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GeoVax Comments on U.S. America First Global Health Strategy and Highlights Company's Role in Advancing American Innovation, Pandemic Preparedness, and Global Health Security

Pipeline Intersects With the Vast Majority of Strategic Initiatives to Make America Safer, Stronger, and More Prosperous

GeoVax’s pipeline, including its Mpox/Smallpox vaccine (GEO-MVA), next-generation multi-antigen COVID-19 vaccine (GEO-CM04S1), and other infectious disease vaccines in development directly aligns with the policy’s pillars of making America safer, stronger, and more prosperous.

Advancing Pandemic Preparedness

The new strategy highlights the urgent need for rapid outbreak detection and deployment of medical countermeasures. GeoVax is rapidly developing a continuous cell-line (AGE1) manufacturing technology which will enhance scalability, speed, and resilience - addressing longstanding supply chain vulnerabilities in U.S. biodefense. Utilizing this advanced manufacturing process, GeoVax’s MVA-based platform is uniquely suited for rapid vaccine response against infectious disease threats including Mpox, smallpox, Zika, and hemorrhagic fever viruses.

GeoVax is also committed to developing regional supply capabilities to ensure timely and equitable access to vaccines worldwide. The Company’s GEO-MVA program for Mpox and smallpox, which recently received favorable EMA scientific advice recommending an expedited regulatory pathway via an immuno-bridging study, will serve as the cornerstone of this strategy. This favorable regulatory guidance not only provides a potentially faster path to approval, but also significantly accelerates GeoVax’s commercialization and revenue opportunities, reinforcing the Company’s position as a U.S.-based innovator in global health security.

Promoting American Innovation Abroad

The American First strategy also emphasizes leveraging U.S. foreign assistance procurements to expand global access to American-made health solutions. GeoVax is positioned as a U.S.-based alternative to the existing foreign monopoly in poxvirus vaccines, supporting national security priorities while strengthening U.S. competitiveness in emerging global health markets.

Supporting Bilateral Agreements and Global Partnerships

With the strategy calling for bilateral health agreements and integration with local health systems, GeoVax’s multi-antigen vaccine design offers other countries efficient, cost-effective solutions that reduce dependency on fragmented, siloed programs. The Company’s approach directly complements U.S. goals of building resilient, country-led health systems.

"The America First Global Health Strategy represents a historic opportunity to align U.S. innovation with global health needs in a way that strengthens America’s leadership while protecting our citizens and economy,” said David Dodd, Chairman & CEO of GeoVax. “GeoVax is proud to be at the forefront of this vision, with vaccine and immunotherapy programs that deliver innovation, security, and scalability. Our mission is directly aligned with this strategy - to make America safer, stronger, and more prosperous while saving lives around the world.”

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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