress and immunologic responses, adverse impact on metabolic functions and increased risk of mortality.

CIN-107 was designed with high selectivity to specifically overcome this challenge. Inparticular, CIN-107 selectively targets aldosterone synthase, which is encoded by the CYP11B2 gene. Importantly, it has low affinity for 11ß-hydroxylase, the enzyme responsible for cortisol synthesis,which is encoded by the CYP11B1 gene. In multiple preclinical in vivo studies, CIN-107 significantly lowered aldosterone levels without affecting cortisol levels across a wide range of doses. Similarobservations were made in multiple Phase 1 clinical trials in healthy volunteers. We observed a dose-dependent reduction of plasma aldosterone levels with patients receiving a 10 mg dose demonstrating an approximately 85% to 90% reduction inthe single ascending dose trial, and with patients receiving a 1.5 mg to 5 mg dose range demonstrating a 65% to 71% reduction in the multiple ascending dose trial. These reductions were compared to baseline levels measured the day prior toinitial dosing and were not observed in individuals receiving a placebo. Importantly, no effects on cortisol levels were observed at doses up to 360 mg, the highest dose evaluated. In the multiple ascending dose trial, for doses up to 5 mgonce-daily administered for 10 days, there was no observed suppression of cortisol synthesis.

Phase 1 Development of CIN-107

To date, multiple Phase 1 clinical trials of CIN-107 have been conducted in healthy volunteers to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CIN-107, as summarized in the table below. CIN-107 was well tolerated in healthy volunteers across all Phase 1 clinical trials conducted to date, with no

 

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serious adverse events, or SAEs, or treatment-emergent adverse events, or TEAEs, leading to treatment withdrawal associated with CIN-107. In addition, aPhase 1 clinical trial was conducted in subjects with varying degrees of renal function. In this trial, one SAE not related to CIN-107 was observed.

Summary of Completed Phase 1 Clinical Trials of CIN-107

 

Trial ID

 

Trial Description/N

 

Study Objectives

 

Key Observations

WP28586 Part 1 

•   Single oral dose of CIN-107 at seven different doses ranging from 1 mg to 360 mg in fasted state

 

•   64 healthy male volunteers (48 CIN-107, 16placebo)

 

Primary objectives:

 

•   To assessthe safety and tolerability of oral single ascending doses, or SAD, of CIN-107 in healthy male subjects

 

•   To investigate the pharmacokinetics of CIN-107after single oral doses and if appropriate, its metabolite(s)

 

•   To assess pharmacodynamic effects of CIN-107 aftersingle oral doses (under normal salt and low salt diet and following a Cortrosyn test).

 

Secondary objective:

 

•   To assess the pharmacokinetics of a single IV dose ofCIN-107 in healthy male subjects

 

 

•   Significantreductions of aldosterone levels (70% to 80%) observed, beginning at the 1 mg dose, increasing with dose level

 

•   No effect observed on cortisol levels at all doses tested following an ACTH, or Cotrosyn,stimulation test, where subjects were administered ACTH, a hormone secreted by the pituitary gland, to stimulate the production of aldosterone and cortisol

 

•   100% selectivity observed up to 90 mg

 

•   Partial impactobserved on the precursors of cortisol at doses above 90 mg, but no effect observed on actual cortisol levels up to 360 mg

 

•   Pharmacokinetics profile for CIN-107 that issupportive of once-daily dosing

 

•   No clinically relevant differences observed between fasted, low salt diet or normal saltdiet conditions

 

 Part 2A 

•   Single oral dose of CIN-107 (1mg, 3 mg and 10 mg) under low salt diet or normal salt diet conditions

 

•   24 healthy male volunteers (18 CIN-107, 6placebo)

 

  Part 2B 

•   Single IV dose of CIN-107 (3 mg)

 

•   8 healthy male volunteers (8 CIN-107)

 

CIN-107-111 

•   Multiple oral doses of CIN- 107 daily for 10 days (0.5 mg, 1.5 mg, 2.5 mg and 5 mg) under low salt diet or normal salt diet conditions

 

•   56 healthy volunteers (42 CIN-107, 14placebo)

 

•   To assess the safety andtolerability of CIN-107 following oral dosing once daily for 10 days under normal and low salt conditions

 

•   To characterize the pharmacokinetics of CIN-107following oral dosing once-daily for 10 days under normal and low salt conditions

 

•   To characterize the pharmacodynamic effects ofCIN-107 following oral

 

•   Multiple doses of CIN-107 resulted in approximately 2x accumulation of CIN-107 in the blood

 

•   Average aldosterone reductions of 65% to 71% at daily doses of CIN-107 of 1.5 mg or greater, regardless of dietary salt intake; reductions were greater in subjects on a low salt diet

 

•   Consistent pharmacokinetics as observed in the SAD trial

 

 

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Trial ID

 

Trial Description/N

 

Study Objectives

 

Key Observations

 

 

  

 

 

dosing once-daily for 10 days under normal and low salt conditions

 

  

 

CIN-107-112 

•   Crossover study to evaluatebioavailability of tablet formulation vs. oral solution and to assess food effect

 

•   Three treatments of CIN-107 separated by 7 days: 5mg oral solution in fasted state; 5 mg tablet in fasted state; 5 mg tablet in fed state

 

•   14 healthy volunteers

 

 

•   To assess the safety andtolerability of CIN-107 following single oral doses of CIN-107 tablet and oral solution

 

•   To determine the relative bioavailability of a tablet formulation of CIN-107 as compared to the oral solution

 

•   To characterize the effect of food on the CIN-107tablet

 

•   To explorethe effects of single doses of CIN-107 on various measures associated with the RAAS.

 

 

•   No meaningful difference inbioavailability observed between tablet formulation and oral solution of CIN-107

 

•   No meaningful difference in pharmacokinetics whenCIN-107 is administered with food

 

CIN-107-113 

•   Single oral dose of 10 mg of CIN-107 to assess safety and pharmacokinetics in individuals with varying degrees of renal function

 

•   10 subjects with eGFR > 60 mL/ min (normal renal function or mild renal impairment)

 

•   11 subjects with eGFRof 15-59 mL/min (moderate to severe renal impairment) and 12 subjects with eGFR < 15 mL/ min (kidney failure; all on dialysis)

 

 

 

•   To assess the safety andtolerability of a single oral dose of CIN-107 administered to subjects with varying degrees of renal function

 

•   To characterize the pharmacokinetics of a single oral dose of CIN-107 administered to subjects with varying degrees of renal function

 

 

•   Data analysis and reviewongoing

 

 

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Trial ID

 

Trial Description/N

 

Study Objectives

 

Key Observations

CIN-107-114 

•   Randomized, open-label, two-period, crossover study to evaluate the

 

effect of CIN-107 on the pharmacokinetics of metformin, in healthy volunteers

 

•   27 healthyvolunteers

 

 

 

•   To assess the impact of CIN-107 on the pharmacokinetics of immediate-release metformin

 

•   To assess the safety and tolerability of co-administration of CIN-107 and metformin as compared to that of metformin alone

 

 

•   Metformin was well tolerated whenadministered alone or 2 hours after a dose of CIN107

 

 

•   CIN107 did not result in an increase in metformin plasma concentrations or a decrease inmetformin renal clearance when compared with administration of metformin alone

 

Single Ascending Dose (SAD) Phase 1 Clinical Trial

A two-part, single ascending dose Phase 1 clinical trial of CIN-107 in healthy malevolunteers evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of CIN-107 ranging from 1 mg to 360 mg. Two hours after the administration of a single dose of CIN-107, the majority of subjects in part 1 of the trial underwent an ACTH challenge, which stimulates the synthesis of both aldosterone and cortisol. Four hours later, the subjects participated in a standingaldosterone challenge, which involved moving from a sitting position to a standing position, a movement that immediately increases aldosterone levels as a normal physiological response, as shown in the blue line for the placebo group in the leftfigure below.

CIN-107 reduced plasma aldosterone levels in a dose-dependentmanner following the ACTH challenge and, in contrast to placebo, reduced levels were maintained following the standing challenge, as shown in the left figure below. Significant reductions of 70% to 80% in aldosterone levels were observed at the 1 mgand 3 mg dose levels, and near complete suppression of aldosterone was observed at the 10 mg and higher doses of CIN-107. The reductions in aldosterone levels increased in a dose-dependent manner until 10 mg,after which the reduction levels plateaued through 360 mg. No effect on plasma cortisol levels was observed at all dose levels tested, as shown by the minimal differences between the CIN-107 treatment groupsand placebo on the right figure below.

CIN-107 Demonstrated Dose-Dependent Suppression ofAldosterone Levels

With No Effect on Cortisol in Healthy Volunteers

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The results of this trial demonstrated CIN-107’s ability to selectivelyinhibit aldosterone synthesis without meaningfully impacting cortisol synthesis.

CIN-107 was well tolerated in healthy volunteers across all doses evaluated in the SADtrial, with no SAEs, treatment discontinuations due to a TEAE or deaths reported. No dose-limiting toxicities were reported and the maximum tolerated dose, or MTD, was at the highest dose tested of 360 mg. The most frequently reported AEsfollowing the administration of a single dose of CIN-107 were headache, nasopharyngitis, diarrhea, asthenia, dizziness and nausea. The majority of AEs reported were considered to be mild and not related to CIN-107. AEs considered to be either moderate in intensity or related to CIN-107 included: two events of moderate gastroenteritis (one from the 180 mg dose cohort and one fromthe placebo group); one event of dizziness considered to be related to CIN-107; one event of fractured coccyx; and one event of concussion. There were no AEs related to markedly abnormal safety laboratoryvalues reported and there were no clinically significant or dose-dependent changes observed over time in vital signs, ocular assessments, cardiac function as measured by electrocardiogram, or ECG, or corrected QT interval by Fridericia formula, orQTcF.

This trial demonstrated a desirable pharmacokinetics profile for CIN-107that is supportive of once-daily dosing. CIN-107 was rapidly absorbed with maximum concentrations in the plasma occurring within one to two hours after administration.CIN-107 plasma concentrations declined from peak in a biphasic manner, with a mean half-life of 25 to 31 hours, which makes CIN-107 conducive to once daily dosing. It was also observed that dietary salt intake did not affect the pharmacokinetics properties of CIN-107.

Multiple Ascending Dose (MAD) Phase 1 Clinical Trial

A randomized, double-blind, multiple ascending dose Phase 1 clinical trial in healthy volunteers evaluated the safety,tolerability, pharmacokinetics and pharmacodynamics of multiple daily doses of CIN-107 ranging from 0.5 mg to 5 mg. A total of 56 subjects were randomized into the trial, with 42 subjects receiving once-dailydoses of CIN-107 and 14 subjects receiving once-daily doses of placebo for ten days. In both groups, subjects were placed either on a low salt diet or a normal salt diet. Subjects in the initial two cohortswere on a low salt diet in order to stimulate aldosterone levels and to enable the evaluation of safety in potential patients who may be following a low salt diet. Subjects in these two cohorts underwent three ACTH challenges: on day -1 (prior to receiving their first dose of CIN-107), on day 1 (after receiving their first dose of CIN-107) and on day 10 (afterreceiving their tenth dose of CIN-107).

As shown in the figure below, averagealdosterone reductions of 65% to 71% were observed after ten days of once-daily dosing of CIN-107 at doses of 1.5 mg or greater, regardless of dietary salt intake. However, the reductions in aldosterone levels appeared to be greater in the subjectswho received a low salt diet. These findings are consistent with those from the SAD trial in which the reductions in aldosterone levels increased in a dose dependent manner up to 3 mg, after which the extent of reductions plateaued.

 

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CIN-107 Demonstrated Dose-Dependent Reductions inPlasma Aldosterone in Healthy Volunteers

 

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Additionally, as shown below, there was an appropriate increase in cortisol levels afterACTH stimulation, and no meaningful difference in the cortisol responses between the ACTH challenge given before administration of CIN-107 and the ACTH challenge given before the tenth dose of CIN-107.

CIN-107 Demonstrated No Meaningful Difference inCortisol Response vs. Placebo

 

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Once-daily administration of CIN-107 for ten dayswas well tolerated in healthy volunteers across all doses tested in the MAD trial. There were no deaths, SAEs or treatment discontinuations due to a TEAE reported, and there were no apparent increases in incidence or severity of AEs with increasingdoses of CIN-107. The most common TEAEs among subjects receiving CIN-107 were headache, postural dizziness and dizziness. All TEAEs reported were mild in severity,except for one moderate event of ventricular tachycardia in a subject receiving placebo. There were no clinically meaningful changes observed in laboratory parameters, physical examination results or cardiac function as measured by ECG, including nomeaningful changes in QTcF.

In this trial, mild and dose-dependent increases in plasma potassium levels and decreases inplasma sodium levels were observed with corresponding changes in urine sodium and potassium levels. However, despite this initial increase in the urine sodium to potassium ratio, which indicates that sodium loss in the urine is greater than thepotassium retention, the ratio was normalized by Day 10 of treatment, suggesting that the balance between sodium excretion and potassium absorption was restored.

The pharmacokinetics observed in this trial were consistent with what was observed in the SAD trial. The data suggests CIN-107 was rapidly absorbed, with maximum concentrations in the plasma occurring within two to three hours after administration. Systemic exposure to CIN-107 demonstrated apredictable increase in plasma concentration and generally in a dose-dependent manner across the dose levels tested. Based on the observed average half-life of CIN-107 of 26 to 31 hours, steady state plasmaconcentrations of CIN-107 were achieved within approximately 5 days of once-daily dosing. At steady state, the plasma accumulation of CIN-107 was observed to beapproximately two times higher with daily dosing as compared to a single dose of CIN-107, which suggests that the blood levels at the 1.5 mg and 5 mg doses in the MAD trial should be comparable to the 3 mg and10 mg doses in the SAD trial.

CIN-107 for the Treatment of Hypertension

The first indication we are pursuing for CIN-107 is hypertension, with an initial focuson the subpopulation of patients with rHTN. We are currently conducting our BrigHtn trial in hypertensive patients who failed to achieve blood pressure control on three antihypertensive agents, including a diuretic, at their maximally tolerateddoses. A review of blinded, preliminary safety data from 124 patients who had either completed 12 weeks of treatment or withdrew from the trial demonstrated an average SBP level of 132 mm Hg, compared to a baseline mean of 147 mm Hg. Due to theblinded nature of the BrigHtn trial, we currently do not know if participants receiving CIN-107 experienced any decrease in blood pressure, or if the decreases in blood pressure, if any, differed from participants receiving a placebo. In addition,the BrigHtn trial is ongoing, and we will not know whether treatment with CIN-107 lowers blood pressure in a clinically meaningful manner until all clinical trials we intend to complete prior to submitting a request for marketing authorization havebeen conducted and the

 

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FDA makes its efficacy determination. Furthermore, this preliminary data is not subject to the same quality control measures as final data, which creates a risk that the final results could bematerially different from the preliminary results observed in this blinded data review. Final topline data from this trial is expected in the second half of 2022.

It is generally well understood that lowering aldosterone levels, regardless of baseline levels, will result in a reduction ofblood pressure. We plan to evaluate the potential efficacy of CIN-107 across the continuum of hypertensive patients, including those with uHTN, where there remains a significant unmet medical need. In additionto our ongoing BrigHtn trial, we recently initiated our HALO trial in hypertensive patients with elevated aldosterone levels who have failed to achieve blood pressure control on one antihypertensive agent at its maximally tolerated dose.

Overview of Hypertension

Hypertension, which is defined by the American College of Cardiology and the American Heart Association as resting bloodpressure above 130/80 mm Hg, is generally acknowledged to be one of the most common preventable risk factors for premature death worldwide. Though often asymptomatic, hypertension significantly increases the risk of heart disease, stroke andkidney disease, amongst other diseases. It is estimated that as much as 20% of the global population suffers from hypertension, and the U.S. Centers for Disease Control estimated that as many as 108 million Americans could be hypertensive.

The main classifications of hypertension are primary hypertension and secondary hypertension. Primary, or essential,hypertension, which accounts for over 90% of total cases, is not associated with any identifiable cause. However, it may be derived from genetic or lifestyle factors. Secondary hypertension, which affects approximately 10% of hypertensiveindividuals, occurs when elevated blood pressure is attributable to other medical conditions, such as kidney disease and PA.

The current standard-of-care for patientsnewly diagnosed with hypertension is based on a set of guidelines set forth by the American College of Cardiology and the American Heart Association. Depending on baseline blood pressure levels, these guidelines recommend the patient typically beginwith lifestyle modifications and then, assuming blood pressure is not controlled, to initiate treatment with antihypertensive agents selected primarily from the following four classes of drugs:

 

  

Thiazide diuretics, which increase fluid excretion from the kidney by blocking reabsorption of sodium andchloride in the nephron;

 

  

ACE inhibitors, which inhibit the RAAS axis by blocking the action of ACE in the lungs;

 

  

ARBs, which block the effects of angiotensin II at the level of the angiotensin receptor; and

 

  

Calcium channel blockers, which slow cardiac contractions by preventing calcium from entering the cells of theheart and arteries.

When baseline blood pressure is relatively high, initial therapy can be comprisedof a combination of two antihypertensive agents. If patients are not adequately controlled on the initial treatment prescribed, physicians may decide to increase the dose of the agents and/or add additional hypertensive agents to a patient’streatment regimen. However, despite the widespread availability and use of many generic antihypertensive agents, as well as the general awareness of the dire consequences of hypertension, the proportion of patients with uncontrolled blood pressurecontinues to grow. In a 2020 study published in the Journal of the American Medical Association, it was shown that the percentage of Americans with hypertension, with blood pressure levels above 140/90 mm Hg in this study, increased from 51.5% in2007/08 to 56.3% in 2017/18.

Moreover, the recently reported Systolic Blood Pressure Intervention Trial, or the SPRINTstudy, presented by the National Institutes of Health’s National Heart, Lung, and Blood Institute in 2020, showed that intensive

 

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blood pressure control to reduce SBP to less than 120 mm Hg resulted in significant cardiovascular benefit in high-risk patients with hypertension compared with routine SBP control to less than140 mm Hg. The SPRINT study demonstrated not only that lower blood pressure correlates with a lower risk of death, but also that setting a target blood pressure goal lower than the standard treatment goal of 140/90 mm Hg prevented many more deaths.Based on these SPRINT results, many guidelines are being revised to now recommend that certain high-risk patients with high blood pressure aim for a target blood pressure goal of 130/80 mm Hg. Globally, only one in seven hypertensive patientsachieve blood pressure control, which means that approximately 86% of the hypertensive patients are unable to control their blood pressure. Among the estimated 489 million patients who are treated with antihypertensive agents, approximately297 million patients are unable to achieve blood pressure control.

Patients who fail to maintain blood pressurelevels of 130/80 mm Hg or less, despite being compliant with at least three antihypertensive agents, including a diuretic, are considered to have rHTN. The rHTN patient population represents an estimated 17% to 20% of the total hypertensivepopulation in the United States, or approximately 12-15 million individuals. For these patients, treatment options are limited and the currentstandard-of-care is to introduce an MRA agent to their antihypertensive regimen. MRAs inhibit the effects of aldosterone by preventing aldosterone from binding with themineralocorticoid receptor. However, MRAs, such as spironolactone, are associated with multiple adverse effects, including a variety of anti-androgenic effects such as breast tenderness and enlargement in men, decreased libido in men and menstrualirregularities in women. In addition, spironolactone treatment can lead to potentially harmful increases in blood potassium levels. Due to these side effects associated with MRAs, many patients are unable to tolerate these agents over the long-term.Newer generations of MRAs, which are non-steroidal and more selective than earlier generations, are in clinical development and have demonstrated less significant potassium fluctuations than observed withcurrently available MRAs, but appear to retain the aldosterone elevating effects and the inability to mitigate the mineralocorticoid receptor-independent effects of aldosterone.

Our Solution—CIN-107

CIN-107 is designed to directly and selectively inhibit aldosterone synthase. Based on its unique mechanism of action, CIN-107 has the potential to achieve the goal of reducing the deleterious genomic and non-genomic effects of aldosterone, regardless of whether aldosterone production isRAAS-mediated or renin-independent, while having minimal effects on plasma potassium, sodium and cortisol levels. In order to evaluate the safety and efficacy of CIN-107 across the continuum of hypertension,our clinical development plan for CIN-107 for the treatment of hypertension includes our ongoing BrigHtn trial in patients with rHTN and our recently initiated HALO trial in patients with uHTN. We chose therHTN patient population for our first Phase 2 clinical trial of CIN-107 based on the high unmet medical need among these patients, the likelihood of reimbursement from payors for this population based onour market analysis, if approved, and the expected translatability of data from this highly difficult-to-treat patient population to less severe hypertensive patients.If our clinical trials are successful, we believe CIN-107 has the potential to improve the treatment options for patients with hypertension, including potential use as an earlier line of therapy.

Phase 2 BrigHtn Clinical Trial in rHTN

Our ongoing BrigHtn trial is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, dose-rangingPhase 2 clinical trial designed to evaluate the safety and efficacy of CIN-107 for the treatment of hypertension. We plan to enroll approximately 260 patients who are adherent to a stable regimen of at least three antihypertensive agents,including one diuretic, for at least four weeks prior to randomization. To ensure adherence, a central pharmacy provides screened patients with their regimen of background hypertensive medications for two weeks followed by an additional 2-weeksingle-blind run-in period, during which adherence to background medications, as measured by pill counts, must be at least 70% in order to be eligible for randomization. Following the 2-week single-blind run-in period, eligible patients who continueto meet the elevated blood pressure criteria are randomized on a 1:1:1 basis to receive 12 weeks of treatment with once-daily

 

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oral doses of 1 mg of CIN-107, 2 mg of CIN-107 or placebo. The primary endpoint of this trial is the change from baseline in mean seated SBP as measured by Automated Office BloodPressure Measurement, or AOBPM, following 12 weeks of treatment. The secondary endpoints of this clinical trial are (i) the change from baseline in mean seated diastolic blood pressure, or DBP, and (ii) the percentage of patientsachieving a seated blood pressure response below 130/80 mm Hg, both after 12 weeks of treatment.

Our BrigHtn trialis a placebo-controlled trial. Placebo effect has been reported in many studies, including hypertension trials. In a publication describing the meta-analysis of a series of hypertension trials that led to the approval by FDA of five antihypertensivedrugs (azilsartan, aliskiren, nebivolol, eplerenone and olmesartan) since 2000, the authors described that blood pressure fell by 5.92 mm Hg on average in the non-treatment-resistant hypertension studies in the placebo arm across 52 trials involving7,451 subjects. The authors also reported on eight resistant hypertension trials in 694 patients, where the average blood pressure reduction in the placebo arm was 8.76 mm Hg. Based on such observations by others, we consistently designed our trialswith a placebo-controlled arm wherever relevant.

When this trial was planned, we did not have any clinical data showingthe reduction in blood pressure as a function of a reduction in aldosterone levels. As expected, the Phase 1 clinical trials in healthy volunteers did not demonstrate significant blood pressure reduction, as these subjects were not hypertensiveand had normal blood pressure levels. Therefore, as shown in the figure below, our BrigHtn trial was designed as an adaptive design trial, which allowed us the flexibility to add an additional dose cohort following a preliminary safety data review.

Design of Our Phase 2 BrigHtn Clinical Trial

 

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Preliminary Safety Data Review Conducted by the DRC

The Data Review Committee, or DRC, conducted the preliminary safety data review after the first 39 randomized patients eithercompleted 12 weeks of treatment or withdrew from the trial or withdrew from the trial. We intentionally scheduled the DRC review at an early point of the trial in order to allow us sufficient time to add and collect data on a fourth dose cohort tothe trial design without substantially extending the duration of the ongoing trial.

In the first half of 2021, the DRCconducted its preliminary safety review based on data from 34 patients who had completed the trial as well as five patients who had discontinued treatment or withdrawn from the trial prematurely. The DRC reviewed clinical and laboratory safety dataand vital sign information, including blood pressure levels, of the 39 patients included in the review, all of which was aggregated by dose cohort. Based on their review, the DRC recommended the addition of a 0.5 mg dose cohort to the ongoingBrigHtn trial. The DRC reported that this recommendation was not based on safety or tolerability concerns, and, rather, was intended to allow for exploration of dose response across a broader range of doses of CIN-107.

 

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Based on the DRC’s recommendation, the fourth cohort of 0.5 mg ofCIN-107 was initiated in August 2021, and since August 2021, the randomization schedule has been adjusted to enable a near equal number of patients across all dose cohorts, including the newly added 0.5 mg dose cohort, to complete 12 weeks oftreatment during the remainder of the trial.

Blinded, Preliminary Interim Data from Ongoing Phase 2 BrigHtn ClinicalTrial

In August 2021, we conducted a review of blinded, preliminary safety data of 124 patients, whichincluded 105 patients who had completed 12 weeks of treatment and 19 patients who had discontinued treatment or withdrawn from the trial. The purpose of this blinded data review was to enable an assessment of the overall management and conduct ofthe trial, without unblinding any individual patient data. Due to the preliminary and blinded nature of the data, this interim data set was not subject to the standard quality control measures typically associated with final clinical trial results.For example, the data that is available at the conclusion of a trial would be unblinded following a data cleansing review, source verification of data using documents from the local clinical trial sites, and other quality control measures to ensurethe highest level of accuracy and fidelity possible. In contrast, the blinded data used for our preliminary safety reviews did not undergo this process and is therefore highly preliminary and not yet validated.

As of August 17, 2021, we have enrolled 169 patients across all four cohorts, including 124 patients from the first threecohorts who have either completed 12 weeks of treatment or withdrew from the trial. The figure below shows the mean SPB levels from baseline through 12 weeks, with the orange line showing the mean of the 39 patients included in the DRC review andthe blue line showing the mean of all 124 who have completed or discontinued treatment. These mean SBP calculations include all patients, regardless of dose cohort, which means that the blood pressure levels shown below include data from theplacebo, 1 mg and 2 mg dose cohorts.

Aggregate Mean SBP in Two Preliminary Reviews of BrigHtn Trial

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As shown above, the mean SBP at baseline was 147 mm Hg for all patients included in thereview, and, following 12 weeks, SBP levels declined to a mean of 132 mm Hg for the 124 patients who had either completed 12 weeks of treatment or withdrew from the trial, and to a mean of 133 mm Hg for the initial 39 patients who were included inthe DRC review. Due to the blinded nature of the BrigHtn trial, we currently do not know if participants receiving CIN-107 experienced any decrease in blood pressure, or if the decreases in blood pressure, if any, differed from participantsreceiving a placebo. In addition, the BrigHtn trial is ongoing, and we will not know whether treatment with CIN-107 lowers blood pressure in a clinically meaningful manner until all clinical trials we intend to complete prior to submitting a requestfor marketing authorization have been conducted and the FDA makes its efficacy determination. Furthermore, this preliminary data is not subject to the same quality control measures as final data, which creates a risk that the final results could bematerially different from the preliminary results observed in this review.

 

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We also reviewed the mean change in serum potassium levels across allpatients on a blinded and pooled basis. As shown below, the average change in serum potassium levels observed were modest, with a mean increase from a baseline of 4.1 milliequivalents per litre, or mEq/L to 4.3 mEq/L following 12 weeks in the 39patients who completed or discontinued treatment prior to the DRC review and a mean increase from 4.0 mEq/L to 4.3 mEq/L in the 124 patients who have completed or discontinued treatment since the beginning of the BrigHtn trial. Similar to our reviewof SBP changes, the changes in serum potassium levels shown below include all three dose cohorts, including the placebo cohort.

MinimalEffects on Plasma Potassium Observed in BrigHtn Trial

 

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Additional Clinical Trials for CIN-107 in Hypertension

Phase 2 HALO Clinical Trial in uHTN

In order to establish the efficacy and safety profile of CIN-107 in a broaderhypertensive population, we recently initiated our HALO trial, a Phase 2, randomized, double-blind, placebo-controlled, multicenter, parallel-group, clinical trial designed to assess the safety and efficacy of CIN-107 in approximately 250patients with SBP greater than 140 mm Hg, or greater than 130 mm Hg if diabetic, on one antihypertensive agent at its maximally tolerated dose and with a plasma aldosterone level greater than 7 nanograms per deciliter, or ng/dL, or greater than 6ng/dL if diabetic. Similar to our ongoing BrigHtn trial, we intend to evaluate three doses levels of CIN-107, 0.5 mg, 1 mg and 2 mg, as compared to placebo. The primary endpoint of our HALOtrial is the change in SBP after eight weeks of treatment. The secondary endpoints of our HALO trial are (i) change from baseline in mean seated DBP, (ii) change from baseline in 24-hour urine and serum aldosterone levels and (iii) thepercentage of patients achieving a mean seated SBP response below 130 mm Hg, all after 8 weeks of treatment. Background antihypertensive therapy will be discontinued after eight weeks; patients who respond to treatment and achieve the target SBP of130 mm Hg or below are followed for an additional four weeks while continue taking the same study medication. Patients who do not respond adequately will be offered 2 mg CIN-107 for four weeks. We may choose to conduct other Phase 1 orPhase 2 clinical trials in countries outside of the United States.

 

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Design of Our Phase 2 HALO Clinical Trial

 

 

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Planned Pivotal Phase 3 Clinical Trials in Hypertension

Based on the results of our ongoing Phase 2 clinical trials, we intend to conduct two pivotal Phase 3 clinical trialsof CIN-107 in hypertensive patients whose blood pressure is not controlled on an antihypertensive agent. The target enrollment for our Phase 3 clinical trials will be based on the number of patientsrequired by the FDA to build an adequately sized safety database for a chronic treatment, which includes 1,500 patients with short-term drug exposure, 300 to 600 patients with at least six months of drug exposure at clinical doses and 100 patientswith at least one year of drug exposure at clinical doses. We expect to satisfy these requirements based on the combination of our ongoing Phase 2 clinical trials and our planned Phase 3 pivotal clinical trials of CIN-107. It remains possible that we will need to conduct additional clinical trials or preclinical studies. Following the completion of our Phase 2 clinical trials ofCIN-107 in rHTN and uHTN, we plan to request an end-of-Phase 2 meeting with the FDA to discuss our Phase 2 results andthe proposed clinical design of our planned Phase 3 clinical trials. We may choose to conduct Phase 3 clinical trials in countries outside of the United States.

CIN-107 for the Treatment of Primary Aldosteronism (PA)

The preclinical and clinical data generated to date for CIN-107 suggests that it couldhave a beneficial clinical effect in the broader hypertensive population, especially in patients for whom aldosterone plays a more prominent role in the pathogenesis of hypertension. We are exploring the potential of CIN-107 in PA with ourPhase 2 spark-PA clinical trial of CIN-107 in patients with PA initiated earlier this year, with topline data expected in 2023.

Overview of Primary Aldosteronism

PA is a hormonal disorder that is caused by the autonomous production of aldosterone by the adrenal gland and often leads tohypertension that can be difficult to treat. Although previously considered a rare disease, PA is now understood to be one of the more common causes of secondary hypertension, accounting for 5% to 10% of all hypertensive patients and approximately20% to 30% of patients with rHTN, or approximately 5 to 11 million individuals in the United States. Compared to primary hypertension, PA causes more end-organ damage and is associated with higher risks ofcardiovascular morbidity and mortality, and can result in heart failure or stroke. Therefore, it is now increasingly recognized that it is important to diagnose these patients early in their disease progression. However, PA continues to beunderdiagnosed due to the complexity of the current diagnostic guidelines recommended by the Endocrine Society and the inherent variability in plasma aldosterone measurements.

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such as ACE inhibitors and ARBs, PA patients are often treated with an MRA agent, such as spironolactone, or in some rare cases, by surgical resection of the adrenal gland. However, MRAs,including spironolactone, are associated with multiple adverse effects, including a variety of anti-androgenic effects.

ClinicalDevelopment Plan for PA

Our ongoing spark-PA trial is a randomized,double-blind, placebo-controlled, multicenter, parallel-group, dose-ranging, Phase 2 clinical trial designed to evaluate the safety and efficacy of CIN-107 for the treatment of hypertensive patients withconfirmed PA. As shown in the figure below, the enrollment eligibility criteria include a washout period of any RAAS-modifying antihypertensive agents and a confirmed diagnosis of PA through both the measured renin PA ratio and the captoprilchallenge test. Captopril is an ACE inhibitor that when administered should lead to RAAS-driven aldosterone reduction. However, in patients with autonomous aldosterone secretion, such as those with PA, captopril does not reduce aldosterone levels tothe same extent as patients who do not exhibit autonomous aldosterone secretion. Patients will also be required to adhere to a stable antihypertensive regimen of non-RAAS-modifying antihypertensive agents fora period of two weeks prior to randomization. We designed our spark-PA trial as an adaptive design trial to allow flexibility to add additional dose cohorts based on a preliminary safety data review. In theinitial portion of the trial, approximately 30 patients will be randomized on a 1:1:1 basis to receive once-daily oral treatment with 4 mg of CIN-107, 6 mg of CIN-107 orplacebo for four weeks. After these approximately 30 patients complete four weeks of treatment, we intend to have a DRC conduct a preliminary safety data review to determine the necessary number of patients and, if needed, to add an additional CIN-107 dose cohort for the second part of trial. The primary endpoint is to evaluate the change in baseline SBP as measured by AOBPM after four weeks of treatment with eitherCIN-107 or placebo. The secondary endpoints of our spark-PA clinical trial are (i) change from baseline in mean seated DBP by AOBPM, (ii) percentage of patients achieving a mean seated blood pressure responsebelow 140/90 mm Hg, (iii) percentage of patients achieving a mean seated blood pressure response below 130/80 mm Hg, (iv) percentage of patients who achieve either a plasma aldosterone concentration of less than 15 ng/dL and a plasma reninactivity less than or equal to 0.5 ng/mL/h, or an aldosterone-to-renin ratio of less than 30, and (v) change from baseline in potassium levels, all after 4 weeks of treatment. The trial design for the spark-PA trial outlined above was generatedin discussions with the FDA. Should elements of the trial design prove challenging to recruitment of the trial, we may have to re-design certain elements of the trial to better enable patient recruitment. If this is required, the re-design would bediscussed with regulatory authorities so that similar development goals may be achieved.

Clinical Trial Design of Our Phase 2 spark-PA Clinical Trial

 

 

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Following the completion of our Phase 2 spark-PAclinical trial, we plan to request an end-of-Phase 2 meeting with the FDA to discuss the regulatory path to approval for this indication. As the drugs currently

 

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utilized for treating the blood pressure of patients with PA are all approved as general anti-hypertensive agents, it is not essential that a specific approval for the indication of the treatmentof PA be obtained. As a CIN-107 approval for general hypertension would also be expected to enable its use in patients with PA, the decision to seek a specific indication approval for PA will be dependent on the data produced in our spark-PA trialand other CIN-107 clinical trials in combination with other commercial and business considerations. Given the high unmet medical need in patients with PA, we will explore the most efficient path to approval ofCIN-107 for this patient population. Depending on the data observed in our spark-PA trial, we may be able to submit applications for Fast Track Designation and/or Breakthrough Therapy Designation to the FDA.

CIN-107 for the Treatment of Chronic Kidney Disease

We are also developing CIN-107 to evaluate its utility in ameliorating complications ofCKD. Aldosterone plays a significant role in the pathogenesis of CKD through its hypertensive effect and its non-genomic effects, which are known to enhance oxidative stress and promote inflammation andfibrosis. All of these deleterious effects are known to exert pressure on kidney function, especially over the multi-year course of disease progression. Multiple third-party studies and meta-analyses have demonstrated that inhibiting the effect ofaldosterone reduces proteinuria, as measured by the level of albumin in the urine, and ultimately delays the progression of CKD. Reductions in systemic aldosterone levels are associated with a blood pressure lowering effect, as well as a directeffect on the progression of CKD. We plan to initiate a Phase 2 clinical trial to evaluate the efficacy and safety of CIN-107 in patients with CKD who have uncontrolled blood pressure in the first half of2022.

Overview of CKD

CKD is a condition characterized by a gradual degradation of renal function over time as measured by glomerular filtrationrate, or GFR, which measures how much blood the kidneys filter each minute, and by proteinuria levels. According to the CDC, CKD afflicts approximately 15% of the U.S. adult population, or approximately 37 million people. Hypertension, diabetesand glomerulonephritis, or inflammation of the tiny filters in the kidneys, are considered to be the leading contributing factors to the development and progression of CKD. CKD has no cure, and currently available therapeutic options are designed todelay the onset of the more severe manifestations of the disease, most notably kidney failure. Patients with early-stage CKD are recommended to undertake dietary and lifestyle changes in order to improve overall health and reduce renal stress. Giventhe role of hypertension in CKD, many of the therapeutics prescribed to treat hypertension are also used for the treatment of CKD.

The current treatment paradigm for CKD includes, among others, the use of several classes of aldosterone-targeting agents,including ACE inhibitors, ARBs and MRAs. However, prolonged use of ACE inhibitors and ARBs are associated with aldosterone breakthrough in a significant proportion of patients, leading to enhanced decline in GFR and increased levels of proteinuria,both of which can lead to CKD progression. Furthermore, MRAs cause a compensatory increase in aldosterone levels and patients experience a broad range of adverse effects, including a variety of anti-androgenic effects. Treatment with spironolactonecan also lead to potentially harmful increases in potassium. Despite the range of treatments currently available for CKD, these patients continue to experience significant mortality and morbidity and a reduced quality of life.

Preclinical Data

To evaluate the potential of an aldosterone synthase inhibitor, or ASI, in CKD, an in vivo preclinical study wasconducted using the ZSF1 rat model, where ZSF1 rats were infused with angiotensin II, or Ang II, which causes an elevation in aldosterone levels. In this study, markers of kidney injury, kidney function and inflammation were compared across fourgroups of rats: (1) those that received only vehicle and were not subjected to Ang II infusion; (2) those that received the Ang II infusion but no active treatment; (3) those that received the Ang II infusion and were treated with anASI; and (4) those that received the Ang II infusion and were treated with eplerenone, an approved MRA.

 

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This study demonstrated that following the infusion of Ang II, the markersof kidney injury (urea excretion in 24 hours, growth differentiation factor-15, or GDF-15, and neutrophil gelatinase-associated lipocalin, or NGAL, levels), kidneyfunction (albumin excretion in 24 hours and albumin/creatinine ratio) and inflammatory cytokines (transforming growth factor beta, or TGF-ß, and monocyte chemo-attractantprotein-1, or MCP1, levels) all worsened as the rats developed CKD in response to increases in aldosterone levels. However, the administration of both the ASI and eplerenone together with the Ang II infusionameliorated the worsening of these kidney injury parameters. Importantly, the ASI improved these measures of kidney injury to a greater extent than eplerenone.

We believe the results of this trial support the further evaluation of CIN-107 in aclinical trial to assess the potential of CIN-107 in delaying the progression of CKD.

CIN-107 Clinical Development Plan for CKD

We are planning to initiate a Phase 2clinical trial to evaluate the efficacy and safety of CIN-107 in patients with CKD who have uncontrolled blood pressure in the first half of 2022. The primary objective of this trial will be to assess theimpact of CIN-107 in reducing blood pressure and delaying the progression of CKD in these patients. As we explore the utility of CIN-107 in ameliorating the complications of CKD, we will evaluate the best pathfor maximizing the value of CIN-107, including as a monotherapy or in combination with other treatments.

Manufacturing

We currently rely, and expect to continue to rely for the foreseeable future, on third-party contract manufacturingorganizations, or CMOs, to produce CIN-107 for clinical testing. We plan to continue to rely on third-party manufacturers for any future trials and commercialization ofCIN-107 and any future product candidates, if approved.

We require all of ourCMOs to conduct manufacturing activities in compliance with current good manufacturing practice, or cGMP, requirements. We have assembled a team of experienced employees and external consultants to provide the necessary technical, quality andregulatory oversight over our CMOs and have implemented a comprehensive plan for audits of our CMOs.

We currently do notown or operate any manufacturing facilities. Currently, we have manufacturing and supply agreements with our CMOs for the manufacture of CIN-107, including work related to the synthesis of the activepharmaceutical ingredient, or API, for future use, as well as manufacture of drug product for ongoing and upcoming Phase 1 and/or Phase 2 clinical trials, and in the future, plan to enter into additional agreements with CMOs to support Phase 3clinical trials and commercial scale production, but we do not have any formal agreements at this time with these CMOs. If needed, we believe we can identify and establish additional CMOs to provide API and finished drug product without significantdisruption to our business or clinical development timelines.

Competition

We believe the ability of CIN-107 to selectively inhibit aldosterone synthase withoutnegatively impacting cortisol synthesis with a once-daily oral formulation represents a meaningful competitive advantage in successfully developing a novel and highly effective treatment for hypertension, PA and CKD. However, the biopharmaceuticalindustry is characterized by the rapid evolution and advancement of technologies and understanding of disease etiology, intense competition and a strong emphasis on intellectual property. We may face competition from multiple sources, includingpharmaceutical, specialty pharmaceutical and existing or emerging biotechnology companies, academic research institutions and governmental agencies and public and private research institutions worldwide. Many of our competitors, either alone orthrough collaboration, have significantly greater financial resources and expertise in research and development, manufacturing and marketing

 

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than we do. These entities may also compete with us in hiring and retaining scientific and management personnel, establishing clinical trial sites, enrolling patients in clinical trials andpursuing strategic collaborations. As a result, our competitors may discover, develop or commercialize products before or more successfully than we do. If CIN-107 does not offer sustainable advantages overcompeting products, we may not be able to successfully compete against current and future competitors.

In particular, weface competition from companies in the pharmaceutical, biotechnology and other related markets that are pursuing the development of treatments for hypertension, PA and CKD. If approved, we expect CIN-107 tocompete with widely available standard-of-care antihypertensive agents, such as ACE inhibitors, ARBs, thiazide diuretics and calcium channel blockers, many of which areavailable as generic products. In addition, for the treatment of rHTN patients who fail to maintain blood pressure levels of 130/80 mm Hg or less, despite being compliant with at least three antihypertensive agents, of which one is a diuretic, weexpect CIN-107 to compete with MRA agents, such as spironolactone, that are typically introduced to patients’ antihypertensive treatment regimens as part of standard-of-care.

In addition to these currently available antihypertensiveagents, there are multiple other aldosterone synthase inhibitors in clinical development, such as Mineralys Therapeutics, Inc.’s MLS-101, which has commenced a Phase 2 clinical trial for hypertension, andDamian Pharma AG’s DP13, which completed a Phase 2 trial in PA. CIN-107 may also face competition from product candidates utilizing other mechanisms of action to lower blood pressure, such as:aprocitentan, a dual A & B endothelin receptor antagonist in Phase 3 development by Idorsia Ltd.; firibastat, an aminopeptidase A inhibitor in Phase 3 development by Quantum Genomics; Sas IONIS-AGT-LRx and ALN-AGT, angiotensinogen antisense production inhibitors in Phase 2 and Phase 1 development by Ionis Pharmaceuticals, Inc. and AlnylamPharmaceuticals, Inc., respectively; and KBP-5074, an MRA in Phase 2 development by Sihuan Pharmaceutical Holdings Group Ltd and KBP BioSciences Co., Ltd.; among others. Some of these product candidates are indevelopment for certain subpopulations that may not overlap with patient populations we are initially targeting with CIN-107.

We could see a reduction in or elimination of our commercial opportunity if our competitors develop and commercialize drugsthat are safer, more effective, more convenient to administer, less expensive or receiving a more favorable label than CIN-107. Our competitors may also obtain FDA or other regulatory approval for their drugsmore rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. The key competitive factors affecting the success of CIN-107, if approved, are likely to be efficacy, safety, convenience, price and the availability of reimbursement from government and other third-party payors.

License Agreement with Roche

In May 2019, following the closing of the initial tranche of our Series A preferred stock financing, we entered into a licenseagreement, or the Roche Agreement, with F. Hoffmann-La Roche Ltd and Hoffmann La-Roche Inc., whom we collectively refer to in this prospectus as Roche, pursuant to which we obtained an exclusive, worldwide, royalty-bearing license under certainpatents and specified know-how owned or controlled by Roche and Roche’s interest in joint patents and covering certain specified small molecule aldosterone synthase inhibitors, or the Roche Technology, toresearch, develop, register, use, make, import, export, market, distribute, sell (as well as the right to have each of the foregoing done) and otherwise exploit products containing such aldosterone synthase inhibitors, or the Licensed Products, forany and all uses, including the treatment, prevention or diagnosis of any and all diseases and medical conditions in humans and animals. We have the right to sublicense our rights granted or to assign our rights under the Roche Agreement toaffiliates, as well as to third parties subject to terms and conditions, provided that any subsequent sublicense granted (a) by an affiliate to a third party to which we assign rights or grant a sublicense or (b) by a third party to whichwe assign rights or grant a sublicense, is subject to Roche’s prior written consent. Roche is responsible for prosecution and maintenance of the patents included in the Roche Technology, with the Company having a comment right, unless Rocheelects to assign responsibility for such activities to us.

 

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We are obligated to use commercially reasonable efforts to develop andcommercialize one or more Licensed Products in the United States, the European Union, the United Kingdom, Japan and such other countries as we deem appropriate. We are solely responsible for all non-clinicaland clinical development, including regulatory activities, and for all commercialization of Licensed Products, at our expense.

Pursuant to the Roche Agreement, we paid Roche a one-time, upfront non-refundable license fee of $2.0 million and one $1.0 million milestone payment in connection with the completion of the multiple ascending dose Phase 1 clinical trial of CIN-107. If we desire toinitiate research and development activities with respect to any additional aldosterone synthase inhibitors that are not specified in the Roche Agreement as of the effective date, but are covered by the patents included in the Roche Technology, suchadditional compounds are included within our exclusive licenses, but we will be required to negotiate in good faith with Roche to agree upon the financial terms applicable to such additional compounds prior to the initiation of any such activities.

In connection with the Roche Agreement, we also agreed to issue to Roche Finance Ltd. warrants to acquire shares of ourcommon stock, which we refer to collectively as the Roche Warrants. The first Roche Warrant, which was issued in connection with our Series A preferred stock financing, is exercisable for 1,400,000 shares of our common stock. The third RocheWarrant, issued in connection with our Series B preferred stock financing, is exercisable for 386,271 shares of our common stock. The second Roche Warrant, issued in connection with our Series A preferred stock financing, is exercisable for1,120,476 shares of our common stock. The Roche Warrants are collectively exercisable for 2,906,747 shares of our common stock at an exercise price of $0.01 per share. The Roche Warrants will automatically net exercise in whole for an aggregate of                 shares of our common stock immediately prior to the effectiveness of the registration statement of which this prospectus forms a part (assuming aninitial public offering price of $                 per share, which is the midpoint of the price range listed on the cover page of this prospectus).

We are required to pay Roche up to an aggregate of $41.0 million with respect to the first Licensed Product upon theachievement of certain development and regulatory milestone events, of which we have paid $1.0 million in connection with the completion of the multiple ascending dose Phase 1 clinical trial of CIN-107. Additionally, we are required to pay Roche, ona one-time basis, up to $175.0 million in the aggregate upon the achievement of specified net sales milestones for a Licensed Product. In addition, on a Licensed Product-by-Licensed Product and country-by-country basis, we will be obligated to pay Roche tiered royalties on net salesof Licensed Products at percentages ranging from the mid single-digits to 10%. The royalty rates are subject to specified reductions and offsets for necessary third-party intellectual property rights, expiration of the licensed patents and genericentry, subject to a specified floor for aggregate reductions and offsets. We will be required to pay royalties to Roche under the Roche Agreement commencing on the first commercial sale of the applicable Licensed Product in the applicable countryand ending on the later of ten years following first commercial sale, or the expiration of the valid claims of all Roche patents and joint patents covering the use, manufacture, import, offering for sale or sale of such Licensed Product in suchcountry. If we grant one or more sublicenses under the Roche Agreement to a third party and/or effect a change of control of the Company prior to the earlier of the effectiveness of the registration statement of which this prospectus is a part orthe closing of a reverse merger, we will be required to pay to Roche a specified percentage of the net proceeds of any such transaction based ranging from percentages starting in the mid-teens and reducing tothe very low double digits.

The Roche Agreement will expire, unless earlier terminated by either party, upon expirationof all royalty or other payment obligations under the agreement. Either party has the right to terminate the Roche Agreement for insolvency of the other party or for a material breach that is uncured within a specified number of days of receiving anotice of default. We also have the right to terminate the Roche Agreement without cause in its entirety or on a Licensed Product-by-Licensed Product or country-by country basis at any time by providing six months’ notice of termination to Roche prior to the first commercial sale of a Licensed Product, or nine month’s written notice following the firstcommercial sale of a Licensed Product. If the Roche Agreement is terminated by Roche for our material breach or insolvency, or terminated by us for convenience, then all rights in the Licensed Products revert to Roche, provided that Roche will berequired to pay us a royalty on net sales of

 

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Licensed Products and a portion of any sublicensing revenue received by Roche in connection with the grant of a sublicense to develop and commercialize the reverted Licensed Products, in eachcase at a percentage and for a period determined by the timing of such termination.

Intellectual Property

We strive to protect and enhance the proprietary technologies, inventions and improvements that we believe are important to ourbusiness, including seeking, maintaining and defending patent rights, whether developed internally or licensed from third parties. Our policy is to seek to protect our proprietary position by, among other methods, pursuing and obtaining patentprotection in the United States and in jurisdictions outside of the United States including Australia, Canada, China, Europe, Japan, and Mexico, related to our proprietary technology, inventions, improvements, platforms and our product candidatesthat are important to the development and implementation of our business.

As of November 15, 2021, ourRoche-licensed patent portfolio includes two issued U.S. patents, 107 issued foreign patents, and 16 pending foreign applications, directed to CIN-107 and its back-upcompound, as well as pharmaceutical compositions comprising CIN-107 or the back-up compound, with expected expiry dates not earlier than 2032.

With regard to our hypertension drug candidate, CIN-107, as of November 15, 2021,we are the exclusive licensee of one U.S. patent, 53 foreign patents, and 8 pending foreign patent application. These patent rights relate to our product candidate’s composition of matter and compositions containing it. These patents areexpected to expire in 2032, however, a patent term extension may be available.

With regard to the use of our hypertensiondrug candidate, CIN-107, as of December 16, 2021, we are the sole owner of two U.S. provisional patent applications. Assuming the applications will be converted at their 12-month conversion deadlines, patents issuing from these applications would beexpected to expire in 2042, however, a patent term extension may be available.

With regard to our additional hypertensiondrug candidate, a back-up compound to CIN-107, as of November 15, 2021, we are the exclusive licensee of licensee of one U.S. patent, 54 foreign patents, and 8pending foreign patent application. These patent rights relate to our product candidate’s composition of matter and compositions containing it. These patents are expected to expire in 2032, however, a patent term extension may be available.

Individual patents extend for varying periods depending on the date of filing of the patent application or the date ofpatent issuance and the legal term of patents in the countries in which they are obtained. Generally, patents issued for regularly filed applications in the United States are granted a term of 20 years from the earliest effective non-provisional filing date. In addition, in certain instances, a patent term can be extended to recapture a portion of the U.S. Patent and Trademark Office, or the USPTO, delay in issuing the patent as well as aportion of the term effectively lost as a result of the FDA regulatory review period. However, as to the FDA component, the restoration period cannot be longer than five years and the total patent term including the restoration period must notexceed 14 years following FDA approval. The duration of foreign patents varies in accordance with provisions of applicable local law, but typically is also 20 years from the earliest effective filing date. However, the actual protection afforded bya patent varies on a product-by-product basis, from country to country and depends upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the availability of legal remedies in aparticular country and the validity and enforceability of the patent.

Furthermore, we rely upon know-how and continuing technological innovation to develop and maintain our competitive position. We seek to protect our proprietary information, in part, using confidentiality agreements with our collaborators,employees and consultants and invention assignment agreements with our employees. We

 

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also have confidentiality agreements or invention assignment agreements with our collaborators and consultants. These agreements are designed to protect our proprietary information and, in thecase of the invention assignment agreements, to grant us ownership of technologies that are developed through a relationship with a third party. These agreements may be breached, and we may not have adequate remedies for any breach. In addition, ourtrade secrets may otherwise become known or be independently discovered by competitors. To the extent that our collaborators, employees and consultants use intellectual property owned by others in their work for us, disputes may arise as to therights in related or resulting know-how and inventions.

Our commercial successwill also depend in part on not infringing upon the proprietary rights of third parties. It is uncertain whether the issuance of any third-party patent would require us to alter our development or commercial strategies, or our product candidates orprocesses, obtain licenses or cease certain activities. Our breach of any license agreements or failure to obtain a license to proprietary rights that we may require to develop or commercialize our future product candidates may have an adverseimpact on us. If third parties have prepared and filed patent applications prior to March 16, 2013 in the United States that also claim technology to which we have rights, we may have to participate in interference proceedings in the USPTO, todetermine priority of invention. For more information, please see “Risk Factors — Risks Related to Intellectual Property.”

GovernmentRegulation and Product Approval

Government authorities in the United States, at the federal, state and local levels,and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import and export of pharmaceuticalproducts, such as those we are developing. The processes for obtaining regulatory approvals in the United States and in foreign countries, along with subsequent compliance with applicable statutes and regulations, require the expenditure ofsubstantial time and financial resources.

United States Government Regulation

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementingregulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure tocomply with the applicable United States requirements at any time during the drug development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusalto approve a pending New Drug Application, or NDA, withdrawal of an approval, imposition of a clinical hold, issuance of warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution,injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

Theprocess required by the FDA before a drug may be marketed in the United States generally involves:

 

  

completion of preclinical laboratory tests, animal studies and formulation studies in compliance with theFDA’s good laboratory practice, or GLP, regulations;

 

  

submission to the FDA of an IND, which must become effective before human clinical trials may begin;

 

  

approval by an independent institutional review board, or IRB, at each clinical site before each trial may beinitiated;

 

  

performance of adequate and well controlled clinical trials, in accordance with good clinical practice, orGCP, requirements to establish the safety and efficacy of the proposed drug for each indication;

 

  

submission to the FDA of an NDA;

 

  

satisfactory completion of an FDA advisory committee review, if applicable;

 

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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the productis produced to assess compliance with cGMP requirements, and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;

 

  

satisfactory completion of an FDA inspection of selected clinical sites to assure compliance with GCPs and theintegrity of the clinical data;

 

  

payment of user fees; and

 

  

FDA review and approval of the NDA.

Preclinical Studies

Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies toassess potential safety and efficacy. An IND sponsor must submit the results of the nonclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, among other things, to the FDA as part ofan IND. Some nonclinical testing may continue even after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposedclinical trials and places the clinical trial on a clinical hold.

In such a case, the IND sponsor and the FDA mustresolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.

Clinical Trials

Clinical trials involve the administration of the investigational new drug to human subjects under the supervision of qualifiedinvestigators in accordance with GCP requirements, which include the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under protocolsdetailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted tothe FDA as part of the IND. In addition, an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution, and the IRB must continue to oversee theclinical trial while it is being conducted. Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health, or NIH, for public dissemination on their ClinicalTrials.gov website.

Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined. In Phase 1, thedrug is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an initial indication of itseffectiveness. In Phase 2, the drug typically is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and todetermine dosage tolerance and optimal dosage. In Phase 3, the drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well controlled clinical trials to generate enough data tostatistically evaluate the safety and efficacy of the product for approval, to establish the overall risk benefit profile of the product and to provide adequate information for the labeling of the product.

Progress reports detailing the results of the clinical trials must be submitted, at least annually, to the FDA, and morefrequently if serious adverse events occur. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the sponsor may suspend or terminate a clinical trial at anytime on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not beingconducted in accordance with the IRB’s requirements, or if the drug has been associated with unexpected serious harm to patients.

 

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Marketing Approval

Assuming successful completion of the required clinical testing, the results of the preclinical and clinical studies, togetherwith detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. Inmost cases, the submission of an NDA is subject to a substantial application user fee. Under the Prescription Drug User Fee Act, or PDUFA, guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing”of a standard NDA for a new molecular entity to review and act on the submission. This review typically takes twelve months from the date the NDA is submitted to the FDA because the FDA has approximately two months to make a “filing”decision.

In addition, under the Pediatric Research Equity Act, certain NDAs or supplements to an NDA must contain datathat are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe andeffective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric datarequirements. The FDA also may require submission of a risk evaluation and mitigation strategy, or REMS, plan to ensure that the benefits of the drug outweigh its risks. The REMS plan could include medication guides, physician communication plans,assessment plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries or other risk minimization tools.

The FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for filing,to determine whether they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information.The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA reviews an NDA todetermine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product’s continued safety, quality and purity.

The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independentexperts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisorycommittee, but it considers such recommendations carefully when making decisions.

Before approving an NDA, the FDAtypically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequateto assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or more clinical trial sites to assure compliance with GCP requirements.

The testing and approval process for an NDA requires substantial time, effort and financial resources, and takes several yearsto complete. Data obtained from preclinical and clinical testing are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval of an NDA on atimely basis, or at all.

After evaluating the NDA and all related information, including the advisory committeerecommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains astatement of specific conditions that must be met in order to secure final approval of the NDA and may require additional clinical or preclinical testing in order for FDA to reconsider the application. Even with submission of

 

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this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’ssatisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.

Even if the FDA approves a product, it may limit the approved indications for use of the product, require thatcontraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess a drug’s safety after approval, require testing andsurveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market andprofitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding newindications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and FDA review and approval.

Special FDA Expedited Review and Approval Programs

The FDA has various programs, including fast track designation, accelerated approval, priority review, and breakthrough therapydesignation, which are intended to expedite or simplify the process for the development and FDA review of drugs that are intended for the treatment of serious or life threatening diseases or conditions and demonstrate the potential to address unmetmedical needs. The purpose of these programs is to provide important new drugs to patients earlier than under standard FDA review procedures.

To be eligible for a fast track designation, the FDA must determine, based on the request of a sponsor, that a product isintended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need. The FDA will determine that a product will fill an unmet medical need if it will provide a therapy where noneexists or provide a therapy that may be potentially superior to existing therapy based on efficacy or safety factors. The FDA may review sections of the NDA for a fast track product on a rolling basis before the complete application is submitted. Ifthe sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the firstsection of the NDA.

The FDA may give a priority review designation to drugs that are designed to treat seriousconditions, and if approved, would provide a significant improvement in treatment, or provide a treatment where no adequate therapy exists. A priority review means that the goal for the FDA to review an application is six months, rather than thestandard review of ten months under current PDUFA guidelines. Under the current PDUFA agreement, these six and ten month review periods are measured from the “filing” date rather than the receipt date for NDAs for new molecular entities,which typically adds approximately two months to the timeline for review and decision from the date of submission. Most products that are eligible for fast track designation are also likely to be considered appropriate to receive a priority review.

In addition, products studied for their safety and effectiveness in treating serious or life-threatening illnesses andthat provide meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on asurrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity ormortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require a sponsor of a drug receivingaccelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the drug may be subject to accelerated withdrawal procedures.

 

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Breakthrough therapy designation is for a drug that is intended, alone or incombination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or moreclinically significant endpoints, such as substantial treatment effects observed early in clinical development. The FDA must take certain actions, such as holding timely meetings and providing advice, intended to expedite the development and reviewof an application for approval of a breakthrough therapy.

Even if a product qualifies for one or more of these programs,the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. We may explore some of these opportunities for our product candidates asappropriate.

Post Approval Requirements

Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA,including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, most changes to theapproved product, such as adding new indications, manufacturing changes or other labeling claims, are subject to further testing requirements and prior FDA review and approval. There also are continuing annual user fee requirements for any marketedproducts and the establishments at which such products are manufactured, as well as application fees for supplemental applications with clinical data.

Even if the FDA approves a product, it may limit the approved indications for use of the product, require thatcontraindications, warnings or precautions be included in the product labeling, including a boxed warning, require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess a drug’s safety after approval,require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms under a REMS, which can materially affect the potentialmarket and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs.

In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are requiredto register their establishments with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA and these state agencies for compliance with cGMP requirements. Changes to the manufacturing process are strictlyregulated and often require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-partymanufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.

Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is notmaintained or if problems occur after the product reaches the market.

Later discovery of previously unknown problems witha product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety information;imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among other things:

 

  

restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from themarket or product recalls;

 

  

fines, warning letters or holds on post-approval clinical trials;

 

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refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation ofproduct approvals;

 

  

product seizure or detention, or refusal to permit the import or export of products; or

 

  

injunctions or the imposition of civil or criminal penalties.

The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs maybe promoted only for the approved indications and in accordance with the provisions of the approved label, although physicians, based on their independent medical judgement, may prescribe approved drugs for unapproved indications. However,biopharmaceutical companies may only share truthful and not misleading information that is otherwise consistent with the labeling. The FDA and other agencies actively enforce the laws and regulations prohibiting their promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant civil, criminal and administrative liability.

In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act, orPDMA, which regulates the distribution of drugs and drug samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution ofprescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.

Federal and State Fraudand Abuse, Data Privacy and Security, and Transparency Laws and Regulations

In addition to FDA restrictions onmarketing of pharmaceutical products, federal and state healthcare laws and regulations restrict business practices in the biopharmaceutical industry. These laws may impact, among other things, our current and future business operations, includingour clinical research activities, and proposed sales, marketing and education programs and constrain the business or financial arrangements and relationships with healthcare providers, third-party payors, customers and other parties through which wemarket, sell and distribute our products for which we obtain marketing approval. These laws include anti-kickback and false claims laws and regulations, data privacy and security, and transparency laws and regulations, including, without limitation,those laws described below.

The federal Anti-Kickback Statute prohibits any person or entity from, among other things,knowingly and willfully offering, paying, soliciting or receiving remuneration (including any kickback, bribe, or rebate), directly or indirectly, to induce or in return for purchasing, leasing, ordering or arranging for or recommending thepurchase, lease or order of any item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federal healthcare programs. The term “remuneration” has been broadly interpreted to include anything of value. Thefederal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. Although there are a number of statutory exceptions andregulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection. Practices that involve remuneration that may be alleged to beintended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose ofan arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute has been violated. Further, a person or entity does not need to have actual knowledge of this statute or specific intent to violate itin order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of thefederal civil False Claims Act.

Federal civil and criminal false claims laws, including the federal civil False ClaimsAct, which can be enforced by individuals through civil whistleblower or qui tam actions, and the Civil Monetary Penalties Law, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false

 

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claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease orconceal an obligation to pay money to the federal government. A claim includes “any request or demand” for money or property presented to the U.S. government. Several pharmaceutical and other healthcare companies have been prosecuted underthese laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of thecompanies’ marketing of products for unapproved, and thus non-reimbursable, uses.

The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created additional federal criminalstatutes that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing orcovering up by any trick or device a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their respectiveimplementing regulations, impose specified requirements on certain types of individuals and entities relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’ssecurity standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities, which include certain healthcare providers, healthcare clearinghouse and health plans, that create, receive,maintain or transmit individually identifiable health information in connection with providing a service for or on behalf of a covered entity, and their covered subcontractors. HITECH also increased the civil and criminal penalties that may beimposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorney’s fees andcosts associated with pursuing federal civil actions.

The federal Physician Payments Sunshine Act requires certainmanufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers forMedicare & Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), and teaching hospitals, and applicablemanufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians and their immediate family members. Beginning in 2022, applicable manufacturers also will be required toreport such information regarding payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwivesprovided during the previous year.

We may also be subject to analogous state anti-kickback and false claims laws that mayapply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers, or that apply regardless of payor,state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state and local laws that require drugmanufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, state laws that require drug manufacturers to report information on the pricing of certaindrugs, state and local laws that require the registration of pharmaceutical sales representatives, and state and foreign laws governing the privacy and security of health information in some circumstances, many of which differ from each other insignificant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

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such laws. If our operations are found to be in violation of any of the federal and state laws described above or any other governmental regulations that apply to us, we may be subject tosignificant criminal, civil and administrative penalties including damages, fines, imprisonment, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm, diminished profits and future earnings, disgorgement, exclusion from participation in government healthcare programs and the curtailment orrestructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign lawsand regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, implementation of corporate compliance programs, reporting of payments or transfers of value tohealthcare professionals, and additional data privacy and security requirements.

Coverage and Reimbursement

The future commercial success of our, or any of our collaborators’, product candidates, if approved, will depend in parton the extent to which third-party payors, such as governmental payor programs at the federal and state levels, including Medicare and Medicaid, private health insurers and other third-party payors, provide coverage of and establish adequatereimbursement levels for our product candidates. Third-party payors generally decide which products they will pay for and establish reimbursement levels for those products. In particular, in the United States, no uniform policy for coverage andreimbursement exists. Private health insurers and other third-party payors often provide coverage and reimbursement for products based on the level at which the government, through the Medicare program, provides coverage and reimbursement for suchproducts, but also have their own methods and approval process apart from Medicare determinations. Therefore, coverage and reimbursement can differ significantly from payor to payor.

In the United States, the European Union, or EU, and other potentially significant markets for our product candidates,government authorities and third-party payors are increasingly attempting to limit or regulate the price of products, particularly for new and innovative products, which often has resulted in average selling prices lower than they would otherwisebe. Further, the increased emphasis on managed healthcare in the United States and on country and regional pricing and reimbursement controls in the European Union will put additional pressure on product pricing, reimbursement and usage. Thesepressures can arise from rules and practices of managed care groups, judicial decisions and laws and regulations related to Medicare, Medicaid and healthcare reform, pharmaceutical coverage and reimbursement policies and pricing in general.

Third-party payors are increasingly imposing additional requirements and restrictions on coverage and limiting reimbursementlevels for products. For example, federal and state governments reimburse products at varying rates generally below average wholesale price. These restrictions and limitations influence the purchase of products. Third-party payors may limit coverageto specific products on an approved list, or formulary, which might not include all of the FDA-approved products for a particular indication. Third-party payors are increasingly challenging the price andexamining the medical necessity and cost-effectiveness of products, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of ourproduct candidates, in addition to the costs required to obtain the FDA approvals. Nonetheless, our product candidates may not be considered medically necessary or cost-effective. Furthermore, a payor’s decision to provide coverage for aproduct does not imply that an adequate reimbursement rate will be approved. Accordingly, adequate third-party payor reimbursement may not be available to enable us to realize an appropriate return on our investment in product development.Legislative proposals to reform healthcare or reduce costs under government insurance programs may result in lower reimbursement for our product candidates, if approved, or exclusion of our product candidates from coverage and reimbursement. Thecost containment measures that third-party payors and providers are instituting and any healthcare reform could significantly reduce our revenues from the sale of any approved product candidates.

 

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Healthcare Reform

The United States and some foreign jurisdictions are considering enacting or have enacted a number of additional legislativeand regulatory proposals to change the healthcare system in ways that could affect our ability to sell our product candidates profitably, if approved. Among policy makers and payors in the United States and elsewhere, there is significant interestin promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts, which includemajor legislative initiatives to reduce the cost of care through changes in the healthcare system, including limits on the pricing, coverage, and reimbursement of pharmaceutical and biopharmaceutical products, especially under government-fundedhealth care programs, and increased governmental control of drug pricing.

The Patient Protection and Affordable Care Actof 2010, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively the PPACA, became law in March 2010 and substantially changed the way healthcare is financed by both third-party payors. Among other measures that mayhave an impact on our business, the PPACA establishes an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents; a new Medicare Part D coverage gap discount program; and a newformula that increases the rebates a manufacturer must pay under the Medicaid Drug Rebate Program. Additionally, the PPACA extends manufacturers’ Medicaid rebate liability, expands eligibility criteria for Medicaid programs, and expandsentities eligible for discounts under the Public Health Service Act.

There have been executive, judicial andCongressional challenges to certain aspects of the PPACA. While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the PPACA have been signed into law. The Tax Cuts and JobsAct of 2017, or Tax Act, included a provision that repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the PPACA on certain individuals who fail to maintainqualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” In addition, the 2020 federal spending package permanently eliminated, effective January 1, 2020, the PPACA-mandated“Cadillac” tax on high-cost employer-sponsored health coverage and medical device tax and, effective January 1, 2021, also eliminated the health insurer tax. The Bipartisan Budget Act of 2018, or the BBA, among other things, amendedthe PPACA, effective January 1, 2019, to increase from 50% to 70% the point-of-sale discount that is owed by pharmaceutical manufacturers who participate inMedicare Part D and to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.” Furthermore, on June 17, 2021, the United States Supreme Court dismissed a challenge on procedural grounds thatargued the PPACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Thus, the PPACA will remain in effect in its current form. Further, prior to the United States Supreme Court ruling onJanuary 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the PPACA marketplace, which began on February 15, 2021 and will remain openthrough August 15, 2021. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstrationprojects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the PPACA. It is possible that the PPACA will be subject to judicial orCongressional challenges in the future.

In addition, other legislative changes have been proposed and adopted since thePPACA was enacted. In August 2011, President Obama signed into law the Budget Control Act of 2011, as amended, which, among other things, included aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began in 2013 and,following passage of subsequent legislation, including the BBA, will continue through 2030 with the exception of a temporary suspension from May 1, 2020 through December 31, 2021 due to the COVID-19pandemic, unless additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was enacted which, among other things, reduced Medicare payments to several providers and increased the statute of limitationsperiod for the government to recover overpayments to providers from three to five years.

 

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Further, there has been increasing legislative and enforcement interest inthe United States with respect to drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency todrug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. At the federal level, the Trump administration used several means to propose or implementdrug pricing reform, including through federal budget proposals, executive orders and policy initiatives. For example, on July 24, 2020 and September 13, 2020, the Trump administration announced several executive orders related toprescription drug pricing that attempted to implement several of the administration’s proposals. As a result, the FDA released a final rule on September 24, 2020, effective November 30, 2020, implementing a portion of the importationexecutive order providing guidance for states to build and submit importation plans for drugs from Canada. Further, on November 20, 2020, the U.S. Department of Health & Human Services, or HHS, finalized a regulation removing safeharbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The implementation of the rule has beendelayed by the Biden administration from January 1, 2022 to January 1, 2023 in response to ongoing litigation. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers, the implementation of which have also been delayed by the Bidenadministration until January 1, 2023. On November 20, 2020, CMS issued an interim final rule implementing the Trump administration’s Most Favored Nation executive order, which would tie Medicare Part B payments for certainphysician-administered drugs to the lowest price paid in other economically advanced countries. The Most Favored Nation regulations mandate participation by identified Medicare Part B providers and will apply in all U.S. states and territories for aseven-year period beginning January 1, 2021 and ending December 31, 2027. On December 28, 2020, the U.S. District Court in Northern California issued a nationwide preliminary injunction against implementation of the interim finalrule. It is unclear whether the Biden administration will work to reverse these measures or pursue similar policy initiatives. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to controlpharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourageimportation from other countries and bulk purchasing. It also possible that governmental action will be taken in response to the COVID-19 pandemic.

Foreign Regulation

In order to market any product outside of the United States, we would need to comply with numerous and varying regulatoryrequirements of other countries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our product candidates. For example, in the European Union, we mustobtain authorization of a clinical trial application, or CTA, in each member state in which we intend to conduct a clinical trial. Whether or not we obtain FDA approval for a drug, we would need to obtain the necessary approvals by the comparableregulatory authorities of foreign countries before we can commence clinical trials or marketing of the drug in those countries. The approval process varies from country to country and can involve additional product testing and additionaladministrative review periods. The time required to obtain approval in other countries might differ from and be longer than that required to obtain FDA approval. Regulatory approval in one country does not ensure regulatory approval in another, buta failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others.

Employees and Human Capital

As of November 15, 2021, we had 10 full-time employees, 5 of whom were primarily engaged in research and developmentactivities and four of our employees had an M.D. or Ph.D. degree. None of our employees is represented by a labor union and we consider our employee relations to be good.

 

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Our human capital objectives include, as applicable, identifying,recruiting, retaining, incentivizing and integrating our existing and additional employees. The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through the grantingof stock-based compensation awards.

Facilities

Our headquarters is currently located in Boston, Massachusetts and consists of 1,161 square feet of rented office space rentedon a monthly basis. In addition, we also lease 221 square feet of office space in Mason, Ohio. We do not have laboratory space. We believe that our facilities are adequate to meet our current needs and that, should it be needed, suitable additionalor alternative space will be available on commercially reasonable terms.

Legal Proceedings

From time to time, we may become involved in other legal proceedings arising in the ordinary course of our business. We are notcurrently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have an adverse effect on our business, operating results or financial condition.

On October 29, 2021, CinRx Pharma, LLC, or CinRx, filed a complaint in Ohio state court against two of our current employees,including Catherine Pearce, M.B.A., D.H.Sc., our Chief Operating Officer and co-founder, alleging several claims, including breach of contract, breaches of fiduciary duties to CinRx, fraud, unjust enrichment, breach of non-solicitation agreement andfraudulent misrepresentation and material breach of subscription agreements, or the Ohio Complaint. The Ohio Complaint claims that these two employees are required to transfer to CinRx any of our shares they have received or will receive uponexercise of the options awarded to them in March 2021, which represent approximately 1,400,595 shares of our common stock in the aggregate. We have entered into indemnification agreements with each of the employees named in the complaint whereby wehave agreed to indemnify them to the fullest extent permitted by applicable law against all claims and actions against them arising out of their service to or positions with us, including with respect to any claims or actions made by CinRx orpersons affiliated with CinRx. As a result, we may be liable for any damages, expenses, judgments, fines or amounts paid in connection with any judgment, litigation or settlement incurred by us or our employees named in the complaint. Furthermore,on November 5, 2021, CinRx filed a complaint in Superior Court of the State of Delaware against us and three of our investors alleging breach of contract in connection with our Series B preferred stock financing and seeking compensatory damages. Thecomplaint contends that the waiver of participation rights in our Series B preferred stock financing pursuant to the Investors’ Rights Agreement, dated May 13, 2019, or the IRA, was invalid and diluted the shares of our common stock held byCinRx, and that CinRx’s allocation of our Series B preferred stock in our Series B preferred stock financing was insufficient under the IRA. We do not believe any of the claims alleged in either complaint have any merit and plan to vigorouslydefend ourselves and our employees against these claims. If CinRx prevails on its claims regarding the disputed shares of our common stock, the investors in this offering may be diluted by up to % per share of our common stock (in addition to thedilution resulting from the difference between the initial public offering price per share and the pro forma as adjusted net tangible book value per share immediately after the offering). Any dispute, claim, counterclaim, lawsuit or investigation,including the litigation described above may divert our management’s attention away from our business. We have incurred significant expenses in addressing the dispute with CinRx and may continue to incur significant expenses in addressing ordefending any dispute, claim, counterclaim or lawsuit, and we may be required to pay damage awards or settlements, which could materially and adversely affect our business, financial condition and results of operations.

 

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MANAGEMENT

Executive Officers and Directors

The following table provides information regarding our current executive officers and directors, including their ages, as ofNovember 15, 2021.

 

Name

  

Age

   

Position(s)

Executive Officers

    

Marc de Garidel

   63   

Chief Executive Officer and Director

Mary Theresa Coelho, M.B.A.

   60   

Executive Vice President, Chief Financial Officer and Chief

Business Development Officer

Catherine Pearce, M.B.A., D.HSc.

   46   

Chief Operating Officer

Mason Freeman, M.D.

   70   

Executive Vice President, Clinical Development

Non-EmployeeDirectors

    

James I. Healy, M.D., Ph.D.

   56   

Chairman of the Board of Directors

David Allison, Ph.D.

   40   

Director

Maina Bhaman, M.B.A.

   49   

Director

Troy Ignelzi

   54   

Director

June Lee, M.D.(1)

   55   

Director

Jason Pitts, Ph.D

   35   

Director

John F. Thero

   61   

Director

 

(1)

Dr. Lee’s appointment as a director will be effective upon the effectiveness of the registrationstatement of which this prospectus forms a part.

Executive Officers

Marc de Garidel has served as our Chief Executive Officer and a member of our board of directors since July 2021.Prior to being appointed as our Chief Executive Officer, he served as the chief executive officer of AZTherapies, Inc. from September 2020 to April 2021. Mr. de Garidel serves on the board of directors of AZTherapies, Inc. and ClarisBiotherapeutics, Inc. Prior to September 2020, Mr. de Garidel served as the chief executive officer of Corvidia Therapeutics, Inc. from January 2018 until their acquisition by Novo Nordisk A/S in August 2020. Mr. de Garidel also served asthe chief executive officer of Ipsen SA from November 2010 to July 2016, and has served as the chairman of Ipsen’s board of directors since November 2010. Mr. de Garidel started his career at Eli Lilly pharmaceutical group in1983, where he held various roles of increasing responsibility before joining Amgen Inc., in 1995 as its chief financial officer in Europe. Mr. de Garidel graduated from the Ecole Spéciale des Travaux Publics and obtained a master ofinternational management at Thunderbird School of Global Management. We believe Mr. de Garidel’s substantial leadership experience in the biotechnology industry qualifies him to serve on our board of directors.

Mary Theresa Coelho, M.B.A., has served as our Executive Vice President, Chief Financial Officerand Chief Business Development Officer since November 2021. Previously, Ms. Coelho served as the executive vice president, chief financial officer and treasurer of BioDelivery Sciences International, Inc. from January 2019 to October 2021 and aschief financial officer and treasurer at Balchem Corporation from October 2017 to October 2018. In addition, she also served as chief operating officer for Diversey, Inc., from September 2017 to October 2017 and held senior finance positions atDiversey Care, a division of Sealed Air Corporation from October 2014 through August 2017, including as chief financial officer and vice president of global commercial excellence. She has served on the board of directors of First Wave BioPharma Incsince August 2021, and currently serves as

 

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chair for the audit committee and member of the compensation committee for First Wave BioPharma Inc. Ms. Coelho earned an M.B.A. in finance from Ibmec in Brazil and a B.A. in both economics andinternational relations, summa cum laude, from the American University School of International Service.

CatherinePearce, M.B.A., D.HSc., co-founded our company in 2018 and has served as our Chief Operating Officer since May 2019. Previously, Ms. Pearce served as both the chief operating officerof CinRx and the vice president, strategic alliances at Medpace from September 2015 until August 2021. Ms. Pearce also served as the vice president, research and development at Teva Pharmaceutical Industries Ltd. from April 2013 until September2015. Ms. Pearce has a B.S. and an M.B.A. from Xavier University and a doctorate of health sciences from Nova Southeastern University.

Mason Freeman, M.D., has served as our Executive Vice President, Clinical Development since August2021, and as a member of our scientific advisory board since June 2019. Dr. Freeman also serves as a venture partner at 5AM Venture Management, LLC, a position he has held since May 2008. In addition, Dr. Freeman serves as the Director of theMassachusetts General Hospital’s Translational Research Center. Previously, Dr. Freeman served as a member of the board of directors of scPharmaceuticals Inc. from July 2018 to December 2020 and Crinetics Pharmaceuticals, Inc. from November2015 to July 2019. Dr. Freeman holds a B.A. from Harvard College and M.D. from the University of California, San Francisco.

Non-Employee Directors

David Allison, Ph.D., has served as a member ofour board of directors since May 2019. Dr. Allison has served as a partner at 5AM Venture Management, LLC since July 2018, and was previously a principal at 5AM Venture Management, LLC from February 2017 to June 2018. Dr. Allisonpreviously served as a principal at Versant Ventures Management, LLC, or Versant Ventures, from April 2014 to August 2016. Prior to Versant Ventures, Dr. Allison worked at Split Rock Partners, LLC as a principal from August 2009 to August 2014,and at PTV Healthcare Capital as a senior associate from 2006 to 2009. Before his venture career, he worked in the diagnostics and drug discovery business unit at SurModics, Inc. in 2004 and was a National Science Foundation Research Fellow at TheCleveland Clinic Foundation’s Heart Valve Laboratory. Dr. Allison currently serves on the boards of directors of Impel NeuroPharma, Inc. and various private companies. Dr. Allison has a Ph.D. in bioengineering from Rice Universitywith a focus in cell biology and extracellular matrix in cardiovascular disease, and a B.S.E in biomedical engineering from the University of Iowa. We believe that Dr. Allison is qualified to serve on our board of directors based on hisexpertise in corporate governance, financing and financial matters and his extensive investment experience in the health care industry.

Maina Bhaman, M.B.A., has served as a member of our board of directors sinceMay 2019. Ms. Bhaman has been a general partner of Sofinnova Partners SAS, or Sofinnova Partners, since January 2018. Prior to joining Sofinnova Partners, she was director of healthcare investment at Touchstone Innovations LLC (formerlyImperial Innovations) in London from April 2006 to November 2017. Ms. Bhaman is currently on the board of directors of four private biopharmaceutical companies, Catamaran Bio, Inc., ENYO Pharma SA, Myricx Pharma Ltd., Mironid Ltd.Ms. Bhaman has a B.S. from the University of Texas at Austin and an M.B.A. from the Imperial Business School in London. We believe that Ms. Bhaman is qualified to serve on our board of directors based on her experience in thebiopharmaceutical industry, including as a long-term healthcare investor.

James I. Healy,M.D., Ph.D., has served as a member of our board of directors since May 2019. Dr. Healy has been a general partner of Sofinnova Investments, Inc., a biotech investment firm, since June 2000. Priorto June 2000, Dr. Healy held various positions at Sanderling Ventures, Bayer Healthcare Pharmaceuticals LLC and ISTA Pharmaceuticals, Inc. Dr. Healy is currently on the board of directors of Bolt BioTherapeutics, Inc., Ascendis Pharma A/S,Coherus BioSciences, Inc., Karuna Therapeutics, Inc., Natera, Inc., NuCana PLC, ObsEva SA, and Y-mAbs Therapeutics, Inc. and several private companies. Previously, he served as a board member ofAmarin Corporation, Auris Medical Holding AG, Edge Therapeutics, Inc., Hyperion Therapeutics, Inc., InterMune, Inc., Anthera Pharmaceuticals, Inc., Durata Therapeutics, Inc., CoTherix, Inc., Iterum Therapeutics,

 

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plc, Movetis NV and several private companies. In 2011, Dr. Healy won the IBF Risk Innovator Award and was named as one of the industry’s top leading Life Science investors in 2013 byForbes Magazine. Dr. Healy has a B.A. in molecular biology and a B.A. in Scandinavian studies from the University of California, Berkeley, and has an M.D. and Ph.D. in immunology from Stanford University School of Medicine. We believe thatDr. Healy is qualified to serve on our board of directors due to his extensive experience in the biopharmaceutical industry, including as a venture capital investor and a member of the boards of directors of other biopharmaceutical companies.

Troy Ignelzi has served as a member of our board of directors since May 2021. Mr. Ignelzi has servedas the chief financial officer of Karuna Therapeutics, Inc. since March 2019. Prior to that, Mr. Ignelzi was the chief financial officer of scPharmaceuticals Inc. from March 2016 to February 2019, and provided consulting services toscPharmaceuticals Inc. in February and March 2016. Mr. Ignelzi previously served as chief financial officer and as a member of the executive leadership teams at Juventas Therapeutics Inc., a privately held biotechnology company, from October2014 to February 2016. From October 2013 to October 2014, Mr. Ignelzi served as Senior Vice President—Operations and Business Development of Pharmalex GmbH. Prior to Pharmalex, Mr. Ignelzi was vice president—business developmentat Esperion Therapeutics, Inc., a public pharmaceutical company, from January 2009 to September 2013. Mr. Ignelzi is currently on the board of directors of several private companies. Mr. Ignelzi has a B.S. in Accounting from Ferris StateUniversity. We believe Mr. Ignelzi’s experience in corporate finance and the biopharmaceutical industry qualifies him to serve on our board of directors.

June Lee, M.D., has been elected to become a member of our board of directors upon the effectiveness of theregistration statement of which this prospectus is a part. Dr. Lee was most recently founder and chief executive officer of Esker Therapeutics until September 2021. Dr. Lee previously served as the executive vice president and chief developmentofficer of MyoKardia, Inc. from January 2019 to June 2020, and was the chief operating officer from February 2017 until January 2019, and the chief development officer from October 2017 to January 2019. From April 2011 until February 2017, Dr. Leeserved on the faculty of the University of California, San Francisco, or UCSF, where she was director of the Catalyst program at the Clinical and Translational Science Institute and a professor in the School of Medicine, and was responsible foroverall strategy and operations for enabling and supporting translational research at the university. Catalyst is an internal UCSF accelerator for therapeutics, devices, diagnostics, and digital health technologies. Prior to UCSF, Dr. Lee was adisease area lead, early clinical development, at Genentech, Inc. from 2006 to 2011, where she was responsible for all strategy and activities as well as management of staff, budget, and resource allocation in the early clinical development group inmultiple therapeutic areas. Dr. Lee served as a medical director in the clinical development group at Genentech, Inc. from 2004 to 2006, where she was responsible for clinical activities for licensed product of the company. She currently serves onJohns Hopkins University Center for Therapeutic Translation’s Advisory Board, serves on the board of directors of Tenaya Therapeutics Inc, Eledon Pharmaceuticals Inc. and GenEdit, and is a member of the Scientific Advisory Board for ForesiteLabs. Dr. Lee holds a B.A. in chemistry from Johns Hopkins University and an M.D. from the University of California, Davis. We believe that Dr. Lee is qualified to serve on our board of directors based on her expertise in clinical development andthe biopharmaceutical industry.

Jason Pitts, Ph.D., has served as a member of our board of directors sinceSeptember 2021. Dr. Pitts has served as a Vice President at General Atlantic since March 2021. Dr. Pitts previously was employed by Sofinnova Investments, serving as a principal from June 2019 to January 2021 and an associate from January 2018 toMay 2019. Prior to joining Sofinnova Investments, Dr. Pitts worked at McKinsey & Company as an associate from February 2016 to January 2018. Dr. Pitts received a B.S. in neuroscience from Cornell University and a Ph.D. in neuroscience fromRockefeller University. We believe that Dr. Pitts is qualified to serve on our board of directors based on his expertise in corporate governance, financing and financial matters and his investment experience in the health care industry.

John F. Thero has served as a member of our board of directors since May 2021. Mr. Thero was president and chiefexecutive officer of Amarin Corporation plc from January 2014 through July 2021 after previously

 

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serving as that company’s president, commencing in 2010, and its chief financial officer, commencing in 2009. Mr. Thero also served on the board of directors of Amarin Corporation plcthroughout his tenure as its chief executive officer and on the board of directors of Chiasma, Inc. from November 2015 until that company was acquired in August 2021. Prior to his tenure at Amarin Corporation plc, Mr. Thero served as chief financialofficer of at ViaCell, Inc., and Abiomed, Inc., where he held multiple positions of increasing responsibility, including serving as its senior vice president of business operations and chief financial officer. Mr. Thero began his professional careerat Arthur Andersen LLP. Mr. Thero has a B.A. in economics and accounting from The College of the Holy Cross. In 2019, Mr. Thero was awarded EY’s Entrepreneur of the Year for Life Sciences. We believe Mr. Thero is qualified to serve on our boardof directors based on his operational and financial background, including his over 25 years of experience in the life sciences industry.

BoardComposition

Our business and affairs are managed under the direction of our board of directors. Our board of directorscurrently consists of seven members and following completion of this offering and appointment of Dr. Lee, will consist of eight members. Our directors were elected to, and currently serve on, the board pursuant to a voting agreement among us and allof our stockholders and voting rights granted by our current amended and restated certificate of incorporation. The voting agreement will terminate upon the closing of this offering, after which there will be no further contractual obligationsregarding the election of our directors.

In accordance with our amended and restated certificate of incorporation andamended and restated bylaws that will be in effect upon the closing of this offering, our board of directors will be divided into three classes, each of which will consist, as nearly as possible, of one-thirdof the total number of directors constituting our entire board and which will serve staggered three-year terms. At each annual meeting of stockholders, the successors to directors whose terms then expire will be elected to serve from the time ofelection and qualification until the third annual meeting following election. Our directors will be divided among the three classes as follows:

 

  

Class I, which will consist of Dr. Allison and Dr. Pitts, and their terms will expire at our first annualmeeting of stockholders to be held after the closing of this offering;

 

  

Class II, which will consist of Ms. Bhaman, Mr. de Garidel and Dr. Healy, and their terms will expire atour second annual meeting of stockholders to be held after the closing of this offering; and

 

  

Class III, which will consist of Mr. Ignelzi, Dr. Lee and Mr. Thero, and their terms will expire at ourthird annual meeting of stockholders to be held after the closing of this offering.

Our amended andrestated bylaws, which will become effective upon the closing of this offering, will provide that the authorized number of directors may be changed only by resolution approved by a majority of our board of directors. Any additional directorshipsresulting from an increase in the number of directors will be distributed among the three classes so that, as nearly as possible, each class will consist of one-third of the directors. The division of ourboard of directors into three classes with staggered three-year terms may delay or prevent a change of our management or a change of control.

DirectorIndependence

Applicable Nasdaq rules and regulations, or the Nasdaq Listing Rules, require a majority of a listedcompany’s board of directors to be composed of independent directors within one year of listing. In addition, the Nasdaq Listing Rules require that, subject to specified exceptions, each member of a listed company’s audit, compensation andnominating and corporate governance committees be independent and that audit committee members also satisfy independence criteria set forth in Rule 10A-3 under the Exchange Act of 1934, as amended, or theExchange Act. The Nasdaq independence definition includes a series of objective tests, such as that the director is not, and has not been for at least three years, one of our employees, that neither the director nor any of his family members hasengaged in various types of business dealings with us and that the director is not

 

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associated with the holders of more than 5% of our common stock. In addition, under applicable Nasdaq Listing Rules, a director will only qualify as an “independent director” if, in theopinion of the listed company’s board of directors, that person does not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director.

Our board of directors has determined that all of our directors other than Mr. de Garidel, representing seven of our eightdirectors following completion of this offering and the appointment of Dr. Lee, are “independent directors” as defined under applicable Nasdaq Listing Rules. In making such determination, our board of directors considered the current andprior relationships that each such director has with our company and all other facts and circumstances that our board of directors deemed relevant in determining his or her independence, including the beneficial ownership of our capital stock byeach director and the transactions described in the section titled “Certain Relationships and Related Party Transactions.”

There are no family relationships among any of our directors or executive officers.

Role of the Board in Risk Oversight

One of the key functions of our board of directors is informed oversight of our risk management process. Our board of directorsdoes not have a standing risk management committee, but rather administers this oversight function directly through the board of directors as a whole, as well as through various standing committees of our board of directors that address risksinherent in their respective areas of oversight. In particular, our board of directors is responsible for monitoring and assessing strategic risk exposure. Following the completion of this offering, we intend for our audit committee to have theresponsibility to consider and discuss our major financial risk exposures and the steps our management has taken to monitor and control these exposures, including guidelines and policies to govern the process by which risk assessment and managementis undertaken. The audit committee will also monitor compliance with legal and regulatory requirements.

Board Committees

Our board of directors has established an audit committee, compensation committee and a nominating and corporate governancecommittee, each of which operate pursuant to a committee charter. Our board of directors may establish other committees to facilitate the management of our business. The composition and functions of each committee are described below.

Audit Committee

Upon the completion of this offering, our audit committee will consist of Mr. Ignelzi, Dr. Allison and Ms. Bhaman, withMr. Ignelzi, serving as chair of the audit committee. Our board of directors has determined that each of these individuals meets the independence requirements of Rule 10A-3 under the Securities ExchangeAct of 1934, or the Exchange Act, and the applicable listing standards of Nasdaq. Each member of our audit committee can read and understand fundamental financial statements in accordance with Nasdaq audit committee requirements. Our board ofdirectors has also determined that Mr. Ignelzi qualifies as an audit committee financial expert within the meaning of SEC regulations and meets the financial sophistication requirements of the Nasdaq Listing Rules. In arriving at thesedeterminations, the board has examined each audit committee member’s scope of experience and the nature of their prior and/or current employment.

The functions of this committee include, among other things:

 

  

helping our board of directors oversee our corporate accounting and financial reporting processes;

 

  

managing the selection, engagement, qualifications, independence and performance of a qualified firm to serveas the independent registered public accounting firm to audit our financial statements;

 

  

discussing the scope and results of the audit with the independent registered public accounting firm, andreviewing, with management and the independent accountants, our interim and year-end operating results;

 

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developing procedures for employees to submit concerns anonymously about questionable accounting or auditmatters;

 

  

reviewing related person transactions;

 

  

obtaining and reviewing a report by the independent registered public accounting firm at least annually thatdescribes our internal quality control procedures, any material issues with such procedures and any steps taken to deal with such issues when required by applicable law; and

 

  

approving or, as permitted, pre-approving, audit and permissible non-audit services to be performed by the independent registered public accounting firm.

We believe that the composition and functioning of our audit committee will comply with all applicable SEC and Nasdaq rulesand regulations. We intend to comply with future requirements to the extent they become applicable to us.

Compensation Committee

Upon the completion of this offering, our compensation committee will consist of Mr. Thero and Drs. Healy and Lee,with Mr. Thero, serving as chair of the compensation committee. Each of these individuals is a non-employee director, as defined in Rule 16b-3 promulgated under theExchange Act. Our board of directors has determined that each of these individuals is “independent” as defined under the applicable listing standards of Nasdaq, including the standards specific to members of a compensation committee. Thefunctions of this committee include, among other things:

 

  

reviewing, modifying and approving (or if it deems appropriate, making recommendations to the full board ofdirectors regarding) our overall compensation strategy and policies;

 

  

making recommendations to the full board of directors regarding the compensation and other terms of employmentof our executive officers;

 

  

reviewing and making recommendations to the full board of directors regarding performance goals and objectivesrelevant to the compensation of our executive officers and assessing their performance against these goals and objectives;

 

  

reviewing and approving (or if it deems it appropriate, making recommendations to the full board of directorsregarding) the equity incentive plans, compensation plans and similar programs advisable for us, as well as modifying, amending or terminating existing plans and programs;

 

  

evaluating risks associated with our compensation policies and practices and assessing whether risks arisingfrom our compensation policies and practices for our employees are reasonably likely to have a material adverse effect on us;

 

  

reviewing and making recommendations to the full board of directors regarding the type and amount ofcompensation to be paid or awarded to our non-employee board members;

 

  

establishing policies with respect to votes by our stockholders to approve executive compensation to theextent required by Section 14A of the Exchange Act and, if applicable, determining our recommendations regarding the frequency of advisory votes on executive compensation;

 

  

reviewing and assessing the independence of compensation consultants, legal counsel and other advisors asrequired by Section 10C of the Exchange Act;

 

  

administering our equity incentive plans;

 

  

establishing policies with respect to equity compensation arrangements;

 

  

reviewing the competitiveness of our executive compensation programs and evaluating the effectiveness of ourcompensation policy and strategy in achieving expected benefits to us;

 

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reviewing and making recommendations to the full board of directors regarding the terms of any employmentagreements, severance arrangements, change in control protections and any other compensatory arrangements for our executive officers;

 

  

reviewing with management and approving our disclosures under the caption “Compensation Discussion andAnalysis” in our periodic reports or proxy statements to be filed with the SEC, to the extent such caption is included in any such report or proxy statement;

 

  

preparing the report that the SEC requires in our annual proxy statement; and

 

  

reviewing and evaluating on an annual basis the performance of the compensation committee and the compensationcommittee charter.

We believe that the composition and functioning of our compensation committee willcomply with all applicable SEC and Nasdaq rules and regulations. We intend to comply with future requirements to the extent they become applicable to us.

Nominating and Corporate Governance Committee

Upon the completion of this offering, our nominating and corporate governance committee will consist of Mr. Thero and Drs.Healy and Pitts, with Dr. Healy, serving as chair of the nominating and corporate governance committee. Our board of directors has determined that each of these individuals is “independent” as defined under the applicable listing standardsof Nasdaq and SEC rules and regulations. The functions of this committee include, among other things:

 

  

identifying, reviewing and evaluating candidates to serve on our board of directors;

 

  

determining the minimum qualifications for service on our board of directors;

 

  

evaluating director performance on the board and applicable committees of the board and determining whethercontinued service on our board is appropriate;

 

  

evaluating, nominating and recommending individuals for membership on our board of directors;

 

  

evaluating nominations by stockholders of candidates for election to our board of directors;

 

  

considering and assessing the independence of members of our board of directors;

 

  

developing a set of corporate governance policies and principles and recommending to our board of directorsany changes to such policies and principles;

 

  

reviewing and making recommendations to the board of directors with respect to management succession planning;

 

  

considering questions of possible conflicts of interest of directors as such questions arise; and

 

  

reviewing and evaluating on an annual basis the performance of the nominating and corporate governancecommittee and the nominating and corporate governance committee charter.

We believe that thecomposition and functioning of our nominating and corporate governance committee will comply with all applicable SEC and Nasdaq rules and regulations. We intend to comply with future requirements to the extent they become applicable to us.

Compensation Committee Interlocks and Insider Participation

None of our directors who serve as a member of our compensation committee is, or has at any time during the past year been, oneof our officers or employees. None of our executive officers currently serves, or in the past year has served, as a member of the board of directors or compensation committee of any other entity that has one or more executive officers serving on ourboard of directors or compensation committee.

 

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Code of Business Conduct and Ethics

Effective upon the closing of this offering, we will adopt a Code of Business Conduct and Ethics, or the Code of Ethics,applicable to all of our employees, executive officers and directors. This includes our principal executive officer, principal financial officer and principal accounting officer or controller, or persons performing similar functions. Following theclosing of this offering, the full text of the Code of Ethics will be available on our website at www.cincor.com. We intend to post on our website all disclosures that are required by law or the listing standards of the Nasdaq Global Marketconcerning any amendments to, or waivers from, any provision of the Code of Ethics. Information contained on, or that can be accessed through, our website is not incorporated by reference into this prospectus. We have included our website in thisprospectus solely as an inactive textual reference.

Non-Employee Director Compensation

Prior to this offering, we did not have a formal director compensation policy or pay compensation to any of our non-employee directors. While we did not have a formal director compensation policy, in connection with the appointments of Troy Ignelzi and John Thero to our board of directors in May 2021, we grantedeach of them a stock option award of 123,502 shares of common stock. In addition, in December 2021, we granted Messrs. Ignelzi and Thero a stock option award of 200,000 shares of common stock and each of our other directors a stock option awardof 100,000 shares of common stock. We do reimburse all of our non-employee directors for theirreasonable out-of-pocket expenses incurred in attending board of directors and committee meetings, attending functions on our behalf and in performance oftheir duties as directors. No compensation was earned by or paid to our non-employee directors for fiscal year 2020. The compensation of Dr. Isaacsohn as a named executive officer is set forth in thesection titled “Executive Compensation.”

We intend to adopt anon-employee director compensation policy prior to the closing of this offering.

 

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EXECUTIVE COMPENSATION

Compensation Overview

The following table shows the total compensation awarded to, earned by, or paid to during the year ended December 31, 2020to (1) our principal executive officer during fiscal year 2020; and (2) our two next most highly compensated executive officers who earned more than $100,000 during fiscal year 2020 and were serving as executive officers as ofDecember 31, 2020. We refer to these individuals in this prospectus as our named executive officers.

Our namedexecutive officers for 2020 who appear in the Summary Compensation Table are:

 

  

Jonathan Isaacsohn, M.D., FACC, who served as our Chief Executive Officer during fiscal year 2020 until 2021;

 

  

Catherine Pearce, M.B.A., D.HSc., who serves as our Chief Operating Officer; and

 

  

Piyush Patel, Ph.D., who served as our Chief Science Officer until January 2021.

Summary Compensation Table

 

Name and Principal Position

  Year   Salary
($) (1)
  All Other
Compensation
($)(2)
   Total
($)
 

Jonathan Isaacsohn, M.D., FACC(3)(4)

   2020    350,972(5)   9,750    360,722 

Former Chief Executive Officer, Chief Scientific Officer and Director

       

Catherine Pearce, M.B.A., D.HSc.(6)

   2020    187,986(7)   6,273    194,259 

Chief Operating Officer

       

Piyush Patel, Ph.D.(8)

   2020    370,944(9)   11,400    382,344 

Former Chief Science Officer

       

 

(1)

Salary amounts represent actual amounts paid during 2020. See “—Narrative to the SummaryCompensation Table—Annual Base Salary” below.

(2)

Represents company matching contributions to a 401(k) savings plan.

(3)

Dr. Isaacsohn served as our Chief Executive Officer during fiscal year 2020 until his resignation inJuly 2021. He was appointed our Chief Scientific Officer in July 2021, and was terminated from that position in November 2021. Dr. Isaacsohn worked on a part-time basis for us (approximately 80%).

(4)

Dr. Isaacsohn was also a member of our board of directors and did not receive any additionalcompensation in his capacity as a director.

(5)

Dr. Isaacsohn is an officer and an employee of CinRx Pharma, LLC, or CinRx, and as an officer and employeeof CinRx also provides services to CinRx or its subsidiaries and receives compensation from CinRx in addition to compensation from us. Of the amounts set forth above, $260,860 was paid to Dr. Isaacsohn by CinRx for services attributed to uspursuant to the terms of the amended and restated management services agreement with CinRx described further in the section titled “Certain Relationships and Related Party Transactions – CinRx Pharma, LLC”.

(6)

Ms. Pearce worked on a part-time basis for us in 2020 (approximately 80%) until August 2021.

(7)

Ms. Pearce was an officer and an employee of CinRx until August 2021, and as an officer and employee ofCinRx also provided services to CinRx or its subsidiaries and received compensation from CinRx in addition to compensation from us. Of the amounts set forth above, $138,000 was paid to Ms. Pearce for services attributed to us pursuant to the termsof the amended and restated management services agreement with CinRx described further in the section titled “Certain Relationships and Related Party Transactions – CinRx Pharma, LLC”.

(8)

Dr. Patel resigned from his position as our Chief Science Officer in January 2021.

 

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(9)

Dr. Patel is an officer and an employee of CinRx, and as an officer and employee of CinRx also providesservices to CinRx or its subsidiaries and receives compensation from CinRx in addition to compensation from us. Of the amounts set forth above, $174,468 was paid to Dr. Patel for services attributed to us pursuant to the terms of the amended andrestated management services agreement with CinRx described further in the section titled “Certain Relationships and Related Party Transactions – CinRx Pharma, LLC”.

Narrative to the Summary Compensation Table

Amended and Restated Management Services Agreement with CinRx Pharma, LLC

In April 2020, we entered into an amended and restated management services agreement, or the Management Services Agreement,with CinRx, pursuant to which CinRx provides us with certain professional services. The Management Services Agreement has a term of two years, and is automatically renewable for successive one-year periodsunless terminated. Certain of our named executive officers are officers and employees of CinRx, and as an officer and employee of CinRx also provide services to CinRx or its subsidiaries and received compensation from CinRx in addition tocompensation from us.

Prior to March 2021, we received and paid for services from the individuals who were serving as ourexecutive officers pursuant to the terms of the Management Services Agreement. In May 2021, we entered into formal employment arrangements with certain then serving executives, including Dr. Isaacsohn and Ms. Pearce, effective March 2021. In August2021, we also entered into an amended and restated employment agreement with Ms. Pearce. Dr. Isaacsohn was terminated from his position as our Chief Scientific Officer in November 2021.

In exchange for services provided to us under the Management Services Agreement, we paid CinRx monthly fees for managementservices calculated based on costs incurred by CinRx in the provision of services to us, plus a reasonable mark-up. Accordingly, in terms of officer compensation, under the Management Services Agreement, wepaid a portion of the executive’s salary as reflected in the respective footnote to the Summary Compensation Table and a portion of the executive’s salary was paid by CinRx. We provided notice to terminate the Management Services Agreementon November 4, 2021. Pursuant to the terms of the Master Services Agreement, the termination shall become effective no later than February 2, 2022. See the section titled “Certain Relationships and Related Party Transactions — CinRxPharma, LLC” elsewhere in this prospectus for more information.

Review of Executive Compensation

Our board of directors reviews compensation annually for all employees, including our named executive officers. In settingexecutive base salaries and bonuses and granting equity incentive awards, we consider compensation for comparable positions in the market, the historical compensation levels of our executives, individual performance as compared to our expectationsand objectives, our desire to motivate our employees to achieve short- and long-term results that are in the best interests of our stockholders and a long-term commitment to our company.

In connection with this offering, we have established a compensation committee. After this offering, the compensationcommittee will review and recommend to the board for approval the compensation and other terms of employment of our chief executive officer, and evaluates the chief executive officer’s performance in light of relevant corporate goals andobjectives. Our chief executive officer will discuss his recommendations for all other executives (other than himself) with the compensation committee and the board. Based on those discussions and its discretion, the compensation committee willrecommend the compensation of each executive officer to the board, and the board of directors will then approve. We generally do not provide perquisites or personal benefits except in limited circumstances, and we did not provide any perquisites orpersonal benefits to our named executive officers in 2020.

 

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Annual Base Salary

The annual base salaries of our named executive officers are generally determined, approved and reviewed periodically by ourcompensation committee in order to compensate our named executive officers for the satisfactory performance of duties to our company. Annual base salaries are intended to provide a fixed component of compensation to our named executive officers,reflecting their skill sets, experience, roles and responsibilities. Base salaries for our named executive officers have generally been set at levels deemed necessary to attract and retain individuals with superior talent.

The following table sets forth the annual base salaries for our chief executive officer and each of our named executiveofficers for 2020 and 2021.

 

Name

  2020
Base Salary
($)
   2021
Base Salary
($)
 

Marc de Garidel(1)

   N/A    500,000 

Jonathan Isaacsohn(2)

   350,972    480,000 

Catherine Pearce(3)

   187,986    350,000 

Piyush Patel(3)

   345,944    N/A 

 

(1)

Mr. de Garidel was appointed as our Chief Executive Officer in July 2021.

(2)

Dr. Isaacsohn was appointed as our Chief Scientific Officer in July 2021 and previously served as ourChief Executive Officer. His salary did not change in connection with his position change. Dr. Isaacsohn worked on a part-time basis for us (approximately 80%) and received an annualized salary of $480,000. He was terminated from his position as ourChief Scientific Officer in November 2021.

(3)

Ms. Pearce worked on a part-time basis for us (approximately 80%) until August 2021 and received anannualized salary of $279,996. Ms. Pearce’s annualized salary increased to $350,000 in connection with the entry into her amended and restated employment agreement in August 2021.

(4)

Dr. Patel resigned from his position as our Chief Science Officer in January 2021.

Non-Equity Incentive Plan Compensation

During fiscal year 2020, we did not have a formal bonus incentive program and our executive officers did not receive any bonuspayments from us or CinRX.

As discussed further below, we entered into an amended and restated employment agreement withMs. Pearce in August 2021. In accordance with the terms of her employment agreement, our board, in its sole discretion, may establish a discretionary annual bonus award for Ms. Pearce, which may be expressed as a percentage of her average annualbase salary for the applicable performance period or a fixed dollar amount or such other amount or based on such other formula or factors as the board may determine in its sole discretion. Our employment arrangement with Mr. de Garidel sets hisannual target bonus opportunity as an annual percentage of his gross base salary. In connection with this offering, the board will approve bonus targets for our chief executive officer and named executive officers that will become effective upon theeffective date of the registration statement of which this prospectus forms a part.

The following table sets forth the2021 bonus target percentage for our chief executive officer and each of our named executive officers for 2021.

 

Name

  2021
Bonus
Target
(%)
 

Marc de Garidel

   (1) 

Jonathan Isaacsohn, M.D., FACC

   (2) 

Catherine Pearce

   (1) 

Piyush Patel

   N/A (3) 

 

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(1)

The bonus targets will be approved by the board of directors prior to the effectiveness of the registrationstatement of which this prospectus forms a part.

(2)

Dr. Isaacsohn resigned from his position as our Chief Executive Officer and was appointed as our ChiefScientific Officer in July 2021. He was terminated from his position as our Chief Scientific Officer in November 2021.

(3)

Dr. Patel resigned from his position as our Chief Science Officer in January 2021.

Equity-Based Incentive Awards

Our equity-based incentive awards granted to our named executive officers are designed to align our interests and those of ourstockholders with those of our employees and consultants, including our executive officers. As of the date of this prospectus, stock option awards were the only form of equity awards we have granted to any of our executive officers.

We have historically used stock options as an incentive for long-term compensation to our executive officers because the stockoptions allow our executive officers to profit from this form of equity compensation only if our stock price increases relative to the stock option’s exercise price, which exercise price is set at the fair market value of our common stock onthe date of grant. Vesting of equity awards is generally tied to each officer’s continuous service with us and serves as an additional retention measure. We may grant equity awards at such times as our board of directors or compensationcommittee determines appropriate. Our executives generally are awarded an initial grant in the form of a stock option award in connection with their commencement of employment with us. Additional grants may occur periodically in order tospecifically incentivize executives with respect to achieving certain corporate goals or to reward executives for exceptional performance.

Prior to this offering, we have granted all stock options pursuant to our 2019 Stock Option Plan, or the 2019 Plan. Followingthis offering, we will grant equity incentive awards under the terms of the 2022 Equity Incentive Plan, or the 2022 Plan. The terms of our equity plans are described below under “— Equity Incentive Plans.”

All options are granted with an exercise price per share that is no less than the fair market value of our common stock on thedate of grant of such award. Our stock option awards generally vest over a four-year period and may be subject to acceleration of vesting and exercisability under certain termination and change in control events. See “— Outstanding EquityAwards at Fiscal Year-End.”

Health and Welfare Benefit; Retirement Benefits

These payments and benefits discussed above are in addition to eligibility to participate in benefits available generally tosalaried employees, subject to the satisfaction of certain eligibility requirements. These health and welfare benefits include medical and dental benefits, life insurance benefits and short- and long-term disability insurance, and are not generallydescribed.

Perquisites and Other Personal Benefits

We do not view perquisites or other personal benefits as a significant component of our executive compensation program.Accordingly, we do not provide significant perquisites or other personal benefits to our named executive officers except as generally made available to all our employees, or in situations where we believe it is appropriate to assist an individual inthe performance of his or her duties, to make our executive officers more efficient and effective, and for recruitment and retention purposes. During fiscal year 2020, none of our named executive officers received perquisites or other personalbenefits except as generally made available to all our employees.

 

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Outstanding Equity Awards at Fiscal Year-End

As of December 31, 2020, there were no outstanding equity awards granted to our named executive officers.

March 2021 and May 2021 Equity Grants

Subsequent to December 31, 2020, our board of directors approved the following grants of options under our 2019 Plan to ourchief executive officer and our named executive officers.

 

Name and Principal

Position

  Grant Date   Vesting
Commencement
Date
   Number of
Securities
Underlying
Option Award (#)
  Option
Exercise
Price
($)(1)
   Option
Expiration
Date
 

Marc de Garidel

   6/18/2021    5/5/2021    2,470,044   1.71    5/5/2031 

Jonathan Isaacsohn

   3/14/2021    3/7/2021    1,750,743(2)   0.75    3/14/2031 

Catherine Pearce

   3/14/2021    3/7/2021    817,014(2)   0.75    3/14/2031 

Piyush Patel

   N/A    N/A    N/A   N/A    N/A 

 

(1)

All of the option awards listed in the table were granted with an exercise price per share that is no lessthan the fair market value of our common stock on the date of grant of such award, as determined in good faith by our board of directors.

(2)

Fifty percent of the common stock subject to this award vested immediately on the vesting commencement date,and the remaining shares vested in 36 equal monthly installments thereafter, subject to the officer’s continued service through each vesting date. Upon Dr. Isaacsohn’s termination in November 2021, 680,845 shares of the common stocksubject to this award were forfeited.

On and after this offering, we may, on an annual basis orotherwise, grant additional equity awards to our executive officers pursuant to our 2022 Plan, the terms of which are described below under “—Equity Incentive Plans—2022 Equity Incentive Plan.”

Employment Arrangements with Our Named Executive Officers

We have entered into employment agreements with Mr. de Garidel and Ms. Pearce. The agreements generally provide for employmentwithout any specific term and set forth the executive officer’s base salary, bonus eligibility, eligibility for employee benefits and certain confidentiality, non-solicitation and non-competition provisions. Except as described in Mr. de Garidel’s employment agreement below, we do not currently provide any severance, change in control or retention benefits.

Marc de Garidel. We entered into an employment agreement with Mr. de Garidel in May 2021, effective upon thecommencement of Mr. de Garidel’s employment in July 2021, in connection with his appointment as our Chief Executive Officer. Pursuant to his employment agreement, Mr. de Garidel is entitled to an annual base salary of $500,000 and is eligibleto receive an annual bonus up to 40% of his then-current base salary determined in the discretion of our board of directors. As contemplated by his employment agreement, on May 5, 2021, we granted Mr. de Garidel an option to acquire 2,470,044 sharesof our common stock pursuant to the 2019 Plan, with an exercise price of $1.71. Twenty-five percent of the award will vest upon the one-year anniversary of the grant, with the remaining shares of the award vesting in equal installments each monthover the following 36 months such that it will be vested in full on the fourth-year anniversary, subject to Mr. de Garidel’s continuous service through such vesting dates.

In addition, Mr. de Garidel is eligible to receive a “true-up grant” following certain preferred stock financingevents to acquire such number of shares of our common stock that would bring his ownership of the Company to an amount equal to no less than 5% of the Company’s post-financing fully diluted equity, with an exercise price equal to the fairmarket value as of the date of the grant, as determined in the discretion of our board of directors. Twenty-

 

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five percent of the award will vest upon the one-year anniversary of the earlier of the date of the closing of the financing or three months after the effective date of the employment agreement,with the remaining shares of the award vesting in equal installments each month over the following 36 months such that it will be vested in full on the fourth-year anniversary, subject to Mr. de Garidel’s continuous service through such vestingdates.

In the event Mr. de Garidel’s employment is terminated by us without cause or by Mr. de Garidel for goodreason, he is entitled to severance equal to twelve months of his then-current base salary, payable in accordance with our normal payroll procedures. Mr. de Garidel will also be entitled to receive a pro-rated portion of his annual bonus payable ina lump sum on the later of the date that annual performance bonuses are normally paid to other executives or the execution and non-revocation of a general release of claims. We will also continue to pay for continued coverage for Mr. de Garidelunder COBRA until the earlier of twelve months following the termination date, the date when Mr. de Garidel becomes eligible for substantially equivalent health insurance coverage in connection with new employment or self-employment, or the date heceases to be eligible for COBRA. Such severance obligations are contingent upon Mr. de Garidel’s timely execution and non-revocation of a general release of claims. Lastly, the unvested portion of all time-based equity awards outstanding on thedate of termination that would have vested over the twelve-month period following termination will be automatically vested and exercisable as of the date of termination.

Furthermore, in the event Mr. de Garidel’s employment is terminated by us without cause or by Mr. de Garidel for goodreason within 3 months prior to or 12 months following a change in control, he will be entitled to the foregoing severance obligations and all vesting and exercisability of all outstanding equity awards held by Mr. de Garidel will immediately beaccelerated in full.

Catherine Pearce, M.B.A., D.HSc. We entered into an amended and restated employmentagreement with Ms. Pearce in August 2021 in connection with her appointment as our Chief Operating Officer and Co-Founder. Pursuant to her amended and restated employment agreement, Ms. Pearceis entitled to an annual base salary of $350,000 and is eligible to receive an annual bonus determined in the discretion of our board of directors. As contemplated by her employment agreement entered into in May 2021, effective March 7, 2021,on March 14, 2021, we granted Ms. Pearce an option to acquire 817,014 shares of our common stock pursuant to the 2019 Plan, with an exercise price of $0.75. Fifty percent of the award vested immediately upon grant, with the remaining shares ofthe award vesting monthly over the following 36 months such that it will be vested in full on the third-year anniversary, subject to Ms. Pearce’s continuous service through such vesting dates.

Equity Incentive Plans

2019 StockOption Plan

Our 2019 Stock Option Plan, or the 2019 Plan, was originally adopted by our board of directors andapproved by our stockholders on May 6, 2019. No additional awards may be granted under the 2019 Plan, however, outstanding awards continue in full effect in accordance with their existing terms.

Awards. Our 2019 Plan provides for the grant of incentive stock options, or ISOs, to employees, and for the grant ofnonstatutory stock options, or NSOs to employees, directors, advisors, and consultants of the company or its subsidiaries.

Share Reserve. 11,742,926 shares of common stock were reserved for issuance under our 2019 Plan. As of September 30,2021, options to purchase 5,057,647 shares of common stock, at exercise prices ranging from $0.21 to $1.71 per share, or a weighted average exercise price of $1.34 per share, were outstanding under our 2019 Plan. Shares subject to awards grantedunder our 2019 Plan that are cancelled, forfeited, settled in cash, used to pay withholding obligations, pay the exercise price of an option, or that expire by their terms at any time will again be available for grant and issuance in connection withother awards.

Plan Administration. The 2019 Plan is administered by our board of directors, or a duly authorizedcommittee of its board of directors and is referred to as the “plan administrator” herein.

 

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Stock Options. ISOs and NSOs are granted under stock optionagreements adopted by the plan administrator. Each grant will specify an option price, provided that the option price generally cannot be less than 100% of the fair market value of a share on the date of grant. The plan administrator determines theterm of stock options granted under the 2019 Plan, up to a maximum of 10 years. If an optionholder’s service relationship with us or any of our affiliates ceases for any reason other than disability, death, or cause the optionholder maygenerally exercise any vested options for a period of three months following the cessation of service. If an optionholder’s service relationship with us or any of our affiliates ceases due to death the optionholder or a beneficiary maygenerally exercise any vested options for a period of 12 months following the date of death. If an optionholder’s service relationship with us or any of our affiliates ceases due to disability, the optionholder may generally exercise any vestedoptions for a period of 12 months following the cessation of service. In the event of a termination for cause, any option held by the optionholder will terminate immediately.

Tax Limitations on ISOs. The aggregate fair market value, determined at the time of grant, of our common stock withrespect to ISOs that are exercisable for the first time by an option holder during any calendar year under all of our stock plans may not exceed $100,000. Options or portions thereof that exceed such limit will generally be treated as NSOs. No ISOmay be granted to any person who, at the time of the grant, owns or is deemed to own stock possessing more than 10% of our total combined voting power or that of any of our affiliates unless (i) the option exercise price is at least 110% of the fairmarket value of the stock subject to the option on the date of grant; and (ii) the option is not exercisable after the expiration of five years from the date of grant.

Changes to Capital Structure. The board provides for adjustments in the option price and in the number or kind ofshares or other securities covered by outstanding options, as the board in its sole discretion determines to be equitably required in order to prevent dilution or enlargement of the rights of participants that would otherwise result from any (a)stock dividend, stock split, combination of shares, recapitalization or other changes in the capital structure of the company, (b) merger, consolidation, separation, reorganization, partial or complete liquidation, issuance of rights or warrants topurchase stock, or (c) other corporate transaction or event having an effect similar to any of the foregoing.

Changein Control. In the event of a change in control, as defined under our 2019 Plan, the board may, in its sole discretion, and without the consent of any participant, take one or more of the following actions:

 

  

Cause any or all outstanding options to become vested and immediately exercisable, in whole or in

part;

 

  

Cause any or all outstanding unvested options to be cancelled without consideration therefore;

 

  

Cancel any option in exchange for a substitute option; or

 

  

Cancel any option in exchange for cash and/or other substitute consideration with a value equal to (a) thenumber of shares subject to the option, multiplied by (b) the difference, if any, between the fair market value per share on the date of the change in control and the exercise price of that option; provided, that if the fair market value per shareon the date of the change in control does not exceed the exercise price of any such option, the board may cancel that option without payment of consideration.

Under our 2019 Plan, a change in control means a “deemed liquidation event” as defined in our certificate ofincorporation, or if this term is not defined therein, it will mean: (i) a sale of all of the outstanding equity interests of the company to an unrelated person or entity; (ii) the sale of all or substantially all of the assets of the company on aconsolidated basis to an unrelated person or entity; (iii) a merger, reorganization, or consolidation after which the holders of the voting stock of the company immediately prior to such transaction (and their related persons or entities) own lessthan 50% of the outstanding voting power of the surviving or resulting entity immediately upon completion of such transaction; or (iv) the dissolution or liquidation of the company.

Transferability. A participant may not transfer options under our 2019 Plan other than by will, the laws of descent anddistribution, or as otherwise provided under our 2019 Plan.

 

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Plan Amendment or Termination. Our board has the authority to amendour 2019 Plan in whole or in part. No option may be granted pursuant to the 2019 Plan more than 10 years after the earlier of the date on which the 2019 Plan was first approved by the stockholders or was adopted by the board.

2022 Equity Incentive Plan

Our board of directors adopted, and our stockholders approved, our 2022 Equity Incentive Plan, or the 2022 Plan,in                , 2022. Our 2022 Plan provides for the grant of incentive stock options, or ISOs, to employees, including employees of any parent or subsidiary, andfor the grant of nonstatutory stock options, or NSOs, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of stock awards to employees, directors, and consultants, including employeesand consultants of our affiliates. Our 2022 Plan is a successor to the 2019 Plan, and will become effective on the execution of the underwriting agreement related to this offering.

Authorized Shares. Initially, the maximum number of shares of our common stock that may be issued under our 2022 Planafter it becomes effective will be                shares, which is the sum of(i)                new shares; plus (ii)                the number of shares that remainavailable for issuance under the 2019 Plan at the time our 2022 Plan becomes effective; and (iii) any shares subject to outstanding stock options or other stock awards that were granted under the 2019 Plan that are forfeited, terminate, expireor are otherwise not issued. In addition, the number of shares of our common stock reserved for issuance under our 2022 Plan will automatically increase on January 1 of each calendar year, starting on January 1, 2023 and continuing throughJanuary 1, 2032, in an amount equal to                 % of the total number of shares of our capital stock outstanding on the last day of the calendar month beforethe date of each automatic increase, or a lesser number of shares determined by our board of directors. The maximum number of shares of our common stock that may be issued on the exercise of ISOs under our 2022 Planis                .

Shares subject tostock awards granted under our 2022 Plan that expire or terminate without being exercised in full, or that are paid out in cash rather than in shares, do not reduce the number of shares available for issuance under our 2022 Plan. Additionally,shares become available for future grant under our 2022 Plan if they were issued under stock awards under our 2022 Plan if we repurchase them or they are forfeited. This includes shares used to pay the exercise price of a stock award or to satisfythe tax withholding obligations related to a stock award.

Plan Administration. Our board of directors, or a dulyauthorized committee of our board of directors, will administer our 2022 Plan. Our board of directors may also delegate to one or more of our officers the authority to (i) designate employees (other than officers) to receive specified stockawards and (ii) determine the number of shares subject to such stock awards. Under our 2022 Plan, our board of directors has the authority to determine and amend the terms of awards and underlying agreements, including:

 

  

recipients;

 

  

the exercise, purchase or strike price of stock awards, if any; the number of shares subject to each stockaward;

 

  

the vesting schedule applicable to the awards, together with any vesting acceleration; and

 

  

the form of consideration, if any, payable on exercise or settlement of the award.

Under the 2022 Plan, the board of directors also generally has the authority to effect, with the consent of any adverselyaffected participant:

 

  

the reduction of the exercise, purchase, or strike price of any outstanding award;

 

  

the cancellation of any outstanding award and the grant in substitution therefore of other awards, cash, orother consideration; or

 

  

any other action that is treated as a repricing under generally accepted accounting principles.

 

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Stock Options. ISOs and NSOs are granted under stock optionagreements adopted by the plan administrator. The plan administrator determines the exercise price for stock options, within the terms and conditions of the 2022 Plan, provided that the exercise price of a stock option generally cannot be less than100% of the fair market value of our common stock on the date of grant. Options granted under the 2022 Plan vest at the rate specified in the stock option agreement as determined by the plan administrator.

Tax Limitations on ISOs. The aggregate fair market value, determined at the time of grant, of our common stock withrespect to ISOs that are exercisable for the first time by an option holder during any calendar year under all of our stock plans may not exceed $100,000. Options or portions thereof that exceed such limit will generally be treated as NSOs. No ISOmay be granted to any person who, at the time of the grant, owns or is deemed to own stock possessing more than 10% of our total combined voting power or that of any of our affiliates unless (i) the option exercise price is at least 110% of thefair market value of the stock subject to the option on the date of grant; and (ii) the option is not exercisable after the expiration of five years from the date of grant.

Restricted Stock Unit Awards. Restricted stock units are granted under restricted stock unit award agreements adoptedby the plan administrator. Restricted stock units may be granted in consideration for any form of legal consideration that may be acceptable to our board of directors and permissible under applicable law. A restricted stock unit may be settled bycash, delivery of stock, a combination of cash and stock as deemed appropriate by the plan administrator, or in any other form of consideration set forth in the restricted stock unit agreement. Additionally, dividend equivalents may be credited inrespect of shares covered by a restricted stock unit. Except as otherwise provided in the applicable award agreement, restricted stock units that have not vested will be forfeited once the participant’s continuous service ends for any reason.

Restricted Stock Awards. Restricted stock awards are granted under restricted stock award agreements adopted bythe plan administrator. A restricted stock award may be awarded in consideration for cash, check, bank draft or money order, past services to us, or any other form of legal consideration that may be acceptable to our board of directors andpermissible under applicable law. The plan administrator determines the terms and conditions of restricted stock awards, including vesting and forfeiture terms. If a participant’s service relationship with us ends for any reason, we may receiveany or all of the shares of common stock held by the participant that have not vested as of the date the participant terminates service with us through a forfeiture condition or a repurchase right.

Stock Appreciation Rights. Stock appreciation rights are granted under stock appreciation grant agreements adopted bythe plan administrator. The plan administrator determines the purchase price or strike price for a stock appreciation right, which generally cannot be less than 100% of the fair market value of our common stock on the date of grant. A stockappreciation right granted under the 2022 Plan vests at the rate specified in the stock appreciation right agreement as determined by the plan administrator.

Performance Awards. The 2022 Plan permits the grant of performance-based stock and cash awards. The plan administratormay structure awards so that the shares of our stock, cash, or other property will be issued or paid only following the achievement of certain pre-established performance goals during a designatedperformance period. The performance criteria that will be used to establish such performance goals may be based on any measure of performance selected by the plan administrator. The performance goals may be based on a company-wide basis, withrespect to one or more business units, divisions, affiliates, or business segments, and in either absolute terms or relative to the performance of one or more comparable companies or the performance of one or more relevant indices. Unless specifiedotherwise (i) in the award agreement at the time the award is granted or (ii) in such other document setting forth the performance goals at the time the goals are established, we will appropriately make adjustments in the method ofcalculating the attainment of performance goals as follows: (1) to exclude restructuring and/or other nonrecurring charges; (2) to exclude exchange rate effects; (3) to exclude the effects of changes to generally accepted accountingprinciples; (4) to exclude the effects of any statutory adjustments to corporate tax rates; (5) to exclude the effects of items that are “unusual” in nature or

 

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occur “infrequently” as determined under generally accepted accounting principles; (6) to exclude the dilutive effects of acquisitions or joint ventures; (7) to assume thatany business divested by us achieved performance objectives at targeted levels during the balance of a performance period following such divestiture; (8) to exclude the effect of any change in the outstanding shares of our common stock byreason of any stock dividend or split, stock repurchase, reorganization, recapitalization, merger, consolidation, spin-off, combination or exchange of shares or other similar corporate change, or anydistributions to common stockholders other than regular cash dividends; (9) to exclude the effects of stock based compensation and the award of bonuses under our bonus plans; (10) to exclude costs incurred in connection with potentialacquisitions or divestitures that are required to be expensed under generally accepted accounting principles; (11) to exclude the goodwill and intangible asset impairment charges that are required to be recorded under generally acceptedaccounting principles; and (12) to exclude the effects of the timing of acceptance for review and/or approval of submissions to the FDA or any other regulatory body. In addition, we retain the discretion to reduce or eliminate the compensationor economic benefit due upon attainment of the goals. The performance goals may differ from participant to participant and from award to award.

Other Stock Awards. The plan administrator may grant other awards based in whole or in part by reference to our commonstock. The plan administrator will set the number of shares under the stock award and all other terms and conditions of such awards.

Non-Employee Director Compensation Limit. The aggregatevalue of all compensation granted or paid to any non-employee director with respect to any calendar year, including stock awards granted and cash fees paid by us tosuch non-employee director, will not exceed $                 in total value, or in the event such non-employee director is first appointed or elected to the board during such annual period, $                 in totalvalue (in each case, calculating the value of any such stock awards based on the grant date fair value of such stock awards for financial reporting purposes).

Changes to Capital Structure. In the event there is a specified type of change in our capital structure, such as astock split, reverse stock split, or recapitalization, appropriate adjustments will be made to (i) the class and maximum number of shares reserved for issuance under the 2022 Plan, (ii) the class and maximum number of shares by which theshare reserve may increase automatically each year, (iii) the class and maximum number of shares that may be issued on the exercise of incentive stock options, and (iv) the class and number of shares and exercise price, strike price, orpurchase price, if applicable, of all outstanding stock awards.

Corporate Transactions. The following applies tostock awards under the 2022 Plan in the event of a corporate transaction, unless otherwise provided in a participant’s stock award agreement or other written agreement with us or one of our affiliates or unless otherwise expressly provided bythe plan administrator at the time of grant.

In the event of a corporate transaction, any stock awards outstanding underthe 2022 Plan may be assumed, continued or substituted for by any surviving or acquiring corporation (or its parent company), and any reacquisition or repurchase rights held by us with respect to the stock award may be assigned to the successor (orits parent company). If the surviving or acquiring corporation (or its parent company) does not assume, continue or substitute for such stock awards, then with respect to any such stock awards that are held by participants whose continuous servicehas not terminated prior to the effective time of the transaction, or current participants, the vesting (and exercisability, if applicable) of such stock awards will be accelerated in full to a date prior to the effective time of the transaction(contingent upon the effectiveness of the transaction), and such stock awards will terminate if not exercised (if applicable) at or prior to the effective time of the transaction, and any reacquisition or repurchase rights held by us with respect tosuch stock awards will lapse (contingent upon the effectiveness of the transaction). With respect to performance awards with multiple vesting levels depending on performance level, unless otherwise provided by an award agreement or by theadministrator, the award will accelerate at 100% of target. If the surviving or acquiring corporation (or its parent company) does not assume, continue or substitute for such stock awards, then with respect to any such stock awards thatare held by persons

 

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other than current participants, such awards will terminate if not exercised (if applicable) prior to the effective time of the transaction, except that any reacquisition or repurchase rightsheld by us with respect to such stock awards will not terminate and may continue to be exercised notwithstanding the transaction. The plan administrator is not obligated to treat all stock awards or portions of stock awards in the same manner and isnot obligated to take the same actions with respect to all participants.

In the event a stock award will terminate if notexercised prior to the effective time of a transaction, the plan administrator may provide, in its sole discretion, that the holder of such stock award may not exercise such stock award but instead will receive a payment equal in value to the excess(if any) of (i) the value of the property the participant would have received upon the exercise of the stock award over (ii) any exercise price payable by such holder in connection with such exercise.

Change in Control. In the event of a change in control, as defined under our 2022 Plan, awards granted under our 2022Plan will not receive automatic acceleration of vesting and exercisability, although this treatment may be provided for in an award agreement.

Under our 2022 Plan, a corporate transaction is defined to include: (i) a sale of all or substantially all of our assets;(ii) the sale or disposition of more than 50% of our outstanding securities; (iii) the consummation of a merger or consolidation where we do not survive the transaction; and (iv) the consummation of a merger or consolidation where wedo survive the transaction but the shares of our common stock outstanding before such transaction are converted or exchanged into other property by virtue of the transaction, unless otherwise provided in an award agreement or other written agreementbetween us and the award holder. Under the 2022 Plan, a change in control is defined to include (1) the acquisition by any person or company of more than 50% of the combined voting power of our then outstanding stock; (2) a merger,consolidation or similar transaction in which our stockholders immediately before the transaction do not own, directly or indirectly, more than 50% of the combined voting power of the surviving entity (or the parent of the surviving entity); (3) theapproval by the stockholders or the board of directors of a plan of complete dissolution or liquidation of the company, or the occurrence of a complete dissolution or liquidation of the company, except for a liquidation into a parent corporation;(4) a sale, lease, exclusive license or other disposition of all or substantially all of our assets other than to an entity more than 50% of the combined voting power of which is owned by our stockholders; and (5) an unapproved change inthe majority of the board of directors.

Transferability. A participant may not transfer stock awards under our2022 Plan other than by will, the laws of descent and distribution, or as otherwise provided under our 2022 Plan.

PlanAmendment or Termination. Our board of directors has the authority to amend, suspend, or terminate our 2022 Plan, provided that such action does not materially impair the existing rights of any participant without such participant’s writtenconsent. Certain material amendments also require the approval of our stockholders. No incentive stock options may be granted after the tenth anniversary of the date our board of directors adopted our 2022 Plan. No stock awards may be granted underour 2022 Plan while it is suspended or after it is terminated.

2022 Employee Stock Purchase Plan

Our board of directors adopted, and our stockholders approved, our 2022 Employee Stock Purchase Plan, or the ESPP,in                , 2022. The ESPP will become effective on the execution of the underwriting agreement related to this offering. The purpose of the ESPP is to securethe services of new employees, to retain the services of existing employees, and to provide incentives for such individuals to exert maximum efforts toward our success and that of our affiliates. The ESPP is intended to qualify as an “employeestock purchase plan” within the meaning of Section 423 of the Code for U.S. employees.

Share Reserve.Following this offering, the ESPP authorizes the issuance of shares of our common stock under purchase rights granted to our employees or to employees of any of our designated affiliates. The ESPP

 

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will initially provide participating employees with the opportunity to purchase up to an aggregateof                 shares of our common stock. The number of shares of our common stock reserved for issuance will automatically increase on January 1 of eachcalendar year, starting on January 1, 2023 and continuing through January 1, 2032, by the lesser of (i)                % of the total number of shares of ourcommon stock outstanding on the last day of the calendar month before the date of the automatic increase; and (ii) shares; provided that before the date of any such increase, our board of directors may determine that such increase will be lessthan the amount set forth in clauses (i) and (ii). As of the date hereof, no shares of our common stock have been purchased under the ESPP.

Administration. Our board of directors intends to delegate concurrent authority to administer the ESPP to ourcompensation committee. The ESPP is implemented through a series of offerings under which eligible employees are granted purchase rights to purchase shares of our common stock on specified dates during such offerings. Under the ESPP, we may specifyofferings with durations of not more than 27 months, and may specify shorter purchase periods within each offering. Each offering will have one or more purchase dates on which shares of our common stock will be purchased for employees participatingin the offering. An offering under the ESPP may be terminated under certain circumstances.

Payroll Deductions.Generally, all regular employees, including executive officers, employed by us or by any of our designated affiliates, may participate in the ESPP and may contribute, normally through payroll deductions, up to    % of theirearnings (as defined in the ESPP) for the purchase of our common stock under the ESPP. Unless otherwise determined by our board of directors, common stock will be purchased for the accounts of employees participating in the ESPP at a price per sharethat is at least the lesser of (i) 85% of the fair market value of a share of our common stock on the first date of an offering; or (ii) 85% of the fair market value of a share of our common stock on the date of purchase.

Limitations. Employees may have to satisfy one or more of the following service requirements before participating inthe ESPP, as determined by our board of directors, including: (i) being customarily employed for more than 20 hours per week; (ii) being customarily employed for more than five months per calendar year; or (iii) continuous employmentwith us or one of our affiliates for a period of time (not to exceed two years). No employee may purchase shares under the ESPP at a rate in excess of $25,000 worth of our common stock based on the fair market value per share of our common stock atthe beginning of an offering for each year such a purchase right is outstanding. Finally, no employee will be eligible for the grant of any purchase rights under the ESPP if immediately after such rights are granted, such employee has voting powerover 5% or more of our outstanding capital stock measured by vote or value under Section 424(d) of the Code.

Changes to Capital Structure. In the event that there occurs a change in our capital structure through such actions asa stock split, merger, consolidation, reorganization, recapitalization, reincorporation, stock dividend, dividend in property other than cash, large nonrecurring cash dividend, liquidating dividend, combination of shares, exchange of shares, changein corporate structure, or similar transaction, the board of directors will make appropriate adjustments to: (i) the number of shares reserved under the ESPP; (ii) the maximum number of shares by which the share reserve may increaseautomatically each year; (iii) the number of shares and purchase price of all outstanding purchase rights; and (iv) the number of shares that are subject to purchase limits under ongoing offerings.

Corporate Transactions. In the event of certain significant corporate transactions, including: (i) a sale of allor substantially all of our assets; (ii) the sale or disposition of more than 50% of our outstanding securities; (iii) the consummation of a merger or consolidation where we do not survive the transaction; and (iv) the consummation ofa merger or consolidation where we do survive the transaction but the shares of our common stock outstanding immediately before such transaction are converted or exchanged into other property by virtue of the transaction, any then-outstanding rightsto purchase our stock under the ESPP may be assumed, continued or substituted for by any surviving or acquiring entity (or its parent company). If the surviving or acquiring entity (or its parent company) elects not to assume, continue, orsubstitute for such purchase rights, then the participants’ accumulated payroll contributions will be used to purchase shares of our common stock within ten business days before such corporate transaction, and such purchase rights willterminate immediately.

 

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Amendment or Termination. Our board of directors has the authority toamend or terminate our ESPP, provided that except in certain circumstances such amendment or termination may not materially impair any outstanding purchase rights without the holder’s consent. We will obtain stockholder approval of anyamendment to our ESPP, as required by applicable law or listing requirements.

Limitations on Liability and Indemnification Matters

Upon the closing of this offering, our amended and restated certificate of incorporation will contain provisions that limit theliability of our current and former directors for monetary damages to the fullest extent permitted by Delaware law. Delaware law provides that directors of a corporation will not be personally liable for monetary damages for any breach of fiduciaryduties as directors, except liability for:

 

  

any breach of the director’s duty of loyalty to the corporation or its stockholders;

 

  

any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

 

  

unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 ofthe Delaware General Corporation Law; or

 

  

any transaction from which the director derived an improper personal benefit.

This limitation of liability does not apply to liabilities arising under federal securities laws and does not affect theavailability of equitable remedies such as injunctive relief or rescission.

Our amended and restated certificate ofincorporation and our amended and restated bylaws will provide that we are required to indemnify our directors to the fullest extent permitted by Delaware law. Our amended and restated bylaws will also provide that, upon satisfaction of certainconditions, we are required to advance expenses incurred by a director in advance of the final disposition of any action or proceeding, and permit us to secure insurance on behalf of any officer, director, employee or other agent for any liabilityarising out of his or her actions in that capacity regardless of whether we would otherwise be permitted to indemnify him or her under the provisions of Delaware law. Our amended and restated bylaws will also provide our board of directors withdiscretion to indemnify our officers and employees when determined appropriate by the board.

We have entered intoindemnification agreements with each of our directors and expect to enter into indemnification agreements with each of our executive officers prior to the closing of this offering. With certain exceptions, these agreements provide forindemnification for related expenses including, among other things, attorneys’ fees, judgments, fines and settlement amounts incurred by any of these individuals in any action or proceeding. We believe that these bylaw provisions andindemnification agreements are necessary to attract and retain qualified persons as directors and executive officers. We also maintain customary directors’ and officers’ liability insurance.

The limitation of liability and indemnification provisions in our amended and restated certificate of incorporation andamended and restated bylaws may discourage stockholders from bringing a lawsuit against our directors for breach of their fiduciary duty. They may also reduce the likelihood of derivative litigation against our directors and officers, even though anaction, if successful, might benefit us and other stockholders. Further, a stockholder’s investment may be adversely affected to the extent that we pay the costs of settlement and damage awards against directors and officers as required bythese indemnification provisions.

Insofar as indemnification for liabilities arising under the Securities Act may bepermitted for our directors, executive officers or persons controlling us, we have been informed that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

 

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Rule 10b5-1 Sales Plans

Our directors and executive officers may adopt written plans, known as Rule 10b5-1plans, in which they will contract with a broker to buy or sell shares of our common stock on a periodic basis. Under a Rule 10b5-1 plan, a broker executes trades pursuant to parameters established by thedirector or officer when entering into the plan, without further direction from them. The director or officer may amend a Rule 10b5-1 plan in some circumstances and may terminate a plan at any time. Ourdirectors and executive officers also may buy or sell additional shares outside of a Rule 10b5-1 plan when they are not in possession of material nonpublic information subject to compliance with the termsof our insider trading policy. Prior to 180 days after the date of this offering, subject to early termination, the sale of any shares under such plan would be prohibited by the lock-up agreement that thedirector or officer has entered into with the underwriters.

 

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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

The following is a description of transactions since our inception in March 2018 to which we have been a participant in whichthe amount involved exceeded or will exceed $120,000, and in which any of our directors, executive officers or holders of more than 5% of our voting securities, or any members of their immediate family, had or will have a direct or indirect materialinterest, other than compensation arrangements that are described under “Management—Non-Employee Director Compensation” and “Executive Compensation.”

Private Placements of Our Securities

Series A Preferred Stock Financing

In May 2019, we entered into a stock purchase agreement with certain investors, including beneficial owners of greater than 5%of our capital stock, members of our board of directors and affiliates of members of our board of directors, pursuant to which we issued and sold to such investors an aggregate of 35,714,282 shares of our Series A preferred stock at a purchase priceof $1.40 per share for aggregate gross proceeds of $50.0 million.

The table below sets forth the aggregate number ofshares of Series A preferred stock issued to our related parties in this financing:

 

Name

  Series A
Preferred
Stock
(#)
   Aggregate
Purchase
Price
($)
 

Sofinnova Venture Partners X,L.P.(1)

   13,571,428   $18,999,999 

Sofinnova Capital IX(2)

   9,999,999   $13,999,999 

5AM Ventures VI, L.P.(3)

   9,999,999   $13,999,999 

CinRx Pharma, LLC(4)

   2,142,856   $2,999,998 

 

(1)

James Healy, a member of our board of directors at the time of the second tranche of the Series A preferredstock financing, is affiliated with Sofinnova Venture Partners X, L.P., which became a holder of more than 5% of our capital stock in connection with the Series A preferred stock financing.

(2)

Maina Bhaman, a member of our board of directors at the time of the second tranche of the Series A preferredstock financing, is affiliated with Sofinnova Capital IX, which became a holder of more than 5% of our capital stock in connection with the Series A preferred stock financing.

(3)

David Allison, a member of our board of directors at the time of the second tranche of the Series Apreferred stock financing, is affiliated with 5AM Ventures VI, L.P., which became a holder of more than 5% of our capital stock in connection with the Series A preferred stock financing.

(4)

Jonathan Isaacsohn, M.D., a member of our board of directors and our Chief Executive Officer at the time ofSeries A preferred stock financing, and August J. Troendle, M.D., M.B.A., a member of our board of directors at the time of Series A preferred stock financing, are affiliated with CinRx Pharma, LLC, a holder of more than 5% of our capital stock atthe time of the Series A preferred stock financing.

Series B Preferred Stock Financing

In September 2021 and October 2021, we entered into a preferred stock purchase agreement, or the Series B Purchase Agreement,with certain investors, including beneficial owners of greater than 5% of our capital stock, members of our board of directors and affiliates of members of our board of directors, pursuant to which we issued and sold to such investors an aggregateof 35,716,249 shares of our Series B preferred stock at a purchase price of $4.00 per share for aggregate gross proceeds of $142.9 million.

 

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The table below sets forth the aggregate number of shares of Series Bpreferred stock issued to our related parties in this financing:

 

Name

  Series B
Preferred
Stock
(#)
   Aggregate
Purchase
Price
($)
 

General Atlantic (CIN), L.P.(1)

   8,250,000   $33,000,000 

Sofinnova Venture Partners X,L.P.(2)

   4,275,000   $17,100,000 

Sofinnova Capital IX(3)

   3,150,000   $12,600,000 

Entities affiliated with 5AM Ventures VI,L.P.(4)

   3,150,000   $12,600,000 

CinRx Pharma, LLC(5)

   2,013,749   $8,054,996 

 

(1)

Jason Pitts, who became a member of our board of directors at the time of the Series B preferred stockfinancing, is affiliated with General Atlantic (CIN), L.P., which became a holder of more than 5% of our capital stock in connection with the Series B preferred stock financing.

(2)

James Healy, a member of our board of directors at the time of the Series B preferred stock financing, isaffiliated with Sofinnova Venture Partners X, L.P., a holder of more than 5% of our capital stock at the time of the Series B preferred stock financing.

(3)

Maina Bhaman, a member of our board of directors at the time of the Series B preferred stock financing, isaffiliated with Sofinnova Capital IX, a holder of more than 5% of our capital stock at the time of the Series B preferred stock financing.

(4)

David Allison, a member of our board of directors at the time of the Series B preferred stock financing, isaffiliated with 5AM Ventures VI, L.P., a holder of more than 5% of our capital stock at the time of the Series B preferred stock financing.

(5)

Jonathan Isaacsohn, M.D., a member of our board of directors and Chief Scientific Officer at the time of theSeries B preferred stock financing, and August J. Troendle, M.D., M.B.A., a member of our board of directors at the time of Series B preferred stock financing, are affiliated with CinRx Pharma, LLC, a holder of more than 5% of our capital stock atthe time of the Series B preferred stock financing.

In connection with our Series B preferred stock financing, weagreed to indemnify new purchasers of our capital stock, along with Dr. Pitts, from any losses, liabilities, claims, damages, or expenses (including attorneys’ fees) incurred in connection with investigating, defending, or participating in anylegal action or proceeding by reason of their payment under the Series B Purchase Agreement or other related events. Additionally, we also agreed to indemnify Dr. Pitts and General Atlantic (CIN), L.P. against any claims arising from Dr. Pitts’status as a member of our board of directors, agent or fiduciary.

Investors’ Rights, Voting and Right of First Refusal Agreements

In connection with the sales of preferred stock described above, we entered into an amended and restated investors’ rightsagreement, an amended and restated voting agreement and an amended and restated right of first refusal and co-sale agreement containing registration rights, information rights, voting rights and rights offirst refusal, among other things, with the holders of our preferred stock. These agreements will terminate upon the closing of this offering, except for the registration rights granted under our amended and restated investors’ rightsagreement, as more fully described in the section of this prospectus titled “Description of Capital Stock—Registration Rights.”

CinRxPharma, LLC

We were incorporated in March 2018 as a subsidiary of CinRx Pharma, LLC, or CinRx, and spun out as anindependent company in May 2019 after the closing of our Series A preferred stock financing and the execution of our in-licensing transaction with Roche.

 

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During December 31, 2019 and 2020, we recorded business management feestotaling $0.8 million and $1.6 million, respectively, of which $173,000 and $99,000 are included in general and administrative expenses on our statements of operations and comprehensive loss for the years ended December 31, 2019 and 2020,respectively. Prior to May 2019, we did not incur any business management fees pursuant to the Management Services Agreement.

Amendedand Restated Management Services Agreement with CinRx Pharma, LLC

On April 16, 2020, we entered into an amendedand restated management services agreement, or the Management Services Agreement, with CinRx, pursuant to which CinRx provides us with certain professional, management and consulting services. Services were performed on a task order basis, wherebythe specific services and fees to be provided for each project under the Management Services Agreement were separately specified in a written task order on terms mutually acceptable to the parties. The Management Services Agreement had an initial two-year term, which automatically renewed for additional one-year terms unless ether party provided written notice of termination. We provided notice to terminate theManagement Services Agreement on November 4, 2021. Pursuant to the terms of the Master Services Agreement, the termination shall become effective no later than February 2, 2022. For further information on our termination of the Management ServicesAgreement, please see “Risk Factors—Risks Related to Our Dependence on Third Parties—We terminated our Management Services Agreement with CinRx, a related party we have relied on to provide us with services since our inception, and wemay not be able to effectively replace those services.” elsewhere in this prospectus.

Medpace Holdings, Inc.

August J. Troendle, M.D., M.B.A., a former member of our board of directors, is the president, chief executive officer andchairman of the board of directors of Medpace Holdings, Inc., or Medpace, and Jonathan Isaacsohn, M.D., FACC, our former Chief Executive Officer, former Chief Scientific Officer and former member of our board of directors, is an officer of Medpace.

Master Services Agreement with Medpace

On January 1, 2018, we entered into a Master Services Agreement with Medpace, or the Medpace Agreement, pursuant to whichMedpace provides us with certain clinical trial related services. Services are performed on a task order basis, whereby the specific services and fees to be provided for each project under the Medpace Agreement are separately specified in a writtentask order on terms mutually acceptable to the parties. We may terminate any task order without cause immediately upon giving Medpace notice of such termination. As of December 31, 2018, 2019 and 2020, $0, $0.5 million and $12.8 million,respectively, of these fees are included in research and development expenses on our statements of operations and comprehensive loss.

Transactionswith Roche

License Agreement

In May 2019, following the closing of the initial tranche of our Series A preferred stock financing, we entered into a licenseagreement, or the Roche Agreement, with F. Hoffmann-La Roche Ltd and Hoffmann La-Roche Inc., whom we collectively refer to in this prospectus as Roche, pursuant to whichwe obtained an exclusive, worldwide, royalty-bearing license under certain patents and specified know-how owned or controlled by Roche and Roche’s interest in joint patents and covering certain specifiedsmall molecule aldosterone synthase inhibitors to research, develop, register, use, make, import, export, market, distribute, sell and otherwise exploit products containing such aldosterone synthase inhibitors, as more fully described in the sectionof this prospectus titled “Business—License Agreement with Roche.”

 

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Warrants

In connection with the Roche Agreement, we also agreed to issue to an affiliate of Roche warrants to acquire shares of ourcommon stock, which we refer to collectively as the Roche Warrants. The first Roche Warrant, which was issued in connection with our Series A preferred stock financing, is exercisable for 1,400,000 shares of our common stock. The second RocheWarrant, issued in connection with our Series A preferred stock financing, is exercisable for 1,120,476 shares of our common stock. The third Roche Warrant, issued in connection with our Series B preferred stock financing, is exercisable for 386,271shares of our common stock. The Roche Warrants are collectively exercisable for 2,906,747 shares of our common stock at an exercise price of $0.01 per share. The Roche Warrants will automatically net exercise in whole immediately prior to theeffectiveness of this registration statement for an aggregate of                shares of our common stock immediately prior to the effectiveness of the registrationstatement of which this prospectus forms a part (assuming an initial public offering price of $                per share, which is the midpoint of the price range listedon the cover page of this prospectus).

Employment Arrangements

We have entered into employment agreements with our executive officers. For more information regarding these agreements withour named executive officers, see the sections titled “Executive Compensation—Employment Agreements with our Named Executive Officers” and “Management.”

Executive and Director Compensation

We have granted options to certain of our executive officers and directors. See the sections titled“Management—Non-Employee Director Compensation” and “Executive Compensation” for a description of these equity awards.

Indemnification Agreements

Our amended and restated certificate of incorporation that will be in effect upon the closing of this offering will containprovisions limiting the liability of directors, and our amended and restated bylaws will provide that we will indemnify each of our directors to the fullest extent permitted under Delaware law. Our amended and restated certificate of incorporationand amended and restated bylaws will also provide our board of directors with discretion to indemnify our officers and employees when determined appropriate by the board.

In addition, we have entered into indemnification agreements with each of our directors, and we expect to enter intoindemnification agreements with each of our executive officers prior to the closing of this offering. For more information regarding these agreements, see “Executive Compensation—Limitations on Liability and Indemnification Matters.”

Directed Share Program

At our request, the underwriters have reserved up to         % of the shares offered bythis prospectus, for sale at the initial public offering price through a directed share program to certain of our directors, officers, employees and business associates and other parties related to us. If purchased by these persons, these shareswill be subject to a 180-day lock-up restriction. Morgan Stanley & Co. LLC will administer our directed share program. See the section titled “Underwriting—Directed Share Program.”

Related Person Transaction Policy

Prior to this offering, we have not had a formal policy regarding approval of transactions with related parties. In connectionwith this offering, we have adopted a written related party transaction policy that sets forth

 

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our procedures for the identification, review, consideration and approval or ratification of related party transactions. This policy became effective upon the effectiveness of the registrationstatement of which this prospectus is a part. For purposes of this policy only, a “related person transaction” is a transaction, arrangement or relationship (or any series of similar transactions, arrangements or relationships) in which weand any related person are participants involving an amount that exceeds $120,000. Transactions involving compensation for services provided to us as an employee, consultant or director are not considered related-person transactions under thispolicy. A “related person” is any executive officer, director, nominee to become a director or a holder of more than 5% of our share capital, or any affiliate or member of the immediate family of the foregoing.

Under the policy, where a transaction has been identified as a related-person transaction, management will be required topresent information regarding the proposed related-person transaction to our audit committee or, where review by our audit committee would be inappropriate due to a conflict of interest, to another independent body of our board of directors, forreview. The presentation will need to include a description of, among other things, all of the parties, the direct and indirect interests of the related persons, the purpose of the transaction, the material facts, the benefits of the transaction tous and whether any alternative transactions are available, an assessment of whether the terms are comparable to the terms available from unrelated third parties and management’s recommendation. To identify related-person transactions inadvance, we will rely on information supplied by our executive officers, directors and certain significant stockholders. In considering related-person transactions, our audit committee or another independent body of our board of directors will takeinto account the relevant available facts and circumstances including, but not limited to:

 

  

the risks, costs and benefits to us;

 

  

the impact on a director’s independence in the event the related person is a director, immediate familymember of a director or an entity with which a director is affiliated;

 

  

the terms of the transaction;

 

  

the availability of other sources for comparable services or products; and

 

  

the terms available to or from, as the case may be, unrelated third parties under the same or similarcircumstances.

All of the transactions described in this section were entered into prior to theadoption of this policy. Although we have not had a written policy for the review and approval of transactions with related persons, our board of directors has historically reviewed and approved any transaction where a director or officer had afinancial interest, including the transactions described above. Prior to approving such a transaction, the material facts as to a director’s or officer’s relationship or interest in the agreement or transaction were disclosed to our boardof directors. Our board of directors took this information into account when evaluating the transaction and in determining whether such transaction was fair to us and in the best interest of all our stockholders.

 

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PRINCIPAL STOCKHOLDERS

The following table sets forth information regarding beneficial ownership of our capital stock by:

 

  

each person, or group of affiliated persons, known by us to beneficially own more than 5% of our common stock;

 

  

each of our directors;

 

  

each of our named executive officers; and

 

  

all of our current executive officers and directors as a group.

We have determined beneficial ownership in accordance with the rules of the SEC. Under these rules, beneficial ownershipincludes any shares of common stock as to which the individual or entity has sole or shared voting power or investment power. Applicable percentage ownership is based on 77,501,182 shares of common stock outstanding as of November 15, 2021, aftergiving effect to the conversion of all of our preferred stock. In computing the number of shares beneficially owned by an individual or entity and the percentage ownership of that person, shares of common stock subject to options held by such personthat are currently exercisable or will become exercisable within 60 days of November 15, 2021 are considered outstanding, although these shares are not considered outstanding for purposes of computing the percentage ownership of any other person.

The following table does not reflect any shares of common stock that may be purchased in this offering pursuant to ourdirected share program described under “Underwriting—Directed Share Program.” If any shares are purchased by our existing principal shareholders, directors, executive officers or their affiliated entities, the number and percentage ofshares beneficially owned by them after this offering will differ from those set forth in the following table.

Unlessnoted otherwise, the address of all listed stockholders is c/o CinCor Pharma, Inc., 200 Clarendon Street, 6th Floor, Boston, Massachusetts 02116.

Except as indicated by the footnotes below, we believe, based on information furnished to us, that each of the stockholderslisted has sole voting and investment power with respect to the shares beneficially owned by the stockholder unless noted otherwise, subject to community property laws where applicable.

 

   Number of
Shares
Beneficially
Owned
   Percentage of Shares Beneficially
Owned
 

Name of Beneficial Owner

  Before
Offering
  After
Offering
 

5% Stockholders

     

Sofinnova Venture Partners X,L.P.(1)

   17,846,428    23.0  % 

Sofinnova Capital IX(2)

   13,149,999    17.0  % 

Entities affiliated with 5AM Ventures VI,L.P.(3)

   13,149,999    17.0  % 

CinRx Pharma, LLC(4)

   8,406,605    10.8  % 

General Atlantic (CIN), L.P.(5)

   8,250,000    10.6  % 

Named Executive Officers and Directors

     

Marc de Garidel

           

Mary Theresa Coelho, M.B.A.

           

Mason Freeman, M.D.(6)

   85,505    *   * 

Catherine Pearce, M.B.A., D.HSc.(7)

   521,981    *   * 

David Allison, Ph.D.

           

James I. Healy, M.D., Ph.D.(8)

   17,846,428    23.0  % 

John F. Thero

           

Maina Bhaman, M.B.A.

           

June Lee, M.D.

           

Troy Ignelzi

           

Jason Pitts, Ph.D.

           

All current executive officers and directors as a group (11 persons)

   18,453,914    23.8  % 

 

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*

Represents beneficial ownership of less than one percent.

(1)

Consists of (a) 13,571,428 shares of common stock issuable upon conversion of Series A preferred stock and(b) 4,275,000 shares of common stock issuable upon conversion of Series B preferred stock. James Healy, a member of our board of directors, and Maha Katabi are the managing members of Sofinnova Management X, L.L.C., or SM X, the general partner ofSofinnova Venture Partners X, L.P., or SVP X, and may be deemed to have shared voting and investment control over the shares held by SVP X. Each of such individuals disclaims beneficial ownership of such shares except to the extent of theirpecuniary interest therein. The address of Sofinnova Venture Partners X, L.P. is c/o Sofinnova Investments, Inc., 3000 Sand Hill Road, Building 4-Suite 250, Menlo Park, California 94025.

(2)

Consists of (a) 9,999,999 shares of common stock issuable upon conversion of Series A preferred stock and(b) 3,150,000 shares of common stock issuable upon conversion of Series B preferred stock. Sofinnova Partners SAS, or Sofinnova Partners, is the management company of Sofinnova Capital IX, or SC IX. Each of Antoine Papiernik, Denis Lucquin, MoniqueSaulnier, Graziano Seghezzi and Henrijette Richter is a managing partner of Sofinnova Partners and may be deemed to have shared voting and investment control over the shares held by SC IX. Each of such individuals disclaims beneficial ownership ofsuch shares except to the extent of their pecuniary interest therein. The address of Sofinnova Capital IX is 7 Boulevard Haussmann 75009 Paris, France.

(3)

Consists of (a) 9,999,999 shares of common stock issuable upon conversion of Series A preferred stock and2,525,000 shares of common stock issuable upon conversion of Series B preferred stock held by 5AM Ventures VI, L.P., or 5AM Ventures VI, and (b) 625,000 shares of common stock common stock issuable upon conversion of Series B preferred stock held by5AM Opportunities I, L.P., or 5AM Opportunities I.

David Allison, a member of our board of directors, isalso a partner at 5AM Venture Management, LLC and has no voting or dispositive power over the shares held by 5AM Ventures VI or 5AM Opportunities I.

Andrew Schwab and Dr. Kush Parmar are the managing members of 5AM Partners VI, LLC, or 5AM Partners, the general partnerof 5AM Ventures VI and may be deemed to have shared voting and investment control over the shares held by 5AM Ventures VI.

Andrew Schwab and Dr. Kush Parmar are the managing members of 5AM Opportunities I (GP), LLC, or 5AM Opportunities, thegeneral partner of 5AM Opportunities I and may be deemed to have shared voting and investment control over the shares held by 5AM Opportunities I.

The address for all entities and individuals referenced in this footnote is 501 2nd Street, Suite 350, San Francisco,California 94107.

 

(4)

Consists of (a) 4,250,000 shares of common stock, (b) 2,142,856 shares of common stock issuable uponconversion of Series A preferred stock and (c) 2,013,749 shares of common stock issuable upon conversion of Series B preferred stock. Each of Jon Isaacsohn, August Troendle, Jesse Geiger and Steve Ewald is a member of the Board of Managers of CinRxPharma, LLC, or CinRx, and may be deemed to have shared voting and investment control over the shares held by CinRx. Each of such individuals disclaims beneficial ownership of such shares except to the extent of their pecuniary interest therein. Theaddress of CinRx Pharma, LLC is 5375 Medpace Way Cincinnati, OH 45227.

(5)

Consists of 8,250,000 shares of common stock issuable upon conversion of Series B preferred stock. GeneralAtlantic (SPV) GP, LLC, or GA LLC, is the general partner of General Atlantic (CIN), L.P., or GA CIN. GA CIN is ultimately controlled by the management committee of GASC MGP, LLC, or the GA Management Committee, of which is comprised of 9 members.Each of the members of the GA Management Committee disclaims ownership of all such shares except to the extent he or she has a pecuniary interest therein. Jason Pitts, a member of our board of directors, is also a vice president of General Atlanticand disclaims ownership of all such shares except to the extent he has a pecuniary interest therein, The address of General Atlantic (CIN), L.P. is c/o General Atlantic Service Company, L.P., 55 East 52nd Street, 33rd Floor, New York, New York10055.

(6)

Consists of 85,505 shares of common stock issuable upon the exercise of options within 60 days of November15, 2021.

 

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(7)

Consists of 442,549 shares of common stock and 79,432 shares of common stock issuable upon the exercise ofoptions within 60 days of November 15, 2021

(8)

Consists of (a) 13,571,428 shares of common stock issuable upon conversion of Series A preferred stock and(b) 4,275,000 shares of common stock issuable upon conversion of Series B preferred stock held by SVP X. James Healy, a member of our board of directors, is a managing member of SM X, the general partner of SVP X, and may be deemed to have sharedvoting and investment control over the shares held by SVP X.

 

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DESCRIPTION OF CAPITAL STOCK

The following description of our capital stock, certain provisions of our amended and restated certificate of incorporationand amended and restated bylaws, as each will be in effect following the completion of this offering, and certain provisions of Delaware law are summaries. You should also refer to the amended and restated certificate of incorporation and theamended and restated bylaws, which are filed as exhibits to the registration statement of which this prospectus is part.

General

Upon the completion of this offering, our amended and restated certificate of incorporation will authorize us to issue up to1,000,000,000 shares of common stock, $0.00001 par value per share, and 10,000,000 shares of preferred stock, $0.00001 par value per share, all of which shares of preferred stock will be undesignated. Our board of directors may establish the rightsand preferences of the preferred stock from time to time.

As of September 30, 2021, we had outstanding 6,046,335 sharesof common stock, held by five stockholders of record. As of September 30, 2021, after giving effect to the conversion of all of the outstanding shares of our preferred stock, there would have been 75,463,117 shares of common stock issued andoutstanding, held by 26 stockholders of record.

Common Stock

Voting Rights

Each holder of our common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders,including the election of directors. The affirmative vote of holders of at least 662/3% of the voting power of all of the then-outstandingshares of capital stock, voting as a single class, will be required to amend certain provisions of our amended and restated certificate of incorporation, including provisions relating to amending our amended and restated bylaws, the classifiedboard, the size of our board, removal of directors, director liability, vacancies on our board, special meetings, stockholder notices, actions by written consent and exclusive forum.

Dividends

Subject to preferences that may be applicable to any then-outstanding preferred stock, holders of common stock are entitled toreceive ratably those dividends, if any, as may be declared from time to time by the board of directors out of legally available funds.

Liquidation

In the event of our liquidation, dissolution or winding up, holders of common stock will be entitled to share ratably in thenet assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities and the satisfaction of any liquidation preference granted to the holders of any then-outstanding shares of preferred stock.

Rights and Preferences

Holders of common stock have no preemptive, conversion or subscription rights and there are no redemption or sinking fundprovisions applicable to the common stock. The rights, preferences and privileges of the holders of common stock are subject to, and may be adversely affected by, the right of the holders of shares of any series of preferred stock that we maydesignate in the future.

 

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Preferred Stock

As of September 30, 2021, there were 35,714,282 shares of our Series A preferred stock outstanding and 33,702,500 shares of ourSeries B preferred stock outstanding. All currently outstanding shares of preferred stock will be converted into an aggregate of 69,416,782 shares of common stock upon the closing of this offering.

Following the closing of this offering, our board of directors will have the authority under our amended and restatedcertificate of incorporation, without further action by our stockholders, to issue up to 10,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each such series, to fix therights, preferences and privileges of the shares of each wholly unissued series and any qualifications, limitations or restrictions thereon, and to increase or decrease the number of shares of any such series, but not below the number of shares ofsuch series then outstanding.

Our board of directors may authorize the issuance of preferred stock with voting orconversion rights that could adversely affect the voting power or other rights of the holders of our common stock. The purpose of authorizing our board of directors to issue preferred stock and determine its rights and preferences is to eliminatedelays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while providing flexibility in connection with possible acquisitions and other corporate purposes, could, among other things, have the effect ofdelaying, deferring or preventing a change in control of us and may adversely affect the market price of our common stock and the voting and other rights of the holders of our common stock. It is not possible to state the actual effect of theissuance of any shares of preferred stock on the rights of holders of common stock until the board of directors determines the specific rights attached to that preferred stock.

We have no present plans to issue any shares of preferred stock following the completion of this offering.

Options

As ofSeptember 30, 2021, there were options to purchase 5,057,647 shares of common stock outstanding. For additional information regarding the terms of our 2022 Plan, see “Executive Compensation—Equity Incentive Plans.”

Warrant

In May 2019, inconnection with our entry into a license agreement with Roche, we also agreed to issue the Roche Warrants. The first Roche Warrant, which was issued in connection with our Series A preferred stock financing, is exercisable for 1,400,000 shares ofour common stock. The second Roche Warrant, issued in connection with our Series A preferred stock financing, is exercisable for 1,120,476 shares of our common stock. The third Roche Warrant, issued in connection with our Series B preferred stockfinancing, is exercisable for 386,271 shares of our common stock. The Roche Warrants are collectively exercisable for 2,906,747 shares of our common stock at an exercise price of $0.01 per share. The Roche Warrants will automatically net exercise inwhole for an aggregate of                shares of our common stock immediately prior to the effectiveness of the registration statement of which this prospectus forms apart (assuming an initial public offering price of $                per share, which is the midpoint of the price range listed on the cover page of this prospectus).

Registration Rights

We, the holders of our existing preferred stock and certain holders of our existing common stock have entered into an amendedand restated investors’ rights agreement. The registration rights provisions of this agreement provide those holders with demand, piggyback and Form S-3 registration rights with respect to the sharesof common stock currently held by them and issuable to them upon conversion of our preferred stock in connection with our initial public offering. These shares are collectively referred to herein as registrable securities.

 

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Demand Registration Rights

At any time beginning 180 days following the effective date of the registration statement of which this prospectus is a part,the holders of a majority of registrable securities then outstanding have the right to demand that we file a registration statement covering at least 10% of the registrable securities then outstanding. We are obligated to effect at most tworegistrations in response to these demand registration rights. These demand registration rights are subject to specified conditions and limitations, including the right of the underwriters, if any, to limit the number of shares included in any suchregistration under specified circumstances. Upon such a request, we are required to effect the registration as soon as practicable, but in any event no later than 60 days after the receipt of such request.

Piggyback Registration Rights

If we propose to register any of our common stock under the Securities Act either for our own account or for the account ofother stockholders, the holders of registrable securities will each be entitled to notice of the registration and will be entitled to include their shares of common stock in the registration statement. These piggyback registration rights are subjectto specified conditions and limitations, including the right of the underwriters to limit the number of shares included in any such registration under specified circumstances, and do not apply to a registration relating to any equity incentive plan,stock purchase or similar plan, a transaction under Rule 145 of the Securities Act, a registration on any form that does not include substantially the same information as would be required to be included in a registration statement covering the saleof the registrable securities or a registration related to common stock issued upon conversion of debt securities.

Registration on Form S-3

At any time after we become eligible to file a registrationstatement on Form S-3, the holders of at least 20% of the registrable securities then outstanding will be entitled to request to have such shares registered by us on a FormS-3 registration statement. These Form S-3 registration rights are subject to other specified conditions and limitations, including the condition that the anticipatedaggregate offering price, net of certain selling expenses, is at least $1.0 million. Upon receipt of this request, the holders of registrable securities will each be entitled to participate in this registration. We will not be required toeffect such a registration if, within the preceding twelve month period, we have already effected two registrations on Form S-3 for the holders of registrable securities.

Expenses of Registration

We are required to pay all expenses, including fees and expenses of one counsel to represent the selling stockholders, relatingto any demand, piggyback or Form S-3 registration, other than underwriting discounts and commissions, stock transfer taxes and any additional fees of counsel for the selling stockholders, subject to specifiedconditions and limitations. We are not required to pay registration expenses if a demand registration request is withdrawn at the request of the holders of a majority of registrable securities then outstanding, unless holders of a majority of theregistrable securities agree to forfeit their right to one demand registration.

The amended and restated investors’rights agreement contains customary cross-indemnification provisions, pursuant to which we are obligated to indemnify the selling stockholders in the event of material misstatements or omissions in the applicable registration statement attributableto us, and the selling stockholders are obligated to indemnify us for material misstatements or omissions in the registration statement attributable to them, subject to certain limitations.

Termination of Registration Rights

The registration rights granted under the amended and restated investors’ rights agreement will terminate with respect toany particular stockholder upon the earlier of (i) the closing of a deemed liquidation event, as

 

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defined in our certificate of incorporation; (ii) with respect to each stockholder, at such time such stockholder is able to sell all of its shares pursuant to Rule 144 or another similarexemption under the Securities Act during a three-month period without registration; and (iii) the third anniversary of the closing of this offering.

Anti-Takeover Provisions

Section 203 of the Delaware General Corporation Law

We are subject to Section 203 of the Delaware General Corporation Law, which prohibits a Delaware corporation fromengaging in any business combination with any interested stockholder for a period of three years after the date that such stockholder became an interested stockholder, with the following exceptions:

 

  

before such date, the board of directors of the corporation approved either the business combination or thetransaction that resulted in the stockholder becoming an interested stockholder;

 

  

upon completion of the transaction that resulted in the stockholder becoming an interested stockholder, theinterested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction began, excluding for purposes of determining the voting stock outstanding, but not the outstanding voting stock owned by theinterested stockholder, those shares owned (i) by persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to theplan will be tendered in a tender or exchange offer; or

 

  

on or after such date, the business combination is approved by the board of directors and authorized at anannual or special meeting of the stockholders, and not by written consent, by the affirmative vote of at least 662/3% of the outstandingvoting stock that is not owned by the interested stockholder.

In general, Section 203 defines a“business combination” to include the following:

 

  

any merger or consolidation involving the corporation or any direct or indirect majority-owned subsidiary ofthe corporation and the interested stockholder;

 

  

any sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving theinterested stockholder (in one transaction or a series of transactions);

 

  

subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation orby any direct or indirect majority-owned subsidiary of the corporation of any stock of the corporation or of such subsidiary to the interested stockholder;

 

  

any transaction involving the corporation or any direct or indirect majority-owned subsidiary of thecorporation that has the effect of increasing the proportionate share of the stock or any class or series of the corporation beneficially owned by the interested stockholder; or

 

  

the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or otherfinancial benefits by or through the corporation.

In general, Section 203 defines an“interested stockholder” as an entity or person who, together with the person’s affiliates and associates, beneficially owns, or within three years prior to the time of determination of interested stockholder status did own, 15% ormore of the outstanding voting stock of the corporation.

Amended and Restated Certificate of Incorporation and Amended and RestatedBylaws

Our amended and restated certificate of incorporation to be in effect upon the completion of this offering,or our restated certificate, will provide for our board of directors to be divided into three classes with staggered three-year terms. Only one class of directors will be elected at each annual meeting of our stockholders, with the other classescontinuing for the remainder of their respective three-year terms. Because our stockholders do not

 

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have cumulative voting rights, stockholders holding a majority of the shares of common stock outstanding will be able to elect all of our directors. Our restated certificate and our amended andrestated bylaws to be effective upon the completion of this offering, or our restated bylaws, will also provide that directors may be removed by the stockholders only for cause upon the vote of662/3% or more of our outstanding common stock. Furthermore, the authorized number of directors may be changed only by resolution of theboard of directors, and vacancies and newly created directorships on the board of directors may, except as otherwise required by law or determined by the board, only be filled by a majority vote of the directors then serving on the board, eventhough less than a quorum.

Under our restated certificate of incorporation and amended and restated bylaws ourstockholders will not have cumulative voting rights. Because of this, the holders of a majority of the shares of common stock entitled to vote in any election of directors can elect all of the directors standing for election, if they should sochoose.

Our restated certificate and restated bylaws will also provide that all stockholder actions must be effected at aduly called meeting of stockholders and will eliminate the right of stockholders to act by written consent without a meeting. Our restated bylaws will also provide that only our Chairman of the board, Chief Executive Officer or the board ofdirectors pursuant to a resolution adopted by a majority of the total number of authorized directors may call a special meeting of stockholders.

Our restated bylaws will also provide that stockholders seeking to present proposals before a meeting of stockholders tonominate candidates for election as directors at a meeting of stockholders must provide timely advance notice in writing, and will specify requirements as to the form and content of a stockholder’s notice.

Our restated certificate and restated bylaws will provide that the stockholders cannot amend many of the provisions describedabove except by a vote of 662/3% or more of our outstanding common stock.

As described in “—Preferred Stock” above, our restated certificate will give our board of directors theauthority, without further action by our stockholders, to issue up to 10,000,000 shares of preferred stock in one or more series, with any rights, preferences and privileges as they may designate, including the right to approve an acquisition orother change in control.

The combination of these provisions will make it more difficult for our existing stockholders toreplace our board of directors as well as for another party to obtain control of us by replacing our board of directors. Since our board of directors has the power to retain and discharge our officers, these provisions could also make it moredifficult for existing stockholders or another party to effect a change in management. In addition, the authorization of undesignated preferred stock makes it possible for our board of directors to issue preferred stock with voting or other rightsor preferences that could impede the success of any attempt to change our control.

These provisions are intended toenhance the likelihood of continued stability in the composition of our board of directors and its policies and to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to reduce our vulnerability tohostile takeovers and to discourage certain tactics that may be used in proxy fights. However, such provisions could have the effect of discouraging others from making tender offers for our shares and may have the effect of delaying changes in ourcontrol or management. As a consequence, these provisions may also inhibit fluctuations in the market price of our stock that could result from actual or rumored takeover attempts. We believe that the benefits of these provisions, includingincreased protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure our company, outweigh the disadvantages of discouraging takeover proposals, because negotiation oftakeover proposals could result in an improvement of their terms.

 

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Choice of Forum

Our amended and restated certificate of incorporation will provide that the Court of Chancery of the state of Delaware will bethe exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

 

  

any derivative action or proceeding brought on our behalf;

 

  

any action asserting a breach of fiduciary duty;

 

  

any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our restatedcertificate, or our amended and restated bylaws; or

 

  

any action asserting a claim against us that is governed by the internal affairs doctrine.

The provision would not apply to suits brought to enforce a duty or liability created by the ExchangeAct. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims. Toprevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated certificate of incorporation will also provide that unless weconsent in writing to the selection of an alternative forum, the federal district courts of the United States shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.

While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder maynevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our restatedcertificate of incorporation. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.

These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it findsfavorable for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officers and other employees. If a court were to find either exclusive-forum provision in our amended andrestated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving the dispute in other jurisdictions, all of which could seriously harm our business.

Our amended and restated certificate of incorporation will further provide that the federal district courts of the UnitedStates of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, subject to and contingent upon a final adjudication in the State of Delaware of the enforceability of suchexclusive forum provision.

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is American Stock Transfer & Trust Company, LLC. The transferagent’s address is 6201 15th Avenue Brooklyn, NY 11219.

Listing

We have applied to list our common stock on the Nasdaq Global Market under the trading symbol “CINC.”

 

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SHARES ELIGIBLE FOR FUTURE SALE

Prior to this offering, no public market existed for our common stock. Future sales of our common stock in the public market,or the availability of such shares for sale in the public market, could adversely affect market prices prevailing from time to time. As described below, only a limited number of shares will be available for sale shortly after this offering due tocontractual and legal restrictions on resale. Nevertheless, sales of our common stock in the public market after such restrictions lapse, or the perception that those sales may occur, could adversely affect the prevailing market price at such timeand our ability to raise equity capital in the future.

Based on the number of shares outstanding as of September 30,2021, upon the closing of this offering and assuming no exercise of the underwriters’ option to purchase additional shares,                  shares of common stockwill be outstanding, assuming no outstanding options are exercised. All of the shares of common stock sold in this offering will be freely tradable without restrictions or further registration under the Securities Act, except for any shares sold toour “affiliates,” as that term is defined under Rule 144 under the Securities Act. The remaining                  shares of common stock held by existingstockholders are “restricted securities,” as that term is defined in Rule 144 under the Securities Act. Restricted securities may be sold in the public market only if registered or if their resale qualifies for exemption from registrationdescribed below under Rule 144 promulgated under the Securities Act or another available exemption.

As a result of the lock-up agreements described below and the provisions of Rules 144 and 701 under the Securities Act, the shares of common stock that will be deemed restricted securities after this offering will be available forsale in the public market as follows:

 

  

none of the existing restricted shares will be eligible for immediate sale upon the completion of thisoffering; and

 

  

                restrictedshares will be eligible for sale in the public market upon expiration of lock-up agreements 180 days after the date of this prospectus, subject in certain circumstances to the volume, manner of sale and otherlimitations under Rule 144 and Rule 701 under the Securities Act, which are summarized below.

Rule 144

In general, non-affiliate persons who have beneficially owned restricted shares of ourcommon stock for at least six months, and any affiliate of the company who owns either restricted or unrestricted shares of our common stock, are entitled to sell their securities without registration with the SEC under an exemption fromregistration provided by Rule 144 under the Securities Act.

Non-Affiliates

Any person who is not deemed to have been one of our affiliates at the time of, or at any time during the three monthspreceding, a sale may sell an unlimited number of restricted securities under Rule 144 if:

 

  

the restricted securities have been held for at least six months, including the holding period of any priorowner other than one of our affiliates (subject to certain exceptions);

 

  

we have been subject to the Exchange Act periodic reporting requirements for at least 90 days before the sale;and

 

  

we are current in our Exchange Act reporting at the time of sale.

Any person who is not deemed to have been an affiliate of ours at the time of, or at any time during the three monthspreceding, a sale and has held the restricted securities for at least one year, including the holding period of any prior owner other than one of our affiliates, will be entitled to sell an unlimited number of restricted

 

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securities without regard to the length of time we have been subject to Exchange Act periodic reporting or whether we are current in our Exchange Act reporting.Non-affiliate resales are not subject to the manner of sale, volume limitation or notice filing provisions of Rule 144.

Affiliates

Persons seeking to sell restricted securities who are our affiliates at the time of, or any time during the three monthspreceding, a sale, would be subject to the restrictions described above. They are also subject to additional restrictions, by which such person would be required to comply with the manner of sale and notice provisions of Rule 144 and would beentitled to sell within any three-month period only that number of securities that does not exceed the greater of either of the following:

 

  

1% of the number of shares of our common stock then outstanding, which will equal approximately                 shares immediately after the completion of this offering based on the number of shares outstanding as of September 30, 2021; or

 

  

the average weekly trading volume of our common stock on the stock exchange on which our shares are listedduring the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale.

Additionally, persons who are our affiliates at the time of, or any time during the three months preceding, a sale may sellunrestricted securities under the requirements of Rule 144 described above, without regard to the six-month holding period of Rule 144, which does not apply to sales of unrestricted securities.

Rule 701

Rule 701 underthe Securities Act, as in effect on the date of this prospectus, permits resales of shares in reliance upon Rule 144 but without compliance with certain restrictions of Rule 144, including the holding period requirement. Most of our employees,executive officers or directors who purchased shares under a written compensatory plan or contract may be entitled to rely on the resale provisions of Rule 701, but all holders of Rule 701 shares are required to wait until 90 days after the date ofthis prospectus before selling their shares. However, substantially all Rule 701 shares are subject to lock-up agreements as described below and in the section titled “Underwriting” and will becomeeligible for sale upon the expiration of the restrictions set forth in those agreements.

Form S-8 RegistrationStatements

We intend to file one or more registration statements on Form S-8under the Securities Act to register all shares of common stock subject to outstanding stock options and common stock issued or issuable under our equity plans. We expect to file the registration statement covering shares offered pursuant to ourstock plans as soon as practicable after the closing of this offering, permitting the resale of such shares by non-affiliates in the public market without restriction under the Securities Act and the sale byaffiliates in the public market, subject to compliance with the resale provisions of Rule 144 and expiration or release from the terms of the lock-up agreements described above.

Lock-Up Agreements

We, our executive officers and directors and substantially all of the holders of our common stock outstanding on the date ofthis prospectus have entered into lock-up agreements with the underwriters or otherwise agreed, subject to certain exceptions, that we and they will not, directly or indirectly, offer, sell, contract to sell,pledge, grant any option to purchase, make any short sale, or otherwise dispose of or hedge any of our shares of common stock, any options or warrants to purchase shares of our common stock, or any securities convertible into, or exchangeable for orthat represent the right to receive shares of our common stock, without the prior written consent of Morgan Stanley & Co. LLC, Jefferies LLC and Evercore Group L.L.C. for a period of 180 days from the date of this prospectus.

 

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In addition to the restrictions contained in the lock-up agreements described above, we have entered into an agreement with the holders of our preferred stock that contains market stand-off provisions imposing restrictionson the ability of such security holders to sell or otherwise transfer or dispose of any registrable securities for a period of 180 days following the date of this prospectus.

Registration Rights

Uponthe closing of this offering, the holders of                  shares of our common stock, including common stock issuable upon the conversion of our preferred stock, ortheir transferees, will be entitled to specified rights with respect to the registration of their registrable shares under the Securities Act, subject to certain limitations and the expiration, waiver or termination of the lock-up agreements. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act immediately upon effectiveness of theregistration. See “Description of Capital Stock—Registration Rights” for additional information.

 

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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS OF OUR

COMMON STOCK

The following is a summary of certain material U.S. federal income tax consequences tonon-U.S. holders (as defined below) of the ownership and disposition of our common stock offered pursuant to this prospectus. This discussion is not a complete analysis of all potential U.S. federal income taxconsequences relating thereto, does not address the potential application of the Medicare contribution tax on net investment income, the alternative minimum tax, or the special tax accounting rules under Section 451(b) of the Code, and does notaddress any U.S. federal non-income tax consequences such as estate or gift tax consequences or any tax consequences arising under any state, local, or non-U.S. taxlaws, or any other U.S. federal tax laws. This discussion is based on the Code and applicable Treasury Regulations promulgated thereunder, judicial decisions and published rulings, and administrative pronouncements of the Internal Revenue Service,or IRS, all as in effect as of the date hereof. These authorities are subject to differing interpretations and may change, possibly retroactively, resulting in U.S. federal income tax consequences different from those discussed below. We have notrequested a ruling from the IRS with respect to the statements made and the conclusions reached in the following summary, and there can be no assurance that the IRS or a court will agree with such statements and conclusions.

This discussion is limited to non-U.S. holders who purchase our common stock offeredby this prospectus and who hold our common stock as a “capital asset” within the meaning of Section 1221 of the Code (generally, property held for investment). This discussion does not address all of the U.S. federal income taxconsequences that may be relevant to a particular holder in light of such holder’s particular circumstances. This discussion also does not consider any specific facts or circumstances that may be relevant to holders subject to special rulesunder the U.S. federal income tax laws, including:

 

  

certain former citizens or long-term residents of the United States;

 

  

partnerships or other entities or arrangements treated as partnerships, pass-throughs, or disregarded entitiesfor U.S. federal income tax purposes (and investors therein), S corporations or other pass-through entities (including hybrid entities);

 

  

“controlled foreign corporations;”

 

  

“passive foreign investment companies;”

 

  

corporations that accumulate earnings to avoid U.S. federal income tax;

 

  

banks, financial institutions, investment funds, insurance companies, brokers or dealers in securities;

 

  

persons who have elected to mark securities to market;

 

  

tax-exempt organizations and governmental organizations;

 

  

tax-qualified retirement plans;

 

  

persons that acquired our common stock through the exercise of employee stock options or otherwise ascompensation or through a tax-qualified retirement plan;

 

  

persons that acquired our common stock pursuant to the exercise of warrants or conversion rights underconvertible instruments;

 

  

persons who hold common stock that constitutes “qualified small business stock” underSection 1202 of the Code, or “Section 1244 stock” under Section 1244 of the Code;

 

  

persons who acquired our common stock in a transaction subject to the gain rollover provisions of the Code(including Section 1045 of the Code);

 

  

persons that own, or have owned, actually or constructively, more than 5% of our common stock;

 

  

“qualified foreign pension funds” as defined in Section 897(l)(2) of the Code and entities allof the interests of which are held by qualified foreign pension funds; and

 

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persons holding our common stock as part of a hedging or conversion transaction or straddle, or a constructivesale, or other risk reduction strategy or integrated investment.

If an entity or arrangement that isclassified as a partnership for U.S. federal income tax purposes holds our common stock, the U.S. federal income tax treatment of a partner in the partnership will generally depend on the status of the partner and the activities of the partnership.Partnerships holding our common stock and the partners in such partnerships are urged to consult their tax advisors about the particular U.S. federal income tax consequences to them of holding and disposing of our common stock.

THIS DISCUSSION IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT TAX ADVICE. PROSPECTIVE INVESTORS SHOULD CONSULT THEIR TAXADVISORS REGARDING THE PARTICULAR U.S. FEDERAL INCOME TAX CONSEQUENCES TO THEM OF ACQUIRING, OWNING, AND DISPOSING OF OUR COMMON STOCK, AS WELL AS ANY TAX CONSEQUENCES ARISING UNDER ANY STATE, LOCAL, ORNON-U.S. TAX LAWS AND ANY U.S. FEDERAL NON-INCOME TAX LAWS, OR UNDER ANY APPLICABLE INCOME TAX TREATY.

Definition of Non-U.S. Holder

For purposes of this discussion, a non-U.S. holder is any beneficial owner of ourcommon stock that is not a “U.S. person” or a partnership (including any entity or arrangement treated as a partnership) for U.S. federal income tax purposes. A U.S. person is any person that, for U.S. federal income tax purposes, is or istreated as any of the following:

 

  

an individual who is a citizen or resident of the United States;

 

  

a corporation (or entity treated as a corporation for U.S. federal income tax purposes) created or organizedunder the laws of the United States, any state thereof or the District of Columbia;

 

  

an estate, the income of which is subject to U.S. federal income tax regardless of its source; or

 

  

a trust (1) whose administration is subject to the primary supervision of a U.S. court and which has oneor more U.S. persons who have the authority to control all substantial decisions of the trust or (2) that has a valid election in effect under applicable Treasury Regulations to be treated as a U.S. person.

Distributions on Our Common Stock

As described in the section titled “Dividend Policy,” we have not paid and do not anticipate paying dividends in theforeseeable future. However, if we make cash or other property distributions on our common stock, such distributions will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings andprofits, as determined under U.S. federal income tax principles. Amounts that exceed such current and accumulated earnings and profits and, therefore, are not treated as dividends for U.S. federal income tax purposes will constitute a return ofcapital and will first be applied against and reduce a holder’s tax basis in our common stock, but not below zero. Any amount distributed in excess of basis will be treated as gain realized on the sale or other disposition of our common stockand will be treated as described under the section titled “Gain on Disposition of Our Common Stock” below.

Subject to the discussions below regarding effectively connected income, backup withholding, and Sections 1471 through 1474 ofthe Code, or FATCA, dividends paid to a non-U.S. holder of our common stock generally will be subject to U.S. federal withholding tax at a rate of 30% of the gross amount of the dividends or such lower ratespecified by an applicable income tax treaty. To receive the benefit of a reduced treaty rate, a non-U.S. holder must furnish us or the applicable withholding agent with a valid IRS Form W-8BEN or IRS Form W-8BEN-E (or applicable successor form) certifying such holder’s qualification for the reduced rate. Thiscertification must be provided to us or the applicable withholding agent before the payment of dividends and must be updated periodically. If the non-U.S. holder holds the stock through a financial institutionor other agent

 

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acting on the non-U.S. holder’s behalf, the non-U.S. holder will be required to provide appropriatedocumentation to the agent, which then will be required to provide certification to us or the applicable withholding agent, either directly or through other intermediaries.

Non-U.S. holders that do not provide the required certification on a timely basis, butthat qualify for a reduced treaty rate, may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS.

If a non-U.S. holder holds our common stock in connection with the conduct of a tradeor business in the United States, and dividends paid on our common stock are effectively connected with such holder’s U.S. trade or business (and are attributable to such holder’s permanent establishment or fixed base in the United States,if required by an applicable tax treaty), the non-U.S. holder will generally be exempt from U.S. federal withholding tax. To claim the exemption, the non-U.S. holdermust generally furnish a valid IRS Form W-8ECI (or applicable successor form) to the applicable withholding agent.

However, any such effectively connected dividends paid on our common stock generally will be subject to U.S. federal incometax on a net income basis at the regular U.S. federal income tax rates in the same manner as if such holder were a resident of the United States. A non-U.S. holder that is a foreign corporation also may besubject to an additional branch profits tax equal to 30% (or such lower rate specified by an applicable income tax treaty) of its effectively connected earnings and profits for the taxable year, as adjusted for certain items. Non-U.S. holders should consult their tax advisors regarding any applicable income tax treaties that may provide for different rules.

Gain on Disposition of Our Common Stock

Subject to the discussions below regarding backup withholding and FATCA, a non-U.S.holder generally will not be subject to U.S. federal income tax on any gain realized on the sale or other disposition of our common stock, unless:

 

  

the gain is effectively connected with the non-U.S. holder’sconduct of a trade or business in the United States and, if required by an applicable income tax treaty, is attributable to a permanent establishment or fixed base maintained by the non-U.S. holder in theUnited States;

 

  

the non-U.S. holder is a nonresident alien individual present in theUnited States for 183 days or more during the taxable year of the disposition, and certain other requirements are met; or

 

  

our common stock constitutes a “United States real property interest” by reason of our status as aUnited States real property holding corporation, or USRPHC, for U.S. federal income tax purposes at any time within the shorter of the five-year period preceding the disposition or the non-U.S. holder’sholding period for our common stock, and our common stock is not regularly traded on an established securities market as defined by applicable Treasury Regulations.

Determining whether we are a USRPHC depends on the fair market value of our U.S. real property interests relative to the fairmarket value of our other trade or business assets and our foreign real property interests. We do not believe that we are, or have been, and do not anticipate becoming a USRPHC for U.S. federal income tax purposes, although there can be no assurancewe will not in the future become a USRPHC. Even if we are or were to become a USRPHC, gain arising from the sale or other taxable disposition by a non-U.S. holder of our common stock may not be subject to U.S.federal income tax if our common stock is “regularly traded,” as defined by applicable Treasury Regulations, on an established securities market.

Gain described in the first bullet point above generally will be subject to U.S. federal income tax on a net income basis atthe regular U.S. federal income tax rates in the same manner as if such holder were a resident of the United States. A non-U.S. holder that is a foreign corporation also may be subject to an additional branch

 

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profits tax equal to 30% (or such lower rate specified by an applicable income tax treaty) of its effectively connected earnings and profits for the taxable year, as adjusted for certain items.Gain described in the second bullet point above will be subject to U.S. federal income tax at a flat 30% rate (or such lower rate specified by an applicable income tax treaty), but may be offset by certain U.S.-source capital losses (even though theindividual is not considered a resident of the United States), provided that the non-U.S. holder has timely filed U.S. federal income tax returns with respect to such losses.Non-U.S. holders should consult their tax advisors regarding any applicable income tax treaties that may provide for different rules.

Information Reporting and Backup Withholding

Annual reports are required to be filed with the IRS and provided to each non-U.S.holder indicating the amount of distributions on our common stock paid to such holder and the amount of any tax withheld with respect to those distributions. These information reporting requirements apply even if no withholding was required (becausethe distributions were effectively connected with the holder’s conduct of a U.S. trade or business, or withholding was reduced or eliminated by an applicable income tax treaty) and regardless of whether such distributions constitute dividends.This information also may be made available under a specific treaty or agreement with the tax authorities in the country in which the non-U.S. holder resides or is established. Backup withholding, currently ata 24% rate, generally will not apply to payments to a non-U.S. holder of dividends on or the gross proceeds of a disposition of our common stock provided the non-U.S.holder furnishes the required certification for its non-U.S. status, such as by providing a valid IRS Form W-8BEN, IRS Form W-8BEN-E, or IRS Form W-8ECI, or certain other requirements are met. Backup withholding may apply if the payor has actual knowledge, or reason to know, that the holderis a U.S. person who is not an exempt recipient.

Backup withholding is not an additional tax. If any amount is withheldunder the backup withholding rules, the non-U.S. holder should consult with a U.S. tax advisor regarding the possibility of and procedure for obtaining a refund or a credit against the non-U.S. holder’s U.S. federal income tax liability, if any.

Withholding on Foreign Entities

FATCA imposes a U.S. federal withholding tax of 30% on certain payments made to a “foreign financial institution” (asspecially defined under these rules) unless such institution enters into an agreement with the U.S. government to withhold on certain payments and to collect and provide to the U.S. tax authorities substantial information regarding certain U.S.account holders of such institution (which includes certain equity and debt holders of such institution, as well as certain account holders that are foreign entities with U.S. owners) or an exemption applies. FATCA also generally will impose a U.S.federal withholding tax of 30% on certain payments made to a non-financial foreign entity unless such entity provides the withholding agent a certification identifying certain direct and indirect U.S. ownersof the entity or an exemption applies. An intergovernmental agreement between the United States and an applicable foreign country may modify these requirements. Under certain circumstances, a non-U.S. holdermight be eligible for refunds or credits of such taxes. FATCA applies to dividends paid on our common stock and, subject to the proposed Treasury Regulations described below, also applies to gross proceeds from sales or other dispositions of ourcommon stock. The U.S. Treasury Department released proposed Treasury Regulations which, if finalized in their present form, would eliminate the federal withholding tax of 30% applicable to the gross proceeds of a disposition of our common stock. Inits preamble to such proposed Treasury Regulations, the U.S. Treasury Department stated that taxpayers (including applicable withholding agents) may generally rely on the proposed Treasury Regulations until final regulations are issued.

Prospective investors are encouraged to consult with their own tax advisors regarding the possible implications of thislegislation on their investment in our common stock.

 

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UNDERWRITING

Under the terms and subject to the conditions in an underwriting agreement dated the date of this prospectus, the underwritersnamed below, for whom Morgan Stanley & Co. LLC, Jefferies LLC and Evercore Group L.L.C. are acting as representatives, have severally agreed to purchase, and we have agreed to sell to them, severally, the number of shares of common stockindicated below:

 

Name

  

Number of

Shares

 

Morgan Stanley & Co. LLC

  

Jefferies LLC

  

Evercore Group L.L.C.

  

Oppenheimer & Co. Inc.

                

Total:

  
  

 

 

 

The underwriters and the representatives are collectively referred to as the“underwriters” and the “representatives,” respectively. The underwriters are offering the shares of common stock subject to their acceptance of the shares from us and subject to prior sale. The underwriting agreement providesthat the obligations of the several underwriters to pay for and accept delivery of the shares of common stock offered by this prospectus are subject to the approval of certain legal matters by their counsel and to certain other conditions. Theunderwriters are obligated to take and pay for all of the shares of common stock offered by this prospectus if any such shares are taken. However, the underwriters are not required to take or pay for the shares covered by the underwriters’option to purchase additional shares described below.

The underwriters initially propose to offer part of the shares ofcommon stock directly to the public at the offering price listed on the cover page of this prospectus and part to certain dealers at a price that represents a concession not in excess of$                per share under the public offering price. After the initial offering of the shares of common stock, the offering price and other selling terms may fromtime to time be varied by the representatives.

We have granted to the underwriters an option, exercisable for 30 daysfrom the date of this prospectus, to purchase up to                additional shares of common stock at the public offering price listed on the cover page of thisprospectus, less underwriting discounts and commissions. To the extent the option is exercised, each underwriter will become obligated, subject to certain conditions, to purchase about the same percentage of the additional shares of common stock asthe number listed next to the underwriter’s name in the preceding table bears to the total number of shares of common stock listed next to the names of all underwriters in the preceding table.

The following table shows the per share and total public offering price, underwriting discounts and commissions, and proceedsbefore expenses to us. These amounts are shown assuming both no exercise and full exercise of the underwriters’ option to purchase up to anadditional                shares of common stock.

 

       Total 
   Per
Share
   No Exercise   Full Exercise 

Public offering price

  $            $                $              

Underwriting discounts and commissions:

  $    $    $  

Proceeds, before expenses, to us

  $    $    $  
  $    $    $  

The estimated offering expenses payable by us, exclusive of the underwriting discounts andcommissions, are approximately $                . We have agreed to reimburse the underwriters for expenses of up to $40,000 relating to the clearance of this offeringwith the Financial Industry Regulatory Authority, Inc., compliance with state securities or “blue sky” laws.

 

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The underwriters have informed us that they do not intend sales todiscretionary accounts to exceed 5% of the total number of shares of common stock offered by them.

We have applied tolist our common stock on the Nasdaq Global Market under the trading symbol “CINC.”

We and all of ourdirectors and officers and the holders of all of our outstanding common stock, stock options and other securities convertible into, exercisable or exchangeable for our common stock outstanding immediately prior to the closing of this offering haveagreed that, without the prior written consent of Morgan Stanley & Co. LLC, Jefferies LLC and Evercore Group L.L.C. on behalf of the underwriters, we and they will not, and will not publicly disclose an intention to, during the period ending 180days after the date of this prospectus, or the restricted period:

 

  

offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option orcontract to sell, grant any option, right or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any shares of common stock or any securities convertible into or exercisable or exchangeable for shares of commonstock;

 

  

file any registration statement with the Securities and Exchange Commission relating to the offering of anyshares of common stock or any securities convertible into or exercisable or exchangeable for common stock; or

 

  

enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economicconsequences of ownership of the common stock.

whether any such transaction described above is to be settled bydelivery of common stock or such other securities, in cash or otherwise. In addition, we and each such person agrees that, without the prior written consent of the representatives on behalf of the underwriters, we or such other person will not,during the restricted period, make any demand for, or exercise any right with respect to, the registration of any shares of common stock or any security convertible into or exercisable or exchangeable for common stock.

The restrictions described in the immediately preceding paragraph to do not apply to our directors, officers andsecurityholders with respect to:

 

  

transfers or dispositions of shares of our common stock or other securities acquired in (i) open markettransactions after the completion of this offering or (ii) as part of this offering; provided that no filing under Section 16(a) of the Exchange Act reporting a reduction in beneficial ownership of our common stock shall be voluntarily made inconnection with subsequent sales of common stock or other securities acquired in this offering or in such open market transactions; provided, further, that all necessary filings on Form 13F and all necessary filings under Schedule 13G or 13Dregarding beneficial ownership shall be permitted;

 

  

transfers or distributions of shares of our common stock or any security convertible into or exercisable orexchangeable for such common stock (i) as a bona fide gift or charitable contribution, (ii) by will or intestacy or to any immediate family or to a trust for the direct or indirect benefit of the holder and/or any immediate family,(iii) to limited partners, members, stockholders or holders of similar equity interests in the holder or (iv) to another corporation, partnership, limited liability company, trust or other business entity that is an affiliate (as definedin Rule 405 promulgated under the Securities Act of 1933 as amended) of the holder, or to any investment fund or other entity controlled or managed by the holder or affiliates of the holder; provided that (A) each transferee, donee ordistributee shall sign and deliver a lock up agreement and (B) no filing under Section 16(a) of the Exchange Act or other public disclosure, reporting a reduction in beneficial ownership of shares of common stock, shall be required or shall bevoluntarily made during the restricted period;

 

  

transfers of shares of our common stock or any security convertible into or exercisable or exchangeable forsuch common stock by operation of law pursuant to a qualified domestic order or other court order

 

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or in connection with a divorce settlement; provided that (i) any filing under Section 16(a) of the Exchange Act made during the restricted period shall clearly indicate in the footnotesthereto that (A) the filing relates to the circumstances described in this clause and (B) no securities were sold by the holder, and (ii) the holder does not otherwise voluntarily effect any other public filing or report regardingsuch transfers during the restricted period;

 

  

the receipt from us of shares of our common stock upon the transfer or disposition of shares of common stockor any securities convertible into common stock to us upon a vesting or settlement event of the our securities or vesting of restricted stock unit awards or upon the exercise of options to purchase our securities on a “cashless” or“net exercise” basis, in each case pursuant to our equity incentive plan described in this prospectus and to the extent permitted by the instruments representing such restricted stock unit awards or options outstanding as of the date ofthis prospectus (and solely to cover withholding tax obligations in connection with such transaction and any transfer to us for the payment of taxes as a result of such transaction), provided that (i) the shares received upon exercise orsettlement of the option are subject to the terms of a lock-up agreement, (ii) no public disclosure or filing under Section 16(a) of the Exchange Act shall be voluntarily made during the restricted period and (iii) to the extent a filingunder Section 16(a) of the Exchange Act is required during the restricted period as a result of transfers in this clause, it shall clearly indicate that (A) the filing relates to the circumstances described in this clause, including that thesecurities remain subject to the restrictions described above and (B) no securities were sold by the holder other than pursuant to this clause;

 

  

transfers to us in connection with the repurchase of common stock in connection with the termination of theholder’s employment with us pursuant to contractual agreements with us as in effect as of the date of this prospectus, provided that no public disclosure or filing under Section 16(a) of the Exchange Act shall be required or shall bevoluntarily made during the restricted period;

 

  

the conversion of our outstanding preferred stock described in this prospectus into shares of common stock,provided that such shares of common stock received upon conversion shall be subject to the restrictions described above;

 

  

the establishment of a trading plan on behalf of a stockholder, officer or director pursuant to Rule 10b5-1under the Exchange Act for the transfer of shares of our common stock, provided that (i) such plan does not provide for the transfer of our common stock during the restricted period and (ii) to the extent a public announcement or filingunder the Exchange Act, if any, is required of or voluntarily made regarding the establishment of such plan, such announcement or filing shall include a statement to the effect that no transfer of common stock may be made under such plan during therestricted period; or

 

  

transfers of shares of our common stock (or any securities convertible into or exercisable or exchangeable forsuch common stock) pursuant to a bona fide third-party tender offer for all of our outstanding common stock or securities convertible into or exchangeable for common stock, merger, consolidation or other similar transaction approved by our board andmade to all holders of our securities involving a change of control (including, without limitation, the entering into any lock-up, voting or similar agreement pursuant to which the holder may agree to transfer, sell, tender or otherwise dispose ofour common stock or other such securities in connection with such transaction, or vote any common stock or other such securities in favor of any such transaction); provided that in the event that such tender offer, merger, consolidation or othersuch transaction is not completed, such securities held by the holder shall remain subject to the restrictions described above.

The restrictions on transfers or other dispositions by us described above do not apply to:

 

  

the shares to be sold in this offering;

 

  

the issuance by us of shares of common stock upon the exercise of an option or warrant or the conversion of asecurity outstanding on the date hereof as described in this prospectus;

 

  

facilitating the establishment of a trading plan on behalf of one of our stockholders, officers or directorspursuant to Rule 10b5-1 under the Exchange Act for the transfer of shares of common stock,

 

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provided that (i) such plan does not provide for the transfer of common stock during the restricted period and (ii) to the extent a public announcement or filing under the Exchange Act,if any, is required of or voluntarily made by us regarding the establishment of such plan, such announcement or filing shall include a statement to the effect that no transfer of common stock may be made under such plan during the restricted period;

 

  

the grants of any options, restricted stock or other equity awards and the issuance of our common stock orsecurities convertible into or exercisable for our common stock (whether upon the exercise of stock options or otherwise) to our employees, officers, directors, advisors, or consultants pursuant to the terms of a plan in effect on the date hereof;

 

  

the filing of a registration statement on Form S-8 to register our common stock issuable pursuant to anyemployee benefit plans, qualified stock option plans or other employee compensation plans; or

 

  

the issuance of shares of our common stock or any securities convertible into or exercisable or exchangeablefor, our common stock, or the entrance into an agreement to issue our common stock or any securities convertible into, or exercisable or exchangeable for, our common stock, in connection with any merger, joint venture, strategic alliances,commercial or other collaborative transaction or the acquisition or license of the business, property, technology or other assets of another individual or entity or the assumption of an employee benefit plan in connection with a merger oracquisition; provided, that the aggregate number of shares of common stock or any securities convertible into, or exercisable or exchangeable for, common stock that we may issue or agree to issue shall not exceed        % of our total outstanding share capital immediately following the issuance of the shares to be sold in this offering and provided further, that the recipients thereof provide to the representatives asigned lock-up letter.

Morgan Stanley & Co. LLC, Jefferies LLC and Evercore Group L.L.C., in theirsole discretion, may release the common stock and other securities subject to the lock-up agreements described above in whole or in part at any time.

In order to facilitate the offering of the common stock, the underwriters may engage in transactions that stabilize, maintainor otherwise affect the price of the common stock. Specifically, the underwriters may sell more shares than they are obligated to purchase under the underwriting agreement, creating a short position. A short sale is covered if the short position isno greater than the number of shares available for purchase by the underwriters under the option to purchase additional shares described above. The underwriters can close out a covered short sale by exercising such option or purchasing shares in theopen market. In determining the source of shares to close out a covered short sale, the underwriters will consider, among other things, the open market price of shares compared to the price available under such option. The underwriters may also sellshares in excess of such option, creating a naked short position. The underwriters must close out any naked short position by purchasing shares in the open market. A naked short position is more likely to be created if the underwriters are concernedthat there may be downward pressure on the price of the common stock in the open market after pricing that could adversely affect investors who purchase in this offering. As an additional means of facilitating this offering, the underwriters may bidfor, and purchase, shares of common stock in the open market to stabilize the price of the common stock. These activities may raise or maintain the market price of the common stock above independent market levels or prevent or retard a decline inthe market price of the common stock. The underwriters are not required to engage in these activities and may end any of these activities at any time.

We and the underwriters have agreed to indemnify each other against certain liabilities, including liabilities under theSecurities Act.

A prospectus in electronic format may be made available on websites maintained by one or moreunderwriters, or selling group members, if any, participating in this offering. The representatives may agree to allocate a number of shares of common stock to underwriters for sale to their online brokerage account holders. Internet distributionswill be allocated by the representatives to underwriters that may make Internet distributions on the same basis as other allocations.

 

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The underwriters and their respective affiliates are full service financialinstitutions engaged in various activities, which may include securities trading, commercial and investment banking, financial advisory, investment management, investment research, principal investment, hedging, financing and brokerage activities.Certain of the underwriters and their respective affiliates have, from time to time, performed, and may in the future perform, various financial advisory and investment banking services for us, for which they received or will receive customary feesand expenses.

In addition, in the ordinary course of their various business activities, the underwriters and theirrespective affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own account and for the accounts of theircustomers and may at any time hold long and short positions in such securities and instruments. Such investment and securities activities may involve our securities and instruments. The underwriters and their respective affiliates may also makeinvestment recommendations or publish or express independent research views in respect of such securities or instruments and may at any time hold, or recommend to clients that they acquire, long or short positions in such securities and instruments.

Pricing of the Offering

Prior to this offering, there has been no public market for our common stock. The initial public offering price will bedetermined by negotiations between us and the representatives. Among the factors to be considered in determining the initial public offering price are our future prospects and those of our industry in general, our results of operations and certainother financial and operating information in recent periods, and the price-earnings ratios, price-sales ratios, market prices of securities, and certain financial and operating information of companies engaged in activities similar to ours.

Directed Share Program

At our request, the underwriters have reserved up to % of the shares offered by this prospectus, for sale at the initial publicoffering price through a directed share program to certain of our directors, officers, employees and business associates and other parties related to us. If purchased by these persons, these shares will be subject to a 180-day lock-up restriction.

The number of shares available for sale to the general public will be reduced to the extent that such persons purchasesuch reserved shares. Any reserved shares not so purchased will be offered by the underwriters to the general public on the same basis as the other shares offered by this prospectus. Other than the underwriting discount described on the front coverof this prospectus, the underwriters will not be entitled to any commission with respect to shares sold pursuant to the directed share program. We will agree to indemnify Morgan Stanley & Co. LLC against certain liabilities and expenses,including liabilities under the Securities Act, in connection with sales of the shares reserved for the directed share program. Morgan Stanley & Co. LLC will administer our directed share program.

Selling Restrictions

Canada

The shares may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that are accreditedinvestors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration Requirements,Exemptions and Ongoing Registrant Obligations. Any resale of the shares must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.

Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission ordamages if this prospectus (including any amendment thereto) contains a misrepresentation,

 

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provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s province or territory.The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particulars of these rights or consult with a legal advisor.

Pursuant to section 3A.3 (or, in the case of securities issued or guaranteed by the government of a non-Canadian jurisdiction,section 3A.4) of National Instrument 33-105 Underwriting Conflicts (NI 33-105), the underwriters are not required to comply with the disclosure requirements of NI 33-105 regarding underwriter conflicts of interest in connection withthis offering.

European Economic Area

In relation to each Member State of the European Economic Area and the United Kingdom, each, a Relevant State, no securitieshave been offered or will be offered pursuant to the offering to the public in that Relevant State prior to the publication of a prospectus in relation to the securities which has been approved by the competent authority in that Relevant State or,where appropriate, approved in another Relevant State and notified to the competent authority in that Relevant State, all in accordance with the Prospectus Regulation, except that offers of securities may be made to the public in that Relevant Stateat any time under the following exemptions under the Prospectus Regulation:

 

(a)

to any legal entity which is a qualified investor as defined under the Prospectus Regulation;

 

(b)

to fewer than 150 natural or legal persons (other than qualified investors as defined under the ProspectusRegulation), subject to obtaining the prior consent of the representatives; or

 

(c)

in any other circumstances falling within Article 1(4) of the Prospectus Regulation,

provided that no such offer of shares shall require us or any of our representatives to publish a prospectus pursuant to Article 3 of theProspectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation.

For the purposes ofthis provision, the expression an “offer to the public” in relation to any shares in any Relevant State means the communication in any form and by any means of sufficient information on the terms of the offer and any shares to be offeredso as to enable an investor to decide to purchase any shares, and the expression “Prospectus Regulation” means Regulation (EU) 2017/1129 (as amended).

United Kingdom

Each underwriter has represented and agreed that:

 

(a)

it has only communicated or caused to be communicated and will only communicate or cause to be communicatedan invitation or inducement to engage in investment activity (within the meaning of Section 21 of the Financial Services and Markets Act 2000, or the FSMA) received by it in connection with the issue or sale of the shares of our common stock incircumstances in which Section 21(1) of the FSMA does not apply to us; and

 

(b)

it has complied and will comply with all applicable provisions of the FSMA with respect to anything done byit in relation to the shares of our common stock in, from or otherwise involving the United Kingdom.

Japan

No registration pursuant to Article 4, paragraph 1 of the Financial Instruments and Exchange Law of Japan (LawNo. 25 of 1948, as amended), or the FIEL, has been made or will be made with respect to the solicitation of the application for the acquisition of the shares of common stock.

 

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Accordingly, the shares of common stock have not been, directly orindirectly, offered or sold and will not be, directly or indirectly, offered or sold in Japan or to, or for the benefit of, any resident of Japan (which term as used herein means any person resident in Japan, including any corporation or otherentity organized under the laws of Japan) or to others for re-offering or re-sale, directly or indirectly, in Japan or to, or for the benefit of, any resident of Japanexcept pursuant to an exemption from the registration requirements, and otherwise in compliance with, the FIEL and the other applicable laws and regulations of Japan.

For Qualified Institutional Investors (“QII”)

Please note that the solicitation for newly-issued or secondary securities (each as described in Paragraph 2, Article 4 of theFIEL) in relation to the shares of common stock constitutes either a “QII only private placement” or a “QII only secondary distribution” (each as described in Paragraph 1, Article 23-13 ofthe FIEL). Disclosure regarding any such solicitation, as is otherwise prescribed in Paragraph 1, Article 4 of the FIEL, has not been made in relation to the shares of common stock. The shares of common stock may only be transferred to QIIs.

For Non-QII Investors

Please note that the solicitation for newly-issued or secondary securities (each as described in Paragraph 2, Article 4 of theFIEL) in relation to the shares of common stock constitutes either a “small number private placement” or a “small number private secondary distribution” (each as is described in Paragraph 4, Article23-13 of the FIEL). Disclosure regarding any such solicitation, as is otherwise prescribed in Paragraph 1, Article 4 of the FIEL, has not been made in relation to the shares of common stock. The shares ofcommon stock may only be transferred en bloc without subdivision to a single investor.

Hong Kong

Shares of our common stock may not be offered or sold by means of any document other than (i) in circumstances which donot constitute an offer to the public within the meaning of the Companies Ordinance (Cap.32, Laws of Hong Kong), (ii) to “professional investors” within the meaning of the Securities and Futures Ordinance (Cap.571, Laws of Hong Kong)and any rules made thereunder, or (iii) in other circumstances which do not result in the document being a “prospectus” within the meaning of the Companies Ordinance (Cap.32, Laws of Hong Kong), and no advertisement, invitation, ordocument relating to shares of our common stock may be issued or may be in the possession of any person for the purpose of issue (in each case whether in Hong Kong or elsewhere), which is directed at, or the contents of which are likely to beaccessed or read by, the public in Hong Kong (except if permitted to do so under the laws of Hong Kong) other than with respect to shares of our common stock which are or are intended to be disposed of only to persons outside Hong Kong or only to“professional investors” within the meaning of the Securities and Futures Ordinance (Cap.571, Laws of Hong Kong) and any rules made thereunder.

Singapore

This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectusand any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of shares of our common stock may not be circulated or distributed, nor may the shares of our common stock be offered or sold, or bemade the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore other than (i) to an institutional investor under Section 274 of the Securities and Futures Act, Chapter 289 ofSingapore, or the SFA, (ii) to a relevant person, or any person pursuant to Section 275(1A), and in accordance with the conditions, specified in Section 275 of the SFA or (iii) otherwise pursuant to, and in accordance with theconditions of, any other applicable provision of the SFA.

Where shares of our common stock are subscribed or purchasedunder Section 275 by a relevant person which is: (i) a corporation (which is not an accredited investor) the sole business of which is to hold investments

 

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and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor; or (ii) a trust (where the trustee is not an accredited investor) whosesole purpose is to hold investments and each beneficiary is an accredited investor, shares, debentures, and units of shares and debentures of that corporation or the beneficiaries’ rights and interest in that trust shall not betransferable for 6 months after that corporation or that trust has acquired shares of our common stock under Section 275 except: (a) to an institutional investor under Section 274 of the SFA or to a relevant person, or any personpursuant to Section 275(1A), and in accordance with the conditions, specified in Section 275 of the SFA; (b) where no consideration is given for the transfer; or (c) by operation of law.

Switzerland

The shares of common stock may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange, or SIX,or on any other stock exchange or regulated trading facility in Switzerland. This document has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or thedisclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this document nor any other offering or marketingmaterial relating to the shares or the offering may be publicly distributed or otherwise made publicly available in Switzerland. Neither this document nor any other offering or marketing material relating to the offering, us, or the shares have beenor will be filed with or approved by any Swiss regulatory authority. In particular, this document will not be filed with, and the offer of shares will not be supervised by, the Swiss Financial Market Supervisory Authority, or FINMA, and the offer ofshares has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes, or CISA. The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend toacquirers of shares.

Dubai International Financial Centre

This prospectus relates to an Exempt Offer in accordance with the Offered Securities Rules of the Dubai Financial ServicesAuthority, or DFSA. This prospectus is intended for distribution only to persons of a type specified in the Offered Securities Rules of the DFSA. It must not be delivered to, or relied on by, any other person. The DFSA has no responsibility forreviewing or verifying any documents in connection with Exempt Offers. The DFSA has not approved this prospectus nor taken steps to verify the information set forth herein and has no responsibility for the prospectus. The shares to which thisprospectus relates may be illiquid and/or subject to restrictions on their resale. Prospective purchasers of the shares offered should conduct their own due diligence on the shares. If you do not understand the contents of this prospectus you shouldconsult an authorized financial advisor.

 

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LEGAL MATTERS

The validity of the shares of common stock offered hereby will be passed upon for us by Cooley LLP, Boston, Massachusetts.Certain legal matters will be passed upon for the underwriters by Wilmer Cutler Pickering Hale & Dorr LLP, New York, New York.

EXPERTS

The financial statements of CinCor Pharma, Inc. at December 31, 2019 and 2020, and for each of the two years in theperiod ended December 31, 2020, appearing in this Prospectus and Registration Statement have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon appearing elsewhereherein, and are included in reliance upon such report given on the authority of such firm as experts in accounting and auditing.

WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the shares of common stock being offered by this prospectus. This prospectus, which constitutes part of the registration statement, does not contain all of theinformation in the registration statement and its exhibits. For further information with respect to our company and the common stock offered by this prospectus, we refer you to the registration statement and its exhibits. Statements contained inthis prospectus as to the contents of any contract or any other document referred to are not necessarily complete, and in each instance, we refer you to the copy of the contract or other document filed as an exhibit to the registration statement.Each of these statements is qualified in all respects by this reference.

You can read our SEC filings, including theregistration statement, over the internet at the SEC’s website at www.sec.gov. Upon completion of this offering, we will be subject to the information reporting requirements of the Exchange Act, and we will file reports, proxy statementsand other information with the SEC. These reports, proxy statements and other information will be available at www.sec.gov.

We also maintain a website at www.cincor.com, at which you may access these materials free of charge as soon as reasonablypracticable after they are electronically filed with, or furnished to, the SEC. The information contained in, or that can be accessed through, our website is not part of, and is not incorporated into, this prospectus. We have included our website inthis prospectus solely as an inactive textual reference.

 

 

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CinCor Pharma, Inc.

Financial Statements

Years Ended December 31, 2019 and 2020

Contents

 

 

 

CinCor Pharma, Inc.

Condensed Financial Statements (Unaudited)

Nine Months Ended September 30, 2020 and 2021

Contents

 

 

 

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Report of Independent Registered Public Accounting Firm

To the Stockholders and Board of Directors of

CinCor Pharma, Inc.

Opinion on the FinancialStatements

We have audited the accompanying balance sheets of CinCor Pharma, Inc. (the “Company”) as ofDecember 31, 2020 and 2019, the related statements of operations and comprehensive loss, redeemable convertible preferred stock and stockholders’ deficit, and cash flows for the years then ended, and the related notes (collectively,referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2020 and 2019, and the results of its operations andits cash flows for the years then ended in conformity with U.S. generally accepted accounting principles.

Restatement of December 31, 2020 and 2019Financial Statements

As discussed in Note 8 of the financial statements, the December 31, 2020 and 2019 financial statements have beenrestated to correct the number of shares of common stock issued and outstanding. Our opinion is not modified with respect to this matter.

TheCompany’s Ability to Continue as a Going Concern

The accompanying financial statements have been preparedassuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has incurred losses from operations, has negative cash flows from operating activities, and has stated that substantial doubtexists about the Company’s ability to continue as a going concern. Management’s evaluation of these events and conditions and management’s plans regarding these matters are also described in Note 1. The financial statements do notinclude any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinionon the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to theCompany in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform theaudit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control overfinancial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control overfinancial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess therisks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures inthe financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits providea reasonable basis for our opinion.

/s/ Ernst & Young LLP

We have served as the Company’s auditor since 2019.

Cincinnati, Ohio

June 23, 2021,except for the matters discussed in Note 8 and Note 10, as to which the date is November 30, 2021.

 

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CinCor Pharma, Inc.

Balance Sheets

 

   December 31 
   2019  2020 

Assets

   

Current assets:

   

Cash and cash equivalents

  $11,484,152  $ 26,078,064 

Related-party accounts receivable

   8,424    

Prepaid research and development contracts

   388,214   694,504 

Prepaid expenses and other current assets

   43,541   27,403 
  

 

 

  

 

 

 

Total current assets

   11,924,331   26,799,971 
  

 

 

  

 

 

 

Total assets

  $11,924,331  $ 26,799,971 
  

 

 

  

 

 

 

Liabilities, redeemable convertible preferred stock, and stockholders’deficit

   

Current liabilities:

   

Accounts payable

  $ 780,368  $ 3,666,017 

Related-party accounts payable

   172,537   98,781 

Warrant derivative liabilities

   680,529   1,890,357 

Accrued expenses and other liabilities

   89,703   1,236,209 
  

 

 

  

 

 

 

Total current liabilities

   1,723,137   6,891,364 

Series A redeemable convertible preferred stock, $0.00001 par value, 35,714,282 shares authorizedand 35,714,282 and 11,904,760 issued and outstanding at December 31, 2019 and 2020

   15,183,192   47,173,259 

Stockholders’ deficit:

   

Common stock (restated), $0.00001 par value, 46,686,492 shares authorized, and 4,250,000 issuedand outstanding at December 31, 2019 and 2020

   43   43 

Additional paid-in capital

   53,409   69,300 

Accumulated deficit

   (5,035,450  (27,333,995
  

 

 

  

 

 

 

Total stockholders’ deficit

   (4,981,998  (27,264,652
  

 

 

  

 

 

 

Total liabilities, redeemable convertible preferred stock, and stockholders’ deficit

  $11,924,331  $ 26,799,971 
  

 

 

  

 

 

 

See accompanying notes which are an integral part of these financial statements.

 

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CinCor Pharma, Inc.

Statements of Operations and Comprehensive Loss

 

   Year Ended December 31 
   2019  2020 

Operating expenses

   

Research and development

  $3,926,221  $17,952,208 

General and administrative

   1,210,595   3,173,237 
  

 

 

  

 

 

 

Total operating expenses

   5,136,816   21,125,445 

Loss from operations

   5,136,816   21,125,445 

Other (income) expense:

   

Interest income

   (101,706  (36,728

Change in fair value of warrant derivative liabilities

      1,209,828 
  

 

 

  

 

 

 

Total other (income) expense

   (101,706  1,173,100 
  

 

 

  

 

 

 

Net and comprehensive loss

  $5,035,110  $22,298,545 
  

 

 

  

 

 

 

Net and comprehensive loss per share attributable to common stockholders, basic and diluted(restated)

  $ 5.25  $ 1.18 
  

 

 

  

 

 

 

Weighted average common stock used in computing net and comprehensive loss per share attributableto common stockholders, basic and diluted (restated)

   4,250,000   4,250,000 

See accompanying notes which are an integral part of thesefinancial statements.

 

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CinCor Pharma, Inc.

Statements of Redeemable Convertible Preferred Stock and Stockholders’ Deficit

 

  Redeemable Convertible
Preferred Stock
  Stockholders’ Deficit 
  Series A Redeemable
Convertible Preferred Stock
  Common Stock
(restated)
  Additional
Paid-In
Capital
  Accumulated
Deficit
  Total
Stockholders’
Deficit
 
  Shares  Amount  Shares  Amount 

Balance at January 1, 2019

    $   4,000,000  $40  $  $(340 $(300

Issuance of common stock

        250,000           3   49,997      50,000 

Issuance of redeemable convertible preferred stock, net of issuance costs cost of$802,944

  11,904,760   15,863,721                

Allocation of proceeds to warrant derivative liabilities

     (680,529               

Stock-based compensation expense

              3,412      3,412 

Net and comprehensive loss

                 (5,035,110  (5,035,110
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2019

  11,904,760   15,183,192   4,250,000   43   53,409   (5,035,450  (4,981,998

Issuance of redeemable convertible preferred stock, net of issuance costs cost of$1,343,268

  23,809,522   31,990,067                

Stock-based compensation expense

              15,891      15,891 

Net and comprehensive loss

                 (22,298,545  (22,298,545
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2020

  35,714,282  $47,173,259   4,250,000  $43  $69,300  $(27,333,995 $(27,264,652
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

See accompanying notes which are an integral part of these financial statements.

 

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CinCor Pharma, Inc.

Statements of Cash Flows

 

   Year Ended December 31 
   2019  2020 

Operating activities

   

Net and comprehensive loss

  $(5,035,110 $(22,298,545

Adjustments to reconcile net and comprehensive loss to net cash used in operatingactivities:

   

Stock-based compensation expense

   3,412   15,891 

Change in fair value of warrant derivative liabilities

      1,209,828 

Changes in operating assets and liabilities:

   

Related-party accounts receivable

   (8,424  8,424 

Prepaid research and development contracts

   (388,214  (306,290

Prepaid expenses and other current assets

   (43,541  16,138 

Accounts payable

   780,068   2,885,649 

Related-party accounts payable

   172,537   (73,756

Accrued expenses and other liabilities

   89,703   1,146,506 
  

 

 

  

 

 

 

Net cash used in operating activities

   (4,429,569  (17,396,155

Financing activities

   

Proceeds from the issuance of common stock

   50,000    

Proceeds from the issuance of Series A redeemable convertible preferred stock inclusive ofproceeds attributable to warrant derivative liabilities

   16,666,665   33,333,335 

Issuance cost for redeemable convertible preferred stock

   (802,944  (1,343,268
  

 

 

  

 

 

 

Net cash provided by financing activities

   15,913,721   31,990,067 
  

 

 

  

 

 

 

Increase in cash and cash equivalents

   11,484,152   14,593,912 

Cash and cash equivalents at beginning of year

      11,484,152 
  

 

 

  

 

 

 

Cash and cash equivalents at end of year

  $11,484,152  $26,078,064 
  

 

 

  

 

 

 

See accompanying notes which are an integral part of these financial statements.

 

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CinCor Pharma, Inc.

Notes to Financial Statements

December 31, 2019 and 2020

1.Nature of Business

CinCor Pharma, Inc. (the “Company”) is a clinical-stage biopharmaceutical company focusedon developing its lead clinical candidate, CIN-107, for the treatment of hypertension and other cardio-renal diseases. CIN-107 is a highly selective, oral small moleculeinhibitor of aldosterone synthase, the enzyme responsible for the synthesis of aldosterone in the adrenal gland. The Company is currently conducting a Phase 2 clinical trial of CIN-107 in patients withtreatment resistant hypertension, which is referred to as the BrigHtn trial, and plan to initiate a separate Phase 2 clinical trial in patients whose blood pressure is not controlled despite treatment with at least one antihypertensive agent. Inaddition to hypertension, the Company is developing CIN-107 for the treatment of primary aldosteronism and chronic kidney disease. The Company was incorporated in 2018 in the State of Delaware.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including,but not limited to, possible failure of preclinical studies or clinical trials, the need to obtain marketing approval for its product candidates, development by competitors of new technological innovations, dependence on key personnel, protection ofproprietary technology, compliance with government regulations, the need to successfully commercialize and gain market acceptance of any of the Company’s products that are approved and the ability to secure additional capital to fundoperations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing, and regulatory approval prior to commercialization. These effortsrequire significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Companywill realize revenue from product sales.

The Company has funded its operations to date primarily through private sales ofredeemable convertible preferred stock.

Going Concern Considerations

In accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there areconditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.

The Company incurred losses from operations and had negative cash flows from operating activities for the years endedDecember 31, 2019 and 2020, and since inception. The Company’s current operating plan indicates it will continue to incur losses from operations and generate negative cash flows from operating activities, given ongoing expenditures relatedto extensive research and development and the Company’s lack of revenue-generating activities at this point in the Company’s life cycle. These events and conditions raise substantial doubt about the Company’s ability to continue as agoing concern.

The Company will need to raise additional funds in order to further advance its research and developmentprograms, operate its business, and meet its obligations as they come due. However, financing may not be available to the Company in the necessary time frame, in the amounts that the Company requires, on terms that are acceptable to the Company, orat all. If the Company is unable to raise the necessary funds when needed or must reduce spending on currently planned activities, it may not be able to continue the development of its

 

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CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

1. Nature of Business (Continued)

 

products or could be required to delay, scale back, or eliminate some or all of its research and development programs and other operations; consequently, these circumstances will materially harmthe Company’s business, financial position, and results of operations. Based on the Company’s current plans absent any future financings, it is anticipated that the existing cash will allow the Company to conduct planned operations throughthe fourth quarter of 2021.

The accompanying financial statements have been prepared assuming that the Company willcontinue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normalcourse of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might be necessary should the Company be unable to continue as agoing concern. Based on the Company’s current cash position and current financial position as of the date of the financial statements, there is a substantial doubt about the Company’s ability to continue as a going concern.

2. Summary of Significant Accounting Policies

Basis of Presentation

The Company’s financial statements are prepared in accordance with U.S. generally accepted accounting principles(“U.S. GAAP”) and stated in U.S. dollars. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting StandardsUpdates (“ASUs”) of the FASB.

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available forevaluation by the chief operating decision-maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment. All the assets andoperations of the Company are located in the United States.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions thataffect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. Actual results coulddiffer from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls and in developing the estimates and assumptions that are used in the preparation of these financial statements.Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developingestimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amountthat falls within that range of reasonable estimates. Estimates are used in the following areas, among others: prepaid research and development contracts, fair value of the Company’s common stock, fair value of warrant derivative liabilities,and income taxes.

 

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CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

 

The Company utilizes estimates and assumptions in determining the fair valueof its common stock, including stock-based awards. The Company has granted stock options at exercise prices that represented the fair value of its common stock on grant date. The Company utilized various valuation methodologies in accordance withthe framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation, to estimate the fair value of its common stock. Each valuationmethodology includes estimates and assumptions that require the Company’s judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company soldshares of redeemable convertible preferred stock, the superior rights and preferences of the redeemable convertible preferred stock senior to the Company’s common stock at the time, and a probability analysis of various liquidity events, suchas a public offering or sale of the Company, under differing scenarios.

Changes to the key assumptions used in thevaluations could result in different fair values of common stock at each valuation date. Actual results may differ from those estimates or assumptions.

The Company’s results and business operations can also be affected or disrupted by economic, political, legislative,regulatory, legal matters, or public health concerns, such as the coronavirus disease 2019, COVID-19, pandemic. Economic conditions, such as recessionary trends, inflation, interest, changes in regulatory lawsand monetary exchange rates, and government fiscal policies, can also have a significant effect on the Company’s operations. While the Company maintains reserves for anticipated liabilities, the Company could be affected by civil, criminal,regulatory, or administrative actions, claims, or proceedings. The extent to which the Company’s business can be impacted by future events is highly uncertain and cannot be predicted at this time.

Cash and Cash Equivalents

The primary objectives for the Company’s cash and cash equivalents are the preservation of capital and maintenance ofliquidity. The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. At December 31, 2019 and 2020, cash and cash equivalents consist of cash on hand and short-term, highlyliquid investments with original maturities of three months or less at the date of purchase. The carrying value of cash and cash equivalents approximates fair value. The Company has maintained balances with its banks in excess of federally insuredlimits.

Concentration of Credit Risk and Other Risks and Uncertainties

The Company has no significant off-balance sheet concentrations of credit risk, such asforeign currency exchange contracts, option contracts, or other hedging arrangements. Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash and cash equivalents, which consist of moneymarket funds that invest primarily in short-term U.S. government securities.

The Company has not yet generated anyrevenue from the sale of its products and is subject to all of the risks and uncertainties that are typically faced by biotechnology companies that devote substantially all of their efforts to research and development and clinical trials and do notyet have commercial products. The Company expects to continue incurring losses for the foreseeable future.

Redeemable ConvertiblePreferred Stock

In accordance with ASC Topic 480, Distinguishing Liabilities from Equity (ASC 480),preferred stock issued with redemption provisions that are outside of the control of the issuer or that contain certain redemption

 

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CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

 

features in the event of a deemed liquidation is required to be presented outside of stockholders’ deficit on the face of the balance sheet and certain disclosures are required to beincluded in the notes to the financial statements. If required, changes in fair value are recorded as additional paid in capital and/or accumulated deficit in the balance sheets. Changes in fair value that would reduce the fair value of theredeemable convertible preferred stock below the original issue price are limited so that the value of the shares are not recorded below the original issue price.

Fair Value Measurements

The Company’s financial instruments consist of cash equivalents, warrant derivative liabilities, accounts payable, andaccrued expenses and other liabilities. The fair values of accounts payable and accrued expenses and other liabilities approximate the carrying values because of their short-term nature.

The Company is required to disclose information on all assets and liabilities reported at fair value that enables anassessment of the inputs used in determining the reported fair values. ASC Topic 820, Fair Value Measurement, establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes theuse of unobservable inputs by requiring that the observable inputs be used when available.

Observable inputs are inputsthat market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that marketparticipants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value and isnot a measure of the investment credit quality. The three levels of the fair value hierarchy are described below:

 

  

Level 1 – Valuations based on unadjusted quoted prices in active markets for identical assetsor liabilities that the Company has the ability to access at the measurement date

 

  

Level 2 – Valuations based on observable inputs other than quoted prices included inLevel 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated byobservable market data

 

  

Level 3 – Valuations that require inputs that reflect the Company’s own assumptions thatare both significant to the fair value measurement and unobservable

To the extent that a valuation isbased on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest forinstruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. There were no transfers within the fair valuehierarchy in 2019 and 2020.

Research and Development Expenses

Research and development costs, both internal and external, are expensed as incurred. Costs are considered incurred based on anevaluation of the progress to completion of specific tasks under each contract using information and data provided to the Company by its clinical sites and vendors. These costs consist of direct and

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

 

indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company. The Company’s research and developmentexpenses consist primarily of clinical trial expenses, consulting costs and stock-based compensation, and costs associated with required regulatory filings, licenses, and fees.

Stock-Based Compensation

The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718,Compensation – Stock Compensation (ASC 718). ASC 718 requires all stock-based payments to employees, including grants of employee stock options, to be recognized in the statements of operations and comprehensive lossbased on their fair values. The Company’s stock-based awards are subject only to service-based vesting conditions. The Company estimates the fair value of its stock-based awards using the Black-Scholes option pricing model, which requires theinput of assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate, and (d) expected dividends.

Due to the lack of a public market for the trading of the Company’s common stock and a lack of company-specifichistorical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The Company believes that the companies in the group havecharacteristics similar to its own characteristics, including stage of product development and a focus on the life sciences industry. The Company believes the group selected has sufficient similar economic and industry characteristics and includescompanies that are most representative of the Company.

The Company uses the simplified method, as prescribed by theSecurities and Exchange Commission (SEC) Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimatethe expected term for options granted and utilizes the contractual term for options granted. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of the stock options.

Compensation expense related to awards is calculated on a straight-line basis by recognizing the grant date fair value overthe associated service period of the award, which is generally the vesting term.

Derivative Instruments, Including WarrantDerivative Liabilities

The Company accounts for derivatives, specifically freestanding detachable stock purchasewarrants, in accordance with ASC Topic 815, Derivatives and Hedging (ASC 815). This guidance establishes accounting and reporting principles for derivative instruments, including certain derivative instruments embedded in other contracts.

Net and Comprehensive Loss Per Share

The Company’s basic net and comprehensive loss per share attributable to common stockholders is calculated by dividing thenet and comprehensive loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. The diluted net and comprehensive loss per share attributable to common stockholders is computed bygiving effect to all potential common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, redeemable convertible preferred stock and stock options to purchase common stock areconsidered

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

 

to be common stock equivalents but have been excluded from the calculation of diluted net and comprehensive loss per share attributable to common stockholders as their effect is anti-dilutive.

Income Taxes

Income taxes are recorded in accordance with ASC Topic 740, Income Taxes (ASC 740), which provides for deferred taxesusing an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets andliabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates anticipated to be in effect for the year in which thedifferences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all the deferred tax assets will not be realized.

The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positionsexist, the Company recognizes the tax benefit of tax positions to the extent that some or all the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon thetechnical merits of the tax position, as well as consideration of the available facts and circumstances. As of December 31, 2019 and 2020, the Company does not have any significant uncertain tax positions. If the Company were to incur interestand penalties on uncertain tax positions, it would classify them as income tax expense.

The Company files U.S. federaland state income tax returns.

Comprehensive Loss

Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and otherevents and circumstances from non-owner sources. Comprehensive loss equaled net loss for the periods presented.

Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by theCompany as of the specified effective date. Unless otherwise discussed, the Company believes the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations uponadoption.

3. Fair Value Measurements

The following table presents information about the Company’s financial instruments measured at fair value on a recurringbasis based on the fair value hierarchy at:

 

   December 31, 2019 
   Level 1   Level 2   Level 3   Total 

Assets

        

Cash and cash equivalents

  $11,484,152   $   $   $11,484,152 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total assets at fair value

  $11,484,152   $   $   $11,484,152 
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

3. Fair Value Measurements (Continued)

 

   December 31, 2019 
   Level 1   Level 2   Level 3   Total 

Liabilities

        

Warrant derivative liabilities

  $   $            —   $680,529   $680,529 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total liabilities at fair value

  $   $   $680,529   $680,529 
  

 

 

   

 

 

   

 

 

   

 

 

 
   December 31, 2020 
   Level 1   Level 2   Level 3   Total 

Assets

        

Cash and cash equivalents

  $26,078,064   $   $            —   $26,078,064 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total assets at fair value

  $26,078,064   $            —   $   $26,078,064 
  

 

 

   

 

 

   

 

 

   

 

 

 

Liabilities

        

Warrant derivative liabilities

  $            —   $            —   $1,890,357   $1,890,357 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total liabilities at fair value

  $   $   $1,890,357   $1,890,357 
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash equivalents are valued using unadjusted quoted market prices.

The following table sets forth a summary of changes in the fair value of the warrant derivative liabilities, representing arecurring measurement that is classified within Level 3 of the fair value hierarchy:

 

January 1, 2019

  $ 

Issuance of freestanding detachable stock purchase warrants

   680,529 
  

 

 

 

December 31, 2019

   680,529 

Change in fair value

   1,209,828 
  

 

 

 

December 31, 2020

  $1,890,357 
  

 

 

 

The Company estimated the fair value of the warrant derivative liabilities using aBlack-Scholes option pricing model. The valuation model uses the following assumptions at:

 

   December 31 
   2019  2020 

Fair value of common stock

  $        0.27  $        0.75 

Volatility

   96.80  82.40

Expected term (in years)

   9.40   1.50 

Risk-free interest rate

   1.90  0.12

Dividend yield

     

The preceding methods described may produce a fair value calculation that may not beindicative of net realizable value or reflective of future fair values. Furthermore, although the Company believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptionsto determine the fair value could result in a different fair value measurement at the reporting date.

 

F-13


Table of Contents

CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

4. License Agreement

In May 2019, the Company entered into a license agreement (the “Roche Agreement”) with F. Hoffman-La Roche Ltd and Hoffmann-La Roche Inc. (collectively, “Roche”), pursuant to which the Company obtained an exclusive, worldwide, royalty-bearing licenseunder certain patents and specified know-how owned or controlled by Roche and covering certain specified small molecule aldosterone synthase inhibitors (the “Roche Technology”) to research, developand commercialize products containing such aldosterone synthase inhibitors (the “Licensed Products”) for any and all uses, including the treatment, prevention or diagnosis of any and all diseases and medical conditions in humans andanimals. Pursuant to the Roche Agreement, the Company paid Roche a one-time, upfront non-refundable license fee of $2,000,000. Additionally, the Company is required topay Roche certain tiered development event-based milestone payments, certain sales-based milestone payments, as well as a royalty from the future sales of the Licensed Products. The royalty is tiered based on the net sales of each Licensed Product.

The Roche Agreement will expire, unless earlier terminated by either party, upon expiration of all royalty or otherpayment obligations under the Roche Agreement are or will become due. For the year ended December 31, 2019, the Company recorded expense of approximately $2.0 million related to the Roche Agreement as research and development expenses on theCompany’s statement of operations and comprehensive loss.

5. Redeemable Convertible Preferred Stock

In May 2019, the Company authorized the issuance of 35,714,282 shares to be issued in the form of Series A redeemableconvertible preferred stock (“Series A preferred stock”). During the years ended December 31, 2019 and 2020, the Company issued 11,904,760 and 23,809,522 shares of Series A preferred stock at $1.40 per share for total proceeds of$16,666,665 and $33,333,335 , respectively. The Company incurred $802,944 and $1,343,268 of Series A preferred stock issuance costs, which are recorded against the carrying amount of the Series A preferred stock at December 31, 2019 and 2020,respectively. The rights, preferences, and privileges of the Company’s Series A preferred stock are as follows:

Voting

The holders of Series A preferred stock are entitled to a number of votes equal to the number of whole shares ofcommon stock into which the shares of Series A preferred stock are convertible. Except as provided by law or otherwise, the holders of the Series A preferred stock vote together with the holders of common stock as a single class.

Holders of Series A preferred stock, voting as a separate class, are entitled to elect three members of the Board ofDirectors. The holders of the common stock, voting as a separate class, are entitled to elect two members of the Board of Directors. The holders of Series A preferred stock and common stock, voting together as a single class on an as-converted basis, are entitled to elect any additional members of the Board of Directors.

Dividends

Dividends are payable, if permitted by law, in accordance with the Series A preferred stock terms if and when declared by theBoard of Directors. Holders of the Series A preferred stock are entitled to receive dividends out of any assets at the time legally available, at the applicable dividend rate specified for such shares of the Series A preferred stock. Dividends arenot mandatory and are not cumulative. No dividends have been declared or paid since inception of the Company.

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

5. Redeemable Convertible Preferred Stock (Continued)

 

Liquidation

In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holders of shares ofthe Series A preferred stock then outstanding are entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a deemed liquidation event, out of the consideration payable to stockholders insuch an event, before any payment shall be made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the Series A preferred stock original issue price, plus any dividends declared but unpaid. If upon anysuch liquidation, dissolution, or winding up of the Company or a deemed liquidation event, the assets of the Company available for distribution to its stockholders are insufficient to pay the holders of shares of Series A preferred stock the fullamount to which they are entitled, the holders of shares of the Series A preferred stock share ratably in any distribution of the assets available for distribution in proportion to the respective amounts that would otherwise be payable in respect ofthe shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

The remaining available proceeds will be distributed pro rata among the holders of the shares of the Series A preferred stockand common stock, based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted to common stock pursuant to the applicable terms immediately prior to such liquidation,dissolution, or winding up of the Company.

Conversion

Each share of the Series A preferred stock is convertible, at the option of the holder thereof, at any time and from time totime, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of common stock as determined by dividing the Series A preferred stockoriginal issue price by the Series A preferred stock conversion price in effect at the time of conversion. The applicable conversion price is subject to future adjustments upon the occurrence of certain events. However, holders of the Series Apreferred stock do not have the right to convert any shares of the Series A preferred stock at the applicable conversion ratio in effect for preferred shares upon either (i) the closing of a qualified initial public offering of its commonstock at a price per share of at least $4.20 per share (subject to adjustment for any share split, combination or dividend or distribution payable) resulting in at least $50,000,000 in gross proceeds to the Company net of the underwriting discountand commissions, or (ii) the election to convert the preferred shares by at least two of the following three holders of the Company’s Series A preferred stock: (i) Sofinnova Venture Partners X, L.P., (ii) Sofinnova Capital IX and (iii) 5AMVentures VI, L.P.

The Company evaluated the Series A preferred stock and determined that it was considered an equity hostunder ASC 815. In making this determination, the Company’s analysis followed the whole instrument approach, which compares an individual feature against the entire Series A preferred stock instrument that includes that feature. TheCompany’s analysis was based on a consideration of the economic characteristics and risks of the Series A preferred stock. More specifically, the Company evaluated all of the stated and implied substantive terms and features, including(i) whether the Series A preferred stock included redemption features, (ii) how and when any redemption features could be exercised, (iii) whether the holders of the Series A preferred stock were entitled to dividends, (iv) thevoting rights of the Series A preferred stock, and (v) the existence and nature of any conversion rights. The Company concluded that, as the Series A preferred stock represents an equity host, the conversion feature included in the Series Apreferred stock is clearly and closely related to the associated host instrument. Accordingly, the conversion feature is not considered an embedded derivative that requires bifurcation.

 

F-15


Table of Contents

CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

5. Redeemable Convertible Preferred Stock (Continued)

 

The Company accounts for potentially beneficial conversion features under ASCTopic 470-20, Debt with Conversion and Other Options. At the time of the issuances of the shares of Series A preferred stock, the Company’s common stock into which the Company’s Series Apreferred stock was convertible had an estimated fair value less than the effective conversion prices of the shares of Series A preferred stock. Therefore, there was no beneficial conversion element on the issuance dates.

Redemption

The Series A preferred stock are redeemable upon a request by two of three of the requisite holders of the Company’sSeries A preferred stock in the event of a Deemed Liquidation Event, if the Company does not effect a dissolution of the Company within 90 days after such Deemed Liquidation Event, payable at a price equal to the cash or the value of the property,rights, or securities to be paid or distributed to holders pursuant to such Deemed Liquidation Event.

Any redemption isdeemed to be remote at December 31, 2019 and 2020, and the fair value of Series A preferred stock is deemed to be the price paid by the Series A preferred stockholders.

Due to this redemption option, Series A preferred stock is recorded in mezzanine equity and is subject to subsequentmeasurement under the guidance provided under ASC 480. In accordance with that guidance, the Company has elected to recognize changes in redemption value immediately.

However, based on the nature of Series A preferred stock, no subsequent measurement will be recognized until a DeemedLiquidation Event becomes probable. As of December 31, 2019 and 2020, a Deemed Liquidation Event was not probable; as a result, the Series A preferred stock is valued at original issue price, less cost of issuance, and the value is allocated tothe warrant derivative liabilities discussed further below.

Warrant Derivative Liabilities

In connection with the Series A preferred stock , the Company issued two freestanding detachable stock purchase warrants to anunrelated third party to separately purchase 1,400,000 and 1,120,476 shares of common stock (the “2019 Warrants”). The 2019 Warrants are exercisable in whole immediately prior to an initial public offering by the Company and, as such,remain issued, outstanding, and exercisable at December 31, 2019 and 2020. The 2019 Warrants were issued with an initial exercise price of $0.01 and an expiration date of May 13, 2029. The 2019 Warrants qualify as derivative liabilities,which must be accounted for separately from the Series A preferred stock and are measured at fair value on a recurring basis. At December 31, 2019 and 2020, the 2019 Warrants were valued at $680,529 and $1,890,357, respectively, with the change infair value included in the statements of operations and comprehensive loss in the period the change occurs.

6. Stockholders’ Deficit andStock-Based Compensation

Common stock

The voting, dividend, and liquidation rights of the holders of common stock are subject to and qualified by the rights, powers,and preferences of the holders of the Series A preferred stock. The Company’s common stock has the following characteristics:

Voting

The holders of the common stock are entitled to one vote for each share of common stock. However, except as otherwise requiredby law, holders of common stock are not entitled to vote on any amendment to the

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

6. Stockholders’ Deficit and Stock-Based Compensation (Continued)

 

certificate of incorporation that relates solely to the terms of one or more outstanding series of preferred stock if the holders of such affected series are entitled, either separately ortogether with the holders of one or more other such series, to vote thereon pursuant to the certificate of incorporation or pursuant to Delaware General Corporation Law.

Dividends

The holders of common stock are entitled to receive dividends, if and when declared by the Board of Directors. The Company maynot declare or pay any cash dividends to the holders of common stock unless, in addition to obtaining any necessary consents, dividends are paid on the Series A preferred stock in accordance with the respective terms. No dividends have been declaredor paid since inception of the Company.

Liquidation

In the event of any voluntary or involuntary liquidation, dissolution, or winding-up ofthe Company, the holders of common stock are entitled to share ratably with the holders of the Series A preferred stock in the Company’s assets available for distribution to stockholders after payment to the holders of the Series A preferredstock of their liquidation preferences has been made.

Stock Options

As of December 31, 2019 and 2020, options to purchase common stock were outstanding under the Company’s 2019 StockOption Plan (the “2019 Plan”). The Company has reserved 4,201,734 shares of its common stock under the 2019 Plan for grants in the form of incentive stock options and nonqualified stock options to employees, consultants, and directors. Asof December 31, 2019 and 2020, a total of 3,976,000 options were available for issuance under the 2019 Plan.

Thefollowing is a summary of the Company’s stock option activity under its 2019 Plan:

 

   Shares   Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Life (Years)
 

Options outstanding at January 1, 2019

      $     

Options granted

   225,734    0.27     

Options exercised

            

Options forfeited

            
  

 

 

   

 

 

   

 

 

 

Options outstanding at December 31, 2019

   225,734    0.27    9.75 

Options granted

            

Options exercised

            

Options forfeited

            
  

 

 

   

 

 

   

 

 

 

Options outstanding at December 31, 2020

   225,734   $0.27    8.75 
  

 

 

   

 

 

   

 

 

 

As of December 31, 2019 and 2020, there were 16,674 and 91,918 options vested and exercisable,respectively. Unrecognized compensation cost related to stock option awards of $37,528 and $28,101, as of

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

6. Stockholders’ Deficit and Stock-Based Compensation (Continued)

 

December 31, 2019 and 2020, respectively, is expected to be recognized as expense over a weighted average period of 2.8 and 1.8 years, respectively. The total fair value of options vestedwas $3,412 and $15,891 for the years ended December 31, 2019 and 2020, respectively.

Outstanding stock options, ifnot exercised, expire ten years from the date of grant. The Company issues new shares of common stock upon exercise of stock options. The weighted average grant date fair value per share for the outstanding options at December 31, 2019 and2020, was $0.21.

The Company determined the grant-date fair value of stock options using the Black-Scholes option pricingmodel. The fair value of each stock option grant was determined using assumptions that are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with a term equivalent to the option. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available.The peer group was developed based on companies in the therapeutics and pharmaceutical industries. The expected term of stock options represents the weighted average period that the stock options are expected to be outstanding. Because the Companydoes not have historical exercise behavior, it determined the expected life assumption using the simplified method, which is an average of the options ordinary vesting period and the contractual term. The expected dividend assumption was based onthe Company’s history and expectation of dividend payouts at the time of grant. The Company recognizes forfeitures on an actual basis and, as such, did not estimate forfeitures to calculate stock-based compensation.

There were no options granted during the year ended December 31, 2020. The following table presents the weighted averageassumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted during the year ended December 31, 2019:

 

Exercise price

  $0.27 

Stock price on date of grant

   0.27 

Expected term (years)

   6.00 

Expected stock price volatility

   96.75

Risk-free rate of interest

   1.63

Expected dividend yield

   

There is a high degree of subjectivity involved when using option-pricing models to estimatestock-based compensation. There are currently no market-based mechanisms or other practical applications to verify the reliability and accuracy of the estimates stemming from these models, nor is there a means to compare and adjust the estimates toactual values. Although the fair value of the employee stock-based awards is determined using an option-pricing model, the value may not be indicative of the fair value that would be observed in a market transaction between a willing buyer and awilling seller. If factors change and the Company employs different assumptions when valuing its options, the compensation expense that the Company records in the future may differ significantly from what it has historically reported.

7. Income Taxes

Therewas no current or deferred income tax expense or benefit for the years ended December 31, 2019 and 2020, due to the Company’s net and comprehensive loss and increases in its deferred tax asset valuation allowance.

 

F-18


Table of Contents

CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

7. Income Taxes (Continued)

 

The components of net and comprehensive loss are primarily composed ofpermanent items and the change in valuation allowance. The Company’s income tax provision was computed based on the federal statutory rates and the average state statutory rates, net of the federal benefit. Deferred income taxes reflect the nettax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income and for tax carryforwards.

The components of the Company’s deferred tax assets are as follows at December 31:

 

   2019  2020 

Net operating loss carryforwards

  $706,655  $5,505,370 

Licensing fee, contract accruals

   433,064   402,852 

Stock-based compensation

   773   3,865 
  

 

 

  

 

 

 

Total deferred tax assets

   1,140,492   5,912,087 

Valuation allowance

   (1,140,492  (5,912,087
  

 

 

  

 

 

 

Net deferred tax assets

  $  $ 
  

 

 

  

 

 

 

When realization of the deferred tax asset is more likely than not to occur, the benefitrelated to the deductible temporary differences attributable to operations is recognized as a reduction of income tax expense. Valuation allowances are provided against deferred tax assets when, based on all available evidence, it is considered morelikely than not that some portion or all of the recorded deferred tax assets will not be realized in future periods. The deferred tax assets have been fully offset by a valuation allowance, as realization is dependent on future earnings, if any, thetiming and amount of which are uncertain.

As of December 31 2019 and 2020, the Company had gross federal net operatingloss carryforwards of $3,118,649 and $24,296,617 available to reduce future taxable income, respectively. The federal net operating loss carryforward (“NOL”) has no expiration as a result of the Tax Cuts and Jobs Act of 2017. Additionally,the Company has $24,296,617 of gross local NOL carryforward that begin expiring in 2025.

The Company’s effective taxrate for the years ended December 31, 2019 and 2020 is 0%. A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended:

 

   December 31 
   2019  2020 

Statutory federal income tax rate

   (21.00)%   (21.00)% 

State income taxes, net of federal tax benefits

   (1.66  (1.66

Permanent items

   0.01   1.25 

Change in valuation allowance

   22.65   21.41 
  

 

 

  

 

 

 

Total provision for income taxes

     
  

 

 

  

 

 

 

The Company files income tax returns in the U.S. Federal jurisdiction and various state andlocal jurisdictions. All years remain open and are subject to examination.

At December 31, 2019 and 2020, theCompany has no unrecognized tax benefits, and no amounts have been recognized in the statements of operations and comprehensive loss. The Company’s policy is to recognize

 

F-19


Table of Contents

CinCor Pharma, Inc.

Notes to Financial Statements (Continued)

7. Income Taxes (Continued)

 

interest and penalties related to income tax matters in income tax expense. As of December 31, 2019 and 2020, the Company has no accrued interest and penalties related to uncertain taxpositions.

8. Net and Comprehensive Loss Per Share (Restated)

The Company’s basic and diluted net loss per share for the years ended December 31, 2019 and 2020, was $1.18 and $5.25,respectively.

Diluted net and comprehensive loss per share gives effect to all potentially dilutive securities, includingshares issuable upon the exercise of outstanding freestanding detachable stock purchase warrants, redeemable convertible preferred stock, and stock options outstanding under the Company’s stock option plan. For the years ended December 31,2019 and 2020, the Company has excluded the effects of all potentially dilutive shares, which include freestanding detachable stock purchase warrants to purchase common stock, redeemable convertible preferred stock, and outstanding common stockoptions, from the weighted average number of common stock as their inclusion would be anti-dilutive due to net and comprehensive loss. Therefore, the calculation of basic and diluted net comprehensive loss per share is the same.

The following weighted average common stock equivalents were excluded from the calculation of diluted net loss per share forthe periods presented because including them would have had an anti-dilutive effect for the years ended:

 

   December 31 
   2019   2020 

Redeemed convertible preferred stock (if converted)

   11,904,760    35,714,282 

2019 warrants

   2,520,476    2,520,476 

Outstanding options exercisable

   16,674    91,918 

Restatement of Previously Issued Financial Statements

Subsequent to the date of the previously issued financial statements (June 23, 2021) and as part of its financial and legal diligence incontemplation of a potential initial public offering transaction, management determined that certain outstanding common stock of the Company issued to CinRx at the time of incorporation, had not been appropriately reflected in the historicalfinancial statements. The omission of this common stock therefore only impacted net and comprehensive loss per share attribute to common stockholders, basic and diluted, and outstanding common stock, and no other items within the financialstatements, as follows:

 

   Year Ended December 31, 2019 
   As
Reported
   Restatement
Impact
  As
Restated
 
  

 

 

   

 

 

  

 

 

 

Outstanding common stock

   250,000    4,000,000   4,250,000 

Net and comprehensive loss per share attributable to common stockholders, basic anddiluted

   20.14    (18.96  1.18 

 

   Year Ended December 31, 2020 
   As
Reported
   Restatement
Impact
  As
Restated
 
  

 

 

   

 

 

  

 

 

 

Outstanding common stock

   250,000    4,000,000   4,250,000 

Net and comprehensive loss per share attributable to common stockholders, basic anddiluted

   89.19    (83.94  5.25 

 

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Table of Contents

CinCor Pharma, Inc. (Continued)

Notes to Financial Statements (Continued)

 

9. Related-Party Transactions

CinRx Pharma, LLC and subsidiaries (“CinRx”)

Certain former executives and employees of the Company, including the Company’s former chief executive officer and aformer member of the board of directors and a former member of the Company’s board of directors, are members of CinRx’s board of managers and/or have equity investments in CinRx, a biotechnology company. The Company receives businessmanagement services from CinRx from time to time as needed. During the years ended December 31, 2019 and 2020, the Company recorded business management fees totaling $795,000 and $1,552,000, of which approximately $173,000 and $99,000 is included inrelated party accounts payable at December 31, 2019 and 2020, respectively.

10. Subsequent Events

Subsequent to December 31, 2020, the Company authorized the issuance of 35,716,249 shares to be issued in the form ofSeries B redeemable convertible preferred stock (Series B preferred stock).

In September and October 2021, theCompany entered into a Series B preferred stock agreement with certain investors, members of the Company’s board of directors and affiliates of members of their board of directors, pursuant to which the Company issued and sold to such investorsan aggregate of 35,716,249 shares of Series B preferred stock at a purchase price of $4.00 per share for aggregate gross proceeds of approximately $142,870,000. In addition, the Company’s Board of Directors increased the number of authorizedshares of common stock to 95,000,000 shares.

In connection with the Series B preferred stock offering, the Company issueda freestanding detachable stock purchase warrant to an unrelated third party to separately purchase 386,271 shares of common stock (the 2021 Warrants). The 2021 Warrants are exercisable in whole immediately prior to an initial public offering by theCompany.

 

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Table of Contents

CinCor Pharma, Inc.

Condensed Balance Sheets

 

   December 31,
2020
  September 30,
2021
 
      (Unaudited) 

Assets

   

Current assets:

   

Cash and cash equivalents

  $ 26,078,064  $141,708,303 

Prepaid research and development contracts

   694,504   4,225,296 

Prepaid expenses and other current assets

   27,403   1,330,812 
  

 

 

  

 

 

 

Total current assets

   26,799,971   147,264,411 
  

 

 

  

 

 

 

Total assets

  $ 26,799,971  $147,264,411 
  

 

 

  

 

 

 

Liabilities, redeemable convertible preferred stock, and stockholders’deficit

   

Current liabilities:

   

Accounts payable

  $ 3,666,017  $ 4,009,655 

Related-party accounts payable

   98,781   449,431 

Warrant derivative liabilities

   1,890,357   6,512,121 

Accrued expenses and other liabilities

   1,236,209   573,512 
  

 

 

  

 

 

 

Total current liabilities

   6,891,364   11,544,719 

Series A redeemable convertible preferred stock, $0.00001 par value, 35,714,282 sharesauthorized, issued and outstanding at both December 31, 2020 and September 30, 2021

   47,173,259   47,173,259 

Series B redeemable convertible preferred stock, $0.00001 par value, 35,716,249 sharesauthorized, and 0 and 33,702,500 shares issued and outstanding at December 31, 2020 and September 30, 2021, respectively

      133,352,758 

Stockholders’ deficit:

   

Common stock, $0.00001 par value, 95,000,000 and 46,686,492 shares authorized, and 4,250,000 and5,893,754 issued and outstanding at December 31, 2020 and September 30, 2021, respectively

   43   59 

Additional paid-in capital

   69,300   3,553,249 

Accumulated deficit

   (27,333,995  (48,359,633
  

 

 

  

 

 

 

Total stockholders’ deficit

   (27,264,652  (44,806,325
  

 

 

  

 

 

 

Total liabilities, redeemable convertible preferred stock, and stockholders’ deficit

  $ 26,799,971  $147,264,411 
  

 

 

  

 

 

 

See accompanying notes, which are an integral part of these condensed financial statements.

 

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CinCor Pharma, Inc.

Condensed Statements of Operations and Comprehensive Loss (Unaudited)

 

   Nine Months Ended
September 30
 
   2020  2021 

Operating expenses

   

Research and development

  $12,828,674  $10,131,045 

General and administrative

   2,783,063   7,146,983 
  

 

 

  

 

 

 

Total operating expenses

   15,611,737   17,278,028 

Loss from operations

   15,611,737   17,278,028 

Other (income) expense:

   

Interest income

   (29,914  (7,899

Change in fair value of warrant derivative liabilities

   907,391   3,755,509 
  

 

 

  

 

 

 

Total other expense

   877,477   3,747,610 
  

 

 

  

 

 

 

Net and comprehensive loss

  $16,489,214  $21,025,638 
  

 

 

  

 

 

 

Net and comprehensive loss per share attributable to common stockholders, basic anddiluted

  $ 3.88  $ 4.12 
  

 

 

  

 

 

 

Weighted average common shares used in computing net and comprehensive loss per share attributableto common stockholders, basic and diluted

   4,250,000   5,106,876 

See accompanying notes, which are an integral part of these condensed financial statements.

 

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Table of Contents

CinCor Pharma, Inc.

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Deficit (Unaudited)

 

  Redeemable Convertible
Preferred Stock
  Stockholders’ Deficit 
  Series A Redeemable
Convertible Preferred Stock
  Series B Redeemable
Convertible Preferred Stock
  Common Stock  Additional
Paid-In
Capital
  Accumulated
Deficit
  Total
Stockholders’
Deficit
 
  Shares  Amount  Shares  Amount  Shares  Amount 

Balance at January 1, 2020

  11,904,760   15,183,192         4,250,000   43   53,409   (5,035,450  (4,981,998

Issuance of redeemable convertible preferred stock, net of issuance costs of $1,343,268

  23,809,522   31,990,067                      

Stock-based compensation expense

                    18,315      18,315 

Net and comprehensive loss

                       (16,489,214  (16,489,214
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at September 30, 2020

  35,714,282  $47,173,259     $   4,250,000  $43  $ 71,724  $(21,524,664 $(21,452,897
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at January 1, 2021

  35,714,282  $47,173,259     $   4,250,000  $43  $ 69,300  $(27,333,995 $(27,264,652

Ratification and issuance of founders common stock

                           

Issuance of redeemable convertible preferred stock, net of issuance costs of $591,017

        33,702,500   134,219,013                

Allocation of proceeds to warrant derivative liabilities

           (866,255               

Stock options exercised

              1,643,754   16   1,232,799      1,232,815 

Stock-based compensation expense

                2,251,150      2,251,150 

Net and comprehensive loss

                       (21,025,638  (21,025,638
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at September 30, 2021

  35,714,282   47,173,259   33,702,500   133,352,758   5,893,754   59   3,553,249   (48,359,633  (44,806,325

See accompanying notes, which are an integral part of these condensed financial statements.

 

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Table of Contents

CinCor Pharma, Inc.

Condensed Statements of Cash Flows (Unaudited)

 

   Nine Months Ended September 30 
   2020  2021 

Operating activities

   

Net and comprehensive loss

  $(16,489,214 $(21,025,638

Adjustments to reconcile net and comprehensive loss to net cash used in operatingactivities:

   

Stock-based compensation expense

   18,315   2,251,150 

Change in fair value of warrant derivative liabilities

   907,391   3,755,509 

Changes in operating assets and liabilities:

   

Related-party accounts receivable

   8,424    

Prepaid research and development contracts

   (778,508  (3,530,792

Prepaid expenses and other current assets

   356   (1,303,409

Accounts payable

   2,448,737   343,638 

Related-party accounts payable

   (57,455  350,650 

Accrued expenses and other liabilities

   1,621,875   (662,697
  

 

 

  

 

 

 

Net cash used in operating activities

   (12,320,079  (19,821,589

Financing activities

   

Proceeds from the issuance of Series A redeemable convertible preferred stock inclusive ofproceeds attributable to warrant derivative liabilities

   33,333,330    

Proceeds from the issuance of Series B redeemable convertible preferred stock inclusive ofproceeds attributable to warrant derivative liabilities

    134,810,030 

Issuance cost for redeemable convertible preferred stock

   (1,343,268  (591,017

Proceeds from exercise of stock options

      1,232,815 
  

 

 

  

 

 

 

Net cash provided by financing activities

   31,990,062   135,451,828 
  

 

 

  

 

 

 

Increase in cash and cash equivalents

   19,669,983   115,630,239 

Cash and cash equivalents at beginning of year

   11,484,152   26,078,064 
  

 

 

  

 

 

 

Cash and cash equivalents at end of year

  $ 31,154,135  $141,708,303 
  

 

 

  

 

 

 

See accompanying notes, which are an integral part of these condensed financial statements.

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited)

September 30, 2020 and 2021

1.Nature of Business

CinCor Pharma, Inc. (the Company) is a clinical-stage biopharmaceutical company focused ondeveloping its lead clinical candidate, CIN-107, for the treatment of hypertension and other cardio-renal diseases. CIN-107 is a highly selective, oral small moleculeinhibitor of aldosterone synthase, the enzyme responsible for the synthesis of aldosterone in the adrenal gland. CIN-107 has been designed to use a differentiated mechanism of action, direct inhibition of aldosterone synthase production, with thegoal of providing an improved treatment for patients suffering from hypertension, or high blood pressure. Despite the widespread availability of multiple antihypertensive agents, there remains a significant unmet medical need as more than half ofthe 108 million hypertensive patients in the United States do not achieve blood pressure control. We are evaluating the efficacy and safety profile of CIN-107 as a potential treatment for the broader hypertensive population, including differentsubpopulations of hypertensive patients who have not achieved blood pressure control despite treatment. The Company was incorporated in 2018 in the State of Delaware.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including,but not limited to, possible failure of preclinical studies or clinical trials, the need to obtain marketing approval for its product candidates, development by competitors of new technological innovations, dependence on key personnel, protection ofproprietary technology, compliance with government regulations, the need to successfully commercialize and gain market acceptance of any of the Company’s products that are approved and the ability to secure additional capital to fundoperations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing, and regulatory approval prior to commercialization. These effortsrequire significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Companywill realize revenue from product sales.

The Company has funded its operations to date primarily through private sales ofredeemable convertible preferred stock.

Going Concern Considerations

In accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there areconditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the unaudited condensed financial statements are made publiclyavailable.

The Company incurred losses from operations and had negative cash flows from operating activities for the ninemonths ended September 30, 2020 and 2021, and since inception. The Company’s current operating plan indicates it will continue to incur losses from operations and generate negative cash flows from operating activities, given ongoingexpenditures related to extensive research and development and the Company’s lack of revenue-generating activities at this point in the Company’s life cycle.

The Company has been successful in raising funds through equity financings and will need to continue to raise additional fundsin order to further advance its research and development programs, operate its business, and meet its obligations as they come due. However, financing may not be available to the Company in the necessary time frame, in the amounts that the Companyrequires, on terms that are acceptable to the Company, or at all. If the Company is unable to raise the necessary funds when needed or must reduce spending on currently planned activities, it may not be able to continue the development of itsproducts or could be required to delay, scale back, or eliminate some or all of its research and development programs and other operations;

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

1. Nature of Business (Continued)

 

consequently, these circumstances will materially harm the Company’s business, financial position, and results of operations.

Based on the Company’s cash and cash equivalents position as of the date these unaudited condensed financial statementsare made publicly available, it is anticipated that based on the Company’s current operating plans, these funds will allow the Company to conduct planned operations through at least the third quarter of 2023.

2. Summary of Significant Accounting Policies

Basis of Presentation

The Company’s unaudited condensed financial statements are prepared in accordance with U.S. generally accepted accountingprinciples (U.S. GAAP) and stated in U.S. dollars. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASUs)of the FASB.

These unaudited condensed financial statements should be read in conjunction with the audited financialstatements and related notes for the year ended December 31, 2020. The unaudited condensed financial statements for interim periods do not include all disclosures required by U.S GAAP for annual financial statements and are not necessarilyindicative of results for the full year or any subsequent period. Adjustments (consisting of normal recurring accruals) considered necessary for a fair statement of the unaudited condensed financial position, results of operations and cash flows atthe dates and for the periods presented have been included.

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available forevaluation by the chief operating decision-maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment. All the assets andoperations of the Company are located in the United States.

Use of Estimates

The preparation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of income, if applicable, and expenses during thereporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls and in developing the estimates and assumptions that are used in thepreparation of these condensed financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatilityassociated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate futureoutcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: prepaid research and development contracts, fair value of the Company’s common stock,fair value of warrant derivative liabilities, and income taxes.

The Company utilizes estimates and assumptions indetermining the fair value of its common stock, including stock-based awards. The Company has granted stock options at exercise prices that represented the fair

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

2. Summary of Significant Accounting Policies (Continued)

 

value of its common stock on grant date. The Company utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants TechnicalPractice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation, to estimate the fair value of its common stock. Each valuation methodology includes estimates and assumptions that require the Company’sjudgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of redeemable convertible preferred stock, the superior rights andpreferences of the redeemable convertible preferred stock senior to the Company’s common stock at the time, and a probability analysis of various liquidity events, such as a public offering or sale of the Company, under differing scenarios.

Changes to the key assumptions used in the valuations could result in different fair values of common stock at eachvaluation date. Actual results may differ from those estimates or assumptions.

The Company’s results and businessoperations can also be affected or disrupted by economic, political, legislative, regulatory, legal matters, or public health concerns, such as the coronavirus disease 2019 (COVID-19) pandemic. Economicconditions, such as recessionary trends, inflation, interest, changes in regulatory laws and monetary exchange rates, and government fiscal policies, can also have a significant effect on the Company’s operations. While the Company maintainsreserves for anticipated liabilities, the Company could be affected by civil, criminal, regulatory, or administrative actions, claims, or proceedings. The extent to which the Company’s business can be impacted by future events is highlyuncertain and cannot be predicted at this time.

Cash and Cash Equivalents

The primary objectives for the Company’s cash and cash equivalents are the preservation of capital and maintenance ofliquidity. The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. At December 31, 2020 and September 30, 2021, cash and cash equivalents consist of cash on hand andshort-term, highly liquid investments with original maturities of three months or less at the date of purchase. The carrying value of cash and cash equivalents approximates fair value. The Company has maintained balances with its banks in excess offederally insured limits.

Concentration of Credit Risk and Other Risks and Uncertainties

The Company has no significant off-balance sheet concentrations of credit risk, such asforeign currency exchange contracts, option contracts, or other hedging arrangements. Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash and cash equivalents, which consist of moneymarket funds that invest primarily in short-term U.S. government securities.

The Company has not yet generated anyrevenue from the sale of its products and is subject to all of the risks and uncertainties that are typically faced by biotechnology companies that devote substantially all of their efforts to research and development and clinical trials and do notyet have commercial products. The Company expects to continue incurring losses for the foreseeable future.

Deferred Initial PublicOffering (IPO) Costs

Costs directly attributable to the Company’s offering of its equity securities aredeferred and capitalized as prepaid expenses and other current assets. These costs primarily represent legal, underwriting and accounting costs related to the Company’s efforts to raise capital through a public sale of its common stock. Futurecosts will

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

2. Summary of Significant Accounting Policies (Continued)

 

be deferred until the completion of the IPO, at which time they will be reclassified to additional paid in capital as a reduction of the IPO proceeds. If the Company terminates its plan for anIPO or delays such plan for more than 90 days, any costs deferred will be expensed immediately. At September 30, 2021, the Company had capitalized $1.3 million of deferred IPO costs, as prepaid expenses and other current assets ($0 atDecember 31, 2020).

Redeemable Convertible Preferred Stock

In accordance with ASC Topic 480, Distinguishing Liabilities from Equity (ASC 480), preferred stock issued withredemption provisions that are outside of the control of the issuer or that contain certain redemption features in the event of a deemed liquidation is required to be presented outside of stockholders’ deficit on the face of the condensedbalance sheet and certain disclosures are required to be included in the notes to the condensed financial statements. If required, changes in fair value are recorded as additional paid in capital and/or accumulated deficit in the condensed balancesheets. Changes in fair value that would reduce the fair value of the redeemable convertible preferred stock below the original issue price are limited so that the value of the shares are not recorded below the original issue price.

Fair Value Measurements

The Company’s financial instruments consist of cash equivalents, warrant derivative liabilities, accounts payable, andaccrued expenses and other liabilities. The fair values of accounts payable and accrued expenses and other liabilities approximate the carrying values because of their short-term nature.

The Company is required to disclose information on all assets and liabilities reported at fair value that enables anassessment of the inputs used in determining the reported fair values. ASC Topic 820, Fair Value Measurement, establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes theuse of unobservable inputs by requiring that the observable inputs be used when available.

Observable inputs are inputsthat market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that marketparticipants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value and isnot a measure of the investment credit quality. The three levels of the fair value hierarchy are described below:

 

  

Level 1 – Valuations based on unadjusted quoted prices in active markets for identical assetsor liabilities that the Company has the ability to access at the measurement date.

 

  

Level 2 – Valuations based on observable inputs other than quoted prices included inLevel 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated byobservable market data.

 

  

Level 3 – Valuations that require inputs that reflect the Company’s own assumptions thatare both significant to the fair value measurement and unobservable.

To the extent that a valuation isbased on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

2. Summary of Significant Accounting Policies (Continued)

 

by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest levelof any input that is significant to the fair value measurement. There were no transfers within the fair value hierarchy in 2020 and 2021.

Research and Development Expenses

Research and development costs, both internal and external, are expensed as incurred. Costs are considered incurred based on anevaluation of the progress to completion of specific tasks under each contract using information and data provided to the Company by its clinical sites and vendors. These costs consist of direct and indirect costs associated with specific projects,as well as fees paid to various entities that perform certain research on behalf of the Company. The Company’s research and development expenses consist primarily of clinical trial expenses, consulting costs and stock-based compensation, andcosts associated with required regulatory filings, licenses, and fees.

Stock-Based Compensation

The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718,Compensation – Stock Compensation (ASC 718). ASC 718 requires all stock-based payments to employees, including grants of employee stock options, to be recognized in the condensed statements of operations andcomprehensive loss based on their fair values. The Company’s stock-based awards are subject only to service-based vesting conditions. The Company estimates the fair value of its stock-based awards using the Black-Scholes option pricing model,which requires the input of assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate, and (d) expected dividends.

Due to the lack of a public market for the trading of the Company’s common stock and a lack of company-specifichistorical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The Company believes that the companies in the group havecharacteristics similar to its own characteristics, including stage of product development and a focus on the life sciences industry. The Company believes the group selected has sufficient similar economic and industry characteristics and includescompanies that are most representative of the Company.

The Company uses the simplified method, as prescribed by theSecurities and Exchange Commission (SEC) Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimatethe expected term for options granted and utilizes the contractual term for options granted. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of the stock options.

Compensation expense related to awards is calculated on a straight-line basis by recognizing the grant date fair value overthe associated service period of the award, which is generally the vesting term.

Derivative Instruments, Including WarrantDerivative Liabilities

The Company accounts for derivatives, specifically freestanding detachable stock purchasewarrants, in accordance with ASC Topic 815, Derivatives and Hedging (ASC 815). This guidance establishes accounting and reporting principles for derivative instruments, including certain derivative instruments embedded in other contracts.

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

2. Summary of Significant Accounting Policies (Continued)

 

Net and Comprehensive Loss Per Share

The Company’s basic net and comprehensive loss per share attributable to common stockholders is calculated by dividing thenet and comprehensive loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. The diluted net and comprehensive loss per share attributable to common stockholders is computed bygiving effect to all potential common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, redeemable convertible preferred stock and stock options to purchase common stock areconsidered to be common stock equivalents but have been excluded from the calculation of diluted net and comprehensive loss per share attributable to common stockholders as their effect is anti-dilutive.

Income Taxes

Income taxes are recorded in accordance with ASC Topic 740, Income Taxes (ASC 740), which provides for deferred taxesusing an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the condensed financial statements or tax returns. Deferred tax assetsand liabilities are determined based on the difference between the condensed financial statement and tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates anticipated to be in effect for the year in whichthe differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all the deferred tax assets will not be realized.

The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positionsexist, the Company recognizes the tax benefit of tax positions to the extent that some or all the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon thetechnical merits of the tax position, as well as consideration of the available facts and circumstances. As of December 31, 2020 and September 30, 2021, the Company does not have any significant uncertain tax positions. If the Company were toincur interest and penalties on uncertain tax positions, it would classify them as income tax expense.

The Company filesU.S. federal and state income tax returns.

Comprehensive Loss

Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and otherevents and circumstances from non-owner sources. Comprehensive loss equaled net loss for the periods presented.

Litigation and Other Contingencies

The Company is or may be subject to legal proceedings and claims arising from the ordinary course of its business, includingcontract and employment claims. U.S. GAAP requires that a liability for contingencies be recorded when it is probable that a liability has occurred and the amount of the liability can be reasonably estimated. In the opinion of management, theaggregate liability, if any, with respect to such ordinary course of business actions will not have a material adverse effect on the financial position or results of operations of the Company. Based on the information available at the dates ofcondensed balance sheets, there are no amounts related to legal matters recorded at September 30, 2021 or December 31, 2020.

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

2. Summary of Significant Accounting Policies (Continued)

 

Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by theCompany as of the specified effective date. Unless otherwise discussed, the Company believes the impact of recently issued standards that are not yet effective will not have a material impact on its condensed financial position or results ofoperations upon adoption.

3. Fair Value Measurements

The following table presents information about the Company’s financial instruments measured at fair value on a recurringbasis based on the fair value hierarchy at:

 

   December 31, 2020 
   Level 1   Level 2   Level 3   Total 

Assets

        

Cash and cash equivalents

  $26,078,064   $   $   $26,078,064 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total assets at fair value

  $26,078,064   $   $   $26,078,064 
  

 

 

   

 

 

   

 

 

   

 

 

 

Liabilities

        

Warrant derivative liabilities

  $   $   $1,890,357   $1,890,357 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total liabilities at fair value

  $   $   $1,890,357   $1,890,357 
  

 

 

   

 

 

   

 

 

   

 

 

 
   September 30, 2021 
   Level 1   Level 2   Level 3   Total 

Assets

        

Cash and cash equivalents

  $141,708,303   $   $   $141,708,303 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total assets at fair value

  $141,708,303   $   $   $141,708,303 
  

 

 

   

 

 

   

 

 

   

 

 

 

Liabilities

        

Warrant derivative liabilities

  $   $   $6,512,121   $6,512,121 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total liabilities at fair value

  $   $   $6,512,121   $6,512,121 
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash equivalents are valued using unadjusted quoted market prices.

The following table sets forth a summary of changes in the fair value of the warrant derivative liabilities, representing arecurring measurement that is classified within Level 3 of the fair value hierarchy:

 

January 1, 2020

  $680,529 

Change in fair value

   907,371 
  

 

 

 

September 30, 2020

   1,587,900 

Change in fair value

   302,457 
  

 

 

 

December 31, 2020

   1,890,357 

Issuance of freestanding detachable stock purchase warrants

   866,255 

Change in fair value

   3,755,509 
  

 

 

 

September 30, 2021

  $6,512,121 
  

 

 

 

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

3. Fair Value Measurements (Continued)

 

The Company estimated the fair value of the warrant derivative liabilitiesusing a Black-Scholes option pricing model. The valuation model uses the following assumptions at:

 

   December 31,
2020
  September 30,
2021
 

Fair value of common stock

  $        0.75  $        2.24 

Volatility

   82.40  75.5

Expected term (in years)

   1.50   0.27 

Risk-free interest rate

   0.12  0.09

Dividend yield

     

The preceding methods described may produce a fair value calculation that may not beindicative of net realizable value or reflective of future fair values. Furthermore, although the Company believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptionsto determine the fair value could result in a different fair value measurement at the reporting date.

4. License Agreement

In May 2019, the Company entered into a license agreement (the Roche Agreement) with F.Hoffman-La Roche Ltd. and Hoffmann-La Roche Inc. (collectively, Roche), pursuant to which the Company obtained an exclusive, worldwide, royalty-bearing license underpatents and specified know-how owned or controlled by Roche and covering certain specified small molecule aldosterone synthase inhibitors (the Roche Technology) to research and develop products containing suchaldosterone synthase inhibitors (the Licensed Products) for any and all uses, including the treatment, prevention or diagnosis of any and all diseases and medical conditions in humans and animals. Pursuant to the Roche Agreement, the Company paidRoche a one-time, upfront non-refundable license fee of $2,000,000. Additionally, the Company is required to pay certain tiered development event-based milestonepayments, certain sales-based milestone payments, as well as a royalty from the future sales of Licensed Products. The royalty is tiered based on the combined net sales of each Licensed Product.

The Roche Agreement will expire, unless earlier terminated by either party, upon expiration of all royalty or other paymentobligations under the Roche Agreement are or will become due. For the nine months ended September 30, 2020 and 2021, the Company recorded expense of $41,358 and $0, respectively, related to the Roche Agreement as research and developmentexpenses on the Company’s condensed statements of operations and comprehensive loss.

5. Redeemable Convertible Preferred Stock

Series A Redeemable Convertible Preferred Stock

In May 2019, the Company authorized the issuance of 35,714,282 shares to be issued in the form of Series A redeemableconvertible preferred stock (Series A preferred stock). During the nine months ended September 30, 2020, the Company issued 23,809,522 shares of Series A preferred stock at $1.40 per share for total proceeds of $33,333,335. The Company incurred$1,343,263 of Series A preferred stock issuance costs, which are recorded against the carrying amount of the Series A preferred stock at September 30, 2020. The rights, preferences, and privileges of the Company’s Series A preferred stockare as follows:

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

5. Redeemable Convertible Preferred Stock (Continued)

 

Voting

The holders of Series A preferred stock are entitled to a number of votes equal to the number of whole shares of common stockinto which the shares of Series A preferred stock are convertible. Except as provided by law or otherwise, the holders of the Series A preferred stock vote together with the holders of common stock as a single class.

Holders of Series A preferred stock, voting as a separate class, are entitled to elect three members of the Board ofDirectors. The holders of the common stock, voting as a separate class, are entitled to elect two members of the Board of Directors. The holders of Series A preferred stock and common stock, voting together as a single class on an as-converted basis, are entitled to elect any additional members of the Board of Directors.

Dividends

Dividends are payable, if permitted by law, in accordance with the Series A preferred stock terms if and when declared by theBoard of Directors. Holders of the Series A preferred stock are entitled to receive dividends out of any assets at the time legally available, at the applicable dividend rate specified for such shares of the Series A preferred stock. Dividends arenot mandatory and are not cumulative. No dividends have been declared or paid since inception of the Company.

Liquidation

In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holdersof shares of the Series A preferred stock then outstanding are entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a deemed liquidation event, out of the consideration payable tostockholders in such an event, before any payment shall be made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the Series A preferred stock original issue price, plus any dividends declared butunpaid. If upon any such liquidation, dissolution, or winding up of the Company or a deemed liquidation event, the assets of the Company available for distribution to its stockholders are insufficient to pay the holders of shares of Series Apreferred stock the full amount to which they are entitled, the holders of shares of the Series A preferred stock share ratably in any distribution of the assets available for distribution in proportion to the respective amounts that would otherwisebe payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

The remaining available proceeds will be distributed pro rata among the holders of the shares of the Series A preferredstock and common stock, based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted to common stock pursuant to the applicable terms immediately prior to such liquidation,dissolution, or winding up of the Company.

Conversion

Each share of the Series A preferred stock is convertible, at the option of the holder thereof, at any time and from time totime, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of common stock as determined by dividing the Series A preferred stockoriginal issue price by the Series A preferred stock conversion price in effect at the time of conversion. The applicable conversion price is subject to future adjustments upon the occurrence of certain events. However,

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

5. Redeemable Convertible Preferred Stock (Continued)

 

holders of the Series A preferred stock do not have the right to convert any shares of the Series A preferred stock at the applicable conversion ratio in effect for preferred shares uponeither (i) the closing of a qualified initial public offering of its common shares at a price per share of at least $4.20 per share (subject to adjustment for any share split, combination or dividend or distribution payable) resulting in atleast $50,000,000 in proceeds net of the underwriting discount and commissions, or (ii) the election to convert the preferred shares by at least two of the following three holders of the Company’s Series A preferred stock:(i) Sofinnova Venture Partners X, L.P., (ii) Sofinnova Capital IX and (iii) 5AM Ventures VI, L.P.

TheCompany evaluated the Series A preferred stock and determined that it was considered an equity host under ASC 815. In making this determination, the Company’s analysis followed the whole instrument approach, which compares an individual featureagainst the entire Series A preferred stock instrument that includes that feature. The Company’s analysis was based on a consideration of the economic characteristics and risks of the Series A preferred stock. More specifically, the Companyevaluated all of the stated and implied substantive terms and features, including (i) whether the Series A preferred stock included redemption features, (ii) how and when any redemption features could be exercised, (iii) whether theholders of the Series A preferred stock were entitled to dividends, (iv) the voting rights of the Series A preferred stock, and (v) the existence and nature of any conversion rights. The Company concluded that, as the Series A preferredstock represents an equity host, the conversion feature included in the Series A preferred stock is clearly and closely related to the associated host instrument. Accordingly, the conversion feature is not considered an embedded derivative thatrequires bifurcation.

The Company accounts for potentially beneficial conversion features under ASC Topic 470-20, Debt with Conversion and Other Options (ASC Topic 470-20). At the time of the issuances of the shares of Series A preferred stock, the Company’s commonstock into which the Company’s Series A preferred stock was convertible had an estimated fair value less than the effective conversion prices of the shares of Series A preferred stock. Therefore, there was no beneficial conversion element onthe issuance dates.

Redemption

The Series A preferred stock are redeemable upon a request by two of three of the requisite holders of the Company’sSeries A preferred stock in the event of a Deemed Liquidation Event, if the Company does not effect a dissolution of the Company within 90 days after such Deemed Liquidation Event, payable at a price equal to the cash or the value of the property,rights, or securities to be paid or distributed to holders pursuant to such Deemed Liquidation Event.

Any redemption isdeemed to be remote at December 31, 2020 and September 30, 2021, and the fair value of Series A preferred stock is deemed to be the price paid by the Series A preferred stockholders.

Due to this redemption option, Series A preferred stock is recorded in mezzanine equity and is subject to subsequentmeasurement under the guidance provided under ASC 480. In accordance with that guidance, the Company has elected to recognize changes in redemption value immediately.

However, based on the nature of Series A preferred stock, no subsequent measurement will be recognized until a DeemedLiquidation Event becomes probable. As of December 31, 2020 and September 30, 2021, a Deemed Liquidation Event was not probable; as a result, the Series A preferred stock is valued at original issue price, less cost of issuance, and the valueis allocated to the warrant derivative liabilities discussed further below.

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

5. Redeemable Convertible Preferred Stock (Continued)

 

Warrant Derivative Liabilities

In connection with the Series A preferred stock , the Company issued two freestanding detachable stock purchase warrants to anunrelated third party to separately purchase 1,400,000 and 1,120,476 shares of common stock (the 2019 Warrants). The 2019 Warrants are exercisable in whole immediately prior to an initial public offering by the Company and, as such, remain issued,outstanding, and exercisable at December 31, 2020 and September 30, 2021. The 2019 Warrants were issued with an initial exercise price of $0.01 and an expiration date of May 13, 2029. The 2019 Warrants qualify as derivative liabilities,which must be accounted for separately from the Series A preferred stock and are measured at fair value on a recurring basis. At December 31, 2020 and September 30, 2021, the 2019 Warrants were valued at $1,890,357 and $5,645,866, respectively,which the change in fair value included in the condensed statements of operations and comprehensive loss in the period the change occurs.

Series B Redeemable Convertible Preferred Stock

In September 2021, the Company authorized the issuance of 35,716,249 shares to be issued in the form of Series Bredeemable convertible preferred stock (Series B preferred stock). During the nine months ended September 30, 2021, the Company issued 33,702,500 shares of Series B preferred stock at $4.00 per share for total proceeds of $134,810,030. TheCompany incurred $591,017 of Series B preferred stock issuance costs (through September 30, 2021), which are recorded against the carrying amount of the Series B preferred stock at September 30, 2021. The rights, preferences, andprivileges of the Company’s Series B preferred stock are as follows:

Voting

The holders of Series B preferred stock are entitled to a number of votes equal to the number of whole shares of common stockinto which the shares of Series B preferred stock are convertible. Except as provided by law or otherwise, the holders of the Series B preferred stock vote together with the holders of common stock as a single class.

Holders of Series B preferred stock, voting as a separate class, are entitled to elect one member of the Board of Directors.The holders of preferred stock and common stock, voting together as a single class on an as-converted basis, are entitled to elect any additional members of the Board of Directors other than directors electedby the holders of Series A preferred stock and directors elected by holders of the common stock.

Dividends

Dividends at the rate per annum of $0.32 per share accrue on shares of Series B preferred stock. Dividends on the shares ofSeries B preferred stock are not cumulative and are payable, if and when declared by the Board of Directors. The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company unlessthe holders of preferred stock then outstanding first or simultaneously receive a dividend on each outstanding share of redeemable convertible preferred stock in an amount at least equal to the sum of (i) the amount of the aggregate dividendsaccrued but unpaid on such shares of preferred stock and (ii) that dividend per share of preferred stock as would equal the product of (1) the dividend payable on each share of such class or series determined, if applicable, as if allshares of such class or series had been converted into common stock and (2) the number of shares of common stock issuable upon conversion of a share of preferred stock. No dividends have been declared or paid since inception of the Company.

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

5. Redeemable Convertible Preferred Stock (Continued)

 

Liquidation

In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holders of shares ofthe Series B preferred stock then outstanding are entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a deemed liquidation event, out of the consideration payable to stockholders insuch an event, before any payment shall be made to the holders of Series A preferred stock or common stock by reason of their ownership thereof, an amount per share equal to the Series B preferred stock original issue price, plus anydividends declared but unpaid thereon. If upon any such liquidation, dissolution, or winding up of the Company or a deemed liquidation event, the assets of the Company available for distribution to its stockholders are insufficient to pay theholders of shares of Series B preferred stock the full amount to which they are entitled, the holders of shares of the Series B preferred stock shall share ratably in any distribution of the assets available for distribution in proportion to therespective amounts that would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

In the event that the assets of the Corporation available for distribution shall exceed the amount necessary to pay theholders of Series B preferred stock, the holders of shares of Series A preferred stock then outstanding are entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a deemed liquidationevent, out of the consideration payable to stockholders in such an event, before any payment shall be made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the Series A preferred stock original issueprice, plus any dividends declared but unpaid thereon. If upon any such liquidation, dissolution, or winding up of the Company or a deemed liquidation event, the assets of the Company available for distribution to its stockholders are insufficientto pay the holders of shares of Series A preferred stock the full amount to which they are entitled, the holders of shares of the Series A preferred stock shall share ratably in any distribution of the assets available for distribution in proportionto the respective amounts that would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

The remaining available proceeds will be distributed pro rata among the holders of the shares of the Series B preferred stock,Series A preferred stock and common stock, based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted to common stock pursuant to the applicable terms immediately prior to suchliquidation, dissolution, or winding up of the Company.

Conversion

Each share of the Series B preferred stock is convertible, at the option of the holder thereof, at any time and from time totime, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of common stock as determined by dividing the Series B preferred stockoriginal issue price by the Series B preferred stock conversion price in effect at the time of conversion. The Series B preferred stock conversion price shall initially be equal to the Series B original issue price. The applicable conversion priceis subject to future adjustments upon the occurrence of certain events. Upon either (i) the closing of a qualified initial public offering of the Company’s common stock resulting in at least $100,000,000 in proceeds net of the underwritingdiscount and commissions; (ii) the closing of a transaction or series of transactions in which the Company’s outstanding shares of capital stock are exchanged for or converted into securities that are publicly listed on a securitiesexchange through a merger, acquisition, business combination or similar transaction with a “special purpose acquisition company” where the surviving or parent entity receives aggregate gross proceeds, excluding the cash resources of theCompany, of at least $100,000,000;

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

5. Redeemable Convertible Preferred Stock (Continued)

 

or (iii) the date and time, or the occurrence of an event, specified by vote or written consent of the requisite holders and the Series B requisite holders, then all outstanding shares ofpreferred stock shall automatically be converted into shares of common stock at the effective conversion rate.

The Companyevaluated the Series B preferred stock and determined that it was considered an equity host under ASC 815. In making this determination, the Company’s analysis followed the whole instrument approach, which compares an individual feature againstthe entire Series B preferred stock instrument that includes that feature. The Company’s analysis was based on a consideration of the economic characteristics and risks of the Series B preferred stock. More specifically, the Company evaluatedall of the stated and implied substantive terms and features, including (i) whether the Series B preferred stock included redemption features, (ii) how and when any redemption features could be exercised, (iii) whether the holders ofthe Series B preferred stock were entitled to dividends, (iv) the voting rights of the Series B preferred stock, and (v) the existence and nature of any conversion rights. The Company concluded that, as the Series B preferred stockrepresents an equity host, the conversion feature included in the Series B preferred stock is clearly and closely related to the associated host instrument. Accordingly, the conversion feature is not considered an embedded derivative that requiresbifurcation.

The Company accounts for potentially beneficial conversion features under ASC Topic 470-20. At the time of the issuances of the shares of Series B preferred stock, the Company’s common stock into which the Company’s Series B preferred stock was convertible had an estimated fair value lessthan the effective conversion prices of the shares of Series B preferred stock. Therefore, there was no beneficial conversion element on the issuance dates.

Redemption

The holders of the Company’s redeemable convertible preferred stock have no rights to cause the redemption of their sharesoutside of a deemed liquidation event. A deemed liquidation event would constitute a redemption event that may be outside of the Company’s control.

Any redemption is deemed to be remote at December 31, 2020 and September 30, 2021, and the fair value of Series Bpreferred stock is deemed to be the price paid by the Series B preferred stockholders.

Due to this redemption option,Series B preferred stock is recorded in mezzanine equity and is subject to subsequent measurement under the guidance provided under ASC 480. In accordance with that guidance, the Company has elected to recognize changes in redemption valueimmediately.

However, based on the nature of Series B preferred stock, no subsequent measurement will be recognized untila Deemed Liquidation Event becomes probable. As of December 31, 2020 and September 30, 2021, a Deemed Liquidation Event was not probable; as a result, the Series B preferred stock is valued at original issue price, less cost of issuance, andthe value is allocated to the warrant derivative liabilities discussed further below.

Warrant Derivative Liabilities

In connection with the Series B preferred stock, the Company issued freestanding detachable stock purchase warrants to anunrelated third party to separately purchase 386,271 shares of common stock (the 2021 Warrants). The 2021 Warrants are exercisable in whole immediately prior to an initial public offering by the Company and, as such, remain issued, outstanding, andexercisable at September 30, 2021. The 2021 Warrants were issued with

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

5. Redeemable Convertible Preferred Stock (Continued)

 

an initial exercise price of $0.01 and an expiration date of May 13, 2029. The 2021 Warrants qualify as derivative liabilities, which must be accounted for separately from the Series Bpreferred stock and are measured at fair value on a recurring basis. At September 30, 2021, the 2021 Warrants were valued at $866,255 with the change in fair value from the date of issuance included in the condensed statements of operations andcomprehensive loss in the period the change occurs.

6. Stockholders’ Deficit and Stock-Based Compensation

Common stock

The voting, dividend, and liquidation rights of the holders of common stock are subject to and qualified by the rights, powers,and preferences of the holders of the Series A and Series B preferred stock. During the nine months ended September 30, 2021, the Company authorized additional shares of common stock in conjunction with the Series B preferred stock offeringresulting in a total of 95,000,000 authorized shares of common stock at September 30, 2021.

The Company’s commonstock has the following characteristics:

Voting

The holders of the common stock are entitled to one vote for each share of common stock. However, except as otherwise requiredby law, holders of common stock are not entitled to vote on any amendment to the certificate of incorporation that relates solely to the terms of one or more outstanding series of preferred stock if the holders of such affected series are entitled,either separately or together with the holders of one or more other such series, to vote thereon pursuant to the certificate of incorporation or pursuant to Delaware General Corporation Law.

Dividends

The holders of common stock are entitled to receive dividends, if and when declared by the Board of Directors. The Company maynot declare or pay any cash dividends to the holders of common stock unless, in addition to obtaining any necessary consents, dividends are paid on the Series A preferred stock in accordance with the respective terms. No dividends have been declaredor paid since inception of the Company.

Liquidation

In the event of any voluntary or involuntary liquidation, dissolution, or winding-up ofthe Company, the holders of common stock are entitled to share ratably with the holders of the Series A preferred stock in the Company’s assets available for distribution to stockholders after payment to the holders of the Series A preferredstock of their liquidation preferences has been made.

Stock Options

As of December 31, 2020 and September 30, 2021, options to purchase common stock were outstanding under the Company’s2019 Stock Option Plan (the 2019 Plan). The Company has reserved up to 11,742,926 shares of its common stock under the 2019 Plan for grants in the form of incentive stock options and nonqualified stock options to employees, consultants, anddirectors. As of December 31, 2020 and September 30, 2021, a total of 3,976,000 and 4,888,944, respectively, options were available for issuance under the 2019 Plan. The option pool was increased by the Company’s Board of Directors duringthe nine months ended September 30, 2021.

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

6. Stockholders’ Deficit and Stock-Based Compensation (Continued)

 

The following is a summary of the Company’s stock option activity underits 2019 Plan:

 

   Shares   Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Life (Years)
 

Options outstanding at January 1, 2020

   225,734   $0.27    9.75 

Options granted

            

Options exercised

            

Options forfeited

            
  

 

 

   

 

 

   

 

 

 

Options outstanding at September 30, 2020

   225,734    .27    9.00 

Options granted

            

Options exercised

            

Options forfeited

            
  

 

 

   

 

 

   

 

 

 

Options outstanding at December 31, 2020

   225,734    0.27    8.75 

Options granted

   6,829,260    1.20    9.20 

Options exercised

   1,796,335    .75     

Options forfeited

   201,012         
  

 

 

   

 

 

   

 

 

 

Options outstanding at September 30, 2021

   5,057,647   $1.34    9.10 
  

 

 

   

 

 

   

 

 

 

As of December 31, 2020 and September 30, 2021, there were 91,918 and 465,696 options vestedand exercisable, respectively. Unrecognized compensation cost related to stock option awards of $28,101 and $5,955,480, as of December 31, 2020 and September 30, 2021, respectively, is expected to be recognized as expense over a weighted averageperiod of 1.8 and 3.4 years, respectively. The total fair value of options vested was $15,891 and $1,611,258 at December 31, 2020 and September 30, 2021, respectively.

Outstanding stock options, if not exercised, expire ten years from the date of grant. The Company issues new shares of commonstock upon exercise of stock options. The weighted average grant date fair value per share for the outstanding options at September 30, 2021 was $1.34.

The Company determined the grant-date fair value of stock options using the Black-Scholes option pricing model. The fair valueof each stock option grant was determined using assumptions that are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with a term equivalent to the option. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available.The peer group was developed based on companies in the therapeutics and pharmaceutical industries. The expected term of stock options represents the weighted average period that the stock options are expected to be outstanding. Because the Companydoes not have historical exercise behavior, it determined the expected life assumption using the simplified method, which is an average of the options ordinary vesting period and the contractual term. The expected dividend assumption was based onthe Company’s history and expectation of dividend payouts at the time of grant. The Company recognizes forfeitures on an actual basis and, as such, did not estimate forfeitures to calculate stock-based compensation.

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

6. Stockholders’ Deficit and Stock-Based Compensation (Continued)

 

The following table presents the weighted average assumptions used in theBlack-Scholes option pricing model to determine the fair value of stock options granted during the nine months ended September 30, 2021:

 

Exercise price

  $1.34 

Stock price on date of grant

   1.34 

Expected term (years)

   9.1 

Expected stock price volatility

   94.16

Risk-free rate of interest

   0.17

Expected dividend yield

   

There is a high degree of subjectivity involved when using option-pricing models to estimatestock-based compensation. There are currently no market-based mechanisms or other practical applications to verify the reliability and accuracy of the estimates stemming from these models, nor is there a means to compare and adjust the estimates toactual values. Although the fair value of the employee stock-based awards is determined using an option-pricing model, the value may not be indicative of the fair value that would be observed in a market transaction between a willing buyer and awilling seller. If factors change and the Company employs different assumptions when valuing its options, the compensation expense that the Company records in the future may differ significantly from what it has historically reported.

7. Income Taxes

TheCompany did not record a current or deferred income tax expense or benefit for the nine months ended September 30, 2020 and 2021, due to the Company’s net and comprehensive loss and increases in its deferred tax asset valuation allowance.

8. Net and Comprehensive Loss Per Share

The Company’s basic and diluted net loss per share for the nine months ended September 30, 2020 and 2021, was $3.88and $4.12, respectively.

Diluted net and comprehensive loss per share gives effect to all potentially dilutivesecurities, including shares issuable upon the exercise of outstanding freestanding detachable stock purchase warrants, redeemable convertible preferred stock, and stock options outstanding under the Company’s stock option plan. For the ninemonths ended September 30, 2020 and 2021, the Company has excluded the effects of all potentially dilutive shares, which include freestanding detachable stock purchase warrants to purchase common stock, redeemable convertible preferred stock,and outstanding common stock options, from the weighted average number of common stock as their inclusion would be anti-dilutive due to net and comprehensive loss. Therefore, the calculation of basic and diluted net comprehensive loss per share isthe same.

 

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Table of Contents

CinCor Pharma, Inc.

Notes to Condensed Financial Statements (Unaudited) (Continued)

8. Net and Comprehensive Loss Per Share (Continued)

 

The following weighted average common stock equivalents were excluded fromthe calculation of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect for the nine months ended:

 

   September 30  
   2020   2021 

Series A redeemable convertible preferred stock
(if converted)

   35,714,282    35,714,282 

Series B redeemable convertible preferred stock
(if converted)

       33,702,500 

2019 and 2021 warrants

   2,520,476    2,907,197 

Outstanding options exercisable

   54,296    1,112,290 

9. Related-Party Transactions

CinRx Pharma LLC and Subsidiaries (CinRx)

Certain former executives, employees and members of the Company’s Board of Directors, including the chief operatingofficer, are members of CinRx’s board of managers and/or have equity investments in CinRx, a biotechnology company. The Company receives business management services from CinRx from time to time as needed. During the nine months ended September30, 2020 and 2021, the Company recorded business management fees totaling $1,241,355 and $1,046,162, respectively. Business management fees of $303,715 and $449,431 is included in related party accounts payable at December 2020 and September 30,2021, respectively.

10. Subsequent Events

In October 2021, the Company entered into a Series B preferred stock agreement with certain investors, members of ourboard of directors and affiliates of members of our board of directors, pursuant to which the Company issued and sold to such investors an aggregate of 2,013,749 shares of Series B preferred stock at a purchase price of $4.00 per share for aggregategross proceeds of approximately $8,100,000.

 

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Table of Contents

             Shares

 

 

LOGO

Common Stock

PROSPECTUS

JointBook-Running Managers

 

MORGAN STANLEY JEFFERIES      EVERCORE ISI

Lead Manager

OPPENHEIMER & CO.

Until                , 2022 (25 days after the date of thisprospectus), all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting asunderwriters and with respect to their unsold allotments or subscriptions.

            , 2022


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PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution.

The following table indicates the expenses to be incurred in connection with the offering described in this registrationstatement, other than underwriting discounts and commissions, all of which will be paid by us. All amounts are estimated except the Securities and Exchange Commission, or SEC, registration fee, the Financial Industry Regulatory Authority, Inc., orFINRA, filing fee and the Nasdaq initial listing fee.

 

   Amount 

SEC registration fee

  $9,270 

FINRA filing fee

   15,500 

Nasdaq initial listing fee

   * 

Accountants’ fees and expenses

   * 

Legal fees and expenses

   * 

Blue sky fees and expenses

   * 

Transfer agent’s fees and expenses

   * 

Printing and engraving expenses

   * 

Miscellaneous

   * 
  

 

 

 

Total expenses

  $* 
  

 

 

 

 

*

To be provided by amendment

Item 14. Indemnification of Directors and Officers.

We are incorporated under the laws of the State of Delaware. Section 102 of the Delaware General Corporation Law permits acorporation to eliminate the personal liability of directors of a corporation to the corporation or its stockholders for monetary damages for a breach of fiduciary duty as a director, except where the director breached his duty of loyalty, failed toact in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit.

Section 145 of the Delaware General Corporation Law provides that a corporation has the power to indemnify a director,officer, employee or agent of the corporation and certain other persons serving at the request of the corporation in related capacities against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlements actually andreasonably incurred by the person in connection with an action, suit or proceeding to which he is or is threatened to be made a party by reason of such position, if such person acted in good faith and in a manner he reasonably believed to be in ornot opposed to the best interests of the corporation, and, in any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful, except that, in the case of actions brought by or in the right of the corporation, noindemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determinesthat, despite the adjudication of liability but in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or such other court shall deem proper.

As permitted by the Delaware General Corporation Law, our amended and restated certificate of incorporation and bylaws to bein effect upon the closing of this offering will provide that: (i) we are required to indemnify our directors to the fullest extent permitted by the Delaware General Corporation Law; (ii) we may, in our discretion, indemnify our officers,employees and agents as set forth in the Delaware General Corporation Law; (iii) we are required, upon satisfaction of certain conditions, to advance all expenses incurred by our directors in connection with certain legal proceedings;(iv) the rights conferred in the bylaws are not exclusive;


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and (v) we are authorized to enter into indemnification agreements with our directors, officers, employees and agents.

In connection with this offering, we expect to enter into indemnification agreements with each of our directors and executiveofficers that require us to indemnify them against expenses, judgments, fines, settlements and other amounts that any such person becomes legally obligated to pay (including with respect to a derivative action) in connection with any proceeding,whether actual or threatened, to which such person may be made a party by reason of the fact that such person is or was a director or officer of us or any of our affiliates, provided such person acted in good faith and in a manner such personreasonably believed to be in, or not opposed to, our best interests. The indemnification agreements will also set forth certain procedures that will apply in the event of a claim for indemnification thereunder. We intend to enter into similarindemnification agreements with our executive officers prior to the completion of this offering. At present, no litigation or proceeding is pending that involves any of our directors or officers regarding which indemnification is sought, nor are weaware of any threatened litigation that may result in claims for indemnification.

We maintain a directors’ andofficers’ liability insurance policy. The policy insures directors and officers against unindemnified losses arising from certain wrongful acts in their capacities as directors and officers and reimburses us for those losses for which we havelawfully indemnified the directors and officers. The policy contains various exclusions.

In addition, the underwritingagreement filed as Exhibit 1.1 to this Registration Statement provides for indemnification by the underwriters of us and our officers and directors for certain liabilities arising under the Securities Act, or otherwise. Our amended and restatedinvestors’ rights agreement with certain investors also provides for cross-indemnification in connection with the registration of our common stock on behalf of such investors.

Item 15. Recent Sales of Unregistered Securities.

The following list sets forth information regarding all unregistered securities sold by us since our inception in March 2018through the date of the prospectus that forms a part of this registration statement.

Issuances of Capital Stock

In March 2018 and May 2019, we issued an aggregate of 4,250,000 shares of our common stock to CinRx Pharma, LLC at a purchaseprice of $0.00001 per share, for aggregate consideration of $42.50.

In May 2019 and August 2020, we issued an aggregateof 35,714,282 shares of our Series A preferred stock to Sofinnova Venture Partners X, L.P., Sofinnova Capital IX, 5AM Ventures VI, L.P. and CinRx Pharma, LLC at a purchase price of $1.40 per share, for aggregate consideration of approximately$50.0 million.

In September 2021 and October 2021, we issued and sold an aggregate of 35,716,249 shares of ourSeries B preferred stock to 22 investors at a purchase price of $4.00 per share, for aggregate consideration of approximately $142.9 million.

Issuances Pursuant to our Equity Plans

From our inception in March 2018 through the date of this registration statement, we granted options under our 2019 StockOption Plan to purchase an aggregate of                  shares of common stock, at a weighted average exercise price of                 per share, to our employees and consultants. Of these,                 shares have been issued upon the exercise of options.

None of the foregoing transactions involved any underwriters,underwriting discounts or commissions, or any public offering. Unless otherwise specified above, we believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act (andRegulation D or Regulation S promulgated thereunder) or Rule 701 promulgated under Section 3(b) of the Securities Act as transactions by an issuer not involving any public offering or under benefit plans and contracts relating tocompensation as provided under Rule 701. The recipients of the securities in each of these transactions represented their intentions to acquire the securities for investment only and not with a view to or for sale in


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connection with any distribution thereof, and appropriate legends were placed on the share certificates issued in these transactions. All recipients had adequate access, through theirrelationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.

Issuance of Roche Warrant

In September 2021, we issued a warrant to purchase common stock to Roche Finance Ltd., or the Roche

Warrant, in connection with our Series B preferred stock financing, which is exercisable for 386,271 shares of our common stock at an exerciseprice of $0.01 per share. The Roche Warrant will automatically net exercise in whole immediately prior to the effectiveness of the registration statement of which this prospectus forms a part (assuming an initial public offering price of$             per share, which is the midpoint of the price range listed on the cover page of this prospectus).

Item 16. Exhibits and Financial Statement Schedules.

(a) Exhibits.

The exhibits listed below are filed as part of this registration.

 

Exhibit
Number

  

Description of Exhibit

  1.1*  Form of Underwriting Agreement.
  3.1  Amended and Restated Certificate of Incorporation of the Registrant (as amended and currently in effect).
  3.2  Amended and Restated Bylaws of the Registrant (currently in effect).
  3.3  Form of Amended and Restated Certificate of Incorporation of the Registrant (to be effective upon the closing of this offering).
  3.4  Form of Amended and Restated Bylaws of the Registrant (to be effective upon the closing of this offering).
  4.1  Amended and Restated Investors’ Rights Agreement, by and among the Registrant and certain of its stockholders, dated September 22, 2021.
  5.1*  Opinion of Cooley LLP.
10.1+  2019 Stock Option Plan.
10.2+*  2022 Equity Incentive Plan and Forms of Option Grant Notice and Agreement, Exercise Notice, Early Exercise Notice and Restricted Stock Award Notice.
10.3+*  2022 Employee Stock Purchase Plan.
10.4+  Form of Indemnification Agreement with Executive Officers and Directors.
10.5†  License Agreement, dated as of May 13, 2019, by and among the Registrant, F. Hoffman-La Roche Ltd and Hoffmann-La Roche Inc.
10.6  Amended and Restated Management Services Agreement, dated as of April 16, 2020, by and between the Registrant and CinRx Pharma, LLC.
23.1  Consent of Ernst & Young LLP, independent registered public accounting firm.
23.2*  Consent of Cooley LLP (included in Exhibit 5.1).
23.3  Consent of June Lee, M.D.
24.1  Power of Attorney (included on signature page).

 

+

Indicates management contract or compensatory plan.

Certain portions of this exhibit (indicated by asterisks) have been omitted because they are not materialand are the type that the Registrant treats as private or confidential.

*

To be filed by amendment.


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(b) Financial Statement Schedules.

Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or isshown in the financial statements or notes thereto.

Item 17. Undertakings.

The undersigned Registrant hereby undertakes to provide to the underwriters at the closing specified in the underwritingagreement, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers andcontrolling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is,therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successfuldefense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled bycontrolling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

The undersigned Registrant hereby undertakes that:

 

 (1) 

For purposes of determining any liability under the Securities Act, the information omitted from the form ofprospectus filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part ofthis Registration Statement as of the time it was declared effective.

 

 (2) 

For the purpose of determining any liability under the Securities Act, each post-effective amendment thatcontains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.


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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to besigned on its behalf by the undersigned, thereunto duly authorized in the City of Boston, Massachusetts, on this 17th day of December, 2021.

 

CINCOR PHARMA, INC.

 

By:

 

/s/ Marc de Garidel

 

Marc de Garidel

 

Chief Executive Officer

KNOW ALL BY THESE PRESENTS, that each person whose signature appears below herebyconstitutes and appoints Marc de Garidel and Mary Theresa Coelho, M.B.A., and each of them, as his or her true and lawful agents, proxies and attorneys-in-fact, withfull power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to (i) act on, sign and file with the Securities and Exchange Commission any and all amendments (includingpost-effective amendments) to this registration statement together with all schedules and exhibits thereto and any subsequent registration statement filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, together with allschedules and exhibits thereto, (ii) act on, sign and file such certificates, instruments, agreements and other documents as may be necessary or appropriate in connection therewith, (iii) act on and file any supplement to any prospectusincluded in this registration statement or any such amendment or any subsequent registration statement filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, and (iv) take any and all actions which may be necessary orappropriate to be done, as fully for all intents and purposes as he might or could do in person, hereby approving, ratifying and confirming all that such agent, proxy andattorney-in-fact or any of his substitutes may lawfully do or cause to be done by virtue thereof.

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the followingpersons in the capacities and on the dates indicated.

 

Signature

  

Title

 

Date

/s/ Marc de Garidel

Marc de Garidel

  

Chief Executive Officer and Director

(Principal Executive)

 December 17, 2021

/s/ Mary Theresa Coelho, M.B.A.

Mary Theresa Coelho, M.B.A.

  

Chief Financial Officer and Chief Business Development Officer

(Principal Financial Officer and Principal Accounting Officer)

 December 17, 2021

/s/ James I. Healy, M.D., Ph.D.

James I. Healy, M.D., Ph.D.

  Director and Chairman of the Board December 17, 2021

/s/ David Allison, Ph.D.

David Allison, Ph.D.

  Director December 17, 2021

/s/ Maina Bhaman, M.B.A.

Maina Bhaman, M.B.A.

  Director December 17, 2021

/s/ Troy Ignelzi

Troy Ignelzi

  Director December 17, 2021

/s/ Jason Pitts, Ph.D.

Jason Pitts, Ph.D.

  Director December 17, 2021

/s/ John F. Thero

John F. Thero

  Director December 17, 2021
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