As filed with the U.S. Securities and Exchange Commission onAugust 15, 2022.

Registration No. 333-         

UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT 

Under 

The Securities Act of 1933

NuvectisPharma, Inc. 

(Exact name of Registrant as specifiedin its charter)

1 Bridge Plaza 

Suite 275 

Fort Lee, NJ, 07024

(201) 614-3150 

(Address, including zip code, and telephone number, including area code, ofregistrant’s principal executive offices)

Ron Bentsur,M.B.A.

Chairman and Chief Executive Officer 

Nuvectis Pharma, Inc. 

1 Bridge Plaza 

Suite 275 

Fort Lee, NJ, 07024

(201) 614-3151 

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

Copyto: 

MatthewW. Mamak 

Alston &Bird LLP 

90 ParkAvenue 

New York,NY 10016 

(212) 210-1256

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

If any of the securities being registered on this formare to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box.x

If this Form is filed to register additional securitiesfor an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Actregistration statement number of the earlier effective registration statement for the same offering. ¨

If this Form is a post-effective amendment filedpursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statementnumber of the earlier effective registration statement for the same offering. ¨

If this Form is a post-effective amendment filedpursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration number ofthe earlier effective registration statement for the same offering. ¨

Indicate by check mark whether the registrant is alarge accelerated filer, an accelerated filer, a non-accelerated filer, or a 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.

If an emerging growthcompany, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any newor revised financial accounting ¨

The Registrant hereby amends this Registration Statement on such date ordates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states thatthis Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933,as amended, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, actingpursuant to said Section 8(a), may determine.

The informationin this preliminary prospectus is not complete and may be changed. Neither we nor the selling security holders may sell these securitiesuntil the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not anoffer to sell these securities, and it is not soliciting offers to buy these securities in any jurisdiction where the offer or sale isnot permitted.

PRELIMINARY PROSPECTUS         SUBJECT TO COMPLETION DATEDAUGUST    , 2022

1,015,598 Shares of Common Stock 

Up to 909,091 Shares of Class Common StockIssuable Upon Exercise of the Pre-Funded Warrants 

Up to 2,040,170 Shares of Class CommonStock Issuable Upon Exercise of the Preferred Investment Options

NuvectisPharma, Inc.

This prospectus relatesto the offer and resale from time to time by the selling securityholders named in this prospectus (the “Selling Shareholders”)of shares of common stock, par value $0.00001 per share (“Common Stock”) of Nuvectis Pharma, Inc., a Delaware corporation(“Nuvectis”, the “Company”, “we”, “us” or “our) consisting of (i) up to: 1,015,598shares of our Common Stock issued in connection with our private placement offering (the “Shares”); (ii) up to 2,040,170shares of Common Stock that may be obtained upon the exercise of preferred investment options to purchase shares of Common Stock (the “Investment Options”); and (iii) up to 909,091 pre-funded warrants to purchase shares of Common Stock issued in a privateplacement (the “Pre-Funded Warrants”).

We will not receiveany proceeds from the sale of the securities under this prospectus, although we could receive up to $19,765,056 upon the exercise of allof the Investment Options and Pre-Funded Warrants. Any amounts we receive from such exercises will be used for working capital and othergeneral corporate purposes.

Information regardingthe Selling Shareholders, the amounts of shares of Common Stock that may be sold by them and the times and manner in which they may offerand sell the shares of common stock under this prospectus is provided under the sections titled “Selling Shareholders” and “Plan of Distribution,” respectively, in this prospectus. We have not been informed by any of the Selling Shareholders thatthey intend to sell the common stock covered by this prospectus and do not know when or in what amount the Selling Shareholders may offerthe common stock for sale. The Selling Shareholders may sell any, all, or none of the common stock offered by this prospectus.

Our Common Stock islisted on the Nasdaq Capital Market under the symbol “NVCT”. On August 12, 2022, the last reported sale price of our commonstock was $8.71 per share.

We are an “emerginggrowth company” and a “smaller reporting company” as defined under the U.S. federal securities laws and, as such, haveelected to comply with certain reduced reporting requirements.

Investing in ourcommon stock involves a high degree of risk. See “Risk factors” beginning on page 8.

Neither the Securitiesand Exchange Commission nor any other state securities commission has approved or disapproved of these securities or passed upon the accuracyor adequacy of this prospectus. Any representation to the contrary is a criminal offense.

You should rely only on the informationcontained in this prospectus. We have not authorized any dealer, salesperson or other person to provide you with information concerningus, except for the information contained in this prospectus. The information contained in this prospectus is complete and accurate onlyas of the date on the front cover page of this prospectus, regardless of the time of delivery of this prospectus or the sale of anysecurities. This prospectus is not an offer to sell these securities and we are not soliciting an offer to buy these securities in anystate where the offer or sale is not permitted.

The date of this prospectus isAugust 15, 2022.

Table of Contents

About this Prospectus

In this prospectus, unless the context suggestsotherwise, references to “Nuvectis Pharma,” “Nuvectis,” the “Company,” “we,” “us”and “our” refer to Nuvectis Pharma, Inc.

This prospectus ispart of a registration statement on Form S-1 that we filed with the Securities and Exchange Commission (the “SEC”). Underthis registration process, the Selling Shareholders may, from time to time, sell the securities offered by them described in this prospectusthrough any means described in the section titled “Plan of Distribution”. We will not receive any proceeds from the sale bysuch Selling Holders of the securities offered by them described in this prospectus. This prospectus also relates to the issuance by usof the shares of Common Stock issuable upon the exercise of any Investment Option or Pre-Funded Warrant. We will receive proceeds fromany exercise of the Investment Options and Pre-Funded Warrants for cash.

Neither we nor theSelling Shareholders have authorized anyone to provide you with any information or to make any representations other than those containedin this prospectus or any applicable prospectus supplement or any free writing prospectuses prepared by or on behalf of us or to whichwe have referred you. Neither we nor the Selling Shareholders take responsibility for and can provide no assurance as to the reliabilityof, any other information that others may give you. Neither we nor the Selling Shareholders will make an offer to sell these securitiesin any jurisdiction where the offer or sale is not permitted.

We may also providea prospectus supplement or post-effective amendment to the registration statement to add information to, or update or change informationcontained in, this prospectus. Any statement contained in this prospectus will be deemed to be modified or superseded for purposes ofthis prospectus to the extent that a statement contained in such prospectus supplement or post-effective amendment modifies or supersedessuch statement. Any statement so modified will be deemed to constitute a part of this prospectus only as so modified, and any statementso superseded will not be deemed to constitute a part of this prospectus. You should read both this prospectus and any applicable prospectussupplement or post-effective amendment to the registration statement together with the additional information to which we refer you inthe section of this prospectus titled “Where You Can Find More Information.”

Preclinically, NXP900 has been shown toinhibit SRC and YES1 kinases and substantially inhibit growth of primary tumors and bone metastases in several triple negative breastcancer (“TNBC”) animal models.

We plan to initially develop NXP900 in solidtumors where SRC and/or YES1 are implicated. We anticipate submitting an IND or an equivalent submission with a foreign agency in early2023.

Since our inception in 2020, we have devotedall of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, acquiring, discoveringproduct candidates and securing related intellectual property rights and conducting research and development activities for our programs.We do not have any products approved for sale and have not generated any revenue from product sales. We may never be able to develop orcommercialize a marketable product. We have not yet successfully completed any pivotal clinical trials, obtained any regulatory approvals,manufactured a commercial-scale drug, or conducted sales and marketing activities.

Our Strategy

Our strategy is to build a global biopharmaceuticalcompany through the identification, development, and commercialization of therapeutics to address unmet medical needs in oncology withan initial focus on patients with OCCC and endometrioid ovarian cancers. We intend to leverage our core competencies of target selection,drug profiling and clinical and regulatory execution to build a pipeline of product candidates targeting cancers driven by genetic alterations.The key elements driving our business strategy include:

Risk Factors

Aninvestment in our Common Stock is subject to a broad range of risks and should only be made after a careful consideration of suchrisks. For a discussion of some of the risks you should consider before purchasing our Common Stock, you are urged to carefullyreview and consider the section entitled “Risk Factors.”

Recent Developments

Private Placement of Shares of Common Stock, PreferredInvestment Options, and Pre-Funded Warrants

On July 27, 2022, we entered into definitive agreements for the issuance and sale in a private placement (the “Private Placement”)of 1,015,598 shares of its common stock, par value $0.00001 (the “Common Stock”) and pre-funded warrants to purchase up toan aggregate of 909,091 shares of Common Stock at a purchase price of $8.25 per share, referred to as the Pre-Funded Warrants. The investorsin the Private Placement also received preferred investment options to purchase up to an aggregate of 1,924,689 shares of Common Stock,referred to as the Investor Investment Options. The Investor Investment Options will have an exercise price of $9.65, will become exercisablecommencing six months following the date of issuance and will have a term of three and one-half years from the date of issuance.

The Private Placement closed on July 29, 2022. Grossproceeds to the Company from the Private Placement are approximately $15.9 million. The Company intends to use the net proceeds from thePrivate Placement for working capital and other general corporate purposes. See “Use of Proceeds.”

In connection with the Private Placement, the Company enteredinto a registration rights agreement (the “Registration Rights Agreement”) with the Selling Shareholders. Pursuant to theRegistration Rights Agreement, the Company is required to file a resale registration statement (the “Registration Statement”)with the Securities and exchange Commission (the “SEC”) to register for resale of the Shares, the shares issuable upon exerciseof the Pre-Funded Warrants and the Investment Options (as defined below) by August 15, 2022. Pursuant to the Registration RightsAgreement, the Registration Statement shall be declared effective within 45 days after July 27, 2022, or in the event of a full reviewby the SEC, 75 days from July 27, 2022. The Company will be obligated to pay certain liquidated damages to the investor if the Companyfails to file the resale registration statement when required, fails to cause the Registration Statement to be declared effective by theSEC when required, of if the Company fails to maintain the effectiveness of the Registration Statement.

H.C. Wainwright & Co. (“Wainwright) actedas the placement agent in connection with the Private Placement. Pursuant to the engagement agreement, Wainwright was paid a cash feeequal to 7% of the gross proceeds and a management fee of 1% of the gross proceeds. The Company also paid Wainwright $85,000 for non-accountableexpenses. As part of their compensation, certain designees of Wainwright received preferred investment options to purchase up to an aggregateof 115,481 shares of Common Stock, referred to as the Placement Agent Investment Options (and together with the Investor Investment Options,the “Investment Options”). The Placement Agent Investment Options have an exercise price of $10.3125, per share will becomeexercisable commencing six months following the date of issuance and have a term of three and one-half years from the date of issuance.

Risk Factors

Risk Factors

Investing in our Common Stock involvesa high degree of risk. You should consider carefully the risks and uncertainties described below, together with all of the other informationin this prospectus, including the section titled “Management’s Discussion and Analysis of Financial Condition and Resultsof Operations” and our financial statements and related notes, before making a decision to invest in our Common Stock. Our business,results of operations, financial condition and prospects could also be harmed by risks and uncertainties that are not presently knownto us or that we currently believe are not material. If any of the risks actually occur, our business, platform, reputation, brand, resultsof operations, financial condition and prospects could be materially and adversely affected. In such event, the market price of our CommonStock could decline, and you could lose all or part of your investment.

Risks Related to Our Finances and Capital Requirements

Our limited operating historymay make it difficult for you to evaluate the success of our business to date and to assess our future viability.

We are a clinical stage biopharmaceuticalcompany with a limited operating history. We were incorporated in Delaware in July 2020 and commenced operations in May 2021.Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, identifying, investigating,licensing and evaluating potential product candidates, and establishing arrangements with third parties for the manufacture of initialquantities of our lead product candidate and component materials. Our lead product candidate is in early clinical development, and oursecond drug candidate is in preclinical development. We have not yet demonstrated our ability to successfully initiate, conduct or completeany clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf,or conduct sales, marketing and distribution activities necessary for successful product commercialization. Consequently, any predictionsabout our future success or viability may not be as accurate.

We will need to transition at some pointfrom a company with a research and development focus to a company capable of supporting commercial activities related to the full productlife cycle. We may not be successful in such a transition.

We have incurred losses sinceinception and anticipate that we will continue to incur losses for the foreseeable future. We may never achieve or maintain profitability.

Investment in biopharmaceutical productdevelopment is a highly speculative undertaking and entails substantial upfront capital expenditures and significant risk that our currentor potential future product candidates will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approvaland become commercially viable. We are still in the early stages of development of our product candidates and initiated our first clinicaltrial in December 2021. We have no products approved for commercial sale and have not generated any revenue from product sales todate. We continue to incur significant research and development and other expenses related to our ongoing operations. In addition, asa business with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other knownand unknown factors, such as the COVID-19 pandemic.

We have incurred losses in each periodsince we commenced operations. Since inception through the end of June 30, 2022, we had an accumulated deficit of $19.4 million.Those losses mainly include the following: (1), $6.3 million in research and development expenses excluding licensing agreements, (2) inconnection with the exclusive licensing agreement related to our lead product candidate, NXP800, we paid an upfront payment of $3.5 million,and (3) in connection with the exclusive licensing agreement related to NXP900, we also paid an upfront payment of $3.5 million.We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase substantially ifand as we continue our research and development efforts and submit IND applications for our lead product candidate; conduct preclinicalstudies and clinical trials for our current and future product candidates; seek marketing approvals for any current or future productcandidate that successfully completes clinical trials; experience any delays or encounter any issues with any of the above; establisha sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any current or future productcandidates for which we may obtain regulatory approval; obtain, expand, maintain, enforce and protect our intellectual property portfolio;hire additional clinical, regulatory and scientific personnel; and operate as a public company.

Risk Factors

Our lead product candidate, NXP800, is in clinical developmentand our second product candidate, NXP900, is in the preclinical stage of development. Both product candidates will require additionalpreclinical studies, clinical development, regulatory review and approval, substantial investment, access to sufficient clinical and commercialmanufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. The Phase 1 study forNXP800 started in December 2021 and NXP900 has yet to enter clinical trials. To date, we have not generated any revenue from ourproduct candidates. Our ability to generate revenue will depend on a number of factors, including, but not limited to:

Many of the factors listed above arebeyond our control and could cause us to experience significant delays or prevent us from obtaining regulatory approvals or commercializingour current and future product candidates. Even if we can commercialize any current or future product candidates, we may not achieve profitabilitysoon after generating product sales, if ever.

Risk Factors

We will require substantialadditional funding. Raising additional capital may cause dilution to our existing stockholders, or require us to relinquish proprietaryrights. If we are unable to raise capital as needed, we may be compelled to delay, reduce or eliminate our product development programsor commercialization efforts.

We expect our expenses to increase inparallel with our ongoing activities, particularly as we continue our discovery and preclinical development activities to identify newproduct candidates and initiate clinical trials of, and seek marketing approval for, any of our current or future product candidates.In addition, if we obtain marketing approval for any of our current or future product candidates, we expect to incur significant commercializationexpenses related to product sales, marketing, manufacturing, and distribution. Furthermore, we expect to incur significant additionalcosts associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connectionwith our continuing operations. We cannot be certain that additional funding will be available on acceptable terms, or at all. Until suchtime, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of public orprivate equity offerings, debt financings, governmental funding, collaborations, strategic partnerships and alliances or marketing, distributionor licensing arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertibledebt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferencesthat adversely affect your rights as a stockholder. Debt financing and preferred equity financing, if available, may involve agreementsthat include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capitalexpenditures or declaring dividends.

If we raise additional funds throughcollaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that maynot be favorable to us.

If we are unable to raise capital whenneeded or on attractive terms, we could be forced to delay, reduce or eliminate our discovery and preclinical development programs orany future commercialization efforts.

Major public health issues, andspecifically the pandemic caused by the coronavirus COVID-19 outbreak, could have an adverse effect on our clinical trials, financialcondition, results of operations, and other aspects of our business.

In March 2020, the World HealthOrganization declared the outbreak of COVID-19 to be a pandemic. The COVID-19 pandemic is having widespread, rapidly evolving, and unpredictableimpacts on global society, economies, financial markets, and business practices. During 2021, there was a wide distribution of severalvaccinations and medicines to overcome the pandemic. We have shifted our operations to co-exist along with the pandemic, including encouragementof vaccinations to all of our employees worldwide.

The uncertainty to which the COVID-19pandemic impacts the Company’s business, affects management’s judgment and assumptions relating to accounting estimates ina variety of areas that depend on these estimates and assumptions. COVID-19 did not have a material influence on these estimates and judgementssince the Company began operations in 2021.

The Company continues to face relativeuncertainty as to the remaining intensity and duration of and the nature and timeline for recovery from the COVID-19 pandemic going forwardand how all of that impacts the Company, including the extent to which potentially permanent changes clinical trial operations have beencaused by the pandemic. The Company has taken the approach of managing the pandemic (to the extent that it continues to remain a significantfactor) via strengthening its balance sheet and cash assets and avoiding debt while focusing on cost controls. Some factors from the COVID-19outbreak or any outbreak caused by any variant of COVID-19 that may delay or otherwise adversely affect our clinical trial programs, aswell as adversely impact our business generally, include:

Risk Factors

We currently rely on third parties forcertain functions or services in support of our clinical trials and key areas of our operations. If these third parties themselves areadversely impacted by restrictions resulting from the COVID-19 outbreak, we will likely experience delays and/or realize additional costs.As a result, our ability to commence and complete clinical trials in timely fashion, obtain regulatory approvals for, and to commercialize,our current and future product candidates may be delayed or disrupted.

Risks Related to the Developmentof our Product Candidates

Our discovery and preclinicaldevelopment approach focuses on the development of precision medicines for patients with genetically defined cancers and may never leadto marketable products.

The patient populations for our productcandidates and potential future product candidates are limited to those with specific target mutations and may not be completely definedbut are substantially smaller than the general treated cancer population and we will need to screen and identify these patients with thetargeted mutations. Successful identification of patients is dependent on several factors, including achieving certainty as to how specificgenetic alterations respond to our current product candidates or any future product candidate and, if necessary, developing companiondiagnostics to identify such genetic alterations. Furthermore, even if we are successful in identifying patients, we cannot be certainthat the resulting patient populations for each mutation will be large enough to allow us to successfully obtain approval for each mutationtype and commercialize our products and achieve profitability. In addition, even if our approach is successful in showing clinical benefitby downregulating the HSF1 pathway in tumors harboring an ARID1a mutation or alteration, we may never successfully identify additionaloncogenic mutations for other genes. We do not know if our approach of treating patients with genetically defined cancers will be successful;and if our approach is unsuccessful, our business will suffer.

We are very early in our developmentefforts and are substantially dependent on our lead product candidate, NXP800. If we are unable to advance NXP800, NXP900 or any of ourother future product candidates through preclinical and clinical development, obtain regulatory approval and ultimately commercializeNXP800, NXP900 or any of our other future product candidates, or experience significant delays in doing so, our business will be materiallyharmed.

NXP800, our lead product candidate,only recently started to be tested in human subjects. Our ability to generate product revenues will depend heavily on the successful clinicaldevelopment and eventual commercialization of NXP800 or future product candidates. Our second drug candidate, NXP900, has begun IND-enablingstudies or similar studies required by a foreign regulatory agency. Depending on the results of these IND-enabling studies, we may notbe able to submit an IND application with the FDA or a similar submission with a foreign regulatory agency and, therefore, may not beable to conduct clinical trials for NXP900. In addition, our drug development programs may contemplate the development of companion diagnostics,which are assays or tests to identify an appropriate patient population. Companion diagnostics are subject to regulation as medical devicesand must themselves receive marketing authorization from the FDA or certain other foreign regulatory agencies before they may be marketed.If a companion diagnostic is essential to the safe and effective use of any of our current and future product candidates, the FDA mustconclude that the companion diagnostic meets the applicable standard for safety and effectiveness or for substantial equivalence for usewith our product candidates before either the product candidates or companion diagnostic may be marketed in the United States.

Risk Factors

Negative results in the development of our lead product candidatemay also prevent or delay our ability to continue or conduct clinical programs or receive regulatory approvals for our other future productcandidates. For example, although we believe, based on preclinical studies of OCCC models that demonstrated tumor growth inhibition, thatthis cancer type might be particularly sensitive to NXP800, this may not prove true in clinical testing for any or all of the target indications.Moreover, anti-tumor activity may be different in each tumor type that we plan to evaluate in clinical trials. Therefore, even thoughwe plan to potentially pursue tumor-agnostic clinical development of NXP800, the tumor response may be low in patients with some cancerscompared to others. As a result, we may be required to discontinue development of NXP800 for patients with those tumor types and/or mutationsdue to insufficient clinical benefit, while continuing development in a more limited population of patients. Consequently, in order toobtain regulatory approval, we may have to reach agreement with the FDA on defining the optimal patient population, study design and size,any of which may require significant additional resources and delay our clinical trials and ultimately the approval, if any, of any ofour other future product candidates.

We may experience setbacks that coulddelay or prevent regulatory approval of, or our ability to commercialize, our current or future product candidates, including:

Risk Factors

In addition, because we have limitedfinancial and personnel resources and are focusing primarily on developing our lead product candidate, we may forgo or delay pursuit ofother future product candidates that may prove to have greater commercial potential and may fail to capitalize on viable commercial productsor profitable market opportunities. If we do not accurately evaluate the commercial potential or target market for a future product candidate,we may relinquish valuable rights to those future product candidates through collaboration, licensing, or other royalty arrangements incases in which it would have been more advantageous for us to retain sole development and commercialization rights to such future productcandidates.

Clinical drug development involvesa lengthy and expensive process with uncertain outcomes, clinical trials are difficult to design and implement, and any of our clinicaltrials could produce unsuccessful results or fail at any stage in the process.

Clinical trials conducted on humansare expensive and can take many years to complete, and outcomes are inherently uncertain. Failure can occur at any time during the process.Additionally, any positive results of preclinical studies and early clinical trials of a drug candidate may not be predictive of the resultsof later-stage clinical trials, such that drug candidates may reach later stages of clinical trials and fail to show the desired safetyand efficacy traits despite having shown indications of those traits in preclinical studies and early-stage clinical trials. A numberof companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy oradverse safety profiles, notwithstanding promising results in preclinical studies or earlier phases of clinical trials. Therefore, theresults of any future clinical trials we conduct may not be successful.

Clinical trials may be delayed, suspendedor prematurely terminated because costs are greater than we anticipate or for a variety of reasons, such as:

Risk Factors

We rely and plan to continue to relyon CROs, contract manufacturing organizations (“CMOs”) and clinical trial sites to ensure the proper and timely conduct ofour clinical trials. Although we have and expect that we will have agreements in place with CROs and CMOs governing their contracted activitiesand conduct, we will have limited influence over their actual performance. As a result, we ultimately do not and will not have controlover a CRO’s or CMO’s compliance with the terms of any agreement it may have with us, its compliance with applicable regulatoryrequirements, or its adherence to agreed-upon time schedules and deadlines, and a future CRO or CMO’s failure to perform those obligationscould subject any of our clinical trials to delays or failure.

Further, we may also encounter delaysif a clinical trial is suspended or terminated by us, by any IRB or ethics committee, by a Data Safety Monitoring Board, or by the FDAor European Medicines Agency (“EMA”), or other regulatory authority. A suspension or termination may be due to a number offactors, including failure to conduct the clinical trial in accordance with regulatory requirements, inspection of the clinical trialoperations or trial site by the FDA, EMA or other regulatory authorities, exposing participants to health risks caused by unforeseen safetyissues or adverse side effects, development of previously unseen safety issues, failure to demonstrate a benefit from using a drug candidate,or changes in governmental regulations or administrative actions. Therefore, we cannot predict with any certainty the schedule for commencementor completion of any currently ongoing, planned or future clinical trials.

Many of the factors that cause, or leadto, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of marketing approval for ourcurrent or future product candidates.

If we experience delays in the commencementor completion of, or suspension or termination of, any clinical trial for our drug candidates, the commercial prospects of the drug candidatecould be harmed, and our ability to generate product revenues from the drug candidate may be delayed or eliminated. In addition, any delaysin completing our clinical trials will increase our costs, slow down our drug candidate development and approval process and jeopardizeregulatory approval of our drug candidates and our ability to commence sales and generate revenues.

Risk Factors

The occurrence of any of these eventscould harm our business, financial condition, results of operations and prospects significantly.

Difficulty in enrolling patientscould delay or prevent clinical trials of our current or future product candidates.

Identifying and qualifying patientsto participate in clinical studies of our current or future product candidates is critical to our success. The timing of completion ofour clinical studies depends in part on the speed at which we can recruit patients to participate in testing our current or future productcandidates and we may experience delays in our clinical trials if we encounter difficulties in enrollment. Further, because we are focusedon patients with specific indications and genetic mutations, our ability to enroll eligible patients may be limited and may result inslower enrollment than we anticipate. Our clinical trials will compete with other clinical trials for current or future product candidatesthat are in the same therapeutic areas as our current or future product candidates, which may reduce the number and types of patientsavailable to us.

Clinical trials may be subject to delaysas a result of patient enrollment taking longer than anticipated or greater than anticipated subject withdrawal. We may not be able toinitiate or continue clinical trials for our current or future product candidates if we are unable to locate and enroll a sufficient numberof eligible patients to participate in these trials as required by the FDA or foreign regulatory authorities. We cannot predict how successfulwe will be at enrolling subjects in future clinical trials. The enrollment of patients depends on many factors, including:

If we are unable to locate and enrollsufficient eligible patients to participate, as required by the FDA or similar regulatory authorities, we may be unable to initiate orcontinue clinical trials for our current or future product candidates. If necessary, we intend to engage third parties to develop companiondiagnostics for use in our clinical trials. If such third parties are unsuccessful, our difficulty in identifying patients with the targetedgenetic mutations for our clinical trials would be increased. If we are unable to include patients with the targeted genetic mutationsor patients with well-defined serious unmet medical needs, we may be unable to participate in the FDA’s expedited review and developmentprograms, including breakthrough therapy designation and fast track designation, or otherwise seek to accelerate clinical developmentand regulatory timelines.

Risk Factors

Our preclinical studies and clinicaltrials may fail to demonstrate adequately the safety, potency, purity, efficacy or any other necessary pharmacological properties of anyof our current or future product candidates, which would prevent or delay development, regulatory approval and commercialization.

Before obtaining regulatory approvalsfor the commercial sale of our current or future product candidates, including NXP800 and NXP900, we must demonstrate through lengthy,complex and expensive preclinical studies and clinical trials that our current or future product candidates are both safe and effectivefor use in each target indication. Preclinical and clinical testing is expensive and can take many years to complete, and its outcomeis inherently uncertain. Failure can occur at any time during the preclinical study and clinical trial processes, and, because our currentproduct candidates are in an early stage of development, there is a high risk of failure.

The results of preclinical studies andearly clinical trials of our current or future product candidates may not be predictive of the results of later-stage clinical trials.Although product candidates may demonstrate promising results in preclinical studies and early clinical trials, they may not prove tobe effective in subsequent clinical trials. Additionally, while we initiated the first clinical trial for NXP800 in December 2021,clinical trials for any of our current or future product candidates, as is the case with all oncology drugs, it is likely that there maybe side effects associated with their use. Results of our trials could reveal a high and unacceptable severity and prevalence of theseor other side effects. In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authoritiescould order us to halt or cease further development of or deny approval of our current or future product candidates for any or all targetedindications. Drug-related side effects could also affect patient recruitment into the study or patient willingness to remain in the studyand therefore affect our ability to complete clinical trials. Drug-related side effects could also result in potential product liabilityclaims. Any of these occurrences may harm our business, financial condition and prospects significantly.

The FDA and comparable foreignregulatory authorities may not accept data from any preclinical or clinical trials we may conduct in foreign countries.

The FDA’s acceptance of data generatedfor patients recruited outside the United States from clinical trials conducted in whole or in part outside the United States may be subjectto certain conditions, if accepted at all.

Although the FDA has the authority toaccept foreign data as part or even the sole basis for marketing approval, the FDA generally does not approve an application on the basisof foreign data alone unless (i) the data is applicable to the U.S. population and U.S. medical practice, (ii) the trials wereperformed by clinical investigators of recognized competence and pursuant to GCP regulations, and (iii) the FDA’s clinicaltrial requirements were met. Many foreign regulatory authorities have similar approval requirements. In addition, any clinical study conductedin whole or in part outside of the United States would be subject to the applicable local laws of the jurisdiction where the trial wasconducted. We cannot guarantee that the FDA or comparable foreign regulatory authority will accept data from trials conducted in wholeor in part outside of the United States, which may result in the need for additional trials.

We may not be able to submit INDapplications to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit usto proceed.

Our CTA and IND for NXP800 with theMHRA and the FDA, respectively have been approved. However, if we experience manufacturing delays or any other delays, we may be unableto file additional CTAs, IND applications or other clinical research authorizations for other product candidates on our expectedtimelines. Moreover, while we have obtained CTA and IND approvals, we cannot be sure that issues will not arise that suspend or terminatesuch clinical trials. Any failure to file CTAs, IND applications or other clinical research authorizations will adversely impactour expected timelines to obtain regulatory acceptance for the commencement of our trials and may prevent us from completing our clinicaltrials or commercializing our products on a timely basis, if at all.

We currently have no marketingand sales organization and have limited experience in marketing products. If we are unable to establish marketing and sales capabilitiesor enter into agreements with third parties to market and sell any approved product candidates, we may not be able to generate productrevenue.

We will have to compete with other pharmaceuticaland biotechnology companies to recruit, hire, train and retain marketing and sales personnel. If we are unable or decide not to establishinternal sales, marketing, and distribution capabilities, we may pursue arrangements with third-party sales, marketing, and distributioncollaborators regarding the sales and marketing of our products, if approved.

Risk Factors

There can be no assurance that we willbe able to develop in-house sales and distribution capabilities or establish or maintain relationships with third-party collaboratorsto commercialize any product in the United States or overseas.

We face substantial competition,which may result in others discovering, developing or commercializing products before or more successfully than we do.

While we believe that our scientificknowledge, technology, and development expertise provide us with competitive advantages, we face potential competition from many differentsources, including major pharmaceuticals, specialty pharmaceuticals and biotechnology companies, academic institutions and governmentagencies, and public and private research institutes that conduct research, development, manufacturing, and commercialization. Many ofour competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing,regulatory approvals, and product marketing than we do. Our competitors may compete with us in recruiting and retaining qualified scientificand management personnel and establishing clinical trial sites and patient recruitment for clinical trials, as well as in acquiring technologiescomplementary to, or necessary for, our programs. As a result, our competitors may discover, develop, license, or commercialize productsearlier or more successfully than we do.

If our product candidates, NXP800 andNXP900, are approved for the indications for which we are currently conducting or planning preclinical and clinical trials, they willlikely compete with competitor drugs and other drugs that are currently in development. The availability of reimbursement from governmentand other third-party payors will also significantly affect the pricing and competitiveness of our products. Our competitors may alsoobtain FDA or other regulatory approval for their products more rapidly than we do, which could result in our competitors establishinga strong market position before we are able to enter the market.

Risks Related to Government Regulation

Denialof or delay in our receipt of required regulatory approvals may prevent or delay commercialization of our current or future product candidatesand our ability to generate revenue may be materially impaired.

The research, testing, manufacturing,labeling, approval, sale, marketing and distribution of drug products are, and will remain, subject to extensive regulation by the FDAin the United States and by the respective regulatory authorities in other countries where regulations differ. We will not be permittedto market our current or future product candidates in the United States until we receive the respective approval of an NDA from the FDA,or in any foreign countries until we receive the requisite approval from the respective regulatory authorities in such countries. Thetime required to obtain regulatory approval, if any, by the FDA, EMA and comparable foreign authorities is unpredictable, but typicallytakes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretionof the regulatory authorities and the type, complexity and novelty of the product candidates involved. Regulatory authorities have substantialdiscretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approvaland require additional nonclinical studies or clinical trials.

Obtaining regulatory approval requiresthe submission of extensive nonclinical and clinical data and supporting information to regulatory authorities for each therapeutic indicationto establish the product candidate’s safety and efficacy. Securing regulatory approval also requires the submission of informationabout the product manufacturing process, and in many cases the inspection of manufacturing, processing, and packaging facilities by theregulatory authorities. Our current or future product candidates may not be effective, may be only moderately effective or may prove tohave undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval orprevent or limit commercial use, or there may be deficiencies in cGMP compliance by us or by our CMOs that could result in the candidatenot being approved. Moreover, we have not obtained regulatory approval for any drug candidate in any jurisdiction and it is possible thatnone of our existing drug candidates or any drug candidates we may seek to develop in the future will ever obtain regulatory approval.

Risk Factors

Our drug candidates could fail to receive,or could be delayed in receiving, regulatory approval for many reasons, including any one or more of the following:

The time and expense of the approvalprocess, as well as the unpredictability of future clinical trial results and other contributing factors, may result in our failure toobtain regulatory approval to market NXP800, NXP900 or any other drug candidates we may seek to develop in the future, which would significantlyharm our business, results of operations and prospects. In such case, we may also not have the resources to conduct new clinical trialsand/or we may determine that further clinical development of any such drug candidate is not justified and may discontinue any such programs.

In addition, even if we were to obtainregulatory approval in one or more jurisdictions, regulatory authorities may approve any of our drug candidates for fewer or more limitedindications than we request, may not approve prices we may propose to charge for our products, may grant approval contingent on the performanceof costly post-marketing clinical trials (referred to as “conditional” or “accelerated” approval depending onthe jurisdiction), or may approve a drug candidate with a label that does not include the labeling claims necessary or desirable for thesuccessful commercialization of that drug candidate. Any of the foregoing circumstances could materially harm the commercial prospectsfor our drug candidates.

Risk Factors

Obtaining and maintaining regulatoryapproval of our current or future product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatoryapproval of our current or future product candidates in other jurisdictions.

Obtaining and maintaining regulatoryapproval of any of our current or future product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintainregulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may havea negative effect on the regulatory approval process in other jurisdictions. For example, even if the FDA grants regulatory approval ofa product candidate, similar foreign regulatory authorities must also approve the manufacturing, marketing and promotion of the productcandidate in those countries. Drug product approval procedures vary among jurisdictions and can involve requirements and administrativereview periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trialsas clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictionsoutside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction.In some cases, the price that we intend to charge for our products is also subject to approval.

We may also submit marketing applicationsin other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidateswith which we must comply prior to marketing in those jurisdictions. Obtaining similar foreign regulatory approvals and compliance withsimilar foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent theintroduction of our products in certain countries. We do not have any product candidates approved for sale in any jurisdiction, includinginternational markets, and we do not have experience in obtaining regulatory approval in international markets. If we fail to comply withthe regulatory requirements in international markets and/or receive applicable marketing approvals, our target market will be reducedand our ability to realize the full market potential of our current or future product candidates will be harmed.

Even if we receive regulatoryapproval of our current or future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review,which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirementsor experience unanticipated problems with our current or future product candidates.

If any of our current or future productcandidates are approved, activities such as the manufacturing, labeling, packaging, storage, advertising, promotion, sampling, and recordkeeping for the products will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safetyand other post-marketing information and reports, registration, as well as ongoing compliance with cGMP regulations. Drug manufacturersand any CMOs responsible for any product manufacturing processes are required to comply with extensive FDA and comparable foreign regulatoryauthority requirements, including ensuring that quality control and manufacturing procedures conform to cGMP regulations and any applicableforeign equivalents. As such, we and our CMOs will be subject to continual review and inspections to assess compliance with cGMP and adherenceto commitments made in any NDA, other marketing application, and previous responses to inspection observations. Accordingly, we and otherswith whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, productionand quality control.

The FDA or a comparable foreign regulatoryauthority may also impose requirements for costly post-marketing nonclinical studies or clinical trials (often called “Phase 4 trials”)and post-marketing surveillance to monitor the safety or efficacy of the product. If we or a regulatory authority discover previouslyunknown problems with a product, such as adverse events of unanticipated severity or frequency, production problems or issues with thefacility where the product is manufactured or processed, such as product contamination or significant not-compliance with applicable cGMPregulations, a regulator may impose restrictions on that product, the manufacturing facility or us. If we or our third-party providers,including our CMOs, fail to comply fully with applicable regulations, then we may be required to initiate a recall or withdrawal of ourproducts.

Later discovery of previously unknownproblems with our current or future product candidates, including adverse events of unanticipated severity or frequency, or with our third-partymanufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in the following, among otherthings:

Risk Factors

In addition, regulatory authorities’policies (such as those of the FDA or EMA) may change and additional government regulations may be enacted that could prevent, limit ordelay regulatory approval of our current or future product candidates. If we are slow or unable to adapt to changes in existing requirementsor the adoption of new requirements or policies, or if we are otherwise not able to maintain regulatory compliance, we may lose any marketingapproval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.

Non-compliance with European Union requirementsregarding safety monitoring or pharmacovigilance can also result in significant financial penalties. Similarly, failure to comply withthe European Union’s requirements regarding the protection of personal information can also lead to significant penalties and sanctions.

The FDA’s policies may changeand additional government regulations may be enacted that could prevent, limit or delay marketing approval of our current or future productcandidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, orif we are not able to maintain regulatory compliance, this may adversely affect, or even lead to the rescission of, the marketing approvalthat we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.

A variety of risks associatedwith marketing our current or future product candidates internationally could materially adversely affect our business.

We plan to seek regulatory approvalof our current or future product candidates outside of the United States and expect that we will be subject to additional risks relatedto operating in foreign countries including: differing regulatory requirements; unexpected changes in tariffs, trade barriers, price andexchange controls; economic weakness, including inflation, or political instability in particular foreign economies and markets; compliancewith tax, employment, immigration and labor laws for employees living or traveling abroad; foreign currency fluctuations that result inincreased operating expenses, reduced revenue, and other obligations incident to doing business in another country; potential liabilityunder the Foreign Corrupt Practices Act of 1977 or comparable foreign regulations; and challenges enforcing our contractual and intellectualproperty rights, especially in countries that do not recognize intellectual property rights to the same extent as the United States.

Risk Factors

The insurance coverage and reimbursementstatus of newly approved products is uncertain. Our current or future product candidates may become subject to unfavorable pricing regulations,third-party coverage and reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to obtain ormaintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decreaseour ability to generate revenue.

Adverse pricing limitations may hinderour ability to recoup our investment in one or more of our current or future product candidates, even if any such current or future productcandidate we may develop obtains marketing approval.

Our ability to successfully commercializeany current or future product candidates will depend in part on the coverage and reimbursement for the products and related treatmentsfrom government health administration authorities and third-party payors, such as private health insurers and health maintenance organizations.These organizations decide which medications they will pay for and establish reimbursement levels. If coverage and adequate reimbursementis not available, or the approved reimbursement amount is not high enough, we may be unable to establish or maintain pricing sufficientto generate a return on our investment and may be unable to successfully commercialize our current or future product candidates. Reimbursementby a third-party payor may depend upon a number of factors, including, but not limited to, the third-party payor’s determinationthat use of a product is a covered benefit under its health plan, safe, effective and medically necessary, appropriate for the specificpatient, cost-effective, and neither experimental nor investigational. If coverage and adequate reimbursement is not available, or theapproved reimbursement amount is not high enough, we may be unable to establish or maintain pricing sufficient to generate a return onour investment and may be unable to successfully commercialize our current or future product candidates.

A primary trend in the U.S. healthcareindustry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limitingcoverage and the amount of reimbursement for particular medications. In general, the prices of medicines under such systems are substantiallylower than in the United States.

There is also significant uncertaintyrelated to the insurance coverage and reimbursement of newly approved products, and coverage may be more limited than the purposes forwhich the medicine is approved by the FDA or comparable foreign regulatory authorities. In the United States, the principal decisionsabout reimbursement for new medicines are typically made by CMS. As a result, the coverage determination process is often a time consumingand costly process that may require us to provide scientific and clinical support for the use of our products to each payor separately,with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. It is difficultto predict what CMS will decide with respect to reimbursement for fundamentally novel products such as ours. Reimbursement agencies inEurope may be more conservative than CMS. Our inability to promptly obtain coverage and profitable payment rates from both government-fundedand private payors for any approved products we may develop could have a material adverse effect on our operating results, our abilityto raise capital needed to commercialize our current or future product candidates, and our overall financial condition.

Healthcare legislative measuresand changes in policies, funding, staffing and leadership at the FDA and other agencies could hinder or prevent the commercial successof our products.

In the United States, there have beena number of legislative and regulatory changes to the healthcare system that could affect our future results of operations and the futureresults of operations of our potential customers.

In recent years, there has been heightenedgovernmental scrutiny over the manner in which biopharmaceutical manufacturers set prices for their marketed products, which has resultedin several recent government inquiries as well as federal and state legislation designed to, among other things, increase drug price transparency,review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform governmentreimbursement for drug products. Congress and the executive branch have each indicated that they will continue to seek new legislativeand/or administrative measures to control drug costs, making this area subject to ongoing uncertainty. At the state level in the UnitedStates, legislatures have also increasingly passed legislation and implemented regulations designed to control drug product pricing.

Risk Factors

While we cannot predict what impactthese laws or policies will have in general or specifically on any product we may commercialize in the future, such efforts by the governmentand payors may result in downward pressure on reimbursement, which could negatively affect market acceptance of new products. Any rebates,discounts, taxes costs or regulatory or systematic changes on healthcare may have a significant effect on our profitability in the future.

Given recent federal and state governmentinitiatives directed at lowering the total cost of healthcare, the executive branch, Congress and state legislatures will likely continueto focus on healthcare reform and the reform of the Medicare and Medicaid programs. While we cannot predict the full outcome of any suchgovernment action or legislation, it may harm our ability to market our products and generate revenues.

Furthermore, regulatory authorities’assessment of the data and results required to demonstrate safety and effectiveness can change over time and can be affected by many factors,such as the emergence of new information, including on other products, changing policies and agency funding, staffing and leadership.We cannot be sure whether future changes to the regulatory environment will be favorable or unfavorable to our business prospects.

Our future relationships withcustomers and third-party payors in the United States and elsewhere may be subject to applicable anti-kickback, fraud and abuse, falseclaims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminalsanctions, civil penalties, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings.

Healthcare providers, physicians andthird-party payors in the U.S. and elsewhere will play a primary role in the recommendation and prescription of any current or futureproduct candidates for which we obtain marketing approval. Our future arrangements with third-party payors and customers may expose usto broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-KickbackStatute and the federal False Claims Act, which may constrain the business or financial arrangements and relationships through which wesell, market and distribute any current or future product candidates for which we obtain marketing approval. In addition, we may be subjectto transparency laws and patient privacy regulation by the federal and state governments and by governments in foreign jurisdictions inwhich we conduct our business. The applicable federal, state and foreign healthcare laws and regulations that may affect our ability tooperate include, but are not necessarily limited to:

Risk Factors

In November 2020, HHS finalizedsignificant changes to the regulations implementing the Anti-Kickback Statute, as well as the Physician Self-Referral Law and the civilmonetary penalty rules regarding beneficiary inducements, with the goal of offering the healthcare industry more flexibility andreducing the regulatory burden associated with those fraud and abuse laws, particularly with respect to value-based arrangements amongindustry participants.

Efforts to ensure that our businessarrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial costs. It is possiblethat governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations orcase law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violationof any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal andadministrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcareprograms, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, which could have a material adverse effecton our businesses. If any of the physicians or other healthcare providers or entities with whom we expect to do business, including ourcollaborators, is found not to be in compliance with applicable laws, it may be subject to criminal, civil or administrative sanctions,including exclusions from participation in government healthcare programs, which could also materially affect our businesses.

If we fail to comply with environmental,health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverseeffect on the success of our business.

We are subject to numerous environmental,health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment anddisposal of hazardous materials and wastes. Our operations may involve the use of hazardous and flammable materials, including chemicalsand biological and radioactive materials. Our operations also may produce hazardous waste products. We currently contract with third partiesfor the conduct of our manufacturing efforts and preclinical studies and clinical trials and such third parties are responsible for disposalof these materials and wastes. However, we cannot eliminate our risk of contamination or injury from these materials. In the event ofcontamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liabilitycould exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.

Risk Factors

Although we maintain workers’compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardousmaterials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmentalliability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous orradioactive materials.

Risks Related to our IntellectualProperty

We currently hold a license tocertain intellectual property rights relating to our lead product candidate, NXP800 and to NXP900, as well as intellectual property rightsrelating to other compounds that modulate HSF1 and the SRC and YES1 kinases. If we are unable to maintain patent and other intellectualproperty protection for NXP800 and NXP900, and to obtain and maintain patent and other intellectual property protections for our othercurrent or future product candidates and technology, or if the scope of intellectual property protection obtained or maintained is notsufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our abilityto commercialize NXP800, NXP900 or any other current or future product candidates or technology may be adversely affected.

Our success depends in large part onour ability to obtain and maintain patent and other intellectual property protection in the United States and other countries with respectto our current or future product candidates, including NXP800 and NXP900, their respective components, formulations, combination therapies,methods used to manufacture them and methods of treatment and development that are important to our business, as well as successfullydefending these patents against third-party challenges. If we do not adequately protect our intellectual property rights, or if the intellectualproperty rights we are able to obtain are insufficiently broad and exclusive, competitors may be able to erode or negate any competitiveadvantage we may have, which could harm our business and ability to achieve profitability.

We intend to rely upon a combinationof patents, patent applications, confidentiality agreements, trade secret protection and license agreements to protect the intellectualproperty related to our current or future product candidates and technologies. Any disclosure to or misappropriation by third partiesof our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thuseroding our competitive position in our market. We, or any current or future partners, collaborators, or licensees, may fail to identifypatentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patentprotection on them. We may be also unable to exclusively license relevant technology and associated intellectual property developed byothers. Therefore, we may miss potential opportunities to establish our patent position.

If we are unable to secure additionalpatent protection or maintain existing or future patent protection with respect to NXP800, NXP900, or any other proprietary products andtechnology we develop, our business, financial condition, results of operations, and prospects would be materially harmed.

We currently hold a license to certainintellectual property rights relating to NXP800, including its composition of matter and to other compounds that modulate HSF1. In addition,we hold a license to certain intellectual property relating to NXP900, including its composition of matter and to other compounds thatinhibit the SRC and YES1 kinases.

We have licensed one patent family coveringthe composition of matter for NXP800, including two issued U.S. patents covering the composition of matter for NXP800, as well as methodsfor using and making NXP800. Additionally, patents have been issued in major markets, including the U.S., the European Union, and Japan.The statutory expiration for the issued U.S. patents in this family is October 2034, without considering any patent extensions thatmay or may not be possible.

We have licensed a patent family directedto additional compounds that modulate HSF1. A patent from this family has been granted in the U.S., and has a statutory expiration ofApril 2036, without considering any patent extensions that may or may not be possible.

Risk Factors

We have also licensed a patent familydirected to deuterated compounds that modulate HSF1. Any U.S. patent that grants from this family would have a statutory expiration ofOctober 2037, without considering any patent extensions or patent disclaimers that may or may not be possible.

We have licensed one patent family coveringthe composition of matter for NXP900, which has been granted in the U.S., EU, Japan, China and is pending in the United Kingdom and Canada.The statutory expiration for patents in this patent family is April 2036, without considering any possible patent term extension.

If the scope of our patent protection,whether now or in the future, with respect to NXP800, NXP900 or our future product candidates and technology is not sufficiently broad,we will be unable to prevent others from using our technology or from developing or commercializing technology and products similar oridentical to ours or other competing products and technologies. Any failure to obtain or maintain patent protection, through our own patentsor through in-licensing, with respect to NXP800, NXP900 and our future product candidates would have a material adverse effect on ourbusiness, financial condition, results of operations and prospects.

Even if they are unchallenged, our patentapplications, if issued, and any patents we may own or in-license now or in the future, may not provide us with any meaningful protectionor prevent competitors from designing around our patent claims to circumvent any patents we may own or in-license in the future by developingsimilar or alternative technologies or therapeutics in a non-infringing manner. If the patent protection provided by our patent applicationsor any patents we may pursue with respect to our current or future product candidates is not sufficiently broad to impede competition,our ability to successfully commercialize our current or future product candidates could be negatively affected, which would harm ourbusiness.

Additionally, we cannot be certain thatthe claims in our patent applications covering composition of matter (or other related aspects) of our current or future product candidatesor technology will be considered patentable by the USPTO, or by patent offices in foreign countries, or that the claims in any issuedpatents we may own or in-license in the future will be considered patentable by courts in the United States or foreign countries.

The issuance of a patent does not foreclosechallenges to its inventorship, scope, validity or enforceability. Therefore, our owned and in-licensed patents may be challenged in thecourts or patent offices in the United States and elsewhere. Such challenges may result in loss of exclusivity or freedom to operate orin patent claims being narrowed, invalidated, or held unenforceable, in whole or in part. Successful patent challenges could limit ourability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patentprotection of our technology and products. Given the amount of time required for the development, testing and regulatory review of newproduct candidates, patents protecting such product candidates might expire before or shortly after such product candidates are commercialized.As a result, our owned and in-licensed patents may not provide us with sufficient rights to exclude others from commercializing productssimilar or identical to ours.

Moreover, we may be subject to a third-partypre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, inter parties review,post-grant review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination inany such submission, Patent Trial and Appeal Board trial, proceeding or litigation could reduce the scope of, render unenforceable, orinvalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without paymentto us, or result in our inability to manufacture or commercialize products without infringing third party patent rights. In addition,if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies fromcollaborating with us to license, develop or commercialize current or future product candidates.

Risk Factors

If we fail to comply with ourobligations in our current license agreements, or in any future agreements under which we may license intellectual property rights fromthird parties or otherwise experience disruptions to our business relationships with our current or future licensors, we could lose licenserights that are important to our business.

We are currently party to a licensewhich grants us certain intellectual property rights relating to our lead product candidate, NXP800, as well as other compounds that modulateHSF1, and to a license which grants us certain intellectual property rights relating to our second drug candidate, NXP900, as well asother compounds that inhibit the SRC and YES1 kinases. These agreements impose numerous obligations on us to maintain our licensing rights,including development, diligence, payment, commercialization, funding, milestone, royalty, sublicensing, insurance, patent prosecution,enforcement and other obligations. In spite of our efforts, our licensor might conclude that we have materially breached our license agreementand might therefore terminate the license agreement, thereby removing or limiting our ability to develop and commercialize NXP800 or NXP900(and other compounds covered by the licenses).

Additionally, in the future, we maybe party to other license or collaboration agreements with third parties to advance our research or allow commercialization of currentor future product candidates. Such future agreements may impose numerous obligations, such as development, diligence, payment, commercialization,funding, milestone, royalty, sublicensing, insurance, patent prosecution, enforcement and other obligations on us and may require us tomeet development timelines, or to exercise commercially reasonable efforts to develop and commercialize licensed products, in order tomaintain the licenses. In spite of our efforts, our future licensors might conclude that we have materially breached our future licenseagreements and might terminate the license agreements, thereby removing or limiting our ability to develop and commercialize productsand technologies covered by these license agreements.

Any termination of these current orfuture licenses, or failure of the underlying patents to provide the intended exclusivity, could result in the loss of significant rightsand could harm our ability to commercialize our current or future product candidates, and competitors or other third parties would havethe freedom to seek regulatory approval of, and to market, products identical to ours and we may be required to cease our developmentand commercialization of certain of our current or future product candidates. Any of the foregoing could have a material adverse effecton our competitive position, business, financial conditions, results of operations, and prospects.

If we are unable to protect theconfidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to the protection affordedby patents we may own or in-license in the future, we seek to rely on trade secret protection, confidentiality agreements, and licenseagreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce, and any otherelements of our product discovery and development processes that involve proprietary know-how, information, or technology that is notcovered by patents. Although we require all of our employees, consultants, advisors and any third parties who have access to our proprietaryknow-how, information, or technology to enter into confidentiality agreements, trade secrets can be difficult to protect and we have limitedcontrol over the protection of trade secrets used by our collaborators and suppliers.

If we are unable to prevent unauthorizedmaterial disclosure of our intellectual property to third parties, we will not be able to establish or maintain a competitive advantagein our market, which could materially adversely affect our business, financial condition, results of operations and future prospects.

Third-party claims of intellectualproperty infringement, misappropriation or other violations may be costly and time consuming and may prevent or delay our product discoveryand development efforts.

The intellectual property landscapearound precision medicine is crowded, and third parties may initiate legal proceedings alleging that we are infringing, misappropriating,or otherwise violating their intellectual property rights; the outcome of which would be uncertain and could have a material adverse effecton the success of our business. We or any of our future licensors or strategic partners may be party to, exposed to, or threatened with,future adversarial proceedings or litigation by third parties having patent or other intellectual property rights alleging that our currentor future product candidates and/or proprietary technologies infringe, misappropriate or otherwise violate their intellectual propertyrights. Thus, because of the large number of patents issued and patent applications filed in our fields, there may be a risk that thirdparties may allege they have patent rights encompassing our current or future product candidates, technologies or methods.

Risk Factors

Third parties may assert that we areemploying their proprietary technology without authorization. In addition, because some patent applications in the United States may bemaintained in secrecy until the patents are issued, patent applications in the United States and many foreign jurisdictions are typicallynot published until 18 months after filing, and publications in the scientific literature often lag behind actual discoveries, we cannotbe certain that others have not filed patent applications covering our current or future product candidates or technology. If any suchpatent applications issue as patents, and if such patents have priority over our patent applications or patents we may own or in-license,we may be required to obtain rights to such patents owned by third parties which may not be available on commercially reasonable termsor at all, or may only be available on a non-exclusive basis.

In the event of a successful claim of infringement, misappropriationor other violation against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willfulinfringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossibleor require substantial time and monetary expenditure.

Changes to patent law in the UnitedStates and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

Our success is heavily dependent onintellectual property, particularly patents. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection availablein certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regardto our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents,once obtained. Laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patentsor to enforce patents that we might obtain in the future.

We may be subject to claims challengingthe inventorship or ownership of any intellectual property, including any patents we may own or in-license currently or in the future.

We may be subject to claims that formeremployees, collaborators or other third parties have an interest in any patents we may own or in-license currently or in the future, tradesecrets, or other intellectual property as an inventor or co-inventor. Litigation may be necessary to defend against these and other claimschallenging inventorship of any patents we may own or in-license in the future, trade secrets or other intellectual property.

We may be subject to claims thatour employees, consultants or independent contractors have wrongfully used or disclosed confidential information or alleged trade secretsof third parties or competitors or are in breach of non-competition or non-solicitation agreements with our competitors.

We may be subject to claims that weor our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information ortrade secrets of these third parties or our employees’ former employers or our consultants’ or contractors’ currentor former clients or customers. Litigation or arbitration may be necessary to defend against these claims.

If we do not obtain patent termextension and data exclusivity for any of our current or future product candidates we may develop, our business may be materially harmed.

Depending upon the timing, durationand specifics of any FDA marketing approval of any of our current or future product candidates we may develop, one or more U.S. patentswe may own or in-license in the future may be eligible for limited patent term extension under the Drug Price Competition and Patent TermRestoration Act of 1984, or the Hatch-Waxman Amendments. If we are unable to obtain patent term extension or the term of any such extensionis shorter than what we request, our competitors may obtain approval of competing products following expiration of any patents that issuefrom our patent applications, and our business, financial condition, results of operations, and prospects could be materially harmed.

If our trademarks and trade namesare not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adverselyaffected.

Our trademarks or trade names may bechallenged, infringed, diluted, circumvented or declared generic or determined to be infringing on other marks. We intend to rely on bothregistration and common law protection for our trademarks. We may not be able to protect our rights to these trademarks and trade namesor may be forced to stop using these names, which we need for name recognition by potential partners or customers in our markets of interest.If we are unable to obtain a registered trademark or establish name recognition based on our trademarks and trade names, we may not beable to compete effectively and our business may be adversely affected.

Risk Factors

Risks Related to our Reliance onThird Parties

We plan to rely on third partiesto conduct our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractualduties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our current or future productcandidates.

We plan to utilize and depend upon independentinvestigators and collaborators, such as medical institutions, CROs, CMOs, and strategic partners to conduct and support our preclinicalstudies and clinical trials under agreements with us. We rely upon, and plan to continue to rely upon, such third-party entities to executeour clinical trials and preclinical studies and to monitor and manage data produced by and relating to those studies and trials. However,in the future we may not be able to establish arrangements with CROs when needed or on terms that are acceptable to us, or at all, whichcould negatively affect our development efforts with respect to our drug candidates and materially harm our business, operations and prospects.As a result of the use of third-party contractors, we will have only limited control over certain aspects of their activities. Nevertheless,we are responsible for ensuring that each of our studies, including each of our clinical trials, is conducted in accordance with the applicableprotocol, legal and regulatory requirements as well as scientific standards, and our reliance on any third-party entity will not relieveus of our regulatory responsibilities.

Based on our present expectations, weand our third-party contractors will be required to comply with GCP regulations for the clinical development of all of our drug candidates.If we or any of these third parties fail to comply with applicable GLP or GCP regulations, the clinical data generated in our preclinicaland clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additionalclinical trials before approving our marketing applications, which we may not have sufficient cash or other resources to support and whichwould delay our ability to generate revenue from future sales of such drug candidate. Any agreements governing our relationships withCROs or other contractors with whom we currently engage or may engage in the future may provide those outside contractors with certainrights to terminate a clinical trial under specified circumstances. If such an outside contractor terminates its relationship with usduring the performance of a clinical trial, we would be forced to seek an engagement with a substitute contractor, which we may not beable to do on a timely basis or on commercially reasonable terms, if at all, and the applicable clinical trial would experience delaysor may not be completed.

Large-scale clinical trials requiresignificant additional financial and management resources and reliance on third-party clinical investigators, CROs, and consultants, whichmay cause us to encounter delays that are outside of our control. We may be unable to identify and contract with sufficient investigators,CROs, or consultants on a timely basis, if at all.

If these third parties do not successfullycarry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracyof the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, legal and regulatory requirementsor for other reasons, our preclinical or clinical trials may be extended, delayed or terminated and we may not be able to complete developmentof, obtain regulatory approval for, or successfully commercialize, our current or future product candidates. In addition, we will be unableto control whether or not they devote sufficient time and resources to our preclinical and clinical programs. These outside contractorsmay not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves.As a result, our operations and the commercial prospects for the effected drug candidates would be harmed, our costs could increase andour ability to generate revenues could be delayed. These contractors may also have relationships with other commercial entities, someof whom may compete with us. If our contractors assist our competitors to our detriment, our competitive position would be harmed.

If our relationships with any thirdparties conducting our studies are terminated, we may be unable to enter into arrangements with alternative third parties on commerciallyreasonable terms, or at all. Switching or adding third parties to conduct our studies involves substantial cost and requires extensivemanagement time and focus. In addition, there is a natural transition period when a new third party commences work. As a result, delaysoccur, which can materially impact our ability to meet our desired clinical development timelines. Although we carefully manage our relationshipswith third parties conducting our studies, we cannot assure you that we will not encounter similar challenges or delays in the futureor that these delays or challenges will not have a material and adverse effect on our business, financial condition and results of operations.

Risk Factors

We rely, and expect to continueto rely, on the third-party manufacturers to manufacture our current or future product candidates. Reliance on third parties increasesthe risk that we will not have sufficient quantities of our products or such quantities at an acceptable quality and cost, which coulddelay, prevent or impair our development or commercialization efforts.

We do not currently own any facilitythat may be used as our clinical-scale manufacturing and processing facility and must rely on outside vendors to manufacture our currentor future product candidates. We rely on a single CMO for manufacturing the NXP800 drug substance and the NXP800 drug product, which aremanufactured at two different sites of the same CMO. We intend to continue our relationship with this CMO for the supply of NXP800; however,there can be no assurance that we will be able to retain this relationship on commercially reasonable terms, if at all. If we are unableto maintain this relationship, we could experience delays in our development efforts as we locate and qualify a new CMO. For the in vitroand in vivo experiments of NXP900 conducted to date, small, lab-scale, non cGMP material has been used. While we have identified an appropriatecGMP CMO to manufacture drug substance and drug product for NXP900, there is no assurance that such CMO will be successful in manufacturingNXP900 drug substance or product. If NXP800, NXP900 or any other drug candidate we may develop or acquire in the future receives regulatoryapproval, we will rely on one or more CMOs to manufacture the commercial supply of such drugs.

Our anticipated reliance on a limitednumber of third-party manufacturers exposes us to a number of risks, including:

Risk Factors

Each of these risks could delay or preventthe completion of our preclinical or clinical trials or the approval of any of our current or future product candidates by the FDA oranother foreign regulatory authority, result in higher costs or adversely impact commercialization of our current or future product candidates.

Although our agreements with our CMOsrequire them to perform according to certain cGMP requirements such as those relating to quality control, quality assurance and qualifiedpersonnel, we cannot control the conduct of our CMOs to implement and maintain these standards. If any of our CMOs cannot successfullymanufacture material that conforms to our specifications and the regulatory requirements of the FDA, EMA or other comparable foreign authorities,we could be prevented from obtaining regulatory approval for our drug candidates unless and until we engage a substitute CMO that cancomply with such requirements, which we may not be able to do. Any such failure by any of our CMOs would significantly impact our abilityto develop, obtain regulatory approval for or market our drug candidates, if approved.

If our third-party manufacturersuse hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.

Although we believe that our manufacturers’procedures for using, handling, storing, and disposing of hazardous and biological materials comply with legally prescribed standards,we cannot completely eliminate the risk of contamination or injury. In the event of an accident, local, city, state or federal authoritiesmay curtail the use of these materials and interrupt our business operations. Further, we could be held liable for damages or penalizedwith fines, and the liability could exceed our resources. We do not have any insurance for liabilities arising from medical or hazardousmaterials.

Risks Related to Managing Growthand Employee Matters

We are highly dependent on ourkey personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel,we may not be able to successfully implement our business strategy.

Our ability to compete in the highlycompetitive biotechnology and pharmaceutical industries depends upon our ability to attract and retain highly qualified managerial, scientificand medical personnel. We are highly dependent on our management, scientific and medical personnel, including our Chairman, Chief ExecutiveOfficer and President, our Chief Scientific and Business Officer and our Chief Development and Operations Officer. While we expect toengage in an orderly transition process as we integrate newly appointed officers and managers, we face a variety of risks and uncertaintiesrelating to management transition, including diversion of management attention from business concerns, failure to retain other key personnelor loss of institutional knowledge.

We will need to grow the sizeof our organization, and we may experience difficulties in managing this growth.

As of June 30, 2022, we had 10full-time employees. We also contract for various services through consulting and vendor agreements. We intend to hire new employees toconduct our research and development activities in the future. Any delay in hiring such new employees could result in delays in our researchand development activities and would harm our business. As our development and commercialization plans and strategies develop, and aswe transition into operating as a public company, we expect to need additional managerial, operational, sales, marketing, financial andother personnel, as well as additional facilities to expand our operations.

If we are not able to effectively expandour organization by hiring new employees and expanding our groups of consultants and contractors, or we are not able to effectively buildout new facilities to accommodate this expansion, we may not be able to successfully implement the tasks necessary to further developand commercialize our current or future product candidates and, accordingly, may not achieve our research, development and commercializationgoals.

Risk Factors

We will incur significant increasedcosts as a result of operating as a public company, and our management will be required to devote substantial time to compliance activitiesand initiatives.

As a public company, we will incur significantlegal, accounting, and other expenses that we did not incur as a private company. We are now subject to the reporting requirements ofthe Securities Exchange Act of 1934, as amended, which requires, among other things, that we file with the SEC, annual, quarterly, andcurrent reports with respect to our business and financial condition. In addition, the Sarbanes-Oxley Act of 2002 (“SOX”),as well as rules subsequently adopted by the SEC and the Nasdaq Capital Market to implement provisions of SOX, impose significantrequirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls andchanges in corporate governance practices.

Moreover, these rules and regulationswill increase our legal and financial compliance costs and make some activities more time-consuming and costly. For example, these rules andregulations make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be requiredto accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result,it may be more difficult for us to attract and retain qualified persons to serve on our Board of Directors, our Board committees or asexecutive officers.

SOX requires, among other things, thatwe maintain effective internal control over financial reporting and disclosure controls and procedures. As a result, we are required toperiodically perform an evaluation of our internal control over financial reporting to allow management to report on the effectivenessof those controls, as required by Section 404 of SOX. These efforts to comply with Section 404 will require the commitment ofsignificant financial and managerial resources. While we anticipate maintaining the integrity of our internal control over financial reportingand all other aspects of Section 404, we cannot be certain that a material weakness will not be identified when we test the effectivenessof our control systems in the future. If a material weakness is identified, we could be subject to sanctions or investigations by theSEC or other regulatory authorities, which would require additional financial and management resources, costly litigation or a loss ofpublic confidence in our internal control, which could have an adverse effect on the market price of our stock.

Our business and operations wouldsuffer in the event of computer system failures, cyber-attacks, or deficiencies in our or third parties’ cybersecurity.

We are increasingly dependent upon informationtechnology systems, infrastructure, and data to operate our business. In the ordinary course of business, we may collect, store, and transmitconfidential information, including, but not limited to, information related to our intellectual property and proprietary business information,personal information, and other confidential information. We have outsourced elements of our operations to third party vendors, who eachhave access to our confidential information, which increases our disclosure risk. Although we have implemented internal security and businesscontinuity measures, our information technology and other internal infrastructure systems may breakdown, incur damage or be interruptedby system malfunctions, natural disasters, terrorism, war, or telecommunication and electrical failures, as well as by inadvertent orintentional security breaches by our employees, contractors, consultants, business partners, and/or other third parties, or from cyber-attacksby malicious third parties, each of which could compromise our system infrastructure or lead to the loss, destruction, alteration, disclosure,or dissemination of, or damage or unauthorized access to, our data or other assets. Such a security breach may cause loss, damage, ordisclosure of proprietary or confidential information, which could in turn result in significant legal and financial exposure and reputationaldamage that could adversely affect our business. Furthermore, the loss or corruption of clinical trial data from future clinical trialsmay result in delays in our regulatory approval efforts and could significantly increase our costs to recover or reproduce the data.

The costs related to significant securitybreaches or disruptions could be material and our insurance policies may not be adequate to compensate us for the potential losses arisingfrom any such security breach. In addition, such insurance may not be available to us on economically reasonable terms, if at all, maynot cover all claims made against us, and may have high deductibles. Furthermore, if the information technology systems of our third-partyvendors and other contractors and consultants become subject to disruptions or security breaches, we may have insufficient recourse againstsuch third parties and we may have to expend significant resources to mitigate the impact of such an event, and to develop and implementprotections to prevent future events of this nature from occurring.

Risk Factors

Risks Related to Commercial Activities

If any of our current or futureproduct candidates do not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, therevenues from any such current or future product candidate may be limited.

The use of precision medicines as apotential cancer treatment is a recent development and may not become broadly accepted by physicians, patients, hospitals, cancer treatmentcenters, and others in the medical community. We cannot predict whether physicians, patients, hospitals, cancer treatment centers, andgovernment agencies or third-party payors will determine that our product is safe, therapeutically effective, and cost effective as comparedwith competing treatments. If our current or potential future product candidates do not achieve an adequate level of market acceptance,we may not generate significant product revenues and may not become profitable. Factors influencing acceptance of our current or futureproduct candidates in the market, include: the clinical indications for which our product candidates are licensed; whether our productcandidates are viewed as a safe and effective treatment; our ability to demonstrate our product’s advantages, including cost advantages,over alternative treatments; the prevalence and severity of any side effects of our products and of other precision medicines; productlabeling or product insert requirements of the FDA or other regulatory authorities and limitations or warnings contained in the labeling;the timing of market introduction of our product candidates and competitive products; patient willingness to pay out-of-pocket in theabsence of coverage by third-party payors and government authorities; and the effectiveness of our sales and marketing efforts.

If our current or future product candidatesare licensed but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers or others in the medicalcommunity, we will not be able to generate significant revenue. In addition, although our current or future product candidates may differin certain ways from other precision medicine approaches, serious adverse events or deaths in other preclinical or clinical trials involvingprecision medicines, even if not ultimately attributable to our current or future products or product candidates, could result in increasedgovernment regulation, unfavorable public perception and publicity, potential regulatory delays in the testing or licensing of our currentor future product candidates, stricter labeling requirements for those product candidates that are licensed, and a decrease in demandfor any such product candidates.

If product liability lawsuitsare brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future productcandidates.

We face an inherent risk of costly andtime-consuming product liability lawsuits as a result of the planned clinical testing of our current or future product candidates andwill face an even greater risk if we commercialize any products. For example, we may be sued if our current or future product candidatescause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale.If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limitcommercialization of our current or future product candidates. Failure to obtain or retain sufficient product liability insurance at anacceptable cost may prevent or inhibit the commercialization of products we may develop. Although we have clinical trial insurance, ourinsurance policies have various exclusions, and we may be subject to a claim for which we have no coverage. We may have to pay any amountsawarded by a court or negotiated in a settlement that are not covered by or which exceed our insurance coverage, and we may not have sufficientcapital to pay such amounts.

Risks Related to Ownership of ourCommon Stock

We do not know whether an active,liquid and orderly trading market will develop for our Common Stock or what the market price of our Common Stock will be and, as a result,it may be difficult for you to sell your shares of our Common Stock.

Prior to the pricing of our initialpublic offering on February 4, 2022, there was no public trading market for shares of our Common Stock. Although our Common Stockis listed on the Nasdaq Capital Market, an active trading market for our shares is still developing and may not be sustained in the future.The lack of an active market for our Common Stock may impair investors’ ability to sell their shares at the time they wish to sellthem or at a price that they consider reasonable and may reduce the fair market value of their shares. Further, an inactive market mayimpair our ability to raise capital by selling shares of our Common Stock and to enter into strategic partnerships or acquire companiesor products using our shares of Common Stock as consideration.

Risk Factors

Our growth is subject to economic and political conditions.

Our business is affected by global andlocal economic and political conditions as well as the state of the financial markets, inflation, recession, financial liquidity, currencyvolatility, growth, and policy initiatives. There can be no assurance that global economic conditions and financial markets will not worsenand that we will not experience any adverse effects that may be material to our consolidated cash flows, results of operations, financialposition or our ability to access capital, such as the adverse effects resulting from a prolonged shutdown in government operations bothin the United States and internationally. Political changes, including war or other conflicts, some of which may be disruptive, couldinterfere with our supply chain, our customers and all of our activities in a particular location.

We do not intend to pay dividendson our Common Stock in the foreseeable future, so any returns will be limited to the value of our stock, which may be volatile.

We plan to retain future earnings forthe development, operation, and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeablefuture. Any return to stockholders will be limited to the appreciation of their stock, which may never occur. Further, the trading priceof our Common Stock is likely to be highly volatile and may be subject to wide fluctuations in response to various factors, some of whichare beyond our control. Broad market and industry factors may negatively affect the market price of our Common Stock, regardless of ouractual operating performance.

If equity research analysts donot publish research or reports about our business or if they publish negative evaluations of or downgrade our Common Stock, the priceof our Common Stock could decline.

The trading market for our Common Stockrelies in part on the research and reports that equity research analysts publish about us or our business. We do not control these analysts.We may never obtain research coverage by industry or financial analysts. If no or few analysts publish research reports on the Companyor if analysts publish negative research reports about the Company, our stock price may significantly decline.

The holders of our Common Stockwill suffer, and may in the future suffer, substantial dilution due to the Private Placement and our corporate financing practices.

Assuming the issuance of the CommonStock issuable upon exercise of the pre-funded warrants and investment options, together with the issuance of Common Stock pursuant tothe Private Placement, the holders of our Common Stock will suffer substantial dilution. Holders of our Common Stock could suffer additional,substantial dilution in the future due to our corporate financing practices. These additional issuances of shares of Common Stock couldalso cause a significant reduction in the market price of our Common Stock.

Raising additional capital maycause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights to our current or future technologiesor product candidates.

We may seek additional capital througha combination of public and private equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements.Any equity or equity-related financing may dilute our stockholders may subject us to restrictive covenants and interest costs. If we obtainfunding through a strategic collaboration or licensing arrangement, we may be required to relinquish our rights to our current productcandidates or any future product candidates that we may develop.

Additional fundraising efforts may divertour management from their day-to-day activities, which may adversely affect our operations. If we are unable to raise additional capitalas needed or on acceptable terms, we may be required to delay or discontinue any research, development or commercialization programs andmay be unable to expand our operations or otherwise capitalize on our business opportunities. Further, we may be required to seek collaboratorsfor potential product candidates earlier, or on less favorable terms, than might otherwise be desired, or to relinquish or license ourrights to potential product candidates in markets where we otherwise would seek to pursue development or commercialization. Any of theabove events could significantly harm our business, prospects, financial condition and results of operations and cause the price of ourCommon Stock to decline.

Risk Factors

Future issuances of our CommonStock or securities convertible into our Common Stock, or the expiration of lock-up agreements that restrict the issuance of new CommonStock or the trading of outstanding stock, could cause the market price of our Common Stock to decline and would result in the dilutionof your shareholding.

Future issuances of our Common Stockor securities convertible into our Common Stock or the trading of outstanding stock, could cause the market price of our Common Stockto decline. We cannot predict the effect, if any, of the exercise of future issuances of our Common Stock or securities convertible intoour Common Stock on the price of our Common Stock. In all events, future issuances of our Common Stock would result in the dilution ofyour shareholding.

Our principal stockholders andmanagement own a significant percentage of our stock and will be able to exert significant influence over matters subject to stockholderapproval.

As of June 30, 2022, our executiveofficers, directors, and 5% stockholders beneficially owned approximately 70% of our voting stock and anticipate that the same group willhold a significant portion of our outstanding voting stock for the foreseeable future. These stockholders will have the ability to influenceus through their ownership position. This may prevent or discourage unsolicited acquisition proposals or offers for our Common Stock.

Our failure to meet the continuinglisting requirements of the NASDAQ Capital Market could result in a de-listing of our securities.

If we fail to satisfy the continuinglisting requirements of NASDAQ, such as the corporate governance, stockholders’ equity or minimum closing bid price requirements,NASDAQ may take steps to delist our Common Stock. Such a delisting would likely have a negative effect on the price of our Common Stockand would impair our stockholders’ ability to sell or purchase our Common Stock. In the event of a delisting, we would likely takeactions to restore our compliance with NASDAQ’s listing requirements, but we can provide no assurance that any such action takenby us would allow our Common Stock to become listed again, stabilize the market price or improve the liquidity of our securities, preventour Common Stock from dropping below the NASDAQ minimum bid price requirement or prevent future non-compliance with NASDAQ’s listingrequirements.

We are an emerging growth companyand a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companiesand smaller reporting companies will make our Common Stock less attractive to investors.

We are an emerging growth company, asdefined in the JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from variousreporting requirements that are applicable to other public companies that are not emerging growth companies, including: exemption fromthe auditor attestation requirements of Section 404 of SOX, as amended; being permitted to provide only two years of our auditedfinancial statements and correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Resultsof Operations”; exemption from any Public Company Accounting Oversight Board requirement regarding audit firm rotation or an auditorreport supplement providing additional information about the audit and financial statements; reduced disclosure obligations regardingexecutive compensation; and exemption from the nonbinding advisory votes on executive compensation and stockholder approval of any goldenparachute payments not previously approved.

We have elected to take advantage ofcertain of the reduced reporting obligations. We cannot predict whether investors will find our Common Stock less attractive if we relyon these exemptions. If some investors find our Common Stock less attractive as a result, there may be a less active trading market forour Common Stock and our stock price may be reduced or more volatile.

Risk Factors

Provisions in our certificateof incorporation, our bylaws, and Delaware law may discourage, delay, or prevent a change in control of our Company or changes in ourmanagement and, as a result, depress the trading price of our stock.

Provisions of our certificate of incorporation,our bylaws and Delaware law may deter unsolicited takeovers and/or delay or prevent a change in control of our Company, including transactionsin which our stockholders might otherwise receive a premium for their shares.

In addition, the Delaware General CorporationLaw prohibits a publicly held Delaware corporation from engaging in a business combination with an interested stockholder, defined asa person who owns, or within the last three years has owned, 15% of our voting stock, for a period of three years after the date of thetransaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.

The foregoing provisions and anti-takeovermeasures may limit the price that investors might be willing to pay in the future for shares of our Common Stock and may deter potentialacquirers of our Company.

Useof Proceeds

Weare not selling any securities under this prospectus and we will not receive any proceeds from the sale of securities by the SellingShareholders, although we could receive up to $19,764,147 upon the exercise of all of the Investment Options and $909 upon the exerciseof all of the Pre-Funded Warrants. Any amounts we receive from such exercises, along with approximately $15.9 million in net proceedsreceived in the Private Placement will be used for working capital and general corporate purposes. The holders of the Investment Optionsand Pre-Funded Warrants are currently not obligated to exercise the Investment Options or Pre-Funded Warrants and we cannot assure youthat the holders of either will choose to exercise all or any exercise the Investment Option or Pre-Funded Warrants.

DividendPolicy

Wehave never declared or paid any cash dividends on our capital stock. We currently intend to retain any future earnings to fund the developmentand expansion of our business, and therefore we do not anticipate paying cash dividends on our Common Stock in the foreseeable future.Any future determination to pay dividends will be at the discretion of our board of directors and will depend on our results of operations,financial condition, capital requirements, contractual restrictions and other factors deemed relevant by our board of directors.

MARKETPRICE AND DIVIDENDS ON COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

Currently,our shares of Common Stock are listed on the Nasdaq Capital Market under the symbol “NVCT”.

Asof the date of this prospectus, there were 53 holders of record of our shares of Common Stock.

Wehave not paid any cash dividends on our Common Stock and do not plan to pay any cash dividends on our Common Stock in the foreseeablefuture. Our board of directors will determine our future dividend policy on the basis of many factors, including results of operations,capital requirements, and general business conditions, subject to any restrictions under our credit facility.

Management’s Discussion and Analysis of Financial Condition and Results of Operations 

Management’sDiscussion and Analysis of Financial Condition and Results of Operations

Youshould read the following discussion and analysis of our financial condition and results of operations together with our financialstatements and related notes incorporated by reference in this prospectus. Some of the information contained in this discussion and analysisor set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business and relatedfinancing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including thosefactors set forth in the “Risk Factors” section of this prospectus, our actual results could differ materially from theresults described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

Weare a biopharmaceutical company focused on the development of novel targeted small molecule therapeutics for the treatment of cancerin genetically defined patient populations. Our precision medicine approach translates key scientific insights relating to the oncogenicdrivers and pathway addiction of cancer into potent and highly selective anticancer drugs. In addition, we will investigate the relevanceof specific mutations and other DNA alterations as a potential patient selection marker and to identify synthetic lethality targets.This work could support our use of a tumor agnostic development strategy wherein we enroll patients based on the cancer’s geneticand molecular features without regard to the type or location of the cancer. Since our inception in 2020, we have devoted substantiallyall of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, acquiring, discoveringproduct candidates and securing related intellectual property rights and conducting research and development activities for our programs.We do not have any products approved for sale and have not generated any revenue from product sales. We may never be able to developor commercialize a marketable product. We have not yet successfully completed any pivotal clinical trials, obtained any regulatory approvals,manufactured a commercial-scale drug, or conducted sales and marketing activities.

Resultsof Operations

Fromour inception on July 27, 2020, through June 30, 2022, we did not generate any revenue. Our main activities through June 30,2022 have been organizational and capital raising activities and the completion of the in-license agreements for our two drug candidates,NXP800 and NXP900, our Initial New Drug and Clinical Trial Application for the FDA and Medicines and Healthcare Regulatory Agency, respectively,and preparation and ongoing execution of the Phase 1a clinical trial for NXP800, which commenced in December 2021, and beginningour IND-enabling studies for NXP900, which commenced in late 2021. Additionally, we completed our initial public offering in February 2022.

Researchand Development Expenses

Researchand development expenses include costs directly attributable to the conduct of research and development programs, including licensingfees, cost of salaries, share-based compensation expenses, payroll taxes, and other employee benefits, subcontractors, and materialsand service used for research and development activities, including clinical trials, manufacturing costs, and professional services.All costs associated with research and development are expensed as incurred.

Productcandidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development,primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenseswill increase substantially in connection with our ongoing and planned preclinical and clinical development activities in the near termand in the future. The successful development of our product candidates is highly uncertain. At this time, we cannot accurately estimateor know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of anyof our product candidates and we may never succeed in obtaining regulatory approval for any of our product candidates.

Management’s Discussion and Analysis of Financial Condition and Results of Operations 

Generaland Administrative Expenses

Generaland administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation, for our personnelin executive, finance and accounting, and other administrative functions. General and administrative expenses also include legal feesrelating to patent and corporate matters; professional fees paid for accounting, auditing, consulting, and tax services; insurance costs;travel expenses; and facility costs not otherwise included in research and development expenses.

Weanticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continuedresearch and development activities.

The tables below also appear in our Quarterly Report on Form 10-Q filed with the SEC on August10, 2022. 

Thefollowing table summarizes our results of operations expenses for the three months ended June 30, 2022 and the three months endedJune 30, 2021: (in thousands)

Researchand Development Expenses

Thefollowing table summarizes our research and development expenses for the three months ended June 30, 2022 and the three months endedJune 30, 2021: (in thousands)

Researchand development expenses decreased by $1.7 million or 41% during the three months ended June 30, 2022 compared to the sameperiod in 2021. The decrease in research and development expense during the three months ended June 30, 2022 was primarily drivenby $3.5 million in one-time licensing fees expense and paid during the period in 2021 for compound NXP800 partially offset by $1.1 millionin increased clinical expenses, $0.4 in manufacturing expenses mostly related to the NXP800 program and $0.2 million of additional employeeexpenses including $0.3 million in employee stock compensation.

Management’s Discussion and Analysis of Financial Condition and Results of Operations 

Thefollowing table summarizes our general and administrative expenses for the three months ended June 30, 2022 and the three months ended June 30, 2021: (inthousands)

Generaland administrative expenses decreased by $0.6 million or 37% during the three months ended June 30, 2022 compared to the sameperiod in 2021. The decrease in general and administrative expense during the three months ended June 30, 2022 was primarily drivenby the $0.9 million decrease in professional and consulting services related to the private funding round in 2021 which could not benetted against the proceeds, partially offset by a $0.3 million increase in insurance and other expenses associated with the IPO.

Asa result of the foregoing, our loss from operations for the three months ended June 30, 2022, decreased $2.4 million or 40%,compared to the same period in 2021.

Thefollowing table summarizes our results of operations expenses for the six months ended June 30, 2022 and the six months ended June 30,2021: (in thousands)

Researchand Development Expenses

Thefollowing table summarizes our research and development expenses for the six months ended June 30, 2022 and the six months endedJune 30, 2021: (in thousands)

Management’s Discussion and Analysis of Financial Condition and Results of Operations 

Researchand development expenses increased by $0.1 million, or 2%, during the six months ended June 30, 2022 compared to the same periodin 2021. The increase in research and development expense during the six months ended June 30, 2022 was primarily driven by, $1.6million increase in clinical expenses paid out in connection with our product candidates NXP800 and NXP900, $0.6 million in employeecompensation and benefits including $0.4 million in stock based compensation and $0.7 million in manufacturing expenses mostly associatedwith our product NXP800 and $0.2 million in professional services and other expenses associated with the company’s drug productprograms, partially offset by a $3.1 million decrease in license fees paid during 2021 to CRT for NXP800 net of fees owed to the UoEassociated with the company’s 2022 IPO and the UoE License agreement.

Generaland Administrative Expenses

Thefollowing table summarizes our general and administrative expenses for the six months ended June 30, 2022 and the six months endedJune 30, 2021: (in thousands)

Generaland administrative expenses increased by $0.5 million, or 29%, during the six months ended June 30, 2022 compared to the same periodin 2021. The increase in general and administrative expenses for the six months ended June 30, 2022, was primarily driven by $0.5million increase in insurance due to insurance associated with the IPO, $0.2 million in employee compensation including $0.3 millionin stock compensation expense offset by a decrease of $0.3 million in professional and consulting fees paid to third-party providers.

Asa result of the foregoing, our loss from operations for the six months ended June 30, 2022, increased $0.6 million or 9%, comparedto the same period in 2021.

Management’s Discussion and Analysis of Financial Condition and Results of Operations 

Liquidityand Capital Resources

Asof June 30, 2022, we had $13.6 million of cash and cash equivalents. For the three months ended June 30, 2022, and 2021,we had net losses of $3.5 million and $5.9 million, respectively. For the six months ended June 30, 2022, and 2021, we hadnet losses of $6.5 million and $6.0 million, respectively. As of June 30, 2022, we had an accumulated deficit of $19.4 million.

OnFebruary 4, 2022, we entered into an underwriting agreement with H.C. Wainwright & Co. (the “Underwriter”),as sole book-running manager, in connection with our initial public offering of common stock (the “IPO”). On February 4,2022, we announced the pricing of our IPO of 3,200,000 shares of common stock for a price of $5.00 per share, less certain underwritingdiscounts and commissions.We will pay UoE 2.5% of the gross amount of each of the Company’s future fund raisings up to a cumulative total of $3.0 million,including this $0.4 million.

TheIPO closed on February 8, 2022, with gross proceeds of $16.0 million, before deducting underwriting discounts and expenses (fornet proceeds of $12.6 million).

Inaddition, on July 29, 2022, we completed a private placement in which we received gross proceeds of $15.9 million before deductingfees and expenses (for net proceeds of $14.2 million). We believe that the proceeds from our IPO and private placement will enable usto fund our operating expenses and capital expenditures into the second half of 2024. We have based this estimate on assumptions thatmay prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Our future viability in the long termis dependent on our ability to raise additional capital to finance our operations.

FundingRequirements

Weexpect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activitiesand clinical trials of our current or future product candidates, including payments of milestones and sponsored research commitmentsassociated with our license agreements for NXP800 and NXP900. In addition, now that we have closed our initial public, we expect to incuradditional costs associated with operating as a public company, including significant legal, accounting, investor relations and otherexpenses that we did not incur as a private company. The timing and amount of our operating expenditures will depend largely on our abilityto:

Weanticipate that we will require additional capital as we seek regulatory approval of our product candidates and if we choose to pursuein-licenses or acquisitions of other product candidates. If we receive regulatory approval for our other future product candidates, weexpect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, dependingon where we choose to commercialize.

Management’s Discussion and Analysis of Financial Condition and Results of Operations 

Becauseof the numerous risks and uncertainties associated with research, development and commercialization of our product candidates, we areunable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increasesignificantly as a result of many factors, including:

Untilsuch time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of publicor private equity offerings, debt financings, governmental funding, collaborations, strategic partnerships and alliances or marketing,distribution or licensing arrangements with third parties. To the extent that we raise additional capital through the sale of equityor convertible debt securities, your ownership interest may be materially diluted, and the terms of such securities could include liquidationor other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available,may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurringadditional debt, making capital expenditures or declaring dividends. In addition, debt financing would result in fixed payment obligations.

Ifwe raise additional funds through governmental funding, collaborations, strategic partnerships and alliances or marketing, distributionor licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams,research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additionalfunds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate ourresearch, product development or future commercialization efforts or grant rights to develop and market product candidates that we wouldotherwise prefer to develop and market ourselves.

Contractualobligations and other commitments

Weenter into contracts in the normal course of business with clinical research organizations, contract manufacturing organizations, andother third parties for clinical trials, preclinical research studies, and testing and manufacturing services. These contracts are cancelableby us upon prior written notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred,including noncancelable obligations of our service providers, up to the date of cancellation. The amount and timing of such paymentsare not known.

Wehave also entered into license and collaboration agreements with third parties, which are in the normal course of business. We have notincluded future payments under these agreements since obligations under these agreements are contingent upon future events such as ourachievement of specified development, regulatory, and commercial milestones, or royalties on net product sales.

Pursuantto the NXP800 License Agreement, we are required to make payments to the ICR for certain development and regulatory milestones. As ofJune 30, 2022, we were obligated to pay up to $23.0 million in milestone payments to the ICR related to pre-approval milestones,up to $178 million (in addition to the $23.0 million) in regulatory and commercial sales milestones, and mid-single digit to 10% royaltieson a tiered basis on net sales. Additionally, the Company originally agreed to provide the ICR with up to an additional $0.5 millionin research and development. On March 31, 2022, the Company and ICR agreed to research and development support of an additional$0.4 million ($0.9 million total).

Management’s Discussion and Analysis of Financial Condition and Results of Operations 

Pursuantto the NXP900 License Agreement, we are required to make payments to the UoE for certain development and regulatory milestones. As ofJune 30, 2022, we were obligated to make up to $46.0 million in milestone payments to the UoE related to pre-approval milestones,including $0.5 million on the first anniversary of the agreement, up to $279.50 million in regulatory and commercial sales milestones,mid-single digit to 8% royalties on a tiered basis on net sales and 2.5% of the gross amount of each of the Company’s future fundraising up to a cumulative total of $3.0 million. Additionally, the Company will provide UoE with up to an additional $754,000 in researchand development support.

Wedo not currently have any long-term leases. We rent our office space in Fort Lee, New Jersey based on a one-year agreement signed onMay 1, 2022.

CriticalAccounting Policies and Significant Judgments and Estimates

Ourfinancial statements are prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparationof our financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets,liabilities, costs and expenses. We base our estimates on historical experience, known trends and events and various other factors thatwe believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying valuesof assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis.Our actual results may differ from these estimates under different assumptions or conditions.

Whileour significant accounting policies are described in more detail in Note 2 to our financial statements included in our Form 10-K filed with the SEC on March 23, 2022 which is incorporated herein by reference.The preparation of the Company’s financial statements requires management to make estimates and assumptions that impact the reportedamounts of assets, liabilities and expenses in the Company’s financial statements and accompanying notes. The most significantestimates in the Company’s financial statements relate to accruals for research and development expenses, valuation of equity awards,and valuation allowances for deferred tax assets. These estimates and assumptions are based on current facts, future expectations, andvarious other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments aboutthe carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actualresults may differ materially and adversely from these estimates.

Controlsand Procedures

Ourfinancial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation ofour financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets,liabilities, costs and expenses. We base our estimates on historical experience, known trends and events and various other factors thatwe believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying valuesof assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis.Our actual results may differ from these estimates under different assumptions or conditions.

Off-balanceSheet Arrangements

Wedid not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules andregulations of the Securities and Exchange Commission.

Quantitativeand Qualitative Disclosures About Market Risks

Thisdisclosure is not applicable as we are a smaller reporting company.

Management’s Discussion and Analysis of Financial Condition and Results of Operations 

EmergingGrowth Company and Smaller Reporting Company Status

TheJumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extendedtransition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwiseapply to private companies. We have elected to not “opt out” of this provision and, as a result, we will adopt new or revisedaccounting standards at the time private companies adopt the new or revised accounting standard and will do so until such time that weeither (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerginggrowth company.

Weare also a “smaller reporting company” meaning that the market value of our stock held by non-affiliates is less than $700million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smallerreporting company after this offering if either (i) the market value of our stock held by non-affiliates is less than $250 millionor (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of ourstock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerginggrowth company, we may continue to rely on exemptions from certain disclosure 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 statementsin our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosureobligations regarding executive compensation.

Business 

Overview

Business

Weare a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious unmet medicalneeds in oncology. Our development strategy utilizes a precision medicine-based approach that translates key scientific insights relatingto oncogenic drivers, pathway addiction and other cancer-promoting factors into selective and potent anticancer drugs.

Anew generation of approved targeted therapies, such as kinase inhibitors, have transformed the treatment of cancer and demonstrated asignificant benefit to certain patients with genetically defined tumor types. In turn, improved genetic sequencing has led to the discoveryof additional cancer-promoting genetic alterations that were previously unknown, unaddressed, unsuccessfully targeted or overlooked.

Webelieve that these advancements provide the basis for modern development of targeted therapies that will enable the discovery and developmentof anticancer treatments based on genetic characterization of tumors rather than tumor histology.

Nuvectiswas founded and is led by an experienced management team with extensive drug development expertise. Our three co-founders have significantdrug development knowledge and experience, and a demonstrated track record of success including four past FDA approvals of novel medicationsin both oncologic and non-oncologic indications and additional approvals in Europe and Japan.

TheNuvectis Approach

Ourmission is to develop a portfolio of innovative product candidates for the treatment of cancer. We rely on our core competencies of targetselection, drug profiling, licensing, and clinical and regulatory execution to build a pipeline of anticancer drugs. We plan to continueto collaborate with best-in-class technology partners that we believe have the capability to discover selective and potent compoundswith desirable pharmacologic properties.

Weapply our deep understanding of how genetic alterations lead to the development, growth and spread of cancer. This understanding, combinedwith our knowledge of the underlying unmet clinical needs, informs and enables our development of an effective clinical and regulatorystrategy. We believe that our combination of clinical development and preclinical research expertise, could improve the potential forclinical, regulatory, and commercial success.

Withour focus on precision medicine, we aim to pharmacologically target oncogenic drivers, such as certain kinases that are mutated, overexpressed,or overactive, in cases where such alterations to the oncogene result in hyperactivation of pro-malignant signaling pathways, and non-oncogenicaddiction targets, such as support genes required for the survival of cancer cells. Our approach could enable the use of biomarker-drivenpatient selection, which could prospectively identify patients that are more likely to benefit from our targeted therapy, a type of cancertreatment that precisely identifies and attacks a specific pathway of cancer cells, thereby potentially increasing the likelihood ofa successful treatment outcome.

Moreover,we believe that our approach will allow us to potentially improve the time, costs and risks often associated with cancer drug development,and enable us to improve outcomes for patients with cancer.

Business 

Figure6: Nuvectis Precision Medicine Pipeline

OurLeadership Team

Nuvectiswas founded in 2020 and is led by a highly qualified management team comprised of industry veterans with extensive drug development experience,as well as proven capabilities to raise the capital necessary to support clinical development. Our three co-founders, Ron Bentsur, EnriquePoradosu, PhD., and Shay Shemesh, have extensive experience and a proven track record of successful drug development including four pastFDA approvals of novel medications in both oncologic and non-oncologic indications and additional approvals in Europe and Japan.

Collectively,the three co-founders of Nuvectis held leadership roles in four FDA approvals and launches of novel medications in both oncologicand non-oncologic indication, including three NDAs and one BLA, as well as two approvals in the EU, and one approval in Japan(via a Japanese partner). Our co-founders successfully led the approvals and launches of: Auryxia^®, which is used forthe treatment of hyperphosphatemia in patients with dialysis-dependent chronic kidney disease (“CKD”) and for thetreatment of anemia in patients with non-dialysis-dependent CKD; Jelmyto^®, which is used for the treatment of uppertract urothelial carcinoma; and Elzonris^®, which is used for the treatment of blastic plasmacytoid dendritic cellneoplasm. Notably, significant regulatory achievements also include obtaining two Breakthrough Therapy Designations in oncology andsix Orphan Drug Designations (four in the U.S. and two in the EU) and two Fast Track Designations.

Ourprincipals are:

RonBentsur (56), Co-Founder, Chairman, Chief Executive Officer and President of Nuvectis, hasover 20 years of senior leadership experience in the biotechnology industry. He served as CEO of UroGen Pharma, Inc. (NASDAQ:URGN) from August 2015 until January 2019, and as CEO of Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX, acquired byAkebia Therapeutics) from May 2009 until May 2015. At UroGen and Keryx, Mr. Bentsur led the clinical development,regulatory approvals and the commercial infrastructure buildouts for the US commercial launches of Jelmyto and Auryxia,respectively. Mr. Bentsur also led the establishment of a successful worldwide partnership for an earlier-stage program atUroGen and an ex-US development partnership for Auryxia at Keryx. Mr. Bentsur served as CEO of XTLBiopharmaceuticals, Inc. (NASDAQ: XTLB) from January 2006 until April 2009 and as Investor Relations and CFO of Keryxfrom October 2000 until January 2006. Mr. Bentsur worked as an investment banker in NYC and Tel Aviv, Israel,from 1994 until 2000. Mr. Bentsur served as a member of the Board of Directors of Stemline Therapeutics, Inc. from 2009through the approval and launch of Elzonris^® and through the subsequent acquisition of the company by Menarini inJune 2020, and serves on the Board of Directors of Beyond Air, Inc. (NASDAQ: XAIR). Mr. Bentsur holds a BA inEconomics and Business Administration with distinctionfrom the Hebrew University of Jerusalem, Israel and an MBA (Magna Cum Laude), from New York University’s SternSchool of Business.

Business 

EnriquePoradosu, PhD (56), Co-Founder, Executive Vice President, Chief Scientific and Business Officer of Nuvectis,has over 20 years of senior scientific leadership experience in the biotechnology industry. From 2016 until 2020, he served as SVP, Businessand Scientific Strategy at Stemline Therapeutics, Inc. (NASDAQ: STML, acquired by Menarini in June 2020). At Stemline Dr. Poradosuled the licensing and scientific strategy of the company’s pipeline, as well as directly leading strategic planning and operationalexecution of the early-stage drug development programs. Prior to that, Dr. Poradosu served as VP Business and Scientific Strategyat Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX, acquired by Akebia Therapeutics), from 2003 until 2016. From 1998 until 2003, Dr. Poradosuserved as a project manager at a private biomedical incubator.

Dr. Poradosuholds a BSc in Chemistry and Biology with distinction from the Hebrew University of Jerusalem, Israel and a PhD in Biochemistry,from the Hebrew University of Jerusalem.

ShayShemesh (39), Co-Founder, Executive Vice President, Chief Development & Operations Officer of Nuvectis,has over 15 years of multi-disciplinary experience in drug development. From 2015 until 2020, he served as SVP, Clinical and RegulatoryAffairs at Stemline Therapeutics, Inc. (NASDAQ: STML, acquired by Menarini in June 2020) where he led multi-disciplinary developmentteams in early and late-stage projects. In this role, Mr. Shemesh held responsibilities for the strategic planning and operationalexecution of the Elzonris^® clinical program and Biologics License Application, with the FDA and Marketing AuthorizationApplication with EMA, resulting in the approval of Elzonris™ in both regions for the treatment of blastic plasmacytoid dendriticcell neoplasm, an orphan hematologic malignancy. Prior to that, Mr. Shemesh was a clinical operations lead at Keryx Biopharmaceuticals(NASDAQ: KERX, acquired by Akebia Therapeutics), where he managed the late-stage clinical trials for Auryxia™ for the treatmentof anemia in patients with non- dialysis CKD, which led to the approval of Auryxia in this indication in the US and the EU. Mr. Shemeshholds a BSc and MSc in Biotechnology from Bar Ilan University in Israel.

MichaelCarson (46), Vice President of Finance, has over 20 years of broad experience in corporate finance,accounting, and operations. He specializes in clinical stage biopharmaceutical and biotechnology companies. From late 2019 until 2021,he served as Vice President of Finance at XyloCor Theraputics, Inc. where he led the accounting, treasury and finance functions.During 2019, Mr. Carson consulted for Smiths Medical, Inc., a division of Smiths Group, as Global Controller along with servingas Vice President of Finance in a consulting role for several other biopharmaceutical and medical device companies. At Smiths Medical,he led a team responsible for accounting, treasury and foreign currency exposure. From 2015 to 2019 he served as Director of FinancialPlanning and Analysis at Neuronetics (NASDAQ: STIM). In this role, Mr. Carson served as the second in command to the Chief FinancialOfficer and held responsibilities for strategic planning, financial execution, investor relations, and controllership. In the past, hehas held several finance and accounting positions at Abbott Laboratories (NYSE: ABT) and served as an auditor at Crowe LLP and Deloitte.Mr. Carson holds a Bachelor of Arts in Business and Economics along with a Bachelor of Science in Mechanical Engineering from LafayetteCollege in Pennsylvania. He is a licensed Certified Public Accountant in the Commonwealth of Pennsylvania.

NXP800 — Our Lead Product Candidate

Wehave licensed exclusive world-wide commercial rights to NXP800, our lead product candidate, which was developed at the world-renownedInstitute for Cancer Research (“ICR”) in London, England. The ICR is a pioneer in discovery of new anti-cancer agents withunique mechanisms of action. The ICR’s drug discovery unit has discovered several successful product candidates, the most notableof which is Zytiga, a leading drug for metastatic prostate cancer. Our license agreement with the ICR is subject to certain milestoneand royalty payments. For additional information see section “NXP800 License Agreement”.

NXP800is an inhibitor of the Heat Shock Factor 1 (“HSF1”) pathway. A large body of work has verified the importance of HSF1 totumorigenesis and progression in a variety of malignancies. Cancer cells actively exploit HSF1 to overcome diverse stresses and promotebiological activities crucial for the survival, progression, immune evasion, and metastasis. This utilization of the HSF1 pathway bythe cancer cell in order to overcome stress is also referred to as an HSF1 addiction. It was hypothesized that inhibiting the HSF1 pathwaywould substantially impede the survival of cancer cells. This hypothesis led to the discovery of NXP800.

Inpreclinical studies, treatment with NXP800 inhibited tumor growth in human xenografts of ovarian cancer. In addition, we identified agene signature related to a mutation in the AT-Rich Interaction Domain (“ARID1a”) gene that has potential to serve as a biomarkerfor patient selection in ovarian and other cancer types. Based on this work, we plan to initially study the potential efficacy of NXP800in Ovarian Clear Cell Carcinoma (“OCCC”) and endometrioid ovarian carcinoma, and to investigate the use of ARID1a mutationsas a potential patient selection marker for additional types of cancer. The genetic screening for the ARID1a mutation is a standard partof the commercially available screening panels being utilized in the clinic for cancer patients.

Business 

Acomprehensive preclinical data package comprised of pharmacology, pharmacokinetic, and toxicological and other safety studiesrequired as part of an IND Application to the FDA and a CTA to the MHRA for the initiation of a first in human (FIH), Phase1, clinical study of NXP800 were completed by the ICR and by third-party certified labs, supported the approval of the CTA by theMHRA. In preclinical and toxicology studies no meaningful off-target effects were observed when screened against a broad panel ofkinases, bromodomains, GPCRs, orphan receptors, and nuclear hormone receptors. In December 2021, we announced the commencementof the Phase 1 study for NXP800. The Phase 1 study is comprised of two parts: dose-escalation Phase 1a, initiated inDecember 2021, followed by an expansion Phase 1b. In the Phase 1a, the safety and tolerability of NXP800 are evaluated inpatients with advanced solid tumors to identify a dose and dosing schedule for the Phase 1b. In June 2022 we announced that theFDA had accepted the IND for NXP800 and the phase 1a study is currently enrolling patients both in the U.S. and U.K. In the Phase1b, the safety and preliminary anti-tumor activity of NXP800 will be evaluated in biomarker- selected patients, initially in ovarianclear cell carcinoma and endometrioid carcinoma harboring the ARID1a mutation and possibly cohorts of patients with additional typesof solid tumors. Moreover, additional preclinical studies are being conducted in order to assess the preclinical efficacy of NXP800in additional solid tumor types.

ClinicalTrial and Regulatory Execution

Ourclinical development strategy employs a stepwise approach designed to identify signals of activity early in development. In our exploratoryclinical trials, we plan to treat patients whose tumors harbor a specific genetic alteration, the ARID1a mutation. We believe that thispatient enrichment approach improves the likelihood of demonstrating clinical benefit and providing meaningful insight into a productcandidate’s therapeutic potential.

NXP800Scientific Background Cell Stress and Carcinogenesis

Livingcells possess different mechanisms that allow them to adapt to stressful factors in their environment. These cellular mechanisms involvealterations in metabolism, as well as in signal transduction, transcription, translation, protein packaging and/or release. The initialcellular response against a harmful factor is aimed at defense. If the damaging signals are too severe and cause irreversible injury,cells activate death signaling pathways. The activation of protective or destructive pathways depends to a large extent on the natureand duration of the stress, as well as the cell type involved. The final fate of the stressed cell depends on the interplay between theseresponses. Carcinogenesis is a complex multi-step process involving metabolic and functional changes enabling transformed cells to surviveand adapt to the tumor microenvironment. Most cancers are associated with various genetic and epigenetic changes leading to the malfunctioningof critical genes. However, cancer cells also depend on the normal functioning of certain genes. As such, activation of specific cytoprotectivemechanisms can support the survival of transformed cells.

HSF1 — A Guardian of the Proteome

Oneof the main pro-survival responses, a factor promoting the survival of a cell, that protect cancer cells from stress is the transcriptionfactor HSF1, which plays a dominant role in the cellular response to the oncogenic stress imposed on the cancer cell, such as proteotoxicoxidative stress (an imbalance of free radicals and antioxidants resulting from increased metabolic rate of the cancer cell), and acidificationof the microenvironment as well as heavy metals such as iron, all of which are relevant to the etiology of our initial targeted indications.A large body of work has verified the importance of HSF1 to tumorigenesis and cancer progression.

Business 

HSF1can also be considered as one of the guardians of the cellular proteome, or the pool of proteins within a cell. It has been foundthat HSF1 normally regulates a subset of genes involved in the control of cell proliferation, the process that results in anincrease of the number of cells and cell cycle progression, and also extends the survival of transformed cells. Consequently, cancercells may become dependent upon, or addicted to, HSF1. Although HSF1 is neither a tumor suppressor nor a typical oncogene, itaffects many aspects of cellular metabolism that are important for the cancer phenotype by modulating signaling pathways associatedwith growth and proliferation, apoptosis, glucose metabolism, angiogenesis, cell motility, and the response to theproteotoxic stress in the tumor microenvironment (See Figure 7).

Figure7: HSF1 addiction in cancer

Legend:HSF1 is actively exploited by cancer cells to overcome diverse stresses and to promote biological activities crucial for cancer survival,progression, immune evasion and metastasis.

Additionally,HSF1’s activity has been found to modulate signaling pathways that are altered through the expression of mutant oncogenic proteins,thus affecting the phenotype of cancer cells. This phenomenon has been referred to as non-oncogenic addiction, based on the observationthat cancer cells are more dependent on the chaperoning function of HSPs than normal cells. Thus, the HSF1 pathway is a compelling oncologytarget, which led to the discovery of the NXP800 strategy.

Discoveryand Optimization of NXP800

NXP800emerged from a phenotypic screen for antagonists of the HSF1-mediated transcriptional response. In phenotypic screens, small moleculesundergo high-throughput screening against intact cells, and discrete phenotypic changes in the cell are measured and quantified. Phenotypicscreens are unbiased and have several advantages over screens using recombinant proteins. Hits from a phenotypic screen will, by definition,be cell permeable and have cellular activity, potentially reducing optimization cycles and timelines. The ICR screening led to the identificationof the bisamide series, and further optimization of the series led to the identification of NXP800, which was selected as the clinicaldrug candidate.

Figure8: NXP800 — Planned Development

Source:Nuvectis Pharma

Business 

Beyondthe initial target indications of OCCC and endometrioid ovarian carcinoma, we believe that NXP800 has the potential to demonstrate anti-tumoractivity in several additional tumor types, such as endometrial, breast, lung, gastrointestinal, hepatocellular, esophageal and others.Preclinical work is currently being conducted to investigate the use of ARID1a mutation as a potential patient selection marker in additionaltumor types. This work could support our use of a tumor-agnostic development strategy (see Figure 6) wherein we enroll patients basedon the cancer’s genetic and molecular features without regard to the type or location of the cancer. We expect to provide preclinicaland clinical data updates at key medical conferences in 2022.

NXP800Patient Enrichment Strategies

Usinggene expression microarray analysis, we have identified a gene signature that may indicate the sensitivity of specific cancer mutationsto NXP800 and has potential as a biomarker for patient enrichment. Tumor samples from seven different ovarian cancer xenograft modelstudies were split into two groups based on their response to NXP800 treatment (4/7 responsive and 3/7 non-responsive), with probes requiredto express at least a two-fold differential in the responsive groups. Treatment with NXP800 in the IGROV-1, OVISE, SK-OV-3 and TOV-21Gxenografts showed significant anti-tumor effect (as illustrated in Figure 9 showing data for two of these models). These OCCC and endometrioidovarian cancer models all harbor a mutation in ARID1a. ARID1a is frequently mutated in solid tumors and is associated with aberrant cellcycle and loss of control of proliferation, allowing cancer cells to achieve an advantage, but at the expense of lowered defenses againstoncogenic, cellular and environmental stressors such as oxidative stress (an imbalance of free radicals and antioxidants resulting fromincreased metabolic rate of the cancer cell), heavy metals and chemotherapy. The cancer cells compensate for this exposure utilizingthe cell stress response including increased activity of the HSF1 pathway.

Figure9: Inhibition of OCCC Tumor Growth in Preclinical In Vivo Models Harboring the ARID1a Mutation

Legend:NXP800 (CCT361814 in the chart) strongly inhibited tumor growth of SKOV3 and Tov-21G OCCC models in vivo

Thus,ARID1a deficiency offers a potential biomarker for a patient enrichment strategy in ovarian and other cancers. ARID1a testing is availablein commonly used and commercially available and academic molecular diagnostic panels.

Mutationsand epigenetic downregulation, the reduction at the cellular level of the magnitude or rate of a physiological response or abiochemical process, such as the expression of a gene of ARID1a occur in roughly two thirds of all OCCC patients, approximately 40%of all endometrioid ovarian carcinoma patients, as well as in varying percentages in several additional types of cancers.Consequently, the ARID1a mutation provides the potential as a biomarker for patient enrichment strategies in ovarian and othercancer types. Based on this data, we plan to initially study the potential efficacy of NXP800 in OCCC and endometrioid ovariancarcinoma in patients harboring the ARID1a mutation. ARID1a is also frequently mutated in additional solid tumors (see Table2).

Business 

Wehope to become the first company with an approved drug in relapse/refractory OCCC and endometrioid ovarian carcinoma, two unmet medicalneeds with no approved therapies. Additionally, given the potentially wider role of ARID1a, we believe that NXP800 has substantial potentialbeyond our initial indications, and we plan to explore additional development approaches to broaden the market opportunities in a varietyof solid tumors.

Table2: Prevalence of ARID1a mutation and protein loss in solid tumors

N.A. — Data not available

OCCCand Endometrioid Ovarian Carcinoma: Disease Etiology and HSF1

Clinically,it has been observed that OCCC arises predominantly from ovarian endometriotic cysts, which are characterized by repeated bleeding intothe cyst cavity during the menstrual cycle. The content of an endometriotic cyst, consisting of old blood, contains a markedly high concentrationof free iron. Free iron is a source of reactive oxygen species (“ROS”) and excess iron is associated with cancer developmentthrough the induction of persistent oxidative stress (an imbalance of free radicals and antioxidants resulting from increased metabolicrate of the cancer cell) in several organs. Thus, extensive oxidative stress in the endometriotic cyst may contributes to of the developmentof OCCC and endometrioid ovarian carcinoma through induction of DNA damage (see Figure 10 below).

Figure10: Unique microenvironment within endometriotic cysts may lead to ovarian carcinoma

Legend:Microenvironment with especially high concentration of free iron, derived from blood accumulated in the cyst, causes oxidative stress(“ROS”) and leads to DNA damage. Accumulation of DNA damage over the years eventually leads to development of cancer.

Source:Nuvectis Pharma

Inparallel to the DNA damage, exposure to free iron can also trigger ferroptosis, a newly identified, iron- dependent, regulated cell deathmechanism. As described in Figure 11 below, ovarian cancer cells develop an increased capability to overcome ferroptosis, which in turnpromotes cancer cell survival, with the HSF1 pathway playing a major role in this protective mechanism.

Business 

ARID1aEnrichment Strategy — Scientific Rationale

Severalgenes were modulated by treatment with NXP800, including known HSF1 target genes such as HSPB1, which is an important pro-survival factor,a factor promoting the survival of a cell, indicating a direct effect on the HSF1 pathway by NXP800. In addition, treatment with NXP800resulted in upregulation of CHAC-1, whose unique function is the degradation of GSH, a key metabolite in cancer cell protection fromstress (see Figure 11 below).

ARID1ahas been identified as a tumor suppressor in a broad array of cancers, in which loss of function mutations and protein loss are associatedwith aberrant cell cycle and loss of control of proliferation at the expense of lowered defenses against oncogenic and microenvironmentstress. The cancer cells compensate for this vulnerability in different ways, including by increased activity of the HSF1 pathway. Thus,by inhibiting the HSF1 pathway and downregulating the GSH levels in cancer cells with the ARID1a mutation, NXP800 tips the balance towardscancer cell death, with the cancer cell no longer able to tolerate the increased metabolic and other stresses.

ARID1aand Glutathione Metabolism

Anovel relationship was recently established between ARID1a deficiency and glutathione (“GSH”) metabolism (see Figure12), showing that reducing antioxidant GSH metabolism is a weakness of ARID1a. Disruption of the SWI/SNF (SWItch/Sucrose Non-Fermentable)complex, of which ARID1a is a key component, is associated with aberrant cell cycle and loss of control of proliferation, therefore,cancer cells achieve an advantage at a price of lowering their defenses against insults from free iron (which as discussed previouslyis a key stress factor involved in the etiology of OCCC and endometrioid ovarian carcinoma).

Reductionof the metabolic pathway leading to GSH generation can be partially balanced in cancer cells by an increase in the activity of the HSF1-HSPB1axis. The discovery of the link between ARID1a deficiency and reduction of the GSH protective pool has important therapeutic implicationsfor the treatment of ARID1a-deficient tumors, which are susceptible to targeting the HSF1 pathway via synthetically lethality wherebyGSH levels are further reduced through the activation of the main enzyme responsible for GSH degradation (“CHAC1”).

Figure11: CHAC1 and HSPB1 are validated NXP800 Biomarkers and are Key Regulators of Ferroptotic Cell Death

Legend:As the levels of the cystine importer, SLC7A11 are reduced in ARID1a mutations, the cancer cells are increasingly dependent on alternativepathways that are targeted by NXP800 as demonstrated by the validated biomarkers HSPB1 and Chac1

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SyntheticLethality and ARID1a

Syntheticlethality is a clinically validated approach to treating cancer which arises when simultaneous deficiencies in a pair of genes resultin cell death. However, if the deficiency exists in only one gene, the cell survives. The first examples of a molecular targeted therapeuticexploiting synthetic lethality are the PARP inhibitors, which were first approved in 2016. PARP inhibitors include AstraZeneca and Merck’sLynparza^®, and Zejula^® from the GlaxoSmithKline unit Tesaro. PARP is a family of proteins involved in essentialcellular processes such as DNA repair, genomic stability, and programmed cell death. The synthetic lethality approach represents a wayto target lost tumor suppressor genes, which have long evaded drug developers as they cannot be drugged directly. The BRCA mutation isfound in approximately 10-15% of the ovarian epithelial cancer, a slightly lower target patient prevalence compared to OCCC and endometrioidovarian carcinoma combined. In 2017, prior to their additional approval in the maintenance setting in ovarian cancer and in breast cancer,global PARP inhibitors revenue in the heavily pretreated, advanced-stage ovarian cancer setting was reported at $461 million. In 2020,following the label expansion, the global PARP inhibitor market was valued at $2.178 billion.

Thepreclinical data establishing the link between ARID1a deficiency and the overactivation of the HSF1 pathway as a compensation mechanismin cancer cells suggest these cancer cells may be susceptible to a synthetic lethality approach through NXP800’s inhibition ofthe HSF1 pathway. Synthetic lethality results from the interaction between two genes that cause cell death when both are inactivated,if only one of the pair genes is inactivated, the cell survives. In cancer cells, a certain genetic lesion which has no apparent effecton cell viability can create a vulnerability that enables the pharmacological inhibition of a different target, (a synthetic lethalitypair), to kill the cancer cells whereas normal cells (which lack the genetic lesion) are spared the effect of the drug. In cancer cells,one of these genes can be inactivated epigenetically or via mutation; while the other can be inactivated by a drug.

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Figure12. ARID1a and NXP800 Driven Synthetic Lethality

Source:Nuvectis Pharma

Addressingan Unmet Need in Clear Cell Ovarian Cancer and Endometrioid Ovarian Carcinoma

Weplan to initially investigate NXP800 as a treatment for OCCC and endometrioid ovarian carcinoma. NXP800 is precisely targeted for womenwith these diseases who have either the ARID1a mutation or ARID1a epigenetic loss.

OCCCis highly malignant, difficult to treat, and has a very poor survival rate due to frequent recurrence after surgery and first-line treatment.The reported response rate to platinum-based chemotherapy (“PBC”) in patients with relapse/refractory disease is 1%, demonstratinga clear and dire need for a new treatment option for OCCC. OCCC represents approximately 10% of all ovarian cancer cases in the UnitedStates, with an annual incidence of approximately 2,200 patients.

Endometrioidovarian cancer represents approximately 10% of all diagnosed ovarian cancer cases. If diagnosed at early-stage, endometrioid ovariantumors can typically be resected. However, if diagnosed at later stages, these tumors have a substantially worse prognosis. Advanced,platinum-refractory, endometrioid cancer in the United States represents approximately 30% of the endometrioid ovarian cancer segment.Notwithstanding the initial PBC response in the endometrioid ovarian subset, the progression-free survival at three years for patientsdiagnosed with stage III/IV endometrioid ovarian cancer is a dismal 20% and for stage III and 0% for stage IV.

OCCCand endometrioid ovarian carcinoma are subtypes of epithelial ovarian carcinoma with clinical characteristics that are distinct fromthose of the most common ovarian carcinoma, high-grade serious ovarian carcinoma. They exhibit a unique biological profile that is markedlydifferent from those of other histologic types. The incidence of OCCC among ovarian cancer patients is higher in East Asia (approximately25% in Japan), than in Europe and the United States (approximately 10%) (see Table3 below).

Table3: Estimated Annual Incidence of ARID1a Mutated Patients in OCCC and Endometrioid Ovarian Carcinoma in Major Markets

Source:Nuvectis Pharma

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Webelieve that we can become the first company with an approved drug in advanced-stage OCCC and endometrioid ovarian carcinoma. Our Phase1 clinical trial of NXP800 commenced in December 2021.

MarketPotential/Addressable Patient Population in Additional Solid Tumor Types

Beyondour initial target indications, we believe that NXP800 has the potential to demonstrate anti-tumor activity in several additional tumortypes, such as gastric, hepatocellular, esophageal, urothelial carcinoma and others.

ARID1amutations are present in a number of other cancers, most notably gastric, hepatocellular, and esophageal cancers. These may be investigatedas secondary indications (see Table4 below).

Table4: Examples of estimated annual incidence of patients with advanced-stage solid tumors harboring ARID1a mutations

Source:Nuvectis Pharma

Preclinicaldrug discovery and validation

Acomprehensive preclinical data package for NXP800 has been assembled. Preclinical studies of NXP800 conducted were as follows:

Pharmacologystudies

Thein vivo antitumour activity of NXP800 was evaluated in mice bearing human tumor xenografts (in all studies tumor growth inhibition (TGI)was calculated versus vehicle control (i.e., no active drug) that was administered to a concurrently treated group of mice, p-valueswere calculated for the weight-based assessments):

Experimentsin SKOV-3 xenograft models (ovarian cancer model):

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Experimentin TOV-21G xenograft model (ovarian cancer model):

Experimentin OVISE xenograft model (ovarian cancer model):

Experimentin IGROV-1 xenograft model (ovarian cancer model):

Experimentin PA-1 xenograft model (ovarian cancer model):

Experimentin WM266.4 xenograft model (melanoma model):

Experimentin MCF-7 xenograft model (breast cancer model):

Secondarypharmacodynamics

NXP800has been screened against several panels for secondary pharmacology, and no hits were found in any of the screens at concentrations thatare relevant to the free drug target concentrations of NXP800 associated with efficacy (in mouse models) or toxicity (in rat and dog,the species used in the GLP-toxicology studies).

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Safetypharmacology

NXP800was profiled against the Cerep Safetyscreen 87 at a concentration of 10 μM. Hits (> 50% at 10 μM) in thispreliminary screen were then assessed across a range of concentrations in an individual cell- based assay for both agonism andantagonism of the relevant receptors. NXP800 showed no agonism activity with any receptor and antagonist activity with only onereceptor with an IC50 of 2.0 μM. A GLP study was performed to evaluate the effects of NXP800 on cardiovascular parameters andbody temperature in the dog (two groups of two dogs each) following oral administration, and the No Adverse Effect Level (NOEL),driven by a transient increase in arterial blood pressure, was 3 mg/kg.

Pharmacokinetics

Theabsorption, distribution, and metabolism properties of NXP800 were characterized, including apparent permeability in Caco-2 cells andtransporter interaction, plasma protein binding and blood-to-plasma partitioning, intrinsic clearance, identification of metabolites(including a proposed metabolic pathway in human) and inhibition of human CYP isoforms. The excretion of NXP800 was characterized postIV or oral dose in rats.

Toxicology

Thetoxicity of NXP800 was initially assessed in healthy mice. Formal toxicology was then performed in rat and dog. In both rat and dog,non-GLP combined dose range finding and pharmacokinetic (“PK’’) studies were performed prior to the pivotal GLP28-day repeat dose toxicity studies and included an assessment of recovery and toxicokinetics. All pivotal GLP toxicitystudies were conducted at Charles River Laboratories Edinburgh Ltd, UK. The GLP studies were therefore performed in a country thatis a member of the OECD Mutual Acceptance of Data program with the OECD Test Guidelines and Principles of GLP.

Ratand dog were selected as the rodent and non-rodent species for toxicity studies of NXP800 based on similarities to humans with regardto the proportion of hydrolysis metabolism. Based on initial PK studies, free drug exposure levels could be achieved following oral dosingat comparable levels to those required to achieve efficacy in mice. In addition, all metabolites found after exposure of human matricesto NXP800 were also found in matrices of one or both toxicity model species, and therefore their toxicity would be assessed in the toxicologystudies.

Continuousdaily dosing was selected as the initial schedule for NXP800 toxicity studies to facilitate flexibility in clinical administration. Inthe dog, Cmax-driven emesis limited exposure and the schedule changed to continuous twice daily dosing to increase exposure to NXP800.

Basedon the clinical indication (advanced solid tumors) and route of administration (oral) of NXP800, no carcinogenicity, reproductive toxicityor local tolerance studies have been performed at this stage of development. Non GLP mutagenicity studies have been performed. The phototoxicityof NXP800 has also been assessed.

NXP800Clinical Development Plan

Basedon the compelling preclinical data, in December 2021 we announced the commencement of the Phase 1 study for NXP800. The Phase 1study is comprised of two parts: dose-escalation Phase 1a, initiated in December 2021, followed by an expansion Phase 1b. In thePhase 1a, the safety and tolerability of NXP800 are being evaluated in patients with advanced solid tumors to identify a dose and dosingschedule for the Phase 1b. The Phase 1a is being conducted in the U.S. and U.K. In the Phase 1b, the safety and preliminary anti-tumoractivity of NXP800 will be evaluated in biomarker-selected patients, initially in ovarian clear cell carcinoma and endometrioid carcinomaharboring the ARID1a mutation and possibly cohorts of patients with additional types of solid tumors. The endpoints in the Phase 1 studythat will be utilized to inform the primary objective include estimation of the rate and severity of adverse events and dose-limitingtoxicities in the Phase 1a dose escalation stage, and estimation of clinical activity in the Phase 1b expansion stage of the Phase 1study. Secondary objectives include characterization of the pharmacokinetic and pharmacodynamic profile of NXP800. Once a recommendeddose is established, patients will be enrolled in additional cohorts to determine the clinical activity and further characterizethe clinical profile of NXP800. The sample size for the dose escalation portion of the study will be driven by the emerging clinicaldata and is expected to be between 20-50 subjects. In the expansion stage of the Phase 1 study, we plan to enroll three cohorts of 12 – 15 subjects each. We plan to include OCCC or endometrioid ovarian carcinoma patients with the ARID1a mutation in these cohorts.

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NXP900Scientific Background

InAugust 2021 we licensed worldwide commercial rights to NXP900 from the UoE. NXP900 is a preclinical- stage, targeted-therapy,small molecule drug candidate designed to preferentially inhibit the SRC and YES 1 kinases. We started the preclinicalIND-enabling (or equivalent) studies for NXP900 in the fourth quarter of 2021. Following the IND-enabling studies, if successfullycompleted, we plan to submit an IND with the FDA, or an equivalent submission with a foreign agency, in order to begin a Phase 1dose- escalation study of NXP900 in solid tumors in the second half of 2022. Subsequently, upon successful completion of the dose-escalation study, we plan to conduct a clinical trial to investigate NXP900 in solid tumors where the SRC and/or YES1 pathways areoveractivated and implicated.

SRCas an anti-cancer target

SRCis aberrantly activated in many cancer types, including solid tumor cancers such as breast, colon, prostate, pancreatic and ovarian cancers,while remaining predominantly inactive in non-cancerous cells. Increased SRC activity is generally associated with late-stage cancers,metastatic potential and resistance to therapies, and correlates with poor clinical prognosis. Signaling pathways activated by SRC includeproliferation, cell growth, cell migration and metastasis, and angiogenesis mediated by Phosphatidylinositide 3 Kinase (PI3K), Mitogen-ActivatedProtein Kinase (MAPK), Signal Transducer and Activator of Transcription 3 (Stat3), Interleukin (IL) 8, and Vascular EndothelialGrowth Factor (VEGF) (see Figure 13).

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Figure13: Key oncogenic pathways activated by SRC kinase

Legend:Signaling pathways activated by SRC include proliferation, cell growth, cytoskeleton (cell migration and metastasis), and angiogenesismediated by Phosphatidylinositide 3 Kinase (PI3K), Mitogen-Activated Protein Kinase (MAPK), Signal Transducer and Activator of Transcription3 (Stat3), Interleukin (IL) 8, and Vascular Endothelial Growth Factor (VEGF)

SRCis a non-receptor tyrosine kinase and a widely studied member of the SRC family kinases (SFKs), which include LYN, FYN, LCK, HCK, FGR,BLK, FRK and YES. The SRC kinase, product of the first cellular proto-oncogene identified, emerged as a potential therapeutic targetin the early 1980s. Predominantly inactive in non-cancerous cells, SRC is aberrantly activated in many cancer types, including breast,colon, prostate, pancreatic and ovarian cancers. Increased SRC activity is generally associated with late-stage cancers, metastatic potentialand resistance to treatment, and correlates with poor clinical prognosis. Despite the vast amount of evidence gathered over the yearsand the approval of dasatinib and bosutinib, which act as dual SRC/ABL kinase inhibitors to treat chronic myelogenous leukemia and acutelymphoblastic leukemia, both hematologic (liquid) tumors, to date no SFK inhibitor has been approved for the treatment of SRC-activesolid tumor malignancies.

Dueto high structural similarities between their active sites, most inhibitors targeting SFK’s, including the approved drugs dasatiniband bosutinib, display equal potency against the nonreceptor tyrosine kinase ABL. While dual inhibition of ABL and SRC can be beneficialin the treatment of hematologic cancers, this polypharmacological profile is not desirable in the treatment of solid tumors, as severalstudies have found that inhibition of ABL leads to immuno suppressive effects. To date no kinase inhibitor has been approved for thetreatment of SRC-active solid tumor malignancies.

NXP900’sNovel Mechanism of Action

SRCpathway activation is regulated by a switch between an inactive and active conformation. The inactive conformation of SRC family kinasesis associated with lack of membrane binding, lack of phosphorylation of the activation loop, and characterized by a “closed conformation.”The active “open” conformation allows for the binding of SRC to signaling partners such as PI3K and FAK, thus enabling fullactivation of the pathway via SRC’s kinase catalytic activity and the scaffolding property.

NXP900is a targeted-therapy designed to preferentially inhibit the SRC and YES1 kinases. Unlike the approved and clinical-stage SRC kinaseinhibitors, NXP900 induces and locks SRC in its native inactive conformation (see Figure 14), by inhibiting both the catalytic (enzymatic)and scaffolding functions, thus preventing phosphorylation and complex formation with its primary partners. NXP900 is highly selectivecompared to dasatinib, (see figure 15), an approved multitargeted kinase inhibitor, a property typically associated with an improvedtherapeutic window. Moreover, the existing SRC inhibitor drugs only inhibit the catalytic functions of SRC, still enabling it to bindto its primary partners and remain partially active.

Thisunique mechanism of action, which leads to inactivation of the SRC kinase, has resulted in SRC- pathway inhibition in vitro and in vivo.In vivo, treatment with NXP900 inhibited primary and metastatic tumor growth in xenograft models of breast cancer and demonstrated on-targetpharmacodynamic effects. Therefore, this novel mode of inhibiting SRC by NXP900 could lead to improved treatment of SRC-associated oncologicdisorders and provides the potential to treat solid tumors for the first time with a SRC inhibitor.

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Geneamplification of the site containing the YES1 gene has been reported in clinical samples in several tumors including lung, head andneck, bladder and esophageal cancers. Furthermore, it has been found that YES1 gene amplification is a key mechanism of resistanceto EGFR, Alk and HER2 inhibitors. YES1- dependent oncogenic transformation has also been reported, suggesting that YES1 plays a keyrole in these solid tumors — The transforming ability of YES1 has been demonstrated via several experimental methods,for example down-regulating YES1 by short hairpin RNA (shRNA) significantly inhibited cell growth in several malignancies, includingcolon carcinoma, rhabdomyosarcoma, and basal-like breast cancer suggesting YES1 may play a key role in these solid tumors.

NXP900has been shown to inhibit the YES1 kinase in preclinical models, providing an additional target for pharmacological inhibition by NXP900of a biologically-relevant target in various cancer types, some of which may rely on both the SRC and YES1 pathways for their advantage.There are no YES1 inhibitors that are FDA approved or currently in clinical development. We plan to conduct in vivo studies to betterunderstand the effects of YES1 inhibition in solid tumors driven by YES1 overexpression or gene amplification. We expect to continueto provide preclinical data updates at key medical conferences in 2022.

Figure14: Novel mechanism of action compared to other SRC inhibitors

Legend:Complete activation of the SRC pathway requires both catalytic activity and scaffolding of its signal transduction partners in its activeconformation (middle image).NXP900 locks SRC in its inactive conformation (left image) by inhibiting both the catalytic activity of SRCand its ability to bind to its signal transduction partners. Other SRC inhibitors, including dasatinib, only inhibit the catalytic activityof SRC while locking it in its active conformation (right image) thereby only partially inhibiting the SRC pathway.

Figure15: Kinome profiling reveals high selectivity compared with dasatinib

Legend:Kinome-wide activity profile of NXP900 - enzymatic inhibition screen was performed by CarnaBiosciences, against 326 wildtype and mutant kinases. Circles identify kinase targets of NXP900 (0.5μM, lilac) and dasatinib (1μM,deep purple), size represents percent inhibition. Dasatinib data from Remsing Rix et al., Leukemia 23, 477–485 (2009).

NXP900preclinical proof of concept — In Vitro

NXP900is active against the catalytic activity of SRC in vitro at low nanomolar concentrations. NXP900 requires concentrations approximatelythree orders of magnitude (X1000) greater to inhibit ABL. In cells, NXP900 reduces SRC binding toits partner FAK. Notably, the SRC/ABL inhibitor dasatinib (known to bind SRC in its active conformation) induces precisely the oppositeeffect. These results provide convincing evidence that NXP900 and dasatinib bind and promote different conformations in SRC whereby NXP900inhibits both SRC kinase catalytic activity and its scaffolding functions. Further, it has been recently reported that SRC inhibitorssuch as dasatinib are allosteric facilitators of SRC conformational activation, and actually enhance SRC-FAK complex formation and increaseFAK autophosphorylation, leading to activation of signaling via SRC, whereas treatment with NXP900 is not expected to lead to such paradoxicalactivation.

Thekinase inhibitors approved or in clinical development that target SRC activity are examples of non- selective, promiscuous inhibitorstargeting many kinases in addition to SRC and its most closely related family members, often resulting in undesirable off-target effects.Preclinically, NXP900 inhibits YES1 and SRC in concentrations of 0.5 and 2.4 nM respectively. In addition, co-crystal structure analysisreveals that NXP900 induces and stabilizes the native inactive conformation of the SRC kinase domain as shown in Figure 14. The benefitsof targeting the inactive SRC kinase conformation make this a unique property. which could prove advantageous clinically compared toother SRC inhibitors.

NXP900preclinical proof of concept — In Vivo

NXP900demonstrated antitumor activity in mouse models of triple negative breast cancer (TNBC).

NXP900mediated in vivo antitumor activity in murine triple negative breast cancer models, against primary tumors and bone metastases. (Figure16). In the post-treatment period, mice with an intact immune system were able to control tumor growth beyond the treatment phase, whereastumor relapse occurs in immunosuppressed mice as soon as the animals were off treatment. NXP900 was superior compared to dasatinib inan orthotopic model of TNBC. Moreover, this superiority in tumor growth inhibition and duration of response translated into improvedoverall survival of the test mice (Figure 17).

Basedon the preclinical data and novel mechanism of action, we believe that NXP900 represents an important drug candidate for the treatmentof SRC and YES1 associated oncologic disorders.

Figure16: In vivo antitumor activity of NXP900 in murine triple negative breast cancer models, against primary tumors and bone metastases

Legend:(d,e) tumor growth inhibition of a MetBo2 breast cancer model in (d) immunocompetent FVB mice and (e) immunocompromised CD-1mice treated orally daily for 28 d with NXP900 (40 mg/Kg) or vehicle.

(f) Tumorvolumes at days 28 and 39 in FVB vs. CD1 mice treated with NXP900. (g-i) Metastasis inhibition by NXP900 in a breast cancer bone metastasismodel (40 mg/Kg or vehicle). (g) Percentage bioluminescence imaging (BLI) in left andright hind legs. Animals were monitored for 63 d. (h) Comparative analysis of % BLI between groups at day 7. (i) Bioluminescencetomography images of two representative mice from each group at day 7.

Figure17: NXP900 inhibited tumor growth in an orthotopic model of triple negative breast cancer (TNBC) in immunocompetent animals demonstratinga substantial long-term effect after treatment completion and improved survival compared to dasatinib.

Legend:A,B) Comparative analysis of tumor volumes vs dasatinib; C) Kaplan-Meier Survival analysis.

PreclinicalData of NXP900 in Medulloblastoma

Medulloblastomais a rare brain cancer (with an annual incidence of approximately 500 in the U.S.) that affects mostly pediatric patients. While rare,it is the most common pediatric brain tumor, and by the time of diagnosis, as many as 40% of patients carry metastases and have a poorprognosis for survival. Metastatic disease and tumor recurrence are responsible for the lack of improvement in survival rates over thepast decades. In addition, survivors frequently face treatment-related adverse effects.

Outof the four identified subtypes, group 4 is the most prevalent biological subtype, comprising approximately 40% of all medulloblastomapatients. Recent studies have identified aberrant ERBB4-SRC signaling pathway as the hallmark of group 4 patients, indicating the SRCkinase as a potential therapeutic target in this most common medulloblastoma subgroup.

Ina PK study, NXP900 was shown to cross the blood-brain barrier in mice, in concentrations that exceeded the levels required to inhibitSRC in vitro with NXP900. The efficacy of NXP900 in a preclinical xenograft model of Group 4 Medulloblastoma was presented on June ¹2th,2022 at SIOPE Brain Tumour Group (Figure 18). This data supports the further exploration of NXP900in the treatment of group 4 medulloblastoma. We plan to conduct additional preclinical testing of NXP900 to better understand the potentialtherapeutic effect of NXP900 in this indication.

Figure18: NXP900 is highly effective in a preclinical model of group 4 Medulloblastoma

Legend:SrcCA/DNp53 tumour cells were cultured in vitro and transduced using lentivirus expressing Luciferase-eGFP, for tumor tracking.Mice received NXP900 (eCF506) 20mg/kg daily for 28 days via IP in a citric buffer. Tumor response was monitored weekly via bioluminescenceand measured by calliper.

OurStrategy

Wehave a mission-driven strategy to build a global biopharmaceutical company through the identification, licensing, development, and commercializationof therapeutics to address unmet medical needs in oncology, with an initial focus on OCCC and endometrioid ovarian carcinoma patients.We intend to leverage our core competencies of target selection, drug profiling and clinical and regulatory execution to build a pipelineof product candidates targeting cancers driven by genetic alterations. The key elements driving our business strategy include:

IntellectualProperty

Westrive to protect the proprietary technologies that we believe are important to our business, including pursuing, obtaining andmaintaining patent protection intended to cover the composition of matter of our current or future product candidates, includingNXP800, their methods of use, related technologies and other inventions that are important to our business. In addition to patentprotection, we also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do notconsider appropriate for, patent protection. We also rely on know-how and continuing technological innovation to develop andmaintain our proprietary and intellectual property position.

Aswith other biotechnology companies, our commercial success depends in part upon our ability to: obtain, maintain, enforce, and protectour patent, intellectual property, and other proprietary rights for our current or future product candidates and other commercially importanttechnologies, inventions, improvements, and know-how related to our business; defend and enforce our intellectual property, in particular,any patent rights that we may own or in-license;, prevent others from infringing any patents we may own or in-license; preserve the confidentialityof our trade secrets; and operate without infringing the valid and enforceable intellectual property and proprietary rights of thirdparties.

Ourability to maintain and solidify our proprietary and intellectual property position for our current or future product candidates andtechnologies depends on our success in obtaining effective patent claims and enforcing those claims if granted. However, our currentpatent applications and any patent applications that we may in the future file or license from third parties may not result in the issuanceof patents, and any issued patents we may obtain may not guarantee us the right to practice our technology in relation to the commercializationof our products. We also cannot predict the breadth of claims that may be allowed or enforced in any patents we may own or in- licensein the future.

Thepatent positions for biotechnology and pharmaceutical companies like us are generally uncertain and can involve complex legal,scientific, and factual issues. We cannot predict whether the patent applications we are currently pursuing will issue as patents inany particular jurisdiction or whether the claims of any issued patents will provide sufficient proprietary protection fromcompetitors. Any issued patents that we may own or in-license in the future may be challenged, invalidated, circumvented, or havethe scope of their claims narrowed. Furthermore, the coverage claimed in a patent application can be significantly reduced before apatent is issued, and its scope can be reinterpreted and even challenged after issuance.

Moreover,many jurisdictions permit third parties to challenge issued patents in administrative proceedings, which may result in furthernarrowing or even cancellation of patent claims. As a result, we cannot guarantee that any of our current or future productcandidates will be protected or remain protectable by enforceable patents. Moreover, any patents that we hold may be challenged,circumvented or invalidated by third parties. We cannot be certain of the priority of inventions covered by pending third-partypatent applications. If third parties prepare and file patent applications in the United States that also claim technology ortherapeutics to which we have rights, we may have to participate in interference proceedings in the USPTO to determine priority ofinvention, which could result in substantial costs to us, even if the eventual outcome is favorable to us, which is highlyunpredictable. In addition, because of the extensive time required for clinical development and regulatory review of any current orfuture product candidate we may develop, it is possible that, before any current or future product candidates can be commercialized, anyrelated patent may expire or remain in force for only a short period following commercialization, thereby limiting the protectionsuch patent would afford the respective product and any competitive advantage such patent may provide.

Wehave licensed one patent family covering the composition of matter for NXP800, which includes two issued U.S. patents covering the compositionof matter for NXP800, as well as methods of using and making NXP800. Composition of matter patents in this family have also been issuedin other major markets, including Australia, Brazil, China, India, Israel, Mexico, Russia, Singapore, the E.U. and Japan. Thestatutory expiration for patents in this family is October 2034, without taking into account any possible patent term extension,where applicable. We have also licensed a patent family directed to additional compounds, structurally distinct from NXP800, that modulateHSF1. This patent family is granted in the U.S. and has a statutory expiration of April 2036. In addition, we have also licenseda patent family pending in the U.S. and Europe directed to deuterated compounds that modulate HSF1. Any patent that grants from thisfamily would have a statutory expiration of October 2037. We intend to pursue additional patent protection for NXP800 relating tomethods of use and related technologies that we consider important to our business.

Wehave licensed one patent family covering the composition of matter for NXP900, which includes one U.S. patent covering the compositionof matter for NXP900, as well as patents and patent applications issued/pending in major markets, including the E.U. and Japan. The statutoryexpiration for patents in this patent family is April 2036, without taking into account any possible patent term extension, whereapplicable. We have also licensed a patent family directed to additional compounds targeting the SRC family, filed as a priority applicationAugust 2021. Any patent that grants from this family would have a statutory expiration of August 2042.

Theterm of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countriesin which we file, the patent term is 20 years from the earliest date of filing a non- provisional patent application. In the United States,the term of a patent covering an FDA-approved drug may, in certain cases, be eligible for a patent term extension under the Hatch-WaxmanAct as compensation for the loss of patent term during the FDA regulatory review process. The period of extension may be up to five years,but cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. Only one patent applicableto an approved drug is eligible for extension and only those claims covering the approved drug, a method for using it, or a method formanufacturing it may be extended. Similar provisions are available in Europe and in certain other jurisdictions to extend the term ofa patent that covers an approved drug. It is possible that issued U.S. patents covering NXP800 and NXP900, may or will be entitled topatent term extensions. If our current or future product candidates receive FDA approval, we intend to apply for patent term extensions,if available, to extend the term of patents that cover any approved product candidates. We also intend to seek patent term extensionsin any jurisdictions where they are available; however, there is no guarantee that the applicable authorities, including the FDA, willagree with our assessment of whether such extensions should be granted, and even if granted, the length of such extensions.

Inaddition to patent protection, we also rely on trade secret protection for our proprietary information that is not amenable to, or thatwe do not consider appropriate for, patent protection, including certain aspect of our manufacturing processes. However, tradesecrets can be difficult to protect. Although we take steps to protect our proprietary information, including restricting access to ourconfidential information, as well as entering into non-disclosure and confidentiality agreements with our employees, consultants, independentcontractors, advisors, contract manufacturers, CROs, hospitals, independent treatment centers, suppliers, collaborators and other thirdparties, such parties may breach such agreements and disclose our proprietary information including our trade secrets, and we may notbe able to obtain adequate remedies for such breaches. In addition, third parties may independently develop the same or similar proprietaryinformation or may otherwise gain access to our proprietary information. As a result, we may be unable to meaningfully protect our tradesecrets and proprietary information. For more information regarding the risks related to our intellectual property, please see “RiskFactors — Risks Related to Our Intellectual Property.”

NXP800License Agreement

InMay 2021, we entered into a worldwide, exclusive license agreement with the CRT Pioneer Fund (“CRT”) for NXP800 andany of its derivatives (collectively, the “NXP800 Program”). NXP800 is a small molecule product candidate that we believecan be applied to a broad range of cancers.

Priorto Nuvectis, CRT was the commercial owner of the NXP800 Program which it acquired from the ICR. The ICR is a world-renowned researchinstitute focused on the discovery and preclinical development of cancer therapeutics.

Pursuantto the license agreement, we have an obligation to pay success-based milestones and royalties to CRT, as follows:

Inaddition, in connection with the licensing agreement, we intend to provide ICR with approximately $650,000 research and development supportover the next 18 months to conduct additional scientific research and preclinical testing for certain indications that we select in connectionwith the NXP800 Program. We own an exclusive license to intellectual property rights developed in the collaboration, to research, developand commercialize products resulting from the collaboration.

LicenseTerm

Thelicense will remain in effect in each territory subject to the license and will continue until our obligation to pay royalties insuch territory has expired. The royalty term for each licensed product in each country commences with the first commercial sale ofthe applicable licensed product in the applicable country and ending on the expiration of the last to expire of any patent specifiedby the license (with the key composition of matters patent expiring October 2034) or the expiration of any extended exclusivityperiod in the relevant country. CRT may earlier terminate the license if we, or any of our affiliates or sub-licensees,challenge or seek to challenge the validity of any of the licensed patents or upon a change of control in which we become controlledby a Tobacco Party, as such term is defined in the license. Either party may terminate the license upon material breach by the otherparty, and upon the appointment of a receiver or upon a winding-up order or similar or equivalent action.

NXP900License Agreement

InAugust 2021, we entered into a worldwide, exclusive license agreement with the UoE for NXP900 and any of its derivatives (collectively,the “NXP900 Program”). Discovered at the UoE, NXP900 is a targeted therapy, small molecule SRC and YES1 kinase inhibitorproduct candidate that we believe can be applied to a broad range of cancers.

Pursuantto the license agreement, we have an obligation to pay success-based milestones and royalties to the UoE, as follows:

Inaddition, in connection with the licensing agreement, we intend to provide the UoE with up to an additional £580,000 in researchand development support over the next approximately 12 months to conduct additional scientific research and preclinical testing for certain indicationsthat we select in connection with the NXP900 Program. We own an exclusive license to intellectual property rights developed in the collaboration,to research, develop and commercialize products resulting from the collaboration.

LicenseTerm

Theroyalty term for each licensed product in each country is the period commencing with first commercial sale of the applicablelicensed product in the applicable country and ending on the expiration of the last to expire of any patent specified by the license(statutory expiration for the NXP900 patent family is April 2036), or the expiration of any extended exclusivity period in therelevant country. We may terminate the license if we determine that it is not scientifically or commercially viable to research,develop, or commercialize the licensed products which are the subject of the license agreement. UoE may terminate the agreement ifwe: (i) cease to carry on the business regarding the treatment, prevention and/or diagnosis of human diseases; (ii) discontinuethe development of the licensed products which are the subject of the license; (iii) dispose of our assets or business in wholeor in material part; (iv) challenge the validity, ownership, or enforceability of the exclusively licensed technology;(v) contest the secret or substantial nature of certain know-how subject to the license; or (vi) breach certain diligenceobligations or fail to pay any amount due under the license within a specified time frame. The parties may terminate the NXP900License Agreement immediately by written notice upon material breach by the other party, if such breach (if capable of cure) is notso cured to the within thirty (30) business days following the notice of breach.

Competition

Ourindustry is intensely competitive and subject to rapid and significant technological changes. We face competition with respect to ourcurrent product candidates, and will face competition with respect to future product candidates, from segments of the pharmaceutical,biotechnology and other related markets. For example, there are several companies that are developing drugs for various types of ovariancancer, including Immunogen Therapeutics and Constellation Pharma. Of note, in May 2021 Constellation Pharma (acquired by Morphosys,June 2021), has disclosed patient recruitment commencing in May 2021 in a phase 2 expansion cohort for CPI-0209, a small moleculeinhibitor of Enhancer of Zeste Homolog 2 (“EZH2”) in patients with relapsed urothelial carcinoma, relapsed OCCC, and relapsedendometrial carcinoma all with known ARID1A mutations. As of the last update posted on clinicaltrials.gov on May 18^th,2022, this study is open for enrollment.

Inthe SRC/YES1 space Dasatinib (SPRYCEL^®) and bosutinib (BOSULIF^®) are multikinase inhibitors that also targetAbl and SRC and are approved in Philadelphia chromosome-positive chronic myeloid leukemia (CML) and Philadelphia chromosome-positiveacute lymphoblastic leukemia (ALL), both hematological malignancies. These two compounds have been extensively tested in solid tumorsdemonstrating only minor clinical activity. Sarcatinib is an inhibitor of the SRC/ABl family of kinases. It was originally developedby AstraZeneca for various types of cancer, but discontinued in Phase 2 for lack of sufficient efficacy.

TurningPoint Therapeutics (Turning Point) is developing TPX-0022, a MET/SRC/CSF1R inhibitor which is currently being studied in a Phase 1 trialof patients with advanced or metastatic solid tumors harboring MET genetic alterations. The simultaneous inhibition of MET, SRC and CSF1Rkinases has been reported by Turning Point as a key component of the target product profile, and Turning Point has described the programas a strategy for the treatment of MET-driven solid tumors, an area that does not overlap with our development strategy. Turning Pointis also developing TPX-0046, a RET kinase inhibitor that can also inhibit other kinases including SRC family members, YES1, ABl, TRKand JAK2. TPX-0046 is being evaluated in an ongoing Phase 1/2 clinical trial for the treatment of advanced solid tumors with RET genealterations, an area that does not overlap with our development strategy. As of the last update posted on clinicaltrials.gov on April 8^th,2022, this study is open for enrollment.

Ourcompetitors may obtain regulatory approval of their products more rapidly than us, or may obtain patent protection or other intellectualproperty rights that limit our ability to develop or commercialize our current or future product candidates. Our competitors may alsodevelop drugs that are more effective, more convenient, more widely used and less costly, or have a better safety profile than our products;and these competitors may also be more successful than us in manufacturing and marketing their products.

Inaddition, we may need to develop our current or future product candidates in collaboration with diagnostic companies, and we will facecompetition from other companies in establishing these collaborations. Our competitors will also compete with us in recruiting and retainingqualified scientific, management and commercial personnel, establishing clinical trial sites and patient registration for clinical trials,as well as in acquiring technologies complementary to, or necessary for, our programs.

Furthermore,we also face competition more broadly across the market for cost-effective and reimbursable cancer treatments. The most commonmethods of treating patients with cancer are surgery, radiation and drug therapy, including chemotherapy, hormone therapy andtargeted drug therapy, or a combination of such methods. There are a variety of available drug therapies marketed for cancer. Inmany cases, these drugs are administered in combination to enhance efficacy. While our current or future product candidates, if any,are approved, may compete with these existing drug and other therapies, to the extent they are ultimately used in combination with,or as an adjunct to, these therapies, our current or future product candidates may not be competitive with them. Some of these drugsare branded and subject to patent protection, and others are available on a generic basis. Insurers and other third-party payors mayalso encourage the use of generic products or specific branded products. We expect that if any of our current or future productcandidates are approved, they will be priced at a significant premium over competitive generic and branded generic products. As aresult, obtaining market acceptance of, and gaining significant share of the market for, any of our current or future productcandidates that we successfully introduce to the market will pose challenges. In addition, many companies are developing newtherapeutics, and we cannot predict what the standard of care will be as our current or future product candidates progress throughclinical development.

Theacquisition or licensing of pharmaceutical products is also very competitive. If we seek to acquire or license products, we will facesubstantial competition from a number of more established companies, some of which have acknowledged strategies to license or acquireproducts and many of which are bigger than us and have more institutional experience and greater cash flows than we have. These moreestablished companies may have competitive advantages over us, as may other emerging companies taking similar or different approachesto product licenses and/or acquisitions. In addition, a number of established research- based pharmaceutical and biotechnology companiesmay acquire products in late stages of development to augment their internal product lines, which may provide those companies with aneven greater competitive advantage.

Manufacturing

Wedo not have any manufacturing facilities or personnel. We currently rely, and expect to continue to rely, on a third-party manufacturersincluding a single-manufacturer to make the NXP800 drug substance and a single-manufacturer to make the NXP800 drug product. With respectto NXP900, to date, the drug substance has been manufactured by a non-GMP manufacturer for research purposes at lab scale.

Weplan to continue to rely on third party manufacturers for the supply of NXP800 and NXP900, for manufacture of future additional productcandidates, for preclinical testing as well as for clinical trials and commercial manufacture if our current or future product candidatesreceive marketing approval.

Commercialization

Subjectto receiving marketing approvals, we expect to commence commercialization activities by building a focused sales and marketing organizationin the United States to sell our products. We believe that such an organization will be able to address the community of oncologistswho are the key specialists in treating the patient populations for which our current or future product candidates are being developed.Outside the United States, we expect to enter into distribution and other marketing arrangements with third parties for any of our currentor future product candidates that obtain marketing approval.

Wealso plan to build a marketing and sales management organization to create and implement marketing strategies for any products that wemarket through our own sales organization and to oversee and support our sales force. The responsibilities of the marketing organizationwould include developing educational initiatives with respect to approved products and establishing relationships with researchers andpractitioners in relevant fields of medicine.

GovernmentRegulation

Governmentregulation of drugs in the United States

TheFDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, amongother things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging,storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reportingof drugs. We, along with our vendors, contract research organizations and contract manufacturers, will be required to navigate the variouspreclinical, clinical, manufacturing and commercial requirements of the FDA, as well as of any other governing regulatory agency of thecountries in which we wish to conduct studies or seek approval of our current or future product candidates. The process of obtainingregulatory approvals of drugs and ensuring subsequent compliance with appropriate federal, state, local and foreign statutes and regulationsrequires the expenditure of substantial time and financial resources.

Inthe United States, the FDA regulates drug products under the Federal Food, Drug, and Cosmetic Act and its subsequent enactments, itsimplementing regulations, and other laws. Our product candidates have not been approved by the FDA for marketing in the United States.If we fail to comply with applicable FDA or other requirements at any time with respect to product development, clinical testing, approvalor any other legal requirements relating to product manufacture, processing, handling, storage, quality control, safety, marketing, advertising,promotion, packaging, labeling, export, import, distribution, or sale, we may become subject to administrative or judicial sanctionsor other legal consequences. These sanctions or consequences could include, among other things, the FDA’s refusal to approve pendingapplications, the issuance of clinical holds for ongoing studies, suspension or revocation of approved applications, warning or untitledletters, product withdrawals or recalls, product seizures, relabeling or repackaging, total or partial suspensions of manufacturing ordistribution, injunctions, fines, civil penalties or criminal prosecution.

Theprocess required by the FDA before a product candidate is approved as a drug for therapeutic indications in the United States generallyinvolves the following:

Thetesting and approval process requires substantial time, effort, and financial resources, and we cannot be certain that any approvalsfor our current or future product candidates will be granted on a timely basis, if at all.

Preclinicaland clinical trials for drugs

Beforetesting any drug in humans, a product candidate must undergo rigorous preclinical testing. Preclinical studies include laboratoryevaluations of drug chemistry, formulation and stability, as well as in vitro and animal studies to assess safety and address useconcerns. The conduct of preclinical studies is subject to federal and state regulations and requirements, including GCPrequirements for safety/toxicology studies. The results of the preclinical studies, together with manufacturing information andanalytical data must be submitted to the FDA as part of an IND application. An IND application is a request for authorization fromthe FDA to administer an investigational product to humans and must become effective before clinical trials may begin. Somelong-term preclinical testing may continue after the IND is submitted. An IND automatically becomes effective 30 days after receiptby the FDA unless the FDA raises concerns or questions about any portion of the IND application and imposes a clinical hold. In sucha case, the IND sponsor and the FDA need to resolve any outstanding concerns before the clinical trial can begin. Submission of anIND application may result in the FDA not allowing clinical trials to commence or not allowing clinical trials to commence on theterms originally specified in the IND application. A separate submission to an existing IND must also be made for each successiveclinical trial conducted during product development of a product candidate, and the FDA must grant permission, either explicitly orimplicitly by not objecting, before each clinical trial can begin.

Theclinical stage of development involves the administration of a product candidate to healthy volunteers or patients under the supervisionof qualified investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance with GCP requirements,which include the requirements that all research subjects provide their informed consent for their participation in any clinical trial.Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures,subject selection and exclusion criteria and the parameters and criteria to be used in monitoring safety and evaluating efficacy. Eachprotocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND application. Furthermore, anIRB representing each institution that is participating in the clinical trial must review and approve the plan for any clinical trialbefore it commences at that institution, and the IRB must thereafter conduct a continuing review and reapprove the trial at least annually.The IRB must review and approve, among other things, the trial protocol and informed consent information to be provided to clinical trialsubjects. An IRB must operate in compliance with FDA regulations.

Informationabout certain clinical trials, including details of the protocol and eventually study results, also must be submitted withinspecific timeframes to the National Institutes of Health for public dissemination on the ClinicalTrials.gov data registry.Information related to the product, patient population, phase of investigation, study sites and investigators and other aspects ofthe clinical trial is made public as part of the registration of the clinical trial. Sponsors are also obligated to disclose theresults of their clinical trials after completion. Disclosure of the results of these trials can be delayed in some cases forup to two years after the date of completion of the trial. Failure to timely register a covered clinical study or to submit studyresults as provided for in the law can give rise to civil monetary penalties and also prevent the non- compliant party fromreceiving future grant funds from the federal government. The NIH’s Final Rule on ClinicalTrials.gov registration andreporting requirements became effective in 2017, and both NIH and FDA have signaled the government’s willingness to beginenforcing those requirements against non-compliant clinical trial sponsors.

Asponsor who wishes to conduct a clinical trial outside of the United States may obtain FDA authorization to conduct the clinical trialunder an IND. If a foreign clinical trial is not conducted under an IND, the sponsor must submit data from the clinical trial to theFDA in support of an NDA. The FDA may accept a well-designed and well-conducted foreign clinical study not conducted under an IND ifthe study was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite inspection ifdeemed necessary.

Clinicaldevelopment of product candidates to support NDAs are typically conducted in three sequential phases, which may overlap:

Post-approvaltrials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These trials are used togain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandatethe performance of Phase 4 clinical trials as a condition of approval of an NDA.

Progressreports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverseevents, or SAEs, occur. The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including afinding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminateapproval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the clinical protocol,GCP, or other IRB requirements or if the drug has been associated with unexpected serious harm to patients.

Concurrentwith clinical trials, additional animal studies are often completed and additional information about the chemistry and physical characteristicsof the product candidate, including finalization of the process for manufacturing the drug product in commercial quantities in accordancewith cGMP requirements is generated. The manufacturing process must be capable of consistently producing quality batches of the productcandidate and manufacturers must develop, among other things, methods for testing the identity, strength, quality and purity of the finaldrug product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstratethat the product candidate does not undergo unacceptable deterioration over its shelf life.

MarketingApproval in the United States

Assumingsuccessful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailedinformation relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submittedto the FDA as part of an NDA requesting approval to market the product for one or more indications. An NDA is a request for approvalto market a new drug for one or more specified indications and must contain proof of the drug’s safety and efficacy. Datamay come from company-sponsored clinical trials intended to test the safety and efficacy of a product’s use or from a number ofalternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficientin quality and quantity to establish the safety and efficacy of the investigational product to the satisfaction of the FDA. Under federallaw, the fee for the submission of an NDA for which clinical data is substantial (for example, for FY2021 this application fee exceeds$2.8 million), and for which the sponsor of an approved NDA is also subject to an annual program fee, is currently more than $300,000per program. These fees are typically adjusted annually, but exemptions and waivers may be available under certain circumstances.

TheFDA performs a preliminary review of the NDA within 60 days of receipt and informs the sponsor by the 74th day after the FDA’sreceipt of the submission whether an application is sufficiently complete to permit substantive review. The FDA may request additionalinformation 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.

Ifthe NDA is filed, the FDA begins an in-depth substantive review of the NDA. The FDA reviews an NDA to determine, among other things,whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standardsdesigned to assure the product’s continued safety, quality and purity. Under the goals and policies agreed to by the FDA underthe Prescription Drug User Fee Act, or PDUFA, for original NDAs, the FDA has ten months from the filing date in which to complete itsinitial review of a standard application and respond to the applicant, and six months from the filing date for an application with priorityreview. For all new molecular entity, or NME, NDAs, the ten and six-month time periods run from the filing date; for all otheroriginal applications, the ten and six-month time periods run from the submission date. Despite these review goals, it is not uncommonfor FDA review of an NDA to extend beyond the goal date. The review process may be extended by the FDA for three additional months toconsider new information or in the case of a clarification provided by the applicant to address an outstanding deficiency identifiedby the FDA following the original submission.

Beforeapproving an NDA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approvean application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequateto assure consistent production of the new drug product within required specifications. Additionally, before approving an NDA, the FDAmay inspect one or more clinical trial sites to assure compliance with GCP and other requirements and the integrity of the clinical datasubmitted to the FDA.

TheFDA also may require submission of a Risk Evaluation and Mitigation Strategies (“REMS”) plan to ensure that the benefitsof the drug outweigh its risks and to assure the safe use of the drug product. The REMS plan could include medication guides, physiciancommunication plans, assessment plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries,or other risk- minimization tools. The FDA determines the requirement for a REMS, as well as the specific REMS provisions, on a case-by-casebasis. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS. The FDA will not approve an NDA withouta REMS, if required.

TheFDA may refer any NDA to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and otherscientific experts, which reviews, evaluates and provides a recommendation as to whether the application should be approved, and underwhat conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefullywhen making decisions.

Beforeapproving an NDA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approvean application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequateto assure consistent production of the new drug product within required specifications. Additionally, before approving an NDA, the FDAmay inspect one or more clinical trial sites to assure compliance with GCP and other requirements and the integrity of the clinical datasubmitted to the FDA.

Afterevaluating the NDA and all related information, the FDA may issue an approval letter or a complete response letter (“CRL”).An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. A CRLgenerally contains details on specific conditions that must be met to support approval of the NDA, often requiring additional clinicalor preclinical testing in order for the FDA to reconsider the application. Even with submission of this additional information, the FDAultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when the conditions identifiedin the CRL have been met to the FDA’s satisfaction, the FDA may issue an approval letter.

Ifa product receives regulatory approval from the FDA, the approval is limited to the conditions of use (e.g., patient population, indication)described in the application. Further, depending on the specific risk(s) to be addressed, the FDA may limit the approved indicationsfor use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approvalstudies, 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 restrictionsor other risk management mechanisms under a REMS, which can materially affect the potential market 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.After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additionallabeling claims, are subject to further testing requirements and FDA review and approval.

Orphandrug designation and exclusivity

Underthe Orphan Drug Act, the FDA may grant orphan designation to a drug intended to treat a rare disease or condition, which is a diseaseor condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in theUnited States, but there is no reasonable expectation that the cost of developing and making the product available in the United Statesfor the disease or condition will be recovered from sales of the product. Orphan designation must be requested before submitting an NDA.Orphan designation does not convey any advantage in or shorten the duration of the regulatory review and approval process, though companiesdeveloping orphan products are eligible for certain incentives, including tax credits for qualified clinical testing and waiver of applicationfees.

Ifa product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has suchdesignation, the product is entitled to a seven-year period of marketing exclusivity during which the FDA may not approve any other applicationsto market the same therapeutic agent for the same indication, except in limited circumstances. However, competitors may receive approvalof different therapeutic product candidates for the indication for which the orphan product has exclusivity or obtain approval for thesame therapeutic agent for a different indication than that for which the orphan product has exclusivity. Orphan product exclusivitycould block the approval of one of our products for seven years if a competitor obtains approval for the same therapeutic agent for thesame indication before we do, unless we are able to demonstrate that our product is superior. If an orphan designated product receivesmarketing approval for an indication broader than what is designated, it may not be entitled to orphan exclusivity. Further, orphan drugexclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materiallydefective or the manufacturer of the approved product is unable to assure sufficient quantities of the product to meet the needs of patientswith the rare disease or condition.

Expediteddevelopment and review programs

TheFDA is authorized to designate certain products for expedited development or review if they are intended to address an unmet medicalneed in the treatment of a serious or life-threatening disease or condition. These programs include fast track designation, breakthroughtherapy designation and priority review designation.

Anew drug is eligible for fast track designation if it is intended to treat a serious or life-threatening disease or condition and demonstratesthe potential to address an unmet medical need for such disease or condition. Fast track designation provides increased opportunitiesfor sponsor interactions with the FDA during preclinical and clinical development, in addition to the potential for rolling review ofa marketing application once a marketing application is filed, meaning that the agency may review portions of the application beforethe sponsor submits the complete application, as well as priority review, discussed below. In addition, a new drug may be eligible forbreakthrough therapy designation if it is intended, alone or in combination with one or more other drugs or biologics, to treat a seriousor life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvementover existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinicaldevelopment. Breakthrough therapy designation provides all the features of fast track designation in addition to intensive guidance onan efficient drug development program beginning as early as Phase 1, and FDA organizational commitment to expedited development, includinginvolvement of senior managers and experienced review staff in a cross-disciplinary review, where appropriate. Drugs or biologics designatedas breakthrough therapies are also eligible for accelerated approval of their respective marketing applications.

Finally, the FDA may designate a productfor priority review if it is a drug or biologic that treats a serious condition and, if approved, would provide a significant improvementin safety or effectiveness. The FDA determines at the time that the marketing application is submitted, on a case-by-case basis, whetherthe proposed drug represents a significant improvement in treatment, prevention or diagnosis of disease when compared with other availabletherapies. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, eliminationor substantial reduction of a treatment-limiting drug reaction, documented enhancement of patient compliance that may lead to improvementin serious outcomes, or evidence of safety and effectiveness in a new subpopulation. A priority review designation is intended to directoverall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on a marketingapplication from ten months to six months for a new molecular entity NDA from the date of filing.

Even if a product qualifies for one ormore of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that thetime period for FDA review or approval will not be shortened. Furthermore, fast track designation, breakthrough therapy designation andpriority review do not change the standards for approval and may not ultimately expedite the development or approval process.

Pediatric information and pediatricexclusivity

Pediatric exclusivity is a type of non-patentmarketing exclusivity available in the United States and, if granted, it provides for the attachment of an additional six months of marketingprotection to the term of any existing regulatory exclusivity or listed patents. This six-month exclusivity may be granted if an NDAsponsor submits pediatric data that fairly respond to a written request from the FDA for such data. The data do not need to show theproduct to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the FDA’srequest, the additional protection is granted. If reports of requested pediatric studies are submitted to and accepted by the FDA withinthe statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product are extendedby six months. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approveanother application. The issuance of a written request does not require the sponsor to undertake the described studies.

Post-approval requirements

Drugs manufactured or distributed pursuantto FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relatingto recordkeeping, periodic reporting, product sampling and distribution, reporting of adverse experiences with the product, complyingwith promotion and advertising requirements, which include restrictions on promoting products for unapproved uses or patient populations(known as “off-label use”) and limitations on industry-sponsored scientific and educational activities. Although physiciansmay prescribe legally available products for off- label uses, manufacturers may not market or promote such uses. The FDA and other agenciesactively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperlypromoted off-label uses may be subject to significant liability, including investigation by federal and state authorities. Prescriptiondrug promotional materials must be submitted to the FDA in conjunction with their first use or first publication. Further, if there areany modifications to the drug, including changes in indications, labeling or manufacturing processes or facilities, the applicant maybe required to submit and obtain FDA approval of a new NDA or an NDA supplement, which may require the development of additional dataor preclinical studies and clinical trials. The FDA may also impose a number of post- approval requirements as a condition of approvalof an NDA.

In addition, drug manufacturers and theirsubcontractors involved in the manufacture and distribution of approved drugs are required to register their establishments with theFDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliancewith ongoing regulatory requirements, including cGMP, which impose certain procedural and documentation requirements upon us and ourcontract manufacturers. Failure to comply with statutory and regulatory requirements can subject a manufacturer to possible legal orregulatory action, such as warning letters, suspension of manufacturing, product seizures, injunctions, civil penalties or criminal prosecution.

Once an approval or clearance of a drugis granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problemsoccur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events ofunanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result inrevisions to the approved labeling to add new safety information, requirements for post-market studies or clinical trials to assess newsafety risks, or imposition of distribution or other restrictions under a REMS. Other potential consequences include, among other things:

Other regulatory matters

Manufacturing, sales, promotion and otheractivities of product candidates following product approval, where applicable, or commercialization are also subject to regulation bynumerous regulatory authorities in the United States in addition to the FDA, which may include CMS, other divisions of the Departmentof Health and Human Services, the Department of Justice, the Drug Enforcement Administration, the Consumer Product Safety Commission,the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and stateand local governments and governmental agencies.

Other healthcare laws

Healthcareproviders, physicians, and third-party payors will play a primary role in the recommendation and prescription of any products forwhich we obtain marketing approval. Our business operations and any current or future arrangements with third-party payors,healthcare providers and physicians may expose us to broadly applicable fraud and abuse and other healthcare laws and regulationsthat may constrain the business or financial arrangements and relationships through which we develop, market, sell and distributeany drugs for which we obtain marketing approval. In the United States, these laws include, without limitation, state and federalanti-kickback, false claims, physician transparency, and patient data privacy and security laws and regulations. For a descriptionof these risks, please see the section entitled “Risk Factors.”

Insurance coverage and reimbursement

In the United States and markets in other countries,patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely onthird-party payors to reimburse all or part of the associated healthcare costs. Thus, even if a product candidate is approved, salesof the product will depend, in part, on the extent to which third-party payors, including government health programs in the UnitedStates such as Medicare and Medicaid, commercial health insurers and managed care organizations, provide coverage, and establishadequate reimbursement levels for the product. In the United States, the principal decisions about reimbursement for new medicinesare typically made by CMS. CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare andprivate payors tend to follow CMS to a substantial degree. No uniform policy of coverage and reimbursement for drug products existsamong third-party payors. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor. Theprocess for determining whether a third-party payor will provide coverage for a product may be separate from the process for settingthe price or reimbursement rate that the payor will pay for the product once coverage is approved. Third-party payors areincreasingly challenging the prices charged, examining the medical necessity, and reviewing the cost-effectiveness of medicalproducts and services and imposing controls to manage costs. Third-party payors may limit coverage to specific products on anapproved list, also known as a formulary, which might not include all of the approved products for a particular indication.

In order to secure coverage and reimbursement for anyproduct that might be approved for sale, a company may need to conduct expensive pharmacoeconomic studies in order to demonstratethe medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain FDA or other comparableregulatory approvals. Additionally, companies may also need to provide discounts to purchasers, private health plans or governmenthealthcare programs. Nonetheless, product candidates may not be considered medically necessary or cost effective. A decision by athird-party payor not to cover a product could reduce physician utilization once the product is approved and have a material adverseeffect on sales, our operations and financial condition. Additionally, a third-party payor’s decision to provide coverage fora product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination to providecoverage for a product does not assure that other payors will also provide coverage and reimbursement for the product, and the levelof coverage and reimbursement can differ significantly from payor to payor.

The containment of healthcare costs hasbecome a priority of federal, state and foreign governments, and the prices of products have been a focus in this effort. Governmentshave shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement andrequirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictivepolicies in jurisdictions with existing controls and measures, could further limit a company’s revenue generated from the saleof any approved products. Coverage policies and third-party payor reimbursement rates may change at any time. Even if favorable coverageand reimbursement status is attained for one or more products for which a company or its collaborators receive regulatory approval, lessfavorable coverage policies and reimbursement rates may be implemented in the future.

Current and future healthcare reformlegislation

The FDA’s and other regulatoryauthorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delayregulatory approval of our current or future product candidates. For example, in December 2016, the 21st Century Cures Act, orCures Act, was signed into law. The Cures Act, among other things, was intended to modernize the regulation of drugs and devices andto spur innovation, but its ultimate implementation is uncertain. Legislative proposals continue to be discussed in the U.S.Congress as potentially leading to a future “Cures 2.0” bill that is expected to have bipartisan support. In addition,in August 2017, the FDA Reauthorization Act was signed into law, which reauthorized the FDA’s user fee programs andincluded additional drug and biological product provisions. The next legislative reauthorization must be completed in 2022, whichhas the potential to make further changes to FDA authorities or policies pertaining to biopharmaceutical products. If we are slow orunable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able tomaintain regulatory compliance, we may lose any marketing approval that we otherwise may have obtained and we may not achieve orsustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.

In recent years, there has been heightenedgovernmental scrutiny over the manner in which biopharmaceutical manufacturers set prices for their marketed products. Such scrutinyhas resulted in several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, amongother things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reducethe cost of drugs under Medicare, and reform government program reimbursement methodologies for pharmaceutical products. Congress andthe executive branch have each indicated that it will continue to seek new legislative and/or administrative measures to control drugcosts, making this area subject to ongoing uncertainty.

At the state level in the United States, legislatureshave also increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, includingprice or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure andtransparency measures, and in some cases, designed to encourage importation from other countries and bulk purchasing. InDecember 2020, the U.S. Supreme Court held unanimously that federal law does not preempt the states’ ability to regulatepharmaceutical benefit managers, or PBMs, and other members of the healthcare and pharmaceutical supply chain, an important decisionthat may lead to further and more aggressive efforts by states in this area.

We cannot predict the likelihood, natureor extent of government regulation that may arise from future legislation or administrative or executive action, either in the UnitedStates or abroad. We expect that additional federal, state, and foreign healthcare reform measures will be adopted in the future, anyof which could limit the amounts that federal and state governments will pay for healthcare products and services, which could resultin limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing pressures.

Other U.S. environmental, health andsafety laws and regulations

We may be subject to numerous environmental,health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment anddisposal of hazardous materials and wastes. From time to time and in the future, our operations may involve the use of hazardous andflammable materials, including chemicals and biological materials, and may also produce hazardous waste products. Even if we contractwith third parties for the disposal of these materials and waste products, we cannot completely eliminate the risk of contamination orinjury resulting from these materials. In the event of contamination or injury resulting from the use or disposal of our hazardous materials,we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costsassociated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

We maintain workers’ compensationinsurance to cover us for costs and expenses we may incur due to injuries to our employees, but this insurance may not provide adequatecoverage against potential liabilities. However, we do not maintain insurance for environmental liability or toxic tort claims that maybe asserted against us. In addition, we may incur substantial costs in order to comply with current or future environmental, health andsafety laws and regulations. Current or future environmental laws and regulations may impair our research, development or productionefforts. In addition, failure to comply with these laws and regulations may result in substantial fines, penalties or other sanctions.

Government regulation of drugs outsideof the United States

Tomarket any product outside of the United States, we would need to comply with numerous and varying regulatory requirements of othercountries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization oridentification of an alternate regulatory pathway, manufacturing, commercial sales and distribution of our products. For instance,in the European Economic Area (“EEA”) (comprised of the 28 EU Member States plus Iceland, Liechtenstein and Norway),medicinal products must be authorized for marketing by using either the centralized authorization procedure or nationalauthorization procedures.

In the EEA, new products for therapeuticindications that are authorized for marketing (i.e., reference products) qualify for eight years of data exclusivity and an additionaltwo years of market exclusivity upon marketing authorization. The data exclusivity period prevents generic or biosimilar applicants fromrelying on the preclinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilarmarketing authorization in the EU during a period of eight years from the date on which the reference product was first authorized inthe EU. The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product in the EUuntil ten years have elapsed from the initial authorization of the reference product in the EU. The ten-year market exclusivity periodcan be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorization holderobtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization,are held to bring a significant clinical benefit in comparison with existing therapies.

The criteria for designating an “orphanmedicinal product” in the EEA are similar in principle to those in the United States. In the EEA a medicinal product may bedesignated as orphan if (1) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronicallydebilitating condition; (2) either (a) such condition affects no more than five in 10,000 persons in the EU when theapplication is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient returnin the EU to justify investment; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of suchcondition authorized for marketing in the EU, or if such a method exists, the product will be of significant benefit to thoseaffected by the condition. Orphan medicinal products are eligible for financial incentives such as reduction of fees or fee waiversand are, upon grant of a marketing authorization, entitled to ten years of market exclusivity for the approved therapeuticindication. During this ten-year orphan market exclusivity period, no marketing authorization application shall be accepted, and nomarketing authorization shall be granted for a similar medicinal product for the same indication. An orphan product can also obtainan additional two years of market exclusivity in the EU for pediatric studies. The ten-year market exclusivity may be reduced to sixyears if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, forexample, if the product is sufficiently profitable not to justify maintenance of market exclusivity. Additionally, marketingauthorization may be granted to a similar product for the same indication at any time if (i) the second applicant can establishthat its product, although similar, is safer, more effective or otherwise clinically superior; (ii) the applicant consents to asecond orphan medicinal product application; or (iii) the applicant cannot supply enough orphan medicinal product.

Similar to the United States, the various phases ofnon-clinical and clinical research in the European Union are subject to significant regulatory controls. The Clinical TrialsDirective 2001/20/EC, the Directive 2005/28/EC on GCP and the related national implementing provisions of the individual EU MemberStates govern the system for the approval of clinical trials in the European Union. Under this system, an applicant must obtainprior approval from the competent national authority of the EU Member States in which the clinical trial is to be conducted.Furthermore, the applicant may only start a clinical trial at a specific study site after the competent ethics committee has issueda favorable opinion. The clinical trial application must be accompanied by, among other documents, an investigational medicinalproduct dossier (the Common Technical Document) with supporting information prescribed by Directive 2001/20/ EC, Directive2005/28/EC, where relevant the implementing national provisions of the individual EU Member States and further detailed inapplicable guidance documents.

In April 2014, the European Union adopted a newClinical Trials Regulation (EU) No 536/2014, which is set to replace the Clinical Trials Directive 2001/20/EC and will overhaul thecurrent system of approvals for clinical trials in the European Union. Specifically, the new regulation, which will be directlyapplicable in all Member States (meaning that no national implementing legislation in each European Union Member State is required),aims at simplifying and streamlining the approval of clinical trials in the European Union. For instance, the new Clinical TrialsRegulation provides for a streamlined application procedure via a single entry point and strictly defined deadlines for theassessment of clinical trial applications. It is expected that the new Clinical Trials Regulation (EU) No 536/2014 will come intoeffect following confirmation of full functionality of the Clinical Trials Information System, the centralized European Union portaland database for clinical trials foreseen by the new Clinical Trials regulation, through an independent audit, which is currentlyexpected to occur in December 2021.

In addition, the collection, use, storage, disclosure,transfer, or other processing of personal data regarding individuals in the EEA, including personal health data, is subject to theGeneral Data Protection Regulation 2016/679 (“GDPR”), which became effective on May 25, 2018. The GDPR iswide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating toprocessing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providinginformation to individuals regarding data processing activities, implementing safeguards to protect the security and confidentialityof personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors. TheGDPR also imposes strict rules on the transfer of personal data to countries outside the European Union, including the UnitedStates, and permits data protection authorities to impose large penalties for violations of the GDPR, including potential fines ofup to €20 million or 4% of annual global revenues, whichever is greater. The GDPR also confers a private right of action ondata subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtaincompensation for damages resulting from violations of the GDPR. In addition, the GDPR includes restrictions on cross-border datatransfers. Compliance with the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business orrequire us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines andpenalties, litigation, and reputational harm in connection with our European activities.

There is significant uncertainty relatedto the manner in which data protection authorities will seek to enforce compliance with GDPR. Additionally, if we utilize third partydistributors, compliance with such foreign governmental regulations would generally be the responsibility of such distributors, who maybe independent contractors over whom we have limited control.

Payment and reimbursement

Outside the United States, ensuring coverageand adequate payment for a product also involves challenges. Pricing of prescription pharmaceuticals is subject to government controlin many countries. Pricing negotiations with government authorities can extend well beyond the receipt of regulatory approval for a productand may require a clinical trial that compares the cost-effectiveness of a product to other available therapies. The conduct of sucha clinical trial could be expensive and result in delays in commercialization.

In the European Union, pricing and reimbursementschemes vary widely from country to country. Some countries provide that products may be marketed only after a reimbursement pricehas been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particularproduct candidate to currently available therapies or so-called health technology assessments, in order to obtain reimbursement orpricing approval. For example, the European Union provides options for its member states to restrict the range of products for whichtheir national health insurance systems provide reimbursement and to control the prices of medicinal products for human use.European Union member states may approve a specific price for a product or it may instead adopt a system of direct or indirectcontrols on the profitability of the company placing the product on the market. Other member states allow companies to fix their ownprices for products, but monitor and control prescription volumes and issue guidance to physicians to limit prescriptions. Recently,many countries in the European Union have increased the amount of discounts required on pharmaceuticals and these efforts couldcontinue as countries attempt to manage healthcare expenditures, especially in light of the severe fiscal and debt crisesexperienced by many countries in the European Union. The downward pressure on healthcare costs in general, particularly prescriptionproducts, has become intense. As a result, increasingly high barriers are being erected to the entry of new products. Political,economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue afterreimbursement has been obtained. Reference pricing used by various European Union member states, and parallel trade, i.e., arbitragebetween low-priced and high-priced member states, can further reduce prices. There can be no assurance that any country that hasprice controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangementsfor any products, if approved in those countries.

Brexit

On June 23, 2016, the United Kingdom(“UK”) held a referendum in which a majority of voters approved an exit from the EU (“Brexit”). After nearlyyears of negotiation and political and economic uncertainty, the UK’s withdrawal from the EU became effective on January 31,2020. There was a transitional period, during which EU laws, including pharmaceutical laws, continued to apply in the UK, however thisended on December 31, 2020. The UK and EU have signed an EU-UK trade and cooperation agreement (EU-UK Trade and Cooperation Agreement),which became provisionally applicable on January 1, 2021 and will become formally applicable once ratified by both the UK and theEU. This agreement provides details on how some aspects of the UK and EU’s relationship regarding medicinal products will operate,particularly in relation to GMP, however there are still many uncertainties. Many of the regulations that now apply in the UK followingthe transition period (including financial laws and regulations, taxes, intellectual property rights, data protection laws, supply chainlogistics, environmental, health and safety laws and regulations, medicine approval and regulations, immigration laws and employmentlaws), will likely be amended in future as the UK determines its new approach, which may result in significant divergence from EU regulations.This lack of clarity on future UK laws and regulations and their interaction with the EU laws and regulations increases our regulatoryburden of operating in and doing business with both the UK and the EU.

The long-term effects of Brexit will depend, in part,on how the EU-UK Trade and Cooperation Agreement, and any future agreements signed by the UK and the EU, take effect in practice.Such a withdrawal from the EU is unprecedented, and it is unclear how the restrictions on the UK’s access to the Europeansingle market for goods, capital, services and labor within the EU and the wider commercial, legal and regulatory environment, couldimpact our current and future operations and clinical activities in the UK.

We may also face new regulatory costs andchallenges that could have an adverse effect on our operations as a result of Brexit. Since the regulatory framework in the UK coveringquality, safety and efficacy of medicinal products, clinical trials, marketing authorization, commercial sales and distribution of medicinalproducts is derived from EU directives and regulations, Brexit could materially impact the future regulatory regime with respect to theapproval of any of our product candidate or future product candidates in the UK. For instance, the UK will now no longer be covered bythe centralized procedure for obtaining EEA- wide marketing and manufacturing authorizations from the EMA for medicinal products anda separate process for authorization of drug products will be required in the UK. For a period of two years from January 1, 2021,the MHRA may rely on a decision taken by the European Commission on the approval of a new marketing authorization in the centralizedprocedure, in order to more quickly grant a UK marketing authorization, however a separate application will still be required. Any delayin obtaining, or an inability to obtain, any regulatory approvals, as a result of Brexit or otherwise, would delay or prevent us fromcommercializing our current or future product candidates in the UK and could restrict our ability to generate revenue from that market.

We expect that, now the transition periodhas expired, Brexit could lead to legal uncertainty and potentially divergent national laws and regulations as the UK determines whichEU laws to replicate or replace, including those related to the regulation of medicinal products. Any of these effects of Brexit, andothers we cannot anticipate, could negatively impact our business and results of operations in the UK.

The uncertainty concerning the UK’slegal, political and economic relationship with the EU following Brexit may also be a source of instability in the international markets,create significant currency fluctuations, and/or otherwise adversely affect trading agreements or similar cross-border co-operation arrangements(whether economic, tax, fiscal, legal, regulatory or otherwise).

Employees and Human Capital Management

As of June 30, 2022, we had 10 full-timeemployees. Additionally, we have retained and may retain in the future, a number of expert consultants and vendors that help navigateus through and execute the different aspects of our business. We consider our relationship with our employees to be good and have notexperienced any work stoppages, slowdowns or other serious labor problems that have materially impeded our business operations. Noneof our employees are represented by labor unions or covered by collective bargaining agreements.

Our human capital management objectivesinclude, as applicable, identifying, recruiting, retaining, incentivizing, and integrating our new and existing employees. The principalpurpose of our equity incentive plan is to attract, retain, and motivate selected employees, consultants, and directors through the grantingof stock-based compensation awards and cash-based bonus awards.

Facilities

We believe that our current facilitiesare adequate for our current needs and that suitable additional or substitute space at commercially reasonable terms will be availableas needed to accommodate any future expansion of our operations.

Legal proceedings

From time to time, we may become involvedin legal proceedings arising in the ordinary course of our business, the resolution of which we do not anticipate would have a materialadverse impact on our financial position, results of operations or cash flows. However, there is no certainty that any such future litigationthat may arise would not have a material financial impact on our business. As of the date of this prospectus, we were not a party toany material legal matters or claims.

Management

Management

The following table sets forth informationabout our directors, executive officers and other senior management as of June 30, 2022.

Executive Officers and Directors

The following table sets forth certaininformation about our directors and executive officers.

Executive Officers and Senior Management

RonBentsur (56), Co-Founder, Chairman, Chief Executive Officer and President of Nuvectis, has over 20 years of senior leadershipexperience in the biotechnology industry. He served as CEO of UroGen Pharma, Inc. (NASDAQ: URGN) from August 2015 until January 2019,and as CEO of Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX, acquired by Akebia Therapeutics) from May 2009 until May 2015.At UroGen and Keryx, Mr. Bentsur led the clinical development, regulatory approvals and the commercial infrastructure buildoutsfor the US commercial launches of Jelmyto and Auryxia, respectively. Mr. Bentsur also led the establishment of a successful worldwidepartnership for an earlier-stage program at UroGen and an ex-US development partnership for Auryxia at Keryx. Mr. Bentsur servedas CEO of XTL Biopharmaceuticals, Inc. (NASDAQ: XTLB) from January 2006 until April 2009 and as Investor Relations andCFO of Keryx from October 2000 until January 2006. Mr. Bentsur worked as an investment banker in NYC and Tel Aviv, Israel,from 1994 until 2000. Mr. Bentsur served as a member of the Board of Directors of Stemline Therapeutics, Inc. from 2009 throughthe approval and launch of Elzonris® and through the subsequent acquisition of the company by Menarini in June 2020, and serveson the Board of Directors of Beyond Air, Inc. (NASDAQ: XAIR). Mr. Bentsur holds a BA in Economics and Business Administrationwith distinction from the Hebrew University of Jerusalem, Israel and an MBA (Magna Cum Laude), from New York University’sStern School of Business. Mr. Bentsur has been selected to serve on our Board of Directors based on his years of experience in thebiotechnology industry and extensive management experience.

EnriquePoradosu, PhD (56), Co-Founder, Executive Vice President, Chief Scientific and Business Officer of Nuvectis, has over 20 yearsof senior scientific leadership experience in the biotechnology industry. From January 2016 until December 2020, he servedas SVP, Business and Scientific Strategy at Stemline Therapeutics, Inc. (NASDAQ: STML, acquired by Menarini in June 2020).At Stemline Dr. Poradosu led the licensing and scientific strategy of the company’s pipeline, as well as directly leadingstrategic planning and operational execution of the early-stage drug development programs. Prior to that, Dr. Poradosu served asVP Business and Scientific Strategy at Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX), acquired by Akebia Therapeutics (NASDAQ: AKBA)),from 2003 until 2016. From 1998 until 2003, Dr. Poradosu served as a project manager at a private biomedical incubator. Dr. Poradosuholds a BSc in Chemistry and Biology with distinction from the Hebrew University of Jerusalem, Israel and a PhD in Biochemistry,from the Hebrew University of Jerusalem.

Management

ShayShemesh (39), Co-Founder, Executive Vice President, Chief Development Officer of Nuvectis, has over 15 years of multi-disciplinaryexperience in drug development. From 2015 until 2020, he served as SVP, Clinical and Regulatory Affairs at Stemline Therapeutics, Inc.(NASDAQ: STML, acquired by Menarini in June 2020) where he led multi-disciplinary development teams in early and late-stage projects.In this role, Mr. Shemesh held responsibilities for the strategic planning and operational execution of the Elzonris^®Biologics License Application, with the FDA and Marketing Authorization Application with EMA, resulting in the approval of Elzonris™in both regions for the treatment of blastic plasmacytoid dendritic cell neoplasm, an orphan hematologic malignancy. Prior to that, Mr. Shemeshwas a clinical operations lead at Keryx Biopharmaceuticals (NASDAQ: KERX, acquired by Akebia Therapeutics (NASDAQ: AKBA)), where he managedthe late-stage clinical trials for Auryxia™ for the treatment of anemia in patients with non- dialysis CKD, which led to the approvalof Auryxia in this indication in the US and the EU. Mr. Shemesh holds a BSc and MSc in Biotechnology from Bar Ilan University inIsrael.

Non-Employee Directors

KennethHoberman (57), Director, joined our Board of Directors in July 2021. Mr. Hoberman has extensive financial, investorrelations, corporate governance, operational, and business development experience including M&A, strategic alliances and partnershipsboth domestic and international. Mr. Hoberman has served as the Chief Operating Officer of Stemline Therapeutics, Inc. (“Stemline”)since 2013, where he negotiated and closed several licensing agreements and was responsible for multiple vendor contracts. While at Stemline,he helped lead the company from an early-stage drug development company to a fully integrated commercial entity, including through Stemline’ssuccessful initial public offering. Mr. Hoberman directed all Stemline’s functional groups, including manufacturing, commercial,regulatory, R&D, medical affairs, public and investor relations, HR and finance. Mr. Hoberman also led the M&A transactionwhich resulted in the sale of Stemline to the Menarini Group in June 2020 for approximately $750 million. He was previously VicePresident of Corporate and Business Development of Keryx Biopharmaceuticals, Inc., where he initiated and executed a Japanese partnershipvalued at up to $100 million, and originated, negotiated and closed dozens of licensing and operational contracts, including the licensingof Auryxia™, which was approved by the FDA in September 2014. He is on the Board of Directors of TG Therapeutics, Inc.(Nasdaq: TGTX). He received a B.S.B.A. in Finance from Boston University and completed post- baccalaureate studies at Columbia University.Mr. Hoberman has been selected to serve on our Board of Directors based on his extensive experience in the biopharmaceutical industryand in-depth understanding of our business.

MatthewL. Kaplan (54), Director, joined our Board of Directors in September 2021. Mr. Kaplan is an experienced EquityAnalyst with deep knowledge in biotechnology, particularly for analysis and advisement of early-stage companies. With 24 years ofexperience as an Equity Analyst, since 2008, he has been a Managing Director and the Head of Healthcare Equity Research at LadenburgThalmann & Co. Prior to joining Ladenburg Thalmann & Co., he was a Partner and the Director of Healthcare Researchwith Punk, Ziegel & Company, a Senior Biotechnology Analyst at Evolution Capital, and a Director of The Life Sciences Groupat The Carson Group. Mr. Kaplan has received numerous citations as a top ranked Biotechnology Stock Picker by Thomson Reuters,The Financial Times, and Forbes. Mr. Kaplan also spent six years as a Research Associate with the Albert Einstein College ofMedicine / Montefiore Hospital Department of Cardiology, where he co-authored numerous articles on gene regulation in the heart.Mr. Kaplan received his BS in Biology from the University of Michigan.

JamesF. Oliviero, III (45), Director, joined our Board of Directors in July 2021. Mr. Oliviero has over twentyyears of operational experience in the biotechnology industry. Since 2015, Mr. Oliviero has served as the President and ChiefExecutive Officer of Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), where he has completed over $100 million in private andpublic financings for the company to date, while designing and overseeing the company’s development programs for its novelimmuno-oncology and targeted therapy, a type of cancer treatment that precisely identifies and attacks a specific pathway of cancercells, product candidates being evaluated for the treatment of several solid tumor cancer indications. Prior to Checkpoint, fromMay 2003 to September 2015, Mr. Oliviero served in a variety of leadership capacities at KeryxBiopharmaceuticals, Inc., which was subsequently acquired by Akebia. His most recent position at Keryx, beginning inApril 2009, was as Chief Financial Officer, responsible for all of the finance, accounting, investor relations, corporategovernance and legal matters and was also involved in the clinical and regulatory development of Auryxia^®, whichsuccessfully obtained FDA approval in 2014. From August 1999 to May 2003, Mr. Oliviero was Director of Finance forACCESS Oncology, Inc., a privately held biotechnology company. Mr. Oliviero began his professional career as an investmentbanker at Furman Selz LLC in New York City. Mr. Oliviero is a CFA charterholder and holds a B.B.A. in Finance with HighestDistinction from Emory University’s Goizueta Business School. Mr. Oliviero has been selected to serve on our Board ofDirectors based on his extensive experience in the biotechnology industry and in-depth understanding of our business.

Management

Election of Officers and Family Relationships

Our executive officers are appointed by,and serve at the discretion of, our board of directors. There are no family relationships among any of our directors or executive officers.

Board Composition

Our bylaws provide that our board of directorsshall consist of between one and nine directors, which number shall be fixed from time to time by resolution of our board of directors.Currently our board of directors consists of Ron Bentsur, Kenneth Hoberman, James Oliviero, and Matthew Kaplan.

Our bylaws also provide that our directorsmay be removed with or without cause by the affirmative vote of the holders of at least two-thirds of the votes that all our stockholderswould be entitled to cast in an annual election of directors.

Our current and future executive officersand significant employees serve at the discretion of our Board. Our Board may also choose to form certain committees, such as a compensationcommittee and an audit committee.

Director Independence

Our board of directors has determined thatKenneth Hoberman, Matthew Kaplan and James Oliviero are independent directors. In making this determination, our board of directors appliedthe standards set forth in the rules of Nasdaq and in Rule 10A-3 under the Exchange Act. Our board of directors consideredall relevant facts and circumstances known to it in evaluating the independence of these directors, including their current and historicalemployment, any compensation we have given to them, any transactions we have with them, their beneficial ownership of our capital stock,their ability to exert control over us, all other material relationships they have had with us and the same facts with respect to theirimmediate families.

Although there is no specific policy regardingdiversity in identifying director nominees, the board of directors seek the talents and backgrounds that would be most helpful to usin selecting director nominees.

Board Leadership Structure

Mr. Ron Bentsur, our Chief ExecutiveOfficer, is also the Chairman of our board of directors. Our corporate governance guidelines provide our board of directors with flexibilityto select the appropriate leadership structure at a particular time based on what our board of directors determines to be in the bestinterests of the Company. Our board of directors determined that, at the present time, having our Chief Executive Officer also serveas the Chairman of our board of directors provides us with optimally effective leadership and is in our best interests and those of ourstockholders. Twenty years of management experience in our industry as well as his extensive understanding of our business, operations,and strategy make him well qualified to serve as chairman of our board.

Board Oversight of Risk

Risk assessment and oversight are an integralpart of our governance and management processes. Our board of directors encourages management to promote a culture that incorporatesrisk management into our corporate strategy and day-to-day business operations. Management discusses strategic and operational risksat regular management meetings and conducts specific strategic planning and review sessions during the year that include a focused discussionand analysis of the risks facing us. Throughout the year, senior management reviews these risks with the board of directors at regularboard meetings as part of management presentations that focus on particular business functions, operations or strategies, and presentsthe steps taken by management to mitigate or eliminate such risks.

Management

Our board of directors will not have astanding risk management committee, but will rather administer this oversight function directly through our board of directors as a whole,as well as through various standing committees of our board of directors that address risks inherent in their respective areas of oversight.In particular, our board of directors is responsible for monitoring and assessing strategic risk exposure. Our audit committee will coordinatethe board of director’s oversight of our internal control over financial reporting, disclosure controls and procedures, related-partytransactions and code of conduct and corporate governance guidelines. Our compensation committee will assess and monitor whether anyof our compensation policies and programs has the potential to encourage excessive risk-taking as well as succession planning as it relatesto our Chief Executive Officer. While each committee will be responsible for evaluating certain risks and overseeing the management ofsuch risks, our entire board of directors will be regularly informed through committee reports about such risks.

Board Committees

Ourboard of directors has established an audit committee and compensation committee, each of which will operate pursuant to a charter adoptedby our board of directors. Our board of directors may also establish other committees from time to time to assist the management of ourbusiness. The composition and functions of each committee are described below. Members serve on these committees until their resignationor until otherwise determined by our board of directors. Each committee has adopted a written charter that satisfies the applicablerules and regulations of the Sarbanes-Oxley Act, the SEC and Nasdaq Listing Rules, which we have posted on our website at www.nuvectis.com.

Audit Committee

Our audit committee consists of KennethHoberman, Matthew Kaplan and James Oliviero, with James Oliviero serving as chair. Our board of directors has determined that each memberof the audit committee has sufficient knowledge in financial and auditing matters to serve on the Audit Committee. Our board of directorshas determined James Oliviero qualifies as an “audit committee financial expert,” as defined under the applicable rules ofthe SEC. In making this determination, our board has considered prior experience, business acumen and independence. The audit committee’sresponsibilities include:

Management

Compensation Committee

Our compensation committee consists ofKenneth Hoberman, Matthew Kaplan and James Oliviero, with Kenneth Hoberman serving as chair. Our board of directors has determined thateach of the members of our compensation committee is a non-employee director, as defined in Rule 16b-3 promulgated under the ExchangeAct, and satisfies the Nasdaq independence requirements. The functions of this committee include, among other things:

We believe that the composition and functioningof our compensation committee complies with all applicable requirements of the Sarbanes-Oxley Act, and all applicable SEC and Nasdaqrules and regulations. We intend to comply with future requirements to the extent they become applicable to us.

Nominating and Corporate GovernanceMatters

Our board of directorsdoes not currently have a nominating and corporate governance committee or other committee performing a similar function, nor do wehave any formal written policies outlining the factors and process relating to the selection of nominees for consideration formembership on our board of directors by our directors or our stockholders. Our board of directors has adopted resolutions inaccordance with the rules of The Nasdaq Stock Market authorizing a majority of our independent members to recommend qualifieddirector nominees for consideration by the board of directors. Our board of directors believes that it is appropriate for us to nothave a standing nominating and corporate governance committee because of a number of factors, including the number of independentmembers who want to participate in consideration of candidates for membership on our board of directors and in matters that relateto the corporate governance of our company. Our board of directors consists of four members, three of whom are independent. Ourboard of directors considered forming a nominating and corporate governance committee consisting of several of the independentmembers of our board of directors. Forming a committee consisting of less than all of the independent members was unattractivebecause it would have omitted the other independent members of our board of directors who wanted to participate in consideringqualified candidates for board membership and to have input on corporate governance matters related to our company. Since our boardof directors desired the participation in the nominations process of all of its independent directors, it therefore decided not toform a nominating and corporate governance committee and instead authorized a majority of the independent members of our board ofdirectors to make and consider nominations for membership to our board of directors. The independent members of our board ofdirectors do not have a nominating and corporate governance committee charter, but act pursuant to board of director resolutions asdescribed above. Each of the members of our board of directors authorized to recommend director nominees is independent within themeaning of the current “independent director” standards established by The Nasdaq Stock Market rules. Our board ofdirectors intends to review this matter periodically, and may in the future elect to designate a formal nominating and corporategovernance committee.

Management

Compensation Committee Interlocks andInsider Participation

None of our current or former executiveofficers serve as a member of the compensation committee. None of our officers serve, or have served during the last completed fiscalyear, on the board of directors or compensation committee, or other committee serving an equivalent function, of any other entity thathas one or more of its executive officers serving as a member of our board of directors or our compensation committee. For a descriptionof transactions between us and members of our compensation committee and affiliates of such members, please see “Certain Relationshipsand Related-Party Transactions.”

Code of Business Conduct and Ethics

Wehave adopted a written code of business conduct, that applies to our directors, officers and employees, including our principal executiveofficer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A copy ofthe code is posted on our website at www.nuvectis.com.

Director Compensation

Our directors receive an annual cash retainerof $40,000, payable in quarterly installments on the last day of each calendar quarter, with prorated payment for any partial quarters.Each member of the Compensation Committee and Audit Committee also receives an additional $5,000 annual fee for membership on each committee,with the Chairs of the Audit and Compensation Committees receiving $15,000, payable in quarterly installments on the last day of eachcalendar quarter, with prorated payment for any partial quarters. Directors also received (i) an initial equity grant of 29,250options to purchase our Common Stock, with an exercise price of $3.05 per option and (ii) annual option grants valued at approximately$150,000. All option grants will vest in 3 years, with 1/3 of the granted options of each grant vesting on the first, second and thirdanniversaries of the date of such grant. respectively. The Board has full discretion with respect to the annual grants.

Executive Compensation

Overview

The following are our employment arrangementswith our executive officers as of the end of our most recently completed fiscal year:

Ron Bentsur

Annual Base Salary

Mr. Bentsur’s annual base salaryis $575,000 per annum, paid monthly in equal installments, which commenced on the consummation of our initial public offering. On anannual basis, as of the first of January following the Company’s initial public offering, and in any event on each January 1thereafter, the amount of Mr. Bentsur’s salary shall be increased by no less than the greater of (1) the amount determinedby the Company’s Compensation Committee, or (2) the relevant consumer price index (“CPI”). Mr. Bentsur didnot receive any cash compensation in 2021.

Annual Bonus

Mr. Bentsur’s annual bonus targetwill be 75% of his annual base salary, based on the achievement of corporate goals & objectives, paid no later than March 15following such bonus performance calendar year period. The Board or Compensation Committee shall have the discretion to pay Mr. Bentsuran annual performance bonus in excess of the target for performance exceeding goals, which bonus may be awarded without proration inthe event of a partial contract year.

Equity Awards

Mr. Bentsur will be eligible for grantsof equity awards under the Company’s long-term equity incentive plan. On the Effective Date, the Company shall award the followingto the Mr. Bentsur:

Termination Provisions

In the event that Mr. Bentsur is terminatedwithout Cause, for Good Reason, Change of Control, Death or Disability, as each such term is defined in Mr. Bentsur’s employmentagreement, all unvested shares of restricted stock and options shall be immediately accelerated and become fully vested and unrestricted/exercisable. Upon termination for Cause, all unvested shares of restricted shock shall expire and terminate.

If Mr. Bentsur resigns for Good Reason or isterminated due to Death or Disability, Change of Control, or otherwise terminated without Cause, then Mr. Bentsur or his estateor beneficiaries, in the case of Death or Disability, will receive a one-time payment equal to two years of Mr. Bentsur’sthen annual base salary, plus a bonus payment equal to the annual bonus earned in the preceding year (if not already paid), the prorata portion of the target bonus earned in the current year, benefits and expense reimbursement due to Mr. Bentsur, payment inlieu of any accrued but unused vacation time, payment of any unreimbursed expenses, and continued coverage through the longestapplicable limitations period under the Company’s directors and officers insurance policies, all such payments to be madewithin 60 (sixty) days of the date of termination.

Executive Compensation

Notwithstanding the above the Company mayterminate Mr. Bentsur’s employment hereunder at any time, immediately, for Cause, upon written notice to Mr. Bentsur.If Mr. Bentsur’s employment is terminated for Cause, he shall be entitled to receive (i) the unpaid portion of his basesalary then in effect accrued through the effective date of the termination of his employment hereunder, and (ii) payment for anyunused vacation days which have accrued through the effective date of the termination of Mr. Bentsur’s employment, in eachcase to be paid within 30 (thirty) days after such effective date.

In the event that a “Transaction”(as such term is defined in the Company’s Global Equity Incentive Plan, as amended from time to time, or a successor plan) occursduring Mr. Bentsur’s employment, regardless of whether Mr. Bentsur’s employment is terminated, Mr. Bentsurshall receive payment of the termination benefits described above as if his employment had been terminated on the effective date of theTransaction. Following the Transaction, Mr. Bentsur shall not be entitled to receive such termination benefits upon a future terminationof his employment; provided that he shall remain eligible to receive (i) any accrued benefits upon any such subsequent termination,and (ii) cash payments, paid in periodic installments in accordance with the Company’s usual payroll practices, for a periodof 18 months, equal to the cost the Company would have incurred had Mr. Bentsur continued group medical, dental, vision and/or prescriptiondrug benefit coverage for himself and/or his eligible dependents under any Company sponsored group health plan covering Mr. Bentsurand his eligible dependents at the time of the termination of employment.

Enrique Poradosu

Annual Base Salary

Mr. Poradosu’s annual base salaryis $400,000 per annum, paid monthly in equal installments, which commenced on the consummation of our initial public offering. On anannual basis, as of the first January following the Company’s initial public offering, and in any event on each January 1thereafter, the amount of Mr. Poradosu’s salary shall be increased by no less than the greater of (1) the amount determinedby the Company’s Compensation Committee, or (2) the relevant CPI.

In 2021, Mr. Poradosu received cashcompensation of $27,083.

Annual Bonus

Mr. Poradosu’s annual bonustarget shall be 50% of the annual base salary, based on the achievement of corporate goals & objectives, paid no later thanMarch 15 following such bonus performance calendar year period. The Board or Compensation Committee shall have the discretion topay Mr. Poradosu an annual performance bonus in excess of the target for performance exceeding goals, which bonus may be awardedwithout proration in the event of a partial contract year.

Equity Awards

Mr. Poradosu will be eligible forgrants of equity awards under the Company’s long-term equity incentive plan. On the Effective Date, the Company shall award thefollowing to the Mr. Poradosu:

Executive Compensation

Termination Provisions

In the event that Mr. Poradosu’sis terminated without Cause, for Good Reason, Change of Control, Death or Disability (as such terms are defined in Mr. Poradosu’semployment agreement) all unvested shares of restricted stock and options shall be immediately accelerated and become fully vested andunrestricted/ exercisable. Upon termination for Cause, all unvested shares of restricted shock shall expire and terminate.

If Mr. Poradosu resigns for Good Reason or is terminateddue to Death or Disability, Change of Control, or otherwise terminated without Cause, Mr. Poradosu or his estate or beneficiaries,in the case of Death or Disability, will receive a one-time payment equal to two years of Mr. Poradosu’s then annual BaseSalary, plus a bonus payment equal to Mr. Poradosu’s annual bonus earned in the preceding year if not already paid, the prorata portion of the target bonus earned in the current year, benefits and expense reimbursement due to Mr. Poradosu, payment inlieu of any accrued but unused vacation time, payment of any unreimbursed expenses, and continued coverage through the longest applicablelimitations period under the Company’s directors and officers insurance policies, all such payments to be made within 60 (sixty)days of the date of termination.

Notwithstanding the above the Company mayterminate Mr. Poradosu’s employment hereunder at any time, immediately, for Cause, upon written notice to Mr. Poradosu.If Mr. Poradosu’s employment is terminated for Cause, he shall be entitled to receive (i) the unpaid portion of his basesalary then in effect accrued through the effective date of the termination of his employment hereunder, and (ii) payment for anyunused vacation days which have accrued through the effective date of the termination of his employment, in each case to be paid within30 (thirty) days after such effective date.

In the event that a “Transaction”(as such term is defined in the Company’s Global Equity Incentive Plan, as amended from time to time, or a successor plan) occursduring Mr. Poradosu’s employment, regardless of whether Mr. Poradosu’s employment is terminated, Mr. Poradosushall receive payment of the termination benefits described above as if his employment had been terminated on the effective date of theTransaction. Following the Transaction, Mr. Poradosu shall not be entitled to receive such termination benefits upon a future terminationof his employment; provided that he shall remain eligible to receive (i) any accrued benefits upon any such subsequent termination,and (ii) cash payments, paid in periodic installments in accordance with the Company’s usual payroll practices for a periodof 18 months, equal to the cost the Company would have incurred had Mr. Poradosu continued group medical, dental, vision and/orprescription drug benefit coverage for himself and/or his eligible dependents under any Company sponsored group health plan coveringMr. Poradosu and his eligible dependents at the time of the termination of employment.

Shay Shemesh

Annual Base Salary

Mr. Shemesh’s annual base salaryis $400,000 per annum, paid monthly in equal installments which commenced on the consummation of our initial public offering . On anannual basis, as of the first January following the Company’s initial public offering, and in any event on each January 1thereafter, the amount of the Mr. Shemesh’s Salary shall be increased by no less than the greater of (1) the amount determinedby the Company’s Compensation Committee, or (2) the relevant CPI.

In 2021, Mr. Shemesh received cashcompensation of $27,083.

Executive Compensation

Annual Bonus

Mr. Shemesh’s annual bonus target will be50% of his annual base salary, based on the achievement of corporate goals & objectives, paid no later than March 15following such bonus performance calendar year period. The Board or Compensation Committee shall have the discretion to pay theMr. Shemesh an annual performance bonus in excess of the target for performance exceeding goals, which bonus may be awardedwithout proration in the event of a partial contract year.

Equity Awards

Mr. Shemesh will be eligible for grantsof equity awards under the Company’s long-term equity incentive plan. On the Effective Date, the Company shall award the followingto the Mr. Shemesh:

Termination Provisions

In the event that Mr.  Shemesh isterminated without Cause, for Good Reason, Change of Control, Death or Disability (as such terms are defined in the employment agreement)all unvested shares of restricted stock and options shall be immediately accelerated and become fully vested and unrestricted/exercisable.Upon termination for Cause, all unvested shares of restricted shock shall expire and terminate.

If Mr. Shemesh resigns for Good Reason or isterminated due to Death or Disability, Change of Control, or otherwise terminated without Cause, then Mr. Shemesh or his estateor beneficiaries, in the case of Death or Disability, will receive a one-time payment equal to two years of Mr. Shemesh’sthen annual Base Salary, plus a bonus payment equal to the annual bonus earned in the preceding year if not already paid, the prorata portion of the target bonus earned in the current year, plus benefits and expense reimbursement due to Mr. Shemesh,payment in lieu of any accrued but unused vacation time, payment of any unreimbursed expenses, and continued coverage through thelongest applicable limitations period under the Company’s directors and officers insurance policies, all such payments to bemade within 60 (sixty) days of the date of termination.

Notwithstanding the above the Company may terminateMr. Shemesh’s employment hereunder at any time, immediately, for Cause, upon written notice to Mr. Shemesh. IfMr. Shemesh’s employment is terminated for Cause, he shall be entitled to receive (i) the unpaid portion of his basesalary then in effect accrued through the effective date of the termination of his employment hereunder, and (ii) payment forany unused vacation days which have accrued through the effective date of the termination of his employment, in each case to be paidwithin 30 (thirty) days after such effective date.

In the event that a “Transaction”(as such term is defined in the Company’s Global Equity Incentive Plan, as amended from time to time, or a successor plan) occursduring Mr. Shemesh’s employment, regardless of whether Mr. Shemesh’s employment is terminated, Mr. Shemeshshall receive payment of the termination benefits described above as if his employment had been terminated on the effective date of theTransaction. Following the Transaction, Mr. Shemesh shall not be entitled to receive such termination benefits upon a future terminationof his employment; provided that he shall remain eligible to receive (i) any accrued benefits upon any such subsequent terminationand (ii) cash payments, paid in periodic installments in accordance with the Company’s usual payroll practices for a periodof 18 months, equal to the cost the Company would have incurred had Mr. Shemesh continued group medical, dental, vision and/or prescriptiondrug benefit coverage for himself and/or his eligible dependents under any Company sponsored group health plan covering Mr. Shemeshand his eligible dependents at the time of the termination of employment.

Executive Compensation

Employee Benefit and Incentive Plans

We do not maintain any deferred compensation,retirement, pension or profit-sharing plans. Our Board of Directors has adopted an incentive plan, the material terms of which are describedbelow, allowing for the grant of equity and cash-based awards to our employees and directors.

Equity Incentive Plan

2021 Incentive Plan

On May 23, 2021 (the “EffectiveDate”), our Board of Directors (the “Board”) adopted the Centry Pharma, Inc. Global Equity Incentive Plan (the “2021 Plan”), which will continue in effect for ten years from the Effective Date. The material terms of the 2021 Plan aredescribed below. The 2021 Plan will be administered by the Board of Directors or a designated committee thereof (as applicable, the “Administrator”),as further described below.

Purpose.The purpose of the 2021 Plan is to attract and retain the best available personnel for, to provide incentives to service providers ofthe Company (“Service Providers”), and to promote the Company’s business by strengthening the common interest betweensuch individuals and the Company’s stockholders.

Awards.The Administrator may grant any combination of equity awards eligible under the 2021 Plan (an “Award”), as discussed below.The Administrator will determine the details of any such grant, including the timing, the number of shares, the purchase price, timefor forfeiture, the vesting schedule, and any acceleration rights thereto. The Administrator may condition any Award on the attainmentof performance targets or any other factor that the Administrator may deem appropriate. Unless otherwise permitted by

the Administrator, noParticipant may sell, assign, transfer, pledge, hypothecate, or otherwise dispose of any Award, except by will or pursuant to thelaws of intestacy. The Company may, at its discretion, impose as a condition of any Award that the Participant grant an individualdesignated by the Company an irrevocable proxy to vote all shares subject to the Participant’s Award at any general meeting ofthe Company’s stockholders.

PermissibleAwards. The 2021 Plan authorizes awards in any of the following forms:

Executive Compensation

Adjustments.A Participant’s right to purchase shares under the 2021 Plan will be adjusted upon the occurrence of certain events,as described below.

Executive Compensation

Cancellationof Awards. If the Board of Directors determines in good faith that, in the context of a Transaction or Liquidation,certain Awards have no monetary value and the holders of such Awards are not entitled to any consideration under the terms of theTransaction or liquidation, the Board of Directors may terminate the Awards. Further, in connection with a Transaction orliquidation, the Board of Directors may terminate any Award, effective as of the effective date of the Transaction or Liquidation,that has an exercise price that is greater than fair market value at the time of such Transaction or Liquidation, without anyconsideration to the holder thereof.

GoverningLaw. The 2021 Plan is governed by the laws of Delaware.

Outstanding Equity Awards as of December 31,2021

ThroughDecember 31, 2021 we granted 81,003 warrants to service providers with a weighted average exercise price of $3.05. Of thesewarrants, all are fully vested.

Through December 31, 2021 we granted 226,590 optionsto service providers with a weighted average exercise price of $3.05. Of these options, none are fully vested.

Certain U.S. Federal Income Tax Effects

The following discussion is limited to asummary of the U.S. federal income tax provisions relating to the grant, exercise, vesting and settlement of awards under the 2021 Planand the subsequent sale of common stock acquired under the Global Equity Incentive Plan. The tax consequences of awards may vary dependingupon the particular circumstances, and it should be noted that the income tax laws, regulations and interpretations thereof change frequently.This discussion is intended for general information only and does not purport to be a complete analysis of all of the potential tax effectsof the 2021 Plan. Additional taxes, including state, local, and foreign taxes, may apply and may vary from jurisdiction to jurisdiction.

Non-QualifiedStock Options. There typically will be no U.S. federal income tax consequences to the optionee or to us upon the grantof a non-qualified stock option under the Global Equity Incentive Plan. When the optionee exercises a non-qualified option, however, heor she will recognize ordinary income in an amount equal to the excess of the fair market value of our common stock received upon exerciseof the option at the time of exercise over the exercise price, and we will typically be allowed a corresponding U.S. federal income taxdeduction. Any gain that the optionee realizes when he or she later sells or disposes of the option shares will be short-term or long-termcapital gain, depending on how long the shares were held.

Executive Compensation

IncentiveStock Options. There typically will be no U.S. federal income tax consequences to the optionee or to us upon the grantor exercise of an incentive stock option. If the optionee holds the acquired option shares for the required holding period of at leasttwo years after the date the option was granted and one year after exercise, the difference between the exercise price and the amountrealized upon sale or disposition of the option shares will be long-term capital gain or loss, and we will not be entitled to a U.S. federalincome tax deduction on such amount. If the optionee disposes of the option shares in a sale, exchange, or other disqualifying dispositionbefore the required holding period ends, he or she will recognize taxable ordinary income in an amount equal to the excess of the fairmarket value of the option shares at the time of exercise (or, if less, the amount realized on the disposition of the shares) over theexercise price, and we would typically be allowed a U.S. federal income tax deduction equal to such amount. While the exercise of an incentivestock option does not result in current taxable income, the excess of the fair market value of the option shares at the time of exerciseover the exercise price will be an item of adjustment for purposes of determining the optionee’s alternative minimum taxable income.

StockAppreciation Rights. A participant receiving a stock appreciation right typically will not recognize income, and we willnot be allowed a tax deduction, at the time the award is granted. When the participant exercises the stock appreciation right, the amountof cash and the fair market value of any shares of our common stock received will be ordinary income to the participant and we will typicallybe allowed a corresponding U.S. federal income tax deduction at that time.

RestrictedStock. Unless a participant makes an election to accelerate recognition of income to the date of grant as describedbelow, the participant will not recognize income, and we will not be allowed a tax deduction, at the time a restricted stock awardis granted, provided that the award is nontransferable and is subject to a substantial risk of forfeiture. When the restrictionslapse, the participant will recognize ordinary income equal to the fair market value of our common stock as of that date (less anyamount he or she paid for the stock), and we will typically be allowed a corresponding U.S. federal income tax deduction at thattime, subject to limitations in certain circumstances. If the participant files an election under CodeSection 83(b) within 30 days after the date of grant of the restricted stock, he or she will recognize ordinary income asof the date of grant equal to the fair market value of the stock as of that date (less any amount paid for the stock), and we willtypically be allowed a corresponding U.S. federal income tax deduction, subject to limitations in certain circumstances at thattime. Any future appreciation in the stock will be taxable to the participant at capital gains rates. However, if the stock is laterforfeited, the participant will not be able to recover the tax previously paid pursuant to the Section 83(b) election.

RestrictedStock Units. A participant typically will not recognize income, and we will not be allowed a tax deduction, at thetime a restricted stock unit award is granted. When the participant receives shares of our common stock (or the equivalent value incash or other property) in settlement of a restricted stock unit award, a participant will recognize ordinary income equal to thefair market value of our common stock or other property as of that date (less any amount he or she paid for the stock or property),and we will typically be allowed a corresponding U.S. federal income tax deduction at that time, subject to limitations in certaincircumstances.

Cash-BasedPerformance Awards. A participant will not recognize income, and we will not be allowed a tax deduction, at the time acash-based performance award is granted (for example, when the performance goals are established). Upon receipt of cash in settlementof the award, the participant will recognize ordinary income equal to the cash received, and we will typically be allowed a correspondingU.S. federal income tax deduction at that time, subject to limitations in certain circumstances.

Section 409A. The2021 Plan permits the grant of various types of incentive awards, which may or may not be exempt from Code Section 409A. If anaward is subject to Section 409A, and if the requirements of Section 409A are not met, the taxable events as describedabove could apply earlier than described, and could result in the imposition of additional taxes and penalties. Restricted stockawards, and stock options and SARs that comply with the terms of the Global Equity Incentive Plan, are generally exempt from theapplication of Section 409A. Stock units, other stock-based awards and cash-based awards that are granted in one year andpayable in a later year generally are subject to Section 409A unless they are designed to satisfy the short-term deferralexemption from such law. If not exempt, such awards must be specially designed to meet the requirements of Section 409A inorder to avoid early taxation and penalties.

TaxWithholding. We have the right to deduct or withhold, or require a participant to remit to us, an amount sufficient tosatisfy federal, state and local taxes (including employment taxes) required by law to be withheld with respect to any exercise, lapseof restriction or other taxable event arising as a result of the Global Equity Incentive Plan.

 Principal Stockholders

The following table sets forth informationwith respect to the beneficial ownership of our common stock as of June 30, 2022, and as adjusted to reflect the sale of our commonstock offered by us in this offering, for:

We havedetermined beneficial ownership in accordance with the rules of the SEC, which generally means that a person has beneficialownership of a security if he or she possesses sole or shared voting or investment power of that security, including options orwarrants that are currently exercisable or exercisable within 60 days of June 30, 2022. Unless otherwise indicated, to ourknowledge, the persons and entities named in the table below have sole voting and sole investment power with respect to all sharesthat they beneficially own, subject to community property laws where applicable. The information in the table below does notnecessarily indicate beneficial ownership for any other purpose, including for purposes of Sections 13(d) and 13(g) of theSecurities Act.

Unless otherwise indicated, the addressof each beneficial owner listed in the table below is c/o Nuvectis Pharma, Inc., 1 Bridge Plaza, Fort Lee, NJ 07024.

Principal Stockholders

* Represents beneficial ownership of lessthan 1%.

Certain Relationshipsand Related-Party Transactions

Since inception, we have not been involvedin a transaction or series of similar transactions that:

Policies and Procedures for Transactionwith Related Persons

Uponthe consummation of our initial public offering, our board of directors adopted a written related person transaction policy, settingforth the policies and procedures for the review and approval or ratification of related person transactions. This policy covers,with certain exceptions set forth in Item 404 of Regulation S-K under the Securities Act, any transaction, arrangement orrelationship, or any series of similar transactions, arrangements or relationships in which we were or are to be a participant,where the amount involved exceeds $120,000 or 1% of the average of our total assets as of December 31, 2021 and 2020 and a relatedperson had or will have a direct or indirect material interest, including without limitation purchases of goods or services by orfrom the related person or entities in which the related person has a material interest, indebtedness, guarantees of indebtednessand employment by us of a related person. In reviewing and approving any such transactions, our audit committee is tasked toconsider all relevant facts and circumstances, including but not limited to whether the transaction is on terms comparable to thosethat could be obtained in an arm’s length transaction with an unrelated third party and the extent of the relatedperson’s interest in the transaction.

 Description ofCapital Stock

The following descriptions are summariesof the material terms of our amended and restated certificate of incorporation and amended and restated bylaws.

General

Our authorized capital stock consists of60,000,000 shares of Common Stock, par value $0.00001 per share, and 5,000,000 shares of preferred stock, par value $0.00001 per share,all of which shares of preferred stock are undesignated.

As of June 30, 2022, 12,717,794 sharesof our Common Stock were outstanding and held of record by 44 stockholders.

Common Stock

Holders of our Common Stock are entitledto one vote for each share held on all matters submitted to a vote of stockholders and do not have cumulative voting rights. An electionof directors by our stockholders shall be determined by a plurality of the votes cast by the stockholders entitled to vote on the election.Holders of Common Stock are entitled to receive proportionately any dividends as may be declared by our Board of Directors in its solediscretion, subject to any preferential dividend rights of outstanding preferred stock, if any.

In the event of our liquidation or dissolution,the holders of Common Stock are entitled to receive proportionately all assets available for distribution to stockholders after the paymentof all debts and other liabilities and subject to the prior rights of any outstanding preferred stock. Holders of Common Stock have nopreemptive, subscription, redemption or conversion rights. The rights, preferences and privileges of holders of Common Stock are subjectto, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock that we may designate and issuein the future.

Preferred stock

Our board of directors has the authority,without further action by our stockholders, to issue up to 5,000,000 shares of preferred stock in one or more series and to fix the rights,preferences, privileges and restrictions thereof. These rights, preferences and privileges could include dividend rights, conversion rights,voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting, or the designationof, such series, any or all of which may be greater than the rights of Common Stock. The issuance of our preferred stock could adverselyaffect the voting power of holders of Common Stock and the likelihood that such holders will receive dividend payments and payments uponour liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deferring or preventing a change in controlof our company or other corporate action. Immediately after consummation of this offering, no shares of preferred stock will be outstanding,and we have no present plan to issue any shares of preferred stock.

Anti-takeover effects of Delaware lawand certain provisions of our certificate of incorporation and amended and restated bylaws

Our certificate of incorporation and bylawsinclude a number of provisions that may have the effect of delaying, deferring or preventing another party from acquiring control ofus and encouraging persons considering unsolicited tender offers or other unilateral takeover proposals to negotiate with our board ofdirectors rather than pursue non-negotiated takeover attempts. These provisions include the items described below.

Description of Capital Stock

Board composition and filling vacancies

Our certificate of incorporation providesfor the division of our board of directors into three classes serving staggered three-year terms, with one class being elected each year.Our certificate of incorporation also provides that directors may be removed only for cause and then only by the affirmative vote of theholders of two-thirds of the shares then entitled to vote at an election of directors. Furthermore, any vacancy on our board of directors,however occurring, including a vacancy resulting from an increase in the size of our board, may only be filled by the affirmative voteof a majority of our directors then in office even if less than a quorum. The classification of directors, together with the limitationson removal of directors and treatment of vacancies, has the effect of making it more difficult for stockholders to change the compositionof our board of directors.

No written consent of stockholders

Our certificate of incorporation providesthat all stockholder actions are required to be taken by a vote of the stockholders at an annual or special meeting, and that stockholdersmay not take any action by written consent in lieu of a meeting. This limit may lengthen the amount of time required to take stockholderactions and would prevent the amendment of our bylaws or removal of directors by our stockholders without holding a meeting of stockholders.

Meetings of stockholders

Our certificate of incorporation and bylawsprovide that only a majority of the members of our board of directors then in office may call special meetings of stockholders and onlythose matters set forth in the notice of the special meeting may be considered or acted upon at a special meeting of stockholders. Ourbylaws limit the business that may be conducted at an annual meeting of stockholders to those matters properly brought before the meeting.

Advance notice requirements

Our bylaws establish advance notice procedureswith regard to stockholder proposals relating to the nomination of candidates for election as directors or new business to be broughtbefore meetings of our stockholders. These procedures provide that notice of stockholder proposals must be timely given in writing toour corporate secretary prior to the meeting at which the action is to be taken. Generally, to be timely, notice must be received at ourprincipal executive offices not less than 90 days nor more than 120 days prior to the first anniversary date of the annual meeting forthe preceding year. Our bylaws specify the requirements as to form and content of all stockholders’ notices. These requirementsmay preclude stockholders from bringing matters before the stockholders at an annual or special meeting.

Amendment to certificate of incorporationand bylaws

Any amendment of our certificate of incorporationmust first be approved by a majority of our board of directors, and if required by law or our certificate of incorporation, must thereafterbe approved by two- thirds of the outstanding shares entitled to vote on the amendment and two-thirds of the outstanding shares of eachclass entitled to vote thereon as a class. Our bylaws may be amended by the affirmative vote of a majority of the directors then in office,subject to any limitations set forth in the bylaws; and may also be amended by the affirmative vote of two-thirds of the outstanding sharesentitled to vote on the amendment, or, if our board of directors recommends that the stockholders approve the amendment, by the affirmativevote of two-thirds of the outstanding shares entitled to vote on the amendment, in each case voting together as a single class.

Description of Capital Stock

Undesignated preferred stock

Our certificate of incorporation providesfor 5,000,000 authorized shares of preferred stock. The existence of authorized but unissued shares of preferred stock may enable ourboard of directors to discourage an attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise. Forexample, if in the due exercise of its fiduciary obligations, our board of directors were to determine that a takeover proposal is notin the best interests of our stockholders, our board of directors could cause shares of preferred stock to be issued without stockholderapproval in one or more private offerings or other transactions that might dilute the voting or other rights of the proposed acquireror insurgent stockholder or stockholder group. In this regard, our certificate of incorporation grants our board of directors broad powerto establish the rights and preferences of authorized and unissued shares of preferred stock. The issuance of shares of preferred stockcould decrease the amount of earnings and assets available for distribution to holders of shares of Common Stock. The issuance may alsoadversely affect the rights and powers, including voting rights, of these holders and may have the effect of delaying, deterring or preventinga change in control of us.

Delaware anti-takeover statute

We are subject to the provisions of Section 203of the Delaware General Corporation Law. In general, Section 203 prohibits a publicly held Delaware corporation from engaging ina “business combination” with an “interested stockholder” for a three-year period following the time that thisstockholder becomes an interested stockholder, unless the business combination is approved in a prescribed manner. Under Section 203,a business combination between a corporation and an interested stockholder is prohibited unless it satisfies one of the following conditions:

Section 203 defines a business combinationto include:

In general, Section 203 defines aninterested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation andany entity or person affiliated with or controlling or controlled by the entity or person.

Choice of forum

Our amended and restated bylaws providethat the Court of Chancery of the State of Delaware will be the exclusive forum for state law claims for (i) any derivative actionor proceeding brought on our behalf, (ii) any action asserting a breach of fiduciary duty by one or more of our directors, officersor employees, (iii) any action asserting a claim against us arising pursuant to the Delaware General Corporation Law or (iv) anyaction asserting a claim against us that is governed by the internal affairs doctrine, in each case subject to the Court of Chancery havingpersonal jurisdiction over the indispensable parties named as defendants therein (the “Delaware Forum Provision”); provided,however, that this forum provision will not apply to any causes of action arising under the Exchange Act or the Securities Act which,unless we consent in writing to the selection of an alternative forum, are required to be brought exclusively in federal district courtsof the United States of America in accordance with the 2^nd Amended and Restated Articles of Incorporation. In addition, ouramended and restated bylaws will provide that any person or entity purchasing or otherwise acquiring any interest in shares of our CommonStock is deemed to have notice of and consented to the Delaware Forum Provision. We recognize that the Delaware Forum Provision in ourbylaws may impose additional litigation costs on stockholders in pursuing any such claims, particularly if the stockholders do not residein or near the State of Delaware.

Additionally, the Delaware ForumProvision may limit our stockholders’ ability to bring a claim in a judicial forum that they find favorable for disputes withus or our directors, officers or employees, which may discourage such lawsuits against us and our directors, officers and employees.The Court of Chancery of the State of Delaware may also reach different judgments or results than would other courts, includingcourts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgmentsmay be more or less favorable to us than our stockholders.

Stock exchange listing

Our Common Stock is listed on Nasdaq CapitalMarket under the trading symbol “NVCT.”