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EQS-News: GeoVax, Inc.
/ Key word(s): Financial
Program Reaches Strategic Inflection Point as GEO-MVA Advances Toward Pivotal Phase 3 Study ATLANTA - March 11, 2026 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today announced that it has begun engaging with global health and preparedness organizations to explore potential future procurement of its GEO-MVA vaccine candidate for mpox and smallpox preparedness programs. GeoVax has initiated discussions and is soliciting interest from international organizations that influence or directly procure mpox/smallpox vaccines. These organizations play key roles in recommending or directly procuring vaccines for national preparedness stockpiles and international outbreak response programs. The outreach reflects growing global recognition of the need to diversify supply of Modified Vaccinia Ankara (MVA) vaccines used for protection against mpox and smallpox. Currently, global supply of MVA vaccines is concentrated in a single commercial manufacturer. Global preparedness programs for smallpox and mpox vaccines represent a potential multi-billion-dollar procurement market supported by national stockpiles, military preparedness programs, and international health organizations. Governments have invested billions of dollars in medical countermeasure stockpiles over the past two decades, and demand for MVA-based vaccines is expected to further expand as mpox continues to emerge as a recurring global health threat. GeoVax believes that initiating engagement with procurement and preparedness organizations represents an important transition from development toward commercialization planning, reflecting growing confidence in the GEO-MVA program and the potential for the vaccine to contribute to global preparedness stockpiles following successful completion of the planned Phase 3 study, scheduled to initiate in the second half of 2026. Advancing GEO-MVA Through an Expedited Regulatory Pathway GeoVax’s GEO-MVA program has progressed through an extensive regulatory dialogue with the European Medicines Agency (EMA), culminating in scientific advice in support of an expedited development pathway based on a single immunobridging trial to the licensed MVA vaccine. “The EMA carefully evaluated the scientific evidence over an extended period before confirming an expedited pathway. We believe their guidance validates both the scientific foundation of GEO-MVA and the growing recognition that expanding the global MVA vaccine supply is an important public health priority,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “We have also been encouraged by the positive response we are receiving from global health organizations and preparedness agencies as we initiated these discussions,” Dodd continued. “We view this engagement as an endorsement of the progress we have made, our commitment to advancing GEO-MVA, and the potential of GEO-MVA to help address the current worldwide need for expanded MVA vaccine supply. Importantly, it also represents a critical step toward commercialization of GEO-MVA and the potential generation of meaningful revenues through government and global health procurement programs as the program advances through its final development stages.” Implications for Global Preparedness and Biodefense Readiness The discussions initiated by GeoVax occur amid growing policy dialogue regarding the strategic importance of expanding global MVA vaccine manufacturing capacity. GeoVax believes GEO-MVA has the potential to become a strategically important medical countermeasure supporting both global public health preparedness and national biodefense initiatives. Recent mpox outbreaks have reinforced the understanding that mpox is not a single episodic event, but rather an evolving infectious disease threat with potential for continued geographic expansion and recurrence. As a result, governments and international health organizations are increasingly emphasizing the need for manufacturing diversification and supply redundancy for vaccines used in outbreak response and biodefense preparedness. In the United States, policymakers and defense stakeholders have increasingly recognized that no domestic manufacturing capability currently exists for MVA vaccines, a gap with implications for both civilian preparedness and military readiness. “Establishing additional MVA manufacturing capability is increasingly viewed as an important component of global preparedness,” said Dodd. “We are seeing growing interest from public health organizations, governments, and defense stakeholders who recognize the strategic importance of supply diversification.” About GEO-MVA GEO-MVA is GeoVax’s candidate vaccine for protection against mpox and smallpox based on the Modified Vaccinia Ankara (MVA) platform. Pending successful completion of the planned immunobridging trial, GEO-MVA could represent an important additional source of MVA vaccine supply for global preparedness, outbreak response, and biodefense programs. About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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: Media Contact: News Source: GeoVax, Inc.
11.03.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group. |
| Language: | English |
| Company: | GeoVax, Inc. |
| United States | |
| ISIN: | US3736782000 |
| EQS News ID: | 2289738 |
| End of News | EQS News Service |
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2289738 11.03.2026 CET/CEST