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GeoVax Labs, Inc. (Nasdaq: GOVX) is a clinical-stage biotechnology company dedicated to the development of innovative vaccines and immunotherapies targeting some of the world's most pressing health challenges, including infectious diseases and solid tumor cancers. Leveraging its proprietary Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) platform, the company creates advanced therapeutic solutions designed to stimulate robust and durable immune responses. This platform enables the in vivo production of non-infectious virus-like particles (VLPs) directly in the cells of vaccine recipients, mimicking natural infections to activate both humoral and cellular immunity.
Core Focus Areas
GeoVax's development pipeline encompasses a diverse range of preventive and therapeutic vaccines, addressing critical unmet needs in healthcare:
- Infectious Diseases: The company is advancing vaccines for diseases such as COVID-19 (GEO-CM04S1), Mpox (Monkeypox), smallpox, hemorrhagic fevers (Ebola, Marburg, Lassa), Zika virus, HIV, and malaria.
- Oncology: GeoVax is developing immunotherapies for solid tumors, including its lead oncology candidate, Gedeptin®, which targets advanced head and neck cancers using a gene-directed oncolytic therapy approach.
Innovative MVA-VLP Technology
The cornerstone of GeoVax's innovation is its MVA-VLP platform, which combines the safety of the Modified Vaccinia Ankara viral vector with the immunogenicity of virus-like particles. This technology is uniquely capable of presenting multiple antigens to the immune system in a single dose, offering broad-spectrum protection against evolving pathogens and reducing the need for frequent vaccine updates. For instance, the GEO-CM04S1 COVID-19 vaccine incorporates both spike and nucleocapsid antigens, enabling enhanced antibody and T-cell responses against SARS-CoV-2 variants.
Pipeline Highlights
GeoVax's product pipeline is anchored by several promising candidates:
- GEO-CM04S1: A next-generation COVID-19 vaccine designed for immunocompromised populations and as a durable booster for healthy individuals. It is currently in multiple Phase 2 clinical trials.
- Gedeptin®: A novel oncolytic therapy in Phase 1/2 trials for advanced head and neck cancers, with plans to expand into combination therapies with immune checkpoint inhibitors.
- Mpox/Smallpox Vaccine: Aimed at addressing the unmet need for a U.S.-based supplier of vaccines targeting these diseases.
Strategic Positioning
GeoVax operates in a highly competitive biotechnology landscape, distinguishing itself through its proprietary platform, extensive intellectual property portfolio, and focus on underserved patient populations. The company holds over 120 granted or pending patents across 24 patent families, providing robust protection for its technologies and products. Strategic partnerships with contract development and manufacturing organizations (CDMOs) further enhance its ability to scale production efficiently.
Challenges and Market Landscape
As a clinical-stage company, GeoVax faces challenges such as navigating regulatory pathways, securing funding, and competing with established players in the vaccine and immunotherapy sectors. However, its focus on high-need areas, such as immunocompromised patients and rare infectious diseases, positions it as a critical contributor to global health innovation.
Conclusion
GeoVax Labs, Inc. exemplifies innovation in biotechnology, leveraging its MVA-VLP platform to address significant medical challenges. With a diversified pipeline, strong intellectual property, and a commitment to improving vaccine accessibility, GeoVax is poised to make a meaningful impact in the fields of infectious disease prevention and cancer therapy.
GeoVax Labs (Nasdaq: GOVX) has received a Notice of Allowance from the U.S. Patent and Trademark Office for Patent Application No. 17/876,682, titled 'Vaccinia Viral Vectors Encoding Chimeric Virus Like Particles.' The patent strengthens protection for their vector platform expressing tumor-associated antigens in virus-like particles.
The company's MVA-VLP-MUC1 immunotherapy candidate showed promising preclinical results, achieving a 57% reduction in tumor growth when combined with anti-PD-1, and 100% prevention of tumor growth in a preventive model. GeoVax's patent portfolio now includes over 120 granted or pending applications across 24 patent families.
Additionally, GeoVax plans to initiate a Phase 2 clinical trial in first recurrent head and neck cancer for their lead oncology program Gedeptin® combined with an immune checkpoint inhibitor during first half 2025.
GeoVax Labs (Nasdaq: GOVX) announced that Chairman & CEO David Dodd will present at NobleCon20, the Noble Capital Markets Twentieth Annual Emerging Growth Equity Conference, on December 3, 2024, at 11:30 am ET in Boca Raton, FL. The presentation will be webcasted and available on GeoVax's website, Noble Capital Markets' Conference website, and Channelchek for 90 days.
GeoVax is advancing several clinical programs, including GEO-CM04S1, their next-generation COVID-19 vaccine, which recently received BARDA funding for a 10,000-participant Phase 2b trial. The company is also developing Gedeptin®, an oncolytic solid tumor therapy, with a Phase 2 clinical trial planned for first recurrent head and neck cancer in early 2025.
GeoVax Labs announced positive interim data from its Phase 2 clinical trial of GEO-CM04S1, a dual-antigen COVID-19 vaccine booster for chronic lymphocytic leukemia (CLL) patients. The Data Safety Monitoring Board's review showed that while the mRNA control arm failed to meet the primary endpoint, GeoVax's vaccine arm should continue enrollment. The study at City of Hope National Medical Center compares two injections of GEO-CM04S1 against an mRNA vaccine control. GEO-CM04S1 uses a modified vaccinia virus vector containing both Spike and Nucleocapsid antigens, potentially offering broader immune response and better protection for immunocompromised CLL patients who typically show insufficient responses to current COVID-19 vaccines.
GeoVax Labs reported its Q3 2024 financial results and business updates. The company recorded a net loss of $5.8 million ($0.91 per share) for Q3 2024, compared to $8.4 million in Q3 2023. Revenue from BARDA/RRPV Project NextGen was $2.8 million for Q3 2024. Key developments include progress in the GEO-CM04S1 BARDA Phase 2b trial, advancement of Gedeptin® towards Phase 2 clinical trials for head and neck cancer, and development of the GEO-MVA Mpox vaccine. The company reported cash balances of $8.6 million as of September 30, 2024.
GeoVax Labs (Nasdaq: GOVX) announced it will report its third quarter 2024 financial results on Tuesday, November 12, 2024, after U.S. markets close. The biotechnology company, which develops immunotherapies and vaccines against cancers and infectious diseases, will host a conference call and webcast with Q&A at 4:30 PM ET. Management will provide a corporate update and discuss financial results. Participants can access the call through registration, and an audio webcast archive will be available on the company's website for at least 90 days following the event.
GeoVax Labs, a biotechnology company focused on vaccine and cancer immunotherapy development, has announced its participation in the 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024 in New York. David Dodd, the company's Chairman & CEO, will be part of a panel discussion on innovative therapies for solid tumors at 12:30 pm ET.
The company's senior management will also be available for one-on-one meetings with registered attendees. Interested parties can arrange meetings through their ROTH representative or by contacting GeoVax directly at info@geovax.com.
This participation highlights GeoVax's commitment to advancing its research and development in the field of cancer immunotherapies and human vaccines.
GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company focused on developing immunotherapies and vaccines, has announced its participation in two upcoming investor conferences in September 2024. Chairman and CEO David Dodd will present at both events:
1. H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, at 7:00 a.m. ET in New York, NY.
2. Emerging Growth Conference on September 25, 2024, at 2:55 p.m. ET, which will be held virtually.
Both presentations will provide corporate updates on GeoVax. At the H.C. Wainwright conference, senior management will also host one-on-one meetings with registered attendees. Interested parties can contact GeoVax directly at info@geovax.com to arrange meetings.
GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company, has announced a registered direct offering priced at-the-market. The company will sell 975,610 shares of common stock (or equivalents) at $5.125 per share to an institutional investor. Additionally, in a concurrent private placement, GeoVax will issue warrants to purchase up to 975,610 shares at $5.00 per share, exercisable immediately with a five-year term.
The offering is expected to raise approximately $5.0 million in gross proceeds, before deducting fees and expenses. GeoVax plans to use the net proceeds for working capital and general corporate purposes. Roth Capital Partners is acting as the exclusive placement agent. The offering is anticipated to close around August 30, 2024, subject to customary closing conditions.
GeoVax Labs (Nasdaq: GOVX), a biotechnology company focused on developing immunotherapies and vaccines, has announced an upcoming webinar titled 'Now Is Not the Time to Monkey(pox) Around'. The event, scheduled for August 23, 2024, at 11:00am ET, will feature CEO David Dodd providing a detailed overview of Mpox, including insights on its rapid spread and methods for control, treatment, and prevention.
The webinar, hosted by Tribe Public , offers a complimentary registration for participants who can submit questions in advance or during the event. This presentation aims to address the growing concerns surrounding Mpox and highlight GeoVax Labs' potential role in combating the disease.
GeoVax Labs, Inc. (Nasdaq: GOVX) has announced a registered direct offering of 1,700,000 shares of common stock (or equivalents) at $5.00 per share, priced above-the-market. The biotechnology company is expected to raise approximately $8.5 million in gross proceeds. In a concurrent private placement, GeoVax will issue warrants to purchase up to 1,700,000 additional shares at $5.00 per share, exercisable immediately with a five-year term.
Roth Capital Partners is acting as the exclusive placement agent. The offering is expected to close around August 21, 2024. GeoVax intends to use the net proceeds for working capital and general corporate purposes. The offering is made pursuant to a previously filed and effective shelf registration statement.