GeoVax Labs, Inc.
For the period ended Apr 15, 2026. Filed Apr 15, 2026.
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Apr 15, 2026 · Filed Apr 15, 2026
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Contents
EX-99.1 · Priority Program – GEO-MVA
Priority Program–** GEO-MVA**
GeoVax’s primary near-term strategic development focus is the advancement of GEO-MVA, its Modified Vaccinia Ankara (MVA)-based vaccine candidate targeting mpox and smallpox. GEO-MVA is the Company’s most advanced program and its most direct path to potential regulatory approval and commercialization. GEO-MVA is being developed on an expedited regulatory pathway to address a documented global supply constraint in orthopoxvirus vaccines, while supporting both public health preparedness and biosecurity needs, including diversification of supply beyond a single foreign manufacture.
During 2025, the Company achieved several key milestones, advancing GEO-MVA toward late-stage development and commercial readiness:
| ● | Regulatory Alignment: GeoVax received formal Scientific Advice from the European Medicines Agency (EMA), supporting a streamlined and accelerated development pathway for GEO-MVA, including a single Phase 3 immuno-bridging study without the need for prior Phase 1 or Phase 2 trials. |
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| ● | Phase 3 Readiness: The Company is preparing to initiate a pivotal Phase 3 clinical trial in the second half of 2026, representing the critical next step toward potential regulatory approval and product distribution. |
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| ● | Manufacturing Progress: GeoVax completed cGMP manufacturing and fill-finish of clinical-grade GEO-MVA, establishing readiness for clinical supply and potential commercialization. |
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GeoVax believes GEO-MVA is uniquely positioned at the intersection of:
| ● | Recurring global mpox outbreaks and evolving viral strains |
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| ● | Depleted government stockpiles following recent outbreaks |
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