Release Date: November 12, 2024

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 BARDA Project NextGen Award valued at almost $400 million, supporting a 10,000 patient comparative trial.
• The company is advancing its vaccine candidate against monkeypox and smallpox, with production of the first CGMP clinical substance batch underway.
• Geovax Labs Inc (NASDAQ:GOVX) is progressing with its advanced MVA manufacturing process, which could enhance production efficiency.
• The company is actively pursuing business partnerships and collaborations for worldwide development and commercialization.
• Geovax Labs Inc (NASDAQ:GOVX) reported increased revenues of $2.8 million for the third quarter, reflecting progress in its BARDA contract.

Negative Points

• Geovax Labs Inc (NASDAQ:GOVX) reported a net loss of $16.7 million for the first nine months of 2024, primarily driven by manufacturing activities and costs associated with the BARDA contract.
• The company faces challenges in the competitive landscape, with potential development of more effective or easier-to-use products by competitors.
• There is uncertainty regarding the timing of regulatory approvals and the ability to meet expedited pathways for its vaccine candidates.
• Geovax Labs Inc (NASDAQ:GOVX) has ongoing financial needs to support its clinical programs and development activities, requiring careful capital management.
• The company is dependent on successful partnerships and collaborations to achieve its commercialization and distribution goals.

Q & A Highlights

• Warning! GuruFocus has detected 3 Warning Signs with GOVX.

Q: What are the steps required to submit test batches for the A GE one cell line for MVA manufacturing to the FDA, and what is the expected timeline? A: Mark Newman, Chief Scientific Officer, explained that the process involves standard regulatory evaluations, including purifying the virus to FDA standards. The process development is just starting, and it is estimated to take a minimum of 18 months, although it could be expedited with more resources if necessary.

Q: When can we expect interim and final results for the CLL and healthy volunteer trials? A: David Dunn, CEO, stated that interim results for the CLL study are expected by the end of the year, while final results for the healthy volunteer trial might extend into early next year. The company is pushing for both to be reported by year-end.

Q: What progress has been made in seeking an expedited regulatory pathway for the OX vaccine, and when will the 10,000-patient Phase 2 COVID trial start enrolling? A: John Sharkey, VP of Business Development, mentioned active engagement with regulators, indicating an expedited pathway involving abbreviated trials. Kelly McKee, Chief Medical Officer, added that enrollment for the COVID trial is projected to begin in early October 2025.

Q: What are the next steps for the primary vaccine trial, CLL trial, and booster vaccine trial after data release? A: David Dunn, CEO, noted that the company will evaluate interim results from the CLL trial for potential expedited development. The healthy volunteer trial results will inform the larger Project Nextgen trial. The stem cell transplant trial continues to enroll, with additional sites being added.

Q: How does the collaboration and partnership environment look currently, and what is the expected revenue from the Barda contract? A: John Sharkey, VP of Business Development, noted increased engagement and interest in partnerships, particularly for the GEP and CM04 S1 vaccines. Mark Reynolds, CFO, explained that revenue from the Barda contract is on a cost reimbursement basis, with approximately $3 million expected per quarter.

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