GeoVax Labs(GOVX) - 2024 Q1 - Quarterly Results

First Quarter Business Achievements GeoVax advanced its pipeline in Q1 2024 with positive COVID-19 vaccine data, completed Gedeptin® cancer trial enrollment, and new patent grants GEO-CM04S1 Program Update Updates on the GEO-CM04S1 program, including preclinical efficacy against variants and positive Phase 2 booster trial data - Presented data at the World Vaccine Congress showing GEO-CM04S1 induced immunity protects against the original Wuhan variant and the Omicron XBB.1.5 variant in preclinical models[4] - Reported positive initial safety and immune response data from the Phase 2 booster trial, with no serious adverse events and statistically significant increases in neutralizing antibodies against multiple SARS-CoV-2 variants, including Omicron XBB 1.5[6] Gedeptin® Program Update Progress on the Gedeptin® program, including completed patient enrollment for the Phase 1/2 clinical study and plans for follow-on trials - Completed patient enrollment for the Phase 1/2 clinical study of Gedeptin® in patients with advanced head and neck cancer[7] - The company expects to complete the study by the third quarter of 2024 and is in active discussions for a follow-on Phase 2 or Phase 2/3 trial[7] Vaccine Manufacturing Process Development Key advancements in vaccine manufacturing, including the successful transfer and scale-up of the GEO-CM04S1 commercial manufacturing process - Achieved a significant milestone by releasing the first lot of GEO-CM04S1 produced with a commercial manufacturing platform, marking a successful transfer and scale-up of the manufacturing process[8] - The manufacturing was transferred from the City of Hope's research center to the company's cGMP manufacturing partner, Oxford Biomedica[8] Intellectual Property Developments Updates on intellectual property, including new patent grants in Japan and the U.S. for various immunotherapy and vaccine programs - The Japanese Patent Office granted a patent for compositions and methods related to the MUC-1 tumor-associated antigen immunotherapy program[11] - The U.S. Patent and Trademark Office issued three new patents covering the company's vector platform for Marburg virus, multivalent HIV vaccine boost compositions, and compositions for treating or preventing Malaria[11][15] First Quarter 2024 Financial Results GeoVax reported a net loss of $5.6 million in Q1 2024, an increase from Q1 2023, driven by higher R&D expenses, with cash decreasing to $0.8 million Q1 2024 vs Q1 2023 Financial Performance | Financial Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Research & Development Expenses | $4,425,728 | $2,819,189 | +57.0% | | General & Administrative Expenses | $1,457,353 | $1,451,425 | +0.4% | | Net Loss | $5,580,132 | $4,037,916 | +38.2% | | Net Loss Per Share | $2.47 | $2.30 | +7.4% | Balance Sheet Summary | Balance Sheet Item | March 31, 2024 | Dec. 31, 2023 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $768,859 | $6,452,589 | -88.1% | | Total Assets | $3,358,000 | $9,283,000 | -63.8% | | Total Liabilities | $3,304,000 | $3,520,000 | -6.1% | | Stockholders' Equity | $54,000 | $5,763,000 | -99.1% | Corporate Information GeoVax, a clinical-stage biotech, focuses on cancer and infectious diseases with lead programs Gedeptin® and GEO-CM04S1, and provided a corporate update on May 14, 2024 - GeoVax's lead programs are Gedeptin® for advanced head and neck cancers and GEO-CM04S1, a next-generation COVID-19 vaccine for high-risk populations[15] - Management hosted a conference call and webcast on May 14, 2024, to review financial results and provide a corporate update[14] - The company issued a forward-looking statements disclaimer, highlighting risks related to clinical trials, regulatory approvals, and capital requirements[16][17]