GeoVax Labs, Inc. Q1 FY2025 earnings call

• GeoVax remains confident in the progress of GEO-CM04S1, GEO-MVA, Gedeptin, and the advanced MVA manufacturing process, with each product candidate addressing critical unmet healthcare needs.
• BARDA terminated the Project NextGen contract, but the financial impact is estimated at less than $750,000 annually, and it doesn't impact ongoing CM04S1 Phase II trials.
• GEO-MVA completed cGMP production and quality release of the clinical batch and is expected for clinical evaluation later in 2025.
• Gedeptin's Phase II trial for head and neck cancer is underway, with plans for additional solid tumor studies. 2025 priorities include advancing GEO-CM04S1 for immune compromised populations, advancing GEO-MVA to clinical evaluation, and focusing on Gedeptin in oncology.

Mark Reynolds noted that revenues associated with the BARDA contract were $1.6 million in 2025 compared to $0 in 2024. Research and development expenses were $5.4 million in 2025 versus $4.4 million in 2024, an increase of roughly $1 million or 21%. Net loss for the first quarter of 2025 was approximately $5.4 million or $0.45 per share versus $5.9 million in 2024 or $2.47 per share. Cash balances at March 31st were $7.4 million. Outstanding common shares currently stand at 15.2 million. Regarding product segments, GEO-CM04S1 continues Phase II clinical trials for immunocompromised populations; GEO-MVA completed cGMP production and quality release of the clinical batch and is anticipated for clinical evaluation later in the year; Gedeptin has Phase II trial plans for head and neck cancer with plans for additional solid tumor studies.

• Continue to advance GEO-CM04S1 for immune compromised populations.
• Accelerate plans for clinical trials associated with GEO-MVA and Gedeptin.
• Explore strategies like strategic partnerships, non-dilutive funding, and additional common stock offerings to fund development programs and extend cash runway.

• Uncertainty regarding the termination of the BARDA contract.
• Risk of competitive products being more effective or easier to use.
• Risk of not raising sufficient capital to complete development of products.

Q: James Molloy asked about Vaxart's hold lift and comparison with GeoVax's program, and impact of HHS's placebo-controlled vaccine trials statement.

A: David Dodd noted differences between Vaxart's and GeoVax's programs, and stated HHS's comments don't affect current trial designs.

Q: Robert LeBoyer inquired about healthy volunteers trial results and next steps.

A: David Dodd said healthy volunteers trial results expected mid-June, and will focus on CLL trial results, planning company-sponsored expanded trial for registration.

Q: Jeffrey Kraws asked about Mpox vaccine safety and U.S. manufacturing support.

A: David Dodd said MVA vaccine is exquisitely safe, and is working towards U.S.-based manufacturing of MVA-based vaccines, discussing with government staff and influencers for support.