EQS-News: GeoVax Announces Issuance of U.S. Patent Covering Enhanced Therapeutic Use of Gedeptin(R) Gene Therapy

Patent Protects Novel Application of Gedeptin Therapy Across Multiple Solid Tumor Types; Supports Expansion of Gedeptin Product Platform

ATLANTA, GA - December 9, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against cancers and infectious diseases, today announced the issuance of U.S. Patent No. 12,453,760, titled "Enhanced Therapeutic Usage of a Purine Nucleoside Phosphorylase or Nucleoside Hydrolase Prodrug", by the United States Patent and Trademark Office (USPTO). The patent provides composition-of-matter and method-of-use protection for GeoVax’s Gedeptin® platform in combination with targeted delivery approaches for solid tumors, including head and neck cancer.

The newly issued patent, which extends through 2045, enhances the Company’s intellectual property estate for Gedeptin and its use across a range of solid tumor cancers - consolidating GeoVax’s leadership in the field of targeted gene therapies and supporting ongoing clinical development plans.

“The issuance of this patent marks an important milestone in the advancement and protection of GeoVax’s oncology pipeline,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “It underscores our commitment to progressing Gedeptin, both as a monotherapy and in synergistic combination with other oncology treatment approaches as we work to deliver meaningful treatment options for patients with difficult-to-treat solid tumors.”

The Company is actively preparing for a Phase 2 clinical trial evaluating Gedeptin as a first-line therapy in combination with pembrolizumab (Keytruda®) in resectable head and neck cancer, in line with the recent shift toward neoadjuvant checkpoint strategies. Additional preclinical programs are assessing Gedeptin across other tumor types, including breast and cutaneous cancers.

About Gedeptin®

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) designed for targeted use in solid tumors. Delivered via a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP) and followed by systemic fludarabine, Gedeptin generates localized cytotoxic activity within tumors while minimizing systemic toxicity. The therapy has demonstrated safety and disease control in a multi-center Phase 1/2 trial in patients with advanced head and neck cancer and has received FDA Orphan Drug Designation for oral and pharyngeal cancers.

GeoVax plans to advance Gedeptin into a Phase 2 trial in combination with pembrolizumab (Keytruda®) as a neoadjuvant regimen for resectable head and neck squamous cell carcinoma, supported by recent clinical data validating the role of immune checkpoint inhibitors in perioperative settings. Additional preclinical work is underway to assess Gedeptin combinations across other solid tumors.

Key Advantages of Gedeptin

• Localized, tumor-selective cytotoxicity
• Tumor agnostic - expansion potential across multiple solid tumors
• Synergistic potential with checkpoint inhibitors
• Favorable safety profile and orphan drug designation
• Strong patent protection through 2045

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. 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:
info@geovax.com
678-384-7220

Media Contact:
Jessica Starman
media@geovax.com