GeoVax Labs(GOVX) - 2024 Q4 - Annual Results

GeoVax 2024 Year-End Financial Results and Business Update This report summarizes GeoVax's 2024 financial performance and key business developments, including significant clinical trial progress and strategic initiatives CEO Statement and Business Highlights David Dodd, Chairman and CEO, highlighted 2024 as a pivotal year, marked by a significant BARDA Project NextGen award of nearly $400 million to advance the GEO-CM04S1 COVID-19 vaccine, building on positive clinical data and advancing the GEO-MVA vaccine for Mpox and smallpox - Received a BARDA Project NextGen award of nearly $400 million to advance the GEO-CM04S1 vaccine in a Phase 2b clinical trial[4] - Reported positive initial safety and immune response data from the Phase 2 trial of GEO-CM04S1 as a booster for adults who previously received mRNA vaccines, observing statistically significant increases in neutralizing antibody responses[4] - Advancing manufacturing capabilities and development of GEO-MVA, a vaccine candidate for protection against Mpox and smallpox, to address urgent public health needs[5] Clinical Trial Progress and Operational Developments The company reported significant progress across its clinical pipeline, including advancing the BARDA-funded Phase 2b trial for the COVID-19 vaccine GEO-CM04S1, planning a new Phase 2 trial for the cancer therapy Gedeptin®, and preparing for clinical evaluation of the Mpox/Smallpox vaccine GEO-MVA GEO-CM04S1 (COVID-19 Vaccine) Progress for the next-generation COVID-19 vaccine, GEO-CM04S1, is centered on the BARDA-funded 10,000-participant Phase 2b trial, with clinical sites confirmed and manufacturing underway, also being evaluated in immunocompromised patients and as a booster in healthy adults - Preparations are ongoing for the 10,000-participant, randomized, Phase 2b BARDA Project NextGen trial to compare GEO-CM04S1 with an FDA-approved mRNA vaccine[1][10] - In the Phase 2 trial for patients with chronic lymphocytic leukemia (CLL), the DSMB recommended continuing enrollment for the GEO-CM04S1 arm after the mRNA control arm failed to meet its primary endpoint[10] - Enrollment is complete in the Phase 2 booster study for healthy adults, with data readouts anticipated in the first half of 2025[1][10] - The estimated market potential for GEO-CM04S1 is over $30 billion[10] Gedeptin® (Cancer Therapy) GeoVax is advancing its cancer therapy, Gedeptin®, with plans for a Phase 2 clinical trial to evaluate it as a neoadjuvant therapy in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer, holding FDA Orphan Drug designation and addressing a market estimated at over $15 billion - Planning is underway for a Phase 2 clinical trial of Gedeptin® combined with an immune checkpoint inhibitor for recurrent Head & Neck (H&N) cancer[1][10] - The planned trial will be a single-cycle study in approximately 36 patients, with pathologic response rate as the primary endpoint[10] - Gedeptin® has FDA Orphan Drug designation and an estimated market potential of over $15 billion, with potential application in other solid tumors[10] Mpox and Smallpox Vaccine Platform (GEO-MVA) The company is preparing for the clinical evaluation of its GEO-MVA vaccine candidate for Mpox and Smallpox, with trials expected to begin in the second half of 2025, having successfully manufactured a cGMP clinical batch in 2024 and actively seeking strategic partnerships - Clinical evaluation of GEO-MVA, a vaccine for Mpox and Smallpox, is expected to begin in the second half of 2025[1][17] - A clinical batch of GEO-MVA was successfully manufactured under cGMP standards in 2024[17] - The company is pursuing strategic partnerships with governments and NGOs to maximize the reach of its GEO-MVA platform, which addresses an estimated market of over $10 billion[17] Corporate and Financial Overview GeoVax strengthened its corporate position in 2024 by expanding its intellectual property portfolio and planning a strategic entry into the UK, while financially reporting its first-ever revenue of $4.0 million from a government contract, a slightly reduced net loss of $25.0 million, and ending the year with a cash balance of $5.5 million Corporate and Intellectual Property Developments In 2024, GeoVax expanded its intellectual property assets to over 130 granted or pending patents and announced a plan to establish a strategic presence in the United Kingdom to foster European collaborations, manufacturing partnerships, and technology licensing - Announced a plan to establish a strategic presence in the United Kingdom to advance European partnerships and collaborations[17] - The company's intellectual property portfolio was strengthened and now includes over 130 granted or pending patents across 23 different families[17] 2024 Full Year Financial Results For the fiscal year 2024, GeoVax recorded $4.0 million in revenue from its BARDA government contract, a new revenue stream, with the net loss narrowing to $25.0 million compared to $26.0 million in 2023, R&D expenses rising to $23.7 million, and G&A expenses falling to $5.4 million, concluding the year with $5.5 million in cash and cash equivalents Condensed Consolidated Statements of Operations (Year Ended Dec 31) | | 2024 (in thousands) | 2023 (in thousands) | | :--- | :--- | :--- | | Revenue from government contract | $ 3,955 | $ - | | Research and development | $ 23,714 | $ 20,721 | | General and administrative | $ 5,385 | $ 6,022 | | Net loss | $ (24,992) | $ (25,967) | | Net loss per common share | $ (4.82) | $ (14.29) | Condensed Consolidated Balance Sheet (As of Dec 31) | | 2024 (in thousands) | 2023 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $ 5,507 | $ 6,453 | | Total assets | $ 8,156 | $ 9,283 | | Total liabilities | $ 3,107 | $ 3,520 | | Stockholders' equity | $ 5,049 | $ 5,763 | - The increase in R&D expenses to $23.7 million was primarily due to costs of manufacturing materials for clinical trials of GEO-CM04S1 and other costs associated with the BARDA contract[13] - G&A expenses decreased to $5.4 million from $6.0 million in 2023, mainly due to lower stock-based compensation, consulting, and patent costs[14]