GeoVax Labs, Inc. Q2 FY2025 earnings call

• David Dodd discussed updates on GEO-MVA, including EMA guidance for an expedited development path, completion of cGMP production of clinical vaccine batch, and plans for clinical evaluation and potential emergency use. - For GEO-CMO4S1, it's a multi-antigen COVID-19 vaccine with ongoing clinical trials, presentations at various conferences, and focus on immunocompromised patients. - Gedeptin's Phase II trial was modified based on KEYNOTE-689 results, targeting first-line therapy for head and neck cancer with major pathological response as the primary endpoint. - Emphasized the advanced MVA manufacturing process as a game-changing advantage and ongoing efforts in various clinical programs.

For the 6 months ended June 30, 2025, revenues were $2.5 million compared to $301,000 in 2024. Research and development expense was $10 million for the 6-month period in 2025 versus $8.7 million in 2024, an increase of ~$1.4 million or 16%. General and administrative expense was $3.2 million in 2025 versus $2.5 million in 2024, an increase of $686,000 or 27%. Net loss for the 6-month period in 2025 was approximately $10.7 million or $0.79 per share versus $10.9 million in 2024 or $4.68 per share. Cash balances at June 30, 2025, were $3.1 million compared to $5.5 million at December 31, 2024.

• GEO-MVA aims to proceed to a Phase III immunobridging trial and anticipates vaccine availability for clinical evaluation later in 2025. - GEO-CMO4S1 will continue presentations and strategic partnership discussions. - Gedeptin Phase II trial is targeted to initiate in the second half of 2026. - BARDA manufacturing proposal for AGE1 continuous cell line is in a holding basket dependent on funding availability.

• Uncertainty in developing and manufacturing product candidates with desired characteristics in a timely manner. - Dependence on regulatory approvals for product licensing and marketing. - Risk of not raising required capital to complete development. - Competition from more effective or easier-to-use products. - Uncertainty in entering favorable manufacturing and distribution agreements.

Q: Regarding the new patch method to administer the MVA vaccine and the 2H '26 start time.

A: David Dodd stated they don't intend to use the patch for the clinical program, and the 2H '26 start is due to various factors including preparing the clinical trial dossier.

Q: On the MVA trials and U.S. action.

A: John Sharkey said data from the European trial could be used to engage with the FDA, and BARDA may consider using a European-approved vaccine in the U.S. in pressing needs.

Q: On Gedeptin trial endpoint and protocol changes.

A: Kelly McKee explained major pathological response is the primary endpoint, and the trial was modified to target first-line therapy mimicking KEYNOTE-689.

Q: On Gedeptin combo with checkpoint inhibitor.

A: David Dodd stated they plan to use pembro.

Q: On COVID vaccine and clinical trial changes.

A: David Dodd said their focus remains on immunocompromised populations, aligning with HHS guidance, and they're continuing enrollment in relevant trials.