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CDC Reports Changing U.S. Transmission Dynamics Underscore Importance of Continued Surveillance, Vaccine Preparedness and Resilient MVA Vaccine Supply
ATLANTA, GA – September 29, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines against infectious diseases and therapies for solid tumor cancers, today highlighted an important change in the U.S. epidemiology of Clade I mpox reported by the U.S. Centers for Disease Control and Prevention (CDC).
In its September 25 update, CDC reported more than 60 laboratory-confirmed Clade I mpox cases across at least 20 U.S. states. Since August, an increasing proportion of U.S. Clade I cases have occurred among individuals with no recent international travel or known links to recent travelers. Cases with presumed domestic transmission have now been reported in more than 10 jurisdictions, which CDC said indicates a “likely transition to sustained Clade Ib transmission in the United States.” CDC continues to assess the risk from the Clade I outbreak as low for most people in the United States, while noting that additional travel-related and domestically acquired Clade Ib cases are expected.
David Dodd, Chairman and Chief Executive Officer of GeoVax, commented: “CDC’s latest assessment represents an important change in the epidemiology of Clade Ib mpox in the United States. While the risk to the general population remains low, presumed domestic transmission across multiple jurisdictions reinforces the importance of continued surveillance, vaccination of appropriate at-risk populations and sustained preparedness.”
Dodd continued: “Preparedness should not begin when an infectious-disease threat becomes a crisis. The appropriate time to strengthen vaccine capacity, diversify sources of supply and establish scalable manufacturing infrastructure is before those capabilities are urgently needed. The changing geographic footprint and public health threat of mpox is another reminder that infectious diseases do not respect national borders.”
Advancing GEO-MVA as a Potential Additional MVA Vaccine Option
GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine being developed for protection against mpox and smallpox. Following formal guidance from the European Medicines Agency (EMA), GeoVax is advancing GEO-MVA through an expedited clinical development pathway, with traditional Phase 1 and Phase 2 clinical trials not required, allowing the program to proceed directly to a pivotal Phase 3 immunobridging study comparing immune responses generated by GEO-MVA with those generated by the licensed MVA-BN comparator. GeoVax expects to initiate the 500-participant pivotal Phase 3 immunobridging study in the fourth quarter of 2026, with results expected in mid-2027, having completed the manufacturing/fill-finish and clinical operations aspects in support of initiating and completing the pivotal study.
GeoVax is developing GEO-MVA to expand global access to MVA vaccines and scalable production capabilities, with the potential to provide governments and international public health organizations with an additional source of MVA vaccine. The Company believes GEO-MVA can become an important strategic preparedness asset by supporting diversified vaccine supply, scalable manufacturing capacity and greater supply resilience, while strengthening biosecurity, orthopoxvirus preparedness and the ability to respond to evolving global health threats.
Dodd concluded: “Low risk to the general population today and the need for long-term preparedness are not contradictory. CDC’s latest assessment illustrates why preparedness must anticipate changes in infectious-disease transmission rather than react to them after they occur. We believe diversified vaccine supply and scalable MVA manufacturing capacity can become increasingly important as the epidemiology of mpox continues to evolve.”
A Changing Mpox Landscape
The development is particularly noteworthy because the 2022 global mpox outbreak, including the large U.S. outbreak, was caused by Clade IIb. Clade I mpox has historically been associated with more severe disease and higher mortality than Clade II. However, disease severity varies by viral subclade, population and access to medical care. Recent Clade Ib cases identified in high-income countries have generally involved relatively mild illness, underscoring the importance of distinguishing the changing epidemiology of the virus from the immediate risk it poses to the general population.
The significance of CDC’s latest assessment therefore extends beyond disease severity alone. The emergence of likely sustained Clade Ib transmission represents an important change in the geographic footprint and transmission dynamics of mpox in the United States. The new CDC assessment also represents an evolution from earlier U.S. surveillance. As recently as August, CDC reported that sustained Clade Ib transmission had not been detected in the United States during 2024–2025. The September 25 assessment now indicates a likely transition toward sustained domestic transmission.
Globally, Clade I outbreaks have continued in Central and Eastern Africa since late 2023, with subsequent geographic expansion beyond the region, including transmission in parts of Europe and introductions into the United States. The evolving epidemiology follows other recent public-health preparedness actions, including updated CDC vaccination recommendations for certain U.S. travelers at increased risk and international initiatives to strengthen access to mpox vaccines and outbreak-response capabilities.
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 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.
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