GeoVax Commences Site Expansion for Phase 2 Trial of Next-Generation COVID-19 Vaccine

Designed to Protect Immunocompromised Patients Against Severe COVID-19

ATLANTA, GA, October 30, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has commenced the planned site expansion for the Phase 2 clinical trial investigating its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, as a primary vaccine in immunocompromised patients.  In addition to study enrollments completed at the City of Hope Medical Center (Duarte, California), the trial will be initiating enrollment of eligible patients at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Massachusetts), and Fred Hutchinson Cancer Research Center (Seattle, Washington).

The Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) is evaluating the safety and immunogenicity of GEO-CM04S1, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients with hematologic malignancies who have received either an allogeneic hematopoietic stem cell transplant, an autologous hematopoietic stem cell transplant or chimeric antigen receptor (CAR) T cell therapy. Such patients often have difficulty mounting an adequate protective antibody response after receiving currently available COVID-19 vaccines.

David Dodd, GeoVax Chairman and CEO, commented, “We are pleased with these site activations to expand the scope and reach of this trial, which we expect will accelerate patient enrollment for this important study in one of the highest at-risk patient populations, currently underserved by available vaccines. We believe the unique properties of GEO-CM04S1 potentially offer a more robust, durable degree of protection than the current authorized COVID-19 vaccines, not only as a vaccine for highly vulnerable immunocompromised patients for whom the currently authorized mRNA vaccines may be inadequate, but also potentially for healthy patients as a universal booster vaccine to the mRNA vaccines.  In the U.S., there are approximately 15 million individuals who, as a result of their compromised immune systems, often do not adequately respond to the current authorized vaccines.  Worldwide, there are an estimated 240+ million such patients. Our hope is that GEO-CM04S1 provides robust, durable immune protection for such patients, while also providing a critically important alternative to COVID-19 booster vaccines for healthy individuals.”

A recent publication in Vaccines ( https://doi.org/10.3390/vaccines11091492) 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 against ancestral as well as recently evolved SARS-CoV-2 virus strains. These data support the progression of the Phase 2 clinical study, which includes a direct comparison to currently approved mRNA vaccines.

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.

In addition to this ongoing study, GEO-CM04S1 is being evaluated in two other Phase 2 clinical trials:

  • As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. ClinicalTrials.gov Identifier: NCT04639466.  GeoVax recently announced that this trial has fully enrolled.
  • 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.

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 ® , presently 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.

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Importance of Life Sciences M&A Amid Rising Interest Rates

November 6, 2026
Increasingly high bond rates are having important implications for the U.S. life sciences ecosystem – and underscore the role of mergers and acquisitions (M&A) and other pro-competitive partnerships in advancing innovation. The upshot. Developing a new medicine requires significant and sustained investment over many years. This makes the life sciences industry especially sensitive to changes in the cost and availability of capital. With financial conditions tightening, a predictable environment for life sciences M&A is critical to sustaining investment in the next generation of cutting-edge treatments and cures. Why bond rates matter. It can cost billions and take more than a decade to bring a new treatment or cure to patients. Often, these companies operate without a profit and rely on outside investment (such as venture capital) to finance this high-stakes journey. When relatively low-risk investments like U.S. Treasury bonds offer stronger returns, investors need significantly greater potential returns to justify betting on riskier, long-term investments, such as drug development. The cost to early-stage life sciences investment. For emerging life sciences companies, less available capital can mean fewer resources to advance promising science and fewer new cures reaching patients. Research from NBER estimated that an unexpected one-percentage-point increase in interest rates reduces R&D spending across industries by approximately 1–3% and venture investment by roughly 25% over the following one to three years. M&A as an investment incentive. A healthy M&A environment provides a critical incentive for investors to support high-risk science by offering a potential exit. The prospect of an acquisition allows investors to realize returns from financing early-stage research – and reinvest that capital in the next generation of treatments and cures. M&A helps advance promising innovation. M&A is similarly vital to turning the promising science that attracted investment into approved medicines for patients. Emerging companies contribute specialized scientific knowledge and innovative drug candidates – but often depend on partnerships with larger, more established companies to access the clinical-development expertise, regulatory capabilities and infrastructure needed to bring medicines to patients. The evidence reinforces this complementary relationship. Findings from Cornerstone Research show that drug projects acquired from smaller companies by firms with prior launch experience were three times more likely to launch – and five times more likely to launch as novel drugs – than projects acquired by another small firm. A predictable pathway forward. When higher bond rates raise the bar for investing in innovation, policymakers should avoid adding unnecessary barriers to an already challenging investment environment. A predictable and balanced approach to merger enforcement can help preserve life sciences M&A as a vital pathway for transforming promising scientific discoveries into new medicines for patients. Source: Importance of Life Sciences M&A Amid Rising Interest Rates - Partnership for the U.S. Life Science Ecosystem (PULSE)

Georgia's Political Landscape Has Changed. Our Mission Hasn't.

November 4, 2026
CEO Note: A New Political Landscape, A Continued Commitment to Georgia Life Sciences Georgia's 2026 election results mark a historic shift in the state's political landscape, setting the stage for a new administration, new statewide leadership, and a potentially changed balance of power in the General Assembly as we approach the 2027 legislative session. At the national level, Democrats won control of both chambers of Congress , creating a new dynamic for federal policymaking. With the presidency remaining under Republican leadership, the coming years will require bipartisan cooperation to advance legislation. Changes in congressional leadership and committee oversight could significantly affect healthcare, federal research funding, FDA policy, drug pricing, and patient access. The most significant changes for our industry, however, are happening here in Georgia. Keisha Lance Bottoms' victory in the gubernatorial race marks a historic transition in state leadership, ending more than two decades of Republican control of the Governor's Office. She will also become the first Black woman elected governor in U.S. history. Democrats also swept Georgia's statewide executive offices , including lieutenant governor, attorney general, secretary of state, and the commissioners responsible for agriculture, labor, and insurance. These leadership changes create new opportunities for engagement on the policies and investments that shape Georgia's economy. In the General Assembly, Democrats made substantial gains and appear positioned to take control of the Georgia House of Representatives , pending final results in several close races. Republicans retained a narrowed majority in the State Senate. This potentially divided legislative environment will require thoughtful engagement and collaboration across party lines. We can also expect considerable turnover in the General Assembly, with dozens of new legislators beginning their terms in January. Along with a new Governor and incoming administration, this creates an important opportunity to introduce policymakers to Georgia's life sciences industry, its economic contributions, and its potential for future growth. What Does This Mean for Georgia's Life Sciences Industry? Life sciences is an economic development priority that should transcend party lines. Our industry's growth depends on a combination of sound public policy, private investment, research, workforce development, infrastructure, and a business environment that encourages innovation and commercialization. As Georgia establishes its new leadership priorities, several areas will be particularly important: Economic Development and Manufacturing: Positioning Georgia to attract and retain biopharmaceutical, biotechnology, and MedTech companies while advancing the infrastructure and capabilities needed to support scale-up manufacturing. Research and Commercialization: Strengthening connections between Georgia's research institutions, emerging companies, investors, and industry partners to move discoveries from the laboratory into commercial applications. Workforce Development: Expanding investment in technical education, apprenticeships, and industry-aligned training to prepare Georgians for the growing range of life sciences careers. Capital and Investment: Improving access to capital and supporting programs that help Georgia-based companies grow, commercialize technologies, and remain competitive. Healthcare Innovation and Patient Access: Supporting an environment that encourages medical innovation, advances research, and improves patient access to new treatments and technologies. These priorities align directly with Pathways & Partnerships: A Roadmap for Georgia's Life Sciences Sector , our ten-year strategy to position Georgia as a leading scale-up manufacturing hub in the Southeast. Georgia enters this transition with both an opportunity and a clear need to strengthen its competitiveness in life sciences. The recently released BIO/TEConomy report highlights the industry's significant contributions, including more than 42,600 jobs across over 4,200 establishments, while reinforcing the opportunity for Georgia to accelerate growth relative to other states. Our Roadmap provides a foundation for working with policymakers to turn these opportunities into sustained investment, stronger industry partnerships, and high-quality jobs throughout Georgia. GLS's Role Moving Forward For Georgia Life Sciences, this transition reinforces the importance of our role as the industry's statewide voice and convener. We will be intentional about building relationships with the incoming administration, new legislative leadership, returning legislators, and state agencies. We must ensure that policymakers understand not only the healthcare implications of our industry, but also its broader economic impact: high-quality jobs, significant research investment, advanced manufacturing, innovation, and opportunities for communities across Georgia. At the federal level, we will continue working with our national partners and Georgia's congressional delegation to advocate for policies that sustain research and innovation, support a predictable regulatory environment, strengthen American biomanufacturing, and advance patient access. With a new administration and many new legislators, we have an opportunity to establish a stronger understanding of what it takes to build and sustain a competitive life sciences ecosystem. That means bringing industry leaders to the table, communicating our priorities, identifying areas of bipartisan alignment, and advocating for policies that support long-term growth. Our industry's success requires a long-term commitment that extends beyond any election cycle or administration. The political landscape may change, but our commitment to advancing Georgia's life sciences industry remains constant. We look forward to working with leaders on both sides of the aisle to ensure Georgia continues to be a place where life sciences companies can innovate, invest, manufacture, and grow.

Why PDUFA Reauthorization Matters for Georgia’s Patients and Economy

October 30, 2026
For Georgians living with serious and rare diseases, how quickly and predictably a new treatment moves through U.S. Food and Drug Administration (FDA) review can make a real difference. That predictability also matters to the researchers and businesses that make up Georgia’s growing life sciences sector. Both depend in large part on the Prescription Drug User Fee Act (PDUFA), a longstanding bipartisan program that Congress needs to reauthorize by 2027. How PDUFA Works Since 1992, PDUFA has allowed the FDA to collect user fees from biopharmaceutical companies to supplement the agency’s resources for reviewing new medicines. In exchange, the FDA commits to clear, predictable review timelines. The agency’s standards for safety and efficacy remain unchanged. By providing additional resources and establishing clear performance goals, PDUFA helps ensure patients can access new treatments in a more timely and predictable manner. The result of PDUFA have been significant. Before PDUFA, FDA reviews often took more than two years. Today, the median review time is 10 months for standard applications and 8 months for priority applications. In 2025, nearly 70% of new medicines were approved in the U.S. before any other country. What’s at Stake in 2027 Congress reauthorizes PDUFA every five years. The current agreement, PDUFA VII, expires September 30, 2027. Timely reauthorization is critical to maintaining the FDA’s review capacity, preserving regulatory predictability, and ensuring patients continue to benefit from medical innovation. Georgia stakeholders recently came together to talk through what that means here at home. On October 28, Georgia Life Sciences, the MTS Sickle Cell Foundation, and Georgia First hosted “PDUFA: How Medicines Reach People,” a lunch-and-learn at Brookhaven City Centre. Patient advocates, congressional staff, and business and academic leaders heard from Nick Magallanes of Todd Strategy Group, Natalie Crawford of Georgia First, Maria Thacker-Goethe of Georgia Life Sciences, and Mapillar Dahn of the MTS Sickle Cell Foundation. What We Heard At the event, speakers came at PDUFA from different angles, but the common thread was how the program affects Georgians. Mapillar Dahn of the MTS Sickle Cell Foundation stressed that patients need to remain at the center of conversations. As a mother of three daughters with Sickle Cell Disease, Mapillar stressed that she wants the FDA to have what it needs to carry out a thorough review without unnecessary delays. The confidence families place in a treatment depends in part on confidence in that process. Natalie Crawford with Georgia First and Mended Hearts spoke about the need for a fully resourced FDA so that Georgia patients have access to innovative treatments and also for a healthy Georgia economy. Additionally, Maria Thacker-Goethe spoke to what PDUFA reauthorization means for Georgia’s booming life sciences sector. She warned that without PDUFA reauthorization, research across the board will be stifled – ranging from devastating impacts to small startups to significant delays in investments and research. Part of a National Conversation As Congress prepares for the 2027 reauthorization, conversations like these help bring together patients, advocates, and community leaders to highlight the real-world importance of the program. Decisions made in this reauthorization cycle will shape FDA resources and review timelines nationwide. By reauthorizing PDUFA on time, Congress can make sure the FDA can keep reviewing new medicines efficiently and patients in Georgia and across the country can get the treatments they need. 
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