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 (NEWMEDIAWIRE) - 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

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 

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