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GeoVax Endorses Global Call to Sustain Mpox Response as Evidence Confirms Epidemic Is Far From Over

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

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

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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