GENELUX Corp 10-K for FY2025

GENELUX Corp (GNLX)

10-K 2026-03-19 For: 2025-12-31

Added on April 08, 2026

About this 10-K

GENELUX Corp filed this 10-K on March 19, 2026, covering the fiscal year ended December 31, 2025 (FY2025).

Headline figures

Fiscal year ended December 31, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $8000; unchanged from $8000 a year earlier
Net loss: $32.15M; compared with a net loss of $29.87M a year earlier
Diluted EPS: -$0.86; compared with -$0.95 a year earlier

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Delaware		77-0583529
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		GNLX		The Nasdaq Stock Market LLC

☐	☐	☒	☒
Large accelerated filer	Accelerated filer	Non-accelerated filer	Smaller reporting company
			☒
			Emerging growth company

		Page No.
PART I
Item 1.	Business	2
Item 1A.	Risk Factors	27
Item 1B.	Unresolved Staff Comments	97
Item 1C.	Cybersecurity	97
Item 2.	Properties	98
Item 3.	Legal Proceedings	98
Item 4.	Mine Safety Disclosures	98
PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	99
Item 6.	Reserved	99
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	99
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	111
Item 8.	Financial Statements and Supplementary Data	111
Item 9	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	111
Item 9A.	Controls and Procedures	111
Item 9B	Other Information	112
Item 9C	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	112
PART III
Item 10.	Directors, Executive Officers and Corporate Governance	113
Item 11.	Executive Compensation	113
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	113
Item 13.	Certain Relationships and Related Transactions, and Director Independence	113
Item 14.	Principal Accountant Fees and Services	113
PART IV
Item 15.	Exhibits and Financial Statement Schedules	114
Item 16.	Form 10-K summary	114
SIGNATURES		117

	●	the timing, progress and results of clinical studies for our product candidates, including the development of our only clinical-stage product candidate, Olvi-Vec;
	●	the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates;
	●	the potential benefits and market opportunity for our product candidates and CHOICE platform;
	●	expectations regarding the size, scope and design of clinical studies;
	●	our manufacturing, commercialization, and marketing plans and strategies;
	●	our plans to hire additional personnel and our ability to attract and retain such personnel;
	●	our estimates of the number of patients who suffer from the diseases we are targeting and potential growth in our target markets;
	●	our expectations regarding the approval and use of our product candidates;
	●	our competitive position and the development and impact of competing therapies that are or may become available;
	●	expectations regarding future events under collaboration and licensing agreements, including potential future payments, as well as our plans and strategies for entering into further collaboration and licensing agreements;
	●	our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;
	●	the rate and degree of market acceptance and clinical utility of product candidates we may develop;
	●	our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
	●	our future financial performance;
	●	the period over which we estimate our existing cash, cash equivalents, restricted cash and marketable securities will be sufficient to fund our future operations;
	●	our expected use of net proceeds from our financing transactions;
	●	the impact of laws and regulations;
	●	the impact of geopolitical and macroeconomic factors; and
	●	other risks and uncertainties, including those described under Part I, Item 1A, “Risk Factors” in this Annual Report.

	●	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.
	●	We will require substantial additional financing to advance the development of Olvi-Vec and any of our future 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.
	●	Our product candidates are in preclinical and clinical stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable.
	●	We currently have only one product candidate, Olvi-Vec, in clinical development. A failure of this product candidate in clinical development would adversely affect our business and may require us to discontinue development of other product candidates based on the same therapeutic approach.
	●	Our product candidates are based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product candidate development.
	●	Preclinical and clinical development involve a lengthy and expensive process with an uncertain outcome and stringent regulations, and delays can occur for a variety of reasons.
	●	Changes in product candidate manufacturing or formulation may result in additional costs or delay.
	●	If we are unable to manufacture and release any product candidates in the volumes that we require on a timely basis, or fail to comply with stringent regulations applicable to biopharmaceutical manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, any product candidates, and may lose potential revenues.
	●	If we fail to comply with federal and state healthcare laws, including fraud and abuse laws, we could face substantial penalties and our business, financial condition, results of operations, stock price and prospects will be materially harmed.
	●	We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Our (or the third parties with whom we work) actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class-action claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.
	●	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.
	●	We are highly dependent on our key personnel, including our President, Chief Executive Officer and Chairman. If we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
	●	Unfavorable market and economic conditions may have serious adverse consequences on our business, financial condition, results of operations, stock price and prospects.
	●	The market price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.

	●	a Phase 3 registrational trial in the U.S. to treat patients with platinum-resistant/refractory ovarian cancer (PRROC),
	●	a Phase 2 clinical trial in the U.S. to treat patients with recurrent non-small cell lung cancer (NSCLC), and
	●	a Phase 1b/2 clinical trial in China to treat patients with recurrent small cell lung cancer (SCLC).

	●	*Advance our lead product candidate, Olvi-Vec, through a late-stage clinical development program focused on platinum resensitization, and seek regulatory approval.* Our Phase 3 OnPrime/GOG-3076 registration trial of Olvi-Vec in PRROC and our Phase 2 VIRO-25 trial, which is an open-label, randomized and controlled clinical trial of Olvi-Vec in patients with recurrent NSCLC, are being conducted in the United States and are ongoing.

	●	Support the clinical and commercial development of Olvi-Vec with our strategic partner, Newsoara, advise and coordinate the design and initiation of clinical trials in China and provide product supply and technology transfer. Our co-sponsored Phase 1b/2 clinical trial of Olvi-Vec in patients with recurrent SCLC in China is ongoing.

	●	*Prepare for U.S. commercial launch in ovarian cancer.* As our clinical trial program progresses in ovarian cancer, we intend to expand our preliminary commercial strategy initiatives and support corporate development efforts.

	●	*Broaden and strengthen our internal manufacturing capabilities, utilizing our in-house manufacturing facility.* We have strong in-house pharmaceutical development and manufacturing capabilities and have established, equipped and are operating our own cGMP manufacturing facility in San Diego, California for multi-product cGMP manufacturing.

	●	Leverage our CHOICE discovery platform to build a portfolio of oncology product candidates that target a range of immune mechanisms and progress these product candidates into clinical development. We are positioned to strengthen our leadership in the oncolytic viral immunotherapy field by leveraging the VACV product candidates generated by our CHOICE platform.

	●	Seek additional development and commercial collaborations for Olvi-Vec and our other human therapeutic product candidates, while retaining economic and commercial rights in key geographic areas. We intend to retain rights in the United States for our product candidates and to develop an oncology-focused commercial organization of internal and/or contract resources. When economically attractive, we intend to accelerate development and commercialization of, and patient access to, our product candidates by pursuing strategic partnerships with leading biopharmaceutical companies in those geographic areas where we are unlikely to pursue development and commercialization on our own.

	●	Observed to be well tolerated, and whether administered in a single dose or multiple doses per cycle, no maximum tolerated dose (MTD) was reached in any of the trials and there were no significant issues with virus shedding into the environment;

	●	Shown to infect and selectively kill tumor cells, initiate an anti-tumoral response and modulate the tumor microenvironment, including re-sensitizing certain tumors to chemotherapy; and

	●	Shown to enhance chemotherapeutic activities in a combination therapy setting.

	●	Shown to likely overcome pre-existing and/or induced anti-vaccinia antibody levels by high and/or extended dosing;

	●	Detectable in the active state as live virus in blood circulation even at two hours after infusion, which we believe is ample time for the virus to reach distal metastases; and

	●	Capable of infecting tumor tissues and reducing circulating tumor cells.

	●	Viral replication ultimately causes tumor cell necrosis (oncolysis) and release of mature viral particles into the tumor. These newly released viral particles repeat the process by infecting and killing neighboring tumor cells. The oncolytic process can also cause bystander tumor cell killing and viral-changes in tumor-associated vasculature;

	●	Infection enhances the neoantigen presentation and stimulates a tumor-specific immune response which results in the body’s immune system attacking and killing tumor cells; and

	●	Infection converts the tumor microenvironment from immunosuppressive (cold state) to immunoreactive (hot state).

	●	5 evaluable patients
	●	Disease control response (DCR) of 60% (3/5 patients)
	●	Tumor size changes among the three DCR patients were 8.9%, -18.9%, and -22.7%, respectively, as compared to baseline
	●	Olvi-Vec was generally well tolerated

	●	9 evaluable patients
	●	Overall response rate (ORR) of 33% (3/9 patients), including three partial responses (PRs)

	●	Olvi-Vec was generally well tolerated
	●	Exploratory durability signals: Two PR patients across different cohorts have been evaluated in long-term follow-up:

	○	A patient with 1 prior line, at last scan, achieved a PR with an ongoing PFS of 12.1 months
	○	A patient with 4 prior lines had a PFS of 7.7 months, which exceeds the PFS in the immediately preceding line in the same patient (1.9 months) by 5.8 months

	●	Currently marketed products for ovarian cancer include brand and generic chemotherapies, along with the following brand products (some of which are also manufactured as generic products): Abbvie’s ELAHERE, Eisai Inc.’s HEXALEN, Roche/Genentech, Inc.’s AVASTIN, Merck & Co.’s KEYTRUDA, GSK’s ZEJULA, AstraZeneca’s LYNPARZA, Pharma& and Tolmar’s RUBRACA, and Verstem Oncology’s combination of AVMAPKI+FAKZYNJA.

	●	Product candidates that have completed a registration trial and filed for U.S. regulatory approval for PRROC include: Relacorilant, an anti-glucocorticoid, by Corcept Therapeutics Inc.

	●	Completion of preclinical laboratory tests and in vivo studies in accordance with the FDA’s Good Laboratory Practice (GLP) regulations and applicable requirements for the humane use of laboratory animals and/or other applicable regulations;
	●	Submission to the FDA of an Investigational New Drug application IND), which allows human clinical trials to begin unless the FDA objects within 30 calendar days;

	●	Approval by an independent IRB, reviewing each clinical site before each clinical trial may be initiated at such site; Institutional Biosafety Committee (IBC) approval is also required for viral products

	●	Performance of adequate and well-controlled human clinical trials according to the FDA’s Good Clinical Practice (GCP) regulations, and any additional requirements for the protection of human research subjects and their health information, to establish the safety, purity and potency of the proposed biologic product candidate for its intended use;

	●	Preparation and submission to the FDA of a BLA for marketing approval that includes substantial evidence of safety, purity and potency from results of nonclinical testing and clinical trials;

	●	Review of the product by an FDA advisory committee, if applicable;

	●	Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biologic product candidate is produced to assess compliance with cGMP requirements and to assure that the facilities, methods and controls are adequate to preserve the biologic product candidate’s identity, safety, strength, quality, potency and purity;

	●	Potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of the BLA; and

	●	Payment of user fees (if applicable) and FDA review and approval, of the BLA (e.g. product licensure).

	●	Phase 2: The biologic product candidate is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product candidate for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.

	●	Phase 3: Phase 3 clinical trials are commonly referred to as “pivotal” or “registrational” studies, which typically denotes a study which is intended to generate, together with previously generated data, sufficient data for the FDA or other relevant regulatory agency to determine whether or not to approve a biologic product. In Phase 3 studies, the biologic product candidate is administered to an expanded patient population, generally at multiple geographically dispersed clinical trial sites in adequate and well-controlled clinical trials to generate sufficient data to statistically confirm the potency and safety of the product for approval. These clinical trials are intended to establish the overall risk/benefit ratio of the product candidate and provide an adequate basis for product labeling.

	●	The federal civil and criminal false claims laws, including, without limitation, the civil False Claims Act, and the federal Civil Monetary Penalties Law, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment of federal funds, and knowingly making, or causing to be made, a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government.

	●	The Health Insurance Portability and Accountability Act (HIPAA), which prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false, fictitious or fraudulent statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.

	●	The FDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biological products and medical devices.

	●	The federal physician payment transparency requirements, sometimes referred to as the Physician Payments Sunshine Act, created under the ACA and its implementing regulations, which require certain manufacturers of drugs, devices, biological products and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held by such physicians and their immediate family members.

	●	Analogous state and foreign anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, or that apply regardless of payor; state laws that require pharmaceutical companies to obtain certain regulatory licenses to manufacture or distribute pharmaceutical products commercially and/or the registration of pharmaceutical sales representatives in the jurisdiction; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state and local laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws that require the reporting of information related to drug pricing.

	●	advance the Phase 3 registration clinical trial for our lead product candidate, Olvi-Vec, in PRROC;

	●	initiate planned and future clinical trials of Olvi-Vec in other cancer indications;

	●	discover and develop new product candidates, and conduct research and development activities, preclinical studies and clinical trials;

	●	manufacture preclinical, clinical and commercial supplies of our product candidates;

	●	broaden and strengthen our internal manufacturing capabilities, including the expansion and upgrade of our in-house manufacturing facility;

	●	seek regulatory approvals for any product candidates that successfully complete clinical trials;

	●	maintain, expand and protect our intellectual property portfolio;

	●	hire additional research and development, clinical, scientific and management personnel;

	●	add operational, financial and management information systems and personnel;

	●	establish a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain regulatory approval and we commercialize on our own or in collaboration with others; and

	●	incur additional legal, accounting and other expenses operating as a public company.

	●	the timing of, and the costs involved in, obtaining marketing approvals for Olvi-Vec and future product candidates we develop if clinical trials are successful;

	●	the success of any future collaborations;

	●	the cost of commercialization activities for any approved product, including marketing, sales and distribution costs;

	●	the cost and timing of establishing, equipping, and operating our current and planned manufacturing activities;

	●	the cost of manufacturing Olvi-Vec and future product candidates for clinical trials in preparation for marketing approval and commercialization;

	●	our ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements;

	●	the cost, timing and outcome of seeking FDA and any other regulatory approvals for any future product candidates;

	●	the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of such litigation;

	●	our ability to establish and maintain healthcare coverage and adequate reimbursement for our future products, if any;

	●	the timing, receipt, and amount of sales of, or royalties on, our future products, if any;

	●	the emergence of competing cancer therapies and other adverse market developments;

	●	our efforts to enhance operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development of our product candidates;

	●	the costs associated with being a public company;

	●	our need and ability to retain key management and hire scientific, technical, medical and business personnel;

	●	the costs associated with expanding our facilities or building out our laboratory space; and

	●	the impact of geopolitical and macroeconomic events, including future bank failures, new or increased tariffs and other trade measures, funding shortages at governmental and regulatory agencies on which we rely, geopolitical tensions between the United States and China, the Russia/Ukraine conflict, conflicts in the Middle East and global pandemics on U.S. and global economic conditions including changes in monetary and fiscal policy, U.S. political developments and other sources of instability.

	●	obtaining marketing approvals for any product candidates for which we complete clinical trials;

	●	obtaining regulatory approval to use and sell products generated by our existing or future manufacturing processes for Olvi-Vec and future product candidates, including at our existing manufacturing facility and/or by establishing and maintaining supply and manufacturing relationships with third parties;

	●	launching and commercializing product candidates for which we obtain marketing approvals, either directly by establishing a sales force and marketing, medical affairs and distribution infrastructure or, alternatively, with a collaborator or distributor;

	●	establishing and maintaining healthcare coverage and adequate reimbursement for our future products, if any;

	●	obtaining market acceptance of product candidates that we develop as viable treatment options;

	●	addressing any competing technological and market developments;

	●	identifying, assessing, acquiring and developing new product candidates;

	●	negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter and performing our obligations in such collaborations;

	●	maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how; and

	●	attracting, hiring, and retaining qualified personnel.

	●	successful completion of preclinical studies and clinical trials;

	●	sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;

	●	acceptance of IND applications or IND amendments for our planned clinical trials or future clinical trials;

	●	successful enrollment and completion of clinical trials;

	●	successful data from our clinical trials that support FDA conclusion of an acceptable risk-benefit profile of our product candidates in the intended populations;

	●	receipt of regulatory and marketing approvals from applicable regulatory authorities;

	●	obtaining and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates;

	●	obtaining regulatory approval to use our existing or future manufacturing processes for the clinical and commercial manufacture of our product candidates at our existing or future manufacturing facilities or at the facilities of one or more third-party manufacturers with whom we would need to establish supply arrangements;

	●	successfully launching commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others;

	●	acceptance of any products we develop and their benefits and uses, if and when approved, by patients, the medical community and third-party payors;

	●	effectively competing with other therapies;

	●	obtaining and maintaining healthcare coverage and adequate reimbursement from third-party payors; and

	●	maintaining a continued acceptable safety profile of the products following approval.

	●	inability to generate sufficient preclinical or other in vivo or in vitro data to support the initiation of clinical trials;

	●	unexpected toxicities observed in preclinical IND-enabling studies precluding the identification of a safe dose to move forward in human clinical trials;

	●	delays in reaching a consensus with regulatory agencies on study or trial design; and

	●	regulatory authorities not allowing us to rely on previous findings of safety and efficacy for other similar but approved products and published scientific literature.

	●	delays or failures, which may result in clinical site closures, delays to patient enrollment, patients withdrawing prior to receiving treatment (e.g., catheter implantation failure), patients discontinuing their treatment or follow-up visits or changes to trial protocols;

	●	regulators or IRBs, may not authorize us or our investigators to commence a clinical trial, conduct a clinical trial at a prospective trial site, or amend trial protocols, or may require that we modify or amend our clinical trial protocols;

	●	we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites and/or CROs;

	●	clinical trials of our product candidates may produce negative or inconclusive results, or our studies may fail to reach the necessary level of statistical significance, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

	●	the unsuccessful implantation of catheters used to deliver Olvi-Vec;

	●	the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials or be lost to follow-up at a higher rate than we anticipate, or may elect to participate in alternative clinical trials sponsored by our competitors with product candidates that treat the same indications as our product candidates;

	●	third-party contractors may fail to comply with regulatory requirements or the clinical trial protocol, or meet their contractual obligations to us in a timely manner, or at all, or we may be required to engage in additional clinical trial site monitoring;

	●	manufacturing delays;

	●	we, regulators, or IRBs may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks, undesirable side effects, emergent drug-drug interactions between Olvi-Vec and any of the other therapeutic agents given to the clinical trial subjects or other unexpected characteristics of the product candidate, or due to findings of undesirable effects caused by a biologically, chemically or mechanistically similar therapeutic or therapeutic candidate, or flaws in the design of the trial;

	●	changes could be adopted in marketing approval policies during the development period, rendering our data insufficient to obtain marketing approval;

	●	statutes or regulations could be amended, or new ones could be adopted;

	●	changes could be adopted in the regulatory review process for submitted product applications;

	●	the cost of clinical trials of our product candidates may be greater than we anticipate, or we may have insufficient funds for a clinical trial or product manufacture or to pay the substantial user fees required by the FDA upon the submission of a BLA or equivalent authorizations from comparable foreign regulatory authorities;

	●	the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;

	●	the FDA or comparable foreign regulatory authorities may fail to approve the existing or future manufacturing processes or facilities of our company or of third-party manufacturers with which we contract for clinical and commercial supplies;

	●	we may decide, or regulatory authorities may require us, to conduct or gather, as applicable, additional clinical trials, analyses, reports, data, or preclinical studies, or we may abandon product development programs;

	●	we may fail to reach an agreement with regulatory authorities or IRBs regarding the scope, design, or implementation of our clinical trials, and the FDA or comparable foreign regulatory authorities may require changes to our study designs that make further study impractical or not financially prudent;

	●	Regulatory authorities may ultimately disagree with the design or our conduct of our preclinical studies or clinical trials, finding that they do not support product candidate approval;

	●	we may have delays in adding new investigators or clinical trial sites, or we may experience a withdrawal of clinical trial sites;

	●	patients that enroll in our studies may misrepresent their eligibility or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the patients from the study or clinical trial, increase the needed enrollment size for the clinical trial or extend its duration;

	●	there may be regulatory questions or disagreements regarding interpretations of data and results, or new information may emerge regarding our product candidates;

	●	the FDA or comparable foreign regulatory authorities may disagree with our trial design, including endpoints, or our interpretation of data from preclinical studies and clinical trials or find that a product candidate’s benefits do not outweigh its safety risks;

	●	the FDA or comparable foreign regulatory authorities may not accept data from studies with clinical trial sites in foreign countries;

	●	the FDA or comparable foreign regulatory authorities may disagree with our intended indications;

	●	the FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or our manufacturing facilities for clinical and future commercial supplies;

	●	the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;

	●	the FDA or comparable foreign regulatory authorities may take longer than we anticipate to make a decision on our product candidates; and

	●	we may not be able to demonstrate that a product candidate provides an advantage over current standards of care or current or future competitive therapies in development, including, for example, due to a longer-and/or-higher-than-expected response rate determination in the active comparator group or a shorter-and/or-lower-than-expected response rate determination in the experimental drug group.

	●	availability and efficacy of approved therapies for the disease under investigation;

	●	patient eligibility criteria for the trial in question;

	●	risks that enrolled subjects will drop out before completion of the trial, including as a result of emergent drug-drug interactions between Olvi-Vec and any of the other therapeutic agents given to the clinical trial subjects or contracting health conditions;

	●	risks of excessive catheter implantation failures leading to elimination of particular study sites from the trial in question;

	●	perceived risks and benefits of the product candidate under study;

	●	the timely initiation of clinical trial sites;

	●	efforts to facilitate timely enrollment in clinical trials;

	●	patient referral practices of physicians;

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

	●	proximity and availability of clinical trial sites for prospective patients;

	●	withdrawal of consent for any reason;

	●	imbalance in withdrawals between the comparator and treatment arms;

	●	unforeseen limitations of protocol design; and

	●	protocol amendment by the sponsor and/or as requested by applicable regulatory authorities.