GEO-CM04S1 Offers Solution to Overcome HHS-Cited mRNA Deficiencies - Potentially Offering Broader, More Durable Protection

ATLANTA, GA - August 7, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen, MVA-based vaccines and solid tumor immunotherapies, today issued a statement in response to the U.S. Department of Health and Human Services’ (HHS) decision to terminate nearly $500 million in BARDA-funded mRNA vaccine development contracts.

This action reflects a policy shift, underscored by HHS Secretary Kennedy addressing fundamental concerns around mRNA vaccines. In a post on X, Secretary Kennedy stated: “mRNA vaccines don’t perform well against viruses that infect the upper respiratory tract”. The Secretary added that this is due to a concept known as “antigenic shift, meaning that the vaccine paradoxically encourages new mutations and can actually prolong pandemics as the virus constantly mutates”. GeoVax’s vaccine candidates, including GEO-CM04S1 for COVID-19, are designed to induce immunity using multiple antigens. GEO-CM04S1 expresses both the Spike (S) and Nucleocapsid (N) proteins of SARS-CoV-2, enabling broader and more durable protection - even as the virus mutates. Data from clinical studies have demonstrated that GEO-CM04S1 induces immune responses across variants, from the original Wuhan strain through Omicron, even in immunocompromised patients.

“Secretary Kennedy’s remarks spotlight the exact issue our platform was designed to overcome,” said David Dodd, Chairman and CEO of GeoVax. “The mRNA approach, with its single-target design, appears limited relative to durability and antigenic shift. GEO-CM04S1’s multi-antigen construct represents a promising solution - with clinical data demonstrating broader immunity and addressing the mRNA shortcomings Kennedy described, including among the most vulnerable immunocompromised patients.”

Why GeoVax’s MVA-Based Vaccines Align with U.S. Priorities

• Multi‑antigen breadth and durability - GeoVax’s COVID-19 vaccine candidate, GEO‑CM04S1, expresses both SARS‑CoV‑2 Spike and Nucleocapsid proteins - inducing robust and durable antibody and T‑cell immunity in Phase 2 trials. Notably, in a trial among Chronic Lymphocytic Leukemia (CLL) patients, the mRNA comparator arm was halted for failing to meet immune‑response benchmarks, while GEO‑CM04S1 exceeded interim endpoints, with the remainder of the ongoing study only including the GEO-CM04S1 arm. 
• Safety for vulnerable populations - MVA does not replicate in human cells and has been FDA‑approved for use in immunocompromised individuals, pregnant women, and children. This makes it a validated vaccine platform with broad safety.
• Manufacturing innovation and U.S. resilience - GeoVax is advancing AGE.1 manufacturing processes for MVA-based vaccines such as GEO-CM04S1 which is expected to support scalable, decentralized U.S. vaccine manufacturing, providing faster production, higher yield at a reduced cost - a strategic advantage for public health resilience.
• Broad infectious-disease pipeline - Beyond COVID‑19, GeoVax is pursuing MVA‑based vaccines targeting hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg), Zika, and Mpox/Smallpox. This diversified pipeline aligns with HHS, NIH, FDA, and WHO priorities for pandemic preparedness and biodefense.

GeoVax: Delivering on the “Safer, Broader” Vision

GeoVax applauds the call to shift toward multi-antigen vaccine designs with validated safety profiles and resilience to viral mutation. The MVA‑based platform delivers on these goals:

• Evidence‑backed safety for immunocompromised, pediatric, and pregnant populations.
• Broader immune responses with Spike plus Nucleocapsid antigens.
• Strategic manufacturing design for domestic scale and surge capacity.
• Multi‑disease readiness across COVID‑19, hemorrhagic fevers, Zika, and Mpox/Smallpox.

Next Steps: Turning Rhetoric into Resilience

GeoVax urges HHS to proactively support robust, evidence-backed alternatives - including multi-antigen platforms like MVA as part of a diversified, resilient biomedical countermeasure arsenal.

GeoVax invites HHS and other federal partners to collaborate under the FDA’s Commissioner’s National Priority Voucher (CNPV) program and other mechanisms to accelerate regulatory and funding support for GEO-CM04S1 and GEO-MVA, both of which are uniquely positioned to protect high-risk populations and enhance U.S. biomanufacturing self-sufficiency.

Dodd added: “We must now invest in platforms that reflect what we've learned. GeoVax stands ready to lead this transition. Our MVA platform already has a safety track record and is delivering early efficacy where mRNA appears to have fallen short. We stand ready and prepared to assist in supporting HHS’s bold reset into a long-term strategy for national immunization security.”

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®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. 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.

Company Contact:
info@geovax.com
678-384-7220

Media Contact:
Jessica Starman
media@geovax.com