Release Date: March 27, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Geovax Labs Inc (NASDAQ:GOVX) received a significant Project NextGen Award valued at almost $400 million to support their next-generation COVID-19 vaccine, CMO4S1.
• The company has completed CGMP product and quality release for their Mpox and smallpox vaccine candidate, GOMVA, with plans for clinical evaluation in the second half of the year.
• Geovax Labs Inc (NASDAQ:GOVX) is advancing its MVA manufacturing process, which is expected to significantly reduce costs and support decentralized vaccine manufacturing.
• The company's COVID-19 vaccine, CMO4S1, is designed to address unmet needs among immunocompromised patients and has shown potential for broader use as a booster to current mRNA vaccines.
• Geovax Labs Inc (NASDAQ:GOVX) is actively pursuing strategic partnerships and collaborations to support worldwide development and commercialization of their vaccines.

Negative Points

• Geovax Labs Inc (NASDAQ:GOVX) reported a net loss of approximately $25 million for 2024, driven by increased manufacturing activities and costs associated with the BARDA contract.
• The company's cash balance decreased to $5.5 million at the end of 2024, reflecting significant cash usage in operating activities.
• There is uncertainty regarding the ability to sell the Mpox vaccine without clinical testing, despite the urgent global need.
• The start of the next Gein trial has been pushed back to mid to late 2025 due to manufacturing and cell line issues.
• Geovax Labs Inc (NASDAQ:GOVX) faces challenges in securing equitable vaccine access and manufacturing partnerships in low-income countries, despite ongoing discussions.

Q & A Highlights

• Warning! GuruFocus has detected 2 Warning Signs with GOVX.

Q: Given the urgency of the Mpox threat, could GeoVax Labs potentially sell products without clinical testing, considering the testing is supposed to start around the end of 2025? A: David Dodd, Chairman and CEO, explained that while typically you cannot sell without clinical testing, there is an opportunity through emergency use licensing with WHO. The critical global need, especially in Africa, underscores the importance of additional supply options. GeoVax has produced enough product for clinical needs and additional evaluation, which might lead to revenue generation, but this remains uncertain.

Q: How is GeoVax working with international partners and regulatory agencies to ensure equitable vaccine access and manufacturing in low-income countries? A: David Dodd highlighted that equitable vaccine access is a major focus. GeoVax has been in discussions with Africa CDC, European regulatory agencies, and other stakeholders for over a year. They are actively engaging with organizations like UNICEF to support funding and supply chain initiatives.

Q: What is needed to start the next Gein trial, and is there a timeline for enrollment? A: David Dodd stated that they are continuing to manufacture the product and have faced some issues with the cell line. Clinical trial operations are outlined, and investigators are identified. The trial is expected to initiate in the mid to latter part of next year, with a focus on having sufficient product supply.

Q: How will GeoVax test the efficacy and safety of the MVA vaccine, given it's a preventive vaccine? A: Dr. John Sharkey, VP of Business Development, explained that efficacy is typically tested in nonhuman primates, but discussions with regulators are ongoing about potentially using lower animals. Any required animal studies could run parallel to clinical trials, minimizing impact on trial timelines.

Q: With the uncertainty in Washington regarding COVID-19 funding, how might this affect GeoVax's BAA Project NextGen trial? A: David Dodd noted that despite uncertainties, GeoVax maintains regular communication with BARDA, and the project continues as planned. There have been no directives to slow down, and the focus remains on starting the clinical trial by year-end, with all necessary preparations underway.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.