• Revenue: $301,000 from BARDA Project NextGen award for the quarter ended June 30, 2024.
• Research and Development Expenses: $8.7 million for the first six months of 2024, up 15% from $7.5 million in 2023.
• General Administrative Expenses: $2.5 million in 2024, down 13% from $2.9 million in 2023.
• Net Loss: Approximately $11 million for the first six months of 2024, or $4.68 per share, compared to $10 million in 2023, or $5.66 per share.
• Cash Balance: $1.6 million as of June 30, 2024, compared to $6.5 million at December 31, 2023.
• Outstanding Common Shares: 5.3 million following recent financial activities.
• BARDA Project NextGen Award: Total federal support expected between $367 million and $388 million over the next several years.

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

Release Date: August 06, 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 to support their next-generation COVID-19 vaccine, CM04S1, in a Phase IIb trial.
• The company is advancing its Gedeptin therapy into a Phase II trial for squamous cell head and neck cancer, demonstrating tumor stabilization or reduction.
• Geovax Labs Inc (NASDAQ:GOVX) is actively pursuing partnerships and collaborations to support worldwide development, commercialization, and distribution of their products.
• The company's MVA platform, used in their COVID-19 vaccine, is also a standalone vaccine authorized for protection against mpox and smallpox, providing a unique differentiator.
• Geovax Labs Inc (NASDAQ:GOVX) reported $301,000 in revenues from the BARDA Project NextGen award, marking the beginning of billing under this contract.

Negative Points

• Geovax Labs Inc (NASDAQ:GOVX) reported a net loss of approximately $11 million for the first six months of 2024, an increase from the previous year.
• The company's cash balance decreased significantly from $6.5 million at the end of 2023 to $1.6 million as of June 30, 2024.
• Despite the BARDA funding, Geovax Labs Inc (NASDAQ:GOVX) will need to raise additional funds to support ongoing clinical trials and corporate overhead.
• There is significant competition for patient enrollment in the 10,000-patient trial for the CM04S1 vaccine, which could impact recruitment speed.
• The company faces challenges in communicating the value of its assets, which is not currently reflected in its stock price.

Q & A Highlights

Q: Can you provide more details on the Gedeptin trial for squamous cell carcinoma of the head and neck and any additional indications being considered? A: David Dodd, CEO, explained that the next target for the Phase II study will involve approximately 36 patients with first recurrent head and neck cancer, using Gedeptin in combination with an immune checkpoint inhibitor. There is interest in exploring other indications like triple-negative breast cancer, but the current focus is on advancing the Phase II trial for head and neck cancer.

Q: How will the BARDA Project NextGen funding be accounted for, and what impact does it have on financials? A: Mark Reynolds, CFO, stated that the BARDA funding is treated as revenue, recognized as costs are incurred. The funding supports the CM04S1 trial, but the significant portion going to the CRO does not flow through GeoVax's financial statements. The funding provides flexibility but does not cover all ongoing programs, necessitating additional fundraising.

Q: What is the strategy for managing cash burn and fundraising, considering the BARDA funding? A: Mark Reynolds, CFO, acknowledged the need for additional fundraising despite the BARDA funding. The company is exploring various options, including equity and potentially less dilutive approaches, but has not finalized plans. The BARDA funding allows flexibility in managing other programs.

Q: What are the anticipated timelines for CM04S1 trial enrollment and completion, and are there challenges in patient recruitment? A: Kelly McKee, CMO, noted that the ongoing trial for patients with blood cancers is enrolling well, with plans to expand to additional sites. The follow-on international trial is expected to have strong recruitment interest. For the Project NextGen trial, enrollment is anticipated to take about six months, with 80 out of 100 sites already confirmed.

Q: How does the BARDA award impact GeoVax's flexibility in fundraising instruments, and is debt a consideration? A: Mark Reynolds, CFO, expressed caution about using debt due to potential limitations on strategic opportunities. While debt is not ruled out, the focus is on finding the right balance between equity and other funding options to support ongoing programs.

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