GeoVax Labs, Inc. Q3 FY2024 earnings call

• BARDA Project NextGen award of almost $400 million announced, with study sites selected and CRO Allucent paired. - Plans to conduct Phase 2 trial of Gedeptin in combination with immune checkpoint inhibitor for head and neck cancer. - Progress with GEO-MVA vaccine: cGMP production of master seed virus, working seed virus established, first cGMP clinical substance batch in production. - Initiated advanced MVA manufacturing process with AGE.1 master cell bank preparation. - Three Phase 2 trials underway with CM04S1, targeting immunocompromised patients and healthy adults as heterologous booster. - WHO declared Mpox as public health emergency, GeoVax progressing GEOMVA vaccine.

No specific breakdown of product segments with absolute revenue and contribution % provided in the transcript.

• Anticipate interim results of CLL study and final results of healthy volunteer trial by year-end, with Project NextGen trial enrollment starting around early October 2025. - Funding needs for Gedeptin, CM04S1, and EOMDA Mpox programs, with capital formation plans in place.

• Uncertainty in clinical trial timelines and results. - Competition from other products. - Dependence on regulatory approvals and manufacturing/distribution agreements.

Q: Regarding AGE1 cell line for MDA manufacturing, timing and process.

A: Mark Newman discussed 18-month process minimum, can be expedited.

Q: Timing for interim and final results of CLL and healthy volunteer trials.

A: Interim CLL results by year-end, healthy volunteer final results early 2025.

Q: Progress on expedited regulatory pathway for Mpox and enrollment in 10,000-patient Phase 2 COVID trial.

A: Engaging with regulators, enrollment starts early Oct 2025.

Q: Next steps for trials and end game for FDA talks.

A: Evaluate CLL trial results, healthy volunteer trial results, Project NextGen trial.

Q: Collaboration partnership environment and financials.

A: Partnering active, financials on cost reimbursement basis.

Q: R&D expenses and manufacturing materials for CM04S1.

A: Expenses reimbursed by BARDA, relationship with Oxford Biomedica.

Q: Gedeptin Phase 2 trial details.

A: Single cycle of Gedeptin plus pembrolizumab, monitoring pathological response.

Q: Effort to include immunocompromised patients and durability studies.

A: Majority effort on immunocompromised patients, durability studied over 1-year with challenges.

Q: Timetable for 10,000-patient Phase 2 COVID trial enrollment.

A: Enrollment starts early Oct 2025, fully enrolled within 6 months.