As filed with theSecurities and Exchange Commission on July 21, 2021.

No.333- [  ]

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORMS-1

REGISTRATIONSTATEMENT

UNDER

THESECURITIES ACT OF 1933

RenovoRx,Inc.

(Exactname of registrant as specified in its charter)

4546El Camino Real, Suite B1

LosAltos, CA 94022

(650)-284-4433

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

ShaunBagai

ChiefExecutive Officer

RenovoRx,Inc.

4546El Camino Real, Suite B1

LosAltos, CA 94022

(650)-284-4433

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

Copiesof all communications to:

Approximatedate of commencement of proposed sale to the public:

Assoon as practicable after this Registration Statement becomes effective.

Ifany of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under theSecurities Act of 1933, check the following box. [X]

Ifthis Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act of 1933, pleasecheck the following box and list the Securities Act registration statement number of the earlier effective registration statement forthe same offering. [  ]

Ifthis Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list theSecurities Act registration statement number of the earlier effective registration statement for the same offering. [  ]

Ifthis Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list theSecurities Act registration statement number of the earlier effective registration statement for the same offering. [  ]

Indicateby check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany, 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.:

Ifan emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. [  ]

CALCULATIONOF REGISTRATION FEE

(1)Pursuant to Rule 416, the securities being registered hereunder include such indeterminate number of additional securities as maybe issuable to prevent dilution resulting from stock splits, stock dividends or similar transactions.

(2)Estimated solely for the purpose of calculating the registration fee in accordance with Rule 457(o) under the Securities Act of 1933,as amended (the “Securities Act”).

(3)No fee is required pursuant to Rule 457(i) under the Securities Act. 

(4) Theregistrant has agreed to issue, upon the closing of this offering, a purchase option to Roth Capital Partners, LLC entitling it topurchase a number of shares of common stock equal to 5% of the aggregate shares of common stock (including shares of common stockunderlying the Warrants) sold in this offering. The exercise price of the purchase option will be equal to 120% of the publicoffering price of the Units offered hereby

Theregistrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until theregistrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effectivein accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such dateas the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine

Theinformation in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registrationstatement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sellthese securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

SUBJECTTO COMPLETION, DATED JULY 21, 2021

PRELIMINARYPROSPECTUS

[        ]Units

Common Stock and Warrants

Thisis our initial public offering. We are offering up to [        ] of units of securities (the“Units”) pursuant to this prospectus. Prior to this offering, there has been no public market for our common stock. Weanticipate that the initial public offering price of our Units will be between $[        ]and $[        ].

Each Unit consists of(a) one share of our common stock and (b) ______ warrant (the “Warrants”) to purchase one share of our common stock at anexercise price equal to $____[___% of initial public offering price per Unit], exercisable until the fifth anniversary ofthe issuance date, and subject to certain adjustment and cashless exercise provisions as described herein. The shares of our common stockand the Warrants are immediately separable and will be issued separately, but will be purchased together in this offering.

Wehave applied to list our common stock on the Nasdaq Capital Market under the symbol “RNXT.” If we do not meet all of Nasdaq’sinitial listing criteria, we will not complete this offering. We do not intend to apply for any listing of the Warrants on the NasdaqCapital Market or any other securities exchange or nationally recognized trading system, and we do not expect a market to develop forthe Warrants.

Weare an “emerging growth company” under the federal securities laws and have elected to comply with certain reduced publiccompany reporting requirements.

Investingin our securities involves a high degree of risk. See “Risk Factors” beginning on page 29.

Neitherthe Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determinedif this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

(1)We refer you to “Underwriting” beginning on page 111 for additional information regarding underwriters’ compensation.

(2) The public offering corresponds to an assumed public offering priceper share of common stock of $___ and an assumed public offering price per Warrant of $____.

Wehave granted Roth Capital Partners, LLC, as representativeof the underwriters, an option, exercisable one or more times in whole or in part, to purchase up to _____ additional shares ofcommon stock and/or Warrants to purchase up to an aggregate of ______ shares of common stock, in any combinations thereof, from usat $____ per share of common stock and $_____ per Warrant, less the underwriting discounts and commissions, for 45 days after thedate of this prospectus to cover over-allotments, if any.

The underwritersexpect to deliver the Units to purchasers on or about                           ,2021.

Sole Book-Running Manager

RothCapital Partners

Lead Manager

Maxim Group LLC

Thedate of this prospectus is        , 2021

TABLEOF CONTENTS

Neitherwe nor the underwriters have authorized anyone to provide you with information other than that contained in this prospectus. Weand the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other informationthat others may give you. We and the underwriters are offering to sell, and seeking offers to buy, the securities offered herebyonly in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the dateon the front cover page of this prospectus, or other earlier date stated in this prospectus, regardless of the time of delivery of thisprospectus or of any sale of our securities.

Noaction is being taken in any jurisdiction outside the United States to permit a public offering of our securities or possession or distributionof this prospectus in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United Statesare required to inform themselves about and to observe any restrictions as to this offering and the distribution of this prospectus applicableto that jurisdiction.

Thisprospectus includes industry data and forecasts that we have obtained from industry publications and surveys, public filings and internalcompany sources. Industry publications and surveys and forecasts generally state that the information contained therein has been obtainedfrom sources believed to be reliable, but there can be no assurance as to the accuracy or completeness of the included information. Statementsas to our market position and market estimates are based on independent industry publications, government publications, third party forecasts,management’s estimates and assumptions about our markets and our internal research. While we are not aware of any misstatementsregarding the market, industry or similar data presented herein, such data involve risks and uncertainties and are subject to changebased on various factors, including those discussed under the headings “Risk Factors” and “Cautionary Statement ConcerningForward-Looking Statements” in this prospectus.

PROSPECTUSSUMMARY

Thefollowing summary highlights information contained elsewhere in this prospectus. It does not contain all of the information you needto consider in making your investment decision. Before making an investment decision, you should read this entire prospectus carefullyand you should consider, among other things, the matters set forth under “Risk Factors” and our financial statements andrelated notes thereto appearing elsewhere in this prospectus. In this prospectus, except as otherwise indicated, “RenovoRx,”the “Company,” “we,” “our,” and “us” refer to RenovoRx, Inc., a Delaware corporation,and its subsidiaries.

Overview

Weare a clinical-stage biopharmaceutical company focused on developing therapies for the local treatment of solid tumors and conductinga Phase 3 registrational trial for our lead product candidate RenovoGem™. Our therapy platform, RenovoRx Trans-Arterial Micro-Perfusion,or RenovoTAMP™ utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and side effectprofiles, with the goal of increasing their efficacy, improving their safety, and widening their therapeutic window. RenovoTAMP combinesour patented U.S. Food and Drug Administration, or FDA, cleared delivery system, RenovoCath^®, with small molecule chemotherapeuticagents that can be forced across the vessel wall using pressure, targeting these anti-cancer drugs locally to the solid tumors. Whilewe anticipate investigating other chemotherapeutic agents for intra-arterial delivery via RenovoTAMP, our clinical work to date has focusedon gemcitabine, which is a generic drug. Our first product candidate, RenovoGem, is a drug and device combination consisting of intra-arterialgemcitabine and RenovoCath. FDA has determined that RenovoGem will be regulated as, and if approved we expect will be reimbursed as,a new oncology drug product. We have secured FDA Orphan Drug Designation for RenovoGem in our first two indications: pancreatic cancerand cholangiocarcinoma (bile duct cancer, or CCA). We have completed our RR1 Phase 1/2 and RR2 observational registry studies, with 20and 25 patients respectively, in locally advanced pancreatic cancer, or LAPC. These studies demonstrated a median overall survival of27.9 months in patients treated with RenovoGem and radiation. Based on previous large randomized clinical trials, the expected survivalof LAPC patients is 12-15 months in patients receiving only intravenous (IV) systemic chemotherapy or IV chemotherapy plus radiation(which are both considered standard of care). Unlike the randomized trials that established these standard-of-care results, our RR1 andRR2 clinical trials did not prospectively control the standard of care therapy received prior to RenovoTAMP. Based on FDA safety reviewof our Phase 1/2 study the FDA allowed us to proceed to evaluate RenovoGem within our Phase 3 registration Investigational New Drug,or IND, clinical trial. Our Phase 3 trial is over 40% enrolled as of July 15, 2021 and we expect to report data from aplanned interim data readout in the second half of 2022. We intend to evaluate RenovoGem in a second indication in a Phase 2/3 trialin hilar CCA (cancer that occurs in the bile ducts that lead out of the liver and join with the gallbladder, also called extrahepaticcholangiocarcinoma, or HCCA). We plan to propose the trial to the FDA and potentially launch in the first half of 2022. In addition,we may evaluate RenovoGem in other indications, potentially including locally advanced lung cancer, locally advanced uterine tumors,and glioblastoma (an aggressive type of cancer that can occur in the brain or spinal cord). To date, we have used gemcitabine, but inthe future we may develop other chemotherapeutic agents for intra-arterial delivery via RenovoCath.

OurRenovoTAMP therapy platform is focused on optimizing drug concentration in solid tumors using approved small molecule chemotherapeuticsthat enable physicians to isolate segments of the vascular anatomy closest to tumors and force chemotherapy across the blood vessel wallto bathe these difficult-to-reach tumors in chemotherapy. More specifically, our patented approach combines local delivery via our patentedRenovoCath delivery system utilizing pressure to force small molecule chemotherapy into the tumor tissue with pre-treatment of the localblood vessels and tissue with standard-of-care radiation therapy to decrease chemotherapy washout. We believe there are many advantagesto our approach:

Ourlead product candidate, RenovoGem, is a combination of gemcitabine and our patented delivery system, RenovoCath, and is regulated bythe FDA as a novel oncology drug product. Our RenovoTAMP platform therapy utilizes pressure mediated delivery of gemcitabine across thearterial wall to bathe the pancreatic tumor tissue in 120mL of saline with 1,000mg/m² of the drug over a 20-minute deliverytime (approximately a total of 1,500-2,000mg of drug dependent upon patient Body Surface Area). RenovoCath is an adjustable double ballooncatheter designed to isolate the proximal and distal vessel and adjust the distance between the balloons to exclude any branching bloodvessel offshoots.

Whilethe field of oncology has seen progress in treating a handful of deadly cancers over the last few decades, there is a common limitationin chemotherapy: enhanced dosing of the drug to impact the tumor while minimizing systemic toxicity. The characteristics of the vasculature,within and surrounding the tumor, can be a limiting step in this goal. For example, LAPC and HCCA are more difficult to treat due tothe lack of blood vessels that feed these tumors, making it difficult to expose tumors to chemotherapy, which is typically deliveredintravenously. Trans-arterial chemoembolization (TACE) is an established first line therapy for certain solid tumors. A key componentof this approach is to identify and isolate vessels feeding the tumor, known as tumor feeders. However, in patients with pancreatic cancer,no tumor feeder vessels are visible during angiography. In the absence of visible tumor feeders, we can introduce drugs directly acrossthe arterial wall into the surrounding tissue via pressurized diffusion.

Weare currently evaluating RenovoGem in patients with LAPC in a Phase 3 trial entitled “Targeted Intra-arterialGemcitabine vs. Continuation of IV (intravenous) Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IVGemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer”,or TIGeR-PaC, trial at 28 US and Belgian sites. The trial is designed to enroll 340 subjects. 145 patients were enrolled as ofJuly 15, 2021. A planned interim data readout is expected during the second half of 2022. We have secured Orphan Drug Designationfor RenovoGem, which would provide us with seven years of exclusivity to market intra-arterial use of gemcitabine for LAPC upon New DrugApplication, or NDA, approval.

Inaddition, we intend to evaluate RenovoGem in patients with HCCA, and we have secured FDA Orphan Drug Designation for this indication.We intend to potentially pursue additional indications including locally advanced lung cancer, locally advanced uterine tumors, and glioblastoma.

Forour initial indication, LAPC, we have completed two studies. We launched RR1, our first-in-human, dose escalation, Phase 1/2 safety studyin May 2015 to evaluate our RenovoTAMP platform by delivering intra-arterial gemcitabine via our patented RenovoCath delivery system.In this safety study, 20 patients with a diagnosis of Stage 3 pancreatic cancer were enrolled. We established the maximum tolerateddose of 1000mg/m² of intra-arterial gemcitabine delivered via RenovoCath. The most common serious adverse events were neutropeniafollowed by sepsis. After completion of enrollment and demonstration of an early survival efficacy signal in this study, we launchedour RR2 observational registry study in June 2016. The key inclusion criteria was a diagnosis of advanced or borderline resectablepancreatic adenocarcinoma confirmed by histology or cytology. The primary endpoints were survival, tumor response and performance ofRenovoCath. A combination analysis of these two studies demonstrated that survival in “all comers” (n=31) receiving atleast one cycle (two treatments over one month) was 29% at two years. Looking at the prior-radiation therapy subset (n=10), 24-monthsurvival was 60% with a median overall survival (mOS) of 27.9 months. This compares favorably both to IV chemotherapy alone, with 24-monthsurvival of 12%, and to chemotherapy + radiation with 24-month survival of 5% and mOS of 12-15 months as demonstrated in historical studies.

Weintend to submit our proposed Phase 2/3 clinical trial to evaluate RenovoGem in HCCA, BENEFICIAL, to the FDA as part of a pre-IND submissionin the fourth quarter of 2021 and to launch the clinical trial in the first half of 2022. Intra-venous (IV), or systemic, deliveryof gemcitabine has been considered standard of care for several solid tumors, and the drug’s anti-cancer tumor effects are wellprofiled. We intend to explore the application of our RenovoTAMP platform in additional indications including locally advanced lung cancer,locally advanced uterine cancer, and glioblastoma. We have completed and presented data on a lung cancer application in pre-clinicalstudies, and additional pre-clinical experiments in lung cancer may be conducted. Beyond our initial anti-cancer product candidate, RenovoGem,multiple small molecule therapeutics could be incorporated into our RenovoTAMP platform, and we will opportunistically look to developother potential product candidates.

Ourmanagement team, Board of Directors, and Scientific Advisors provide us with expertise across multiple sectors to drive success throughclinical development and subsequent commercialization of our novel therapy platform. Our Chief Executive Officer, Shaun Bagai, has extensiveexperience running clinical trials as well as launching, creating, and developing new markets for novel therapies at Trans Vascular,Medtronic, Ardian, and HeartFlow. Dr. Ramtin Agah, our Co-Founder and Chief Medical Officer, is a practicing cardiovascular specialistwho has 20 years of research experience in vascular biology and disease in both academia and industry. Our Board of Directors includesa wide range of public and private company management and Board experience including drug/device combination and oncology experience.Clinical advisors include experts in surgical oncology, interventional radiology, radiation oncology, and medical oncology. Dr. DanielVon Hoff, a medical oncologist, was instrumental as the Principal Investigator who brought to market standard of care therapies for pancreaticcancer. Dr. Mike Pishvaian, also a medical oncologist, has extensive experience in running oncology studies and is an Associate sociateProfessor, and Department of Oncology Director of the Gastrointestinal, Developmental Therapeutics, and Clinical Research Programs atthe NCR Kimmel Cancer Center at Sibley Memorial Hospital Johns Hopkins University School of Medicine. Dr. Pishvaian is the PrincipalInvestigator/Global Study Chair of our TIGeR-PaC Phase 3 study. Dr. Peter Muscarella is a surgical oncologist and the Director of PancreaticSurgery, General Surgery Site Director, Weiler Hospital Associate Program Director, and General Surgery Residency Training Program atMontefiore Medical Center, Bronx, NY. Dr. Karyn Goodman serves as our Radiation Monitor for our TIGeR-PaC Phase 3 study and Professorand Vice Chair of Clinical Research, Department of Radiation Oncology at the Icahn School of Medicine at Mount Sinai, and Associate Directorof Clinical Research at the Tisch Cancer Institute at Mount Sinai. We have two interventional radiology scientific advisors: Dr. RezaMalek, Neurointerventional Radiologist at Minimally Invasive Surgical Solutions and Dr. Jacob Cynamon, Professor of Clinical Radiologyof the Albert Einstein College of Medicine, Chief of the Division of Vascular and Interventional Radiology, and Program Director of theVascular and Interventional Radiology Fellowship Program at the Montefiore Medical Center, Bronx, NY.

SummaryRisk Factors

Ourprospects should be considered in light of the risks, uncertainties, expenses and difficulties frequently encountered by similar companies.Our ability to realize our business objectives and execute our strategies is subject to risks and uncertainties, including, among others,the following:

Inaddition, we face other risks and uncertainties that may materially affect our business prospects, financial condition, and results ofoperations. You should consider the risks discussed in “Risk Factors” and elsewhere in this prospectus before investing inour securities.

CorporateInformation

Wewere incorporated in the State of Delaware on December 17, 2012. Our principal executive offices are located at 4546 El Camino Real,Suite B1, Los Altos, CA 94022. Our telephone number is (650) 284-4433. Our website address is https://renovorx.com. Informationcontained in our website does not constitute any part of, and is not incorporated into, this prospectus.

Implicationsof Being an Emerging Growth Company

Uponthe completion of this offering, we will qualify as an “emerging growth company” under Jumpstart Our Business Act of 2012,as amended, or the JOBS Act. As a result, we will be permitted to, and intend to, rely on exemptions from certain disclosure requirements.For so long as we are an emerging growth company, we will not be required to:

●have an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;

●comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotationor a supplement to the auditor’s report providing additional information about the audit and the financial statements (i.e., anauditor discussion and analysis);

●submit certain executive compensation matters to stockholder advisory votes, such as “say-on-pay” and “say-on-frequency;”and

●disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisonsof the chief executive officer’s compensation to median employee compensation.

Inaddition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition periodprovided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, or the Securities Act, for complying with new or revised accountingstandards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards wouldotherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period. Our financialstatements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.

Wewill remain an emerging growth company for up to five years from the date of the first sale of equity securities pursuant to an effectiveregistration statement, or until the earliest of (i) the last day of the first fiscal year in which our total annual gross revenues exceed$1.07 billion, (ii) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Securities ExchangeAct of 1934, as amended, or the Exchange Act, which would occur if the market value of our common stock that is held by non-affiliatesexceeds $700 million as of the last business day of our most recently completed second fiscal quarter or (iii) the date on which we haveissued more than $1 billion in non-convertible debt during the preceding three year period.

THEOFFERING

(1)          Thenumber of shares outstanding is based on shares outstanding as of March 31, 2021 and excludes the following:

●4,755,668 shares of our common stock issuable upon the exercise of outstanding options with a weighted-average exercise priceof $0.08 per share;

●3,542,669 shares of Series A-1 Preferred Stock, 3,546,095 shares of Series A-2 Preferred Stock, 2,660,230 shares of Series A-3 PreferredStock and 7,928,359 shares of Series B Preferred Stock which will convert into 3,542,669, 3,546,095, 2,660,230 and 7,928,359 shares ofcommon stock, respectively, upon the closing of this offering (the “Preferred Stock Conversions”);

●[        ] shares of common stock and ___ shares of common stock issuable upon exercise ofwarrants with an exercise price of $___ per share to be issued upon conversion of the 2020 Convertible Notes and2021 Convertible Notes upon the closing of this offering (the “Note Conversions”);

●up to an additional [        ] shares of our common stock issuable under our 2013 Equity IncentivePlan; and

●[        ] shares of our common stock underlying the underwriter’s purchase option tobe issued to the representative of the underwriters in connection with this offering.

Exceptas otherwise indicated herein, all information in this prospectus assumes:

SUMMARYFINANCIAL INFORMATION

Thefollowing tables set forth our summary financial data for the periods and as of the dates indicated. The summary statements of operationsdata for the years ended December 31, 2019 and 2020 have been derived from our audited financial statements included elsewhere in thisprospectus. The summary statements of operations data for the three months ended March 31, 2020 and 2021 and the summary balance sheetdata as of March 31, 2021 have been derived from our unaudited interim condensed financial statements included elsewhere in this prospectus.Our unaudited interim condensed financial statements have been prepared on a basis consistent with our audited financial statements and,in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentationof the financial information set forth in those statements. Our historical results are not necessarily indicative of the results thatmay be expected for any other period in the future and our interim results are not necessarily indicative of our expected results forthe year ending December 31, 2021. You should read the following summary financial data set forth below in conjunction with our financialstatements and the related notes included elsewhere in this prospectus and the information in the section titled Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained elsewherein this prospectus.

RISKFACTORS

Aninvestment in our securities involve a high degree of risk. You should carefully consider the risks described below, together with thefinancial and other information contained in this prospectus, before you decide to purchase our securities. If any of the following risksactually occurs, our business, financial condition, results of operations, cash flows and prospects could be materially and adverselyaffected. In that event, the trading price of our common stock and the market value of the securities offered hereby could decline, andyou may lose all or part of your investment.

RisksRelated to Our Business

Weare a clinical stage company and may never earn a profit.

Weare a clinical stage company and have incurred losses since our formation. As of March 31, 2021, we have an accumulated total deficitof approximately $16.1 million. For both three-month periods ended March 31, 2020 and 2021, we had a net loss of approximately $1.1 million.To date, we have experienced negative cash flow from development ofour product candidate, RenovoGem, our platform technology, Renovo Trans-Arterial Micro-Perfusion, or RenovoTAMP, and our RenovoCath deliverysystem. We have not generated any revenue from operations, and we expect to incur substantial net losses for the foreseeable future aswe seek to further develop and commercialize RenovoGem. We cannot predict the extent of these future net losses, or when we may attainprofitability, if ever. If we are unable to generate significant revenue from RenovoGem or attain profitability, we will not be ableto sustain operations.

Becauseof the numerous risks and uncertainties associated with developing and commercializing RenovoGem, we are unable to predict the extentof any future losses or when we will attain profitability, if ever. We may never become profitable and you may never receive a returnon an investment in our common stock. An investor in our common stock must carefully consider the substantial challenges, risks and uncertaintiesinherent in the attempted development and commercialization of RenovoGem. We may never successfully commercialize RenovoGem, and ourbusiness may not be successful.

Wewill need to raise substantial additional capital to develop and commercialize RenovoGem, and our failure to obtain funding when neededmay force us to delay, reduce or eliminate our product development programs or collaboration efforts. If we do not obtain adequate andtimely funding, we may not be able to continue as a going concern.

Asof March 31, 2021, our cash and cash equivalents were approximately $0.8 million, and our working capital deficit was approximately $3.6million. Due to our recurring losses from operations and the expectationthat we will continue to incur losses in the future, we will be required to raise additional capital to complete the development andcommercialization of our product candidates. We have historically relied upon private sales of our equity as well as debt financingsto fund our operations. In order to raise additional capital, we may seek to sell additional equity and/or debt securities, obtain acredit facility or other loan or enter into collaborations, licenses or other similar arrangements, which we may not be able to do onfavorable terms, or at all. Our ability to obtain additional financing will be subject to a number of factors, including market conditions,our operating performance and investor sentiment. If we are unable to raise additional capital when required or on acceptable terms,we may have to significantly delay, scale back or discontinue the development and/or commercialization of our product candidate, restrictour operations or obtain funds by entering into agreements on unfavorable terms. Failure to obtain additional capital at acceptable termswould result in a material and adverse impact on our operations. As a result, there is substantial doubt about our ability to operateas a going concern.

Ourfinancial statements have been prepared on a going concern basis and do not include any adjustments that may result from the outcomeof this uncertainty. If we fail to raise additional working capital, or do so on commercially unfavorable terms, it would materiallyand adversely affect our business, prospects, financial condition and results of operations, and we may be unable to continue as a goingconcern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about ourability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us oncommercially reasonable terms, if at all. If we are unable to continue as a going concern, we might have to liquidate our assets andthe value we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financialstatements, and our shareholders may lose their entire investment in our ordinary shares.

Ourproduct candidates’ commercial viability remains subject to current and future preclinical studies, clinical trials, regulatoryapprovals, and the risks generally inherent in the development of a pharmaceutical product candidate. If we are unable to successfullyadvance or develop our product candidate, our business will be materially harmed.

Inthe near-term, failure to successfully advance the development of our product candidate may have a material adverse effect on us. Todate, we have not successfully developed or commercially marketed, distributed, or sold any product candidate. The success of our businessdepends primarily upon our ability to successfully advance the development of our current and future product candidates through preclinicalstudies and clinical trials, have the product candidates approved for sale by the FDA or regulatory authorities in other countries, andultimately have the product candidates successfully commercialized by us or a commercial partner. We cannot assure you that the resultsof our ongoing preclinical studies or clinical trials will support or justify the continued development of our product candidate, orthat we will receive approval from the FDA, or similar regulatory authorities in other countries, to advance the development of our productcandidates.

Ourproduct candidates must satisfy rigorous regulatory standards of safety and efficacy before we can advance or complete their clinicaldevelopment, or they can be approved for sale. To satisfy these standards, we must engage in expensive and lengthy preclinical studiesand clinical trials, develop acceptable manufacturing processes, and obtain regulatory approval. Despite these efforts, our product candidatesmay not:

Wecannot assure you that the results of late-stage clinical trials will be favorable enough to support the continued development of ourproduct candidates. A number of companies in the pharmaceutical and biopharmaceutical industries have experienced significant delays,setbacks and failures in all stages of development, including late-stage clinical trials, even after achieving promising results in preclinicaltesting or early-stage clinical trials. Accordingly, results from completed preclinical studies and early-stage clinical trials of ourproduct candidates may not be predictive of the results we may obtain in later-stage trials. Furthermore, even if the data collectedfrom preclinical studies and clinical trials involving our product candidates demonstrate a favorable safety and efficacy profile, suchresults may not be sufficient to support the submission of an NDA to obtain regulatory approval from the FDA in the U.S., or other similarregulatory agencies in other jurisdictions, which is required to market and sell the product.

Ourproduct candidates will require significant additional research and development efforts, the commitment of substantial financial resources,and regulatory approvals prior to advancing into further clinical development or being commercialized by us or collaborators. We cannotassure you that our product candidates will successfully progress through the drug development process or will result in commerciallyviable products. We do not expect our product candidates to be commercialized by us or collaborators for at least several years.

Ourproduct candidates may exhibit undesirable side effects when used alone or in combination with other approved pharmaceutical productsor investigational new drugs, which may delay or preclude further development or regulatory approval or limit their use if approved.

Throughoutthe drug development process, we must continually demonstrate the safety and tolerability of our product candidates to obtain regulatoryapproval to further advance clinical development or to market them. Even if our product candidates demonstrate clinical efficacy, anyunacceptable adverse side effects or toxicities, when administered alone or in the presence of other pharmaceutical products, which canarise at any stage of development, may outweigh potential benefits. In preclinical studies and clinical trials we have conducted to date,our product candidate’s tolerability profile is based on studies and trials that have involved a small number of subjectsor patients over a limited period of time. We may observe adverse or significant adverse events or drug-drug interactions in future preclinicalstudies or clinical trial candidates, which could result in the delay or termination of development, prevent regulatory approval, orlimit market acceptance if ultimately approved.

Raisingadditional capital may cause dilution to our existing stockholders, including purchasers of common stock in this offering, restrict ouroperations or require us to relinquish rights to our product candidates on unfavorable terms to us.

Wemay seek additional capital through a variety of means, including through public or private equity, debt financings or other sources,including up-front payments and milestone payments from strategic collaborations. To the extent that we raise additional capital throughthe sale of equity or convertible debt or equity securities, your ownership interest will be diluted, and the terms may include liquidationor other preferences that adversely affect your rights as a stockholder. Such financing may result in dilution to stockholders, impositionof debt covenants, increased fixed payment obligations or other restrictions that may affect our business. If we raise additional fundsthrough up-front payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuablerights to our product candidates or grant licenses on terms that are not favorable to us. In addition, we may seek additional capitaldue to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or futureoperating plans.

Ifthe results of preclinical studies or clinical trials for our product candidates, including those that are subject to existing or futurelicense or collaboration agreements, are unfavorable or delayed, we could be delayed or precluded from the further development or commercializationof our product candidates, which could materially harm our business.

Inorder to further advance the development of, and ultimately receive regulatory approval to sell, our product candidates, we must conductextensive preclinical studies and clinical trials to demonstrate their safety and efficacy to the satisfaction of the FDA or similarregulatory authorities in other countries, as the case may be. Preclinical studies and clinical trials are expensive, complex, can takemany years to complete, and have highly uncertain outcomes. Delays, setbacks, or failures can occur at any time, or in any phase of preclinicalor clinical testing, and can result from concerns about safety or toxicity, a lack of demonstrated efficacy or superior efficacy overother similar products that have been approved for sale or are in more advanced stages of development, poor study or trial design, andissues related to the formulation or manufacturing process of the materials used to conduct the trials. The results of prior preclinicalstudies or clinical trials are not necessarily predictive of the results we may observe in later stage clinical trials. In many cases,product candidates in clinical development may fail to show desired safety and efficacy characteristics despite having favorably demonstratedsuch characteristics in preclinical studies or earlier stage clinical trials.

Inaddition, we may experience numerous unforeseen events during, or as a result of, preclinical studies and the clinical trial process,which could delay or impede our ability to advance the development of, receive regulatory approval for, or commercialize our productcandidate, including, but not limited to:

Evenif the data collected from preclinical studies or clinical trials involving our product candidates demonstrate a favorable safety andefficacy profile, such results may not be sufficient to support the submission of an NDA to obtain regulatory approval from the FDA inthe U.S., or other similar foreign regulatory authorities in foreign jurisdictions, which is required to market and sell the product.

Ifthird party vendors upon whom we intend to rely on to conduct our preclinical studies or clinical trials do not perform or fail to complywith strict regulations, these studies or trials of our product candidate may be delayed, terminated, or fail, or we could incur significantadditional expenses, which could materially harm our business.

Wehave limited resources dedicated to designing, conducting, and managing preclinical studies and clinical trials. We intend to rely onthird parties, including clinical research organizations, consultants, and principal investigators, to assist us in designing, managing,monitoring and conducting our preclinical studies and clinical trials. We intend to rely on these vendors and individuals to performmany facets of the drug development process, including certain preclinical studies, the recruitment of sites and patients for participationin our clinical trials, maintenance of good relations with the clinical sites, and ensuring that these sites are conducting our trialsin compliance with the trial protocol, including safety monitoring and applicable regulations. If these third parties fail to performsatisfactorily, or do not adequately fulfill their obligations under the terms of our agreements with them, we may not be able to enterinto alternative arrangements without undue delay or additional expenditures, and therefore the preclinical studies and clinical trialsof our product candidate may be delayed or prove unsuccessful. Further, the FDA, or other similar foreign regulatory authorities, mayinspect some of the clinical sites participating in our clinical trials in the U.S., or our third-party vendors’ sites, to determineif our clinical trials are being conducted according to Good Clinical Practices. If we or the FDA determine that our third-party vendorsare not in compliance with, or have not conducted our clinical trials according to, applicable regulations we may be forced to delay,repeat, or terminate such clinical trials.

Wehave limited capacity for recruiting and managing clinical trials, which could impair our timing to initiate or complete clinical trialsof our product candidate and materially harm our business.

Wehave limited capacity to recruit and manage the clinical trials necessary to obtain FDA approval or approval by other regulatory authorities.By contrast, larger pharmaceutical and bio-pharmaceutical companies often have substantial staff with extensive experience in conductingclinical trials with multiple product candidates across multiple indications. In addition, they may have greater financial resourcesto compete for the same clinical investigators and patients that we are attempting to recruit for our clinical trials. If potential competitorsare successful in completing drug development for their product candidates and obtain approval from the FDA, they could limit the demandto participate in clinical trials of our product candidates.

Asa result, we may be at a competitive disadvantage that could delay the initiation, recruitment, timing, completion of our clinical trialsand obtaining regulatory approvals, if at all, for our product candidates.

We,and our collaborators, if any, must comply with extensive government regulations in order to advance our product candidates through thedevelopment process and ultimately obtain and maintain marketing approval for our products in the U.S. and abroad.

Theproduct candidates that we, or our collaborators, are developing or may develop require regulatory approval to advance throughclinical development and to ultimately be marketed and sold and are subject to extensive and rigorous domestic and foreign governmentregulation. In the U.S., the FDA regulates, among other things, the development, testing, manufacture, safety, efficacy, record-keeping,labeling, storage, approval, advertising, promotion, sale, and distribution of pharmaceutical and biopharmaceutical products.Our product candidates are also subject to similar regulation by foreign governments to the extent we seek to develop or marketthem in those countries. We, or our collaborators, must provide the FDA and foreign regulatory authorities, if applicable, withpreclinical and clinical data, as well as data supporting an acceptable manufacturing process, that appropriately demonstrateour product candidate’s safety and efficacy before it can be approved for the targeted indications. Our product candidateshave not been approved for sale in the U.S. or any foreign market, and we cannot predict whether we or our collaborators willobtain regulatory approval for any product candidates we are developing or plan to develop. The regulatory review and approvalprocess can take many years, is dependent upon the type, complexity, novelty of, and medical need for the product candidate, requiresthe expenditure of substantial resources, and involves post-marketing surveillance and vigilance and potentially post-marketingstudies or Phase 4 clinical trials. In addition, we or our collaborators may encounter delays in, or fail to gain, regulatoryapproval for our product candidate based upon additional governmental regulation resulting from future legislative, administrativeaction or changes in FDA’s or other similar foreign regulatory authorities’ policy or interpretation during the periodof product development. Delays or failures in obtaining regulatory approval to advance our product candidate through clinicaldevelopment, and ultimately commercialize them, may:

Furthermore,any regulatory approvals, if granted, may later be withdrawn. If we or our collaborators fail to comply with applicable regulatory requirementsat any time, or if post-approval safety concerns arise, we or our collaborators may be subject to restrictions or a number of actions,including:

Additionally,at any time we or our collaborators may voluntarily suspend or terminate the preclinical or clinical development of a product candidate,or withdraw any approved product from the market if we believe that it may pose an unacceptable safety risk to patients, or if the productcandidate or approved product no longer meets our business objectives. The ability to develop or market a pharmaceutical product outsideof the U.S. is contingent upon receiving appropriate authorization from the respective foreign regulatory authorities. Foreign regulatoryapproval processes typically include many, if not all, of the risks and requirements associated with the FDA regulatory process for drugdevelopment and may include additional risks.

Clinicaltrials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictiveof future trial results.

Ourproduct candidates may not prove to be safe and efficacious in clinical trials and may not meet all the applicable regulatory requirementsneeded to receive regulatory approval. In order to receive regulatory approval for the commercialization of our product candidates, wemust conduct, at our own expense, extensive preclinical testing and clinical trials to demonstrate safety and efficacy of our productcandidate for the intended indication of use. Clinical testing is expensive, can take many years to complete, if at all, and its outcomeis uncertain. Failure can occur at any time during the clinical trial process.

Theresults of preclinical studies and early clinical trials of new drugs do not necessarily predict the results of later-stage clinicaltrials. The design of our clinical trials is based on many assumptions about the expected effects of our product candidate, and if thoseassumptions are incorrect, they may not produce statistically significant results. Preliminary results may not be confirmed on full analysisof the detailed results of a clinical trial. Product candidates in later stages of clinical development may fail to show safety and efficacysufficient to support intended use claims despite having progressed through earlier clinical testing. The data collected from clinicaltrials of our product candidate may not be sufficient to support the filing of an NDA or to obtain regulatory approval in the UnitedStates or elsewhere. Because of the uncertainties associated with drug development and regulatory approval, we cannot determine if orwhen we will have an approved product for commercialization or achieve sales or profits.

Delaysin clinical testing could result in increased costs to us and delay our ability to generate revenue.

Wemay experience delays in clinical testing of our product candidate. We do not know whether planned clinical trials will begin on time,will need to be redesigned or will be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, includingpandemics, delays in obtaining regulatory approval to commence a clinical trial, in securing clinical trial agreements with prospectivesites with acceptable terms, in obtaining IRB approval to conduct a clinical trial at a prospective site, in recruiting patients to participatein a clinical trial or in obtaining sufficient supplies of clinical trial materials, including RenovoCath. Many factors affect patientenrollment, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for theclinical trial, the existing body of safety and efficacy data with respect to the study drug, competing clinical trials, new drugs approvedfor the conditions we are investigating and health epidemics such as the COVID-19 pandemic. Clinical investigators will need to decidewhether to offer their patients enrollment in clinical trials of our product candidate versus treating these patients with commerciallyavailable drugs that have established safety and efficacy profiles. Any delays in completing our clinical trials will increase our costs,slow down our product development, timeliness and approval process and delay our ability to generate revenue.

Theregulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable,and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.

Thetime required to obtain approval by the FDA and comparable foreign authorities is unpredictable but typically takes many years followingthe commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities.In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during thecourse of a product candidate’s clinical development and may vary among jurisdictions. We have not obtained regulatory approvalfor any product candidate and it is possible that our existing product candidate or any product candidate we may seek to develop in thefuture will ever obtain regulatory approval may fail to receive regulatory approval.

Ourproduct candidate could fail to receive regulatory approval for many reasons, including the following:

Thislengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatoryapproval to market our product candidates, which would significantly harm our business, results of operations and prospects.

Inaddition, even if we were to obtain approval, regulatory authorities may approve our product candidates for fewer or more limited indicationsthan we request, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a productcandidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of thatproduct candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.

Wehave not previously submitted an NDA to the FDA, nor similar drug approval filings to comparable foreign authorities, for our productcandidates, and we cannot be certain that our product candidates will be successful in clinical trials or receive regulatory approval.Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials. If we do not receiveregulatory approvals for our product candidates, we may not be able to continue our operations. Even if we successfully obtain regulatoryapprovals to market one or more of our product candidates, our revenues will be dependent on many factors including the size of the marketsin the territories for which we gain regulatory approval and have commercial rights. If the markets for patients that we are targetingfor our product candidates are not as significant as we estimate, we may not generate significant revenues from sales of such products,if approved.

Weplan to seek regulatory approval and to commercialize our product candidates, directly or with collaborators in the United States, theEuropean Union, and other foreign countries which we have not yet identified. While the scope of regulatory approval is similar in othercountries, to obtain separate regulatory approval in many other countries we must comply with numerous and varying regulatory requirementsof such countries regarding safety and efficacy and governing, among other things, clinical trials and commercial sales, pricing, anddistribution of our product candidates, and we cannot predict success in these jurisdictions.

Wemay be required to suspend or discontinue clinical trials due to unexpected side effects or other safety risks that could preclude approvalof our product candidates.

Ourclinical trials may be suspended at any time for a number of reasons. For example, we may voluntarily suspend or terminate our clinicaltrials if at any time we believe that they present an unacceptable risk to the clinical trial patients. In addition, the FDA or otherregulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any time if they believe that theclinical trials are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safetyrisk to the clinical trial patients.

Administeringour product candidates to humans may produce undesirable side effects. These side effects could interrupt, delay or halt clinical trialsof our product candidates and could result in the FDA or other regulatory authorities denying further development or approval of ourproduct candidate for any or all targeted indications. Ultimately, our product candidates may prove to be unsafe for human use. Moreover,we could be subject to significant liability if any volunteer or patient suffers, or appears to suffer, adverse health effects as a resultof participating in our clinical trials.

Ifwe fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penaltiesand our business, operations and financial condition could be adversely affected.

Asa developer of pharmaceuticals, certain federal and state healthcare laws and regulations pertaining to fraud and abuse, false claimsand patients’ privacy rights are and will be applicable to our business. We could be subject to healthcare fraud and abuse lawsand patient privacy laws of both the federal government and the states in which we conduct our business. The laws include:

Ifour operations are found to be in violation of any of the laws described above or any governmental regulations that apply to us, we maybe subject to penalties, including civil and criminal penalties, damages, fines, and the curtailment or restructuring of our operations.Any penalties, damages, fines, curtailment or restructuring of our operations could adversely affect our ability to operate our businessand our financial results. Although compliance programs can mitigate the risk of investigation and prosecution for violations of theselaws, the risks cannot be entirely eliminated. Any action against us for violation of these laws, even if we successfully defend againstit, could cause us to incur significant legal expenses and divert management’s attention from the operation of our business. Moreover,achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.

Ifwe are unable to satisfy regulatory requirements, we may not be able to commercialize our product candidate.

Weneed FDA approval prior to marketing our product candidates in the United States. If we fail to obtain FDA approval to market our productcandidates, we will be unable to sell our product candidates in the United States and we will not generate any revenue.

TheFDA’s review and approval process, including among other things, evaluation of preclinical studies and clinical trials of a productcandidate as well as the manufacturing process and facility, is lengthy, expensive, and uncertain. To receive approval, we must, amongother things, demonstrate with substantial evidence from well-designed and well-controlled pre-clinical testing and clinical trials thatthe product candidates are both safe and effective for each indication for which approval is sought. Satisfaction of these requirementstypically takes several years, and the time needed to satisfy them may vary substantially, based on the type, complexity and noveltyof the pharmaceutical product. We cannot predict if or when we will submit an NDA for approval for our product candidate currently underdevelopment. Any approvals we may obtain may not cover all of the clinical indications for which we are seeking approval or may containsignificant limitations on the conditions of use.

TheFDA has substantial discretion in the NDA review process and may either refuse to file our NDA for substantive review or may decide thatour data is insufficient to support approval of our product candidates for the claimed intended uses. Following any regulatory approvalof our product candidates, we will be subject to continuing regulatory obligations such as safety reporting, required and additionalpost marketing obligations, and regulatory oversight of promotion and marketing. Even if we receive regulatory approvals, the FDA maysubsequently seek to withdraw approval of our NDA if we determine that new data or a reevaluation of existing data show the product isunsafe for use under the conditions of use upon the basis of which the NDA was approved, or based on new evidence of adverse effectsor adverse clinical experience, or upon other new information. If the FDA does not file or approve our NDA or withdraws approval of ourNDA, the FDA may require that we conduct additional clinical trials, preclinical or manufacturing studies and submit that data beforeit will reconsider our application. Depending on the extent of these or any other requested studies, approval of any applications thatwe submit may be delayed by several years, may require us to expend more resources than we have available, or may never be obtained atall. In addition, we have obtained FDA clearance for our RenovoCath delivery system. In the event adverse events arise with respect tothe RenovoCath delivery system, the FDA could revoke its clearance which would have a material adverse effect on our business.

Wewill also be subject to a wide variety of foreign regulations governing the development, manufacture, and marketing of our products tothe extent we seek regulatory approval to develop and market our product candidates in a foreign jurisdiction. As of the date hereofwe have not identified any foreign jurisdictions which we intend to seek approval from. Whether or not FDA approval has been obtained,approval of a product candidate by the comparable regulatory authorities of foreign countries must still be obtained prior to marketingthe product candidate in those countries. The approval process varies, and the time needed to secure approval in any region such as theEuropean Union or in a country with an independent review procedure may be longer or shorter than that required for FDA approval. Wecannot assure you that clinical trials conducted in one country will be accepted by other countries or that an approval in one countryor region will result in approval elsewhere.

Ifour product candidates are unable to compete effectively with marketed drugs targeting similar indications as our product candidates,our commercial opportunity will be reduced or eliminated.

Weface competition generally from established pharmaceutical and biotechnology companies, as well as from academic institutions, governmentagencies and private and public research institutions. Many of our competitors have significantly greater financial resources and expertisein research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketingapproved products than we do. Small or early-stage companies may also prove to be significant competitors, particularly through collaborativearrangements with large, established companies. We are aware of a number of companies in Phase 3 clinical trials for the treatment ofLAPC including Angiodynamics, Bausch Health, Fibrogen, NovoCure, and SynCore Biotechnology. In addition, we are aware of a number ofcompanies in Phase 1 and Phase 2 clinical trials for the treatment of LAPC including one interventional company, TriSalus Lifesciences.Our commercial opportunity will be reduced or eliminated if our competitors develop and commercialize any products that are safer, moreeffective, have fewer side effects or are less expensive than our product candidates. These potential competitors compete with us inrecruiting and retaining qualified scientific and management personnel, establishing clinical trial sites, and patient enrollment forclinical trials, as well as in acquiring technologies and technology licenses complementary to our programs or advantageous to our business.

Ifapproved and commercialized, RenovoGem would compete with several currently approved prescription therapies for the treatment of LAPCand hilar cholangiocarcinoma. To our knowledge, other potential competitors are in earlier stages of development. If potential competitorsare successful in completing drug development for their product candidates and obtain approval from the FDA, they could limit the demandfor RenovoGem.

Weexpect that our ability to compete effectively will depend upon our ability to:

Becausewe will be competing against significantly larger companies with established track records, we will have to demonstrate that, based onexperience, clinical data, side-effect profiles and other factors, our products, if approved, are competitive with other products. Ifwe are unable to compete effectively and differentiate our products from other marketed drugs, we may never generate meaningful revenue.

Wemay expend our limited resources to pursue one or more product candidates or indications within our product development strategy, whichhas and may continue to change over time, and fail to capitalize on product candidates or indications that may be more profitable orfor which there is a greater likelihood of success.

Becausewe have limited financial and managerial resources, we intend to focus on developing product candidates for specific indications thatwe identify as most likely to succeed, in terms of their potential both to gain regulatory approval and to achieve commercialization.As a result, we may forego or delay pursuit of opportunities with other product candidates or in other indications with greater commercialpotential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.Our spending on current and future research and development programs and product candidates for specific indications may not yield anycommercially viable product candidates. If we do not accurately evaluate the commercial potential or target market for a particular productcandidate, we may relinquish valuable rights to that product candidate through collaboration, licensing, or other royalty arrangementsin cases in which it would have been more advantageous for us to retain sole development and commercialization rights to the productcandidate.

Ifthe manufacturers upon whom we rely fail to produce our product candidates, in the volumes that we require on a timely basis, or failto comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the development and commercializationof our product candidates.

Wedo not currently possess internal manufacturing capacity. We plan to utilize the services of GMP, FDA inspected contractmanufacturers to manufacture our clinical supplies. Any curtailment in the availability of gemcitabine, however, could resultin production or other delays with consequent adverse effects on us. In addition, because regulatory authorities must generallyapprove raw material sources for pharmaceutical products, changes in raw material suppliers may result in production delays orhigher raw material costs.

Weobtain our RenovoCath delivery system from a single source. Gemcitabine is supplied from our clinical sites own pharmacies and used off-labelfor intra-arterial use within our clinical study. We continue to pursue supply agreements for gemcitabine and our RenovoCath deliverysystem. We may be required to agree to minimum volume requirements, exclusivity arrangements or other restrictions with the contractmanufacturers. We may not be able to enter into long-term agreements on commercially reasonable terms, or at all. If we change or addmanufacturers, the FDA and comparable foreign regulators may require approval of the changes. Approval of these changes could requirenew testing by the manufacturer and compliance inspections to ensure the manufacturer is conforming to all applicable laws and regulationsand GMP.

Themanufacture of pharmaceutical products requires significant expertise and capital investment, including the development of advanced manufacturingtechniques and process controls. Manufacturers of pharmaceutical products may encounter difficulties in production, particularly in scalingup production. These problems include difficulties with production costs and yields, quality control, including stability of the productand quality assurance testing, shortages of qualified personnel, as well as compliance with federal, state, and foreign regulations.In addition, any delay or interruption in the supply of clinical trial supplies could delay the completion of our clinical trials, increasethe costs associated with conducting our clinical trials and, depending upon the period of delay, require us to commence new clinicaltrials at significant additional expense or to terminate a clinical trial.

Wewill be responsible for ensuring that our future contract manufacturers comply with the GMP requirements of the FDA and otherregulatory authorities from which we seek to obtain product approval. These requirements include, among other things, qualitycontrol, quality assurance and the maintenance of records and documentation. The approval process for NDAs includes an insepctionof the manufacturer’s compliance with GMP requirements. We will be responsible for regularly assessing a contract manufacturer’scompliance with GMP requirements through record reviews and periodic audits and for ensuring that the contract manufacturer takesresponsibility and corrective action for any identified deviations. Manufacturers of our product candidates may be unable to complywith these GMP requirements and with other FDA and foreign regulatory requirements, if any.

Whilewe will oversee compliance of our contract manufacturers, ultimately, we will not have control over our manufacturers’compliance with these regulations and standards. A failure to comply with these requirements may result in fines and civil penalties,suspension of production, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval.If the safety of our product candidates is compromised due to a manufacturers’ failure to adhere to applicable laws or forother reasons, we may not be able to obtain regulatory approval for or successfully commercialize our product candidates, andwe may be held liable for any injuries sustained as a result. Any of these factors could cause a delay of clinical trials, regulatorysubmissions, approvals, or commercialization of RenovoGem or other product candidates, entail higher costs or result in us beingunable to effectively commercialize our product candidates. Furthermore, if our manufacturers fail to deliver the required commercialquantities on a timely basis and at commercially reasonable prices, we may be unable to meet demand for any approved productsand would lose potential revenues.

Wemay not be able to manufacture our product candidates in commercial quantities, which would prevent us from commercializing our productcandidates.

Todate, our product candidates have been manufactured in small quantities for preclinical studies and clinical trials. If our product candidatesare approved by the FDA or comparable regulatory authorities in other countries for commercial sale, we will need to manufacture suchproduct candidates in larger quantities. We may not be able to successfully increase the manufacturing capacity for our product candidatesin a timely or economic manner, or at all. Significant scale-up of manufacturing may require additional validation studies, which theFDA must review and approve. If we are unable to successfully increase the manufacturing capacity for a product candidate, the clinicaltrials as well as the regulatory approval or commercial launch of that product candidate may be delayed or there may be a shortage insupply. Our product candidates require precise, high quality manufacturing. Our failure to achieve and maintain these high-quality manufacturingstandards in collaboration with our third-party manufacturers, including the incidence of manufacturing errors, could result in patientinjury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems thatcould harm our business, financial condition and results of operations.

Ourproduct candidates, if approved for sale, may not gain acceptance among physicians, patients, and the medical community, thereby limitingour potential to generate revenues.

Ifour product candidates are approved for commercial sale by the FDA or other regulatory authorities, the degree of market acceptance ofany approved product by physicians, healthcare professionals and third-party payors and our profitability and growth will depend on anumber of factors, including:

Ifany product candidate that we develop does not provide a treatment regimen that is as beneficial as, or is perceived as being as beneficialas, the current standard of care or otherwise does not provide patient benefit, that product candidate, if approved for commercial saleby the FDA or other regulatory authorities, likely will not achieve market acceptance. Our ability to effectively promote and sell anyapproved products will also depend on pricing and cost-effectiveness, including our ability to produce a product at a competitive priceand our ability to obtain sufficient third-party coverage or reimbursement. If any product candidate is approved but does not achievean adequate level of acceptance by physicians, patients and third-party payors, our ability to generate revenues from that product wouldbe substantially reduced. In addition, our efforts to educate the medical community and third-party payors on the benefits of our productcandidates may require significant resources, may be constrained by FDA rules and policies on product promotion, and may never be successful.

Guidelinesand recommendations published by various organizations can impact the use of our products.

Governmentagencies promulgate regulations and guidelines directly applicable to us and to our product. In addition, professional societies, practicemanagement groups, private health and science foundations and organizations involved in various diseases from time to time may also publishguidelines or recommendations to the healthcare and patient communities. Recommendations of government agencies or these other groupsor organizations may relate to such matters as usage, dosage, route of administration and use of concomitant therapies. Recommendationsor guidelines suggesting the reduced use of our products or the use of competitive or alternative products that are followed by patientsand healthcare providers could result in decreased use of our proposed products.

Ifthird-party contract manufacturers upon whom we rely to formulate and manufacture our product candidates do not perform, fail to manufactureaccording to our specifications or fail to comply with strict regulations, our preclinical studies or clinical trials could be adverselyaffected and the development of our product candidate could be delayed or terminated or we could incur significant additional expenses.

Wedo not own or operate any manufacturing facilities. We intend to rely on GMP, FDA inspected third-party contractors, atleast for the foreseeable future, to formulate and manufacture these preclinical and clinical materials. Our reliance on third-partycontract manufacturers exposes us to a number of risks, any of which could delay or prevent the completion of our preclinicalstudies or clinical trials, or the regulatory approval or commercialization of our product candidate, result in higher costs,or deprive us of potential product revenues. Some of these risks include:

Inthe event that we need to change our third-party contract manufacturers, our preclinical studies, clinical trials or the commercializationof our product candidate could be delayed, adversely affected or terminated, or such a change may result in significantly higher costs.

Dueto regulatory restrictions inherent in an IND or NDA, or for economic reasons, various steps in the manufacture of our productcandidate may need to be sole-sourced. We currently obtain our RenovoCath delivery system from a single supplier. In accordancewith cGMP regulations, changing manufacturers may require the re-validation of manufacturing processes and procedures,and may require further preclinical studies or clinical trials to show comparability between the materials produced by differentmanufacturers. Changing our current or future contract manufacturers may be difficult for us and could be costly, which couldresult in our inability to manufacture our product candidate for an extended period of time and therefore a delay in the developmentof our product candidate. Further, in order to maintain our development time lines in the event of a change in our third-partycontract manufacturer, we may incur significantly higher costs to manufacture our product candidate.

Wecurrently do not have any internal drug discovery capabilities, and therefore we are dependent on identifying drugs that are off patentor on in-licensing or acquiring development programs from third parties in order to obtain additional product candidates.

Ifin the future we decide to further expand our pipeline, we will be dependent on identifying drugs that are off patent or on in-licensingor acquiring product candidates as we do not have significant internal discovery capabilities at this time. We may face substantial competitionfrom other biotechnology and pharmaceutical companies, many of which may have greater resources then we have, in obtaining in-licensing,sponsored research or acquisition opportunities. In-licensing or acquisition opportunities may not be available to us on terms we findacceptable, if at all. In-licensed compounds that appear promising in research or in preclinical studies may fail to progress into furtherpreclinical studies or clinical trials.

Ifa product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage,we could be forced to pay substantial damage awards that could materially harm our business.

Theuse of any of our existing or future product candidates in clinical trials and the sale of any approved pharmaceutical products may exposeus to significant product liability claims. We have product liability insurance coverage for our proposed clinical trials; however, suchinsurance coverage may not protect us against any or all of the product liability claims that may be brought against us now or in thefuture. We may not be able to acquire or maintain adequate product liability insurance coverage at a commercially reasonable cost orin sufficient amounts or scope to protect us against potential losses. In the event a product liability claim is brought against us,we may be required to pay legal and other expenses to defend the claim, as well as uncovered damage awards resulting from a claim broughtsuccessfully against us. In the event our product candidate is approved for sale by the FDA and commercialized, we may need to substantiallyincrease the amount of our product liability coverage. Defending any product liability claim or claims could require us to expend significantfinancial and managerial resources, which could have an adverse effect on our business.

Wemay delay or terminate the development of our product candidates at any time if we believe the perceived market or commercial opportunitydoes not justify further investment, which could materially harm our business.

Eventhough the results of preclinical studies and clinical trials that have been conducted or may be conducted in the future may supportfurther development of our product candidates, we may delay, suspend or terminate the future development of a product candidate at anytime for strategic, business, financial or other reasons, including the determination or belief that the emerging profile of the productcandidate is such that it may not receive FDA approval, gain meaningful market acceptance, generate a significant return to shareholders,or otherwise provide any competitive advantages in its intended indication or market.

Ourfuture success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel.

Weare highly dependent on the development, regulatory, commercialization, and business development expertise of Shaun Bagai, our ChiefExecutive Officer, as well as the other principal members of our management, scientific and clinical teams. Although we have employmentagreements, offer letters or consulting agreements with our executive officers, these agreements do not prevent them from terminatingtheir services at any time.

Ifwe lose one or more of our executive officers or key employees, our ability to implement our business strategy successfully could beseriously harmed. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of timebecause of the limited number of individuals in our industry with the breadth of skills and experience required to successfully developproduct candidates, gain regulatory approval, and commercialize new products. Competition to hire from this limited pool is intense,and we may be unable to hire, train, retain or motivate these additional key personnel on acceptable terms given the competition amongnumerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientificand clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientificand clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisorsmay be engaged by entities other than us and may have commitments under consulting or advisory contracts with other entities that maylimit their availability to us. If we are unable to continue to attract and retain highly qualified personnel, our ability to developand commercialize product candidates will be limited.

Wewill need to increase the size of our organization, and we may experience difficulties in managing growth.

Weare a small company with 7 employees as of July 15, 2021. Future growth of our company will impose significant additionalresponsibilities on members of management, including the need to identify, attract, retain, motivate and integrate highly skilled personnel.We may increase the number of employees in the future depending on the progress of our development and commercialization of our productcandidates. Our future financial performance and our ability to commercialize our product candidate and to compete effectively will depend,in part, on our ability to manage any future growth effectively. To that end, we must be able to:

Thereis no guarantee that we will be able to accomplish these tasks, and our failure to accomplish any of them could materially adverselyaffect our business, prospects, and financial condition.

Businessdisruptions could seriously harm future revenue and financial condition and increase our costs and expenses.

Ouroperations, and those of our third-party manufacturers, contract research organizations, or CROs, and other contractors and consultants,could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires,extreme weather conditions, medical epidemics and other natural or man-made disasters or business interruptions, for which we are predominantlyself-insured. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increaseour costs and expenses.

Ourcorporate headquarters are located in Silicon Valley, California, an area prone to wildfires and earthquakes. These and other naturaldisasters could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financialcondition and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a significantportion of our headquarters, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers,or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantialperiod of time. Any disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disasteror similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuityplans, which, could have a material adverse effect on our business.

Securitythreats to our information technology infrastructure and/or our physical buildings could expose us to liability and damage our reputationand business.

Itis essential to our business strategy that our and our vendors, partners, clinical trial sites, and third-party providers’ technologyand network infrastructure and physical buildings remain secure and are perceived by our customers and corporate partners to be secure.Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security threats.We may face cyber-attacks that attempt to penetrate our network security, sabotage, or otherwise disable our research and developmentactivities, products and services, misappropriate our or our customers’ and partners’ proprietary information, which mayinclude personally identifiable information, or cause interruptions of our internal systems and services. Despite security measures,we also cannot guarantee security of our physical buildings. Physical building penetration or any cyber-attacks could negatively affectour reputation, damage our network infrastructure and our ability to deploy our products and services, harm our relationship with customersand partners that are affected, and expose us to financial liability.

Additionally,there are a number of state, federal, and international laws protecting the privacy and security of health information and personal data.For example, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) imposes limitations on the use anddisclosure of an individual’s healthcare information by healthcare providers, healthcare clearinghouses, and health insurance plans,or, collectively, covered entities, and also grants individuals rights with respect to their health information. HIPAA also imposes complianceobligations and corresponding penalties for non-compliance on individuals and entities that provide services to healthcare providersand other covered entities. As part of the American Recovery and Reinvestment Act of 2009 (“ARRA”), the privacy and securityprovisions of HIPAA were amended. ARRA also made significant increases in the penalties for improper use or disclosure of an individual’shealth information under HIPAA and extended enforcement authority to state attorneys general. As amended by ARRA and subsequently bythe final omnibus rule adopted in 2013, HIPAA also imposes notification requirements on covered entities in the event that certain healthinformation has been inappropriately accessed or disclosed: notification requirements to individuals, federal regulators, and in somecases, notification to local and national media. Notification is not required under HIPAA if the health information that is improperlyused or disclosed is deemed secured in accordance with encryption or other standards developed by the U.S. Department of Health and HumanServices. Most states have laws requiring notification of affected individuals and/or state regulators in the event of a breach of personalinformation, which is a broader class of information than the health information protected by HIPAA. Many state laws impose significantdata security requirements, such as encryption or mandatory contractual terms, to ensure ongoing protection of personal information.Activities outside of the U.S. implicate local and national data protection standards, impose additional compliance requirements, andgenerate additional risks of enforcement for non-compliance. We may be required to expend significant capital and other resources toensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviateproblems caused by such breaches.

Weand our third-party contract manufacturers must comply with environmental, health and safety laws and regulations, and failure to complywith these laws and regulations could expose us to significant costs or liabilities.

Weand our third-party manufacturers are subject to numerous environmental, health and safety laws and regulations, including those governinglaboratory procedures and the use, generation, manufacture, distribution, storage, handling, treatment, remediation and disposal of hazardousmaterials and wastes. Hazardous chemicals, including flammable and biological materials, are involved in certain aspects of our business,and we cannot eliminate the risk of injury or contamination from the use, generation, manufacture, distribution, storage, handling, treatmentor disposal of hazardous materials and wastes. In the event of contamination or injury, or failure to comply with environmental, healthand safety laws and regulations, we could be held liable for any resulting damages and any such liability could exceed our assets andresources. We could also incur significant costs associated with civil or criminal fines and penalties for failure to comply with suchlaws and regulations.

Althoughwe maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resultingfrom the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintaininsurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposalof biological, hazardous or radioactive materials.

Environmental,health and safety laws and regulations are becoming increasingly more stringent. We may incur substantial costs in order to comply withcurrent or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair ourresearch, development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines,penalties or other sanctions.

Further,with respect to the operations of our third-party contract manufacturers, it is possible that if they fail to operate in compliance withapplicable environmental, health and safety laws and regulations or properly dispose of wastes associated with our products, we couldbe held liable for any resulting damages, suffer reputational harm or experience a disruption in the manufacture and supply of our productcandidates or products.

Avariety of risks associated with operating internationally could materially adversely affect our business.

Doingbusiness internationally involves a number of risks, including but not limited to:

Anyof these factors could significantly harm any current or future international operations and, consequently, our results of operations.

Generaleconomic or business conditions may have a negative impact on our business.

Continuingconcerns over U.S. healthcare reform legislation and energy costs, geopolitical issues, the availability and cost of credit and governmentstimulus programs in the U.S. and other countries have contributed to increased volatility. If the economic climate deteriorates or ispoor, our business, as well as the financial condition of our suppliers and our third-party payors, could be negatively impacted, whichcould materially adversely affect our business, prospects and financial condition.

Healthcarereform measures could adversely affect our business.

Inthe United States and foreign jurisdictions, there have been, and continue to be, a number of legislative and regulatory changes andproposed changes to the healthcare system that could affect our future results of operations. In particular, there have been and continueto be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs. In 2010, the Patient Protectionand Affordable Care Act (the “PPACA”) was enacted, which includes measures to significantly change the way healthcare isfinanced by both governmental and private insurers. Among the provisions of the PPACA of greatest importance to the pharmaceutical andbiotechnology industry are the following:

Someof the provisions of the PPACA have yet to be implemented, and there have been legal and political challenges to certain aspectsof the PPACA. During President Trump’s administration, he signed two executive orders and other directives designed to delay,circumvent, or loosen certain requirements mandated by the PPACA. Concurrently, Congress has considered legislation that wouldrepeal or repeal and replace all or part of the PPACA. While Congress has not passed repeal legislation, the PPACA includesa provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the PPACA on certainindividuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individualmandate”. Congress may consider other legislation to repeal or replace elements of the PPACA.

Manyof the details regarding the implementation of the PPACA are yet to be determined, and at this time, the full effect that the PPACA wouldhave on our business remains unclear.

Individualstates have become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical productpricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing costdisclosure and transparency measures, and to encourage importation from other countries and bulk purchasing. Legally mandated price controlson payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition andprospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determinewhat pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This couldreduce ultimate demand for our products or put pressure on our product pricing, which could negatively affect our business, results ofoperations, financial condition and prospects.

Inaddition, given recent federal and state government initiatives directed at lowering the total cost of healthcare, Congress and statelegislatures will likely continue to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicareand Medicaid programs. While we cannot predict the full outcome of any such legislation, it may result in decreased reimbursement fordrugs and biologics, which may further exacerbate industry-wide pressure to reduce prescription drug prices. This could harm our abilityto generate revenues. Increases in importation or re-importation of pharmaceutical products from foreign countries into the United Statescould put competitive pressure on our ability to profitably price our products, which, in turn, could adversely affect our business,results of operations, financial condition and prospects. We might elect not to seek approval for or market our products in foreign jurisdictionsin order to minimize the risk of re-importation, which could also reduce the revenue we generate from product sales. It is also possiblethat other legislative proposals having similar effects will be adopted.

Furthermore,regulatory authorities’ assessment of the data and results required to demonstrate safety and efficacy can change over time andcan be affected by many factors, such as the emergence of new information, including on other products, changing policies and agencyfunding, staffing and leadership. We cannot be sure whether future changes to the regulatory environment will be favorable or unfavorableto our business prospects. For example, average review times at the FDA for marketing approval applications can be affected by a varietyof factors, including budget and funding levels and statutory, regulatory and policy changes.

Theoutbreak of the novel coronavirus disease, COVID-19, could materially adversely impact our business, results of operations and financialcondition, including our clinical trials.

InJanuary 2020, the World Health Organization declared the outbreak of COVID-19 as a “Public Health Emergency of International Concern,”which continues to spread throughout the world and has adversely impacted global commercial activity and contributed to significant volatilityin financial markets. The COVID-19 outbreak and government responses are creating disruption in global supply chains and adversely impactingmany industries. The outbreak could have a continued material adverse impact on economic and market conditions. We continue to monitorthe impact of the COVID-19 outbreak closely. The extent to which the COVID-19 outbreak will impact our operations or financial resultsis uncertain.

Theoutbreak and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce,as worker shortages have occurred; supply chains have been disrupted; activity at facilities and production have been suspended; anddemand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services,such as travel, has fallen. While the extent of the impact of the COVID-19 pandemic on our business and financial results is uncertain,a continued and prolonged public health crisis such as the COVID-19 pandemic could have a material adverse effect on our business, financialcondition and results of operations. As a result of the COVID-19 pandemic, we may experience disruptions that could severely impact ourbusiness and clinical trials, including:

Wemay be required to develop and implement additional clinical trial policies and procedures designed to help protect subjects from theCOVID-19 virus. For example, in March 2020, the FDA issued guidance, which FDA subsequently updated, on conducting clinical trials duringthe pandemic, which describes a number of considerations for sponsors of clinical trials impacted by the pandemic, including the requirementto include in the clinical trial report contingency measures implemented to manage the trial, and any disruption of the trial as a resultof the COVID-19 pandemic; a list of all subjects affected by the COVID-19 pandemic related study disruption by unique subject identifierand by investigational site and a description of how the individual’s participation was altered; and analyses and correspondingdiscussions that address the impact of implemented contingency measures (e.g., participant discontinuation from investigational productand/or study, alternative procedures used to collect critical safety and/or efficacy data) on the safety and efficacy results reportedfor the trial.

TheCOVID-19 pandemic continues to evolve rapidly, with the status of operations and government restrictions evolving weekly. The extentto which the outbreak impacts our business and clinical trials will depend on future developments, which are highly uncertain and cannotbe predicted with confidence, such as the duration of the pandemic, travel restrictions and social distancing in the United States andother countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countriesto contain and treat the disease.

Theultimate impact of the COVID-19 pandemic on our business operations is highly uncertain and subject to change and will depend on futuredevelopments, which cannot be accurately predicted, including the duration of the pandemic, the ultimate geographic spread of the disease,additional or modified government actions, new information that will emerge concerning the severity and impact of COVID-19 and the actionstaken to contain COVID-19, including vaccination efforts, or address its impact in the short and long term, among others. We do not yetknow the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems orthe global economy. We will continue to monitor the situation closely.

Inaddition, our business could be materially adversely affected by other business disruptions to us or our third-party providers that couldmaterially adversely affect our potential future revenue and financial condition and increase our costs and expenses. Our operations,and those of our CROs, third party manufacturers, and other contractors, consultants and third parties could be subject to other globalpandemics, earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weatherconditions, medical epidemics and other natural or man-made disasters or business interruptions, for which we are predominantly self-insured.The occurrence of any of these business disruptions could materially adversely affect our operations and financial condition and increaseour costs and expenses. We rely on third-party manufacturers to produce and process our product candidate. Our ability to obtain clinicalsupplies of our product candidates could be disrupted if the operations of these suppliers are affected by a man-made or natural disasteror other business interruption.

RisksRelated to Intellectual Property

Ifwe are unable to protect our intellectual property effectively, we may be unable to prevent third parties from using our technologies,which would impair our competitive advantage.

Werely on patent protection as well as a combination of trademark, copyright and trade secret protection, and other contractual restrictions,to protect our proprietary technologies, all of which provide limited protection and may not adequately protect our rights or permitus to gain or keep any competitive advantage. We may not be successful in defending challenges made in connection with our patents andpatent applications. If we fail to protect our intellectual property, we will be unable to prevent third parties from using our technologiesand they will be able to compete more effectively against us.

Inaddition to our patents, we rely on contractual restrictions to protect our proprietary technology. We require our employees and thirdparties to sign confidentiality agreements and our employees are also required to sign agreements assigning to us all intellectual propertyarising from their work for us. Nevertheless, we cannot guarantee that these measures will be effective in protecting our intellectualproperty rights. Any failure to protect our intellectual property rights could materially adversely affect our business, prospects andfinancial condition.

Ourcurrently pending or future patent applications may not result in issued patents and any patents issued to us may be challenged, invalidated,or held unenforceable. Furthermore, we cannot be certain that we were the first to make the invention claimed in our issued patents orpending patent applications in the U.S., or that we were the first to file for protection of the inventions claimed in our foreign issuedpatents or pending patent applications. In addition, there are numerous recent changes to the patent laws and proposed changes to therules of the USPTO, which may have a significant impact on our ability to protect our technology and enforce our intellectual propertyrights. For example, in September 2011, the U.S. enacted sweeping changes to the U.S. patent system under the Leahy-Smith America InventsAct, including changes that transitioned the U.S. from a “first-to-invent” system to a “first-to-file” systemand alter the processes for challenging issued patents. These changes could increase the uncertainties and costs surrounding the prosecutionof our patent applications and the enforcement or defense of our issued patents. In addition, we may become subject to interference proceedingsconducted in the patent and trademark offices of various countries to determine our entitlement to patents, and these proceedings mayconclude that other patents or patent applications have priority over our patents or patent applications. It is also possible that acompetitor may successfully challenge our patents through various proceedings and those challenges may result in the elimination or narrowingof our patents, and therefore reduce our patent protection. Accordingly, rights under any of our issued patents, patent applicationsor future patents may not provide us with commercially meaningful protection for our products or afford us a commercial advantage againstour competitors or their competitive products or processes.

Ifour trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interestand our business may be adversely affected.

Ourunregistered trademarks or trade names may be challenged, infringed, circumvented, or declared generic or determined to be infringingon other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognitionamong potential collaborators or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similarto ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potentialtrade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variationsof our unregistered trademarks or trade names. Over the long term, if we are unable to successfully register our trademarks and tradenames and establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and ourbusiness may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domainnames, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resourcesand could adversely impact our financial condition or results of operations.

Thepatents issued to us may not be broad enough to provide any meaningful protection, one or more of our competitors may develop more effectivetechnologies, designs or methods without infringing our intellectual property rights and one or more of our competitors may design aroundour proprietary technologies.

Ifwe are not able to protect our proprietary technology, trade secrets and know-how, our competitors may use our inventions to developcompeting products. Our patents may not protect us against our competitors, and patent litigation is very expensive. We may not havesufficient cash available to pursue any patent litigation to its conclusion because we currently do not generate revenues other thanlicensing, milestone and royalty income.

Wecannot rely solely on our current patents to be successful. The standards that the USPTO and foreign patent offices use to grant patents,and the standards that U.S. and foreign courts use to interpret patents, are not the same, are not always applied predictably or uniformlyand can change, particularly as new technologies develop. As such, the degree of patent protection obtained in the U.S. may differ substantiallyfrom that obtained in various foreign countries.

Wecannot be certain of the level of protection, if any, that will be provided by our patents if they are challenged in court, where ourcompetitors may raise defenses such as invalidity, unenforceability, or possession of a valid license. In addition, the type and extentof any patent claims that may be issued to us in the future are uncertain. Any patents that are issued may not contain claims that willpermit us to stop competitors from using similar technology.

Wemay incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.

Thirdparties may challenge the validity, inventorship or ownership of our patents and other intellectual property rights, resulting in costlylitigation or other time-consuming and expensive proceedings, which could deprive us of valuable rights. If we become involved in anyintellectual property litigation, interference or other judicial or administrative proceedings, we will incur substantial expenses andthe attention of our technical and management personnel will be diverted. An adverse determination may subject us to significant liabilitiesor require us to seek licenses that may not be available from third parties on commercially favorable terms, if at all. Further, if suchclaims are proven valid, through litigation or otherwise, we may be required to pay substantial monetary damages, which can be tripledif the infringement is deemed willful, or be required to discontinue or significantly delay development, marketing, selling and licensingof the affected products and intellectual property rights.

Ourcompetitors may have filed, and may in the future file, patent applications covering technology similar to ours. Any such patent applicationmay have priority over our patent applications and could further require us to obtain rights to issued patents covering such technologies.There may be third-party patents, patent applications and other intellectual property relevant to our potential products that may blockor compete with our potential products or processes. If another party has filed a U.S. patent application on inventions similar to ours,we may have to participate in an interference proceeding declared by the USPTO to determine priority of invention in the U.S. The costsof these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our U.S.patent position with respect to such inventions. In addition, we cannot assure you that we would prevail in any of these suits or thatthe damages or other remedies that we are ordered to pay, if any, would not be substantial. Claims of intellectual property infringement,misappropriation or other violations against us may require us to enter into royalty or license agreements with third parties that maynot be available on acceptable terms, if at all. We may also be subject to injunctions against the further development and use of ourtechnology, which could materially adversely affect our business, prospects and financial condition.

Someof our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantiallygreater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could materially adverselyaffect our ability to raise the funds necessary to continue our operations.

Obtainingand maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirementsimposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodicmaintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetimeof the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary,fee payment and other provisions during the patent application process and following the issuance of a patent. While an inadvertent lapsecan in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations inwhich noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss ofpatent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent applicationinclude, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failureto properly legalize and submit formal documents. In certain circumstances, even inadvertent noncompliance events may permanently andirrevocably jeopardize patent rights. In such an event, our competitors might be able to enter the market, which would have a materialadverse effect on our business.

Werely on confidentiality agreements to protect our trade secrets. If these agreements are breached by our employees or other parties,our trade secrets may become known to our competitors.

Werely on trade secrets which we seek to protect through confidentiality agreements with our employees and other parties. If these agreementsare breached, our competitors may obtain and use our trade secrets to gain a competitive advantage over us. We may not have any remediesagainst our competitors and any remedies that may be available to us may not be adequate to protect our business or compensate us forthe damaging disclosure. In addition, we may have to expend resources to protect our interests from possible infringement by others.

RisksRelated to this Offering and Our Common Stock

Our 2020 ConvertibleNotes and 2021 Convertible Notes automatically convert at the closing of this offering at a discount to the public offering price ofthe Units, all of which could negatively impact trading in our securities. 

In March 2020, we completedthe offering of $3.0 million principal amount of 2020 Convertible Notes that provided for the automatic conversion into shares of our commonstock and warrants at the closing of this offering at a 20% discount to the public offering price of the Units. In April 2021, we completedthe offering of $2.0 million of 2021 Convertible Notes that provided for the automatic conversion into shares of our common stock and warrantsat the closing of this offering at a 12.5% discount to the public offering price of the Units. As a result, the investors in this offeringwill experience immediate dilution when the 2020 Convertible Notes and 2021 Convertible Notes are automatically converted into sharesof our common stock and warrants in this offering. We estimate that approximately ______ shares and warrants to purchase ______ shareswill be issuable upon conversion of the 2020 Convertible Notes based on a $___ conversion price (assuming an initial public offeringprice of $___ per Unit (the midpoint of the price range set forth on the cover of this prospectus)) and taking into account accrued interestthrough _____, 2021. We estimate that approximately _____ shares and warrants to purchase ______ shares will be issuable upon conversionof the 2021 Convertible Notes based on a $___ conversion price (assuming an initial public offering price of $___ per Unit (the midpointof the price range set forth on the cover of this prospectus)) and taking into account interest earned through ______, 2021. The automaticconversion of the 2020 Convertible Notes and 2021 Convertible Notes into shares of our common stock and warrants in this offering willbe dilutive to our holders and could negatively impact the trading market and price of our common stock following the offering.

Noactive trading market for our common stock currently exists, and an active trading market may not develop.

Priorto this offering, there has not been an active trading market for our common stock. If an active trading market for our common stockdoes not develop following this offering, you may not be able to sell your shares quickly or at the market price. Our ability to raisecapital to continue to fund operations by selling shares of our common stock and our ability to acquire other companies or technologiesby using shares of our common stock as consideration may also be impaired. The initial public offering price of our common stock willbe determined by negotiations between us and the underwriters and may not be indicative of the market prices of our common stock thatwill prevail in the trading market.

Themarket price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasersof our common stock in this offering.

Themarket price of our common stock is likely to be highly volatile and may be subject to wide fluctuations in response to a variety offactors, including the following:

Inaddition, the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the marketprices of equity securities of many companies. These fluctuations have often been unrelated or disproportionate to the operating performanceof those companies. Broad market and industry factors, as well as general economic, political, regulatory and market conditions, maynegatively affect the market price of our common stock, regardless of our actual operating performance. The market price of our commonstock may decline below the initial public offering price, and you may lose some or all of your investment. In particular, stock marketshave experienced extreme volatility due to the ongoing COVID-19 pandemic and investor concerns and uncertainty related to the impactof the pandemic on the economies of countries worldwide.

Wehave broad discretion in the use of our cash and cash equivalents, including the net proceeds we receive in this offering, and may notuse them effectively.

Ourmanagement has broad discretion to use our cash and cash equivalents, including the net proceeds we receive in this offering, to fundour operations and could spend these funds in ways that do not improve our results of operations or enhance the value of our common stock,and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately.The failure by our management to apply these funds effectively could result in financial losses that could have a material adverse effecton our business, cause the price of our common stock to decline. Pending their use to fund our operations, we may invest our cash andcash equivalents, including the net proceeds from this offering, in a manner that does not produce income or that loses value.

Wecould be subject to securities class action litigation.

Inthe past, securities class action litigation has often been brought against companies following a decline in the market price of theirsecurities. This risk is especially relevant for us because biotechnology companies have experienced significant share price volatilityin recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention andresources, which could harm our business.

Ifsecurities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the marketprice for the shares and trading volume could decline.

Thetrading market for our common stock will depend in part on the research and reports that securities or industry analysts publish aboutus or our business. If research analysts do not establish and maintain adequate research coverage or if one or more of the analysts whocovers us downgrades our common stock or publishes inaccurate or unfavorable research about our business, the market price for our commonstock would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly,we could lose visibility in the financial markets, which, in turn, could cause the market price or trading volume for our common stockto decline.

Wedo not expect to pay dividends in the foreseeable future after this offering, and you must rely on price appreciation of your sharesfor return on your investment.

Wehave paid no cash dividends on any class of our stock to date and we do not anticipate paying cash dividends in the near term. For theforeseeable future, we intend to retain any earnings to finance the development and expansion of our business, and we do not anticipatepaying any cash dividends on our stock. Accordingly, investors must be prepared to rely on sales of their shares after price appreciationto earn an investment return, which may never occur. Investors seeking cash dividends should not purchase our shares. Any determinationto pay dividends in the future will be made at the discretion of our board of directors and will depend on our results of operations,financial condition, contractual restrictions, restrictions imposed by applicable law and other factors our board deems relevant.

Asour initial public offering price is substantially higher than our net tangible book value per share, you will experience immediate andsubstantial dilution.

Ifyou purchase Units in this offering, you will pay more for your shares of common stock than the amount paid by our existing stockholdersfor their shares on a per share basis. As a result, you will experience immediate and substantial dilution in net tangible book valueper share in relation to the price that you paid for your shares. We expect the dilution as a result of the offering and the automaticconversion of all outstanding shares of our preferred stock and the automatic conversion of our outstanding convertible notesimmediately prior to the closing of this offering, to be $[ ] per share to new investors purchasing our shares in this offering.In addition, you will experience further dilution to the extent that our shares are issued upon the exercise of any warrants or exerciseof stock options under any stock incentive plans. See “Dilution” for a more complete description of how the value of yourinvestment in our shares will be diluted upon completion of this offering.

Wewill incur increased costs as a result of operating as a public company, and our management will be required to devote substantial timeto new compliance initiatives and corporate governance practices.

Asa public company, and particularly after we no longer qualify as an emerging growth company, we will incur significant legal, accountingand other expenses that we did not incur previously. The Sarbanes-Oxley Act of 2002 (“SOX”), the Dodd-Frank Wall Street Reformand Consumer Protection Act, the listing requirements of Nasdaq, and other applicable securities rules and regulations impose variousrequirements on U.S. reporting public companies, including the establishment and maintenance of effective disclosure and financial controlsand corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these complianceinitiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activitiesmore time-consuming and costly. For example, we expect that these rules and regulations may make it more expensive for us to obtain directorand officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified senior managementpersonnel or members for our board of directors. In addition, these rules and regulations are often subject to varying interpretations,and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosureand governance practices. Pursuant to Section 404 of SOX (“Section 404”), we will be required to furnish a report by oursenior management on our internal control over financial reporting.

Whilewe remain an emerging growth company, we will not be required to include an attestation report on internal control over financial reportingissued by our independent registered public accounting firm. To prepare for eventual compliance with Section 404, once we no longer qualifyas an emerging growth company, we will be engaged in a process to document and evaluate our internal control over financial reporting,which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outsideconsultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continuesteps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implementa continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk thatwe will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effectiveas required by Section 404.

Wehave identified material weaknesses in our internal control over financial reporting. Failure to maintain effective internal controlscould cause our investors to lose confidence in us and adversely affect the market price of our common stock. If our internal controlsare not effective, we may not be able to accurately report our financial results or prevent fraud.

Effectiveinternal control over financial reporting is necessary for us to provide reliable financial reports in a timely manner. In connectionwith the audit of our financial statements as of and for the years ended December 31, 2019 and 2020 and the review of our financialstatements for the three month periods ended March 31, 2020 and 2021, we identified material weaknesses in our internal control overfinancial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting,such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be preventedor detected on a timely basis. Specifically, we have determined that we lack a sufficient number of qualified accounting and financialreporting personnel with an appropriate level of knowledge, training and experience to address complex accounting issues, sufficientwritten policies and procedures for accounting and financial reporting in accordance with GAAP, and adequate management review controls.In addition, we have determined that our financial statement close process includes significant control gaps mainly driven by the smallsize of our accounting and finance staff and, as a result, a significant lack of appropriate segregation of duties.

Theabove material weaknesses could result in a misstatement of our account balances or disclosures that would result in a material misstatementof our annual or interim financial statements that would not be prevented or detected. To address the material weaknesses, we have implemented,and are continuing to implement, measures designed to improve internal control over financial reporting, including expanding our accountingand finance team to add additional qualified accounting and finance resources, which may include third party consultants, and new financialprocesses. We intend to continue to take steps to remediate the material weaknesses through the hiring or engagement of additional experiencedaccounting and financial reporting personnel, formalizing documentation of policies and procedures and further evolving the accountingprocesses, including implementing appropriate segregation of duties. We expect to incur additional costs to remediate these weaknesses,including personnel, consulting and other costs.

Wemay not be successful in implementing these changes or in developing other internal controls, which may undermine our ability to provideaccurate, timely and reliable reports on our financial and operating results. Further, we will not be able to fully assess whether thesteps we are taking will remediate the material weakness in our internal control over financial reporting until we have completed ourimplementation efforts and sufficient time passes in order to evaluate their effectiveness. In addition, until we remediate these weaknesses,or if we identify additional material weaknesses in our internal control over financial reporting, we may not detect errors on a timelybasis and our financial statements may be materially misstated. Moreover, in the future we may engage in business transactions, suchas acquisitions, reorganizations or implementation of new information systems that could negatively affect our internal control overfinancial reporting and result in material weaknesses.

Ifwe identify new material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirementsof Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to assert that our internal control over financial reportingis effective, we may be late with the filing of our periodic reports, investors may lose confidence in the accuracy and completenessof our financial reports, and the market price of our common stock could be negatively affected. As a result of such failures, we couldalso become subject to investigations by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities,and become subject to litigation from investors and stockholders, which could harm our reputation, financial condition or divert financialand management resources from our core business.

Holders of our Warrants will have no rightsas shareholders until they acquire shares of our common stock, if ever, except as set forth in the Warrants.

If you acquire the Warrants to purchase sharesof our common stock in this offering, you will have no rights with respect to our common stock until you acquire shares of such commonstock upon exercise of your Warrants, except as set forth in the Warrants. Upon exercise of your Warrants, you will be entitled to exercise the rights of a holder of commonstock only as to matters for which the record date occurs after the exercise date.

There is no public market for the Warrantsbeing offered by us in this offering and an active trading market for the same is not expected to develop.

There is no established public trading marketfor the Warrants being offered in this offering, and we do not expect a market to develop. In addition, we do not intend to apply forany listing of the Warrants offered hereby on the Nasdaq Capital Market or any other securities exchange or nationally recognized tradingsystem. Without an active market, the liquidity of the Warrants will be severely limited.

Weare an “emerging growth company,” and the reduced reporting requirements applicable to emerging growth companies may makeour common stock less attractive to investors.

Weare an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act (“the JOBS Act”). Foras long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements thatare applicable to other public companies that are not emerging growth companies, including exemption from compliance with the auditorattestation requirements of Section 404, reduced disclosure obligations regarding executive compensation and exemptions from the requirementsof holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previouslyapproved. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifthanniversary of the closing of this offering, (b) in which we have total annual gross revenue of at least $1.07 billion or (c) in whichwe are deemed to be a large accelerated filer, which means the market value of our common stock held by non-affiliates exceeds $700 millionas of the end of our prior second fiscal quarter, and (2) the date on which we have issued more than $1.0 billion in non-convertibledebt during the prior three-year period.

Inaddition, under the JOBS Act, emerging growth companies may delay adopting new or revised accounting standards until such time as thosestandards apply to private companies. We may elect not to avail ourselves of this exemption from new or revised accounting standardsand, therefore, may be subject to the same new or revised accounting standards as other public companies that are not emerging growthcompanies.

Wecannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors findour common stock less attractive as a result, there may be a less active trading market for our common stock and our share price maybe more volatile.

Anti-takeoverprovisions contained in our certificate of incorporation and bylaws to be adopted upon the closing of this offering, as well as provisionsof Delaware law, could impair a takeover attempt.

Ourcertificate of incorporation, bylaws and Delaware law contain or will contain provisions which could have the effect of rendering moredifficult, delaying or preventing an acquisition deemed undesirable by our board of directors. Our corporate governance documents includeor will include provisions:

Theseprovisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management.

Asa Delaware corporation, we are also subject to provisions of Delaware law, including Section 203 of the Delaware General Corporationlaw, which prevents some stockholders holding more than 15% of our outstanding common stock from engaging in certain business combinationswithout approval of the holders of substantially all of our outstanding common stock.

Anyprovision of our certificate of incorporation, bylaws or Delaware law that has the effect of delaying or deterring a change in controlcould limit the opportunity for our stockholders to receive a premium for their shares of our common stock, and could also affect theprice that some investors are willing to pay for our common stock.

Ourcertificate of incorporation, as amended, designates the Court of Chancery of the State of Delaware as the sole and exclusive forum forcertain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ abilityto obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.

Ourcertificate of incorporation requires that, unless we consent in writing to the selection of an alternative forum, the Court of Chanceryof the State of Delaware will, to the fullest extent permitted by law, be the sole and exclusive forum for each of the following:

provided,that, if and only if the Court of Chancery of the State of Delaware dismisses any of the foregoing actions for lack of subject matterjurisdiction, any such action or actions may be brought in another state court sitting in the State of Delaware.

Theexclusive forum provision is limited to the extent permitted by law, and it will not apply to claims arising under the Securities ExchangeAct of 1934, as amended (the “Exchange Act”), or for any other federal securities laws which provide for exclusive federaljurisdiction.

Furthermore,Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly,both state and federal courts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictionsand the threat of inconsistent or contrary rulings by different courts, among other considerations, our second amended and restated certificateof incorporation provides that the federal district courts of the United States of America will be the exclusive forum for resolvingany complaint asserting a cause of action arising under the Securities Act. While the Delaware courts have determined that such choiceof forum provisions are facially valid, a stockholder may nevertheless seek to bring such a claim arising under the Securities Act againstus, our directors, officers, or other employees in a venue other than in the federal district courts of the United States of America.In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our secondamended and restated certificate of incorporation.

Althoughwe believe this provision benefits us by providing increased consistency in the application of Delaware law in the types of lawsuitsto which it applies, this provision may limit or discourage a stockholder’s ability to bring a claim in a judicial forum that itfinds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us andour directors, officers and other employees. Alternatively, if a court were to find the choice of forum provision contained in our certificateof incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such actionin other jurisdictions, which could adversely affect our business and financial condition.

Wenote that there is uncertainty as to whether a court would enforce the provision and that investors cannot waive compliance with thefederal securities laws and the rules and regulations thereunder. Although we believe this provision benefits us by providing increasedconsistency in the application of Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraginglawsuits against our directors and officers.

CAUTIONARYSTATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

Thisprospectus contains certain “forward-looking statements” with respect to our business, financial condition, liquidity andresults of operations. Words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,”“believes,” “seeks,” “estimates,” “could,” “would,” “will,” “may,”“can,” “continue,” “potential,” “should,” and the negative of these terms or other comparableterminology often identify forward-looking statements. These forward-looking statements are not guarantees of future performance andare subject to risks and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-lookingstatements. See “Risk Factors” beginning on page 9.

Manyof the important factors that will determine these results are beyond our ability to control or predict. You are cautioned not to putundue reliance on any forward-looking statements, which speak only as of the date of this prospectus. Except as otherwise required bylaw, we do not assume any obligation to publicly update or release any revisions to these forward-looking statements to reflect eventsor circumstances after such applicable date or to reflect the occurrence of unanticipated events. You should, however, review the factorsand risks we describe in the “Risk Factors” section hereof beginning on page 9 and in reports we will file from time to timewith the SEC after the date of this prospectus.

MARKETAND INDUSTRY DATA

Weobtained the industry, statistical and market data included in this prospectus from our own internal estimates and research as well asfrom industry and general publications and research, surveys and studies conducted by third parties. All of the market data used in thisprospectus involve a number of assumptions and limitations, and the sources of such data cannot guarantee the accuracy or completenessof such information. While we are not aware of any misstatements regarding the third-party information and we believe that each of thesestudies and publications is reliable, the industry in which we operate is subject to a high degree of uncertainty and risk due to a varietyof important factors, including those described in the section titled “Risk Factors.” These and other factors could causeresults to differ materially from those expressed in the estimates made by third parties and by us.

TRADEMARKS,SERVICE MARKS AND TRADE NAMES

Weown or have rights to use a number of registered and common law trademarks, service marks and/or trade names in connection with our businessin the United States and/or in certain foreign jurisdictions.

Solelyfor convenience, the trademarks, service marks, logos and trade names referred to in this prospectus are without the ^® and™ symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicablelaw, our rights or the rights of the applicable licensors to these trademarks, service marks and trade names. This prospectus containsadditional trademarks, service marks and trade names of others, which are the property of their respective owners. All trademarks, servicemarks and trade names appearing in this prospectus are, to our knowledge, the property of their respective owners. We do not intend ouruse or display of other companies’ trademarks, service marks, copyrights or trade names to imply a relationship with, or endorsementor sponsorship of us by, any other companies.

Wehave trademarks for the names RENOVORX, RENOVOGEM, RENOVOCATH, TAMP and DELIVERING THERAPY WHERE IT MATTERS. We have a trademark pendingfor RenovoTAMP.

USEOF PROCEEDS

Weestimate that the net proceeds from this offering will be approximately $       ($        millionif the representative exercises its over-allotment option in full), after deducting the underwriting discount and estimatedoffering expenses payable by us, based on an assumed initial public offering price of $[   ] per share (the midpoint ofthe price range set forth on the cover of this prospectus).

Weintend to use:

Weestimate that our current capital resources, along with the net proceeds from this offering, will be sufficient to fund our operatingexpenses and capital expenditure requirements through mid 2023. However, the net proceeds from this offering, together with our currentcash, will not be sufficient for us to fund the development of RenovoGem through regulatory approval, and we will need to raise additionalcapital to complete the development and commercialization of RenovoGem. At this time, we cannot predict with certainty the amount ofcapital needed to complete the development and commercialization of RenovoGem, but we anticipate seeking additional capital in the futureto fund such capital needs through further equity offerings and/or debt borrowings. We cannot guarantee that we will be able to raiseadditional capital on reasonable terms or at all.

Wemay also use a portion of the net proceeds of this offering to acquire or invest in complementary businesses, products, or technologies,or to obtain the right to use such complementary technologies. We have no commitments with respect to any acquisition or investment,and we are not currently involved in any negotiations with respect to any such transaction.

Asof the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to be received uponthe completion of this offering. The amounts and timing of our actual expenditures will depend on numerous factors, including the statusof our product development efforts, sales and marketing activities, technological advances, amount of cash generated or used by our operationsand competition. Accordingly, our management will have broad discretion in the application of the net proceeds and investors will berelying on the judgment of our management regarding the application of the proceeds of this offering. Pending such use, we intend toinvest the net proceeds in interest-bearing investment-grade securities or government securities.

DIVIDENDPOLICY

Wehave never declared or paid cash dividends on our common stock. We currently intend to retain all available funds and any future earningsfor use in the operation of our business and do not anticipate paying any cash dividends on our common stock in the near future. We mayenter into credit agreements or other borrowing arrangements in the future that will restrict our ability to declare or pay cash dividendson our common stock.

Anyfuture determination to declare dividends will be made at the discretion of our board of directors and will depend on our financial condition,operating results, capital requirements, contractual restrictions, general business conditions and other factors that our board of directorsmay deem relevant.

CAPITALIZATION

Thefollowing table sets forth our total capitalization as of March 31, 2021:

●on an actual basis;

●on a pro forma basis giving effect to the automatic conversion of all outstanding shares of our preferred stock and the automaticconversion of our outstanding convertible note into [  ] shares of common stock and warrants to purchase [  ] shares of commonstock immediately prior to the closing of this offering;

●on a pro forma as adjusted basis giving further effect to the sale and issuance by us of [   ] Units in this offering at the assumed initial public offering price of $[   ] per Unit (the midpoint of the pricerange set forth on the cover of this prospectus) and after deducting underwriting discounts and commissions and estimated offering expensespayable by us.

Youshould read this table together with our financial statements, the related notes included elsewhere in this prospectus and the informationunder “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

Each$1.00 increase (decrease) in the assumed initial public offering price of $[   ] per Unit, the midpoint of theprice range listed on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted amount of each of cash andcash equivalents, working capital, total assets and total stockholders’ equity by approximately $[   ], assumingthat the number of Units offered by us, as set forth on the cover page of this prospectus, remains the same and after deductingunderwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of [   ]Units in the number of Units offered by us at the assumed initial public offering price of $[   ] per Unit,the midpoint of the price range listed on the cover page of this prospectus, would increase (decrease) the pro forma as adjustedamount of each of cash and cash equivalents, working capital, total assets and total stockholders’ equity by approximately $[   ].

DILUTION

Ifyou purchase Units in this offering, your interest will be diluted to the extent of the difference between the initial publicoffering price per share and our net tangible book value per share after this offering. Dilution results from the fact that the assumedinitial public offering price per share is substantially in excess of the net tangible book value per share attributable to the existingstockholders for our presently outstanding common stock.

Ournet tangible book value (deficit) was approximately $(3.3) million or $(0.29) per share, as of March 31, 2021. Ournet tangible book value represents the amount of our total tangible assets (which is calculated by subtracting net intangible assets,deferred tax assets, and prepaid offering expenses from our total assets), less the amount of our total liabilities.

Ourpro forma net tangible book value as of March 31, 2021, was $[   ] million, or $[   ] per share of ourcommon stock. Pro forma net tangible book value represents the amount of our total tangible assets less our total liabilities. Pro formanet tangible book value per share represents pro forma net tangible book value divided by the total number of shares outstanding as ofMarch 31, 2021, after giving effect to the automatic conversion of all outstanding shares of our preferred stock and the automaticconversion of our outstanding convertible notes into [   ] shares of common stock and warrants to purchase [] shares of common stock immediately prior to the closing of this offering as if such conversions had occurred on March 31, 2021.

Aftergiving further effect to the sale and issuance by us of [   ] Units in this offering at the assumed initialpublic offering price of $[   ] per Unit, (the midpoint of the price range as set forth on the cover page ofthis prospectus), after deducting underwriting discounts and commissions and estimated offering expenses payable by us, assumingno exercise of the Warrants being sold in this offering and the warrants issuable upon the automatic conversion of our outstanding convertible notes, our pro forma as adjusted net tangible book value as of March31, 2021 would have been $[   ] or $[   ] per share. This represents an immediate increase in proforma net tangible book value of $[   ] per share to our existing stockholders, and an immediate dilution in proforma as adjusted net tangible book value of $[   ] per share to new investors. The following table illustrates thisper share dilution:

Ifthe representative’s over-allotment option is exercised in full, our pro forma as adjusted net tangible book value per shareafter this offering would be $[   ] and dilution per share to new investors purchasing Units in this offering wouldbe $[   ] at the assumed initial public offering price of $[   ] per Unit, (the midpoint of theprice range as set forth on the cover page of this prospectus) and after deducting the estimated underwriting discounts and commissionsand estimated offering expenses payable by us.

Thepro forma as adjusted information discussed above is illustrative only. Our pro forma as adjusted net tangible book value following thecompletion of this offering is subject to adjustment based on the actual initial public offering price of our Units and otherterms of this offering determined at pricing.

Thefollowing tables summarize the differences between our existing stockholders and the investors purchasing Units in this offeringwith respect to the number of Units purchased from us, the total consideration paid and the average price per share paid, at theassumed initial public offering price of $[   ] per Unit, (the midpoint of the price range as set forth on thecover page of this prospectus) before deducting estimated underwriting discounts and commissions and estimated offering expenses payableby us.

Thetable above assumes no exercise of the representative’s over-allotment option. If the representative’s over-allotmentoption is exercised in full, upon completion of this offering, the percentage of common stock held by existing holders would be reducedto [   ]%, and the percentage of common stock held by new investors purchasing common stock in this offering would beincreased to [   ]%.

Thenumber of shares outstanding is based on shares outstanding as of March 31, 2021 and except as noted above excludes the following:

●4,755,668 shares of our common stock issuable upon the exercise of outstanding options with a weighted-average exercise priceof $0.08 per share;

●3,542,669 shares of Series A-1 Preferred Stock, 3,546,095 shares of Series A-2 Preferred Stock, 2,660,230 shares of Series A-3 PreferredStock and 7,928,359 shares of Series B Preferred Stock which will convert into 3,542,669, 3,546,095, 2,660,230 and 7,928,359 shares ofcommon stock, respectively, upon the closing of this offering (the “Preferred Stock Conversions”);

●[   ] shares of common stock and ____ shares issuable upon exercise of warrants with an exercise price of $___per shae to be issued upon conversion of the 2020 Convertible Notes and 2021 Convertible Notes upon the closing ofthis offering (the “Note Conversions”);

●up to an additional [   ] shares of our common stock issuable under our 2013 Equity Incentive Plan; and

●[   ] shares of our common stock underlying the underwriter’s purchase option to be issued to the representativeof the underwriters in connection with this offering.

MANAGEMENT’SDISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Unlessthe context otherwise requires, all references in this section to the “Company,” “we,” “us, or “our”refer to the business of RenovoRx, Inc. You should read the following discussion and analysis of our financial condition and resultsof operations together with the “Selected Financial Data” section of this prospectus and our financial statements and therelated notes appearing elsewhere in this prospectus. This discussion contains forward-looking statements that reflect our plans, estimates,and beliefs that involve risks and uncertainties. As a result of many factors, such as those set forth under the “Risk Factors”and “Special Note Regarding Forward-Looking Statements” sections and elsewhere in this proxy statement/prospectus, our actualresults may differ materially from those anticipated in these forward-looking statements.

Overview

Weare a clinical-stage biopharmaceutical company focused on developing therapies for the local treatment of solid tumors and conductinga Phase 3 registrational trial for our lead product candidate RenovoGem™. Our therapy platform, RenovoRx Trans-Arterial Micro-Perfusion,or RenovoTAMP™ utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and side effectprofiles, with the goal of increasing their efficacy, improving their safety, and widening their therapeutic window. RenovoTAMP combinesour patented FDA cleared delivery system, RenovoCath^®, with small molecule chemotherapeutic agents that can be forcedacross the vessel wall using pressure, targeting these anti-cancer drugs locally to the solid tumors. While we anticipate investigatingother chemotherapeutic agents for intra-arterial delivery via RenovoTAMP, our clinical work to date has focused on gemcitabine, whichis a generic drug. Our first product candidate, RenovoGem, is a drug and device combination consisting of intra-arterial gemcitabineand RenovoCath. FDA has determined that RenovoGem will be regulated as, and if approved we expect will be reimbursed as, a new oncologydrug product. We have secured FDA Orphan Drug Designation for RenovoGem in our first two indications: pancreatic cancer and cholangiocarcinoma(bile duct cancer, or CCA). We have completed our RR1 Phase 1/2 and RR2 observational registry studies, with 20 and 25 patients respectively,in locally advanced pancreatic cancer, or LAPC. These studies demonstrated a median overall survival of 27.9 months in patients treatedwith RenovoGem and radiation. Based on previous large randomized clinical trials, the expected survival of LAPC patients is 12-15 monthsin patients receiving only intravenous (IV) systemic chemotherapy or IV chemotherapy plus radiation (which are both considered standardof care). Unlike the randomized trials that established these standard-of-care results, our RR1 and RR2 clinical trials did not prospectivelycontrol the standard of care therapy received prior to RenovoTAMP. Based on FDA safety review of our Phase 1/2 study the FDA allowedus to proceed to evaluate RenovoGem within our Phase 3 registration Investigational New Drug, or IND, clinical trial. Our Phase 3 trialis over 40% enrolled as of July 15, 2021 and we expect to report data from a planned interim data readout in the secondhalf of 2022. We intend to evaluate RenovoGem in a second indication in a Phase 2/3 trial in hilar CCA (cancer that occurs in the bileducts that lead out of the liver and join with the gallbladder, also called extrahepatic cholangiocarcinoma, or HCCA). We plan to proposethe trial to the FDA and potentially launch in the first half of 2022. In addition, we may evaluate RenovoGem in other indications, potentiallyincluding locally advanced lung cancer, locally advanced uterine tumors, and glioblastoma (an aggressive type of cancer that can occurin the brain or spinal cord). To date, we have used gemcitabine, but in the future we may develop other chemotherapeutic agents for intra-arterialdelivery via RenovoCath.

Sinceour inception, we have devoted substantially all of our efforts to developing our cancer therapy platform and product candidates, raisingcapital and organizing and staffing our company. To date, we have funded our operations with proceeds from the issuance of convertiblepreferred stock and convertible notes. Through March 31, 2021, we received total net proceeds of $15.0 million of which $11.8 millionwas from the issuance of convertible preferred stock, $3.0 million from convertible notes and $140,000 from a loan under the PaycheckProtection Program, or PPP. In April 2021, the Company entered into a series of convertible note agreements with certain current andnew investors to provide an aggregate $2.0 million in cash proceeds.

Wehave incurred significant operating losses and generated negative cash flows from operations since our inception. As of March 31, 2021,we had cash and cash equivalents of $837,000. We also had net losses of $1.1 million in each of the three months ended March 31, 2020and March 31, 2021. As of March 31, 2021, we had an accumulated deficit of $16.1 million. We expect to continue to incur significantexpenses, increasing operating losses and negative cash flows from operations in 2021 and for the foreseeable future. We do not expectto generate revenues from product sales unless and until we successfully complete development and obtain regulatory approval for oneor more product candidates. We expect that our expenses will increase substantially in connection with our ongoing research and developmentactivities, particularly as we:

Inaddition to the variables described above, if and when any of our product candidates successfully complete development, we will incursubstantial additional costs associated with establishing a sales, marketing, medical affairs and distribution infrastructure to commercializeproducts for which we may obtain marketing approval, regulatory filings, marketing approval, and post-marketing requirements, in additionto other commercial costs. We cannot reasonably estimate these costs at this time.

Asa result, we will need significant additional funding to support our continuing operations. Until such time, if ever, as we can generatesubstantial product revenue, we expect to finance our cash needs through equity issuances, debt financings and collaborations, licensesor other similar arrangements. We currently have no credit facility or committed sources of capital. To the extent that we raise additionalcapital through the future sale of equity or debt, the ownership interests of our stockholders will be diluted and the terms of thesesecurities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raiseadditional funds through the issuance of debt securities, these securities could contain covenants that would restrict our operations.We may require additional capital beyond our currently anticipated amounts and additional capital may not be available on reasonableterms, or at all. If we raise additional funds through collaboration arrangements or other strategic transactions in the future, we mayhave to relinquish valuable rights to our technologies or future revenue streams or grant licenses on terms that may not be favorableto us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit,reduce or terminate development or future commercialization efforts.

Withoutgiving effect to the anticipated net proceeds from this offering, we expect that our existing cash on hand will be insufficient to fundour operating expenses and capital expenditures for at least one year from the date of our financial statements. We will need to raiseadditional capital to finance our operations, which cannot be assured. We have concluded that this circumstance raises substantial doubtabout our ability to continue as a going concern for at least one year from the date of issuance date of our financial statements. SeeNote 2 to our audited financial statements and Note 2 to our unaudited interim condensed financial statements, each included elsewherein this prospectus, for additional information on our assessment. Similarly, our independent registered public accounting firm includedan explanatory paragraph in its report on our audited financial statements as of and for the year ended December 31, 2020, describingthe existence of substantial doubt about our ability to continue as a going concern.

Impactof COVID-19

InDecember 2019, a novel strain of coronavirus, which causes the disease known as COVID-19, was reported to have surfaced in Wuhan, China.Since then, COVID-19 has spread globally. In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. Theongoing COVID-19 global and national health emergency has caused significant disruption in the international and U.S. economies and financialmarkets. The spread of COVID-19 has caused illness, quarantines, cancellation of events and travel, business and school shutdowns, reductionin business activity and financial transactions, labor shortages, supply chain interruptions and overall economic and financial marketinstability.

Inresponse to public health directives and orders and to help minimize the risk of the virus to employees, we have taken precautionarymeasures, including implementing work-from home policies for certain employees. The COVID-19 global pandemic also has negatively affected,and we expect will continue to negatively affect, our clinical studies. For example, we have faced challenges in conducting our clinicaltrials, including recruiting subjects and accommodating patient visits. Additionally, our service providers and their operations maybe disrupted, temporarily closed or experience worker or supply shortages, which could result in additional disruptions or delays inshipments of purchased materials or the continued development of our product candidates. To date, we have not suffered material supplychain disruptions.

Weare not able to estimate the duration of the pandemic and the potential impact on our business. As the global pandemic of COVID-19 continuesto evolve, it could result in significant long-term disruption of global financial markets, reducing our ability to raise additionalcapital when needed and on acceptable terms, if at all, which could negatively affect our liquidity. The extent to which the COVID-19pandemic impacts our clinical development and regulatory efforts will depend on future developments that are highly uncertain and cannotbe predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions,quarantines and social distancing requirements in the United States and other countries, business closures or business disruptions andthe effectiveness of actions taken in the United States and other countries to contain and treat the virus. We will continue to monitorthe COVID-19 situation closely.

InApril 2020, we received $140,000 in funding as a promissory note under the PPP. This promissory note was subsequentlyforgiven in February 2021. See Note 6 to the unaudited condensed interim financial statements appearing at the end of thisprospectus for additional information.

Componentsof Our Results of Operations

Revenue

Wehave not generated any revenue from product sales and do not expect to generate any revenue from the sale of products for several years,if at all. If our development efforts for our current or future product candidates are successful and result in marketing approval orcollaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales orpayments from collaboration or license agreements that we mayenter into with third parties.

OperatingExpenses

Researchand Development

Researchand development expenses consist of costs related to the research and development of our platform technology. Clinical trial costs area significant component of research and development expenses and include costs associated with third-party contractors. We outsourcea substantial portion of our clinical trial activities, utilizing the service of third-party clinical trial sites and contract researchorganizations to assist us with the execution of our clinical trials. In addition, we have FDA 510(k) clearance for the RenovoCath deliverydevice, which comprises part of the RenovoGem product. Accordingly, we were able to charge our clinical trial sites for the RenovoCathdelivery device. To date, proceeds from clinical trial sites have been adequate to cover our direct costs of manufacturing the RenovoCathdelivery devices for which they have paid. Any proceeds we receive from the clinical trial sites for their purchase of the RenovoCathdelivery device are offset against our research and development expenses. We expect our research and development expenses to increasefor the foreseeable future as we continue the development of our product candidates and enroll subjects in our ongoing clinical trials,initiate future clinical trials and pursue regulatory approval of our product candidates. It is difficult to predict with any certaintythe duration and completion costs of our current or future clinical trials of our product candidates or if, when or to what extent wewill achieve regulatory approval and generate revenue from the commercialization and sale of our product candidates. The duration, costsand timing of clinical trials and other development of our product candidates will depend on a variety of factors, including uncertaintiesin clinical trial enrollment, timing and extent of future clinical trials, development of new product candidates and significant andchanging government regulation. We may never succeed in achieving regulatory approval for any of our product candidates.

Ourresearch and development expenses include:

Researchand development costs are expensed as incurred. Costs for certain development activities, such as clinical trials and preclinical studies,are recognized based on evaluation of progress to completion of specific tasks using data such as subject enrollment, clinical site activationsor information provided to us by third party vendors.

Dueto the impact of the COVID-19 pandemic and work-from-home policies and other operational limitations mandated by federal, state, andlocal governments as a result of the pandemic, certain of our research and development activities have been delayed and may be furtherdelayed until such operational limitations are lifted.

Generaland Administrative

Generaland administrative expenses consist of salaries, benefits, and stock-based compensation for personnel in executive, finance and administrativefunctions, professional services and associated costs related to accounting, tax, audit, legal, intellectual property and other matters,consulting costs, conferences, travel and allocated expenses for rent, insurance and other general overhead costs. Following the listingof our common stock on Nasdaq, we expect to continue to incur additional expenses as a result of operating as a public company, includingcosts to comply with the rules and regulations of the Securities and Exchange Commission, or SEC, and Nasdaq listing standards and increasedexpenses in the areas of insurance, professional services and investor relations. As a result, we expect our general and administrativeexpenses to increase for the foreseeable future. General and administrative expenses are expensed as incurred.

OtherIncome (Expense), Net

InterestIncome (Expense) Net

Interestincome (expense), net consists of interest income earned from our cash and cash equivalents net of interest expense. Interest expenseconsists of charges relating to the amortization of the debt discount and debt issuance costs as well as interest on amounts outstandingon our convertible notes.

OtherIncome (Expense), Net

Otherincome (expense), net comprise primarily investment expenses and foreign currency exchange gains and losses. We expect our foreign currencyexchange gains and losses to continue to fluctuate in the future due to changes in foreign currency exchange rates.

Gainon Loan Extinguishment

Gainon loan extinguishment resulted from the forgiveness and cancellation of the Company’s PPP loan.

IncomeTax Expense

Weaccount for income taxes using the asset and liability method. Under this method, deferred income tax assets and liabilities are recordedbased on the estimated future tax effects of differences between the financial statement and income tax basis of existing assets andliabilities. Deferred income tax assets and liabilities are recorded net and classified as noncurrent on the balance sheets. A valuationallowance is provided against our deferred income tax assets when their realization is not reasonably assured.

Weare subject to income taxes in the federal and state jurisdictions. Tax regulations within each jurisdiction are subject to the interpretationof the related tax laws and regulations and require significant judgment to apply. In accordance with the authoritative guidance on accountingfor uncertainty in income taxes, we recognize tax liabilities for uncertain tax positions when it is more likely than not that a taxposition will not be sustained upon examination and settlement with various taxing authorities. Liabilities for uncertain tax positionsare measured based upon the largest amount of benefit that is more-likely-than-not (greater than 50%) of being realized upon settlement.Our policy is to recognize interest and/or penalties related to income tax matters in income tax expense.

OnMarch 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, was enacted. The CARES Act includes severalsignificant provisions for corporations, including the usage of net operating losses, interest deductions and payroll benefits. Corporatetaxpayers may carryback net operating losses, or NOLs, originating during 2018 through 2020 for up to five years.

Resultsof Operations

Thefollowing table summarizes the significant components of our results of operations for the periods presented (in thousands):

Comparisonof the Three Months Ended March 31, 2020 and 2021

Thefollowing table summarizes our results of operations for the three months ended March 31, 2020 and 2021 (in thousands, except percentages):

Researchand Development

Researchand development expenses decreased $170,000, or 21%, in the three months ended March 31, 2021 compared to the three months endedMarch 31, 2020. This decrease was due a reduction of $50,000 in clinical development spending related to travel and off-site meetingsdue to the COVID-19 pandemic, a $42,000 reduction in expenses for preclinical studies due to the completion of sample analysis activities,and a $12,000 reduction in regulatory expenses due to lower support for European filings and vendor audits. Also contributing to thedecrease in research and development expense was an increase of $45,000 in offsetting clinical supply usage and corresponding vendorpayments from clinical trial sites. Vendor payments for delivery devices represents the cash payment made by vendors for the RenovoCathdelivery devices used in clinical trials.

Generaland Administrative Expenses

Generaland administrative expenses increased $170,000, or 69%, in the three months ended March 31, 2021 compared to the three months ended March31, 2020. This increase was due to an increase in professional expenses of $285,000 primarily as a result of preparing for this offeringoffset by a reduction in spending on legal costs of $68,000 due to reduced spending on intellectual property and a decrease of $37,000in executive-level clinical support costs.

InterestIncome (Expense), Net

Theinterest expense for the three-month period ended March 31, 2021 comprises both the stated interest on the note of 5% per annum, or $37,000,as well as the amortization of the discount and debt issuance costs associated with the 2020 Convertible Notes of $193,000. Interestincome for the three months ended March 31, 2020 was de minimis.

OtherExpense, Net

Otherexpense, net for the three months ended March 31, 2021 was de minimis. There was no other expense for the three months ended March 31,2020.

OnMarch 1, 2021, the Company entered into an amendment to the 2020 Convertible Notes which extends the maturity date of the 2020 ConvertibleNotes from March 31, 2021 to October 30, 2021 and provides for the conversion of the 2020 Convertible Notes into shares of the Company’scommon stock upon a Qualified Financing. No other terms to the 2020 Convertible Notes were amended. This amendment was accounted foras a troubled debt restructuring pursuant to FASB ASC Topic 470-60, “Troubled Debt Restructurings by Debtors”. Asthe future undiscounted cash flows of the 2020 Convertible Notes were greater than their carrying amount, the carrying amount was notadjusted and no gain was recognized as a result of the modification of terms.

Gainon Loan Extinguishment

Thegain on loan extinguishment of $140,000 for the three months ended March 31, 2021 resulted from the forgiveness and cancellation of theCompany’s PPP loan.

Comparisonof the Years Ended December 31, 2019 and 2020