GeoVax Labs, Inc. Q4 FY2023 earnings call

• David Dodd discussed progress on Gedeptin: Phase 1/2 trial for advanced head and neck cancer closed enrollment, initial data showed safety and feasibility, expecting final results in H1 2024; strategy includes earlier-stage disease evaluation and expedited registration discussions.
• On GEO-CM04S1: Phase 2 trials ongoing, positive interim data from booster trial in healthy adults, ongoing trials for immunocompromised patients; Project NextGen discussions continue.
• Mark Reynolds provided financial update: R&D and G&A expenses increased, cash balances decreased, ongoing discussions for Project NextGen award which could significantly impact financing.
• MVA vaccine: Anticipated updates on regulatory path and manufacturing process to enable production and distribution.

In 2023, GeoVax had no active grants, resulting in no grant revenues compared to 2022. Research and development expenses were $20.7 million in 2023 vs. $9.1 million in 2022, primarily due to accelerated clinical trial activity for CM04S1 and Gedeptin programs. General and administrative expenses were $6 million in 2023 vs. $5 million in 2022, driven by higher legal, patent, and consulting costs. Interest income was $776,000 in 2023 vs. $7,000 in 2022. Cash balances at December 31, 2023, were approximately $6.5 million, down from $27.6 million at the end of 2022. The company's product segments include Gedeptin (head and neck cancer therapy), GEO-CM04S1 (next-gen COVID-19 vaccine), and MVA vaccine (mpox and smallpox), each in clinical development addressing unmet medical needs.

• Expect final results from CM04S1 Phase 2 booster trial in Q4 2024.
• Plan to report final results from Gedeptin Phase 1/2 trial in H1 2024.
• Anticipate updates on MVA vaccine regulatory path and manufacturing process.
• Potential for Project NextGen award to fund CM04S1 program, with awards potentially providing significant value beyond direct payments.

• Uncertainty regarding regulatory approvals for product candidates.
• Competition from other companies developing similar products.
• Difficulty in raising sufficient capital to complete development of products.
• Risk that competitive products may be more effective or easier to use than GeoVax's offerings.

Q: With the positive interim results that you already gathered for the Phase 2 trial of your COVID booster vaccine in healthy volunteers, do you anticipate similar efficacy against the newer JN.1 COVID variant? And what other findings might you be expecting from this trial once full top line results are gathered?

A: David Dodd stated they're pleased with initial results, trial is fully enrolled and tracking patients through September, no reason to believe efficacy against JN.1 would differ significantly from other variants, but testing needed; Kelly McKee added no reason to expect neutralization of JN.1 to be significantly different from other Omicron variants tested.

Q: For your Gedeptin candidate, what additional indications might you consider for a combination therapy, alongside immune checkpoint inhibitors? And do you currently have any clinical development plans for this program?

A: Kelly McKee mentioned Gedeptin is tumor-agnostic, exploring other solid tumor types as next steps, active discussions with Emory about breast tumor trials, design still under discussion.

Q: The BARDA agreement for other companies has been extremely valuable in terms of market cap appreciation. All of the discussions going on that front, and do things continue to proceed in the direction you would like them to be?

A: David Dodd said discussions are positive and encouraging, though no award received yet, and the value of awards can be significant beyond direct payments.

Q: I had a question on Gedeptin and the clinical trials. I was hoping you could just clarify a little bit of the plans. You had mentioned expansion of the Phase 2 neoadjuvant and combinations with checkpoint inhibitors. Are these going to be separate trials that begin in sequence or arms of one trial?

A: Kelly McKee stated it's under active discussion, advisory committee of oncologists and surgeons will guide next steps, no definitive plan yet on trial structure.

Q: How do you anticipate raising capital over the coming year?

A: Mark Reynolds said they'll raise funds opportunistically, with cash runway through Q2 2024, and Project NextGen award could be a significant catalyst, with awards potentially providing hundreds of millions in value.