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What changed in GENELUX Corp's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of GENELUX Corp's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+595 added−626 removedSource: 10-K (2026-03-19) vs 10-K (2024-12-31)

Top changes in GENELUX Corp's 2025 10-K

595 paragraphs added · 626 removed · 427 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

116 edited+42 added−76 removed142 unchanged
Biggest changeThe 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.
Biggest changeIn the case of product candidates for severe or life-threatening diseases, especially when the product candidate may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients. ● 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.
The biotechnology and pharmaceutical industries are characterized by extensive intellectual property litigation. Our ability to maintain and solidify our proprietary position for our product candidates and technology will depend on our success in obtaining effective claims for our patents and enforcing those claims once a patent is granted.
The biotechnology and pharmaceutical industries are characterized by extensive intellectual property litigation. Our ability to maintain and solidify a proprietary position for our product candidates and technology will depend on our success in obtaining effective claims in our patents and enforcing those claims once a patent is granted.
Many of our potential competitors, alone or with their strategic partners, may have substantially greater financial, technical and other resources than we do, such as larger research and development, clinical, marketing and manufacturing organizations. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors.
Many of our potential competitors, alone or with their strategic partners, have substantially greater financial, technical and other resources than we do, such as larger research and development, clinical, marketing and manufacturing organizations. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors.
Clinical trials must be conducted under written study protocols detailing, among other things, the objectives of the trial, subject selection and exclusion, the trial procedures, the parameters to be used in monitoring safety, the effectiveness criteria to be evaluated, and a statistical analysis plan.
Clinical trials must be conducted under written study protocols detailing, among other things, the objectives of the trial, subject selection and exclusion criteria, the trial procedures, the parameters to be used in monitoring safety, the effectiveness criteria to be evaluated, and a statistical analysis plan.
For more information regarding risks relating to data security, see “Risk Factors – Risks Related to Our Business and Operations – If our information technology systems or those third parties with whom we work or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences .” Additional Regulation In addition to the foregoing, state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservation and Recovery Act and the Toxic Substances Control Act, affect our business.
For more information regarding risks relating to data security, see “Risk Factors – Risks Related to Our Business and Operations – If our information technology systems or those third parties with whom we work or its data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences .” Additional Regulation In addition to the foregoing, state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservation and Recovery Act and the Toxic Substances Control Act, affect our business.
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. THE GENELUX APPROACH Oncolytic VACV Olvi-Vec utilizes VACV as the backbone of our proprietary CHOICE discovery platform.
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. 3 The Genelux Approach Oncolytic VACV Olvi-Vec utilizes VACV as the backbone of our proprietary CHOICE discovery platform.
The FDA may also require post-marketing clinical trials, sometimes referred to as Phase 4 clinical trials, designed to further assess a biologic product’s safety and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have been commercialized. 23 Every five years, the FDA agrees to specified performance goals in the review of BLAs under the PDUFA.
The FDA may also require post-marketing clinical trials, sometimes referred to as Phase 4 clinical trials, designed to further assess a biologic product’s safety and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have been commercialized. Every five years, the FDA agrees to specified performance goals in the review of BLAs under the PDUFA.
Our product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable DNA virus with a large engineering capacity. Employing our proprietary selection technology and discovery and development platform (CHOICE), we have developed an extensive library of isolated and engineered oncolytic VACV immunotherapeutic product candidates.
Our lead product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable DNA virus with a large engineering capacity. Employing our proprietary selection technology and discovery and development platform (CHOICE), we have developed an extensive library of isolated and engineered oncolytic VACV immunotherapeutic product candidates.
Clinical trial sponsors may also choose to discontinue clinical trials as a result of risks to subjects, a lack of favorable results, or changing business priorities. 21 Compliance with cGMP Requirements Manufacturers of biological products must comply with applicable cGMP regulations, including quality control and quality assurance and maintenance of records and documentation.
Clinical trial sponsors may also choose to discontinue clinical trials as a result of risks to subjects, a lack of favorable results, or changing business priorities. Compliance with cGMP Requirements Manufacturers of biological products must comply with applicable cGMP regulations, including quality control and quality assurance and maintenance of records and documentation.
We are positioned to strengthen our leadership in the oncolytic viral immunotherapy field by leveraging the VACV clinical 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 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.
Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payors. The implementation of current and future cost containment measures or other healthcare reforms may adversely affect our operations and prevent us from being able to generate revenue, attain profitability or commercialize our product candidates.
Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payors. The implementation of current and future cost containment measures or other healthcare reforms may adversely affect our operations and prevent it from being able to generate revenue, attain profitability or commercialize our product candidates.
The process required by the FDA before a biologic product candidate may be marketed in the United States generally involves the following: ● 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 IND application, 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; 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 Biologics License Application (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).
The process required by the FDA before a biologic product candidate may be marketed in the United States generally involves the following: ● 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; 14 ● 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).
We anticipate being awarded data exclusivity for each of our biological product candidates that is subject to its own BLA for 12 years in the United States, up to 11 years in Europe and significant durations in other markets.
We anticipate being awarded data exclusivity for each of our biological product candidates that is subject to its own BLA for 12 years in the United States, up to 11 years in Europe and varying durations in other markets.
Item 1. Business OVERVIEW Genelux is a late clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic viral immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. Our clinical and preclinical product candidates are intended to selectively kill tumor cells and induce a robust immune response against a patient’s tumor neoantigens.
Item 1. BUSINESS A. Overview Genelux is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic viral immunotherapies for patients suffering from aggressive and/or difficult-to-treat tumor types. Our clinical and preclinical product candidates are intended to selectively kill tumor cells and induce a robust immune response against a patient’s tumor neoantigens.
In addition, numerous US states have enacted comprehensive data privacy laws, and similar laws are being considered at the federal, state, and local levels. The EU GDPR, UK GDPR, and CCPA are examples of the increasingly stringent and evolving regulatory frameworks related to personal information processing that may increase our compliance obligations and exposure for any noncompliance.
In addition, numerous U.S. states have enacted comprehensive data privacy laws, and similar laws are being considered at the federal, state, and local levels. The EU GDPR, UK GDPR, and CCPA are examples of the increasingly stringent and evolving regulatory frameworks related to personal information processing that may increase our compliance obligations and exposure for any noncompliance.
Agreement In September 2021, we entered into the Newsoara License pursuant to which we granted Newsoara an exclusive license to research, develop, commercialize or exploit (i) any and all oncolytic viruses that are controlled by us, including Olvi-Vec but excluding V-VET1 (licensed viruses); (ii) any pharmaceutical product in final form that is comprised of or contains the licensed viruses as an active ingredient (licensed products); (iii) any virus developed by or behalf of Newsoara that (a) has a vaccinia virus backbone; (b) is not disclosed or covered by any of our patents; and (c) includes modifications (as compared to the licensed viruses) of a gene function with therapeutic intent (derived molecules); and (iv) any pharmaceutical product in final form that is comprised of or contains derived molecule as an active ingredient (derived products), in each case in China (the territory, which includes mainland China, Taiwan, Hong Kong and Macau) for the Newsoara Field.
Newsoara License Agreement In September 2021, we entered into the Newsoara License Agreement, pursuant to which we granted Newsoara an exclusive license to research, develop, commercialize or exploit (i) any and all oncolytic viruses that are controlled by us, including Olvi-Vec but excluding V-VET1 (licensed viruses); (ii) any pharmaceutical product in final form that is comprised of or contains the licensed viruses as an active ingredient (licensed products); (iii) any virus developed by or on behalf of Newsoara that (a) has a vaccinia virus backbone; (b) is not disclosed or covered by any of our patents; and (c) includes modifications (as compared to the licensed viruses) of a gene function with therapeutic intent (derived molecules); and (iv) any pharmaceutical product in final form that is comprised of or contains derived molecule as an active ingredient (derived products), in each case in mainland China, Taiwan, Hong Kong and Macau (the Newsoara Territory) in the field of human diagnostic, prophylactic and therapeutic uses (the Newsoara Field).
The FDA will not approve a BLA unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specification.
The FDA will not approve a BLA unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
Data Privacy and Security In the ordinary course of our business, we collect, receive, process, generate, use, transfer, make accessible, protect, secure, dispose of, transmit and store (collectively, process) confidential and sensitive information, including personal information, intellectual property, trade secrets, and proprietary information owned or controlled by ourselves or other third parties.
Data Privacy and Security In the ordinary course of business, we collect, receive, process, generate, use, transfer, make accessible, protect, secure, dispose of, transmit and store (collectively, process) confidential and sensitive information, including personal information, intellectual property, trade secrets, and proprietary information owned or controlled by us or other third parties.
We are focused on the execution and success of our clinical programs and, over time, on building our organization into a fully-integrated therapeutics company. Key elements of our strategy include: ● Advance our lead product candidate, Olvi-Vec, through a late-stage clinical development program focused on platinum re-sensitization, and seek regulatory approval.
We are focused on the execution and success of our clinical programs and, over time, on building our organization into a fully-integrated therapeutics company. Key elements of our strategy include: ● Advance our lead product candidate, Olvi-Vec, through a late-stage clinical development program focused on platinum resensitization, and seek regulatory approval.
Also, under FDARA, applications for product candidates intended for the treatment of adult cancer which are directed at molecular targets that the FDA determines to be substantially relevant to the growth or progression of pediatric cancer, in place of the PREA investigations, sponsors must submit, with the application, reports from molecularly targeted pediatric cancer investigations designed to yield clinically meaningful pediatric study data, using appropriate formulations, to inform potential pediatric labeling.
Also, under the FDA Reauthorization Act of 2017, applications for product candidates intended for the treatment of adult cancer which are directed at molecular targets that the FDA determines to be substantially relevant to the growth or progression of pediatric cancer, in place of the PREA investigations, sponsors must submit, with the application, reports from molecularly targeted pediatric cancer investigations designed to yield clinically meaningful pediatric study data, using appropriate formulations, to inform potential pediatric labeling.
Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA. 31 At the state level, individual states in the United States have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program. 24 At the state level, individual states in the United States have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
For example, through the process created by the Budget Control Act of 2011, there are automatic reductions of Medicare payments to providers up to 2% per fiscal year, which went into effect in April 2013 and, following passage of the BBA and the Infrastructure Investment and Jobs Act, will remain in effect until 2032 unless additional Congressional action is taken.
For example, through the process created by the Budget Control Act of 2011, there are automatic reductions of Medicare payments to providers up to 2% per fiscal year, which went into effect in April 2013 and, following passage of the Build Back Better Act and the Infrastructure Investment and Jobs Act, will remain in effect until 2032 unless additional Congressional action is taken.
Trademarks We believe our rights under issued and pending trademarks are important and valuable and we strive to and intend to seek, maintain and defend our trademark rights. “Genelux” is the subject of issued trademark registrations in the European Union, the United Kingdom, China and in several other countries. Our unregistered trademarks include “CHOICE”.
Trademarks We believe our rights under issued and pending trademarks are important and valuable and we strive to and intend to seek, maintain and defend our trademark rights. “Genelux” is the subject of issued trademark registrations in the European Union, the United Kingdom, China and in several other countries.
In the Phase 2 portion of the clinical trial, data from patients who received Olvi-Vec-primed immunochemotherapy supported that there was demonstrated responsiveness to platinum- based therapy, to which they previously were deemed resistant or refractory, leading to the hypothesis that treatment with Olvi-Vec may re-sensitize patients to platinum-based therapies.
Olvi-Vec treatment was observed to be well tolerated. 6 In the Phase 2 portion of the clinical trial, data from patients who received Olvi-Vec-primed immunochemotherapy supported that there was demonstrated responsiveness to platinum- based therapy, to which they previously were deemed resistant or refractory, leading to the hypothesis that treatment with Olvi-Vec may re-sensitize patients to platinum-based therapies.
Such restrictions under applicable federal and state healthcare laws and regulations include the following: ● The federal Anti-Kickback Statute, which prohibits, among other things, individuals and entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. 27 ● 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 Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, 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 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; state laws that require the reporting of information related to drug pricing; and state and local laws requiring the registration of pharmaceutical sales representatives. 28 Efforts to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs.
Such restrictions under applicable federal and state healthcare laws and regulations include the following: ● The federal Anti-Kickback Statute, which prohibits, among other things, individuals and entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. 21 ● 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.
December 31, 2028), (b) in which we have total annual gross revenue of at least $1.235 billion or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
December 31, 2028), (b) in which the Company has total annual gross revenue of at least $1.235 billion or (c) in which the Company is deemed to be a large accelerated filer, which means the market value of its common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th and (2) the date on which the Company has issued more than $1.0 billion in non-convertible debt during the prior three-year period.
To date, Olvi-Vec has been studied in multiple early- and mid-phase clinical trials via regional, local and systemic deliveries, as a monotherapy and in combination with other therapies, in approximately 150 patients in seven completed clinical trials with a variety of cancer types.
To date, Olvi-Vec has been studied in multiple early- and mid-phase clinical trials via regional, and systemic deliveries, as a monotherapy and in combination with other therapies, in seven completed clinical trials with a variety of cancer types.
The facility includes laboratories, production cleanrooms, and installed equipment, to accept and prepare raw materials, and produce drug substance and drug product in accordance with cGMPs and all other applicable laws and regulations. We recently leased a 6,755 square-foot building in the same location which, when upgrades are completed, will provide laboratory capabilities and administrative offices.
The facility includes laboratories, production cleanrooms, and installed equipment, to accept and prepare raw materials, and produce drug substance and drug product in accordance with cGMP and all other applicable laws and regulations. We also lease a 6,755 square-foot building in the same location which, when upgrades are completed, will provide laboratory capabilities and administrative offices.
Newsoara is required to use commercially reasonable efforts to research, develop, manufacture and commercialize the licensed products in the territory in the applicable Newsoara Field and is solely responsible for all costs and expenses incurred in connection with such activities.
Pursuant to the Newsoara License Agreement, Newsoara is required to use commercially reasonable efforts to research, develop, manufacture and commercialize the licensed products in the Newsoara Territory in the Newsoara Field and is solely responsible for all costs and expenses incurred in connection with such activities.
The conduct of the preclinical tests must comply with federal regulations and requirements including GLPs. 19 Concurrent with clinical trials, companies usually are required to complete some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, and must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the drug in commercial quantities in accordance with cGMP requirements.
Concurrent with clinical trials, companies usually are required to complete some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, and must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the drug in commercial quantities in accordance with cGMP requirements.
Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities.
Such threats are prevalent and continue to rise. Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities.
Additionally, in a recent communication regarding the Phase 3 OnPrime registrational trial, the FDA stated that an interim analysis of overall survival (OS) should be planned at the time of the primary progression-free survival (PFS) analysis and confirmed that if a clinically meaningful PFS advantage is demonstrated in the absence of a decrement in OS, this could potentially support traditional approval.
Additionally, in communication regarding the Phase 3 OnPrime/GOG-3076 registrational trial in March 2025, the FDA stated that an interim analysis of overall survival (OS) should be planned at the time of the primary PFS analysis and confirmed that if a clinically meaningful PFS advantage is demonstrated in the absence of a decrement in OS, this could potentially support traditional approval.
We completed our initial public offering in January 2023, and our common stock is listed on the Nasdaq Capital Market under the symbol “GNLX.” We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (JOBS Act).
The Company completed its initial public offering (IPO) in January 2023, and its common stock is listed on the Nasdaq Capital Market under the symbol “GNLX.” 26 The Company is an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (JOBS Act).
A provisional patent application is not examined for patentability by the U.S. Patent and Trademark Office (USPTO), and automatically expires 12 months after its filing date. As a result, a provisional patent application cannot mature into an issued patent.
Patents The U.S. patent system permits the filing of provisional and non-provisional patent applications. A provisional patent application is not examined for patentability by the U.S. Patent and Trademark Office (USPTO), and automatically expires 12 months after its filing date. As a result, a provisional patent application cannot mature into an issued patent.
The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements.
The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. Orphan products are also exempt from the PREA requirements.
The experimental arm patients will receive a single cycle (two doses) of Olvi-Vec administered intraperitoneally and, approximately four weeks later, a regimen of a platinum-based doublet plus bevacizumab followed by maintenance therapy. The active comparator arm patients will receive a regimen of single agent chemotherapy with optional platinum, plus bevacizumab followed by maintenance therapy. After discussions with the U.S.
Patients in the experimental arm of the trial receive a single cycle (two doses) of Olvi-Vec administered intraperitoneally and, approximately four weeks later, a regimen of a platinum-based doublet plus bevacizumab followed by maintenance therapy. Patients in the active comparator arm of the trial receive a regimen of single agent chemotherapy with optional platinum, plus bevacizumab followed by maintenance therapy.
Further, clinical trials must be conducted in accordance with federal regulations and GCP requirements, which include the requirements that all research subjects provide their informed consent in writing for their participation in any clinical trial, as well as review and approval by an IRB at each study site participating in the clinical trial or a central IRB.
Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND. 15 Further, clinical trials must be conducted in accordance with federal regulations and GCP requirements, which include the requirements that all research subjects provide their informed consent in writing for their participation in any clinical trial, as well as review and approval by an IRB at each study site participating in the clinical trial or a central IRB.
Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we or our collaborators receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Even if favorable coverage and reimbursement status is attained for one or more products for which we or our collaborators receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Orphan products are also exempt from the PREA requirements. 22 The FDA reviews a BLA within 60 days of submission to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.
The FDA reviews a BLA within 60 days of submission to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.
By way of example, in March 2010, the ACA was signed into law, intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose taxes and fees on the healthcare industry and impose additional health policy reforms. 30 There have been executive, judicial and Congressional challenges and amendments to certain aspects of the ACA.
By way of example, in March 2010, the ACA was signed into law, intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose taxes and fees on the healthcare industry and impose additional health policy reforms.
In the Phase 1b portion of the clinical trial, no virus- related severe organ toxicity was observed by clinical or serologic parameters and a maximum tolerated dose (MTD) was not reached. Olvi-Vec treatment was observed to be well tolerated.
In the Phase 1b portion of the clinical trial, no virus- related severe organ toxicity was observed by clinical or serologic parameters, and a maximum tolerated dose was not reached.
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). 4 The following diagram sets forth Olvi-Vec’s proposed mechanism of action.
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).
In addition, Newsoara is required to use commercially reasonable efforts to conduct a multi-center Phase 2 clinical trial for Olvi-Vec in NSCLC using clinical sites in the United States and China and Newsoara will be responsible for funding such trial.
In addition, Newsoara is required to use commercially reasonable efforts to conduct a multi-center Phase 2 clinical trial for Olvi-Vec in NSCLC using clinical sites in the United States and China, which is the VIRO-25 clinical trial.
DEVELOPMENT PROGRAMS Platinum Resistant/Refractory Ovarian Cancer We envision that Olvi-Vec-primed immunochemotherapy may overcome chemotherapy resistance for patients with end-stage ovarian cancer that would otherwise consider palliative care or use of drugs with historically poor response rates. We initiated a Phase 3 OnPrime registration trial in PRROC in the third quarter of 2022.
The following diagram sets forth Olvi-Vec’s proposed mechanism of action. 5 D. Development Programs Platinum Resistant/Refractory Ovarian Cancer We envision that Olvi-Vec-primed immunochemotherapy may overcome chemotherapy resistance for patients with end-stage ovarian cancer that would otherwise consider palliative care or use of drugs with historically poor response rates. We initiated a Phase 3 OnPrime/GOG-3076 registration trial in PRROC in 2022.
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 ” for additional information about the laws and regulations to which we are or may become subject and about the risks to our business associated with such laws and regulations.
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 ” for additional information about the laws and regulations to which we are or may become subject and about the risks to our business associated with such laws and regulations. 25 Moreover, cyber-attacks, malicious internet-based activity and other similar activities threaten the confidentiality, integrity, and availability of our sensitive information and information technology systems, and those of the third parties with whom we work.
We also contract with a third party for the labeling, packaging and distribution of our clinical material and we expect to do so in the future for commercial Olvi-Vec product, assuming it receives regulatory approval.
We also contract with a third party for the labeling, packaging and distribution of our clinical material and expect to do so in the future for commercial Olvi-Vec product, assuming it receives regulatory approval. We do not have long-term supply arrangements in place with raw material and component suppliers.
Importantly, these product candidates are “off-the-shelf” personalized immunotherapies. In other words, while we administer the same virus product to different patients, the cellular immune response generated is expected to be specific to the unique neoantigens in that patient.
In other words, while we administer the same virus product to different patients, the cellular immune response generated is expected to be specific to the unique neoantigens in that patient.
To the extent that our collaborators, employees and consultants use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our collaborators, employees and consultants use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable healthcare laws and regulations.
Efforts to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable healthcare laws and regulations.
We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of our initial public offering (i.e.
The Company will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of its IPO (i.e.
Total trial enrollment will be a sufficient number of patients to achieve 127 events. We anticipate reporting topline results in the first half of 2026.
Total trial enrollment will be a number of patients sufficient to achieve a primary progression-free survival analysis (PFS) of 127 events. We anticipate reporting topline results in the second half of 2026.
Presidential and Congressional elections, as well as the trend toward managed healthcare and increasing influence of managed care organizations, may result in more rigorous coverage criteria and lower reimbursement, and in additional downward pressure on the price that we receive for any approved product.
We expect that these initiatives, as well as other healthcare reform measures that may be adopted in the future, as well as the trend toward managed healthcare and increasing influence of managed care organizations, may result in more rigorous coverage criteria and lower reimbursement, and in additional downward pressure on the price that we receive for any approved product.
In addition, under the Pediatric Research Equity Act (PREA), a BLA or supplement to a BLA for a new active ingredient, indication, dosage form, dosage regimen, or route of administration, must contain data that are adequate to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
Additionally, no user fees are assessed on BLAs for product candidates designated as orphan drugs, unless the product candidate also includes a non-orphan indication. 17 In addition, under the Pediatric Research Equity Act (PREA), a BLA or supplement to a BLA for a new active ingredient, indication, dosage form, dosage regimen, or route of administration, must contain data that are adequate to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
In September 2021, we entered into a License Agreement (the Newsoara License) with Newsoara BioPharma Co. Ltd. (Newsoara) pursuant to which we granted Newsoara an exclusive license to research, develop, commercialize or exploit Olvi-Vec in China, which includes mainland China, Taiwan, Hong Kong and Macau, for all human diagnostic, prophylactic and therapeutic uses (the Newsoara Field).
We refer herein to the counterparty to the Newsoara License Agreement as Newsoara. Pursuant to the Newsoara License Agreement, we granted Newsoara an exclusive license to research, develop, commercialize or exploit Olvi-Vec in China, which includes mainland China, Taiwan, Hong Kong and Macau, for all human diagnostic, prophylactic and therapeutic uses (the Newsoara Field).
Our current plan is to expand our clinical development program by pursuing additional indications via intravenous delivery. Other indications will be selected from the balance of more than 20 major human cancers against which Olvi-Vec has shown activity in preclinical studies, including blood (other leukemia/lymphoma), breast, colon, kidney, lung, prostate and skin (melanoma) cancers.
Indications for development will be selected from the balance of more than 20 major human cancers against which Olvi-Vec has shown activity in preclinical studies, including blood (other leukemia/lymphoma), breast, colon, kidney, lung, prostate and skin (melanoma) cancers.
Systemic Administration We selected recurrent lung cancers (recurrent SCLC and recurrent NSCLC) as our initial registration-path indications for intravenous delivery of Olvi-Vec-primed immunochemotherapy because of the promising preclinical and clinical data generated in patients with lung disease (primary or metastatic) in our prior clinical trials.
Additionally, 20% of patients were long-term survivors, which is generally regarded as a hallmark of clinically beneficial immunotherapies. 7 Systemic Administration We selected recurrent lung cancers (recurrent SCLC and recurrent NSCLC) as our initial registration-path indications for intravenous delivery of Olvi-Vec-primed immunochemotherapy because of the promising preclinical and clinical data generated in patients with lung disease (primary or metastatic) in our prior clinical trials.
Additionally, product candidates studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may be eligible for accelerated approval upon a determination that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefits, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.
A priority review designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on an original marketing application from ten months to six months from the date of filing. 19 Additionally, product candidates studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may be eligible for accelerated approval upon a determination that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefits, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.
In addition, changes to the manufacturing process or facility generally require prior FDA approval or notification before being implemented, and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval. 26 Moreover, the Drug Quality and Security Act imposes obligations on manufacturers of biopharmaceutical products related to product tracking and tracing.
In addition, changes to the manufacturing process or facility generally require prior FDA approval or notification before being implemented, and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.
Health Reform The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably.
Any country that has price controls or reimbursement limitations may not allow favorable reimbursement and pricing arrangements. 23 Health Reform The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably.
The FDA may impose restrictions and conditions on product distribution, prescribing or dispensing in the form of a REMS, or otherwise limit the scope of any approval.
Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling. The FDA may impose restrictions and conditions on product distribution, prescribing or dispensing in the form of a REMS, or otherwise limit the scope of any approval.
This clinical trial is not yet scheduled to be initiated. 10 Additional Potential Indications for Olvi-Vec We believe our preclinical and clinical data support the broad development of Olvi-Vec in patients with liquid or (metastatic) solid tumors, as a monotherapy or in combination with other therapies.
We expect to report additional updated dose-finding data from this trial throughout 2026. 9 Additional Potential Indications for Olvi-Vec We believe our preclinical and clinical data support the broad development of Olvi-Vec in patients with liquid or (metastatic) solid tumors, as a monotherapy or in combination with other therapies.
COMPETITION The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary rights. We face significant competition from many sources, including pharmaceutical, biopharmaceutical and biotechnology companies, as well as universities and private and public research institutions.
Our unregistered trademarks include “CHOICE”. 12 Competition The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary rights. We face significant competition from many sources, including pharmaceutical, biopharmaceutical and biotechnology companies.
We also have confidentiality agreements or invention assignment agreements with selected consultants. These agreements are designed to protect our proprietary information and, in the case of the invention assignment agreements, to grant us ownership of technologies that are developed through a relationship with a third party.
These agreements are designed to protect our proprietary information and, in the case of the invention assignment agreements, to grant us ownership of technologies that are developed through a relationship with a third party. These agreements may be breached, and we may not have adequate remedies for any breach.
All achieved PFS exceeding any of their respective prior lines, and achieved objective partial response, suggesting meaningful clinical benefit from Olvi-Vec-primed immunochemotherapy. 7 The majority of patients treated with Olvi-Vec-primed immunochemotherapy showed clinical benefits exceeding their own last prior line of therapy (PFS of 11.0 months versus 4.5 months) with preserved or improved performance status.
The majority of patients treated with Olvi-Vec-primed immunochemotherapy showed clinical benefits exceeding their own last prior line of therapy (median PFS of 11.0 months versus 4.5 months) with preserved or improved performance status.
The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject, or their legal representative, reviews and approves the study protocol, and must monitor the clinical trial until completed. Human clinical trials typically are conducted in three sequential phases that may overlap or be combined: ● Phase 1.
The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject, or their legal representative, reviews and approves the study protocol, and must monitor the clinical trial until completed.
OPERATIONS Manufacturing and Distribution We leased a 7,569 square-foot building in San Diego, California where we have established and equipped our own manufacturing facility in order to secure supplies for clinical trials and commercial launch.
We are responsible for supplying Olvi-Vec to Newsoara, and Newsoara will pay us the cost of manufacturing. E. Operations Manufacturing and Distribution We lease a 7,569 square-foot building in San Diego, California where we have established and equipped our own manufacturing facility in order to secure supplies for clinical trials and commercial launch.
We leased a second building in the same location which, when upgrades are completed, will provide laboratory capabilities and administrative offices. 1 PIPELINE Our pipeline is summarized below: OUR STRATEGY Our strategy is to leverage our deep internal capabilities in the clinical development of oncolytic viruses to create a leading immunotherapy company, discovering, developing and commercializing next-generation products for the treatment of a broad range of cancers, including solid tumors, many of which are among the most difficult cancers to treat.
Strategy Our strategy is to leverage our deep internal capabilities in the clinical development of oncolytic viruses to create a leading immunotherapy company, discovering, developing and commercializing next-generation products for the treatment of a broad range of cancers, initially solid tumors, many of which are among the most difficult cancers to treat.
The biologic product candidate initially is introduced into a small number of healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early understanding of its effectiveness.
Human clinical trials typically are conducted in three sequential phases that may overlap or be combined: ● Phase 1: The biologic product candidate initially is introduced into a small number of healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early understanding of its effectiveness.
Adverse event reporting and submission of periodic reports, including annual reports and deviation reports, are required following FDA approval of a BLA. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in significant regulatory actions.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in significant regulatory actions.
The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results.
The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products.
The designation includes all of the Fast Track program features, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of the product candidate, including involvement of senior managers. 24 Any marketing application for a drug submitted to the FDA for approval, including a product candidate with a Fast Track designation and/or Breakthrough Therapy designation, may be eligible for other types of FDA programs intended to expedite the development and review processes, such as priority review and accelerated approval.
Any marketing application for a drug submitted to the FDA for approval, including a product candidate with a Fast Track designation and/or Breakthrough Therapy designation, may be eligible for other types of FDA programs intended to expedite the development and review processes, such as priority review and accelerated approval.
Our Phase 3 OnPrime registration trial of Olvi-Vec in platinum resistant/refractory ovarian cancer (PRROC) initiated enrollment in the third quarter of 2022 and our Phase 2 VIRO-25 trial, an open-label, randomized and controlled clinical trial of Olvi-Vec in patients with recurrent non-small cell lung cancer (NSCLC), initiated enrollment in the United States in the fourth quarter of 2024. ● 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 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 .
Individual patents extend for varying periods of time depending on the date of filing of the patent application, the priority date claimed, and the legal term of patents as determined by the applicable law in the countries in which those patents are obtained.
A non-provisional patent application is examined by the USPTO and can mature into a patent once the USPTO determines that the claimed invention meets the standards of patentability. 11 Individual patents extend for varying periods of time depending on the date of filing of the patent application, the priority date claimed, and the legal term of patents as determined by the applicable law in the countries in which those patents are obtained.
If and when our product candidates receive marketing approval, we intend to commercialize them on our own, or jointly with a partner, in the United States and potentially with pharmaceutical or biotechnology partners in other geographies. We currently have no sales, marketing or commercialization capabilities and have no experience as a company performing such activities.
Sales and Marketing None of our product candidates has been approved for sale. If and when our product candidates receive marketing approval, we intend to commercialize them on our own, or jointly with a partner, in the United States and potentially with pharmaceutical or biotechnology partners in other geographies.
Each of these trials is designed to enroll and re-challenge patients who have failed prior platinum therapy (and, in the case of the NSCLC re-challenge patients who also failed a prior immune checkpoint inhibitor). 8 Non-Small Cell Lung Cancer In the fourth quarter of 2024, we initiated enrollment in the United States in our Phase 2 VIRO-25 trial in the United States, open-label, randomized, and controlled clinical trial of Olvi-Vec in patients with recurrent NSCLC (after progression on a front-line maintenance Immune Checkpoint Inhibitor-based regimen).
Non-Small Cell Lung Cancer In 2024, we initiated enrollment in the dose escalation portion of our Phase 2 VIRO-25 trial in the United States, prior to selecting a dose to potentially move into an open-label, randomized, and controlled clinical trial of Olvi-Vec in patients with recurrent NSCLC (after progression on a front-line maintenance Immune Checkpoint Inhibitor-based regimen).
Manufacturers or distributors of investigational products for the diagnosis, monitoring, or treatment of one or more serious or life-threatening diseases or conditions where no other comparable or satisfactory therapeutic options exist must also have a publicly available policy on evaluating and responding to requests for expanded access, sometimes called “compassionate use,” requests.
Manufacturers or distributors of investigational products for the diagnosis, monitoring, or treatment of one or more serious or life-threatening diseases or conditions where no other comparable or satisfactory therapeutic options exist must also have a publicly available policy on evaluating and responding to requests for expanded access, sometimes called “compassionate use,” requests. 16 Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor that regularly reviews accumulated data and advises the study sponsor regarding the continuing safety of the trial.
Compliance with these and any other applicable data privacy and security obligations is a rigorous and time-intensive process, and we may be required to put in place additional mechanisms to ensure compliance. 32 See the section titled “Risk Factors – Risk Related to Government Regulation – 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, policies and other obligations related to data privacy and security.
See the section titled “Risk Factors – Risk Related to Government Regulation – 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, policies and other obligations related to data privacy and security.
Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. 25 Post-Approval Requirements After approval, there also are continuing annual program user fee requirements for approved products, excluding, under certain circumstances, orphan products.
Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.
A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider the application. If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the BLA, the FDA will issue an approval letter.
A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider the application.
In our clinical trials, irrespective of the route of administration, dosing regimen or cancer type, Olvi-Vec was: ● Observed to be well tolerated, and whether administered in a single dose or multiple doses per cycle, no 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.
In our completed clinical trials, irrespective of the route of administration, dosing regimen or cancer type, Olvi-Vec was: ● 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. 4 In addition, in clinical trials in which Olvi-Vec was systemically administered, Olvi-Vec was: ● 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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeFood and Drug Administration (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; 37 ● 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, tariffs, increased geopolitical tensions between the United States and China, the Russia/Ukraine conflict, the conflicts in the Middle East and global pandemics on U.S. and global economic conditions.
Biggest changeOur future capital requirements depend on many factors, including: ● the scope, progress, results and costs of researching and developing Olvi-Vec and our other product candidates and programs, and of conducting preclinical studies and clinical trials; ● 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; 28 ● 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.
Item 1A. Risk Factors Risk Factors Investing in our common stock involves a high degree of risk.
Item 1A. RISK FACTORS Investing in our common stock involves a high degree of risk.
If we elect to fund and undertake development or commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms, or at all.
If we elect to fund and undertake development or commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms, or at all.
If we, or our collaboration partners, are successful in obtaining marketing approval from applicable regulatory authorities for Olvi-Vec or any other product candidate, our ability to generate revenues from any such products will depend on our success in: ● launching commercial sales of such products, whether alone or in collaboration with others; ● receiving approved labels with claims that are necessary or desirable for successful marketing, and that do not contain safety or other limitations that would impede our ability to market such products; ● creating market demand for such products through marketing, sales and promotion activities; ● hiring, training, and deploying a sales force or contracting with third parties to commercialize such products in the United States; ● creating partnerships with, or offering licenses to, third parties to promote and sell such products in foreign markets where we receive marketing approval; ● manufacturing such products in sufficient quantities and at acceptable quality and cost to meet commercial demand at launch and thereafter; ● establishing and maintaining agreements with wholesalers, distributors, and group purchasing organizations on commercially reasonable terms; 75 ● maintaining patent and trade secret protection and regulatory exclusivity for such products; ● achieving market acceptance of such products by patients, the medical community, and third-party payors; ● achieving coverage and adequate reimbursement from third-party payors for such products; ● achieving patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement from third-party payors; ● competing effectively with other therapies; and ● maintaining a continued acceptable safety profile of such products following launch.
If we, or our collaboration partners, are successful in obtaining marketing approval from applicable regulatory authorities for Olvi-Vec or any other product candidate, our ability to generate revenues from any such products will depend on our success in: ● launching commercial sales of such products, whether alone or in collaboration with others; ● receiving approved labels with claims that are necessary or desirable for successful marketing, and that do not contain safety or other limitations that would impede our ability to market such products; ● creating market demand for such products through marketing, sales and promotion activities; ● hiring, training, and deploying a sales force or contracting with third parties to commercialize such products in the United States; ● creating partnerships with, or offering licenses to, third parties to promote and sell such products in foreign markets where we receive marketing approval; ● manufacturing such products in sufficient quantities and at acceptable quality and cost to meet commercial demand at launch and thereafter; ● establishing and maintaining agreements with wholesalers, distributors, and group purchasing organizations on commercially reasonable terms; ● maintaining patent and trade secret protection and regulatory exclusivity for such products; ● achieving market acceptance of such products by patients, the medical community, and third-party payors; ● achieving coverage and adequate reimbursement from third-party payors for such products; ● achieving patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement from third-party payors; ● competing effectively with other therapies; and ● maintaining a continued acceptable safety profile of such products following launch.
Our ability to generate revenue and achieve profitability depends heavily on our success in achieving a number of goals, including: ● completing research regarding, and preclinical and clinical development of, product candidates and programs, including Olvi-Vec, and identifying and developing new product candidates; 38 ● 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.
Our ability to generate revenue and achieve profitability depends heavily on our success in achieving a number of goals, including: ● completing research regarding, and preclinical and clinical development of, product candidates and programs, including Olvi-Vec, and identifying and developing new product candidates; ● 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.
In addition, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw approvals of such product; ● regulatory authorities may require additional warnings on the label; ● we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; ● we may be forced to suspend marketing of that product, or decide to remove the product from the marketplace; ● we may be required to change the way the product is administered; ● we could be subject to fines, injunctions, or the imposition of criminal or civil penalties; ● we could be sued and held liable for harm caused to patients; and ● the product may become less competitive, and our reputation may suffer.
In addition, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw approvals of such product; ● regulatory authorities may require additional warnings on the label; ● we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; ● we may be forced to suspend marketing of that product, or decide to remove the product from the marketplace; 41 ● we may be required to change the way the product is administered; ● we could be subject to fines, injunctions, or the imposition of criminal or civil penalties; ● we could be sued and held liable for harm caused to patients; and ● the product may become less competitive, and our reputation may suffer.
The commencement and rate of completion of preclinical studies and clinical trials for a product candidate may be delayed by many factors, including, for example: ● 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 obtaining regulatory approval for, and production or manufacturing of, clinical supply; ● 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.
The commencement and rate of completion of preclinical studies and clinical trials for a product candidate may be delayed by many factors, including, for example: ● 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; 34 ● delays in obtaining regulatory approval for, and production or manufacturing of, clinical supply; ● 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.
Even if our product candidates are approved, they may: ● be subject to limitations on the indicated uses or patient populations for which they may be marketed, distribution restrictions, or other conditions of approval; ● contain significant safety warnings, including boxed warnings; 57 ● contain significant contraindications, and precautions which could reduce the size of the patient population; ● not be approved with label statements necessary or desirable for successful commercialization; ● contain requirements for costly post-market testing and surveillance, or other requirements, including the submission of a REMS to monitor the safety or efficacy of the products; or ● be withdrawn from the market because a serious safety issue becomes known after approval is granted.
Even if our product candidates are approved, they may: ● be subject to limitations on the indicated uses or patient populations for which they may be marketed, distribution restrictions, or other conditions of approval; ● contain significant safety warnings, including boxed warnings; ● contain significant contraindications, and precautions which could reduce the size of the patient population; ● not be approved with label statements necessary or desirable for successful commercialization; ● contain requirements for costly post-market testing and surveillance, or other requirements, including the submission of a REMS to monitor the safety or efficacy of the products; or ● be withdrawn from the market because a serious safety issue becomes known after approval is granted.
Regardless of merit or eventual outcome, liability claims may result in: ● loss of revenue from decreased demand for our products and/or product candidates; 111 ● impairment of our business reputation or financial stability; ● costs of related litigation; ● substantial monetary awards to patients or other claimants; ● diversion of management attention; ● withdrawal of clinical trial participants and potential termination of clinical trial sites or entire clinical programs; ● the inability to commercialize our product candidates; ● significant negative media attention; ● decreases in our stock price; ● initiation of investigations and enforcement actions by regulators; and ● product recalls, withdrawals or labeling, marketing or promotional restrictions, including withdrawal of marketing approval.
Regardless of merit or eventual outcome, liability claims may result in: ● loss of revenue from decreased demand for our products and/or product candidates; ● impairment of our business reputation or financial stability; ● costs of related litigation; ● substantial monetary awards to patients or other claimants; ● diversion of management attention; ● withdrawal of clinical trial participants and potential termination of clinical trial sites or entire clinical programs; ● the inability to commercialize our product candidates; ● significant negative media attention; ● decreases in our stock price; ● initiation of investigations and enforcement actions by regulators; and ● product recalls, withdrawals or labeling, marketing or promotional restrictions, including withdrawal of marketing approval.
Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including: ● the scope of rights granted under the license agreement and other interpretation-related issues; ● the extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; ● the sublicensing of patent and other rights under our collaborative development relationships; ● our diligence obligations under the license agreement and what activities satisfy those diligence obligations; ● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and ● the priority of invention of patented technology.
Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including: ● the scope of rights granted under the license agreement and other interpretation-related issues; ● the extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; ● the sublicensing of patent and other rights under our collaborative development relationships; 65 ● our diligence obligations under the license agreement and what activities satisfy those diligence obligations; ● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and ● the priority of invention of patented technology.
These factors include, without limitation: ● “short squeezes”; ● comments by securities analysts or other third parties, including blogs, articles, message boards and social and other media; 116 ● large stockholders exiting their position in our common stock or an increase or decrease in the short interest in our common stock; ● actual or anticipated fluctuations in our financial and operating results; ● negative public perception of us, our competitors, or the biopharmaceutical and biotechnology industries; and ● overall general market fluctuations.
These factors include, without limitation: ● “short squeezes”; ● comments by securities analysts or other third parties, including blogs, articles, message boards and social and other media; ● large stockholders exiting their position in our common stock or an increase or decrease in the short interest in our common stock; ● actual or anticipated fluctuations in our financial and operating results; ● negative public perception of us, our competitors, or the biopharmaceutical and biotechnology industries; and ● overall general market fluctuations.
The enrollment of patients depends on many factors, including: ● availability and efficacy of approved therapies for the disease under investigation; 48 ● 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.
The enrollment of patients depends on many factors, including: ● 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; 37 ● 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.
For example, physicians are often reluctant to switch their patients and patients may be reluctant to switch from existing therapies even when new and potentially more effective or safer treatments enter the market. Efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may not be successful.
For example, physicians are often reluctant to switch their patients and patients may be reluctant to switch from existing therapies even when new and potentially more effective or safer treatments enter the market. 61 Efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may not be successful.
If any of these events occur, our ability to successfully discover, develop and commercialize any product candidates may be impaired and the value of our company could decline significantly. 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.
If any of these events occur, our ability to successfully discover, develop and commercialize any product candidates may be impaired and the value of our company could decline significantly. 31 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.
Even if we succeed in developing our product candidates, our product candidates may not have a therapeutic effect in a broad patient population. 83 Future negative developments in the field of immuno-oncology or the biopharmaceutical industry could also result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of our products.
Even if we succeed in developing our product candidates, our product candidates may not have a therapeutic effect in a broad patient population. Future negative developments in the field of immuno-oncology or the biopharmaceutical industry could also result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of our products.
Adequate third-party coverage and reimbursement might not be available to enable us to maintain price levels sufficient to realize an appropriate return on investment in product development. 97 In addition, in the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor.
Adequate third-party coverage and reimbursement might not be available to enable us to maintain price levels sufficient to realize an appropriate return on investment in product development. In addition, in the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor.
For example, the CCPA applies to the personal data of consumers, business representatives and employees who are California residents, and requires covered businesses to provide specific disclosures in privacy notices and honor requests of such individuals to exercise certain privacy rights. The CCPA provides for and allows private litigants affected by certain data breaches to recover significant statutory damages.
For example, the CCPA applies to the personal data of consumers, business representatives and employees who are California residents, and requires covered businesses to provide specific disclosures in privacy notices and honor requests of such individuals to exercise certain privacy rights. The CCPA provides for fines and allows private litigants affected by certain data breaches to recover significant statutory damages.
Our current collaborations with TVAX and Newsoara, and potential future collaborations we might enter into for Olvi-Vec or our other product candidates, may pose a number of risks, including the following: ● collaborators may not perform their obligations as expected; ● collaborators may not pursue development and commercialization of product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities; 72 ● collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; ● collaborators could fail to make timely regulatory submissions for a product candidate; ● collaborators may not comply with all applicable regulatory requirements or may fail to report safety data in accordance with all applicable regulatory requirements, which could subject them or us to regulatory enforcement actions; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; ● product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates; ● a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product candidate or product; ● disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time consuming and expensive; ● collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; and ● collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability.
Our current collaboration with Newsoara, and potential future collaborations we might enter into for Olvi-Vec or our other product candidates, may pose a number of risks, including the following: ● collaborators may not perform their obligations as expected; ● collaborators may not pursue development and commercialization of product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities; ● collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; ● collaborators could fail to make timely regulatory submissions for a product candidate; ● collaborators may not comply with all applicable regulatory requirements or may fail to report safety data in accordance with all applicable regulatory requirements, which could subject them or us to regulatory enforcement actions; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; ● product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the development or commercialization of our product candidates; ● a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product candidate or product; ● disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time consuming and expensive; ● collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; and ● collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability.
Any of the foregoing may have a material adverse effect our business, financial condition, results of operations, stock price and prospects. We may be subject to claims by third parties asserting that we, our employees or any future collaborators have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
Any of the foregoing may have a material adverse effect our business, financial condition, results of operations, stock price and prospects. 69 We may be subject to claims by third parties asserting that we, our employees or any future collaborators have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
The failure to receive all or some of the committed proceeds would exhaust our available capital resources sooner than expected and will require us to obtain further funding to achieve our business objectives. We have never generated any revenue from commercially approved product sales and may never become profitable.
The failure to receive all or some of the committed proceeds would exhaust our available capital resources sooner than expected and will require us to obtain further funding to achieve our business objectives. 29 We have never generated any revenue from commercially approved product sales and may never become profitable.
Conducting clinical trials outside the United States exposes us to additional risks, including risks associated with: ● additional foreign regulatory requirements; ● compliance with foreign manufacturing, customs, shipment and storage requirements; ● cultural differences in medical practice and clinical research; and ● diminished protection of intellectual property in some countries. 59 Approval by the FDA or comparable foreign regulatory authorities to market a product candidate will be limited to those specific indications and conditions for which approval has been granted, and we may be subject to substantial fines, criminal penalties, injunctions, or other enforcement actions if we are determined to be promoting the use of any products for unapproved or “off-label” uses, resulting in damage to our reputation and business.
Conducting clinical trials outside the United States exposes us to additional risks, including risks associated with: ● additional foreign regulatory requirements; ● compliance with foreign manufacturing, customs, shipment and storage requirements; ● cultural differences in medical practice and clinical research; and ● diminished protection of intellectual property in some countries. 45 Approval by the FDA or comparable foreign regulatory authorities to market a product candidate will be limited to those specific indications and conditions for which approval has been granted, and we may be subject to substantial fines, criminal penalties, injunctions, or other enforcement actions if we are determined to be promoting the use of any products for unapproved or “off-label” uses, resulting in damage to our reputation and business.
This could delay completion of clinical trials, require the conduct of bridging clinical trials or studies, require the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and/or jeopardize our ability to commence product sales and generate revenue. We may rely on CMOs to conduct large-scale manufacture of Olvi-Vec in the future.
This could delay completion of clinical trials, require the conduct of bridging clinical trials or studies, require the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and/or jeopardize our ability to commence product sales and generate revenue. 50 We may rely on CMOs to conduct large-scale manufacture of Olvi-Vec in the future.
Therefore, even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future. 96 There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved therapeutics. Marketing approvals, pricing, and reimbursement for new therapeutic products vary widely from country to country.
Therefore, even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future. There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved therapeutics. Marketing approvals, pricing, and reimbursement for new therapeutic products vary widely from country to country.
Any requests from the FDA or comparable foreign regulatory authority for additional data or information could also result in substantial delays in the approval of our product candidates. 53 Drug-related side effects could also affect subject recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims.
Any requests from the FDA or comparable foreign regulatory authority for additional data or information could also result in substantial delays in the approval of our product candidates. Drug-related side effects could also affect subject recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims.
This could cause our clinical trials to be delayed and limit the commercial opportunities for our product candidates, in which case our business, financial condition, results of operations, stock price and prospects may be materially harmed. We may not be successful in our efforts to expand our pipeline of product candidates and develop marketable products.
This could cause our clinical trials to be delayed and limit the commercial opportunities for our product candidates, in which case our business, financial condition, results of operations, stock price and prospects may be materially harmed. 42 We may not be successful in our efforts to expand our pipeline of product candidates and develop marketable products.
In such a case, we could be required to obtain a license from the other company or institution to use the required or desired package labeling, which may not be available on commercially reasonable terms, or at all. 87 We may not be able to protect our intellectual property and proprietary rights throughout the world.
In such a case, we could be required to obtain a license from the other company or institution to use the required or desired package labeling, which may not be available on commercially reasonable terms, or at all. We may not be able to protect our intellectual property and proprietary rights throughout the world.
However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations, stock price and prospects. The U.S.
However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations, stock price and prospects. 68 The U.S.
For example, we expect that we will need to implement new systems to enhance and streamline the management of our financial, accounting, human resources and other functions. However, such systems will likely require us to complete many processes and procedures for the effective use of the systems, which may result in substantial costs.
For example, we expect that we will need to implement new systems to enhance and streamline the management of our financial, accounting, human resources and other functions. 95 However, such systems will likely require us to complete many processes and procedures for the effective use of the systems, which may result in substantial costs.
For example, the ACA was passed in March 2010 and substantially changed the way healthcare is financed by both governmental and private insurers and continues to significantly impact the U.S. pharmaceutical industry. There have been executive, judicial and congressional challenges and amendments to certain aspects of the ACA.
For example, the ACA was passed in March 2010 and substantially changed the way healthcare is financed by both governmental and private insurers and continues to significantly impact the U.S. pharmaceutical industry. 75 There have been executive, judicial and congressional challenges and amendments to certain aspects of the ACA.
If the safety of any quantities supplied is compromised due to our failure or our raw material and component suppliers’ failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. 67 Any problems or delays we experience in commercial-scale manufacturing of a product candidate or component may result in a delay in product development timelines and FDA or comparable foreign regulatory authority approval of the product candidate or may impair our ability to manufacture commercial quantities or such quantities at an acceptable cost and quality, which could result in the delay, prevention, or impairment of clinical development and commercialization of any product candidates and may materially harm our business, financial condition, results of operations, stock price and prospects.
If the safety of any quantities supplied is compromised due to our failure or our raw material and component suppliers’ failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. 51 Any problems or delays we experience in commercial-scale manufacturing of a product candidate or component may result in a delay in product development timelines and FDA or comparable foreign regulatory authority approval of the product candidate or may impair our ability to manufacture commercial quantities or such quantities at an acceptable cost and quality, which could result in the delay, prevention, or impairment of clinical development and commercialization of any product candidates and may materially harm our business, financial condition, results of operations, stock price and prospects.
We are currently conducting our Phase 2 clinical trial for Olvi-Vec in recurrent NSCLC in the United States and plan to conduct this trial in China as part of a multi-regional clinical trial with our collaboration partner, Newsoara, pending approval to proceed. We may conduct additional clinical trials in China.
We are currently conducting our Phase 2 clinical trial for Olvi-Vec in recurrent NSCLC in the United States and may conduct this trial in China as part of a multi-regional clinical trial with our collaboration partner, Newsoara, pending approval to proceed. We may conduct additional clinical trials in China.
Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business. 107 Public health crises such as pandemics could materially and adversely affect our preclinical studies and clinical trials, business, financial condition and results of operations.
Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business. Public health crises such as pandemics could materially and adversely affect our preclinical studies and clinical trials, business, financial condition and results of operations.
The total net proceeds from the offering were approximately $27.7 million, after deducting underwriting discounts, commissions and offering expenses payable by us. In February 2024, we entered into a Sales Agreement with Guggenheim Securities, LLC (Guggenheim) implementing an “at-the-market” offering program (the ATM).
The total net proceeds from the offering were $27.7 million, after deducting underwriting discounts, commissions and offering expenses payable by us. In February 2024, we entered into a sales agreement with Guggenheim Securities, LLC (Guggenheim) (the 2024 Sales Agreement) implementing an “at-the-market” offering program (the ATM).
Enrollment delays in our clinical trials may result in increased development costs for our product candidates, which could have an adverse effect on our business, financial condition, results of operations, and prospects. 49 Results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials.
Enrollment delays in our clinical trials may result in increased development costs for our product candidates, which could have an adverse effect on our business, financial condition, results of operations, and prospects. Results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials.
The ability to obtain cooperation from the third party may impact our ability to respond to the FDA’s requests which could impact our ability to achieve regulatory approval. Moreover, developments related to the other product or device may impact our clinical trials as well as our commercial prospects should we receive marketing approval.
The inability to obtain cooperation from the third party may impact our ability to respond to the FDA’s requests which could impact our ability to achieve regulatory approval. Moreover, developments related to the other product or device may impact our clinical trials as well as our commercial prospects should we receive marketing approval.
If one or more of these analysts cease to cover our stock, we could lose visibility in the market for our stock, which, in turn, could cause our stock price to decline. Our failure to meet Nasdaq’s continued listing requirements could result in a delisting of our common stock.
If one or more of these analysts cease to cover our stock, we could lose visibility in the market for our stock, which, in turn, could cause our stock price to decline. 96 Our failure to meet Nasdaq’s continued listing requirements could result in a delisting of our common stock.
Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected. Risks Related to Our Common Stock An active, liquid and orderly trading market for our common stock may not be sustained.
Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected. 87 Risks Related to Our Common Stock An active, liquid and orderly trading market for our common stock may not be sustained.
A successful product liability claim or series of claims brought against us could cause our stock price to fall and, if judgments exceed our insurance coverage, could decrease our cash, and materially harm our business, financial condition, results of operations, stock price and prospects. 112 Our employees, independent contractors, consultants, commercial partners, principal investigators, CMOs, or CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could have a material adverse effect on our business.
A successful product liability claim or series of claims brought against us could cause our stock price to fall and, if judgments exceed our insurance coverage, could decrease our cash, and materially harm our business, financial condition, results of operations, stock price and prospects. 85 Our employees, independent contractors, consultants, commercial partners, principal investigators, CMOs, or CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could have a material adverse effect on our business.
Future developments in these and other areas present material uncertainty and risk with respect to our clinical trials, business, financial condition and results of operations. 108 If our information technology systems or those third parties with whom we work or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
Future developments in these and other areas present material uncertainty and risk with respect to our clinical trials, business, financial condition and results of operations. 82 If our information technology systems or those third parties with whom we work or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
The success of our current and future product candidates will depend on several factors, including the following: ● 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 INDs 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; 42 ● 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.
The success of our current and future product candidates will depend on several factors, including the following: ● 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; 32 ● 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.
The most common treatment-related toxicities generally observed in our trials from different routes of administration were pyrexia, nausea, chills and fatigue with additional common treatment-related toxicities observed in our intraperitoneal administration trials being abdominal pain and abdominal distension.
The most common treatment-related toxicities generally observed in our trials from different routes of administration were pyrexia, nausea, vomiting, chills and fatigue with additional common treatment-related toxicities observed in our intraperitoneal administration trials being abdominal pain and abdominal distension.
There are a number of large biopharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of solid tumors, including viral immunotherapy and cancer vaccine approaches.
There are a number of large biopharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of tumors, including viral immunotherapy and cancer vaccine approaches.
If we face such litigation, it could result in substantial costs and a diversion of management’s attention and our resources, which could harm our business. 125 Item 1B. Unresolved Staff Comments. None.
If we face such litigation, it could result in substantial costs and a diversion of management’s attention and our resources, which could harm our business. Item 1B. Unresolved Staff Comments None.
We also could incur significant costs associated with civil or criminal fines and penalties, as well as our curtailment of the use of these materials or even shutting down our facilities and operations. 104 Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.
We also could incur significant costs associated with civil or criminal fines and penalties, as well as our curtailment of the use of these materials or even shutting down our facilities and operations. 79 Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.
Remote work has increased risks to our information technology systems and data, as our employees utilize network connections, computers, and devices outside our premises or network, including working at home, while in transit and in public locations. 109 Future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies.
Remote work has increased risks to our information technology systems and data, as our employees utilize network connections, computers, and devices outside our premises or network, including working at home, while in transit and in public locations. 83 Future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies.
Many product candidates that have received fast track designation have ultimately failed to obtain approval. 51 We may attempt to secure approval from the FDA through the use of the accelerated approval pathway.
Many product candidates that have received fast track designation have ultimately failed to obtain approval. We may attempt to secure approval from the FDA through the use of the accelerated approval pathway.
These False Claims Act (the “FCA”) lawsuits against manufacturers of drugs and biological products have increased significantly in volume and breadth, leading to several substantial civil and criminal settlements, up to $3.0 billion, pertaining to certain sales practices and promoting off-label uses. In addition, FCA lawsuits may expose manufacturers to follow-on claims by private payors based on fraudulent marketing practices.
These False Claims Act (FCA) lawsuits against manufacturers of drugs and biological products have increased significantly in volume and breadth, leading to several substantial civil and criminal settlements, up to $3.0 billion, pertaining to certain sales practices and promoting off-label uses. In addition, FCA lawsuits may expose manufacturers to follow-on claims by private payors based on fraudulent marketing practices.
If we become subject to regulatory and enforcement actions, our business, financial condition, results of operations, stock price and prospects will be materially harmed. 60 Engaging in the impermissible promotion of our products, in the United States, following approval, for off-label uses can also subject us to false claims and other litigation under federal and state statutes.
If we become subject to regulatory and enforcement actions, our business, financial condition, results of operations, stock price and prospects will be materially harmed. 46 Engaging in the impermissible promotion of our products, in the United States, following approval, for off-label uses can also subject us to false claims and other litigation under federal and state statutes.
Manufacturers of therapeutics often encounter difficulties in production, particularly in scaling up initial production, with such risks including: ● quality control, including stability of the product candidate and quality assurance testing; ● shortages of qualified personnel or key raw materials or components; 64 ● product loss during the manufacturing process, including loss caused by contamination, equipment failure or improper installation or operation of equipment, or operator error.
Manufacturers of therapeutics often encounter difficulties in production, particularly in scaling up initial production, with such risks including: ● quality control, including stability of the product candidate and quality assurance testing; ● shortages of qualified personnel or key raw materials or components; 49 ● product loss during the manufacturing process, including loss caused by contamination, equipment failure or improper installation or operation of equipment, or operator error.
If we are unable to obtain and maintain patent protection for our technology or for Olvi-Vec, V2ACT Immunotherapy or our other product candidates, or if the scope of the patent protection obtained is not sufficient, our competitors could develop and commercialize products similar or superior to ours in a non-infringing manner, and our ability to successfully commercialize Olvi-Vec, V2ACT Immunotherapy or our other product candidates and future technologies may be adversely affected.
If we are unable to obtain and maintain patent protection for our technology or for Olvi-Vec or our other product candidates, or if the scope of the patent protection obtained is not sufficient, our competitors could develop and commercialize products similar or superior to ours in a non-infringing manner, and our ability to successfully commercialize Olvi-Vec or our other product candidates and future technologies may be adversely affected.
In addition, shares of common stock that are either subject to outstanding options or reserved for future issuance under our employee benefit plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules and Rule 144 and Rule 701 under the Securities Act of 1933, as amended (the “Securities Act”).
In addition, shares of common stock that are either subject to outstanding options or reserved for future issuance under our employee benefit plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules and Rule 144 and Rule 701 under the Securities Act of 1933, as amended (the Securities Act).
In this case, we could ultimately be forced to cease use of such trademarks. 94 Risks Related to Government Regulation 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.
In this case, we could ultimately be forced to cease use of such trademarks. 72 Risks Related to Government Regulation 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.
If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline. 119 Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline. 91 Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
Commencing with our fiscal year ending December 31, 2024, we must perform system and process evaluation and testing of our internal controls over financial reporting to allow management to report on the effectiveness of our internal controls over financial reporting in our Annual Report on Form 10-K filing for that year, as required by Section 404 of the Sarbanes-Oxley Act.
Commencing with our fiscal year ending December 31, 2025, we must perform system and process evaluation and testing of our internal controls over financial reporting to allow management to report on the effectiveness of our internal controls over financial reporting in our Annual Report on Form 10-K filing for that year, as required by Section 404 of the Sarbanes-Oxley Act.
Changes in corporate tax rates, the realization of net deferred tax assets relating to our operations, the taxation of foreign earnings, and the deductibility of expenses under the Tax Act or future reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges, and could increase our future U.S. tax expense.
Changes in corporate tax rates, the realization of net deferred tax assets relating to our operations, the taxation of foreign earnings, and the deductibility of expenses under the Tax Cuts and Jobs Act or future reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges, and could increase our future U.S. tax expense.
We may be required to obtain additional funds to complete clinical trials and prepare for possible commercialization of our product candidates. We do not know whether any preclinical studies or clinical trials beyond what we currently have planned will be required, will begin as planned, will need to be restructured, or will be completed on schedule or at all.
We may be required to obtain additional funds to complete clinical trials and prepare for possible commercialization of our product candidates. We do not know whether any preclinical studies or clinical trials beyond what we currently have planned will be required, will begin as planned, will need to be redesigned, or will be completed on schedule or at all.
Although we intend to timely file non-provisional patent applications relating to our provisional patent applications, we cannot predict whether any of our future patent applications will result in the issuance of patents that effectively protect our technology or Olvi-Vec, V2ACT Immunotherapy or our other product candidates, or if any of our future issued patents will effectively prevent others from commercializing competitive products.
Although we intend to timely file non-provisional patent applications relating to our provisional patent applications, we cannot predict whether any of our future patent applications will result in the issuance of patents that effectively protect our technology or Olvi-Vec or our other product candidates, or if any of our future issued patents will effectively prevent others from commercializing competitive products.
Such mechanisms include re-examination, inter partes review, post-grant review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions, such as opposition proceedings. Such proceedings could result in revocation, cancellation or amendment to our patents in such a way that they no longer cover and protect Olvi-Vec, V2ACT Immunotherapy and our other product candidates.
Such mechanisms include re-examination, inter partes review, post-grant review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions, such as opposition proceedings. Such proceedings could result in revocation, cancellation or amendment to our patents in such a way that they no longer cover and protect Olvi-Vec and our other product candidates.
Additionally, the number of shares of our common stock reserved for issuance under our 2022 Plan will automatically increase on January 1 of each year, beginning on January 1, 2024 and continuing through and including January 1, 2032, by 5% of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by our board of directors.
Additionally, the number of shares of our common stock reserved for issuance under our 2022 Plan will automatically increase on January 1 of each year, and continuing through and including January 1, 2032, by 5% of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by our board of directors.
Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”) was enacted. There are significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional rules and regulations in these areas such as “say on pay” and proxy access.
Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act (the Dodd-Frank Act) was enacted. There are significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional rules and regulations in these areas such as “say on pay” and proxy access.
If we are not able to generate revenue from the sale of any approved products, we could be prevented from or significantly delayed in achieving profitability. 39 Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
If we are not able to generate revenue from the sale of any approved products, we could be prevented from or significantly delayed in achieving profitability. 30 Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
Some of these events could be the basis for FDA or other regulatory authority action, including injunction, recall, seizure or total or partial suspension of product manufacture. 68 We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials.
Some of these events could be the basis for FDA or other regulatory authority action, including injunction, recall, seizure or total or partial suspension of product manufacture. 52 We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials.
Federal Food, Drug and Cosmetic Act, 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 the Centers for Medicare & Medicaid Services (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 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; state laws that require the reporting of information related to drug pricing; and state and local laws requiring the registration of pharmaceutical sales representatives. 95 If we or our operations are found to be in violation of any federal or state healthcare law, or any other governmental laws or regulations that apply to us, we may be subject to penalties, including significant civil, criminal, and administrative penalties, damages, monetary fines, disgorgement, imprisonment, suspension and debarment from government contracts, and refusal of orders under existing government contracts, exclusion from participation in U.S. federal or state health care programs, additional reporting requirements and/or oversight if we become subject to corporate integrity agreements or similar agreement to resolve allegations of non-compliance, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could materially adversely affect our ability to operate our business and our financial results.
Federal Food, Drug and Cosmetic Act, 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 the Centers for Medicare & Medicaid Services (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 our 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. 73 If we or our operations are found to be in violation of any federal or state healthcare law, or any other governmental laws or regulations that apply to us, we may be subject to penalties, including significant civil, criminal, and administrative penalties, damages, monetary fines, disgorgement, imprisonment, suspension and debarment from government contracts, and refusal of orders under existing government contracts, exclusion from participation in U.S. federal or state health care programs, additional reporting requirements and/or oversight if we become subject to corporate integrity agreements or similar agreement to resolve allegations of non-compliance, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could materially adversely affect our ability to operate our business and our financial results.
We can provide no assurance that we would be successful at developing other product candidates based on an alternative therapeutic approach. 43 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.
We can provide no assurance that we would be successful at developing other product candidates based on an alternative therapeutic approach. 33 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.
Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect Olvi-Vec, V2ACT Immunotherapy and our other product candidates. As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.
Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect Olvi-Vec and our other product candidates. As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.
Patent reform legislation in the United States and other countries, including the Leahy-Smith America Invents Act (the “Leahy-Smith Act”) signed into law in the United States on September 16, 2011, could increase those uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
Patent reform legislation in the United States and other countries, including the Leahy-Smith America Invents Act (the Leahy-Smith Act) signed into law in the United States on September 16, 2011, could increase those uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
The report of our independent registered public accounting firm on our financial statements as of and for the years ended December 31, 2024 and 2023 included an explanatory paragraph indicating that there was substantial doubt about our ability to continue as a going concern.
The report of our independent registered public accounting firm on our financial statements as of and for the years ended December 31, 2025 and 2024 included an explanatory paragraph indicating that there was substantial doubt about our ability to continue as a going concern.
For example, the daily closing market price for our common stock has varied significantly since the commencement of trading of our common stock on Nasdaq on January 26, 2023, ranging between a high price of $40.98 on June 22, 2023, and a low price of $1.60 on August 5, 2024.
For example, the daily closing market price for our common stock has varied significantly since the commencement of trading of our common stock on Nasdaq on January 26, 2023, ranging between a high price of $40.98 on June 20, 2023, and a low price of $1.60 on August 5, 2024.
We also may experience numerous unforeseen events during, or as a result of, any ongoing or future clinical trials that we could conduct that could delay or prevent our ability to receive marketing approval or commercialize Olvi-Vec or any future product candidates, including: ● 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 institutional review boards (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; 45 ● 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; 46 ● 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.
We also may experience numerous unforeseen events during, or as a result of, any ongoing or future clinical trials that we could conduct that could delay or prevent our ability to receive marketing approval or commercialize Olvi-Vec or any future product candidates, including: ● 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; 35 ● 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. 36 For example, we previously modified our manufacturing process and had to demonstrate analytical comparability to the FDA in order to use Olvi-Vec manufactured by this process in our ongoing Phase 3 PRROC trial.
Our commercial success will depend in part on our ability to obtain and maintain patent and other intellectual property protection in the United States and other countries with respect to our technology, including our oncolytic VACV platform, and Olvi-Vec, V2ACT Immunotherapy and our other product candidates.
Our commercial success will depend in part on our ability to obtain and maintain patent and other intellectual property protection in the United States and other countries with respect to our technology, including our oncolytic VACV platform, and Olvi-Vec and our other product candidates.
In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with International Conference on Harmonization (ICH), and Good Clinical Practice (GCP) requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary.
In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with International Conference on Harmonization (ICH), and GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary.
In the ordinary course of our business, we and the third parties with whom we work process proprietary, confidential, and sensitive data, including personal data, de-identified health-related data, intellectual property, proprietary business information and trade secrets (collectively, “sensitive information”).
In the ordinary course of our business, we and the third parties with whom we work process proprietary, confidential, and sensitive data, including personal data, de-identified health-related data, intellectual property, proprietary business information and trade secrets (collectively, sensitive information).
We anticipate that our expenses will increase substantially if, and as, we: ● advance the Phase 3 registration clinical trial for our lead product candidate, Olvi-Vec, in platinum resistant/refractory ovarian cancer (“PRROC”); ● initiate planned and future clinical trials of Olvi-Vec in other cancer indications; 35 ● 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.
We anticipate that our expenses will increase substantially if, and as, we: ● 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.
In addition, pursuant to our Employee Stock Purchase Plan, the number of shares of our common stock reserved for issuance will automatically increase on January 1 of each calendar year, beginning on January 1, 2024 through January 1, 2032, by the lesser of (i) 1% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, and (ii) 2,100,000 shares of common stock; provided that before the date of any such increase, our board of directors may determine that such increase will be less than the amount set forth in clauses (i) and (ii).
In addition, pursuant to our Employee Stock Purchase Plan, the number of shares of our common stock reserved for issuance will automatically increase on January 1 of each calendar year, continuing through and including January 1, 2032, by the lesser of (i) 1% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, and (ii) 2,100,000 shares of common stock; provided that before the date of any such increase, our board of directors may determine that such increase will be less than the amount set forth in clauses (i) and (ii).
If serious adverse or unexpected side effects are identified during development and are determined to be attributed to our product candidates, or the result of drug-drug interactions between our product candidate and any of the concomitant therapies given to the trial subjects, we, the FDA or comparable foreign regulatory authorities, or IRBs and other reviewing entities, could interrupt, delay, or halt clinical trials and could result in a more restrictive label, a Risk Evaluation and Mitigation Strategy (REMS) or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities.
If serious adverse or unexpected side effects are identified during development and are determined to be attributed to our product candidates, or the result of drug-drug interactions between our product candidate and any of the concomitant therapies given to the trial subjects, we, the FDA or comparable foreign regulatory authorities, or IRBs and other reviewing entities, could interrupt, delay, or halt clinical trials and could result in a more restrictive label, a REMS or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities.
If any of the following risks are realized, our business, financial condition, results of operations, stock price and prospects could be materially and adversely affected. In that event, the price of our common stock could decline, and you could lose part or all of your investment. The risks and uncertainties described below are not the only ones we face.
If any of the following risks are realized, our business, financial condition, results of operations, stock price and prospects could be materially and adversely affected. In that event, the price of our common stock could decline, and you could lose part or all of your marketable securities. The risks and uncertainties described below are not the only ones we face.
Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ deficit and working capital. We expect that it will be several years, if ever, before we have a commercialized product. The net losses we incur may fluctuate significantly from quarter to quarter and year to year.
Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital. 27 We expect that it will be several years, if ever, before we have a commercialized product. The net losses we incur may fluctuate significantly from quarter to quarter and year to year.
We cannot be certain that we will be able to: ● complete IND-enabling preclinical studies or develop manufacturing processes and associated analytical methods that meet current good manufacturing practice (cGMP) requirements in time to initiate or to complete our anticipated or future clinical trials in the timeframes we announce; ● obtain sufficient clinical supply of our product candidates to support our anticipated or future clinical trials; 56 ● initiate clinical trials within the timeframes we announce; ● enroll and maintain a sufficient number of subjects to complete or timely complete any clinical trials; or ● collect and analyze the data from any completed clinical trials in the timeframes we announce.
We cannot be certain that we will be able to: ● complete IND-enabling preclinical studies or develop manufacturing processes and associated analytical methods that meet cGMP requirements in time to initiate or to complete our anticipated or future clinical trials in the timeframes we announce; ● obtain sufficient clinical supply of our product candidates to support our anticipated or future clinical trials; ● initiate clinical trials within the timeframes we announce; ● enroll and maintain a sufficient number of subjects to complete or timely complete any clinical trials; or ● collect and analyze the data from any completed clinical trials in the timeframes we announce.
The market price for our common stock may be influenced by many factors, including: ● results from, and any delays in, our clinical trials for Olvi-Vec, our preclinical studies and any other future clinical development programs; ● actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; 117 ● commencement or termination of collaboration, licensing or similar arrangements for our development programs; ● announcements by our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; ● failure or discontinuation of any of our development programs; ● our ability to commercialize Olvi-Vec and our other product candidates, if approved, inside and outside of the United States, either independently or working with third parties; ● our partners’ and collaborators’ ability to successfully commercialize their licensed product candidates; ● developments or setbacks related to drugs that are co-administered with any of our product candidates, such as cellular and targeted therapies; ● regulatory or legal developments in the United States and other countries; ● developments or disputes concerning patent applications, issued patents or other proprietary rights; ● the recruitment or departure of key personnel; ● the level of expenses related to the development of Olvi-Vec and any other product candidate we may develop; ● changes in the competitive landscape in our industry, including results of clinical trials of existing and potential future products that compete with Olvi-Vec and our other product candidates; ● our ability to adequately support future growth; ● variations in our financial results or those of companies that are perceived to be similar to us; ● future accounting pronouncements or changes in our accounting policies; ● announcements or expectations of additional financing efforts by us; ● sales of our common stock by us, our insiders or other stockholders; ● recommendations and changes in estimates or recommendations by securities analysts, if any, that cover our stock; ● changes in the structure of healthcare payment systems; ● market conditions in the pharmaceutical and biotechnology sectors; 118 ● general economic, political, and market conditions and overall fluctuations in the financial markets in the United States and abroad, including bank failures, tariffs, global pandemics, the Russia/Ukraine conflict or the conflicts in the Middle East; and ● investors’ general perception of us and our business.
The market price for our common stock may be influenced by many factors, including: ● results from, and any delays in, our clinical trials for Olvi-Vec, our preclinical studies and any other future clinical development programs; ● actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; ● commencement or termination of collaboration, licensing or similar arrangements for our development programs; ● announcements by our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; ● failure or discontinuation of any of our development programs; ● our ability to commercialize Olvi-Vec and our other product candidates, if approved, inside and outside of the United States, either independently or working with third parties; ● our partners’ and collaborators’ ability to successfully commercialize their licensed product candidates; ● developments or setbacks related to drugs that are co-administered with any of our product candidates, such as cellular and targeted therapies; ● regulatory or legal developments in the United States and other countries; ● developments or disputes concerning patent applications, issued patents or other proprietary rights; ● the recruitment or departure of key personnel; ● the level of expenses related to the development of Olvi-Vec and any other product candidate we may develop; ● changes in the competitive landscape in our industry, including results of clinical trials of existing and potential future products that compete with Olvi-Vec and our other product candidates; ● our ability to adequately support future growth; ● variations in our financial results or those of companies that are perceived to be similar to us; ● future accounting pronouncements or changes in our accounting policies; ● announcements or expectations of additional financing efforts by us; ● sales of our common stock by us, our insiders or other stockholders; 90 ● recommendations and changes in estimates or recommendations by securities analysts, if any, that cover our stock; ● changes in the structure of healthcare payment systems; ● market conditions in the pharmaceutical and biotechnology sectors; ● general economic, political, and market conditions and overall fluctuations in the financial markets in the United States and abroad, including bank failures, new or increased tariffs, global pandemics, changes in monetary and fiscal policy, geopolitical tensions between the U.S. and China, the Russia/Ukraine conflict or conflicts in the Middle East; and ● investors’ general perception of us and our business.
The degree of market acceptance of any product for which we receive marketing approval will depend on a number of factors, including: ● the efficacy of our product, including in combination with other cancer therapies; ● the commercial success of any cancer therapies with which our product may be co-administered; ● the prevalence and severity of adverse events associated with our product or those products with which it is co-administered; ● the clinical indications for which our product is approved and the approved claims that we may make with respect to the product; ● limitations or warnings contained in the FDA-approved labeling of the product or the labeling approved by comparable foreign regulatory authorities, including potential limitations or warnings for our product that may be more restrictive than other competitive products; ● changes in the standard of care for the targeted indications for our product, which could reduce the marketing impact of any claims that we could make following FDA approval or approval by comparable foreign regulatory authorities, if obtained; ● the relative convenience and ease of administration of our product and any products with which it is co-administered; ● the cost of treatment compared with the economic and clinical benefit of alternative treatments or therapies; 81 ● the availability of coverage and adequate reimbursement by third-party payors, such as private insurance companies and government healthcare programs, including Medicare and Medicaid; ● the ability to have our product placed on approved formularies; ● patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement from third-party payors; ● the price concessions required by third-party payors to obtain coverage and adequate reimbursement; ● the extent and strength of our marketing and distribution of our product; ● the safety, efficacy, and other potential advantages over, and availability of, alternative treatments already used or that may later be approved; ● distribution and use restrictions imposed by the FDA or comparable foreign regulatory authorities with respect to our product or to which we agree as part of a REMS or voluntary risk management plan; ● the timing of market introduction of our product, as well as competitive products; ● our ability to offer our product for sale at competitive prices; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● the extent and strength of our raw material supplier and service provider support; ● the actions of companies that market any products with which our product is co-administered; ● the approval of other new products; ● adverse publicity about our product or any products with which it is co-administered, or favorable publicity about competitive products; and ● potential product liability claims. 82 The size of the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates.
The degree of market acceptance of any product for which we receive marketing approval will depend on a number of factors, including: ● the efficacy of our product, including in combination with other cancer therapies; ● the commercial success of any cancer therapies with which our product may be co-administered; ● the prevalence and severity of adverse events associated with our product or those products with which it is co-administered; ● the clinical indications for which our product is approved and the approved claims that we may make with respect to the product; ● limitations or warnings contained in the FDA-approved labeling of the product or the labeling approved by comparable foreign regulatory authorities, including potential limitations or warnings for our product that may be more restrictive than other competitive products; ● changes in the standard of care for the targeted indications for our product, which could reduce the marketing impact of any claims that we could make following FDA approval or approval by comparable foreign regulatory authorities, if obtained; ● the relative convenience and ease of administration of our product and any products with which it is co-administered; ● the cost of treatment compared with the economic and clinical benefit of alternative treatments or therapies; ● the availability of coverage and adequate reimbursement by third-party payors, such as private insurance companies and government healthcare programs, including Medicare and Medicaid; ● the ability to have our product placed on approved formularies; ● patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement from third-party payors; ● the price concessions required by third-party payors to obtain coverage and adequate reimbursement; ● the extent and strength of our marketing and distribution of our product; ● the safety, efficacy, and other potential advantages over, and availability of, alternative treatments already used or that may later be approved; ● distribution and use restrictions imposed by the FDA or comparable foreign regulatory authorities with respect to our product or to which we agree as part of a REMS or voluntary risk management plan; ● the timing of market introduction of our product, as well as competitive products; ● our ability to offer our product for sale at competitive prices; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; 62 ● the extent and strength of our raw material supplier and service provider support; ● the actions of companies that market any products with which our product is co-administered; ● the approval of other new products; ● adverse publicity about our product or any products with which it is co-administered, or favorable publicity about competitive products; and ● potential product liability claims.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe also use third-party service providers to perform a variety of other functions throughout our business, such as application providers, hosting companies, contract research organizations, contract manufacturing organizations, and distributors. We have a vendor management program to manage cybersecurity risks associated with our use of these providers.
Biggest changeWe use third-party service providers to assist us from time to time to identify, assess, and manage material risks from cybersecurity threats, including, for example managed cybersecurity service providers and professional services firms (including legal counsel). 97 We also use third-party service providers to perform a variety of other functions throughout our business, such as application providers, hosting companies, contract research organizations, contract manufacturing organizations, and distributors.
Risk Factors in this Annual Report on Form 10-K, including “ If our information technology systems or those third parties with whom we work or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences .” Governance Our Board of Directors addresses the Company’s cybersecurity risk management as part of its general oversight function.
Risk Factors in this Annual Report on Form 10-K, including “ If our information technology systems or those third parties with whom we work or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences .” Governance Our Board of Directors addresses our risk management as part of its general oversight function.
Our Chief Executive Officer (CEO) is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into the Company’s overall risk management strategy, and communicating key priorities to relevant personnel. The Company’s Cybersecurity Risk Management Team is responsible for developing budgets, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.
Our Chief Executive Officer is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into our overall risk management strategy, and communicating key priorities to relevant personnel. Our Cybersecurity Risk Management Team is responsible for developing budgets, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.
Our cybersecurity incident response and vulnerability management processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including our Chief Financial Officer (CFO) and CEO. Our CFO and CEO work with the Company’s Incident Response Team to help the Company triage, contain, mitigate and remediate cybersecurity incidents of which they are notified.
Our cybersecurity incident response and vulnerability management processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including our General Counsel, and CEO. Our General Counsel and CEO work with the Company’s Incident Response Team to help the Company triage, contain, mitigate and remediate cybersecurity incidents of which they are notified.
This group works to identify and assess risks from cybersecurity threats by monitoring and evaluating our threat environment using various methods, including, for example: manual and automated tools, subscribing to reports and services that identify cybersecurity threats, analyzing reports of threats and actors, conducting scans of the threat environment, and conducting third-party threat assessments.
This group works to identify and assess risks from cybersecurity threats by monitoring and evaluating our threat environment using various methods, including, for example: manual and automated tools, subscribing to reports and services that identify cybersecurity threats, analyzing reports of threats and actors, evaluating threats reported to us, conducting vulnerability assessments, evaluating our and our industry’s risk profile, and conducting third-party threat assessments.
Depending on the environment, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example: a vulnerability management policy, disaster recovery and business continuity plans, network security controls and data segregation (for certain systems), employee training, and cybersecurity insurance.
Depending on the environment, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example: an incident response plan, a vulnerability management policy, disaster recovery and business continuity plans, risk assessments, implementation of security standards or certifications, encryption of certain data, network security controls and data segregation (for certain systems), physical security, asset management, tracking and disposal, systems monitoring, employee training, and cybersecurity insurance.
Cybersecurity risk is addressed as a component of the Company’s enterprise risk management program and identified in the Company’s risk register and senior management prioritizes our risk management processes and reports to the Audit Committee of the Board of Directors, which evaluates our overall enterprise risk.
Our assessment and management of material risks from cybersecurity threats are integrated into our overall risk management processes. Cybersecurity risk is addressed as a component of the our enterprise risk management program and senior management prioritizes our risk management processes and reports to the Audit Committee of the Board of Directors, which evaluates our overall enterprise risk.
The program includes a review of certain vendors’ written security program, a risk assessment for certain vendors, and imposition of information security contractual obligations on certain vendors. 126 For a description of the risks from cybersecurity threats that may materially affect the Company and how they may do so, see our risk factors under Part 1. Item 1A.
For a description of the risks from cybersecurity threats that may materially affect the Company and how they may do so, see our risk factors under Part 1. Item 1A.
The Audit Committee is responsible for overseeing the Company’s cybersecurity risk management processes, including oversight of mitigation of risks from cybersecurity threats.
The Audit Committee is responsible for overseeing our cybersecurity risk management processes, including oversight of mitigation of risks from cybersecurity threats. Our cybersecurity risk assessment and management processes are implemented and maintained by our Cybersecurity Risk Management Team, which includes our General Counsel and an external information technology vendor.
The Company engages two external cybersecurity and information technology consultants to work with the Company, including the general counsel, to help identify, assess and manage the Company’s cybersecurity threats and risks, including through the use of the Company’s information security risk register.
We engage an external information technology company to operate information technology systems for us. This vendor works with us, including our general counsel, to help identify, assess and manage our cybersecurity threats and risks.
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Our assessment and management of material risks from cybersecurity threats are integrated into the Company’s overall risk management processes.
Added
We have a vendor management program to manage cybersecurity risks associated with our use of these providers. The program may include, depending on the provider, a security questionnaire, security audit, a risk assessment for certain vendors, and imposition of information security contractual obligations on certain vendors.
Removed
We use third-party service providers to assist us from time to time to identify, assess, and manage material risks from cybersecurity threats, including, for example cybersecurity consultants and professional services firms (including legal counsel).
Removed
Our cybersecurity risk assessment and management processes are implemented and maintained by our Cybersecurity Risk Management Team, (which includes our General Counsel) an external cybersecurity consultant with over 15 years of experience providing cybersecurity services and training (who is also a member of the Company’s Cybersecurity Risk Management Team) and an external information technology consultant.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe believe that our existing and planned facilities will be adequate to meet our current needs and that our leases can be renewed, or suitable alternative spaces will be available in the future, on commercially reasonable terms.
Biggest changeApproximate Square Footage Primary Use Lease Expiration Remaining Lease Term (year) Westlake Village, California 4,050 Corporate Headquarters July 2027 1.6 San Diego, California 7,569 Manufacturing Facility October 2030 4.8 San Diego, California 6,755 Research and Development Laboratory October 2030 4.8 San Diego, California 3,928 Office Space January 2028 2.0 We believe that our existing and planned facilities will be adequate to meet our current needs and that our leases can be renewed, or suitable alternative spaces will be available in the future, on commercially reasonable terms.
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Item 2. Properties. Our current corporate headquarters are located in Westlake Village, California, consisting of 4,050 square feet of office space. The lease for this facility expires in July 2027.
Added
Item 2. PROPERTIES The following table summarizes the Company’s principal leased facilities as of December 31, 2025.
Removed
We also lease two facilities in San Diego, California, a 7,569 square-foot facility, which contains our manufacturing operations and our translational science laboratory and a 6,755 square foot facility which will provide laboratory capabilities and administrative offices when upgrades are completed.
Removed
The leases expire in October 2030, and we have the option to extend each lease for an additional five years. We have a business office located in Redlands, California, consisting of 1,884 square feet; the lease for this facility is on a month-to-month basis.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Removed
In the future, we may be involved in additional actual and/or threatened legal proceedings, claims, investigations and government inquiries arising in the ordinary course of our business, including legal proceedings, claims, investigations and government inquiries involving intellectual property, data privacy and security, other torts, illegal or objectionable content, consumer protection, securities, employment, contractual rights, civil rights infringement, false or misleading advertising, or other legal claims relating to our business.
Added
Item 3. LEGAL PROCEEDINGS Legal Proceedings are set forth in the Company’s financial statement schedules in Part IV, Item 15 of this Annual Report on Form 10-K and are incorporated herein by reference. See Note 13 — Commitments and Contingencies of Notes to Financial Statements of Part IV, “Item 15. Exhibits and Financial Statement Schedules.”

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeSecurities Authorized for Issuance under Equity Compensation Plans See Item 12 of Part III of this Annual Report on Form 10-K (the Annual Report) for information about our equity compensation plans, which is incorporated by reference herein. Recent Sales of Unregistered Securities None. Purchases of Equity Securities by the Issuer and Affiliated Purchasers Not applicable.
Biggest changeDividends We have never paid dividends on our common stock and do not anticipate that we will do so in the foreseeable future. Securities Authorized for Issuance under Equity Compensation Plans See Item 12 of Part III of this Annual Report on Form 10-K for information about our equity compensation plans, which is incorporated by reference herein.
Prior to that time, there was no established public trading market for our common stock. Holders of Record As of March 13, 2025, there were approximately 1,026 stockholders of record of our common stock. Certain shares are held in street name and accordingly, the number of beneficial owners of such shares is not known or included in the foregoing number.
Holders of Record As of March 3, 2026, there were approximately 979 stockholders of record of our common stock. Certain shares are held in street name and accordingly, the number of beneficial owners of such shares is not known or included in the foregoing number.
Removed
Dividend Policy We have never declared or paid cash dividends on our common stock. We currently intend to retain all available funds and any future earnings, if any, to fund the development and expansion of our business and we do not anticipate paying any cash dividends in the foreseeable future.
Added
Recent Sales of Unregistered Securities None. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. Item 6. RESERVED
Removed
Any future determination to pay dividends will be made at the discretion of our board of directors, subject to applicable laws and will depend upon, among other factors, our results of operations, financial condition, contractual restrictions and capital requirements.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeSignificant variations between periods are primarily a result of a $1.2 million increase in employee compensation in 2024, primarily related to new employee hires in 2024; a $1.2 million increase in stock-related compensation in 2024, relating to the increased cost of stock options and restricted stock units in 2024, and a $4.5 million increase in clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 On Prime Registration trial in 2024 and Phase 2 clinical trial for non-small cell lung cancer, which Newsoara is obligated to fully reimburse per the terms of our agreement; and partially offset by a $0.9 million decrease in manufacturing and laboratory materials in 2024. 133 General and Administrative Expenses The table below summarizes our general and administrative expenses for the years ended December 31, 2024 and 2023 (in thousands): December 31, December 31, General and Administrative Expenses: 2024 2023 Employee compensation and related expenses $ 2,705 $ 2,502 Stock compensation, including the cost of stock options and restricted stock grants 5,024 4,270 Professional services 2,278 2,781 Facility-related expenses 457 371 Insurance expenses 966 1,078 Consulting and contract labor expenses 831 418 Other expenses 445 148 Total general and administrative expenses $ 12,706 $ 11,568 General and administrative expenses were $12.7 million and $11.6 million for the years ended December 31, 2024 and 2023, respectively, an increase of approximately $1.1 million.
Biggest changeGeneral and Administrative Expenses The following table provides detail of general and administrative expenses (in thousands): Year Ended December 31, 2025 2024 Change Employee compensation and related expenses $ 3,826 $ 2,705 $ 1,121 Stock compensation, including the cost of stock options and restricted stock grants 4,666 5,024 (358 ) Professional services 2,527 2,278 249 Facility-related expenses 292 457 (165 ) Insurance expenses 870 966 (96 ) Consulting and contract labor expenses 421 831 (410 ) Other expenses 769 445 324 Total general and administrative expenses $ 13,371 $ 12,706 $ 665 General and administrative expenses increased by $0.7 million for the year ended December 31, 2025 over the same period in 2024 primarily as a result of an increase of $1.1 million in employee compensation driven by the combination of annual salary increases and changes to headcount required to support our operations; partially offset by a decrease of $0.4 million in consulting services.
Even if we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in case of equity financing, or grant unfavorable terms in future licensing agreements.
Even if we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt, or cause substantial dilution for our stockholders, in case of equity financing, or grant unfavorable terms in future licensing agreements.
We expect research and development costs to increase significantly for the foreseeable future as we commence clinical trials and continue the development of our current and future product candidates. However, we do not believe that it is possible at this time to accurately project expenses through commercialization.
We expect research and development costs to increase significantly for the foreseeable future as we commence and conduct clinical trials and continue the development of our current and future product candidates. However, we do not believe that it is possible at this time to accurately project expenses through commercialization.
Significant judgement and estimates are made in determining the accrued expense balances at the end of any reporting period. The successful development of our product candidates is highly uncertain. We cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete development of our current or future product candidates.
Significant judgment and estimates are made in determining the accrued expense balances at the end of any reporting period. The successful development of our product candidates is highly uncertain. We cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete development of our current or future product candidates.
Common Stock Issued for Cash Upon Closing of the Company’s Second Public Offering In May 2024, we completed an underwritten offering of our common stock, in which we issued and sold 7,500,000 shares of our common stock at a price of $4.00 per share, which included 625,000 shares of common stock at $4.00 per share pursuant to the underwriters’ partial exercise of their option to purchase additional shares of common stock.
Common Stock Issued for Cash Upon Closing of Public Offering in May 2024 In May 2024, we completed an underwritten offering of our common stock, in which we issued and sold 7,500,000 shares of our common stock at a price of $4.00 per share, which included 625,000 shares of common stock at $4.00 per share pursuant to the underwriters’ partial exercise of their option to purchase additional shares of common stock.
In addition, because the design and outcome of our anticipated and any future clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of Olvi-Vec or any future product candidates. Our existing cash balance may not be sufficient to complete the development of Olvi-Vec or any other product candidate.
In addition, because the design and outcome of our anticipated and any future clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of Olvi-Vec or any future product candidates. Our existing cash balance may not be sufficient to complete the development of Olvi-Vec or any other product candidate.
Based on our research and development plans, we expect that our existing cash balance may not enable us to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months from the date of filing of this Annual Report.
Based on our research and development plans, we expect that our existing cash balance may not enable us to fund our planned operating expenses and capital expenditure requirements for the next 12 months from the date of filing of this Annual Report.
These factors raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to raise additional funds and implement our strategies. The financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
These factors raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to raise additional funds and implement our strategies. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
Research and development costs are expensed as incurred. Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided to us by our vendors and analyzing the progress of our preclinical and clinical studies or other services performed.
Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided to us by our vendors and analyzing the progress of our preclinical and clinical studies or other services performed.
Operating Expenses Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses. 130 Research and Development Expenses Research and development expenses consist primarily of costs incurred for our research and development activities, including our product candidate discovery efforts and preclinical and clinical studies under our research programs, which include: ● employee-related expenses, including salaries, benefits and stock-based compensation expense for our research and development personnel; ● costs of funding research performed by third parties that conduct research and development and preclinical and clinical activities on our behalf; ● costs of manufacturing drug product and drug supply related to our current or future product candidates; ● costs of conducting preclinical studies and clinical trials of our product candidates; ● consulting and professional fees related to research and development activities, including equity-based compensation to non-employees; ● costs of maintaining our laboratory, including purchasing laboratory supplies and non-capital equipment used in our preclinical studies; ● costs related to compliance with clinical regulatory requirements; and ● facility costs and other allocated expenses, which include expenses for rent and maintenance of facilities, insurance, depreciation and other supplies.
Research and Development Expenses Research and development expenses consist primarily of costs incurred for our research and development activities, including our product candidate discovery efforts and preclinical and clinical studies under our research programs, which include: ● employee-related expenses, including salaries, benefits, and stock-based compensation for our research and development personnel; ● costs of funding research performed by third parties that conduct research and development and preclinical and clinical activities on our behalf; ● costs of manufacturing drug product and drug supply related to our current or future product candidates; ● costs of conducting preclinical studies and clinical trials of our product candidates; ● consulting and professional fees related to research and development activities, including equity-based compensation to non-employees; ● costs of maintaining our laboratory, including laboratory supplies and non-capital equipment used in our preclinical studies; ● costs related to compliance with clinical regulatory requirements; and ● facility costs and other allocated expenses, which include rent and maintenance of facilities, insurance, depreciation, and other supplies. 102 Research and development costs are expensed as incurred.
Our future capital requirements will depend on a number of factors, including: ● the costs of conducting preclinical studies and clinical trials; ● the costs of manufacturing; ● the scope, progress, results and costs of discovery, preclinical development, laboratory testing, and clinical trials for product candidates we may develop, if any; ● the costs, timing, and outcome of regulatory review of our product candidates; ● our ability to establish and maintain collaborations on favorable terms, if at all; ● the achievement of milestones or occurrence of other developments that trigger payments under any license or collaboration agreements we might have at such time; ● the costs and timing of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval; ● the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; ● the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining and enforcing our intellectual property rights, and defending intellectual property-related claims; ● our headcount growth and associated costs as we expand our business operations and research and development activities; ● the costs of operating as a public company; and ● the impact of geopolitical and macroeconomic events, including future bank failures, tariffs, increased geopolitical tensions between the U.S. and China, the Russia/Ukraine conflict, the Israel-Hamas war and global pandemics on U.S. and global economic conditions that may affect our ability to access capital on acceptable terms, if at all.
Our future capital requirements will depend on a number of factors, including: ● the costs of conducting preclinical studies and clinical trials; ● the costs of manufacturing; ● the scope, progress, results and costs of discovery, preclinical development, laboratory testing, and clinical trials for product candidates we may develop, if any; ● the costs, timing, and outcome of regulatory review of our product candidates; ● our ability to establish and maintain collaborations on favorable terms, if at all; ● the achievement of milestones or occurrence of other developments that trigger payments under any license or collaboration agreements we might have at such time; ● the costs and timing of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval; ● the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; ● the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining and enforcing our intellectual property rights, and defending intellectual property-related claims; ● our headcount growth and associated costs as we expand our business operations and research and development activities; ● the costs of operating as a public company; and ● the impact of geopolitical and macroeconomic events, including future bank failures, new or increased tariffs, funding shortages at governmental and regulatory agencies on which we rely, geopolitical tensions between the U.S. 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 development and other sources of instability that may impact our ability to access capital on acceptable terms, if at all.
This is due to the numerous risks and uncertainties associated with developing product candidates, including the uncertainty of: ● the scope, rate of progress, and expenses of our ongoing research activities as well as any preclinical studies and clinical trials and other research and development activities; ● establishing an appropriate safety profile; ● successful enrollment in and completion of clinical trials; ● whether our product candidates show safety and efficacy in our clinical trials; ● receipt of marketing approvals from applicable regulatory authorities; ● establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; ● obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates; ● commercializing product candidates, if and when approved, whether alone or in collaboration with others; and ● continued acceptable safety profile of the products following any regulatory approval. 131 A change in the outcome of any of these variables with respect to the development of our current and future product candidates would significantly change the costs and timing associated with the development of those product candidates.
This is due to the numerous risks and uncertainties associated with developing product candidates, including the uncertainty of: ● the scope, rate of progress, and expenses of our ongoing research activities as well as any preclinical studies and clinical trials and other research and development activities; ● establishing an appropriate safety profile; ● successful enrollment in and completion of clinical trials; ● whether our product candidates show safety and efficacy in our clinical trials; ● receipt of marketing approvals from applicable regulatory authorities; ● establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; ● obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates; ● commercializing product candidates, if and when approved, whether alone or in collaboration with others; and ● continued acceptable safety profile of the products following any regulatory approval.
Until we can generate sufficient product revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings and debt financings, or other capital sources such as potential collaborations, strategic alliances, licensing arrangements and other arrangements.
Until we can generate sufficient product revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt and/or other capital sources such as milestone payments, royalties or other payments or funding from existing or potential collaborations, strategic alliances, licensing arrangements and other arrangements.
Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements.
Until we generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings, debt and/or other sources, such as milestone payments, royalties or other payments or funding from existing or potential collaboration agreements, strategic alliances, licensing arrangements and other arrangements.
In November 2023, we agreed with Newsoara that Genelux would directly engage a contract research organization on mutually agreeable terms to conduct certain startup activities for the NSCLC trial in the U.S. only, with Newsoara reimbursing us for the costs and expenses of such agreed-upon startup activities.
In November 2023, the Company agreed with Newsoara that the Company would directly engage a contract research organization (CRO) on mutually agreeable terms to conduct certain startup activities for the VIRO-25 Trial in the U.S. only, with Newsoara reimbursing the Company for the costs and expenses of such agreed-upon startup activities.
There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development programs and plans.
There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development.
We also anticipate increased expenses associated with being a public company, including costs for audit, legal, regulatory and tax-related services related to compliance with the rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”), and listing standards applicable to companies listed on a national securities exchange, director and officer insurance premiums, and investor relations costs.
We also anticipate incurring additional expenses associated with operating as a public company, including audit, legal, regulatory and tax-related costs to comply with the rules and regulations of the U.S. Securities and Exchange Commission (the SEC), and listing standards applicable to companies listed on a national securities exchange, increased director and officer insurance premiums, and investor relations costs.
Other significant costs include professional service and consulting fees, including legal fees relating to intellectual property and corporate matters, accounting fees, recruiting costs and costs for consultants who we utilize to supplement our personnel, insurance costs, travel costs, facility and office-related costs not included in research and development expenses.
Other significant costs include professional service and consulting fees, including legal fees relating to intellectual property and corporate matters, accounting and recruiting fees and fees paid to consultants engaged to supplement our personnel as well as insurance, travel, and office-related costs not included in research and development expenses.
We anticipate that our general and administrative expenses will increase in the future as our business expands to support expected growth in research and development activities, including our future clinical programs. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside service providers, among other expenses.
We anticipate that our general and administrative expenses will increase in the future as our business expands to support expected growth in research and development activities, including our future clinical programs. These increases are expected to result primarily from higher personnel-related costs associated with hiring additional personnel and increased fees paid to outside service providers, among other expenses.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
Off-Balance Sheet Arrangements During the years ended December 31, 2024 and 2023, we did not have, and we do not currently have, any off-balance sheet arrangements (as defined under SEC rules). 139 Recent Accounting Pronouncements For a description of recently issued accounting standards that may have a material impact on our financial statements or will otherwise apply to our operations, please see Note 2 to our audited financial statements appearing elsewhere in this Annual Report.
We have not entered into, nor do we currently have, any off-balance sheet arrangements (as defined under SEC rules). 110 Recent Accounting Pronouncements For a description of recently issued accounting standards that may have a material impact on our financial statements or will otherwise apply to our operations, please see Note 1 to the audited financial statements appearing elsewhere in this Annual Report.
In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing, and distribution activities. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.
In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing, and distribution activities.
Our ability to raise additional funds also may be adversely impacted by potential worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from geopolitical and macroeconomic events such as actual or anticipated changes in interest rates and economic inflation, current and future bank failures, tariffs, global pandemics, geopolitical tensions between the United States and China and the impact of the Russia/Ukraine conflict and the conflicts in the Middle East.
The ability to raise additional funds may also be adversely affected by global economic conditions and volatility in U.S. and international credit and financial markets resulting from geopolitical and macroeconomic events, including changes in interest rates and inflation, current or future bank failures, tariffs, global pandemics, geopolitical tensions between the United States and China, the Russia/Ukraine conflict, and conflicts in the Middle East.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, our common stockholders’ ownership interests may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect the rights of our common stockholders.
To the extent additional capital is raised through the issuance of equity or convertible debt securities, existing stockholders’ ownership interests may be diluted, and such securities may include liquidation or other preferences that could adversely affect the rights of common stockholders.
US-Based Phase 2 Trial in NSCLC In October 2024, we announced that the first patient had been dosed in a Phase 2, open-label, randomized, and controlled clinical trial designed to evaluate the efficacy and safety of intravenously delivered Olvi-Vec oncolytic VACV for patients with recurrent non-small cell lung cancer (NSCLC) in the United States.
The net proceeds received from the offering were $18.5 million after deducting underwriting discounts, and commissions, and offering expenses payable by us. 101 US-Based Phase 2 Trial in NSCLC In October 2024, the Company announced that the first patient had been dosed in a Phase 2, open-label, randomized, and controlled clinical trial designed to evaluate the efficacy and safety of intravenously delivered Olvi-Vec oncolytic VACV for patients with recurrent non-small cell lung cancer (NSCLC) in the United States.
Please also see the section titled “Special Note Regarding Forward- Looking Statements.” Overview Genelux is a late clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic viral immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types.
Please also see the section titled “Special Note Regarding Forward- Looking Statements.” OVERVIEW Genelux is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic viral immunotherapies for patients suffering from aggressive and/or difficult-to-treat tumor types. Our clinical and preclinical product candidates are intended to selectively kill tumor cells and induce a robust immune response against a patient’s tumor neoantigens.
The gross proceeds received from the offering were $10.5 million before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.
The gross proceeds received from the offering were $10.5 million and we raised $9.6 million in net proceeds after deducting underwriting discounts and commissions and offering expenses payable by the Company.
We anticipate needing to obtain further funding to achieve our business objectives beyond such date. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements.
We anticipate needing to obtain further funding to achieve our business objectives beyond such date. 108 Until such time, if ever, as substantial product revenues are generated, cash requirements are expected to be financed through public or private equity offerings, debt and/or other sources, including as milestone payments, royalties or other payments or funding from existing or potential collaboration agreements, strategic alliances, licensing arrangements and other arrangements.
In the ATM, we may offer and sell, from time to time and at our option, up to an aggregate of $100.0 million of shares of our common stock through Guggenheim, acting as sales agent. Guggenheim is entitled to a fixed commission rate of up to 3.0% of the gross sales proceeds of shares sold under the ATM.
In the ATM, we had the ability to offer and sell, from time to time and at our option, up to an aggregate of $100.0 million of shares of our common stock through Guggenheim, acting as sales agent.
Funding Requirements We expect our expenses to increase in connection with our ongoing activities, particularly as we continue our research and development, initiate and conduct preclinical studies and clinical trials, and seek marketing approval for our current and any of our future product candidates.
In March 2026, we terminated the 2024 Sales Agreement. 107 Funding Requirements We expect our expenses to increase in connection with ongoing operations, particularly as research and development activities continue, including the initiation and conduct of preclinical studies and clinical trials, and efforts to obtain marketing approval for current and future product candidates.
The gross proceeds received from the offering were $10.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.
The net proceeds received from the offering were $18.5 million after deducting underwriting discounts and commissions and offering expenses payable by us.
We determine the fair value of restricted common stock awards based on the fair value of our common stock on the date of grant. Commitments and Contingencies From time to time, we may have certain contingent liabilities that arise in the ordinary course of business.
Commitments and Contingencies From time to time, we may have certain contingent liabilities that arise in the ordinary course of business.
Informed by our CHOICE platform and supported by extensive clinical and preclinical data, we believe we have the capacity to develop a pipeline of treatment options to address high unmet medical needs for those patients with insignificant or unsatisfactory responses to standard-of-care therapies, including chemotherapies.
Informed by our CHOICE platform and supported by extensive clinical and preclinical data, we believe we have the capacity to develop a pipeline of treatment options to address high unmet medical needs for those patients with insignificant or unsatisfactory responses to standard-of-care therapies, including chemotherapies. 99 Since inception, our operations have focused on organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, establishing our intellectual property portfolio, identifying potential product candidates and undertaking preclinical and clinical studies and manufacturing.
General and Administrative Expenses General and administrative expenses include salaries and other compensation-related costs, including stock-based compensation, for personnel in executive, finance and accounting, business development, operations and administrative roles.
Additionally, future commercial and regulatory factors beyond our control will impact our clinical development programs and plans. 103 General and Administrative Expenses General and administrative expenses include salaries and other compensation-related costs, including stock-based compensation, for personnel in executive, finance, business development, operations and administrative roles.
Other Income (Expenses), net Other income (expenses), net, were $1.8 million and $(4.1) million for the years ended December 31, 2024 and 2023, respectively.
Other Income Other income was $1.1 million and $1.8 million for the year ended December 31, 2025 and 2024, respectively.
During the year ended December 31, 2024, we sold an aggregate of 5,460 shares of common stock under the ATM for net proceeds of approximately $15.2 thousand after deducting compensation of approximately $470 payable to Guggenheim.
Guggenheim was entitled to a fixed commission rate of up to 3.0% of the gross sales proceeds of shares sold under the ATM. During the year ended December 31, 2024, we sold an aggregate of 5,460 shares of common stock under the ATM for net proceeds of $0.02 million after deducting compensation.
Since inception, we have incurred significant operating losses. Our net losses were $29.9 million and $28.3 million, respectively, for the years ended December 31, 2024 and 2023. As of December 31, 2024, we had an accumulated deficit of $251.4 million.
We do not have any products approved for sale and have not generated any revenue from product sales. Since inception, we have incurred significant operating losses. Our net losses were $32.1 million and $29.9 million, respectively, for the years ended December 31, 2025 and 2024. As of December 31, 2025, we had an accumulated deficit of $283.5 million.
Employing our proprietary selection technology and discovery and development platform (CHOICE), we have developed an extensive library of isolated and engineered oncolytic VACV immunotherapeutic product candidates. These provide potential utility in multiple tumor types in both the monotherapy and combination therapy settings, via physician-preferred administration techniques, including regional (e.g., intraperitoneal), local and systemic (e.g., intravenous) delivery routes.
These provide potential utility in multiple tumor types in both the monotherapy and combination therapy settings, via physician-preferred administration techniques, including regional (e.g., intraperitoneal), local and systemic (e.g., intravenous) delivery routes.
We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all.
We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Failure to raise capital or enter into such agreements as and when needed, could have a material adverse effect on our business, results of operations and financial condition.
In addition, if we obtain marketing approval for any of our current or our future product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution, which costs we may seek to offset through entry into collaboration agreements with third parties.
In addition, if marketing approval is obtained for any current or future product candidates, significant commercialization expenses are expected, including costs related to product sales, marketing, manufacturing, and distribution, which may be partially offset through collaboration agreements with third parties. Additional costs associated with operating as a public company are also expected.
In accordance with our license agreement with our partner in China, Newsoara BioPharma Co. Ltd. (Newsoara), Newsoara is generally obligated to fund the Phase 2 clinical trial in its entirety.
Pursuant to the Company’s license agreement (as amended, the Newsoara License Agreement) with its partner in China, Newsoara HYK Biopharmaceuticals Co., Ltd. (Newsoara), Newsoara is generally obligated to fund the Phase 2 NSCLC trial in its entirety in the United States and China (VIRO-25 Trial).
Equity Financings Common Stock Issued for Cash Upon Closing of the Company’s Third Public Offering On March 26, 2025, the Company completed an underwritten offering of 3,000,000 shares of its common stock at an offering price of $3.50 per share.
Equity Financings Common Stock Issued for Cash Upon Closing of Public Offering in January 2026 In January 2026, we completed an underwritten offering of 6,666,667 shares of our common stock at an offering price of $3.00 per share.
During the year ended December 31, 2024, we recognized revenue of $0.01 million relating to the Company’s license agreement with ELIAS Animal Health, LLC.
In January 2026, the Company announced the appointment of Jason Litten as Chief Medical Officer. 2025 Financial Performance Summary Net Sales During the year ended December 31, 2025 and 2024, we recognized revenue of $0.01 million relating to our license agreement with ELIAS Animal Health, LLC, respectively.
There were no other expenses during the year ended December 31, 2024. Liquidity and Capital Resources We have experienced recurring losses from operations since inception and incurred a net loss of $29.9 million and used cash in operations of $21.2 million during the year ended December 31, 2024.
There was a decrease of $0.7 million in 2025 due to lower bond accretion income of $0.4 million and gain on extinguishment of accounts payable in 2024 of $0.4 million. 105 Liquidity and Capital Resources We have experienced recurring losses from operations since inception and incurred a net loss of $32.1 million and used cash in operations of $25.3 million during the year ended December 31, 2025.
As of December 31, 2024, we had cash and short-term investments of $30.9 million, however we do not have any committed external source of funds or other support for our development efforts.
However we do not have any committed external source of funds or other support for our development efforts, except for the Newsoara License Agreement.
If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts. 136 We believe that our existing cash, cash equivalents and short-term investments may not enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months from the date of filing of this Annual Report.
We believe that our existing cash, cash equivalents, restricted cash and marketable securities may not enable us to fund our operating expenses and capital expenditure requirements for the next 12 months from the date of filing of this Annual Report.
Determination of the Fair Value of Equity-Based Awards We estimate the fair value of stock option awards granted using the Black-Scholes option-pricing model, which uses as inputs the fair value of our common stock and subjective assumptions we make, including expected stock price volatility, the expected term of the award, the risk-free interest rate, and expected dividends.
We account for forfeitures as they occur. The grant-date fair value of stock option awards is estimated using the Black-Scholes option pricing model, which requires the use of subjective assumptions, including expected term, expected volatility, risk-free interest rate, and expected dividend yield.
In other words, while we administer the same virus product to different patients, the cellular immune response generated is expected to be specific to the unique neoantigens in that patient. Our product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable DNA virus with a large engineering capacity.
Importantly, our oncolytic immunotherapy product candidates are “off-the-shelf” personalized immunotherapies. In other words, while we administer the same virus product to different patients, the cellular immune response generated is expected to be specific to the unique neoantigens in that patient.
We are currently evaluating our potential remedies with respect to these investors’ non-compliance with their contractual obligations to the Company. At-the-Market Offering In February 2024, we entered into a Sales Agreement with Guggenheim Securities, LLC (Guggenheim) implementing an “at-the-market” offering program (the ATM).
The warrants expire five years from the date of grant At-the-Market Offering In February 2024, we entered into a Sales Agreement with Guggenheim Securities, LLC (Guggenheim) (the 2024 Sales Agreement) implementing an “at-the-market” offering program (the ATM).
The failure to receive all or some of the committed proceeds would exhaust our available capital resources sooner than expected and will require us to obtain further funding to achieve our business objectives. 134 No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company.
No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to us.
Stock-Based Compensation We measure stock options and other stock-based awards granted to employees and directors based on the fair value of the award on the date of the grant and recognize compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. We recognize forfeitures as they occur.
Stock-Based Compensation We recognize stock-based compensation expense for equity awards, including stock options, restricted stock units (RSUs), and shares issued under the Employee Stock Purchase Plan (ESPP), based on the estimated grant-date fair value of the awards. Compensation expense is recognized on a straight-line basis over the requisite service period, generally the vesting period.
If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
If additional funding cannot be obtained when needed, product development or future commercialization efforts may be delayed, limited, reduced, or terminated, or rights to develop and commercialize product candidates may need to be granted to third parties that would otherwise be retained.
Additional debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. 137 If we raise funds through potential collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us.
If funding is obtained through collaborations, strategic alliances, or licensing arrangements with third parties, valuable rights to technologies, future revenue streams, research programs, or product candidates may be relinquished, or licenses may be granted on terms that are not favorable.
During the year ended December 31, 2024, we closed a second public offering and received $27.7 million of net proceeds from that offering. Due to the funds received through these offerings, and the conversion of preferred stock and convertible notes payable upon the closing of the IPO, we have shareholders’ equity of $27.9 million at December 31, 2024.
As a result of the proceeds received through public offerings, and the conversion of preferred stock and convertible notes payable upon the closing of the IPO, we have stockholders’ equity of $11.5 million at December 31, 2025. In January 2026, we completed an underwritten offering of 6,666,667 shares of our common stock at an offering price of $3.00 per share.
Cash Flows The table below summarizes our cash flow activities for the years ended December 31, 2024 and 2023 (in thousands): December 31, December 31, Net cash provided by (used in): 2024 2023 Operating activities $ (21,228 ) $ (20,275 ) Investing activities (8,131 ) (14,724 ) Financing activities 28,506 44,020 Net increase (decrease) in cash $ (853 ) $ 9,021 Operating Activities During the year ended December 31, 2024, we used cash from operating activities of $21.2 million, compared to $20.3 million used during the year ended December 31, 2023.
Cash Flows The following table presents a summary of cash flows (in thousands): Year Ended December 31, Cash Flow from: 2025 2024 Operating activities $ (25,268 ) $ (21,228 ) Investing activities 12,141 (8,131 ) Financing activities 9,895 28,506 Net decrease in cash, cash equivalents and restricted cash $ (3,232 ) $ (853 ) Cash, cash equivalents and restricted cash at end of period $ 5,333 $ 8,565 During the year ended December 31, 2025, cash flow used in operating activities was $25.3 million, which consisted of a net loss of $32.1 million and, non-cash expense of stock-related compensation of $7.6 million, partially offset by a decrease in accrued expenses of $1.2 million.
For the year ended December 31, 2024, cash provided by financing activities consisted of proceeds from the sale of common stock of $27.7 million, proceeds from the exercise of stock warrants of $0.7 million, and proceeds from our company’s equity awards programs of $0.1 million. 135 For the year ended December 31, 2023, cash provided by financing activities consisted of proceeds from the issuance of notes payable totaling $0.9 million, proceeds from the sale of common stock related to our IPO and private placements totaling $39.6 million, the exercise of stock options of $1.5 million and the exercise of stock warrants of $3.0 million.
Cash used in investing activities was $8.1 million, which was primarily attributable to net purchase of marketable securities of $7.8 million. Cash provided by financing activities of $28.5 million was related to proceeds from the sale of common stock of $27.7 million and proceeds from the exercise of stock warrants of $0.7 million.
While our significant accounting policies are more fully described in Note 2 to our financial statements appearing elsewhere in this Annual Report, we believe the following are the critical accounting policies used in the preparation of our financial statements that require significant estimates and judgments.
Actual results may vary from what we anticipate and different assumptions or estimates about the future could change its reported results. We believe the following accounting policies are the most critical to us, in that they require our most difficult, subjective or complex judgments in the preparation of our financial statements.
We expect our cash, cash equivalents and short-term investments, totaling $30.9 million at December 31, 2024, to last until the first quarter of 2026. Recent Developments Underwritten Public Offering On March 26, 2025, we completed an underwritten offering of 3,000,000 shares of our common stock at an offering price of $3.50 per share.
The net proceeds received from the offering were $18.5 million after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Common Stock Issued for Cash Upon Closing of Public Offering in March 2025 In March 2025, we completed an underwritten offering of 3,000,000 shares of our common stock, at an offering price of $3.50- per share.
Removed
Our clinical and preclinical product candidates are intended to selectively kill tumor cells and induce a robust immune response against a patient’s tumor neoantigens. Importantly, our oncolytic immunotherapy product candidates are “off-the-shelf” personalized immunotherapies.
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Our lead product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable DNA virus with a large engineering capacity. Employing our proprietary selection technology and discovery and development platform (CHOICE), we have developed an extensive library of isolated and engineered oncolytic VACV immunotherapeutic product candidates.
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Since inception, our operations have focused on organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, establishing our intellectual property portfolio, identifying potential product candidates and undertaking preclinical and clinical studies and manufacturing. We do not have any products approved for sale and have not generated any revenue from product sales.
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As a result, we will require substantial additional funding to support our continuing operations and to pursue our growth strategy.
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Our failure to raise capital or enter into such agreements as and when needed, could have a material adverse effect on our business, results of operations and financial condition. 129 During the year ended December 31, 2023, we closed our IPO and two private placements (the Private Placements) and received $37.8 million of net proceeds from these offerings.
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During the year ended December 31, 2025, we completed an underwritten offering of 3,000,000 shares of our common stock at an offering price of $3.50 per share. The gross proceeds received from the offering were $10.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by us.
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Newsoara is permitted to defer such reimbursement payments until the completion of its next round of financing, which Newsoara expects to occur in 2025.
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We expect our cash, cash equivalents, restricted cash and marketable securities, totaling $14.6 million at December 31, 2025, and subsequent net proceeds of $18.5 million that were received in January 2026, representing a pro forma balance of $33.1 million, to last into the first quarter of 2027.
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During the quarter ended September 30, 2024, the Company entered into a Clinical Trial Services Agreement with Hong Kong Tigermed Consulting Co., Ltd., to provide regulatory and development support services for the NSCLC trial in the United States.
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Business Highlights Data from Lung Cancer Clinical Trials On January 5, 2026, we announced interim results from two ongoing trials evaluating systemic (intravenous) administration of Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and progressive non-small cell lung cancer (NSCLC), respectively, after failure of prior platinum-based regimens. 100 Platinum-relapsed or platinum-refractory advanced SCLC (Ph1b/2 SCLC trial) The open-label Phase 1b/2 SCLC trial (NCT07136285) is evaluating a single intravenous cycle with multiple doses of Olvi-Vec administered in combination with platinum and etoposide chemotherapy in SCLC patients with platinum-relapsed or platinum-refractory disease after failing previous treatment with platinum and etoposide chemotherapy.
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Components of Results of Operations Net Sales During the year ended December 30, 2023, under our license agreement with Newsoara, we invoiced and collected $0.2 million relating to supplying product for Newsoara to use in its clinical trials.
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The trial is being conducted by the Company’s licensing partner, Newsoara, in China.
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In addition, if we obtain regulatory approval for any of our product candidates and do not enter into a third-party commercialization collaboration, we expect to incur significant expenses related to building a sales and marketing team to support product sales, marketing and distribution activities. 132 Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023 (in thousands): December 31, December 31, 2024 2023 Revenues $ 8 $ 170 Operating Expenses: Research and development 18,998 12,767 General and administrative 12,706 11,568 Total operating expenses 31,704 24,335 Loss from operations (31,696 ) (24,165 ) Other income (expenses): Interest income 1,457 244 Gain on extinguishment of accounts payable 370 — Interest expense — (173 ) Debt discount amortization — (649 ) Financing costs — (3,152 ) Debt extinguishment costs — (402 ) Total other income (expenses), net 1,827 (4,132 ) Net loss $ (29,869 ) $ (28,297 ) Research and Development Expenses The table below summarizes our research and development expenses for the years ended December 31, 2024 and 2023 (in thousands): December 31, December 31, Research and Development Expenses: 2024 2023 Employee compensation and related expenses $ 3,766 $ 2,538 Stock compensation, including the cost of stock options and restricted stock grants 3,090 1,876 Manufacturing and laboratory materials and other expenses 556 1,502 Outsourced manufacturing services 1,602 1,145 Clinical and regulatory expenses 8,204 3,698 Facility-related expenses, including depreciation 1,320 1,356 Consulting expenses and contract labor 414 595 Other expenses 46 57 Total research and development expenses $ 18,998 $ 12,767 Research and development expenses were $19.0 million and $12.8 million for the years ended December 31, 2024 and 2023, respectively, an increase of approximately $6.2 million.
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As of the data review cutoff date of December 23, 2025, systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved the following preliminary results: ● 9 evaluable patients Overall response rate (ORR) of 33% (3/9 patients), including three partial responses (PRs) - Two of the three PRs occurred in Cohort 4, the highest dose cohort tested as of the data review cutoff date, with tumor shrinkage of approximately 55% and 85% from baseline, representing an ORR of 67% (2/3) in Cohort 4 and potentially suggesting a dose-response trend - Disease control rate (DCR) of 67% (6/9 patients) - Tumor shrinkage of 24–85% among the six DCR patients, all of whom experienced a reduction in all target lesions from baseline - Olvi-Vec 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 progression-free survival (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 Advanced or metastatic recurrent NSCLC (Phase 2 VIRO-25 Clinical trial) The open-label Phase 2 VIRO-25 trial (NCT06463665) is evaluating a single intravenous cycle with multiple doses of Olvi-Vec in combination with platinum chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent NSCLC who failed standard frontline treatment of platinum chemotherapy and an ICI.
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Significant variations between periods are primarily a result of a $0.2 million increase in employee compensation in 2024, a $0.8 million increase in stock compensation expense in 2024, due to the increase in the cost of stock options and restricted stock units in 2024, a $0.4 million increase in consulting and contract labor expenses in 2024, primarily resulting from increased accounting and finance costs in 2024, partially offset by a $0.5 million decrease in professional services, primarily resulting from the decrease in legal expenses in 2024.
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The trial is being conducted in the United States.
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During the year ended December 31, 2024, other income consisted of interest income of $1.4 million from the investment into money market funds and short and long-term investments, while during the same period in 2023, other income consisted of interest income of $0.2 million.
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As of the data review cutoff date of December 31, 2025, systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved the following preliminary results: ● 5 evaluable patients ● 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 generally well tolerated Underwritten Public Offering In March 2025, we completed an underwritten offering of 3,000,000 shares of our common stock at $3.50 per share.
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In 2024, other income also includes a gain on the extinguishment of accounts payable of $0.4 million. Other expenses during the year ended December 31, 2023, consisted of $0.2 million of interest expense, $0.6 of debt discount amortization, $0.4 of debt extinguishment costs, and $3.2 million of financing costs.
Added
The net proceeds received from the offering were $9.6 million, after deducting underwriting discounts, and commissions, and offering expenses payable by the Company. In January 2026, we completed an underwritten offering of 6,666,667 shares of our common stock at an offering price of $3.00 per share.
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We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
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Pursuant to a letter of understanding (the LOU), in September 2025, the Company agreed with Newsoara that the CRO would conduct additional study activities beyond startup for the VIRO-25 Trial in the United States and Newsoara would reimburse the Company for costs and expenses related to such additional activities; however, Newsoara is permitted to defer reimbursement of the foregoing costs and expenses until the earlier of: (i) completion of its next round of financing or (ii) December 31, 2026.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Item 7A. Quantitative and Qualitative Disclosures about Market Risks We are not currently exposed to significant market risk related to changes in foreign currency exchange rates. However, we have contracted with and may continue to contract with foreign vendors that are located in Europe. Our operations may be subject to fluctuations in foreign currency exchange rates in the future.
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Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK We are subject to market risk exposures primarily due to our investing activities. The primary market risk exposure is change in interest rates. Adverse changes to rates may occur due to changes in the liquidity of a market or to changes in market perceptions of creditworthiness and risk tolerance.
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Inflation generally affects us by increasing our cost of labor. We do not believe that inflation had a material effect on our business, financial condition or results of operations during the years ended December 31, 2024 and 2023. Item 8.
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We primarily invest our excess cash in securities of reputable financial institutions, corporations, and U.S. government agencies with strong credit ratings.
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Due to the relatively short-term nature of the investments that we hold, we do not believe that the results of operations or cash flows would be affected to any significant degree by a sudden change in market interest rates relative to its investment portfolio. Item 8.

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