EQS-News: GeoVax Anticipates Significant 2025 Progress With Catalyst-Rich Milestones Across Key Programs

Strategic Progress Across COVID-19, Mpox, Oncology Therapies and AI Integration Positions GeoVax for Strong Momentum

ATLANTA, GA - February 5, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today outlined its 2025 strategic milestones and business outlook. Building on a history of delivering on key commitments, GeoVax enters 2025 with a robust pipeline, a catalyst-rich milestone schedule, and an unwavering commitment to addressing unmet medical needs on a global scale.

An Important Year Ahead for GEO-CM04S1, a Next-Generation COVID-19 Vaccine

GEO-CM04S1 continues to demonstrate potential for both immunocompromised patients and as a booster vaccine for those previously inoculated with mRNA vaccines. In 2025, the Company anticipates completion of the evaluation trial among Chronic Lymphocytic Leukemia (CLL) patients, a patient population recognized to currently have minimal COVID-19 vaccine options. Interim data reported in Q4 2024 suggest GEO-CM04S1 may offer superior immune responses to CLL patients compared to an mRNA vaccine.

GeoVax also expects to report final results from its healthy adults booster trial, offering valuable data on the vaccine's safety and immunogenicity profile. Another pivotal milestone for GEO-CM04S1 in 2025 is the anticipated initiation of patient enrollment in the BARDA-funded Project NextGen Phase 2b trial, which will evaluate GEO-CM04S1 compared to an authorized mRNA vaccine within a 10,000-patient study. As both a booster and a primary vaccine for immune-compromised patient populations, GEO-CM04S1 remains central to GeoVax’s mission to address the ongoing and evolving challenges of COVID-19.

As part of its strategy, GeoVax will continue to explore and establish strategic partnerships and collaborations to accelerate the development, commercialization, and global accessibility of GEO-CM04S1.

GEO-MVA: Addressing Biosecurity and Global Health Gaps

GEO-MVA, a vaccine designed to combat Mpox and Smallpox, has emerged as a critical solution amid rising global biosecurity concerns. In 2025, the Company plans to initiate clinical evaluations for GEO-MVA while continuing discussions with various stakeholders regarding the opportunity to utilize GEO-MVA among underserved populations in regions including Africa. With ongoing geopolitical and logistical challenges limiting vaccine availability, GEO-MVA's ability to offer multi-disease protection, minimal refrigeration needs, and scalability through implementation of an advanced MVA manufacturing process, GEO-MVA represents a potential transformative resource for both national biosecurity strategies and global health initiatives.

GeoVax recognizes that addressing these critical global challenges requires collaborative efforts. In 2025, the Company will actively pursue strategic partnerships with governments, NGOs, and private-sector stakeholders to maximize the impact and reach of its GEO-MVA platform.

Gedeptin: Unlocking Potential in Solid Tumor Cancer Therapy

GeoVax’s oncology program, centered around Gedeptin®, continues to progress in addressing unmet medical needs in solid tumor therapies. Following encouraging results from Phase 1 and Phase 1/2 trials, Gedeptin is advancing into a Phase 2 clinical trial in 2025, where it will be evaluated in combination with an immune checkpoint inhibitor, targeting first recurrent head and neck cancer. This trial aims to validate the potential synergy between Gedeptin’s targeted gene-directed enzyme prodrug therapy and the powerful immune responses activated by checkpoint inhibitors.

As an FDA-designated Orphan Drug for anatomically accessible oral and pharyngeal cancers, Gedeptin is strategically positioned to address not only head and neck cancers but also other solid tumor indications, such as triple-negative breast cancer, soft tissue sarcoma and melanoma. GeoVax’s clinical roadmap for Gedeptin represents a significant market opportunity, with the potential to reshape how these cancers are treated worldwide.

GeoVax remains open to collaborations with oncology leaders, academic research institutions, and industry partners to further enhance the clinical impact and commercial success of Gedeptin.

Next-Generation Manufacturing: Pioneering Scalable Vaccine Production

To amplify the value of its clinical programs, GeoVax is also focused on advancing MVA vaccine manufacturing through validation of continuous cell line manufacturing processes, ensuring consistent, high-quality vaccine production capabilities. These advancements address long-standing challenges in vaccine scalability and cost-effectiveness, positioning GeoVax as a leader in MVA-based vaccine manufacturing solutions, potentially implementing a proprietary MVA manufacturing process supporting more flexible, localized MVA manufacturing at lower production cost, specifically enabling vaccine self-sufficiency manufacturing in low-middle income regions such as Africa.

GeoVax recognizes that strong manufacturing partnerships are vital to bringing these innovations to market efficiently and cost-effectively. The Company plans to collaborate with manufacturing partners worldwide to scale up production capabilities and meet the growing global demand for MVA-based vaccines.

AI Integration: Optimizing Processes and Driving Innovation

In alignment with its 2025 objectives, GeoVax has expanded the integration of Artificial Intelligence (AI) across its vaccine development and cancer immunotherapy activities. Leveraging AI is anticipated to accelerate vaccine development, optimize cancer therapies, streamline clinical trials, and enhance manufacturing processes, potentially in the following manners:

• Vaccine and Therapy Innovation: Predicting pathogen mutations and optimizing GEO-CM04S1 and Gedeptin® design, ensuring effectiveness in variant-proof vaccines and cancer therapies.
• Clinical Trial Optimization: Refining patient selection, accelerating recruitment, and enhancing diversity for trials targeting high-risk and underserved populations.
• Streamlined Manufacturing: Enhancing scalability and logistics, enabling efficient production and distribution, particularly in underserved regions.

Addressing a $55+ Billion Pipeline Market Opportunity

GeoVax’s pipeline addresses significant unmet and underserved medical needs worldwide in both infectious disease vaccines and oncology, representing a collective potential global market opportunity in excess of $55 billion. Each program - GEO-CM04S1, GEO-MVA, and Gedeptin - addresses significant gaps in existing treatment and prevention strategies, backed by emerging clinical data and a focus towards achieving the necessary regulatory milestones in support of product registration.

David Dodd, Chairman & CEO of GeoVax, commented: "2024 was a transformative year for GeoVax, and our focus and commitment in 2025 is unwavering, focused on critically needed unmet medical needs. Our pipeline, enriched with value-driven milestones, positions us well for successful growth and development.  Collaborations and partnerships remain core to our strategy, ensuring our innovations reach those who need them most. With GEO-CM04S1, GEO-MVA, Gedeptin, our MVA manufacturing advancements, and leveraging AI to optimize our processes and drive innovation, we are prepared to make meaningful contributions to global health, delivering value to our fellow shareholders, various stakeholders and, providing compelling career development opportunities to our staff colleagues."

For further details on GeoVax's pipeline and strategic initiatives, 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.