GeoVax Labs(GOVX) - 2025 Q1 - Quarterly Results

Business Update and Highlights GeoVax reported significant progress across its key clinical programs in Q1 2025, advancing its multi-antigen COVID-19 vaccine, Mpox/smallpox vaccine, and Gedeptin® oncology program while maintaining focus on unmet needs in oncology, infectious diseases, and biodefense GEO-CM04S1 (COVID-19 Vaccine) The GEO-CM04S1 program is advancing in Phase 2 trials for immunocompromised patients, with healthy adult booster trial data expected in Q2 2025 and continued enrollment in a CLL patient study after early termination of the mRNA vaccine arm - Despite the unexpected termination of the Project NextGen award by BARDA, GeoVax remains committed to advancing GEO-CM04S1[3] - Data readout for the healthy adult booster trial is expected in the second quarter of 2025[1][5] - In the Chronic Lymphocytic Leukemia (CLL) patient study, the Data Safety Review Board recommended early termination of the mRNA arm, while the GEO-CM04S1 arm continues to enroll[5] - The company estimates the market potential for its COVID-19 vaccine at over $30 billion[8] Gedeptin® (Oncology) The Gedeptin® program is advancing to a Phase 2 clinical trial for recurrent head and neck cancer in combination with an immune checkpoint inhibitor, having received Orphan Drug designation and showing potential for other solid tumors - Gedeptin® is advancing to a Phase 2 trial for recurrent head and neck cancer in combination with an immune checkpoint inhibitor[1][4][8] - Gedeptin® has received Orphan Drug designation for use in advanced head & neck cancer patients[8] - The estimated market potential for Gedeptin® in head and neck cancer is over $15 billion[8] GEO-MVA (Mpox/Smallpox Vaccine) GeoVax plans to initiate clinical trials for its GEO-MVA Mpox/smallpox vaccine candidate in H2 2025, having successfully produced cGMP clinical product to provide a U.S.-developed biosecurity alternative - Clinical evaluation of GEO-MVA is expected to begin in the second half of 2025[1][4][8] - The company has successfully produced cGMP clinical product for GEO-MVA in preparation for clinical trials[8] - The estimated market potential for GEO-MVA is over $10 billion[8] Corporate and Strategic Developments GeoVax is scaling MVA manufacturing for global reach, establishing a UK presence for European partnerships, and appointed Dr. Senthil Ranganathan to support commercialization efforts - Advancing continuous cell line manufacturing for MVA-based vaccines to enable scalable, cost-effective production[7] - Announced a plan to establish a strategic presence in the United Kingdom to advance manufacturing and European collaborations[9] - Appointed Senthil Ranganathan, Ph.D., as Vice President, Technical Development & CMC Operations, to focus on product authorization and commercialization[9] First Quarter 2025 Financial Results GeoVax reported a net loss of $5.4 million in Q1 2025, an improvement from the prior year, with $1.6 million in government contract revenue and increased R&D and G&A expenses, while cash improved to $7.4 million Financial Performance Summary Q1 2025 saw a narrowed net loss of $5.4 million, $1.6 million in government contract revenue, increased R&D and G&A expenses, and a cash balance of $7.4 million | Metric | Q1 2025 (Millions USD) | Q1 2024 (Millions USD) | Change (Millions USD) | | :--- | :--- | :--- | :--- | | Revenue | $1.6 | $0 | +$1.6 | | R&D Expenses | $5.4 | $4.4 | +$1.0 | | G&A Expenses | $1.7 | $1.5 | +$0.2 | | Net Loss | $5.4 | $5.9 | -$0.5 | | Date | Cash Balance (Millions USD) | | :--- | :--- | | March 31, 2025 | $7.4 | | Dec 31, 2024 | $5.5 | Condensed Consolidated Financial Statements Detailed financial tables for Q1 2025 show a net loss of $5.358 million or ($0.45) per share, with total assets of $10.833 million and stockholders' equity of $7.898 million as of March 31, 2025 | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenue from government contract (Thousands USD) | $1,637 | $- | | Research and development (Thousands USD) | $5,355 | $4,426 | | General and administrative (Thousands USD) | $1,687 | $1,457 | | Loss from operations (Thousands USD) | $(5,405) | $(5,883) | | Net loss (Thousands USD) | $(5,358) | $(5,850) | | Net loss per common share (USD) | $(0.45) | $(2.47) | | Weighted average common shares outstanding | 11,954,797 | 2,367,050 | | Metric | March 31, 2025 | Dec. 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents (Thousands USD) | $7,439 | $5,507 | | Total assets (Thousands USD) | $10,833 | $8,156 | | Total liabilities (Thousands USD) | $2,935 | $3,107 | | Stockholders' equity (Thousands USD) | $7,898 | $5,049 | | Common shares outstanding | 13,839,478 | 10,536,875 | Conference Call Information GeoVax will host a conference call and live audio webcast on May 1, 2025, at 4:30 p.m. ET to discuss financial results and provide a corporate update, with an archive available on the investor relations website - A conference call is scheduled for May 1, 2025, at 4:30 p.m. ET to review financial results and corporate developments[14] - An archive of the audio webcast will be available on the GeoVax website for at least 90 days following the event[16] Company Overview and Forward-Looking Statements GeoVax is a clinical-stage biotechnology company developing novel vaccines and cancer therapies, with the report including standard forward-looking statements subject to various risks and uncertainties - GeoVax is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers[18] - The report contains forward-looking statements subject to risks and uncertainties, including clinical trial outcomes, regulatory approvals, manufacturing, and competition[19]