EQS-News: GeoVax Achieves Significant Progress in Next-Generation COVID-19 Vaccine Development Throughout 2024

Advancements Position GEO-CM04S1 as a Leading Vaccine Candidate Addressing Unmet Medical Needs, Especially Among Immunocompromised Patients

ATLANTA, GA - January 13, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in immunotherapies and vaccines against infectious diseases and cancers, is pleased to announce substantial progress in the clinical development of its COVID-19 vaccine portfolio during 2024. These achievements underscore the potential of GEO-CM04S1 to address critical public health needs, particularly among immunocompromised populations.

Project NextGen (PNG) Award

In June 2024, GeoVax received a significant award through the Rapid Response Partnership Vehicle (RRPV), funded by the Biomedical Advanced Research and Development Authority (BARDA) as part of PNG. This award supports a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 compared to an approved COVID-19 vaccine. The study is set to commence in the second half of 2025, with Allucent, a global clinical research organization, selected to conduct and manage the trial.

Chronic Lymphocytic Leukemia (CLL) Interim Study Results

In November 2024, the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1 as a booster vaccine for patients with CLL conducted an interim data review of the study. Following its review, the DSMB recommended that the study should continue enrollment of the experimental arm utilizing GEO-CM04S1, but that the mRNA control arm of the study should be halted as it failed to meet the predetermined primary immune endpoint. This suggests a potentially superior immune response in this vulnerable population. Further enrollment of the remaining patient participants is expected to be completed during 2025.

Completion of Enrollment in Booster Vaccine Study for Healthy Adult Volunteers

GeoVax has successfully completed enrollment in its Phase 2 clinical trial evaluating GEO-CM04S1 as a booster vaccine in healthy adults who previously received COVID-19 vaccines. This study aims to assess the vaccine's safety and immunogenicity at two different dose levels, with data readouts anticipated in the first half of 2025.

Ongoing Stem Cell Transplant Study

The Company continues to advance its Phase 2 clinical trial of GEO-CM04S1 as a primary vaccine for immunocompromised patients undergoing stem cell transplantation. This study addresses a critical need for effective vaccination strategies in populations that may not respond adequately to existing vaccines.

Potential Benefits of GEO-CM04S1 Over Existing Authorized COVID-19 Vaccines

GEO-CM04S1 offers several potential benefits compared to currently authorized COVID-19 vaccines:

• Public Health Impact: By providing robust protection for immunocompromised individuals, GEO-CM04S1 could significantly reduce COVID-19-related risks of morbidity and mortality among such high-risk patient populations.
• Durability: Preliminary data suggest that GEO-CM04S1 may offer longer-lasting immunity, potentially reducing the frequency of booster doses required.
• Breadth of Protection: The inclusion of both Spike (S) and Nucleocapsid (N) antigens in GEO-CM04S1 may confer broader immunity, making it more effective against a range of variants without the need for frequent reformulation.
• Primary Vaccine for Immunocompromised Patients: With approximately 40 million immunocompromised individuals in the U.S. and an estimated 400+ million worldwide, many of whom may not respond adequately to current vaccines, GEO-CM04S1 has the potential to become the preferred vaccine for this population.
• Safety. The safety profile of MVA as the platform for GEO-CM04S1 is well-established, with decades of data supporting its use as a smallpox vaccine, as well as its use as a platform with diverse vaccine candidates. This robust safety record is particularly important as the new HHS administration prioritizes transparency and rigorous oversight in vaccine safety evaluation. GEO-CM04S1 aligns with these priorities, offering a scientifically validated platform backed by comprehensive safety data.

Market Potential and Partnering Opportunities

GEO-CM04S1 offers an alternative approach to boosting existing COVID-19 vaccines, providing enhanced and more durable immunity. Its applicability for immunocompromised patients further broadens its public health and commercial value. GeoVax estimates the annual market potential for GEO-CM04S1 to be approximately $30 billion, reflecting the critical medical need to better address high-risk immunocompromised patients. The global need for a next-generation COVID-19 vaccine with the advantages offered by GEO-CM04S1 creates multiple partnering opportunities for GeoVax.

Looking Ahead to 2025

The continued development of GEO-CM04S1 is a key component of GeoVax's catalyst-rich agenda for 2025. The Company anticipates multiple data readouts and regulatory milestones that will further define the vaccine's role in combating COVID-19.

"Our progress in 2024 has been remarkable, particularly in advancing GEO-CM04S1 as a next-generation COVID-19 vaccine," said David Dodd, Chairman & CEO of GeoVax. "The MVA platform underlying our vaccine offers unique advantages, including the potential for broader and more durable protection, which is especially critical for immunocompromised individuals. We are committed to delivering solutions that address unmet medical needs and improve public health outcomes."

Upcoming Presentations

GeoVax's CEO, David Dodd, will present the Company's 2024 progress and future outlook at the following conferences:

• Biotech Showcase: January 14, 2025, at 10:30 AM PST
• Emerging Growth Conference: January 16, 2025, at 2:35 PM ET

For more information on GeoVax's portfolio and developments, please visit www.geovax.com

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is 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. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned to initiate during the first half of 2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. 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.