GeoVax Labs, Inc. Q4 FY2024 earnings call

• BARDA Project Next-Gen Award: Valued at almost $400 million, supporting GEO-CM04S1, with study sites confirmed and manufacturing underway.
• GEO-MVA: Completed cGMP product and quality release of clinical batch, anticipating clinical evaluation in H2 2025, with sufficient product for clinical and potential additional use.
• Phase II Gedeptin trial: Clinical operations plans underway, with regulatory aspects and product manufacturing in support.
• Advanced MVA manufacturing process: Utilizing AGE-1 Master Cell Bank to produce more MVA-based vaccine material faster, reducing costs.
• Mpox threat: WHO has a critical need for expanded Mpox vaccine supply, and GeoVax is well-positioned to address this with GEO-MVA.
• Oncology focus: Gedeptin planned for evaluation in combination with immune checkpoint inhibitor for solid tumors, with upcoming presentations at AACR.

In 2024, revenues from the BARDA contract were approximately $4 million, compared to $0 in 2023. Research and development expenses were $23.7 million in 2024 versus $20.7 million in 2023, an increase of ~$3 million. General and administrative expenses were $5.4 million in 2024 versus $6 million in 2023, a decrease of $600,000. Net loss for 2024 was approximately $25 million, or $4.82 per share, versus $26 million in 2023, or $14.29 per share. Cash balances at December 31, 2024 were $5.5 million.

• Prioritize advancing GEO-CM04S1, including initiating the trial later in 2024 or early 2026 as planned.
• Anticipate GEO-MVA clinical evaluation in H2 2025.
• Progress Phase II Gedeptin trial, including animal validation studies and presentations at conferences.
• Pursue strategic partnerships and collaborations for worldwide development, commercialization, and distribution.

• Competitive products may be more effective or easier to use.
• Uncertainty in regulatory approvals for product candidates.
• Difficulty in raising required capital to complete development.
• Challenges in entering favorable manufacturing and distribution agreements.

Q: Given the urgency of the Mpox threat, could GeoVax be part of a near-term response by selling product without clinical testing?

A: David Dodd stated they don't know, but usually can't, but there's opportunity with WHO emergency use licensing. Africa needs 20-25 million doses now, and current supply is insufficient.

Q: How will efficacy and safety be tested for MVA vaccine?

A: John Sharkey mentioned using non-human primates, with animal testing potentially running parallel to clinical trials. Endpoint is immunological, with estimated 400 patients. Testing will be in Europe and Sub-Saharan Africa.

Q: When to anticipate data readouts for remaining Phase 2 trials in immunocompromised patients?

A: Kelly McKee said readouts from blood cancer patients with cell transplant therapies expected in early to mid-2026; CLL study at City of Hope expected to be fully enrolled by end of 2024 with data presentations before yearend.

Q: How might changes in Washington regarding COVID-19 funding affect the BARDA Project NextGen trial?

A: David Dodd said they're in regular touch with BARDA, discussions continue with no direction to slow down, working on starting the trial before yearend with all sites confirmed and regulatory filings on track