GeoVax to Launch Pivotal Phase 3 Mpox Vaccine Trial in H2 2026
GeoVax secured EMA scientific advice enabling a single Phase 3 immuno-bridging trial for its GEO-MVA mpox and smallpox vaccine, scheduled to start in the second half of 2026. The company reported a $21.5 million net loss and $3.1 million cash balance for 2025, with R&D expenses down to $18.1 million.
1. Phase 3 Trial Planning
GeoVax plans to initiate a pivotal Phase 3 immuno-bridging study for its GEO-MVA mpox and smallpox vaccine candidate in the second half of 2026, representing its most direct path toward regulatory approval and commercialization.
2. EMA Scientific Advice
The company received formal scientific advice from the European Medicines Agency endorsing a streamlined development pathway that allows GEO-MVA to advance directly to a single Phase 3 trial without prior Phase 1 or Phase 2 studies.
3. 2025 Financial Performance
GeoVax reported a net loss of $21.5 million for 2025, driven by R&D expenses of $18.1 million and general administrative costs of $6.0 million, while government contract revenues declined to $2.5 million following the termination of the BARDA/RRPV award.
4. Cash Position and Strategic Focus
As of December 31, 2025, GeoVax held $3.1 million in cash, and it is prioritizing key GEO-MVA clinical and regulatory milestones, strategic partnerships, and selective advancement of other pipeline programs to address critical medical and biosecurity needs.