GeoVax Labs (GOVX) Investor update summary

Market opportunity and demand

• Mpox and smallpox vaccine market estimated at $2 billion, with $700 million in sales last year and $1.3 billion in unmet demand, especially from Africa CDC and global agencies.

• Eight million doses were supplied last year, but 15 million additional doses were requested and not fulfilled.

• Strategic stockpiles exist globally, with demand from agencies like UNICEF, Gavi, HERA, WHO, BARDA, and national stockpiles in multiple countries.

Product development and regulatory pathway

• GEO-MVA, an MVA-based vaccine for Mpox and smallpox, is set for a pivotal phase III trial in Q4, with EMA granting an expedited pathway waiving phase I/II trials.

• The phase III trial will enroll 500 healthy adults, comparing GEO-MVA to Bavarian Nordic's MVA-BN, focusing on neutralizing antibody and seroconversion endpoints.

• If non-inferiority is shown, the company will seek Emergency Use Listing with WHO and expedited EMA approval, followed by a 3,000-patient safety study.

• All product for the trial has been manufactured and packaged, with trial sites and CRO selected; results expected mid-2027.

Manufacturing and scalability

• Current manufacturing is through Oxford Biomedica in the UK and France, with plans to transition to U.S.-based facilities and scalable cell line manufacturing within 3–5 years.

• New process aims for a tenfold increase in output and fivefold cost reduction, enabling local manufacturing and lower costs.