GeoVax Labs (GOVX) Emerging Growth Conference 79 summary

Program updates and priorities

• Advancing three priority programs: next-generation COVID-19 vaccine, Mpox (monkeypox) vaccine, and Gedeptin solid tumor therapy.

• Next-generation COVID-19 vaccine received a $400 million BARDA award; Phase 2b, 10,000-patient trial expected to start by year-end, pending site contracts.

• Gedeptin Phase 2 trial for recurrent head and neck cancer is in planning, with protocol finalization and CRO recently assigned.

Mpox (monkeypox) vaccine developments

• Mpox declared a Public Health Emergency of International Concern by WHO, with rising global cases and higher mortality rates (3-10%).

• Africa needs 25 million vaccine doses in 2025, but current global supply is only 2-5 million doses this year.

• GEO-MVA vaccine completed GMP manufacturing in December; vials expected to be ready by midyear and available to stakeholders.

• Discussions ongoing with WHO, UNICEF, and others for supply; clinical evaluation and emergency use licensing planned for the second half of the year.

• New advanced manufacturing process in development to increase output and lower costs, expected in a couple of years.

Clinical trial locations and timelines

• Project NextGen COVID-19 trial will be conducted entirely in the U.S.

• GEO-MVA Mpox vaccine trials planned for the U.S., Europe, and Africa.

• Gedeptin trial protocol being finalized; product manufacturing underway to support trial start, targeted for this year.