ATLANTA, GA, July 31, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced the next steps for the clinical development of its Gedeptin® cancer therapy, following a clinical advisory committee review. The primary goal of the planned Phase 2 trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in first-recurrenc ...

Company plans Phase 2 trial in first-recurrence head & neck cancer, in combination with immune checkpoint inhibitor ATLANTA, GA, July 31, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (NASDAQ:GOVX), a clinicalstage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced the next steps for the clinical development of its Gedeptin® cancer therapy, following a clinical advisory committee review. GeoVax and a specially convened clinical advisory committ ...

Core Insights - The article highlights the relevance of GeoVax's stock (GOVX) due to its advancements in developing a next-generation Covid-19 vaccine, GEO-CM04S1, which has received funding from the Biomedical Advanced Research and Development Authority (BARDA) [2][3][5] Company Developments - GeoVax has partnered with Allucent to conduct a Phase 2b clinical trial for its GEO-CM04S1 Covid vaccine, which has led to a significant increase in GOVX stock price, rising over 110% before some gains were pared back [5] - The Phase 2b trial will involve 10,000 participants and aims to evaluate the efficacy of GEO-CM04S1 against an already approved Covid vaccine, with the unique feature of delivering multiple antigens in a single dose [8] Industry Context - The ongoing concern regarding Covid-19, particularly among vulnerable populations with chronic diseases, underscores the need for more effective vaccines, thereby enhancing the relevance of GeoVax's developments in the biotech sector [3]

[First Quarter Business Achievements](index=1&type=section&id=First%20Quarter%20Business%20Achievements) 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](index=1&type=section&id=GEO-CM04S1%20Program%20Update) 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](index=4&type=chunk) - 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](index=6&type=chunk) [Gedeptin® Program Update](index=2&type=section&id=Gedeptin%C2%AE%20Program%20Update) 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](index=7&type=chunk) - 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](index=7&type=chunk) [Vaccine Manufacturing Process Development](index=2&type=section&id=Vaccine%20Manufacturing%20Process%20Development) 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](index=8&type=chunk) - The manufacturing was transferred from the City of Hope's research center to the company's cGMP manufacturing partner, Oxford Biomedica[8](index=8&type=chunk) [Intellectual Property Developments](index=2&type=section&id=Intellectual%20Property%20Developments) 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](index=11&type=chunk) - 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](index=11&type=chunk)[15](index=15&type=chunk) [First Quarter 2024 Financial Results](index=3&type=section&id=First%20Quarter%202024%20Financial%20Results) 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](index=3&type=section&id=Corporate%20Information) 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](index=15&type=chunk) - Management hosted a conference call and webcast on May 14, 2024, to review financial results and provide a corporate update[14](index=14&type=chunk) - The company issued a forward-looking statements disclaimer, highlighting risks related to clinical trials, regulatory approvals, and capital requirements[16](index=16&type=chunk)[17](index=17&type=chunk)

Product Development and Clinical Trials - GeoVax is developing immunotherapies and vaccines for infectious diseases and solid tumor cancers, with ongoing clinical trials for a next-generation Covid-19 vaccine and gene-directed therapy for advanced head and neck cancer[46]. - A Phase 2 trial for GEO-CM04S1 is evaluating its safety and efficacy as a Covid-19 vaccine in high-risk immunocompromised patients, showing high immunogenicity with neutralizing antibody responses[48]. - The first lot of GEO-CM04S1 was produced using a commercial manufacturing platform, marking a significant milestone in the MVA-based vaccine manufacturing process[52]. - Gedeptin is undergoing a Phase 1/2 trial for advanced head and neck cancer, with interim data indicating safety and tumor growth impairment in most patients[55]. - The company is in advanced discussions with BARDA for potential funding related to Project NextGen, aimed at developing innovative vaccines and therapeutics[73]. Financial Performance - The company has not generated any revenues to date from product sales, indicating a focus on research and development efforts[59]. - Net loss for the three months ended March 31, 2024, was $5,850,132, an increase of $1,812,216 from the net loss of $4,037,916 in 2023[66]. - Cash and cash equivalents decreased to $768,859 as of March 31, 2024, down from $6,452,589 as of December 31, 2023[69]. - Net cash used in operating activities was $5,683,730 for the three months ended March 31, 2024, compared to $3,762,872 in 2023[69]. - The company has not generated any product revenue to date and anticipates continued losses as it seeks regulatory approvals and commercializes product candidates[71]. Research and Development Expenses - Research and development expenses are expected to increase significantly as GeoVax advances its product candidates through clinical trials, particularly for Gedeptin and GEO-CM04S1 programs[60]. - Research and development expenses increased by $1,606,539 (57%) to $4,425,728 for the three months ended March 31, 2024, compared to $2,819,189 in 2023, primarily due to clinical trial costs and personnel expenses[66]. General and Administrative Expenses - General and administrative expenses are expected to rise as the company prepares for potential commercialization and maintains compliance with regulatory requirements[61]. - General and administrative expenses rose by $5,928 (0.4%) to $1,457,353 for the three months ended March 31, 2024, compared to $1,451,425 in 2023[67]. Funding and Capital Requirements - A bridge financing was conducted on May 10, 2024, issuing $150,000 in unsecured promissory notes to board members and senior management, with a 15% annual interest rate[72]. - The company expects to need substantial additional funding to support ongoing operations and product development[75]. - Future capital requirements will depend on various factors, including clinical trial costs, manufacturing expenses, and regulatory approval timelines[79]. Intellectual Property - The U.S. Patent and Trademark Office issued multiple patents to GeoVax in February 2024, covering compositions for malaria and Marburg virus, enhancing the company's intellectual property portfolio[56][57]. Market Environment - The company operates in a highly competitive and regulated environment, with ongoing risks and uncertainties affecting future performance and financial results[45]. Stock and Compliance - A reverse stock split of 1-for-15 was executed to regain compliance with Nasdaq listing requirements, converting every fifteen shares into one[58].

Presentation Made During the 24th Annual World Vaccine Congress ATLANTA, GA, April 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (NASDAQ:GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that its Chief Scientific Officer, Mark Newman, PhD, presented data on GEO-CM04S1, the Company's next-generation Covid-19 vaccine candidate, during the 24th Annual World Vaccine Congress in Washington, DC. During his presentat ...

ATLANTA, GA, March 12, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (NASDAQ:GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today that its Chairman and CEO, David Dodd, will present at the 36th Annual Roth Conference, taking place in Dana Point, CA on March 17-19, 2024. Presentation Details: Presenter:       David Dodd, Chairman & CEODate/Time:      March 18, 2024, 2:30 pm PTLocation:         Dana Point, CAWebcast Li ...

Manufacturing Process for Phase 3 and Commercial Production Being Developed for GeoVax MVA-Based Vaccines ATLANTA, GA, March 06, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (NASDAQ:GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced a significant milestone toward implementation of a validated chicken embryonic fibroblast (CEF) based production system for the company's MVA-based vaccines, with the release of its fi ...

GeoVax Labs, Inc. (NASDAQ:GOVX) Q4 2023 Earnings Conference Call February 29, 2024 4:30 PM ET Company Participants Max Gadicke - Stern, IR David Dodd - Chairman and CEO Mark Reynolds - CFO Kelly McKee - Chief Medical Officer John Sharkey - VP, Business Development Conference Call Participants Laura Suriel - Alliance Global Partners Jeffrey Kraws - Crystal Research Robert LeBoyer - NOBLE Capital Markets Jason Kolbert - Dawson James Vernon Bernardino - H.C. Wainwright Operator Good afternoon, and welcome, eve ...

Catalyst-rich 2024 with data readouts planned throughout the year Company to host conference call and webcast today at 4:30 p.m. ET ATLANTA, GA, February 29, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023. "2023 marked another year of advancement of our ongoing clinical programs for GEO-CM04S1, our ne ...