Release – GeoVax Highlights Gedeptin® as a Potential Immune-Sensitizing Platform Amid Rising Industry Investment in In Vivo Cancer Therapies

GeoVax

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    Positioned to Enhance Efficacy of Checkpoint Inhibitors and Next-Generation Oncology Modalities Across Solid Tumors

    ATLANTA, GA – April 27, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today highlighted the strategic positioning of its oncology asset, Gedeptin® (Ad/PNP), in the context of accelerating industry investment in next-generation in vivo cancer therapies.

    Recent high-profile transactions and investments across the biopharmaceutical sector underscore a growing focus on therapies designed to simplify delivery, improve scalability, and expanding therapeutic reach. As these approaches advance, a central challenge remains: many tumors are immunologically “cold,” limiting the effectiveness of even the most advanced therapeutic modalities. GeoVax believes Gedeptin is uniquely positioned to address this challenge.

    “While the industry is investing heavily in next-generation cell and gene therapies, the ability to positively modify the local tumor environment is believed to be one of the critical determinants of clinical success,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Gedeptin is designed to directly destroy both proliferating and non-proliferating tumors, while also demonstrating high bystander activity due to the ability of the in situ generated cytotoxic agent ability to diffuse into neighboring tumor cells.”

    Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT), delivered intratumorally, designed to generate PNP, selectively destroy both proliferating and non-proliferating tumor cells within the treated tumor. In vivo preclinical experiments have shown PNP treatment to be additive or synergistic with checkpoint blockade–type agents. For example, studies in preclinical in vivo tumor models of metastasis, have demonstrated treatment of a single lesion can robustly sensitize tumors to checkpoint blockade inhibitors, presumably by destroying tumor tissue (including the tumor microenvironment), exposing neoantigens, and enhancing immune response and activity of immune check point inhibitors (ICIs) at distant PNP-untreated lesions This dual mechanism – localized cytotoxicity combined with enhancing the immune response and activity of immune check point inhibitors against both Gedeptin treated and untreated tumors – has the potential to offer an improved therapeutic approach to addressing solid tumor metastatic disease.

    GeoVax has generated preclinical, clinical and translational data supporting Gedeptin’s ability to:

    • Induce localized tumor cell death against both proliferating and non-proliferating tumors, while minimizing systemic toxicity
    • Potentially improve response rates when combined with immune checkpoint inhibitors

    Aligned with the Next Phase of Immuno-Oncology Innovation

    As checkpoint inhibitors continue to move earlier in treatment paradigms, including neoadjuvant and first-line settings, the need for complementary approaches that enhance response rates is becoming increasingly evident.

    GeoVax is advancing Gedeptin in combination with checkpoint inhibition in a planned Phase 2 clinical trial in first-line head and neck cancer therapy, with additional solid tumor indications under evaluation.

    “Checkpoint inhibitors have transformed cancer care, but many patients still do not achieve durable responses,” said Kelly T. McKee, M.D., Chief Medical Officer of GeoVax. “We believe Gedeptin is well positioned as a combination-enabling platform designed to enhance therapeutic response across checkpoint inhibitors and other emerging oncology modalities.”

    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 administration of a systemically delivered prodrug, the encoded enzyme converts the prodrug into a cytotoxic agent directly within the tumor microenvironment. This localized approach is designed to selectively destroy tumor cells while promoting immune recognition and minimizing systemic toxicity. Gedeptin has received Orphan Drug Designation for oral and pharyngeal cancers.

    The Company continues to evaluate strategic partnerships and collaborations to advance the clinical development and potential commercialization of Gedeptin-based combination therapies.

    About GeoVax

    GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. 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. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding GeoVax’s business plans. 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.

    Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

    Company Contact:

    [email protected]

    678-384-7220

    Media Contact:

    Jessica Starman

    [email protected] 

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