Company Aligns Resources With Programs Demonstrating Strong Clinical, Regulatory, and Market Momentum
ATLANTA, GA - May 26, 2026 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines, today announced a strategic prioritization of its development portfolio to concentrate resources on its lead programs, GEO-MVA and Gedeptin®, reflecting increasing clinical, regulatory, and market alignment across these programs. As part of this decision, the Company has elected to discontinue active development activities related to its GEO-CM04S1 COVID-19 vaccine candidate. This decision was not related to any safety concerns with the vaccine but reflects the continued evolution and contraction of the global COVID-19 vaccine market, and GeoVax’s focus on programs with clearer regulatory pathways, stronger demand visibility, and more immediate commercialization potential. GeoVax emphasized that portfolio prioritization is a standard and essential practice within the biotechnology industry, enabling companies to align resources with the highest-value opportunities as market conditions and scientific landscapes evolve.
“GeoVax is at an important inflection point, and this decision reflects a deliberate and disciplined focus on the programs we believe can deliver the greatest near-term and long-term value,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “As GEO-MVA advances toward clinical validation and potential commercialization, and as Gedeptin gains relevance within emerging immuno-oncology treatment paradigms, we are aligning our resources to support focused execution against these high-potential opportunities.”
GEO-MVA: Expedited Pathway and Near-Term Commercial Opportunity
GEO-MVA, GeoVax’s Modified Vaccinia Ankara (MVA) vaccine candidate targeting mpox and smallpox, is advancing under an expedited regulatory pathway supported by European Medicines Agency (EMA) scientific advice. This approach enables potential approval based on a single pivotal immunobridging study demonstrating non-inferiority to an approved MVA vaccine - significantly accelerating development timelines and reducing clinical risk.
The program has clinical-grade material manufactured and released in preparation for the planned Phase 3 immunobridging study. Following successful completion, GEO-MVA is expected to advance toward regulatory submission and potential commercialization within a streamlined timeframe, including potential Emergency Use Licensing.
GeoVax has initiated outreach with global procurement and preparedness stakeholders - including government agencies, international organizations, and biodefense programs - supporting potential vaccine supply agreements aligned with national stockpiling and outbreak response needs. These activities position GEO-MVA to serve as a critical additional supplier of MVA-vaccine supporting supply-chain resilience and biodefense preparedness.
Gedeptin®: Aligned with Emerging Immuno-Oncology Treatment Paradigm
Gedeptin®, GeoVax’s gene-directed enzyme prodrug therapy (GDEPT) platform, is being advanced in alignment with a rapidly evolving oncology landscape, highlighted by the landmark KEYNOTE-689 Phase 3 trial demonstrating improved event-free survival with neoadjuvant checkpoint inhibitor therapy in resectable head and neck cancers.
GeoVax’s planned Phase 2 study (AdPNP-203) will evaluate Gedeptin in combination with pembrolizumab and fludarabine in a neoadjuvant setting, with the objective of enhancing tumor immune visibility and improving clinical outcomes.
Gedeptin’s tumor-targeting mechanism is designed to significantly damage or destroy treated lesions through the localized, in situ generation of a potent chemotherapeutic agent. In addition, Gedeptin appears to sensitize tumors to checkpoint inhibitors, likely through the exposure and release of neoantigens from treated lesions, thereby enhancing responses in both treated and untreated lesions. This mechanism may expand response rates and improve durability of outcomes in patients who derive limited benefit from checkpoint inhibition alone. These developments underscore the growing relevance of Gedeptin within this evolving treatment paradigm and support GeoVax’s decision to prioritize its advancement within the Company’s portfolio.
“This is a strategic step forward for GeoVax,” Dodd added. “By concentrating our efforts on GEO-MVA and maintaining our oncology innovation with Gedeptin, we believe we are positioning the Company for a more focused, execution-driven path toward late-stage development, commercialization and long-term value creation”.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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.
Company Contact:
info@geovax.com
678-384-7220
Media Contact:
Jessica Starman
media@geovax.com
