GeoVax's 2025 Q2: Unpacking Contradictions in Vaccine Manufacturing and Clinical Trials

Manufacturing and trial initiation timeline for COVID-19 vaccine, manufacturing timeline and vaccine availability, clinical trial start date and funding, manufacturing of MVA vaccine, trial design and population for Gedeptin are the key contradictions discussed in GeoVax Labs' latest 2025Q2 earnings call.



Revenue and Research & Development Expenses:
- GeoVax Labs reported revenues of $2.5 million for the 6 months ended June 30, 2025, compared to $301,000 in 2024, marking a significant increase.
- Research & development expense was $10 million during the 6-month period in 2025, representing an increase of $1.4 million or 16% compared to 2024.
- The revenue growth was primarily due to the BARDA project NextGen contract, while the increase in R&D expenses was mainly due to costs associated with the BARDA contract, GEO-MVA, and Gedeptin programs.

GEO-MVA Vaccine Development and EMA Guidance:
- GeoVax received guidance from the EMA for GEO-MVA, providing an expedited development path that allows bypassing Phase I and Phase II clinical trials and proceeding directly to a Phase III immunobridging trial.
- The company completed cGMP production and quality release of the clinical batch of GEO-MVA, with vaccine availability expected later in the year.
- This progress was driven by the EMA's expedited development path, which will allow for potential revenue generation and market authorization sooner.

COVID-19 Vaccine (GEO-CMO4S1) Continued Enrollment:
- GeoVax continues to advance its multi-antigen COVID-19 vaccine, GEO-CMO4S1, particularly among severely immunocompromised patients, with a focus on stem cell transplant and CLL patients.
- The company initiated a second site for CLL patient enrollment in Orange County, California, contributing to ongoing enrollment and clinical trials.
- The focus on immunocompromised patients is due to their inadequate response to first-generation vaccines and the need for a more robust immune response.

Gedeptin Oncology Trial Update:
- The Gedeptin Phase II trial in head and neck cancer was updated to target first-line therapy, mimicking the KEYNOTE-689 trial as a historical control.
- The primary endpoint was changed to major pathological response, with a focus on evaluating neoadjuvant Gedeptin and pembro.
- The modification was made following impressive results from the KEYNOTE-689 study, aiming to evaluate the efficacy and tolerability of Gedeptin in combination with pembro.

Financial Status and Strategic Partnerships:
- GeoVax's cash balances at June 30, 2025, were $3.1 million, reflecting a decrease from $5.5 million at December 31, 2024.
- The company explored various strategies to fund development programs, including strategic partnerships and offerings of common stock.
- The decrease in cash balances is due to funds used in operating activities, partially offset by financing transactions, emphasizing the need for strategic partnerships to extend the cash runway.