Annual Report (10-k)

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)


☒	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2022


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO

Commission File Number 001-39575

ONCORUS, INC.

(Exact name of Registrant as specified in its Charter)


Delaware		47-3779757
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

4 Corporate Drive Andover, Massachusetts		01810
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (339) 240-3330

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading
Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

ONCR

The Nasdaq Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☐ No ☒

Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ☐ No ☒

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ NO ☐

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ NO ☐

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

If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the Registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive oﬃcers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒

The aggregate market value of the Registrant’s common stock held by non-affiliates as of June 30, 2022 (the last business day of the Registrant's most recently completed second quarter) was $25.9 million, based on the closing price of the Registrant’s common stock on The Nasdaq Global Market on that date.

The number of shares of Registrant’s common stock outstanding as of March 20, 2023 was 26,095,363.

DOCUMENTS INCORPORATED BY REFERENCE

The Registrant intends to file a definitive proxy statement pursuant to Regulation 14A relating to the 2022 Annual Meeting of Stockholders within 120 days of the end of the Registrant’s fiscal year ended December 31, 2022. Portions of such definitive proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent stated herein.

Table of Contents


		Page
PART I
Item 1.	Business	1
Item 1A.	Risk Factors	26
Item 1B.	Unresolved Staff Comments	80
Item 2.	Properties	80
Item 3.	Legal Proceedings	80
Item 4.	Mine Safety Disclosures	80

PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	81
Item 6.	[Reserved]	81
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	82
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	93
Item 8.	Financial Statements and Supplementary Data	93
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	116
Item 9A.	Controls and Procedures	116
Item 9B.	Other Information	117
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	117

PART III
Item 10.	Directors, Executive Officers and Corporate Governance	118
Item 11.	Executive Compensation	118
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	118
Item 13.	Certain Relationships and Related Transactions, and Director Independence	118
Item 14.	Principal Accounting Fees and Services	118

PART IV
Item 15.	Exhibits and Financial Statement Schedules	119
Item 16	Form 10-K Summary	122

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases, investors can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not limited to, statements concerning the following:

•

the initiation, timing, progress and expected results of our preclinical studies and clinical trials for product candidates from our self-amplifying RNA platform, including our planned Phase 1 clinical trial of ONCR-021;

•

the potential therapeutic benefit of our therapies and their ability to improve upon existing immuno-oncology and RNA-based therapies;

•

the ability of our self-amplifying RNA platform to avoid the challenges associated with neutralizing antibodies;

•

our manufacturing capabilities and plans to manufacture our product candidates in-house, our good manufacturing practices, or GMP, compliant manufacturing facility and related operational timelines;

•

the timing of certain regulatory milestones, including the submission of an investigational new drug applications, or INDs, for ONCR-021 and ONCR-788, and our ability to receive the required regulatory approvals and clearances to successfully market and sell our products in the United States and certain other countries;

•

our expectations regarding the potential market size and the rate and degree of market acceptance for product candidates from our self-amplifying RNA platform or any products we develop;

•

the commercialization of our product candidates, if approved;

•

the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements or partnerships;

•

the effects of competition with respect to our current or future product candidates, as well as innovations by current and future competitors in our industry;

•

our ability to fund our working capital requirements;

•

our intellectual property position, including the scope of protection we are able to establish, maintain and enforce for intellectual property rights covering our product candidates;

•

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

•

the sufficiency of our existing funding and our ability to obtain additional funding for our operations including our ability to continue as a going concern; and

•

other risks and uncertainties, including those listed under the “Risk Factors” section of this Annual Report on Form 10-K.

These forward-looking statements are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management's beliefs and assumptions and are not guarantees of future performance or development. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under “Summary Risk Factors,” “Risk Factors” and elsewhere in this Annual Report on Form 10-K. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Annual Report on Form 10-K may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this report. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Annual Report on Form 10-K to conform these statements to new information, actual results or changes in our expectations, except as required by law.

iii

SUMMARY RISK FACTORS

Our business is subject to a number of risks of which investors should be aware before making a decision to invest in our common stock. These risks are more fully described in the “Risk Factors” section of this Annual Report on Form 10-K, but a summary of the risks that could materially and adversely affect our business, financial condition, operating results and prospects includes the following:

•

We will require substantial additional capital to advance the development of our product candidates, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital could force us to delay, limit, reduce or terminate our product development programs, potential commercialization efforts or other operations.

•

We have a limited operating history. We have incurred significant losses since our inception and anticipate that we will incur significant and increasing losses for the foreseeable future and we may never achieve or maintain profitability.

•

Our product candidates are in the early stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable.

•

We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.

•

Following our decision to discontinue the Phase 1 clinical trial of ONCR-177, we do not currently have any product candidates in clinical development. This decision may adversely affect our business and future product development efforts.

•

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

•

We are subject to multiple manufacturing risks, any of which could substantially increase our costs, limit supply of our product candidates and result in delays in our planned clinical trials.

•

We have built out internal manufacturing capabilities at our facility in Andover, Massachusetts, which will be costly and time consuming and may not ultimately be successful.

•

We may not be successful in managing our manufacturing facility or satisfying manufacturing-related regulatory requirements.

•

Negative developments in the field of immuno-oncology, particularly with respect to viral immunotherapies, could damage public perception of our self-amplifying RNA and HSV platforms and our product candidates, which would adversely affect our business.

•

If we are unable to obtain, maintain and protect our intellectual property rights for our technology and product candidates, or if our intellectual property rights are inadequate, our competitive position could be harmed.

•

Our portfolio reprioritization and the associated workforce reduction announced in November 2022 may not result in anticipated cost savings, could result in total costs and expenses that are greater than expected and could disrupt our business.

•

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

•

The market price of our common stock has been and is likely to continue to be volatile and fluctuate substantially.

•

If we cannot comply with Nasdaq’s continued listing standards, our common stock could be delisted, which would harm our business and could have an adverse impact on the liquidity and trading price of our common stock and our ability to raise additional capital.

•

Market and economic conditions may negatively impact our business, financial condition and stock price.

PART I

Unless otherwise stated or the context otherwise indicates, references to “Oncorus,” the “Company,” “we,” “our,” “us,” or similar terms refer to Oncorus, Inc.

Item 1. Business.

Overview

We are a preclinical-stage biopharmaceutical company focused on the intravenous administration of self-amplifying RNA to transform outcomes for cancer patients. We believe that our product candidates have the potential to bring significant benefit to patients who are currently underserved by approved immuno-oncology therapies, including other viral immunotherapies and immune checkpoint inhibitors.

Our self-amplifying RNA immunotherapy platform improves upon key characteristics of this therapeutic class to enhance systemic activity. Our approach involves encapsulating genomes of RNA viruses known to kill cancer cells within a lipid nanoparticle, or LNP, creating a selectively self-amplifying vRNA immunotherapy to be administered intravenously, or IV. We believe this approach has the potential to avoid the rapid immune clearance caused by neutralizing antibodies otherwise observed to date with IV-administered oncolytic viruses, which is thought to have limited the effectiveness of RNA viruses in the clinic. Once inside the tumor, the viral RNA genome is first amplified via transcription and then instructs tumor cells to synthesize proteins via translation that then self assemble into infectious virions, which thereafter causes an immunogenic tumor cell lysis before daughter virions infect nearby tumor cells.

Our two product candidates from our self-amplifying RNA platform are ONCR-021 and ONCR-788. ONCR-021, our lead product candidate, is an IV administered viral RNA encoding an optimized genome of Coxsackievirus 21A, or CVA21, encapsulated within an LNP. We plan to submit an investigational new drug application, or IND, to the U.S. Food and Drug Administration, or FDA, in mid-2023 to evaluate ONCR-021 in multiple indications, including non-small cell lung cancer, renal cell carcinoma, melanoma, and anaplastic thyroid cancer, both as monotherapy and in combination with immune checkpoint inhibitors and other cancer treatments. We are also developing ONCR-788, which encodes for a modified version of the Seneca Valley Virus, or SVV. Both CVA21 and SVV have extensive clinical experience and favorable safety profiles when administered IV. Following the IND submission for ONCR-021 and pending the receipt of additional financing, which is not certain at this time, we may submit an IND for ONCR-788 to enable its development in small cell lung cancer, neuroendocrine prostate and other neuroendocrine cancers, both as a single agent and in combination with immune checkpoint inhibitors and other cancer treatments. Alongside our self-amplifying RNA platform, we are also developing a proprietary LNP platform intended to efficiently deliver nucleic acids after both intramuscular and IV administration.

Our product candidate ONCR-177 is an intratumorally, or iTu, administered viral immunotherapy based on our oncolytic HSV-1 platform, which leverages the Herpes Simplex Virus type 1, or HSV-1, a virus which has been clinically proven to effectively treat certain cancers. In November 2022, we announced our decision to discontinue our Phase 1 clinical trial of ONCR-177. We plan to present the results of the Phase 1 clinical trial in conjunction with a medical conference in 2023. Further development product candidates from our HSV platform, including ONCR-719, an armed HSV-1 engineered for viral entry via the EGFR receptor for the treatment of glioblastoma multiforme, or GBM, is dependent on our ability to obtain additional financing or enter into a partnership, collaboration, strategic alliance or licensing arrangement with a third party.

We plan to manufacture our product candidates at our manufacturing facility in Andover, Massachusetts. The facility is approximately 105,000 square feet, of which 41,000 square feet are specifically dedicated to processes that are compliant with good manufacturing practices, or GMP. We began process development activities at the facility in 2021 and, as of November 2022, construction was complete and the facility is currently fully operational. We have completed initial engineering batches of ONCR-021 at the facility, with additional engineering batches planned for the first half of 2023.

Our Pipeline

The status of our current product candidates from our self-amplifying RNA platform is shown in the table below. We have retained worldwide rights to all of our product candidates.

*Further development of ONCR-788 is contingent upon availability of future funding or entry into a strategic arrangement with a third party.

Our Founders, Leadership Team and Key Investors

Our company was co-founded by a team including MPM Capital executive partner Mitchell Finer, Ph.D., who has over three decades of experience in cancer immunotherapy, cell and gene therapy and regenerative medicine. Dr. Finer previously served as our chief executive officer, chief scientific officer and executive chairman and currently serves as chairman of our board of directors. Our HSV platform, including ONCR-177 and ONCR-719, is based upon the work of renowned scientist Professor Joseph Glorioso III, Ph.D. Professor Glorioso has conducted over four decades of research related to the basic biology and genetics of herpes simplex virus and is a pioneer in the design and application of HSV-1 gene vectors.

Our leadership team has extensive experience in developing and manufacturing oncology therapies, including advancing product candidates from preclinical research through clinical development and commercialization. Our President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., was previously Head of Oncology Development at Moderna Therapeutics, Inc. and Global Head of Leukine® (rhu GM-CSF) and Elitek®S/Fasturtec® (rasburicase) within Sanofi Oncology at Sanofi S.A., and also held multiple business development roles at Genzyme Corporation. John Goldberg, M.D., our Chief Medical Officer, is a pediatric oncologist who trained at the Dana Farber Cancer Institute with clinical development experience at both H3 Biomedicine Inc. and Agenus, Inc.

Traditional Cancer Therapy, Immunotherapy and the Need for New Options for Cancer Patients

The treatment of certain cancers has improved markedly over the past decade. Whereas many cancer treatments were historically limited to surgical removal, cytotoxic chemotherapy and/or radiation, recent advances target specific genetic changes in individual tumors or redirect the patient’s immune system, particularly T cells, to eliminate tumors and improve outcomes. Unfortunately, most patients are either not eligible for or do not respond to these therapies. For example, the efficacy of immune-based approaches in patients who qualify for this type of therapy is limited to around 12 percent. While these therapies have advanced the treatment of cancer for some patients, many are still underserved and therapies with improved clinical outcomes are still desperately needed.

The goal of immuno-oncology is to harness an individual’s immune system and better enable it to identify, attack and kill tumor cells and to form long-term immunologic memory against such tumors. We believe that the best way to significantly improve outcomes for cancer patients is to stimulate not only T cells, as has been the focus of approved immune checkpoint inhibitors, but also additional key immune cells within the innate and adaptive immune systems.

The immune system is generally divided into two arms, the innate and the adaptive, which are responsible for driving immediate and lasting anti-tumor responses. The innate immune system involves a diverse set of cells, including Natural-Killer, or NK, cells, macrophages and dendritic cells, all of which generate a rapid response to any foreign body, pathogen or tumor cell. The adaptive immune system is a second line of defense that is specific to a pathogen or antigen and is triggered when the innate immune system releases signals to activate and recruit cells from the adaptive immune system. The adaptive immune system is composed of T cells and B cells that can form immunologic memory, activating upon reintroduction of the initial antigen or pathogen. Many of the recent advances in immuno-oncology, such as immune checkpoint inhibitors, have focused on improving the function of T cells, which are a key cell type within a patient’s adaptive immune system.

We see a vast opportunity for therapies that can stimulate robust anti-tumor responses by activating both the innate and adaptive immune systems that also influence both the immunosuppressive tumor microenvironment and systemic immune responses. We believe that virus-based immunotherapies offer this potential benefit by delivering potent immune stimulating agents to tumors, including not only T cells, but also NK cells and dendritic cells, and, to inhibit immune suppression within tumors, immune checkpoint inhibitors.

Our Focus—Unlock the Full Potential of RNA Therapeutics for Cancer

We believe that RNA therapeutics are the most promising modality available today to activate multiple arms of the immune system and improve outcomes for cancer patients. Self-amplifying viral RNA, or vRNA, selectively infects and destroys tumor cells and leverages key cell types from the patient’s innate and adaptive immune systems, resulting in a robust and durable anti-tumor response. In the process of directly killing the tumor, tumor-specific antigens and danger signaling molecules are released. These molecules recruit and activate the innate and adaptive immune responses to identify, attack and destroy tumors and to develop long-term immunity against such tumors. vRNA can also be engineered to express transgenes to further stimulate and prevent downregulation of the immune system. Self-amplifying vRNA has several properties that differentiates it from other anti-tumor therapies, which make it a particularly attractive addition to today’s anti-cancer arsenal, including the ability to:

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Selectively kill tumor cells. Self-amplifying vRNA can be designed to selectively kill tumor cells while sparing healthy cells. Tumor cells are often more vulnerable to killing by vRNA replication than healthy cells because tumors often have diminished innate immune defenses, creating an environment conducive to RNA replication.

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Create an inflammatory state that turns cold tumors hot. Following vRNA replication and subsequent tumor cell death, the cells release tumor-specific antigens and danger signals, which activate the innate immune system and promote inflammation within the tumor microenvironment. This in turn attracts both innate and adaptive immune cells to the area. Viral and RNA-based immunotherapies have been shown in the clinic to transform so-called cold tumors with low numbers of infiltrated immune cells into hot tumors with high numbers of infiltrated immune cells, which are more likely to respond to checkpoint inhibitors.

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Cause the release and presentation of tumor-specific antigens. The breadth of antigens that are presented by vRNA immunotherapy-induced tumor cell lysis, or tumor cell death, is far greater than that of other anti-tumor vaccine approaches that rely on single antigens or small collections of neoantigens. These antigens can then be presented by the recruited innate immune cells, such as macrophages and dendritic cells, to cells of the adaptive immune system to stimulate highly effective antigen-specific immunity. By activating the adaptive immune response, anti-tumor T cells can then identify and attack all tumors in the body in addition to forming immunologic memory, which can provide patients with durable protective immunity.

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Express transgenes within the tumor microenvironment that encode for immunostimulatory proteins. Viral RNA can be engineered to carry transgenes into tumors where they can be expressed in high concentrations. These transgenes have the ability to encode immunostimulatory cytokines, immune checkpoint antibodies and other proteins that can further amplify anti-tumor immune responses. The ability of vRNA to deliver potent immunostimulatory factors directly to tumors with minimal systemic exposure represents a powerful method of amplifying the initial immune response by both stimulating the infiltrating immune cells and preventing their suppression in tumors, leading to improved outcomes for cancer patients.

Our Self-Amplifying RNA Platform—A Novel Selectively Self-Amplifying RNA Strategy

Our pioneering IV-administered, self-amplifying RNA approach involves encapsulating the RNA genomes of viruses known to kill cancer cells (i.e., viral immunotherapies) in a lipid nanoparticle, or LNP, creating a vRNA/LNP immunotherapy.

This LNP delivery strategy evades the host immune response and allows for systemic distribution throughout the body to tumor sites. The LNP, which is intended to be less immunogenic than a natural viral capsid, is designed to overcome the challenges caused by neutralizing antibodies that have limited the efficacy of previous industry efforts to administer viruses intravenously to treat tumors.

Once inside the tumor cells, and as is the case with other viral immunotherapies, these genomes replicate and generate a burst of infectious virions that then spread locally and lyse adjacent tumor cells, as illustrated in Figure 1 below. In healthy cells, the innate immune system senses genomic replication, shuts down transcription, and no virions are produced.

Figure 1. Schematic representation of the mode of action of our self-amplifying RNA platform.

Current programs from our self-amplifying RNA platform, ONCR-021 and ONCR-788, are based on coxsackievirus A21, or CVA21, and Seneca Valley Virus, or SVV, respectively, which have both demonstrated acceptable safety and tolerability in early clinical trials conducted by others when virions have been administered IV, but where the efficacy was likely limited by the subsequent development of neutralizing antibodies.

We have demonstrated proof of concept of this approach in preclinical models showing that self-amplifying RNAs based on both CVA21 and SVV, when administered IV, are able to successfully deliver an RNA viral genome to tumors leading to the production of replication competent viruses within the tumors and the inhibition of tumor growth. Product candidates to be developed from our self-amplifying RNA platform will utilize shared formulation, regulatory and manufacturing strategies, allowing us to be more efficient in the development of subsequent product candidates.

In October 2022, we published preclinical data in the journal Nature Communications highlighting the potential of our self-amplifying RNA platform as a novel approach to treating cancer by enabling repeat IV administration. The data demonstrated that delivery of RNA encoding for the genome of a replication-competent virus encapsulated within an LNP enabled selective replication, virus assembly, viral spread and lysis of tumor cells, leading to potent anti-tumor activity even in the presence of virus-neutralizing antibodies in the bloodstream. These RNA constructs were well tolerated in preclinical models and resulted in tumor-specific in situ production of oncolytic virions, broad immune cell recruitment and tumor destruction. Activity was observed across multiple cancer models, including xenografts, PDX, GEMM and syngeneic models, with survival benefit observed in an orthotopic small cell lung cancer tumor model. Overall, these constructs were well tolerated after single or multiple IV doses in both mice and non-human primates. We believe these preclinical results support the potential of this modality to safely and effectively kill tumor cells and stimulate multiple arms of the immune system to better fight cancer.

We plan to submit an IND to the FDA in mid-2023 to evaluate ONCR-021 in multiple indications, including non-small cell lung cancer, renal cell carcinoma, melanoma and anaplastic thyroid cancer, both as monotherapy and in combination with immune checkpoint inhibitors and other cancer treatments. Following the IND submission for ONCR-021 and pending the receipt of additional financing, which is not certain at this time, we may submit an IND for ONCR-788 to enable its development in small cell lung cancer, neuroendocrine prostate and other neuroendocrine cancers, both as a single agent and in combination with immune checkpoint inhibitors and other cancer treatments.

Our Self-Amplifying RNA Product Candidate Selection Criteria

In May 2021, we announced the nomination of our first product candidates from our self-amplifying RNA platform, ONCR-021 and ONCR-788. We selected genomes for development for our self-amplifying RNA platform based upon two factors, as discussed below:

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Clinical experience with these viruses. The foremost factor which drives our selection of viral genomes for our self-amplifying RNA platform has been clinical experience with these viruses demonstrating their tolerability after IV dosing in cancer patients as well as their ability to replicate in tumors. For example, both CVA21 and SVV have been well tolerated in clinical trials after IV dosing of infectious virions. Furthermore, these viruses were shown to replicate in patients’ tumors expanding on preclinical observation made for both CVA21 and SVV in animal models indicating that these viruses can lyse tumor cells. We believe these early viral immunotherapy product candidates would likely have been further advanced in the clinic if not for the emergence of neutralizing antibodies after the first one to two doses, which limit the ability of subsequently dosed virions to reach tumor sites.

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Technical feasibility. The identification of, and clinical utility of LNPs, has been driven by the need to intravenously deliver other therapeutics, typically nucleic acids such as RNA, to patients. The recent approval of patisiran, marketed as ONPATTRO® by Alnylam, provides validation that LNPs can be used to safely and effectively deliver nucleic acid therapies to patients through repeat IV administration. The synthesis of LNPs for tumor distribution requires the selection of viruses with genome sizes compatible with the loading capacity of an LNP. This has steered our selection of synthetic viruses for product development to oncolytic RNA viruses such as CVA21 and SVV.

ONCR-021—Our Lead Self-Amplifying RNA Immunotherapy Leveraging Synthetic CVA21

We are developing ONCR-021, a vRNA product candidate for repeat IV administration based on CVA21. We selected CVA21 for our first vRNA program based on a number of attractive properties such as clinical safety and tolerability after IV dosing in patients, ability to replicate in solid tumors, and its inability to insert into the host chromosome, eliminating the potential of insertional mutagenesis. CVA21 is a picornavirus that has broad tumor tropism, in particular for non-small cell lung cancer, or NSCLC, melanoma, kidney and other solid tumors. We intend to develop ONCR-021 for non-small cell lung cancer, renal cell carcinoma, melanoma, anaplastic thyroid cancer and hepatocellular carcinoma. In preclinical studies conducted by us and others, we observed that treatment with CVA21 resulted in significant tumor growth inhibition in mouse tumor models including NCI-H1299 and NCI-H2122 NSCLC cells and SK-MEL-28 melanoma cells.

Coxsackievirus A21 (CVA21)

Coxsackievirus A21 is a naturally occurring RNA virus that normally causes mild upper respiratory tract infections in humans. Most studies on coxsackievirus focus on the CVA21 kuykendall strain which is currently in clinical development for NSCLC by Merck as V937 (formerly CAVATAK).

In early clinical trials, V937 was well-tolerated when dosed either iTu or IV and associated with both local and distant tumor responses. In a Phase 2 clinical trial, iTu injections of V937 in patients with late-stage melanoma demonstrated durable objective responses in 21.1% of patients. Tumor biopsies of treated patients demonstrated the presence of virions and increased infiltration of immune cells in tumors. Clinical trials of IV administered V937 found that neutralizing antibodies developed against the virus after approximately five to seven days, resulting in a limited window where repeat IV doses could potentially be delivered effectively. Even with the development of neutralizing antibodies, V937 administered IV in combination with pembrolizumab generated an overall response rate of 23% in NSCLC. In December 2022, Merck announced its plans to discontinue clinical development of V937 in solid tumors, citing a pipeline re-prioritization. We have reviewed clinical data of other intratumoral therapies under development and, based on that review, we hypothesize that iTu delivery of V937 was insufficient to generate meaningful responses in advanced, disseminated solid tumor. Based on this review and findings from our preclinical data, we believe that IV delivery of V937 was hindered by the presence of neutralizing antibodies. Our preclinical data support our hypothesis that ONCR-021 can be delivered IV, repeatedly without loss of efficacy due to neutralizing antibodies.

ONCR-021 preclinical data

We selected a CVA21 viral strain, referred to as ONCR-CVA21 prior to candidate nomination, that demonstrates more potent oncolytic activity in cancer cell lines than the Kuykendall strain developed by Merck as V937. In preclinical studies, IV dosing of ONCR-021 resulted in tumor shrinkage in two xenograft models of NSCLC, including in the NCI-H1299 tumor model, as shown in Figure 2 below, which provides us with preclinical validation for our ONCR-021 program.