GeoVax Labs(GOVX) - 2025 Q2 - Quarterly Results

Business Highlights GeoVax reported a pivotal second quarter, marked by significant clinical and regulatory achievements, underscoring the company's progress in both oncology and infectious disease preparedness - Received favorable European regulatory guidance for GEO-MVA, supporting a streamlined development pathway for its Mpox and smallpox vaccine[1][2] - GEO-CM04S1 demonstrated superior immune responses in Chronic Lymphocytic Leukemia (CLL) patients compared to an authorized mRNA vaccine, with data presented at the EHA 2025 conference[1][2] - Gedeptin® showed strong safety and efficacy data for treating solid tumors in a presentation at the AACR 2025 conference[1][2] Clinical Trial Progress and Operational Developments The company detailed significant progress across its three lead programs, including a clear regulatory pathway for GEO-MVA, superior immunogenicity for GEO-CM04S1, and promising safety and efficacy for Gedeptin® GEO-MVA (Mpox/Smallpox Vaccine) GeoVax received favorable Scientific Advice from the European Medicines Agency (EMA) for GEO-MVA, confirming a streamlined development process for market authorization in the EU - The EMA confirmed a single Phase 3 immuno-bridging trial is sufficient for potential market authorization in the EU, eliminating multiple common development steps[5] - GeoVax plans to initiate the Phase 3 trial in the second half of 2026[5] - The estimated market potential for GEO-MVA is over $10 billion[5] GEO-CM04S1 (COVID-19 Vaccine) GEO-CM04S1 demonstrated superior performance in multiple clinical settings, including enhanced T cell responses in CLL patients and cross-protective potential against Mpox - In CLL patients, GEO-CM04S1 showed significantly better T cell responses (IFN-γ secretion and AIM+) than an authorized mRNA vaccine, which failed its primary endpoint[9] - Unlike the mRNA vaccine, GEO-CM04S1 elicited statistically significant SARS-CoV-2 Nucleocapsid (N)-specific IgG and T cell responses[9] - The vaccine demonstrated dual protective potential, inducing immune responses against both SARS-CoV-2 and Mpox[9] - The estimated market potential for GEO-CM04S1 is over $30 billion[9] Gedeptin® (Solid Tumor Therapy) Clinical data highlighted Gedeptin's strong safety and efficacy profile in heavily pretreated patients with advanced solid tumors, showing promising survival rates with no dose-limiting toxicities - In a Phase 1/2 trial with eight heavily pretreated patients (median 4 prior therapies), Gedeptin® demonstrated a median Progression-Free Survival (PFS) and Overall Survival (OS) of 7.0 months[9] - The treatment was well-tolerated, with no dose-limiting toxicities (DLTs) reported, with minimal injection site pain as the most common adverse event[9] - The estimated market potential for Gedeptin® is over $15 billion[9] Second Quarter 2025 Financial Results For the second quarter of 2025, GeoVax reported a net loss of $5.4 million, or $0.35 per share, with increased R&D and G&A expenses, and a cash position of $3.1 million at quarter-end, bolstered by a $5.6 million financing in July 2025 Second Quarter Financial Performance (Amounts in Millions, Except Per Share Data) | Financial Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Net Loss | $5.4M | $5.1M | Increased Loss | | Loss Per Share | $0.35 | $1.99 | Decreased (due to more shares) | | Revenue | $0.85M | $0.30M | +183% | | R&D Expenses | $4.7M | $4.3M | +9.6% | | G&A Expenses | $1.5M | $1.1M | +36.7% | - The BARDA/RRPV Project NextGen contract, which generated all revenue in the quarter, was terminated for convenience by the government[12] - Cash and cash equivalents were $3.1 million as of June 30, 2025, down from $5.5 million at December 31, 2024, with the company raising approximately $5.6 million in net proceeds from a public offering in July 2025[15] Other Corporate Updates GeoVax strengthened its intellectual property portfolio with new patents for a Malaria vaccine and Gedeptin® therapy, while enhancing leadership with a key appointment in technical development - Issued U.S. Patent No. 12,329,808 for a novel vaccine construct designed to prevent Malaria infection[16] - Received a Notice of Allowance for additional patent claims covering the synergistic use of Gedeptin® therapy with radiation for solid tumors[16] - Appointed Dr. Senthil Ranganathan, with over 20 years of experience, as Vice President, Technical Development and CMC Operations[16] Financial Tables The condensed consolidated financial statements provide detailed figures for the company's operations and financial position, showing an increase in revenue and operating expenses, and a decrease in total assets and stockholders' equity Condensed Consolidated Statements of Operations (Amounts in Thousands, Except Per Share Data) | Financial Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue from government contract | $2,489 | $301 | | Research and development | $10,083 | $8,703 | | General and administrative | $3,230 | $2,543 | | Loss from operations | $(10,824) | $(10,945) | | Net loss | $(10,727) | $(10,914) | | Loss per common share | $0.79 | $4.68 | Condensed Consolidated Balance Sheet (Amounts in Thousands, Except Share Data) | Financial Metric | June 30, 2025 | Dec. 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,094 | $5,507 | | Total current assets | $5,135 | $7,935 | | Total assets | $5,350 | $8,156 | | Total liabilities | $2,529 | $3,107 | | Stockholders' equity | $2,821 | $5,049 | | Common shares outstanding | 15,924,593 | 10,536,875 |