NASDAQ: GOVX

The Company is also developing GEO-CM04S1, a next-generation multi-antigen COVID-19 vaccine which is currently being evaluated in two Phase 2 clinical trials, (i) as a primary vaccine for immunocompromised patients, including those with hematologic cancers and other patient populations for whom currently authorized COVID-19 vaccines are inadequate and (ii) as a booster vaccine in patients with chronic lymphocytic leukemia (CLL), where an interim Data Safety Monitoring Board (DSMB) review demonstrated superior immune responses versus an mRNA vaccine. An additional clinical trial evaluating GEO-CM04S1 as a more robust booster vaccine in healthy adults who previously received an mRNA vaccine has completed enrollment with data readouts anticipated in the first half of 2026.

Our corporate strategy is to advance, protect, and strategically leverage our proprietary vaccine and immunotherapy platforms to develop differentiated preventive and therapeutic solutions for infectious diseases and solid tumors. We aim to efficiently progress our product candidates through clinical development and pursue regulatory approval and commercialization through internal development and selective external licensing and partnership arrangements. We also work collaboratively with academic, governmental, and industry partners to validate our technologies, support development efforts and enhance the strategic value of our pipeline.

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Our Clinical Development Pipeline

The table below summarizes the status of our clinical development programs, including our lead near-term priority, GEO-MVA, each of which are discussed in greater detail in the sections that follow, along with earlier stage programs.

Product

Indication

Clinical Trial

Status

GEO-MVA

mpox & smallpox

Vaccine against mpox and smallpox

Phase 3

Initiation planned for H2 2026

Gedeptin®

Advanced

Head & Neck Cancer

Effect on Targeted Tumors

Phase 1/2

Completed

Squamous Cell

Head & Neck Cancer*

First Line Therapy in Combination

With Immune Checkpoint Inhibitor

Phase 2

Initiation planned for H1 2027

Primary Vaccine for Immunocompromised/

Stem Cell Transplant Patients

Phase 2

Enrollment ended

Data readouts expected during 2026

GEO-CM04S1

COVID-19

Booster Vaccine for Immunocompromised/

Chronic Lymphocytic Leukemia Patients

Phase 2

Enrollment completion expected during 2026

Booster Vaccine for Healthy Adults

Phase 2

Enrollment ended

Data readouts expected during H1 2026

GEO-MVA - Mpox and Smallpox Vaccine

Modified Vaccinia Ankara (MVA) was originally developed as a third-generation smallpox vaccine approximately 50 years ago and is characterized by its inability to replicate in human cells. As a result, MVA-based vaccines are generally considered suitable for use in high-risk populations such as pregnant women, children and immunocompromised individuals who may be at increased risk from replicating vaccinia-based smallpox vaccines. An MVA vaccine is currently approved and stockpiled for protection against smallpox and is also approved for use against other orthopoxviruses, including mpox. Additionally, vaccines built on the MVA platform offer the potential for cross-protection against both mpox and smallpox in regions where these orthopoxvirus threats persist or re-emerge.

GeoVax’s primary near-term strategic focus is the development of GEO-MVA, an MVA vaccine candidate intended to address a documented global supply constraint for orthopoxvirus vaccines and to support both civilian public-health and biodefense preparedness objectives.

In recent years, mpox has evolved from a geographically limited zoonotic infection into a recurring global public-health concern affecting civilian populations across multiple continents. Ongoing viral evolution, including the emergence of more virulent Clade I strains and reports of recombinant variants containing genetic elements from multiple mpox clades, has heightened concern regarding disease severity, transmissibility, and the durability of existing outbreak-response strategies. These developments underscore the risk of continued periodic outbreaks with increasing public-health, economic, and societal impact, including in regions that previously experienced limited exposure.

In November 2022 GeoVax secured rights from the National Institutes of Health (NIH) covering preclinical, clinical, and commercial uses of NIH-MVA against mpox and smallpox viruses. GeoVax has previously demonstrated that an experimental HIV vaccine utilizing NIH-MVA as the vaccine vector protected non-human primates from a lethal mpox challenge three years after vaccination. In addition, investigators at City of Hope (COH), the institution that originally developed GEO-CM04S1, published results in August 2022 showing that both their proprietary synthetic MVA (sMVA) construct and GEO-CM04S1 (COVID-19 vaccine candidate) elicited robust orthopoxvirus-specific binding and neutralizing antibody responses, supporting the potential of MVA-based approaches for addressing unforeseen mpox outbreaks.

The 2022 global mpox outbreak significantly depleted existing MVA vaccine stockpiles, including the U.S. Strategic National Stockpile, exposing vulnerabilities in the availability and surge capacity of orthopoxvirus vaccines. This unfortunate situation was repeated following the 2024 mpox outbreak. These vulnerabilities are compounded by the fact that current MVA-based mpox/smallpox vaccine supply is concentrated with a single foreign manufacturer. Dependence on one non-U.S. source for a critical public-health and biodefense countermeasure introduces supply-chain, geopolitical, and logistical risks, particularly amid recurrent outbreaks, increasing global demand, and the emergence of more virulent viral variants.

Recent policy actions and statements from the current U.S. Administration and Congress have emphasized the urgency of strengthening domestic manufacturing capacity for critical medical countermeasures, reducing reliance on foreign suppliers, and enhancing preparedness against biological threats. These priorities include onshoring vaccine manufacturing, diversifying supply sources for essential biodefense products, and reinforcing national biosecurity infrastructure to address both naturally occurring outbreaks and deliberate biological threats.

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Against this backdrop, GEO-MVA is being developed as a dual-use vaccine candidate intended to support outbreak response, routine preparedness, and protection of vulnerable populations. In preparedness and biosecurity contexts, an additional domestically supported MVA-based vaccine supply could enhance resilience of the U.S. Strategic National Stockpile, support force-protection considerations, and reduce systemic risk associated with single-source foreign dependence for a critical countermeasure.

Given the continued global circulation of mpox, depletion of orthopoxvirus MVA vaccine stockpiles, and the reliance of the U.S. Strategic National Stockpile on a limited number of approved vaccine suppliers, GeoVax has evaluated regulatory pathways that could support timely development and potential authorization of additional MVA-based vaccine supply. In parallel with longer-term U.S. regulatory considerations, the Company has engaged with international regulatory authorities to pursue development strategies that align with global public-health preparedness needs, address supply constraints across multiple regions, and provide regulatory clarity for late-stage clinical development.

GeoVax has achieved engagement with the European Medicines Agency (EMA), which has established regulatory frameworks for MVA-based vaccines and oversees a centralized authorization process applicable across the European Union. The Company believes that alignment with the EMA may provide a potentially expedited pathway to evaluate GEO-MVA through a comparative immuno-bridging approach against an approved MVA vaccine, while also positioning the program to support broader global procurement and preparedness objectives. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness.

Gedeptin® - Solid Tumor Cancer Therapy

Gedeptin is a novel patented technology for the treatment of solid tumors using a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). In September 2021, GeoVax entered into an assignment and license agreement with PNP Therapeutics, Inc. (PNP), granting GeoVax exclusive worldwide rights to develop and commercialize Gedeptin. The Gedeptin technology was developed with funding support from the National Cancer Institute (NCI), part of the NIH. GeoVax’s license to Gedeptin includes the rights to expand its use to all human diseases and/or conditions including, but not limited to, other solid tumors.

In February 2026, GeoVax entered into an exclusive worldwide license agreement with Emory University for intellectual property covering the use of Gedeptin in combination ICIs. The licensed technology includes patent applications and associated know-how supporting the combination of GDEPT-based tumor debulking with checkpoint blockade within a defined field of use.

In GDEPT, a replication-deficient adenovirus vector is used to infect and transduce tumor cells with a nonhuman gene, which expresses an enzyme capable of converting an inactive prodrug into an active antitumor compound, in situ. A cycle of Gedeptin therapy consists of intra-tumoral injections of Gedeptin followed by administration of a prodrug, fludarabine phosphate, over a pre-defined time period. A Phase 1 dose ranging study, evaluating the safety of a single cycle of Gedeptin therapy, found the therapy to be well tolerated, with evidence of tumor size reduction in patients with solid tumors.

We recently completed a multi-site Phase 1b/2a trial (PNP-002) (ClinicalTrials.gov Identifier: NCT03754933), evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with advanced head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. The PNP-002 trial design involved repeat administration using Gedeptin followed by systemic fludarabine phosphate, in order to gain preliminary information on the utility of multiple cycles of therapy. This trial was intended to guide the design of larger studies involving patients at earlier stages of the disease. This trial was funded in part by the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug designation for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavity sites.

During 2024, we convened a special clinical advisory board to conduct a comprehensive review of the PNP-002 trial results, together with the previously completed Phase 1 trial (PNP-001). This review concluded that Gedeptin demonstrated an acceptable safety and efficacy profile to support continued development. In addition, the therapy demonstrated sufficient tumor stabilization/reduction activity to warrant advancement into an expanded Phase 2 clinical trial.

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ICIs have become a cornerstone of treatment across multiple solid tumor indications; however, a substantial proportion of patients fail to achieve durable responses. GeoVax believes that Gedeptin’s localized tumor-debulking and immune-sensitizing mechanism may complement checkpoint inhibition by increasing antigen release and immune recognition within the tumor microenvironment. The Emory license strengthens GeoVax’s intellectual property position around Gedeptin-based combination therapies and is intended to support current and planned clinical development activities evaluating Gedeptin in combination with ICIs.

We have initiated activities in support of a Phase 2 clinical study, evaluating Gedeptin therapy in combination with an approved ICI as first-line treatment of patients with squamous cell head and neck cancer eligible for curative surgery. The trial is designed to assess major pathological response (MPR) as well as associated immunologic and biomarker outcomes following two pre-surgical cycles of therapy, and event-free survival over a one-year period. Gedeptin’s tumor-targeting and immune-sensitizing mechanism may help overcome the limitations of checkpoint monotherapy by enhancing immune activation within the tumor microenvironment. Necessary planning activities are underway, including protocol development, manufacturing and CRO selection, with the trial anticipated to begin in the first half of 2027.

Coronavirus Vaccine Programs

Severe respiratory illnesses caused by the SARS-CoV-2 virus remain a serious public health issue of international concern. SARS-CoV-2 is an enveloped, single-stranded, positive-sense RNA virus belonging to the family Coronavidae within the genus beta-coronavirus. The genome of SARS-CoV-2 encodes one large Spike (S) protein that plays a pivotal role in viral attachment to the host receptor and entry into host cells. The S protein is the basis for most approved vaccines used to protect against SARS-CoV-2. Neutralizing antibodies targeting the receptor binding domain (RBD) of the S protein block the virus from binding to host cells. Over 90% of all neutralizing antibodies produced in response to infection are directed to the RBD.

COVID-19 vaccines currently authorized for use in in the U.S. are primarily designed to induce antibodies specific for the S protein of SARS-CoV-2 but they rely on different approaches to present the S protien to the immune system, including recombinant proteins, whole inactivated virus, adenovirus vectors (three different types) or mRNA. Continued viral adaptation and mutation has resulted in variants that partially evade neutralization by vaccine-induced antibodies, reducing clinical efficacy. This has required the continued adjustment of vaccine composition and repeated booster administration. Moreover, current vaccines tend to stimulate only modest T-cell responses, which are critical for long-term immune memory and for protection against severe COVID-19. As a result, the FDA has indicated the likely need for continued vaccine updates and at least annual boosters, similar to the approach used for influenza vaccines.

Our vaccine candidate, GEO-CM04S1, utilizes a sMVA vector expressing both spike (S) and nucleocapsid (N) proteins of SARS-CoV-2 and was initially developed at COH Medical Center.

MVA as a viral vaccine vector platform offers several potential advantages:

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MVA has a large genetic coding capacity which provides the foundation for vaccines based on multiple SARS-CoV-2 proteins, rather than a singular focus on the S protein. This approach is intended to induce broader immune responses.

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MVA is known to effectively induce durable T-cell responses in addition to antibodies.

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MVA does not replicate in human cells, contributing to a strong safety profile.

As a result of these properties, MVA is well-suited as a platform for next generation, multi-antigen COVID-19 vaccines, particularly for patient populations with compromised immune systems, including patients with a variety of cancers, organ transplant recipients, and renal dialysis patients.

In a placebo-controlled Phase 1 clinical trial conducted by COH in healthy adults, GEO-CM04S1 was shown to be safe and immunogenic. In November 2021, GeoVax entered into a license agreement with COH, granting exclusive worldwide rights to further develop and commercialize the vaccine. Based on its immunogenicity and safety profile, we believe GEO-CM04S1 is ideally suited for use in immunocompromised patients.

The U.S. Centers for Disease Control and Prevention (CDC) and other global public health agencies identify immunocompromised patients, including patients with solid tumors, hematologic malignancies, stem cell transplants, or CAR-T therapy, as being at highest risk for severe SARS-CoV-2 disease.

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Stem Cell Transplant Study

GEO-CM04S1 is being evaluated in an ongoing Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) to assess its safety and immunogenicity as a primary vaccine, compared to the Pfizer/BioNTech or Moderna mRNA-based vaccines, in blood cancer patients who have previously received an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant, or CAR T cell therapy. The trial is the first to compare an investigational multi-antigenic SARS-CoV-2 vaccine to the current FDA-approved mRNA vaccines in immunocompromised individuals who often exhibit a suboptimal immune response to currently available COVID-19 vaccines. Patient enrollment into this trial was closed at the end of 2025.

CLL Study

GEO-CM04S1 is also being studied in an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355), as a booster vaccine in immunocompromised patients with CLL. Despite high vaccination rates, CLL patients remain at elevated risk for lethal COVID-19 infection due impaired antibody responses to SARS-Cov-2 infections or vaccination. GEO-CM04S1 may induce protective immunity in this patient population by targeting both the S and N protein antigens, potentially mitigating reduced efficacy associated with inadequate antibody responses. The study is evaluating two injections of GEO-CM04S1 administered three months apart, with the Pfizer-BioNTech bivalent vaccine serving as the control arm.

In November 2024, the DSMB conducted an interim review. Following its evaluation, the DSMB recommended continuation of enrollment in the GEO-CM04S1 experimental arm, but discontinuation of the mRNA control arm due to failure to meet the predetermined primary immune endpoint. This outcome suggests a potentially superior immune response in this vulnerable population, however no efficacy conclusions can be drawn until the study is complete. Enrollment of the remaining patient participants is ongoing.

GEO-CM04S1 as a Booster Vaccine

Since GEO-CM04S1 is designed to stimulate both humoral and cellular immune responses against both the S and N proteins, GeoVax believes its administration as a booster may induce a broader and more sustained immune response compared to mRNA boosters. In addition, GEO-CM04S1 addresses the waning effectiveness observed with current COVID-19 vaccines over time, due to the constant sequence variation observed with the S antigen because the N antigen tends not to change significantly amongst variants.

GEO-CM04S1 is being evaluated in a Phase 2 trial (ClinicalTrials.gov Identifier: NCT04639466), as a heterologous booster following FDA-approved mRNA vaccines from Pfizer/BioNTech or Moderna.

The Phase 2 booster study was designed to evaluate the safety and immunogenicity of two dose levels of GEO-CM04S1. The study enrolled 63 healthy adults previously vaccinated with an FDA-approved SARS-CoV-2 mRNA vaccine. Immunological endpoints including binding antibodies, neutralizing antibodies and T-cell responses against variants of concern (VOC), including Delta and Omicron variants.

In February 2024, we announced positive initial safety and immune response findings at one month post-vaccination. Follow-up of enrolled participants was completed in September 2024. No serious adverse events related to vaccination were observed; all adverse events were consistent with those seen following routine vaccinations. Immunological responses included binding antibodies, neutralizing antibodies against multiple variants (including Omicron) and variant-specific T-cell responses. Enrollment for this trial has closed and data readouts are expected in the first half of 2026.

GEO-CM04S1 -- BARDA Project NextGen Award - Phase 2b Trial

In June 2024, we announced our receipt of an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1 in a Phase 2b clinical trial. The RRPV is a consortium funded by the Biomedical Advanced Research Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Advanced Technology International (ATI) administers the RRPV programs on behalf of BARDA.

On April 11, 2025, we received written notification from ATI (the Notice) directing the Company to immediately cease all work related to the ATI-RRPV contract. The Notice instructed GeoVax to halt all activities associated with the project agreement, including all subcontracting, procurement of materials, and any other project-related expenditures. The Notice further indicated that BARDA had determined to terminate the contract for convenience pursuant to the terms of the ATI-RRPV contract. As of receipt of the Notice, GeoVax had met all milestone requirements of the ATI-RRPV contract.

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Other Infectious Disease Programs (Preclinical)

Hemorrhagic Fever Virus Vaccines (Ebola Zaire, Ebola Sudan, Marburg). Ebola (EBOV, formerly designated as Zaire ebolavirus), Sudan (SUDV), and Marburg viruses (MARV) are among the most virulent species of the Filoviridae family, causing hemorrhagic fever illnesses with fatality rates of up to a 90% in humans. In December 2019, FDA approved the first live recombinant Ebola vaccine for the prevention of Ebola disease caused by Zaire virus. This rVSV-ZEBOV, by virtue of being replication competent, may pose risks to immunocompromised individuals, such as those infected with HIV living in West Africa where recent Ebola epidemics originated.

To address the unmet need for a product that can respond to future hemorrhagic fever outbreaks, we are developing vaccines utilizing our GV-MVA-VLP™ platform. This platform is based on the ability of the MVA vaccine vector to encode multiple genes, enabling expression of viral surface and internal matrix proteins that can support the formation of non-infectious virus-like particles (VLP) in vivo. VLP mimic authentic viruses in structure but are neither infectious nor capable of replicating. Immune responses induced against VLP are generally highly efficacious and may prevent infection and/or severe disease.

Our initial preclinical studies in rodents and nonhuman primate, evaluating our GEO-EM01-Z (Ebola-Zaire, EBOV) vaccine candidate, have shown significant levels of protection against lethal doses of EBOV. Recent studies in lethal challenge guinea pig models demonstrated that GeoVax vaccines GEO-EM01-S (Ebola Sudan, SUDV) and GEO-MM01 (Marburg virus, MARV) conferred 100% protection from death. These vaccine candidates were subsequently evaluated in a rigorous cynomolgus macaque infectious challenge model, where they demonstrated protection characterized and reduced viremia, reduced weight loss and decreased mortality following viral challenge. Evaluation of immune responses following vaccination demonstrated the presence of both neutralizing antibodies and functional T cells, indicating a broad immune response that may contribute to optimal protection. The nonhuman primate studies conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the U.S. Department of Defense (DoD) have been completed. Potential clinical development programs are under consideration. Further advancement of these programs will be dependent upon additional funding support via federal grants, corporate collaborations, or other sources.

Government Regulation

Regulation by governmental authorities in the U.S. and other countries is a significant factor in our research, development, manufacturing, and potential commercialization activities. Compliance with applicable regulatory requirements involves substantial time, expense, and expertise, and regulatory outcomes are inherently uncertain.

United States Regulatory Framework - In the U.S., drugs and biologics are subject to extensive regulation by the FDA under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), the Public Health Service Act, and regulations promulgated thereunder, as well as other federal and state statutes and regulations. These laws govern, among other things, preclinical testing, clinical trial conduct, manufacturing, quality control, safety, efficacy, labeling, storage, recordkeeping, approval, advertising, and promotion.

Product development and approval under the FDA regulatory framework are difficult to predict, typically require several years, and involve significant expense. The steps generally required before a vaccine or biologic may be marketed in the U.S. include:

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Preclinical laboratory and in vivo studies;

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Manufacturing and testing in compliance with current Good Manufacturing Practice (cGMP) regulations;

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Submission of an Investigational New Drug (IND) application to the FDA, which must become effective before clinical trials can commence;

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Adequate and well-controlled clinical trials to establish safety and efficacy;

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Submission of a Biologics License Application (BLA) to the FDA, along with applicable user fees; and

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FDA approval of the BLA prior to commercial distribution

Before marketing any biologic for human use in the U.S., the product sponsor must obtain FDA approval. In addition, each manufacturing establishment must be registered with the FDA and is subject to inspection, including pre-approval inspections, to assess compliance with cGMP requirements.

The FDA also has authority to issue Emergency Use Authorizations (EUAs) under Section 564 of the FD&C Act to facilitate the availability and use of medical countermeasures during declared public health emergencies, when certain statutory criteria are met. While this authority may provide a potential pathway for certain products during emergencies, there can be no assurance that any of our product candidates would qualify for, or be granted, an EUA.

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International Regulatory Framework and EMA Engagement - In addition to U.S. regulatory requirements, approval by regulatory authorities in foreign jurisdictions is required prior to the commercial sale of products in those countries. Regulatory systems outside the U.S., including those in the European Union, impose their own requirements governing preclinical studies, clinical trials, manufacturing, and product approval. These requirements may differ materially from those applicable in the U.S., and the time required to obtain approval may be longer or shorter depending on the jurisdiction.

GeoVax has increasingly engaged with non-U.S. regulatory authorities as part of its global development strategy, particularly with respect to GEO-MVA. In Europe, medicinal products are regulated by the EMA through a centralized authorization process applicable across European Union member states.

GeoVax has received formal Scientific Advice from the EMA regarding the clinical and non-clinical development pathway for GEO-MVA. This advice confirmed alignment with the Company’s proposed immuno-bridging strategy, supported progression directly to a single pivotal Phase 3 immuno-bridging clinical trial, and indicated that Phase 1 and Phase 2 studies could be omitted, subject to the absence of unexpected findings. The EMA also concurred with the Company’s proposed immunogenicity endpoints to demonstrate non-inferiority and confirmed the sufficiency of the proposed clinical safety database to support a potential Marketing Authorization Application (MAA) via the centralized procedure.

While regulatory guidance such as Scientific Advice does not guarantee approval, GeoVax believes that this engagement provides clarity regarding regulatory expectations in Europe and supports planning for future development and potential authorization activities outside the U.S.

Manufacturing Oversight and Compliance - Because GeoVax does not currently manufacture vaccines for human use in wholly owned facilities, we must ensure regulatory compliance both in our own operations and in the operations of third-party manufacturers. FDA-regulated manufacturing establishments, including foreign facilities that export products to the U.S., are subject to inspection by the FDA and must comply with applicable cGMP regulations. Similarly, manufacturing facilities supporting products intended for use in Europe are subject to inspection and oversight by EMA-designated authorities.

Regulatory authorities assess compliance through documentation review, inspections, and other enforcement mechanisms. Available enforcement actions range from requests for corrective action to product recalls, facility shutdowns, or other civil or criminal sanctions for serious violations.

Even after regulatory approval, approved products remain subject to ongoing regulatory oversight. Post-approval requirements may include pharmacovigilance, adverse event reporting, manufacturing inspections, labeling changes, and other obligations. The discovery of previously unknown safety issues or failure to comply with regulatory requirements could result in restrictions on marketing or withdrawal of a product from the market.

Other Regulatory Considerations - GeoVax is also subject to various federal, state, and local laws and regulations relating to occupational safety, laboratory practices, animal research, and the handling, storage, and disposal of hazardous materials used in research and manufacturing. Future legislative or administrative actions could increase the extent or scope of regulatory requirements applicable to our operations, although the impact of such changes cannot be predicted.

Recent Government Initiatives

US Regulators and Senior White House and Congressional Leaders have recently announced multiple objectives and initiatives that may impact GeoVax. These include:

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The reshoring and protection of the domestic biotech ecosystem – GeoVax represents the first potential domestic source for MVA (smallpox/mpox vaccine) production which is currently controlled by a single foreign entity.

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Replenishing the U.S. stockpile with additional vaccines addressing critical diseases including mpox, smallpox and hemorrhagic fevers – GeoVax has multiple products in development.

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Assisting African countries in their quest to prevent an array of debilitating illnesses including those caused by hemorrhagic fever viruses – GeoVax has multiple products in development.

FDA Tropical Disease Priority Review Voucher Program

Section 524 of the FD&C Act authorizes the FDA to award priority review vouchers (PRVs) to sponsors of approved tropical disease product applications that meet certain criteria. To qualify for a PRV, a sponsor’s application must be for a drug or biological product for the prevention or treatment of a “tropical disease,” must otherwise qualify for priority review, and must contain no active ingredient (including any salt or ester of an active ingredient) that has been approved in any other application under Section 505(b)(1) of the FD&C Act or Section 351 of the Public Health Services Act. Priority review means that the FDA aims to render a decision in 6 months.

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The PRV may be sold. For example, a small company might win a voucher for developing a drug for a neglected disease and sell the voucher to a large company for use on a commercial disease. The price of the voucher depends on supply and demand. The voucher’s value derives from three factors: shifting sales earlier, longer effective patent life due to earlier entry, and competitive benefits from earlier entry relative to competitors. Top-selling treatments can yield billions in sales each year, so being approved months earlier can be worth hundreds of millions of dollars for the holder of the voucher. Since the first voucher sale in 2014, the price of the vouchers has ranged from $68 million to $350 million.

GeoVax believes that its vaccine programs in Ebola, Sudan, and Marburg may each be eligible for a PRV and we intend to apply for a PRV at the appropriate time. There can be no assurance, however, that we will qualify or be approved for a PRV.

Manufacturing

The successful development and commercialization of our product candidates depend on our ability to manufacture clinical and, ultimately, commercial quantities of product in compliance with applicable regulatory requirements and at an acceptable cost. To date, we have not commercialized any products, and we have not yet demonstrated the ability to manufacture our product candidates at commercial scale. If we are unable to manufacture products in sufficient quantities or in accordance with regulatory standards, whether internally or through third-party manufacturers, our clinical development, regulatory approvals, and potential commercialization efforts could be delayed, which could adversely affect our competitive position and prospects for profitability.

Consistent with industry practice, our manufacturing strategy relies primarily on established third-party contract manufacturing organizations (CMOs) rather than on the construction and operation of wholly owned manufacturing facilities. We currently engage qualified third-party manufacturers to produce clinical trial material in compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements of FDA and, where applicable, the EMA. We believe that our current manufacturing arrangements are sufficient to support our planned clinical development activities; however, manufacturing capacity constraints, contractor availability, cost increases, or the need to qualify alternative suppliers could result in delays or increased expenses.

The raw materials and other supplies used in the manufacture of our vaccines and in our research activities are generally available from multiple commercial suppliers. While we currently do not anticipate material shortages for foreseeable clinical development needs, disruptions in the supply chain, increased demand for specialized materials, or geopolitical factors could affect availability or cost.

Transition to Continuous Cell-Line manufacturing for MVA-Based products

Historically, MVA-based vaccines have been manufactured using primary chicken embryonic fibroblast (CEF) cultures derived from specific-pathogen-free (SPF) eggs. While suitable for limited production volumes and stockpile-oriented use cases, CEF-based manufacturing is labor-intensive, batch-dependent, and constrained in scalability, making it less suitable for sustained commercial production or rapid surge capacity.

To address these limitations, GeoVax has been advancing a transition toward a continuous, cell-line–based manufacturing process for MVA-based vaccines and immunotherapies. Continuous avian cell-line systems are designed to support growth in bioreactors, enabling higher yields, improved process control, and greater consistency relative to traditional primary-cell methods. These attributes are increasingly viewed as important for commercial-scale vaccine manufacturing and for supporting reliable supply in the context of recurring outbreaks or public health emergencies.

In September 2023, GeoVax entered into a commercial, multi-product license agreement for ProBioGen’s AGE1.DR.piX® (AGE1) suspension avian cell line, a validated continuous cell-line platform with demonstrated utility across multiple viral vaccine applications. The AGE1 system is designed to support scalable, serum-free, suspension-based manufacturing in standard bioreactor formats and has been shown to support efficient replication of MVA. GeoVax believes that adoption of this platform has the potential to improve manufacturing yields, reduce production costs, and increase flexibility across its MVA-based development programs, including GEO-MVA.

Implementation of a continuous cell-line manufacturing process represents a significant evolution in GeoVax’s manufacturing approach. If successfully developed and validated, this process could support more reliable scale-up, facilitate technology transfer across manufacturing sites, and reduce dependence on legacy production systems that are constrained by raw material availability and batch throughput. These attributes may be particularly relevant for supporting sustained civilian supply as well as preparedness and biosecurity-related requirements for orthopoxvirus vaccines.

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Manufacturing Progress and Readiness

GeoVax has completed cGMP manufacture and fill-finish of clinical-grade GEO-MVA material to support planned late-stage clinical development activities. In parallel, the Company has continued to strengthen its technical development and CMC capabilities to support process development, scale-up, and regulatory readiness, including the advancement of continuous cell-line manufacturing strategies for its MVA platform.

While we believe that advances in continuous cell-line manufacturing offer the potential for improved scalability and supply resilience, the successful implementation of these processes will require additional development, validation, regulatory review, and capital investment. There can be no assurance that such manufacturing approaches will be successfully implemented on a commercial scale or that they will achieve the anticipated benefits in cost, yield, or supply reliability.

GeoVax is modernizing the Gedeptin manufacturing platform by switching to the CAP Ad™ suspension cell line for manufacturing, a cell line tailored for adenoviral vector production that minimizes replication-competent adenovirus (RCA). The timelines remain aggressive for going through the development phases to GMP manufacture of product, to make it available for the clinic.

Competition

Our product candidates face, and will continue to face, intense competition from large pharmaceutical companies, specialty pharmaceutical and biotechnology companies as well as academic and research institutions. We compete in an industry that is characterized by rapid technological change, evolving industry standards, emerging competition, and new product introductions. Competitors have existing products and technologies that will compete with our pipeline candidates and technologies and may develop and commercialize additional products and technologies that will compete with our pipeline candidates and technologies. Because competing companies and institutions may have greater financial resources than we do, they may be able to provide broader services and product lines; and make greater investments in research and development. Competitors may also have greater development capabilities than we do and have substantially greater experience in undertaking non-clinical and clinical testing of products, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products. They may also have greater name recognition and better access to customers.

We face general market competition from several subsectors of the vaccine development field, including large, multinational pharmaceutical companies including Sanofi, GSK, Merck, Mitsubishi Tanabe, Takeda, and Pfizer; mid-size pharmaceutical companies and emerging biotechnology companies including Dynavax, Novavax, Moderna, BioNTech and Bavarian Nordic; and academic and not-for-profit vaccine researchers and developers including the NIH. The industry is typified by extensive collaboration, licensing, and merger and acquisition activity despite the intense competition.

More than forty COVID-19 vaccines are currently authorized for use in one or more countries around the world, including three in the U.S. (from Pfizer/BioNTech, Moderna, and Novavax). All these vaccines are based on the S protein of the SARS-CoV-2 virus but rely on different mechanisms for presentation or expression of the S antigen, including whole, inactivated virus, defective adenovirus vectors (three different types) or mRNA. Published reports indicated that there are approximately 141 COVID vaccines in various stages of development.

A number of companies are developing various types of therapeutic vaccines or other immunotherapy approaches to treat cancer including Advaxis, Immune Design, Oncothyreon, Bavarian Nordic, Roche Pharmaceuticals, Merck, Bristol Myers Squibb, and AstraZeneca.

There are currently no FDA licensed and commercialized hemorrhagic fever virus vaccines (other than for Ebola Zaire) available anywhere in the world. We are aware of several development-stage and established enterprises, including major pharmaceutical and biotechnology firms, which are actively engaged in vaccine research and development in these areas. For hemorrhagic fever viruses these include NewLink Genetics and Merck, Johnson & Johnson, Novavax, Inovio and GlaxoSmithKline. In December 2019, the FDA approved the first vaccine (ERVEBO®) for prevention of Ebola Zaire, developed by Merck.

Our Intellectual Property

Our commercial success depends in part on our ability, and our licensors’ ability, to obtain and maintain proprietary protection for our clinical product candidates, including our MVA and MVA-VLP-based vaccines, our in-licensed sMVA COVID-19 vaccine candidate, and our in-licensed Gedeptin gene-directed enzyme prodrug therapy, and on methods of treatment using the same.

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We, and in collaboration with our licensors for our in-licensed assets, seek patent protection on each of our products and developmental candidates and, where applicable, on combinations with other therapeutic and/or antigenic agents and dosing schedules. Our success also depends on our ability to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary rights. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. patent applications and, where appropriate, foreign patent applications covering our proprietary technology, inventions, and improvements that are important to the development and implementation of our business. We collaborate with our licensors to ensure the filing of U.S. patent applications and, where appropriate, foreign patent applications covering our in-licensed technology, inventions, and improvements that are important to the development and implementation of our business. We also rely on trade secrets, know-how, continuing technological innovation and potential in-licensing opportunities to develop and maintain our proprietary position. Additionally, we expect to benefit, where appropriate, from statutory frameworks in the U.S., Europe, and other countries that provide a period of clinical data exclusivity to compensate for the time required for regulatory approval of our clinical product candidates.

We continually assess and refine our intellectual property strategies as we develop new technologies and product candidates. We plan to file additional patent applications based on our intellectual property strategies where appropriate, including where we seek to improve our basic technology, adapt to competition, or to improve business opportunities. Further, we plan to file patent applications, as we consider appropriate under the circumstances, to protect new technologies that we develop.

Currently, our owned, co-owned, and in-licensed patent estate, on a worldwide basis, includes 22 granted or allowed U.S. patent applications, 16 pending U.S. patent applications, 30 granted foreign patents, 70 pending foreign patent applications, 1 Patent Cooperation Treaty (PCT) application, and 1 U.S. provisional application spread over 23 patent families. The term of individual patents depends upon the laws of the countries in which they are obtained. In the countries in which we currently file, the patent term is 20 years from the earliest date of filing of a non-provisional patent application which serves as the priority application. In addition, we plan to seek patent term adjustments, restorations, and/or patent term extensions where applicable in the U.S. and other jurisdictions. For example, depending upon the timing, duration, and specifics of FDA approval of our vaccine products, some of our U.S. patents may be eligible for a patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the “Hatch-Waxman Amendments,” and codified as 35 U.S.C. § 156. 35 U.S.C. § 156 permits restoration of the patent term of up to five years as compensation for patent term lost during product development and FDA regulatory review process. Patent term restoration, however, cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally one half the time between the effective date of an IND application and the submission date of a BLA, plus the time between the submission date of a BLA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence. Only one patent applicable to an approved vaccine product is eligible for such an extension and the application for the extension must be submitted prior to the expiration of the patent. The U.S. Patent and Trademark Office (USPTO), in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. A similar kind of patent extension, referred to as a Supplementary Protection Certificate, is available in Europe. Legal frameworks are also available in certain other jurisdictions to extend the term of a patent. We currently intend to seek patent term extensions on any of our, or our exclusively licensed, issued patents in any jurisdiction where we have a qualifying patent and the extension is available; however, there is no guarantee that the applicable regulatory authorities, including the FDA in the U.S., will agree with our assessment of whether such extensions should be granted, and even if granted, the length of such extensions. Further, even if our patent is extended, the patent, including the extended portion of the patent, may be held invalid or unenforceable by a court of final jurisdiction in the U.S. or a foreign country.

We wholly own one granted U.S. patent (U.S. 11,701,418) directed to preventive vaccines against Ebola virus, and two granted U.S. patents (U.S. 11,896,657 and U.S. 12,370,249) directed to Marburg virus and uses thereof. These patents, where issued, valid, and enforceable, will expire in 2036, exclusive of any patent term extensions.

We wholly own one granted U.S. patent (US 11,638,750) directed to preventive vaccines against Zika virus and uses thereof. This patent where issued, valid, and enforceable, will expire in 2037, exclusive of any patent term adjustments.

We wholly own three granted U.S. patents (U.S. 11,311,612, U.S. 11,857,611, and U.S. 12,329,808), and an allowed U.S. patent application directed to preventive vaccines against malaria and use thereof. These applications, where issued, valid, and enforceable, will expire in 2038, exclusive of any patent term adjustments or extensions.

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We wholly own three granted U.S. patents (U.S. 11,278,607, U.S. 11,413,341, and U.S. 12,247,214), and granted foreign applications in Australia, Europe (validated in Germany, Spain, France, Great Britain, Italy, Poland, Turkey, and Switzerland), China, Japan, and India directed to our immuno-oncology vaccine compositions and methods of use thereof. Applications are pending in Canada, China, and Hong Kong. The patent applications of these families, where issued, valid, and enforceable, will expire between 2037-2040, exclusive of any patent term adjustments or extensions.

We wholly own one pending patent family directed to various MVA-based vaccines for the treatment of SARS CoV-2. An application has been allowed in the U.S. Applications are pending in Argentina, Australia, Brazil, Canada, China, Hong Kong, the European Patent Office, Israel, Japan, South Korea, Mexico, South Africa, and Taiwan. The patent applications in this family, if issued, valid, and enforceable, will expire in 2041, exclusive of any patent term adjustments or extensions. We have non-exclusively in-licensed from the NIH two patent families directed to certain aspects of our MVA-viral backbone used in our SARS-CoV-2 vaccine, which will expire between 2027 and 2032. We have non-exclusively in-licensed from the NIH two patent families relating to coronavirus spike protein compositions relevant to our MVA SARS-CoV-2 vaccine candidates. The patent applications for these families, where issued, valid, and enforceable, will expire between 2037 and 2041, exclusive of any patent term adjustments or extensions.

We also wholly own one pending PCT application directed to next generation MVA-based SARS-CoV-2 vaccines. This patent family if issued, valid, and enforceable, will expire in 2046, exclusive of any patent term adjustments or extensions.

We co-own with Leidos, Inc. one patent family directed to viral constructs for use in enhancing T-cell priming during vaccination. Applications have been filed in the U.S., Australia, Brazil, Canada, China, Europe, Hong Kong, Israel, India, Japan, Korea, Mexico, and Taiwan. The patent applications in this patent family, if issued, valid, and enforceable, will expire in 2042, exclusive of any patent term adjustments or extensions.

The MVA we have been using in several of our vaccines was provided to us by the laboratory of Dr. Bernard Moss of the NIAID, Laboratory of Viral Diseases (LVD). We have a non-exclusive commercial license to the NIH MVA for our SARS CoV-2 vaccine with the NIAID of the NIH on behalf of the U.S., which includes the use of certain patents and patent applications arising from the Moss laboratory and the provided materials. This non-exclusive commercial license was further amended in December 2023 to expand the Field of Use to include the use of our SARS-CoV-2 vaccine against smallpox and/or mpox and in February 2026 to expand the Field of Use to provide for a broader range of licensed MVA-SAR-CoV-2 constructs. We also have a non-exclusive research and development license to use the MVA backbone for our other vaccine candidates. If we later decide to commercialize vaccine candidates that are under the research and development license, we will need to negotiate appropriate commercialization licenses. These in-licensed NIH patents and patent applications, if and where issued, valid, and enforceable, will expire between 2027 and 2032.

In November 2022, the Company entered into a Clinical Materials Transfer Agreement (MVA Vaccine Agreement) under which the Company has the right to develop and commercialize the unmodified (parental) MVA 1974/NTH Clone l strain as a vaccine against Mpox and smallpox.

We have exclusively in-licensed five patent families from COH in the field of vaccine products targeted for prevention, reduction, amelioration or treatment of coronaviruses, including SARS-CoV-2, pursuant to an Exclusive License Agreement entered into on November 9, 2021, and as further amended on April 11, 2023. The in-licensed patent families are directed to sMVA vectors, including sMVA vaccines encoding one or more SARS-CoV-2 antigens, and their methods of production and use including for the prevention of a coronavirus and monkeypox infection, and encompass COH04S1, a multi-antigenic pan-SARS vaccine currently undergoing Phase 2 human clinical trials. These in-licensed COH patent families, if issued, valid, and enforceable, will expire between 2041 and 2043, exclusive of any patent term adjustments or extensions.

We have also exclusively in-licensed two additional patent families from COH in the field of vaccine products targeted for prevention, reduction, amelioration, or treatment of SARS-CoV-2 variants. The in-licensed patent families are directed to sMVA vectors, including sMVA vaccines encoding one or more SARS-CoV-2 variant antigens, and their methods of production and use. Applications have been filed in the U.S. These in-licensed COH patent families, if issued, valid, and enforceable, will expire in 2042, exclusive of any patent term adjustments or extensions.

We have exclusively in-licensed two patent families from the University of Alabama at Birmingham (UAB) and the Southern Research Institute (SRI) pursuant to an Assignment and License Agreement with PNP entered into on September 28, 2021. One patent family is directed to the use of tail-mutant purine nucleoside phosphorylase enzymes and fludarabine for the treatment of cancer, and covers aspects of the use of our Gedeptin clinical product candidate. This in-licensed patent family, where issued, valid, and enforceable, will expire in 2029, exclusive of any patent term adjustments or extensions. The other family is directed to the use of tail-mutant purine nucleoside phosphorylase enzymes and fludarabine in further combination with radiation. This in-licensed patent family, where issued, valid, and enforceable, will expire between 2032 and 2034, exclusive of any patent term adjustments or extensions.

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We have exclusively in-licensed one patent family from Emory University pursuant to a License Agreement entered into in February 2026. Applications in this patent family are pending in the U.S. and at the European Patent Office and encompass the use of tail-mutant purine nucleoside phosphorylase enzymes and fludarabine in further combination with an ICI for the treatment of cancer. This in-licensed patent family, where issued, valid, and enforceable, will expire in 2041, exclusive of any patent term adjustments or extensions.

We cannot be certain that any of the current pending patent applications we have or have licensed, or any new patent applications we may file or license, will ever be issued in the U.S. or any other country. Even if issued, there can be no assurance that those patents will be sufficiently broad to prevent others from using our products or processes. Furthermore, our patents, as well as those we have licensed or may license in the future, may be held invalid or unenforceable by a court, or third parties could obtain patents that we would need to either license or to design around, which we may be unable to do. Current and future competitors may have licensed or filed patent applications or received patents and may acquire additional patents or proprietary rights relating to products or processes competitive to ours. In addition, any claims relating to the infringement of third-party proprietary rights, or earlier date of invention, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, divert management’s attention and resources and require us to enter royalty or license agreements which are not advantageous to us, if available at all.

We also expect to benefit, where appropriate, from statutory frameworks in the U.S., Europe, and other countries that provide a period of regulatory exclusivity to compensate for the time and cost required in securing regulatory approval of our clinical products. For example, in 2010, the U.S. enacted the Biologics Price Competition and Innovation Act (BPCIA). Under the BPCIA, innovator manufacturers of biological products may be granted 12 years of exclusive use before biosimilar versions of such products can be licensed for marketing in the U.S. This means that the FDA may not approve an application for a biosimilar version of our products until 12 years after the date the product is approved for sale (with a potential six-month extension of exclusivity if certain pediatric studies are conducted and the results accepted by the FDA), although a biosimilar application may be submitted four years after the date we receive approval from the FDA to sell our product. Additionally, the BPCIA establishes procedures by which potentially relevant patents may be shared and litigation over patents may proceed in advance of approval. The BPCIA also provides incentives to biosimilar applicants by providing a period of exclusivity to the first biosimilar of a product approved by the FDA. The 12-year data exclusivity provision of the BPCIA does not prevent a competitor from seeking marketing approval of one of our products, or a product similar thereto, by submitting its own original BLA.

We intend to benefit, where applicable, from additional market exclusivity provisions in various jurisdictions that reward the treatments of rare diseases. For example, in the U.S. under the Orphan Drug Act of 1983, the FDA may grant orphan designation to a vaccine product intended to prevent or treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the U.S., or more than 200,000 individuals in the U.S. and for which there is no reasonable expectation that the cost of developing and making the product available in the U.S. for this type of disease or condition will be recovered from sales of the product. Orphan designation must be requested before submitting a BLA. After the FDA grants orphan designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication for seven years from the date of such approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety, or providing a major contribution to patient care, or in instances of drug supply issues. Competitors, however, may receive approval of either a different product for the same indication or the same product for a different indication; in the latter case, because health care professionals are free to prescribe products for off-label uses, the competitor’s product could be used for the orphan indication despite our orphan exclusivity.

We are not a party to any litigation, opposition, interference, or other potentially adverse proceeding with regard to our patent positions. However, if we become involved in litigation, interference proceedings, oppositions or other intellectual property proceedings, for example as a result of an alleged infringement or a third-party alleging an earlier date of invention, we may have to spend significant amounts of money and time and, in the event of an adverse ruling, we could be subject to liability for damages, invalidation of our intellectual property and injunctive relief that could prevent us from using technologies or developing products, any of which could have a significant adverse effect on our business, financial conditions or results of operations. In addition, any claims relating to the infringement of third-party proprietary rights, or earlier date of invention, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, divert management’s attention and resources and require us to enter royalty or license agreements which are not advantageous if available at all.

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In addition to patents, we rely upon unpatented, proprietary trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position. We seek to protect our proprietary information, in part, using confidentiality agreements with our commercial partners, collaborators, employees, and consultants, and invention assignment agreements with our employees. 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. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our commercial partners, 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.

Primary License Agreements

City of Hope License – On November 9, 2021, we entered into an Exclusive License Agreement (COH License) with COH, a California nonprofit public benefit corporation, under which the Company obtained exclusive worldwide rights to further develop and commercialize COH04S1, a multi-antigenic SARS-CoV-2 vaccine currently undergoing Phase 2 human clinical trials. The COH License grants GeoVax exclusive rights to key patents, know-how, regulatory filings and clinical materials for use against COVID-19. The terms of the COH License include milestone payments due upon the achievement of selected development, regulatory and sales events. The Company will also pay COH an annual royalty on net sales of products covered by the patents licensed from COH on a country-by-country and licensed product-by-licensed product basis, subject to specified reductions.

Gedeptin License – On September 28, 2021, we entered into an Assignment and License Agreement (Gedeptin License) with PNP, under which the Company obtained exclusive worldwide rights to key intellectual property, including Gedeptin patents, know-how, regulatory filings, clinical materials, and trademarks. The Gedeptin patent portfolio was originally licensed from UAB and SRI by PNP. Under the terms of the Gedeptin License, the Company is the successor to PNP under the Exclusive License Agreement between UAB, SRI, and PNP, and has acquired the exclusive rights to develop and commercialize Gedeptin, a novel patented product for the treatment of solid tumors.

The terms of the Gedeptin License include milestone payments due upon the achievement of selected development and regulatory events. The Company will also pay tiered percentage annual royalties in the low-to-mid teens on Net Sales (as defined in the Gedeptin License) of products covered under the Gedeptin License on a country-by-country and product-by-product basis, subject to specified reductions. The Gedeptin License will remain in effect during the original term, which concludes upon FDA approval of a generic or biosimilar product, and then will automatically renew for additional five-year terms, subject to customary termination rights.

NIH Licenses – On December 16, 2022, the Company entered into a Clinical Materials Transfer Agreement (MVA Vaccine Agreement) under which the Company has the right to develop and commercialize the unmodified (parental) MVA 1974/NIH Clone l strain as a vaccine against mpox and smallpox.

On November 25, 2020, the Company entered into a Patent and Biological Materials License Agreement for Internal Research Use (Research License) with HHS, as represented by NIAID, in support of the Company’s non-clinical development of vaccines against numerous pathogens. The Research License allows GeoVax to use these materials and patent rights owned by agencies of the HHS in combination with the Company’s proprietary technology for the creation of preventive and/or therapeutic MVA-VLP vaccines against Ebola-Zaire virus, Ebola-Sudan virus, Lassa virus, Marburg virus, Zika virus and malaria. The agreement also extends to the Company’s research and development efforts in certain oncology areas. The agreement provides GeoVax with nonexclusive rights for the nonclinical development and manufacturing of its vaccine and immunotherapy candidates using HHS patents and materials.

On October 22, 2020, the Company entered into a Patent and Biological Materials License Agreement (COVID License) with HHS, as represented by NIAID, in support of the Company’s development of a vaccine against SARS-CoV-2, the virus that causes COVID-19. The COVID License allows GeoVax to use these materials and patent rights owned by agencies of the HHS, in combination with the Company’s proprietary technology, for the creation of a preventive MVA-VLP vaccine that primes and/or boosts the immune system against COVID-19. The COVID License provides GeoVax with nonexclusive rights to develop, manufacture and commercialize its COVID-19 vaccine and includes access to NIAID’s patent rights in the stabilized S protein, which is the protein that SARS-CoV-2 uses to gain entry into human tissue. In December 2023, the COVID License was amended to expand GeoVax’s commercial license to include mpox and smallpox as additional indications. In February 2026, the COVID License was further amended to expand GeoVax’s commercial license to include all MVA vaccine constructs against SARS-CoV-2.

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Research and Development

Our expenditures for research and development activities were $18.1 million and $23.7 million during the years ended December 31, 2025 and 2024, respectively. As our vaccines continue to go through the process of obtaining regulatory approval, we expect our research and development costs to increase. We have not yet formulated any plans for marketing and sales of any vaccine candidate we may successfully develop. Compliance with environmental protection laws and regulations has not had a material effect on our capital expenditures, earnings or competitive position to date.

Scientific Advisors

We seek guidance from our Scientific Advisory Board (SAB) on scientific, clinical, translational, and development matters related to our vaccine and immunotherapy programs. Members of the SAB are selected based on their scientific expertise, clinical experience, and leadership in fields relevant to the Company’s development priorities. The SAB provides non-binding advice and does not have decision-making authority with respect to the Company’s operations, development programs, or strategic decisions.

Infectious Disease and Vaccine Scientific Advisory Board - In December 2025, GeoVax announced the formation of an expanded SAB focused on infectious diseases and vaccine development, particularly in support of the Company’s MVA platform and its lead GEO-MVA mpox/smallpox vaccine program. This SAB brings together internationally recognized experts in vaccine immunology, T-cell biology, viral pathogenesis, and clinical research in vulnerable and immunocompromised populations. The collective expertise of this SAB spans antigen design, viral vector immunology, immune durability, clinical trial strategy, and vaccine performance in high-risk populations. The Company believes this expertise is directly relevant to the development and potential global deployment of GEO-MVA and other MVA-based vaccine candidates. Current members of the Infectious Disease and Vaccine SAB include:

Name

Position/Institutional Affiliation

Teresa Lambe, PhD, OBE, FMedSCi

Calleva Head of Vaccine Immunology, Oxford Vaccine Group / Jenner Institute, University of Oxford

Alessandro Sette, Dr. Biol. Sci.

Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology

Lance Turtle, PhD, MBBS, FRCP, DTMH

Chair in Immunity and Infectious Diseases, University of Liverpool and Royal Liverpool Hospital

Thushan I. de Silva, MBBS, PhD, MRCP

Professor of Infectious Diseases and Immunology, University of Sheffield

Joshua A. Hill, MD, FIDSA

Associate Professor, University of Washington School of Medicine and Fred Hutchinson Cancer Center

Oncology Scientific Advisory Board - In February 2026, GeoVax announced the expansion of its Oncology Scientific Advisory Board to support the advancement of Gedeptin®, the Company’s gene-directed enzyme prodrug therapy (GDEPT), across solid tumor indications, including planned combination strategies with ICIs. The expanded Oncology SAB is intended to provide scientific, translational, and clinical guidance related to oncology drug development, immuno-oncology combination strategies, early- and mid-stage clinical trial design, biomarker strategy, and regulatory-aligned development pathways as Gedeptin advances in combination and neoadjuvant clinical settings. These advisors bring experience spanning translational medicine, immuno-oncology drug development, checkpoint inhibitor combination strategies, and early-phase to neoadjuvant clinical trial execution. The Company believes this expertise is relevant to the continued evaluation of Gedeptin as a localized, immune-sensitizing therapy intended to complement systemic immuno-oncology approaches. Current members of the Oncology SAB include:

Name

Position/Institutional Affiliation

Chas Bountra, PhD, OBE

Professor of Translational Medicine, University of Oxford; former Pro-Vice-Chancellor for Innovation, University of Oxford; former Vice President and Head of Biology, GlaxoSmithKline

Marc S. Ernstoff, MD

Director, Experimental Cell Therapy, Dartmouth Health; former Chief, Immuno-Oncology Branch, National Cancer Institute

Anthony J. Olszanski, MD, RPh

Professor of Medicine and Vice Chair for Clinical Research, Fox Chase Cancer Center

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GeoVax may further evolve the composition and scope of its SABs over time as its development priorities advance. There can be no assurance regarding the timing, scope, or impact of advisory input on the outcome of any development program.

Human Capital Resources

We currently have nineteen full-time employees. None of our employees are covered by collective bargaining agreements and we believe that our employee relations are good. We also engage consultants and independent contractors to fulfill key roles and/or provide expert services on both an ongoing and short-term basis.

We believe that our future success largely depends upon our continued ability to attract and retain highly skilled employees. We provide our employees with competitive compensation, opportunity for equity ownership, and a robust employment package that promotes wellness across all aspects of their lives, including healthcare, retirement planning, and paid time off.

Corporate Background

Our primary business is conducted by our wholly owned subsidiary, GeoVax, Inc., which was incorporated under the laws of Georgia in June 2001. Our address is 1955 Lake Park Drive, Suite 300, Smyrna, Georgia 30080, and our telephone number at that address is 678-384-7220. The predecessor of our parent company, GeoVax Labs, Inc. (the reporting entity) was originally incorporated in June 1988 under the laws of Illinois as Dauphin Technology, Inc. (Dauphin). In September 2006, Dauphin completed a merger with GeoVax, Inc. As a result of the merger, GeoVax, Inc. became a wholly owned subsidiary of Dauphin, and Dauphin changed its name to GeoVax Labs, Inc. In June 2008, the Company was reincorporated under the laws of Delaware. We currently do not conduct any business other than GeoVax, Inc.’s business of developing new products for the treatment or prevention of human diseases. Our principal offices are in Smyrna, Georgia (metropolitan Atlanta).

Available Information

Our website address is www.geovax.com. We make our filings with the U.S. Securities and Exchange Commission (SEC), such as proxy statements, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports available on this website under “Investors – SEC Reports,” free of charge, as soon as reasonably practicable after we electronically file or furnish such materials to the SEC. We also make available our Code of Business Conduct on this website under the heading “Investors – Corporate Governance”. Information contained on our website is not incorporated into this Annual Report.