Tag: GeoVax Labs

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Release – GeoVax Initiates Outreach Regarding Future Procurement of GEO-MVA Mpox/Smallpox Vaccine

Posted on March 11, 2026March 11, 2026 by aweinsoff@channelchek.com

Program Reaches Strategic Inflection Point as GEO-MVA Advances Toward Pivotal Phase 3 Study

Atlanta, GA – March 11, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today announced that it has begun engaging with global health and preparedness organizations to explore potential future procurement of its GEO-MVA vaccine candidate for mpox and smallpox preparedness programs.

GeoVax has initiated discussions and is soliciting interest from international organizations that influence or directly procure mpox/smallpox vaccines. These organizations play key roles in recommending or directly procuring vaccines for national preparedness stockpiles and international outbreak response programs.

The outreach reflects growing global recognition of the need to diversify supply of Modified Vaccinia Ankara (MVA) vaccines used for protection against mpox and smallpox. Currently, global supply of MVA vaccines is concentrated in a single commercial manufacturer.

Global preparedness programs for smallpox and mpox vaccines represent a potential multi-billion-dollar procurement market supported by national stockpiles, military preparedness programs, and international health organizations. Governments have invested billions of dollars in medical countermeasure stockpiles over the past two decades, and demand for MVA-based vaccines is expected to further expand as mpox continues to emerge as a recurring global health threat.

GeoVax believes that initiating engagement with procurement and preparedness organizations represents an important transition from development toward commercialization planning, reflecting growing confidence in the GEO-MVA program and the potential for the vaccine to contribute to global preparedness stockpiles following successful completion of the planned Phase 3 study, scheduled to initiate in the second half of 2026.

Advancing GEO-MVA Through an Expedited Regulatory Pathway

GeoVax’s GEO-MVA program has progressed through an extensive regulatory dialogue with the European Medicines Agency (EMA), culminating in scientific advice in support of an expedited development pathway based on a single immunobridging trial to the licensed MVA vaccine.

“The EMA carefully evaluated the scientific evidence over an extended period before confirming an expedited pathway. We believe their guidance validates both the scientific foundation of GEO-MVA and the growing recognition that expanding the global MVA vaccine supply is an important public health priority,” said David Dodd, Chairman and Chief Executive Officer of GeoVax.

“We have also been encouraged by the positive response we are receiving from global health organizations and preparedness agencies as we initiated these discussions,” Dodd continued. “We view this engagement as an endorsement of the progress we have made, our commitment to advancing GEO-MVA, and the potential of GEO-MVA to help address the current worldwide need for expanded MVA vaccine supply. Importantly, it also represents a critical step toward commercialization of GEO-MVA and the potential generation of meaningful revenues through government and global health procurement programs as the program advances through its final development stages.”

Implications for Global Preparedness and Biodefense Readiness

The discussions initiated by GeoVax occur amid growing policy dialogue regarding the strategic importance of expanding global MVA vaccine manufacturing capacity. GeoVax believes GEO-MVA has the potential to become a strategically important medical countermeasure supporting both global public health preparedness and national biodefense initiatives.

Recent mpox outbreaks have reinforced the understanding that mpox is not a single episodic event, but rather an evolving infectious disease threat with potential for continued geographic expansion and recurrence. As a result, governments and international health organizations are increasingly emphasizing the need for manufacturing diversification and supply redundancy for vaccines used in outbreak response and biodefense preparedness.

In the United States, policymakers and defense stakeholders have increasingly recognized that no domestic manufacturing capability currently exists for MVA vaccines, a gap with implications for both civilian preparedness and military readiness.

“Establishing additional MVA manufacturing capability is increasingly viewed as an important component of global preparedness,” said Dodd. “We are seeing growing interest from public health organizations, governments, and defense stakeholders who recognize the strategic importance of supply diversification.”

About GEO-MVA

GEO-MVA is GeoVax’s candidate vaccine for protection against mpox and smallpox based on the Modified Vaccinia Ankara (MVA) platform. Pending successful completion of the planned immunobridging trial, GEO-MVA could represent an important additional source of MVA vaccine supply for global preparedness, outbreak response, and biodefense programs.

About GeoVax

Forward-Looking Statements

Company Contact:

678-384-7220

Media Contact:

Jessica Starman

Release – GeoVax Announces Oncology Advisory Board to Advance Gedeptin® Development Across Solid Tumors

Posted on February 24, 2026February 24, 2026 by aweinsoff@channelchek.com

Members Bring Deep Expertise in Immuno-Oncology, Translational Medicine, and Checkpoint Inhibitor Combination Strategies

ATLANTA, GA – February 24, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines for cancers and infectious diseases, today announced the formation of its Oncology Advisory Board with the appointment of three internationally recognized leaders in immuno-oncology, translational medicine, and clinical development.

This Advisory Board will play a central role in guiding the scientific, translational, and clinical advancement of GeoVax’s oncology program, focused primarily on Gedeptin®, the company’s gene-directed enzyme prodrug therapeutic (GDEPT). GeoVax plans to conduct a Phase 2 trial with Gedeptin in the neoadjuvant setting, pairing it with an immune checkpoint inhibitor (ICI) in locally advanced head and neck squamous cell carcinoma. In parallel, it will be evaluating combination Gedeptin + ICI strategies across additional solid tumor indications.

Oncology Advisory Board Members

Chas Bountra, PhD, OBE
Professor of Translational Medicine, University of Oxford
Former Pro-Vice-Chancellor for Innovation, University of Oxford
Former Vice President & Head of Biology, GlaxoSmithKline

Dr. Bountra brings extensive leadership spanning academia, biotech, and global pharmaceutical R&D. He is widely recognized for building translational drug discovery engines, advancing novel therapeutic modalities into the clinic, and creating high-impact academic–industry partnerships. His expertise in translational medicine, drug development strategy, and innovation ecosystems will support Gedeptin’s progression from proof-of-concept to clinically scalable development programs aligned with regulatory and partnership pathways.

Marc S. Ernstoff, MD
Director, Experimental Cell Therapy, Dartmouth Health
Former Chief, Immuno-Oncology Branch, National Cancer Institute (NIH)

Dr. Ernstoff is a recognized pioneer in cancer immunotherapy with significant experience across cytokine therapy, checkpoint inhibitors, and combination immuno-oncology trials. His career includes leadership roles at the National Cancer Institute, Roswell Park Comprehensive Cancer Center, Dartmouth-Hitchcock, and Yale, with direct involvement in numerous landmark immunotherapy studies. His expertise will inform Gedeptin’s clinical positioning, trial design considerations, and biomarker-driven evaluation alongside immune checkpoint inhibitors, as well as its potential role in immune-sensitizing solid tumors.

Anthony J. Olszanski, MD, RPh
Professor of Medicine and Vice Chair for Clinical Research
Fox Chase Cancer Center

Dr. Olszanski is a nationally recognized leader in early-phase oncology drug development, with deep experience running first-in-human and Phase 1/2 trials across solid tumors, including multiple checkpoint inhibitor combinations, oncolytic approaches, and novel immune-modulating agents. His background in clinical pharmacology and trial execution will be instrumental as GeoVax advances Gedeptin into combination, neoadjuvant, and expansion-stage clinical settings.

Strategic Focus: Advancing Gedeptin in Combination Immuno-Oncology

This Oncology Advisory Board, with expertise in oncology and translational medicine, reflects GeoVax’s increasing focus on Gedeptin as a differentiated immune-sensitizing platform, particularly in combination with immune checkpoint inhibitors. Gedeptin’s intratumoral delivery and localized tumor-debulking mechanism are designed to enhance antigen release and immune activation within the tumor microenvironment – an approach that may complement and extend the efficacy of systemic checkpoint blockade.

In addition to scientific strategy, these advisors will provide integrated guidance on clinical trial design, translational biomarker strategy, patient selection, and regulatory-aligned development pathways as Gedeptin advances through combination and neoadjuvant clinical programs.

David A. Dodd, Chairman & Chief Executive Officer of GeoVax, commented: “The addition of these three exceptional oncology leaders significantly strengthens our scientific and clinical foundation as we advance Gedeptin into its next stage of development. Their collective experience – from early drug discovery through late-stage immuno-oncology trials and regulatory strategy – directly aligns with our goal of positioning Gedeptin as a novel immune-sensitizing therapy across solid tumors.”

Kelly T. McKee, MD, Chief Medical Officer of GeoVax, added: “Gedeptin sits at the intersection of localized tumor control and systemic immune activation. As checkpoint inhibitors move earlier in treatment paradigms, including neoadjuvant settings, expert guidance on trial design, patient selection, and translational endpoints is critical as we move into clinically consequential combination strategies. We anticipate that this Advisory Board will provide precisely that level of integrated scientific and clinical insight.”

About Gedeptin®

Gedeptin® is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally using a non-replicating viral vector encoding purine nucleoside phosphorylase (PNP). Following systemic administration of a prodrug, the encoded enzyme converts it into a cytotoxic agent directly within the tumor microenvironment, selectively destroying tumor cells while promoting immune recognition. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and has received Orphan Drug Designation for oral and pharyngeal cancers.

About GeoVax

Forward-Looking Statements

Company Contact:

678-384-7220

Media Contact:

Jessica Starman

Release – GeoVax Endorses Global Call to Sustain Mpox Response as Evidence Confirms Epidemic Is Far from Over

Posted on February 17, 2026February 17, 2026 by aweinsoff@channelchek.com

Company Highlights GEO-MVA Manufacturing Readiness and Clear Clinical Pathway to Support Global Supply Diversification

ATLANTA, GA – February 17, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today issued a statement endorsing the urgent call to action articulated by Rosamund Lewis, MD (WHO Head, Poxviruses Programme) and colleagues in their recently published PLOS Medicine article, “The mpox epidemic is not over: Reducing disproportionate burden in Africa and persistent global risk require a sustained response.” (https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1004893&type=printable)

The article underscores that, despite declining attention in some regions, mpox transmission, morbidity, and mortality continue, particularly across Africa, driven by evolving viral clades, constrained vaccine supply, and persistent inequities in access to countermeasures. Dr. Lewis reinforced these concerns in a recent public call to action, emphasizing that sustained political will, financing, and expanded vaccine availability remain essential to controlling mpox as a global health threat.

“GeoVax strongly endorses Dr. Lewis’s message that the mpox epidemic is not over and that complacency would be a costly mistake,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “The data are clear: mpox continues to circulate, evolve, and disproportionately impact vulnerable populations. A durable response requires sustained investment, diversified vaccine supply, and readiness that extends beyond reactive surge manufacturing.”

GEO-MVA: Advancing Toward an Expanded Global MVA Vaccine Supply

GeoVax’s GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine for the prevention of mpox and smallpox, is being developed specifically to help address the structural vulnerabilities highlighted in the PLOS Medicine analysis – most notably the world’s continued dependence on a single manufacturer for licensed MVA vaccine supply.

Key GEO-MVA program milestones include:

Completion of GEO-MVA clinical material, positioning the program for late-stage clinical execution and supply readiness
Planned initiation of a pivotal Phase 3 immunobridging study in Q4 2026, aligned with formal Scientific Advice from the European Medicines Agency supporting an expedited registration pathway
Anticipated availability of immunobridging results in Q2 2027, supporting potential regulatory submissions and procurement discussions

“With a clearly defined regulatory pathway ahead, GEO-MVA is transitioning from preparedness planning to execution,” Dodd added. “This program is designed not only to meet regulatory requirements, but to support long-term global readiness by expanding MVA vaccine capacity in a market that remains chronically supply-constrained.”

Sustained Preparedness Requires Sustained Supply

The PLOS Medicine authors emphasize that mpox will continue to pose a global risk due to ongoing zoonotic spillover, viral evolution, and efficient transmission networks, particularly in settings where health systems are under-resourced. GeoVax believes these realities reinforce the need for redundant, geographically diversified MVA manufacturing capacity – a principle that underpins the GEO-MVA program.

“As the mpox response evolves from emergency reaction to long-term control, vaccine supply resilience becomes a cornerstone of preparedness,” said Dodd. “GeoVax is committed to supporting that objective by advancing GEO-MVA as an additional MVA vaccine option for public-health and biodefense stakeholders worldwide.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

Company Contact:

678-384-7220

Media Contact:

Jessica Starman

Release – GeoVax Labs Announces $1 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

Posted on February 13, 2026February 13, 2026 by aweinsoff@channelchek.com

ATLANTA, GA, February 13, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX) (the “Company”), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into definitive agreements for the purchase and sale of 432,902 shares of its common stock (or pre-funded warrants in lieu thereof) at a purchase price of $2.31 per share (or pre-funded warrant in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (the “Offering”). In a concurrent private placement, the Company will issue unregistered series A-1 warrants to purchase up to 432,902 shares of common stock and unregistered series A-2 warrants to purchase up to 432,902 shares of common stock. The warrants will have an exercise price of $2.31 per share and will be exercisable beginning on the effective date of shareholder approval of the issuance of the shares of common stock upon exercise of the warrants. The series A-1 warrants will expire five years after the date of shareholder approval and the series A-2 warrants will expire two years after the date of shareholder approval.

The closing of the Offering is expected to occur on or about February 17, 2026, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $1 million, before deducting placement agent fees and other estimated offering expenses. The Company intends to use the net proceeds from the Offering to advance its product candidates, including research and development, manufacturing, clinical studies, and working capital.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the Offering.

The shares (or pre-funded warrants) (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) in the registered direct offering described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-277585) previously filed with the Securities and Exchange Commission (the ”SEC”) and declared effective by the SEC on March 13, 2024. The registered direct offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the registered direct offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 236,000 shares of the Company’s common stock that were previously issued to the investors in July 2025, with an exercise price of $4.35 per share, respectively, effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $2.31 per share and will be exercisable beginning on the effective date of shareholder approval of the issuance of the shares upon exercise of the warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans, including, but not limited to, statements regarding the completion of the offering, the satisfaction of customary closing conditions related to the offering, the receipt of shareholder approval and the anticipated use of proceeds from the offering. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Company Contact:

678-384-7220

Media Contact:

Jessica Starman

Release – GeoVax Highlights 2026 as a Pivotal Year for Progress

Posted on January 20, 2026January 20, 2026 by aweinsoff@channelchek.com

Management Highlights 2026 as a Portfolio-Wide Inflection Year Driven by Regulatory De-Risking, Clinical Readouts, and Scalable Manufacturing

ATLANTA, GA – January 20, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today provided a post-conference update following the J.P. Morgan Healthcare Conference Week in San Francisco, where, during investor, banker and partner engagements, the Company outlined 2026 as a pivotal inflection year driven by multiple late-stage clinical, regulatory, and manufacturing milestones across its diversified portfolio.

“GeoVax enters 2026 with increasing clarity on execution, prioritization, and value creation,” said David Dodd, Chairman & CEO of GeoVax. “With GEO-MVA representing an expedited path to potential commercialization, alongside multiple clinical data readouts relative to GEO-CM04S1, our multi-antigen COVID-19 vaccine and, the anticipated initiation of the Phase 2 Gedeptin^® trial, we believe that this year will provide a meaningful convergence of regulatory, clinical, and manufacturing catalysts for the Company.”

Dodd added, “We were particularly encouraged by the level of interest and the quality of discussions we had during JP Morgan/Biotech Showcase with investors, potential strategic partners, and global health stakeholders. The feedback we received around GeoVax’s progress, our differentiated platforms, and our regulatory momentum, especially for GEO-MVA, reinforces our confidence that 2026 has the potential to be a pivotal breakout year for the Company.”

GEO-MVA (Mpox & Smallpox): Expedited Path to Commercialization in a Currently Constrained Market

GEO-MVA is GeoVax’s most advanced program and represents the Company’s near-term opportunity for potential commercialization. The global Mpox and smallpox vaccine market remains constrained by reliance on a single foreign manufacturer whose production capacity has proven insufficient to meet sustained worldwide demand, particularly during periods of expanding or recurring outbreaks. This structural supply imbalance underscores both the commercial opportunity and the public health imperative for an additional, scalable MVA vaccine source.

Following receipt of supportive Scientific Advice from the European Medicines Agency (EMA), GeoVax has regulatory alignment on a single, pivotal Phase 3 immunobridging study versus the approved MVA vaccine. This guidance supports an expedited development pathway and meaningfully de-risks the regulatory route toward potential approval and revenue generation.

Key 2026 milestones for GEO-MVA include:

Initiation of the pivotal Phase 3 immunobridging trial, expected in the second half of 2026
Continued engagement with European and global health authorities seeking to diversify Mpox and smallpox vaccine supply in light of ongoing global demand pressures
Advancement toward a U.S.-sourced vaccine supply model addressing both civilian public health needs and biodefense preparedness

With GEO-MVA clinical material manufactured and fill-finish completed, the program is positioned to transition from development into Phase 3 execution in 2026, reinforcing its role as GeoVax’s lead value driver and shortest path to potential commercialization.

Gedeptin® (Oncology): Advancing Toward Combination-Driven Value Inflection

In oncology, GeoVax continues to advance Gedeptin^®, its gene-directed enzyme prodrug therapy, following encouraging safety and tumor-response signals from prior clinical studies.

Key 2026 inflection points include:

Publication of results from the recently completed Gedeptin trial
Initiation of a Phase 2 study evaluating Gedeptin in combination with an immune checkpoint inhibitor as a potential first-line therapy for head and neck cancer by year-end
Updates on preclinical evaluations of Gedeptin in combination with immune checkpoint inhibitors, informing potential expansion into additional solid tumor indications.

GeoVax continues to pursue a partnership-oriented development strategy for Gedeptin, designed to advance the program efficiently while preserving long-term upside.

GEO-CM04S1 (COVID-19): Multiple Clinical Data Readouts

GeoVax’s next-generation COVID-19 vaccine, GEO-CM04S1, continues to advance as a differentiated, multi-antigen (Spike + Nucleocapsid) candidate designed to address unmet needs in immunocompromised and high-risk populations inadequately served by current single-antigen vaccines.

During 2026, the Company expects:

Clinical data readouts from ongoing Phase 2 trials
Continued evaluation of GEO-CM04S1 as both a primary and booster vaccine in immunocompromised populations
Additional translational insights supporting future regulatory and partnering discussions

AGE1 Continuous Cell-Line Manufacturing: Advancing MVA Scalability and Supply

The AGE1 continuous avian cell-line manufacturing process has the potential to significantly improve how MVA-based vaccines are produced by addressing historical scalability and supply constraints. By enabling continuous, cell-line–based production, AGE1 provides a more reliable and scalable alternative to traditional chicken embryo fibroblast–dependent methods.

AGE1 is directly integrated into the GEO-MVA program, strengthening GeoVax’s ability to support sustained commercial supply, rapid scale-up, and domestic manufacturing – capabilities increasingly critical as global demand for Mpox and smallpox vaccines exceeds available supply.

Manufacturing progress anticipated during 2026 includes:

Continued optimization of the AGE1 process to support commercial-scale GEO-MVA production
Advancement of AGE1 as a scalable, U.S.-based manufacturing solution aligned with pandemic preparedness and supply-chain resilience priorities

Positioned for Execution

Collectively, these milestones reflect GeoVax’s transition into a catalyst-rich period where multiple programs are advancing in parallel toward late-stage development, regulatory decision points, and potential commercialization pathways.

“As we emphasized during JP Morgan/Biotech Showcase Week, GeoVax has moved beyond platform validation,” Dodd added. “We are now executing against clearly defined milestones, with GEO-MVA leading the portfolio and multiple additional programs advancing toward value-inflection events in 2026 and beyond.”

Dodd concluded, “As we move through 2026, GeoVax is entering a phase where years of platform development, regulatory engagement, and manufacturing investment begin to translate into tangible outcomes. With GEO-MVA advancing along a clearly defined path toward commercialization, multiple clinical data readouts expected across our COVID-19 and oncology programs, and a scalable manufacturing foundation in place, we believe GeoVax is well positioned for a pivotal year of execution and value creation.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

Company Contact:

678-384-7220

Media Contact:

Jessica Starman

Release – GeoVax to Raise Approximately $3.2 Million of Gross Proceeds in Public Offering

Posted on December 19, 2025December 19, 2025 by aweinsoff@channelchek.com

Atlanta, GA, December 19, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into definitive securities purchase agreements with several institutional and individual investors for the purchase and sale of approximately 13.2 million units, each comprised of one share of the Company’s common stock and warrants, as described below, to purchase shares of the Company’s common stock, at a price of $0.245 per unit in a public offering. The Company will issue warrants to purchase up to approximately 26.5 million shares of common stock. The warrants will have an exercise price of $0.245 per share, will be exercisable immediately following the date of issuance and will have a term of five years following the date of issuance.

Roth Capital Partners is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $3.2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. The closing of the offering is expected to occur on or about December 22, 2025, subject to the satisfaction of customary closing conditions.

The shares in the offering described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-292127) previously filed with the Securities and Exchange Commission (the ‘SEC’) and declared effective by the SEC on December 19, 2025. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

Company Contact:

678-384-7220

Media Contact:

Jessica Starman

Release – GeoVax Receives Formal EMA Scientific Advice Supporting Pivotal Phase 3 Immunobridging Trial for GEO-MVA

Posted on December 18, 2025December 18, 2025 by aweinsoff@channelchek.com

EMA Concurrence Enables Acceleration Toward Phase 3 Initiation and Represents a Major Milestone on GeoVax’s Path to Commercialization

ATLANTA, GA – December 18, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today announced that it has received formal Scientific Advice (SA) from the European Medicines Agency (EMA) confirming regulatory alignment on the Company’s proposed pivotal Phase 3 immunobridging trial design for GEO-MVA, its Modified Vaccinia Ankara (MVA)-based vaccine candidate for the prevention of Mpox and smallpox.

The EMA’s feedback concurs with GeoVax’s proposed strategy to evaluate GEO-MVA through a single, pivotal Phase 3 immuno-bridging study versus the approved MVA vaccine, Imvanex®, and supports the Company’s plan to proceed directly into this trial without the need for additional Phase 1 or Phase 2 clinical studies. Receipt of this formal Scientific Advice represents a significant regulatory milestone and enables GeoVax to accelerate operational planning toward implementation and initiation of the Phase 3 program, currently projected to begin in the second half of 2026.

“This formal Scientific Advice from EMA represents a pivotal step forward for GEO-MVA and meaningfully de-risks our regulatory path in Europe,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “EMA’s concurrence positions GeoVax to move efficiently toward a single, registrational Phase 3 study. This is a major milestone on our path toward commercialization.”

The Scientific Advice confirms that non-inferiority immunogenicity endpoints are acceptable to support a future Marketing Authorization Application (MAA) and that GeoVax’s proposed clinical safety database is sufficient to support registration, assuming successful trial outcomes. Importantly, EMA’s feedback provides clarity and confidence across proposed clinical and quality dimensions, allowing the Company to focus on execution rather than redesign of its development strategy.

The receipt of this advice follows GeoVax’s previous announcement of favorable preliminary EMA guidance announced in June 2025 and marks the transition from regulatory alignment to regulatory execution. Together, these milestones substantially strengthen GEO-MVA’s development profile and reinforce its potential role in expanding global Mpox and smallpox vaccine supply beyond the current single-supplier paradigm.

“With formal EMA Scientific Advice now in hand, GEO-MVA moves from a conceptual regulatory pathway to a clearly defined and executable development plan,” Dodd added. “As global health authorities continue to emphasize preparedness, resilience, and diversification of vaccine supply, we believe GEO-MVA is well positioned to play an important role.”

About GEO-MVA

GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine candidate being developed for the prevention of Mpox and smallpox. GEO-MVA leverages the well-characterized MVA platform and is designed to support both civilian public health needs and broader preparedness objectives.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

Company Contact:

678-384-7220

Media Contact:

Jessica Starman

Release – GeoVax Announces Publication of Study Demonstrating Cross-Variant Protection Using the Multi-Antigen GEO-CM04S1 Vaccine

Posted on December 18, 2025December 18, 2025 by aweinsoff@channelchek.com

Animal Models Show Full Protection Against Omicron Variant Despite Absence of Neutralizing Antibodies, Highlighting Critical Importance of T-cell Immunity for Next-generation COVID-19 Vaccines

ATLANTA, GA – December 18, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and cancer, today announced the publication of a peer-reviewed article in Frontiers in Immunology titled: “Multi-antigen MVA-vectored SARS-CoV-2 vaccine, GEO-CM04S1, induces cross-protective immune responses to ancestral and Omicron variants.”

The study provides definitive preclinical evidence that GeoVax’s multi-antigen COVID-19 vaccine candidate, GEO-CM04S1, delivers full cross-variant protection, driven predominantly by robust T-cell responses, even in the absence of neutralizing antibodies.

The findings reinforce the design philosophy behind GeoVax’s MVA-based, multi-antigen platform and provide mechanistic insight that is increasingly relevant for immunocompromised individuals, who often fail to respond optimally to the first-generation COVID-19 vaccines.

Study Highlights: Multi-Antigen Breadth and T-Cell Immunity Drive Protection

The study evaluated GEO-CM04S1 in the K18-hACE2 lethal mouse model, comparing immune responses and efficacy to experimental MVA-vectored vaccine constructs expressing spike alone (S) or nucleocapsid alone (N). Key findings include:

Full protection against both ancestral B.1 and Omicron XBB.1.5: Only GEO-CM04S1 (S+N) maintained 100% survival, preventing weight loss, severe lung inflammation, and virus replication in both upper and lower airways.
Protection against XBB.1.5 occurred despite no detectable neutralizing antibodies: Neutralization assays showed zero detectable neutralizing activity against XBB.1.5 in any group – yet GEO-CM04S1-vaccinated animals were fully protected. This indicates immunity was not antibody-dependent.
CD4+ T cells were identified as the critical effector of protection: Antibody-mediated depletion studies showed:
- Loss of CD4+ T cells eliminated vaccine protection, leading to high viral loads and severe lung pathology.
- Depletion of CD8+ T cells or B cells had minimal impact on vaccine efficacy.
- These results confirm T cell responses as the critical component of vaccine-induced immune responses capable of providing cross-variant protection.
Multi-antigen design (Spike + Nucleocapsid) outperformed spike-only vaccines: GEO-CM04S1 delivered broader and more durable immunity than spike-only MVA vaccines – especially when spike was mismatched to circulating variants.

“This publication provides significant evidence supporting the unique value of a multi-antigen designed to induce high levels of T-cell responses and validates the core design principles that differentiate our vaccine from first-generation, spike-only approaches,” said Mark Newman, PhD, Chief Scientific Officer of GeoVax.

Dr. Newman added: “These findings support the belief that the GEO-CM04S1 vaccine could be a highly relevant product for use in immunocompromised patients, because of the ability to protect through strong, multi-antigen T-cell immunity.”

“This peer-reviewed study provides a compelling scientific foundation for the ongoing clinical advancement of GEO-CM04S1,” stated David Dodd, Chairman & CEO of GeoVax. “As SARS-CoV-2 continues to evolve, it is increasingly clear that next-generation vaccines must move beyond spike-only strategies. GEO-CM04S1 demonstrates the breadth, durability, and variant-proof characteristics that global public-health leaders have been calling for.”

Dodd continued: “More than 40 million immunocompromised individuals in the U.S. alone remain underserved by existing vaccines. The results published in Frontiers in Immunology strengthen the rationale behind our multiple ongoing Phase 2 studies in immunocompromised patient populations.”

About GEO-CM04S1

GEO-CM04S1 is an MVA-vectored vaccine encoding both the Spike (S) and Nucleocapsid (N) proteins from SARS-CoV-2, designed to induce:

Strong CD4+ and CD8+ T-cell responses
Durable immunity supported by conserved N-protein recognition
Multi-antigen breadth that mitigates loss of protection as the virus mutates

GEO-CM04S1 is currently being evaluated in multiple Phase 2 clinical trials in immunocompromised patients, including individuals with hematologic cancers and chronic lymphocytic leukemia.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

Company Contact:

678-384-7220

Media Contact:

Jessica Starman

Release – GeoVax Announces Completion of GEO-MVA Fill-Finish, Supporting Phase 3 Immunobridging Clinical Trial Start-Up in Early 2026

Posted on December 17, 2025December 17, 2025 by aweinsoff@channelchek.com

Milestone Advances Clinical Readiness and Reinforces Urgent U.S. Need for Domestic MVA Vaccine Capacity

ATLANTA, GA – December 17, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today announced the successful completion of fill-finish for the initial clinical batch of GEO-MVA, its next-generation Mpox/smallpox vaccine. The product has now entered final release evaluation, the concluding quality-control and compliance process required before shipment for clinical use, positioning the Company for Phase 3 immunobridging trial start-up activities in Q1 2026.

Clinical and Regulatory Milestone

Fill-finish – the sterile, cGMP-regulated process of filling, sealing, and packaging vaccine vials – marks the last manufacturing step before a vaccine may enter clinical study supply channels. With fill-finish complete and GEO-MVA now undergoing final release evaluation, GeoVax has moved into the final pre-clinical-deployment phase of its EMA-aligned clinical program.

In June 2025, the European Medicines Agency (EMA) Scientific Advice confirmed that a single Phase 3 immunobridging study demonstrating immune comparability to the approved MVA vaccine, Imvanex®, would be sufficient to evaluate GEO-MVA’s efficacy. This provides a clear, accelerated regulatory path to licensure.

Strengthening U.S. and Global Pandemic Preparedness

This milestone coincides with increasing Mpox activity globally – including expanding Clade I outbreaks in Africa and emerging cases in the United States – exposing vulnerabilities associated with global dependence on a sole foreign MVA vaccine supplier. GEO-MVA is designed to expand supply, diversify sources, and strengthen biodefense infrastructure.

David Dodd, Chairman & CEO of GeoVax, commented: “Completion of fill-finish for GEO-MVA and progression into final release evaluation represent critical steps toward Phase 3 initiation and a pivotal advancement in our mission to support U.S. and global health security. America cannot remain dependent on a single foreign manufacturer for MVA-based biodefense vaccines. GEO-MVA provides a clear path toward a diversified and domestically controlled second-source supply – an essential component of modern pandemic preparedness. This milestone also underscores the strong operational progress we are delivering for our shareholders and partners.”

About GEO-MVA

GEO-MVA is a Modified Vaccinia Ankara (MVA)-based Mpox/smallpox vaccine designed to expand global vaccine availability at a time of constrained stockpiles and growing demand for resilient, scalable, and geographically diversified manufacturing capacity. GEO-MVA is a core asset within GeoVax’s broader MVA platform, which also includes next-generation COVID-19 and other infectious disease programs.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

Company Contact:

678-384-7220

Media Contact:

Jessica Starman

Release – GeoVax Announces British Journal of Haematology Publication Highlighting Superior T-Cell Responses of GEO-CM04S1 in CLL Patients

Posted on December 15, 2025December 15, 2025 by aweinsoff@channelchek.com

DSMB Ends Comparator Arm; Trial Proceeds Exclusively With GEO-CM04S1 Following mRNA Vaccine’s Failure to Meet Primary Endpoint

Phase 2 Data Reinforce GEO-CM04S1 as an Important Next-generation Vaccine Candidate for the 40 Million U.S. and 400 Million Global Immunocompromised Patients Underserved by First-generation COVID-19 Vaccines

ATLANTA, GA – December 15, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today announced the publication of interim Phase 2 clinical data on its next-generation COVID-19 vaccine in patients with chronic lymphocytic leukemia (CLL).

The Research Letter in the British Journal of Haematology reports that GEO-CM04S1 met the study’s primary immunologic endpoint, generating significantly stronger and more durable SARS-CoV-2–specific T-cell responses than BNT162b2 (Pfizer-BioNTech) in patients with chronic lymphocytic leukemia (CLL) – a population known for poor vaccine responsiveness.

Importantly, following interim analysis, the trial’s Data and Safety Monitoring Board (DSMB) ruled to discontinue the randomized, double-blind comparator arm after the mRNA vaccine failed to meet the predefined primary immunogenicity endpoint. Enrollment is now proceeding exclusively in a single-arm cohort receiving GEO-CM04S1, as previously described in GeoVax’s clinical update at the European Hematology Association (EHA) 2025 Conference.

GEO-CM04S1’s superior performance in enhancing cellular immune response against SARS-CoV-2 in individuals with CLL, a patient population that generally responds sub optimally to vaccines designed to induce humoral (antibody) responses, underscores its potential to fill a protection gap for profoundly immunocompromised patients. More than 40 million adults in the U.S. and 400 million globally have some degree of compromised immunity, many of whom fail to mount meaningful responses to currently authorized COVID-19 vaccines. GEO-CM04S1 is specifically designed to address this gap through its dual-antigen (Spike + Nucleocapsid), MVA-based platform, which promotes robust, durable T-cell responses that are less impacted by immune dysfunction and viral variation.

Phase 2 Study Overview (NCT05672355)

CLL patients previously vaccinated with mRNA vaccines
31 enrolled; 27 evaluable for primary analysis
Primary endpoint: ≥3-fold rise in antigen-specific IFN-γ–secreting T cells at Day 56
Assessments: T-cell responses, binding/neutralizing antibodies, safety
No Grade ≥3 adverse events reported

Key Findings Published in BJH

1. GEO-CM04S1 achieved superior T-cell responses

40% of GEO-CM04S1 recipients met the primary endpoint vs. 14.3% for BNT162b2
Higher Spike-specific IFN-γ responses at Days 28, 56, and 84

2. Durable activation of Nucleocapsid-specific T cells

~10-fold higher N-specific CD4 T-cell activation vs. BNT162b2
Responses maintained through Day 180

3. Broader immune engagement in spite of CLL-associated humoral defects

GEO-CM04S1 generated sustained N-IgG and a correlation between N-specific antibodies and T-cell activation
mRNA vaccination produced higher early RBD-IgG titers but limited cellular immunity

Kelly T. McKee, MD, MPH, Chief Medical Officer, stated: “These results demonstrate GEO-CM04S1’s ability to address the immune limitations of CLL patients by inducing strong, durable T-cell responses to both spike and nucleocapsid proteins of SARS-CoV-2. The DSMB’s decision to discontinue the comparator arm further validates the vaccine’s clinical relevance for immunocompromised individuals.”

David Dodd, Chairman & CEO, added: “With more than 40 million immunocompromised Americans, many of whom lack durable protection from first-generation vaccines, GEO-CM04S1 represents a purpose-built solution for high-risk patients. This peer-reviewed publication strengthens our regulatory and partnering strategy as we advance toward potential commercialization.”

Medical and Commercial Significance

The findings published in BJH, combined with the DSMB’s action, reinforce the value of the differentiated profile of GEO-CM04S1 across multiple dimensions:

Critical unmet need: Immunocompromised individuals remain vulnerable and, in many cases, sub optimally protected from the threat of SARS-CoV-2.
Multi-antigen design: GEO-CM04S1’s dual-antigen design stimulates immune responses that appear to be more durable and variant-resilient than single-antigen mRNA approaches.
These segments represent a $30B+ annual potential commercial market.

About GEO-CM04S1

GEO-CM04S1 is a dual-antigen MVA-vectored COVID-19 vaccine being evaluated in multiple Phase 2 trials, including a primary vaccination for immunocompromised individuals, and a booster vaccination for CLL patients.

The vaccine has generated robust immune responses in difficult-to-vaccinate populations including CAR-T and stem-cell transplant recipients, who typically fail to respond well to first-generation vaccines.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

Company Contact:

678-384-7220

Media Contact:

Jessica Starman

Release – GeoVax Addresses Identification of New Mpox Variant

Posted on December 11, 2025December 11, 2025 by aweinsoff@channelchek.com

Continued Mpox Evolution Underscores Dependence on a Single Global Supplier, Reinforcing the Critical Importance of GeoVax’s Accelerated GEO-MVA Program

Atlanta, GA – December 11, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today addressed reports from UK health authorities confirming the emergence of a newly evolved “recombinant” Mpox strain. Early analysis indicates the variant contains genetic elements from both Clade I and Clade II Mpox viruses, highlighting the ongoing evolution of the pathogen and the potential implications for disease severity, transmissibility, and vaccine readiness.

The discovery of this recombinant strain comes at a time when global Mpox vaccine supply remains concentrated in a single manufacturer – creating risks around preparedness, surge capacity, and geopolitical access. GEO-MVA is uniquely positioned in developing an expanded supply of MVA vaccine, bolstering domestic and global resilience.

GeoVax Highlights Strategic and Public Health Implications

The virus continues to evolve. Simultaneous circulation of multiple Mpox clades creates ongoing risk for recombination and changing outbreak behavior.
Global supply remains dangerously concentrated. A single-vendor global supply model heightens vulnerability for stockpile readiness and equitable vaccine distribution.
GEO-MVA is progressing as the first U.S.-based Mpox/smallpox vaccine. GeoVax aims to deliver a scalable, domestically manufactured solution that supports national biodefense and global supply diversification.
Clinical and manufacturing progress advancing: Final fill-finish activities of GEO-MVA are scheduled to be completed by year-end, with first-in-human studies planned upon regulatory clearance.

“The emergence of a recombinant Mpox strain is a timely reminder that viral evolution does not pause,” said David Dodd, Chairman & CEO of GeoVax. “With global vaccine supply dependent on a single provider, the risks to preparedness, national security, and market stability are clear. We are developing GEO-MVA to meet this strategic need – a U.S.-manufactured Mpox vaccine capable of supporting both domestic requirements and global demand.”

Favorable EMA Development Pathway Accelerates GEO-MVA

GeoVax recently received positive Scientific Advice from the European Medicines Agency (EMA) confirming that the Company may proceed directly to a single Phase 3 immuno-bridging trial with no Phase 1 or Phase 2 trials required to support a Marketing Authorization Application (MAA) for GEO-MVA. The EMA’s Committee for Medicinal Products for Human Use (CHMP) also affirmed the adequacy of GeoVax’s proposed nonclinical package and agreed with the Company’s immunogenicity endpoints for demonstrating non-inferiority to the licensed comparator vaccine.

This guidance provides a significant acceleration of the regulatory timeline, a de-risked development path, and a potentially earlier commercialization opportunity across all 27 EU member states. As reinforced in a subsequent regulatory communication, the EMA’s pathway positions GeoVax for expedited approval, reduced development cost, and earlier revenue generation as the Company advances GEO-MVA toward Phase 3.

About GEO-MVA

GEO-MVA is GeoVax’s next-generation Modified Vaccinia Ankara (MVA)-based Mpox/smallpox vaccine, engineered to provide a durable, broad immune response with both civilian and biodefense (“dual-use”) applicability. Key attributes include:

U.S.-Based Manufacturing Pathway: GEO-MVA is being developed as the first U.S.-manufactured Mpox/Smallpox vaccine, reducing reliance on foreign suppliers and supporting national security priorities.
Dual-Use Capability: Designed to meet both public health needs and Strategic National Stockpile requirements.
Robust Multi-Antigen Immunity: MVA enables broad antigen presentation to support strong humoral and T-cell responses.
Scalable Modern Production: GeoVax’s planned transition to AGE1 continuous cell-line manufacturing is expected to expand output, reduce cost, and support global self-sufficiency.
Regulatory Momentum: EMA’s streamlined approach provides a clear, accelerated pathway for clinical advancement and commercialization.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

Company Contact:

678-384-7220

Media Contact:

Jessica Starman

Release – GeoVax Announces Addition of Renowned Global Experts to its Scientific Advisory Board

Posted on December 10, 2025December 10, 2025 by aweinsoff@channelchek.com

Newly Appointed Members Include Leaders in Vaccine Immunology, T-Cell Science, and Clinical Research

Atlanta, GA -December 10, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancers, today announced an update to its Scientific Advisory Board (SAB), welcoming internationally recognized experts whose work spans vaccine design, T-cell immunology, viral pathogenesis, and immunocompromised-host medicine.

This strategic expansion is designed to support GeoVax’s current and future development efforts with MVA and its multi-antigen MVA vector platform for vaccines targeting biothreat pathogens and vulnerable or currently underserved populations such as those from low- and middle-income countries, and immunocompromised patients. Future additions to the GeoVax SAB will support its oncology immunotherapy pipeline.

Newly Announced SAB Members

Joining Prof. Teresa Lambe, PhD, OBE, FMedSci – Calleva Head of Vaccine Immunology, Oxford Vaccine Group / Jenner Institute, University of Oxford, whose appointment to the GeoVax SAB was previously announced, are the following:

Dr. Alessandro Sette, Dr of Biological Sciences – Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology

An authority in T-cell epitope mapping and immune correlates of protection, Dr. Sette leads the NIH Immune Epitope Database (IEDB) and is widely recognized by defining T-cell immunity across SARS-CoV-2, Mpox, and Ebola.

Prof. Lance Turtle, PhD, MBBS, FRCP, DTMH – Chair in Immunity and Infectious Diseases, University of Liverpool / Royal Liverpool Hospital

A clinician-scientist specializing in viral pathogenesis and post-infection immune recovery, Prof. Turtle’s research provides key translational insights into long-term immunity and emerging pathogen preparedness.

Prof. Thushan I. de Silva, MBBS, PhD, MRCP – Professor of Infectious Diseases and Immunology, University of Sheffield

An expert in human viral immunology, vaccine responses, and global immunosurveillance, Prof. de Silva leads studies across Europe, Asia, and Africa evaluating population-level vaccine immunity and viral evolution.

Dr. Joshua A. Hill, MD, FIDSA – Associate Professor, University of Washington School of Medicine / Fred Hutchinson Cancer Center

A leading infectious-disease expert focusing on vaccine response in immunocompromised and transplant patients, Dr. Hill’s work aligns with GeoVax’s emphasis on protecting high-risk, under-served populations.

David Dodd, GeoVax Chairman & CEO, commented: “By assembling this exceptional team of global experts, we are further strengthening GeoVax’s position at the forefront of vaccine innovation. Their combined experience – from antigen design to human immunology and clinical translation – perfectly aligns with our mission to deliver durable, broad-spectrum protection to both global and immunocompromised populations.”

Dr. Kelly McKee, Chief Medical Officer, added: “The addition of these renowned experts ensures that our clinical strategy is guided by cutting-edge immunology insight and global research expertise. Their collaboration will be instrumental as GeoVax advances vaccines and immunotherapies designed to protect those who remain most vulnerable – particularly those in low and middle income countries (LMICs), and immunocompromised patients who have been underserved by traditional approaches or currently available vaccines”

Dr. Mark Newman, Chief Scientific Officer, stated: “This expanded SAB strengthens multiple aspects of our R&D platform. With direct input from some of the world’s most respected scientific leaders, we can ensure that our vaccine and immunotherapy candidates deliver real-world impact.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

Company Contact:

678-384-7220

Media Contact:

Jessica Starman