Company Reaffirms Commitment to Innovation in COVID-19, Oncology, and Biosecurity Amid Strategic Program Developments
ATLANTA, GA - April 16, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today addressed the termination of its Project NextGen (PNG) award by the Biomedical Advanced Research and Development Authority (BARDA), effective April 11, 2025. The Company also provided a comprehensive business update across its core programs, including the next-generation COVID-19 vaccine (GEO-CM04S1), cancer immunotherapy (Gedeptin(R)), Mpox/smallpox vaccine (GEO-MVA), and advanced MVA manufacturing process.
GeoVax expressed disappointment in the HHS/BARDA action but remains committed to the critical medical need addressed by GEO-CM04S1, particularly among the more than 40 million immunocompromised Americans - and over 400 million people globally - who remain inadequately protected by the current authorized COVID-19 vaccines. Thus far, clinical data in support of GEO-CM04S1 demonstrate encouraging support of the potential of GEO-CM04S1 for providing (a) more robust immune response, (b) increased durability and (c) protective immunity for those patients with depleted immune systems inadequately responding to the current authorized COVID-19 vaccines.
The Company also noted recent public statements by HHS leadership acknowledging the potential enhanced value of multi-antigen vaccines addressing respiratory viruses. Of special note is that GEO-CM04S1 was the only multi-antigen/polyvalent COVID-19 vaccine candidate selected under the PNG initiative.
"While the recent HHS/BARDA Stop Work Order action was disappointing and surprising, our commitment to protecting vulnerable populations remains unchanged, and our clinical momentum is strong in support of our ongoing Phase 2 GEO-CM04S1 programs," said David Dodd, Chairman and CEO of GeoVax.
Continued Progress Across a Catalyst-Rich Pipeline
GEO-CM04S1: Advancing to Meet Unmet COVID-19 Needs
GEO-CM04S1 continues to demonstrate potential as both a primary and booster vaccine, especially in immunocompromised patients. Key milestones anticipated during 2025 include:
Healthy Adult Booster Trial - Enrollment is complete; data readout expected in H1 2025.
CLL Patient Study (Immunocompromised patient study) - Ongoing enrollment; interim results resulted in continuation of the GEO-CM04S1 arm, whereas the Data Safety Review Board recommended early termination of the mRNA arm, which was subsequently implemented.
Stem Cell Transplant/CAR-T Trial (Immunocompromised patient study) - Enrollment and evaluation continue among hematological patients receiving stem cell transplantation or CAR-T therapy, comparing GEO-CM04S1 to mRNA COVID-19 vaccines.
GEO-CM04S1 is a multi-antigen COVID-19 vaccine, utilizing a synthetic-MVA platform, expressing both S and N antigens, offering the potential for broader, more durable protection than current mRNA vaccines.
Gedeptin(R): Advancing into Phase 2 in Solid Tumors
GeoVax's oncology program, utilizing the Gedeptin(R) technology, is planned to progress to a Phase 2 trial in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer. Gedeptin has received Orphan Drug designation for use among advanced head & neck cancer patients. The Gedeptin technology provides potential for expansion into other solid tumors including triple-negative breast cancer, melanoma, and soft tissue sarcoma.
GEO-MVA: Addressing Biosecurity and Global Vaccine Equity
GeoVax anticipates initiating clinical trials in 2025 for GEO-MVA, its Mpox/smallpox vaccine candidate. The Company has successfully produced cGMP clinical product and is focused on completing the vaccine vialing in support of initiating clinical evaluation during H2 2025. GEO-MVA positions GeoVax to offer a U.S.-developed alternative to foreign-sourced vaccines amid rising global biosecurity threats and constrained supply.
Advanced Manufacturing: Scaling MVA for Global Reach
GeoVax is advancing continuous cell line manufacturing for MVA-based vaccines, offering a path to scalable, cost-effective production - including localized manufacturing for low- and middle-income countries. This innovation addresses critical gaps in vaccine self-sufficiency and supply resilience.
Outlook for 2025
Despite the PNG award termination, GeoVax anticipates a milestone-rich 2025 across its portfolio. The Company will continue to engage with government and industry partners, pursue clinical trial completions, and drive innovation through expanded AI integration to optimize development, trial operations, and manufacturing efficiency.
"Our scientific foundation is strong and our strategy is clear," added Dodd. "GeoVax remains committed to delivering transformative solutions for unmet medical needs in infectious disease and cancer. We're advancing with purpose and fully prepared to deliver on the promise of our development program."
For further details on GeoVax's programs and progress, visit www.geovax.com.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax's business plans. The words "believe," "look forward to," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax's immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax's viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax's immuno-oncology products and preventative vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
