GeoVax Receives BARDA Project NextGen Award to Conduct Phase 2b Clinical Study Evaluating the Company’s Next-Generation COVID-19 Vaccine Candidate, GEO-CM04S1

10,000-participant randomized Phase 2b study will evaluate and compare GeoVax’s multi-antigen, vaccine candidate (GEO-CM04S1) to an approved vaccine against COVID-19 under BARDA’s Clinical Studies Network

Atlanta, GA, June 18, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today 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 fully funded by BARDA under its Clinical Studies Network.


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. BARDA has made separate awards through its Clinical Studies Network to support execution of the study. That funding will represent approximately $343M from the Project NextGen program for a CRO to execute the clinical trial using GeoVax’s vaccine.


“We are honored and proud to receive this award from BARDA to advance our next-generation vaccine against COVID-19. This contract not only provides the vital resources for advancing the development of GEO-CM04S1, but it also advances our MVA platform in infectious diseases,” said David Dodd, Chairman & CEO of GeoVax.


Mr. Dodd continued, “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. Furthermore, there are an estimated 23 million adults in the U.S. with immunocompromised conditions who are less likely to have an adequate response to current vaccines and are more likely to potentially experience severe COVID-19 symptoms, hospitalization and the risk of death, even after vaccination. GEO-CM04S1 was designed to address these limitations by inducing durable neutralizing antibody and T-cell-based immunity against current and future SARS-CoV-2 variants. Our vaccine 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.”


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.


About GEO-CM04S1

GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T-cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.


GEO-CM04S1 is currently being evaluated in three ongoing Phase 2 clinical trials:

  • As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. A recent presentation of unpublished data from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T-cell responses.
  • As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
  • As a booster vaccine for healthy adults who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466.


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. 


Source and Media Contacts: https://geovax.com/investors/press-releases/geovax-receives-barda-project-nextgen-award-to-conduct-phase-2b-clinical-study-evaluating-the-company-s-next-generation-covid-19-vaccine-candidate-geo-cm04s1

Georgia Life Sciences Joins National Coalition Calling for PAHPA Reauthorization

September 22, 2026
Georgia Life Sciences (GLS) has joined more than 80 organizations from across industry, academia, public health and the biosecurity community in calling on congressional leaders to fully reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) before the end of 2026. Led by the Johns Hopkins Center for Health Security, the coalition urged congressional leaders to advance a comprehensive reauthorization of PAHPA, the federal framework that supports the nation’s ability to prepare for and respond to public health emergencies and other health security threats. First enacted in 2006, PAHPA established and strengthened critical components of the nation’s health security infrastructure, including the Biomedical Advanced Research and Development Authority (BARDA). The law also supports public-private partnerships involved in the research, development, manufacturing and procurement of medical countermeasures, including vaccines, therapeutics and diagnostics. PAHPA’s authorization expired in 2023 and key provisions have since continued through short-term extensions. The coalition is calling for a comprehensive reauthorization that provides greater stability and ensures the nation’s preparedness infrastructure can continue adapting to emerging biological, infectious disease and other health security threats. For the life sciences industry, these programs are particularly important. Partnerships between government and industry can help move promising technologies from research through development and manufacturing while maintaining capabilities needed to respond quickly during an emergency. The Biotechnology Innovation Organization (BIO), also a signatory to the letter, has identified several priorities for reauthorization, including continued authorization of BARDA, the Strategic National Stockpile, Project BioShield and the Pandemic Influenza Program, as well as incentives supporting the development of medical countermeasures. Georgia Life Sciences is proud to join organizations across the country in supporting a strong and sustainable national framework for health security, preparedness and biomedical innovation. Read the coalition letter and view the full list of signatories.

Georgia Life Sciences Urges Protection of Patient Access as Georgia Implements Medicaid Changes

September 14, 2026
Georgia Life Sciences has submitted comments to the Georgia Department of Community Health (DCH) regarding the Georgia Pathways to Coverage program and implementation of new federal Medicaid requirements. As Georgia prepares for these changes, Georgia Life Sciences is urging state leaders to prioritize continuity of care and minimize unnecessary administrative barriers that could delay or disrupt access to medically necessary treatment . This is particularly important for Georgians living with serious, chronic, rare, and medically complex conditions who may rely on ongoing medications, diagnostics, therapies, medical technologies, specialty care, and coordinated treatment plans. Even temporary disruptions in coverage can interrupt care and create additional challenges for patients and families. In its comments, Georgia Life Sciences encouraged DCH to protect continuity of coverage during eligibility and redetermination processes, provide patients and caregivers with clear and timely information, minimize unnecessary administrative burdens, and establish appropriate safeguards when a coverage disruption could interrupt an established course of treatment. “As Georgia implements these new federal requirements, we want to ensure that patients remain at the center of the process,” said Maria Thacker Goethe, MPH, President & CEO of Georgia Life Sciences. “Administrative changes should not become barriers between patients and the care they need. Protecting continuity of care is particularly important for Georgians managing serious and complex health conditions.” Read Georgia Life Sciences’ full comments to DCH here.

White House Fact Sheet: President Donald J. Trump Announces Deal with Nine Additional Pharmaceutical Manufacturers to Lower Drug Prices for Americans

August 31, 2026
The White House, August 31, 2026 - ADVANCING MOST-FAVORED-NATION (MFN) PRICING: Today, President Donald J. Trump announced nine new agreements with pharmaceutical manufacturers to lower prescription drug prices for Americans in line with the lowest prices paid by other developed nations (known as the most-favored-nation, or MFN, price). The agreements bring the total number of pharmaceutical manufacturers with MFN deals to 26, covering 89% of the branded drug market. The nine manufacturers are comprised of mid-sized pharmaceutical companies, including Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, and UCB. The agreements reduce prices on drugs that treat numerous costly, chronic, and even rare diseases, including hemophilia, Parkinson’s disease, macular degeneration, glaucoma, liver disease, skin conditions, and various forms of cancer. The agreements will provide every State Medicaid program in the country access to MFN drug prices on products made by the nine companies, resulting in billions of dollars in savings for Americans and continuing President Trump’s historic efforts to strengthen the program for the most vulnerable. The agreements ensure foreign nations can no longer use price controls to freeride on American innovation by guaranteeing MFN prices on all new innovative medicines the nine companies bring to market. Each of these manufacturers has agreed to fundamentally rebalance international drug pricing by providing MFN pricing to American patients. BOLSTERING AMERICA’S PHARMACEUTICAL SUPPLY CHAINS AND RESERVES: These nine pharmaceutical manufacturers committed to invest at least $19.6 billion collectively in U.S. manufacturing in the near term. Additionally, as part of the MFN agreements, several companies are donating active pharmaceutical ingredients for key products to the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) to reduce reliance on foreign nations and ensure the United States has an adequate supply of such products in the event of an emergency. UCB will contribute 163 tons of levetiracetam, an anticonvulsant used to control and prevent certain types of seizures, to the SAPIR. Sun Pharma will contribute 71.4 tons of clindamycin and 6.75 tons of doxycycline; both antibiotics to treat bacterial infections, to the SAPIR. Teva Pharmaceuticals will contribute 45 metric tons of metronidazole, an antibiotic and antiprotozoal used to treat certain bacterial and parasitic infections, and 4.8 tons of amlodipine, an antihypertensive drug, to the SAPIR. Astellas will contribute 25 kg of tacrolimus, an immunosuppressant used to prevent organ rejection in people who have had organ transplants, to the SAPIR. LOWERING COSTS FOR AMERICANS: President Trump’s decisive and historic actions are lowering drug prices for the American people. Since its February launch, patients have saved more than $700 million on medicines through TrumpRx, including massive discounts on some of the most popular and costly medications used to treat obesity and infertility. In July of 2026, senior citizens without access to GLP-1 coverage to treat obesity gained access for just $50 per month. In the two months since the launch of this program, over 500,000 seniors have saved a total of $216 million dollars on these life-changing medicines. The Council of Economic Advisers estimates the total savings from President Trump’s MFN deals to reach $600 billion over the next decade. DELIVERING ON PROMISES TO PUT AMERICAN PATIENTS FIRST: President Trump is delivering on promises for American patients, accomplishing historic wins that the political establishment did not believe were possible. On May 12, 2025, President Trump signed an Executive Order titled: “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” directing the Administration to take numerous actions to bring American drug prices in line with those paid by similar nations. On July 31, 2025, President Trump sent letters to 17 of the leading pharmaceutical manufacturers outlining the steps they must take to bring down the prices of prescription drugs in the United States to match the lowest price offered in other developed nations. There are now MFN deals with each of those leading pharmaceutical manufacturers. On September 30, 2025, President Trump announced the first agreement, with the drug manufacturer Pfizer, to bring MFN prices to American patients. On December 1, 2025, the Office of the United States Trade Representative, the Department of Commerce, and the Department of Health and Human Services announced an agreement with the United Kingdom (U.K.) that will increase the net price of new prescription drugs by 25% in the U.K., helping ensure they pay their fair share for innovative medicines. On December 19, 2025, President Trump announced nine new agreements with major pharmaceutical companies. On February 5, 2026, President Trump launched TrumpRx.gov , where patients can access large discounts on many of the most popular and highest-priced medicines in the country, paying prices in line with the MFN price. As of today, August 31, the Administration now has agreements with Pfizer, Astra Zeneca, EMD Serono, Eli Lilly, Novo Nordisk, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck, Novartis, Sanofi, Johnson & Johnson, AbbVie, Regeneron, Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, and UCB. President Trump is calling on Congress to enact the Great Healthcare Plan , a comprehensive plan to lower drug prices, lower insurance premiums, hold big insurance companies accountable, and maximize price transparency. Source: Fact Sheet: President Donald J. Trump Announces Deal with Nine Additional Pharmaceutical Manufacturers to Lower Drug Prices for Americans – The White House
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