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Positive EMA Scientific Advice Positions GeoVax for Expedited European Approval
ATLANTA, GA – July 21, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today reinforced the strategic and commercial significance of the recent positive Scientific Advice (SA) received from the European Medicines Agency (EMA) for its GEO-MVA vaccine targeting Mpox and smallpox.
The EMA’s feedback indicated that a single Phase 3 immuno-bridging trial—bypassing the need for Phase 1 and 2 studies—may be sufficient to support a Marketing Authorization Application (MAA) under the EU’s centralized procedure. The ability to proceed without Phase 1 and 2 clinical trials substantially reduces development risk and timelines, positioning GeoVax to achieve product commercialization and revenue generation significantly earlier than previously anticipated.
Immuno-bridging studies allow for vaccine approval by the immune response elicited by a candidate vaccine comparable to that of an already approved vaccine. This approach, when accepted by regulatory authorities, can reduce the need for large-scale efficacy trials, thereby reducing development time while maintaining regulatory standards for safety and immunogenicity.
“This EMA guidance is more than a regulatory milestone—it represents a potential commercial inflection point,” said David Dodd, Chairman and CEO of GeoVax. “We now have a clear, expedited path to commercialization in one of the world’s largest vaccine markets. With the Phase 3 trial in operational preparation, we are entering a potential revenue acceleration phase supported by growing global demand, regulatory momentum, and our progressing advanced MVA manufacturing platform.”
Key Investor Highlights:
- Expedited Approval Path: EMA confirmed that one Phase 3 immuno-bridging trial—if successful—meets criteria for market authorization in all 27 EU countries.
- De-Risked Development: Moving directly to a Phase 3 immuno-bridging trial significantly reduces development timelines, cost, and clinical execution risk.
- Market Timing Advantage: EMA guidance coincides with the WHO’s fourth Mpox PHEIC declaration and Clade I outbreaks across multiple continents.
- First-Mover Opportunity: GEO-MVA would be the only MVA-based Mpox vaccine alternative to Bavarian Nordic’s Imvanex/Imvamune, addressing global supply constraints and monopolistic risk.
- Revenue Visibility: GeoVax expects to initiate its Phase 3 trial in 2H 2026.
- Manufacturing Readiness: Current CEF-based production supports near-term supply; transition to AGE1 cell line to enable scalable, cost-efficient output for global procurement.
GeoVax is actively engaging with European regulatory bodies, public health stakeholders, and procurement agencies to advance GEO-MVA access and funding partnerships in support of both public health and commercial goals.
“From an investor perspective, this EMA development potentially shortens our path to revenue generation and significantly enhances our strategic value,” said Dodd. “GeoVax is now on the radar as a viable near-term commercial vaccine company, not just a development-stage biotech.”
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 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.
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678-384-7220
Investor Relations Contact:
212-698-8696
Media Contact:
Jessica Starman
