GeoVax Provides First Half 2024 Business Update

Award of BARDA Project NextGen contract represents a significant milestone event;

total value of award to GeoVax and its CRO partner total approximately $367-388 million

BARDA-funded 10,000-participant Phase 2b study will evaluate and compare GeoVax’s

multi-antigen vaccine candidate (GEO-CM04S1) to an approved vaccine against COVID-19 

Progress across pipeline with planned data readouts in multiple trials expected during H2 2024

ATLANTA, GA - (NewMediaWire) - July 09, 2024 - GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today provided a business update for the first half of 2024. 

In June, GeoVax announced that it received an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial.  The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of GEO-CM04S1 with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. Preparations for the study are underway, and execution of the study will be funded by BARDA under its Clinical Studies Network.

BARDA has made separate awards through its Clinical Studies Network to support execution of the study. GeoVax has partnered with Allucent, a global clinical research organization (CRO), to conduct the trial. The direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. The combined value of the awards to GeoVax and Allucent toward the clinical evaluation of GEO-CM04S1 is approximately $367-388 million.

Funding for this award is provided under Project NextGen, a $5 billion initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 than the first generation COVID vaccines and medicines. BARDA is supporting the development of new vaccines and therapeutics to better address the waning immunity and resistance to current and future SARS-CoV2 viral strains. GeoVax’s vaccine candidate provides many of the features identified by BARDA including broader protection among variants of concern (VOC) and a longer duration of protection. 

This project is being funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) number: 75A50123D00005. Allucent’s role in the project is being funded in whole or in part with federal funds from the Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract 75A50120D00016/75A50123F33005.

Management Commentary

David Dodd, GeoVax’s Chairman and CEO, stated “We have achieved continued and significant progress during the first half of 2024 across numerous development areas, culminating in the recent announcements related to the BARDA Project NextGen program. We view this BARDA award as a watershed event, similar to funding catalysts during Operation Warp Speed, igniting the development and growth of GeoVax. Our focus is to now successfully execute on the clinical trial, validating the potential unique benefits of GEO-CM04S1.

“GEO-CM04S1 has continued to demonstrate induction of potent immune responses with potential to drive broad and durable clinical protection, and we eagerly anticipate commencing the Phase 2b study to further demonstrate the value and advantages of our technology. First-generation COVID-19 vaccines were beneficial during the peak of the pandemic but are limited in breadth and durability of clinical protection, requiring frequent updates. Now that COVID-19 is in an endemic stage, many people continue to have their everyday lives impacted in meaningful ways.”  

Dodd concluded, “We look forward to successfully advancing to initiation of the BARDA-funded Phase 2b clinical trial, reporting further progress on each of our other ongoing clinical trials as well as our additional data readouts, and execution on our long-term strategy across our portfolio of assets.  We expect a catalyst-rich remainder of 2024.”

Additional First Half Business Achievements

GEO-CM04S1

-       Presented data on GEO-CM04S1, at the 24^th Annual World Vaccine Congress in April 2024. The presentation, titled “Vaccine Induction of Broadly-Specific Antibody and T Cell Responses to Combat SARS-CoV-2 Variation,” focused on results delineating the unique immune system driven mechanisms that contribute to the broad efficacy of GEO-CM04S1. The data presented were generated in collaboration with scientists at Georgia State University using the human ACE2 transgenic mice, one of the “gold standard” small animal models used for studying COVID vaccines. Overall, the presentation highlighted that vaccine induced immunity protects against infections, serious disease symptoms and death against the original Wuhan variant as well as the Omicron XBB.1.5 variant, which is the basis of the currently approved mRNA booster vaccines.

-       Positive initial safety and immune response findings from Phase 2 clinical trial at one month following administration of GEO-CM04S1. The trial, evaluating GEO-CM04S1 as a heterologous booster in 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466), was fully enrolled at the end of Sept 2023. The study is designed to evaluate the safety and immunogenicity of two GEO-CM04S1 dose levels. The trial remains blinded to dose of vaccine received, with study subjects being followed for a total of one year. To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations. The immunological responses measured throughout the study period include both neutralizing antibodies against SARS-CoV-2 variants and specific T-cell responses. Consolidated data from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5; additional testing against the JN.1 variant is underway. 

Gedeptin^®

-       Completion of patient enrollment for the Phase 1/2 clinical study evaluating Gedeptin® in patients suffering from advanced head and neck cancer. Completion of this trial will be a significant milestone in the Gedeptin clinical development program. Allowing time for the maximum number of cycles of Gedeptin therapy and patient follow-up, GeoVax expects to complete the study by the third quarter of this year. In the interim, active discussions are taking place with advisors on protocol development in support of a follow-on Phase 2 or Phase 2/3 trial among patients with advanced head and neck cancer in whom current therapeutic options are suboptimal. 

Vaccine Manufacturing Process Development

-      Achieved an important milestone in manufacturing process development for Phase 3 and Commercial Production.This is an important step toward implementation of a validated chicken embryonic fibroblast (CEF) based production system for the company’s MVA-based vaccines, with the release of the first lot of GEO-CM04S1 (next-generation COVID-19 vaccine) produced with a commercial manufacturing platform. This milestone marks the successful completion of the transfer and scale-up of manufacturing from the research-focused Center for Biomedicine & Genetics at City of Hope to Oxford Biomedica, the Company’s cGMP (current Good Manufacturing Procedures) manufacturing partner.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, which recently completed enrollment in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, 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.