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GeoVax

COVID-19 vaccine program progressing with additional data evaluating GEO-CM04S1 as booster to mRNA vaccines in healthy adults expected in second quarter of 2025

Clinical evaluation of GEO-MVA, vaccine candidate for protection against Mpox and Smallpox, expected to initiate in second half of 2025

Gedeptin® advancing into Phase 2 clinical trial of as treatment for first recurrent head and neck cancer in combination with immune checkpoint inhibitor

GeoVax reported cash balances of $7.4 million at March 31, 2025

GeoVax Receives Favorable European Regulatory Guidance Supporting Streamlined Development Pathway for GEO-MVA

READ THE INVESTOR PRESENTATION HERE

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Hello Everyone,

Pull up GOVX right away and put it at the top of your screen after you write it down.

Today this one got some MAJOR momentum and closed up 28% on huge momentum. GOVX is now well on the other side of the crititical $1 level. Is this the beginning of a short squeeze? GOVX has been sitting in a fairly tight channel since the beginning of April. Before today it had not closed outside the top of that channel since March.

When you look back at the year chart you are going to see a lot of that volatility that we love here at Insider.

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.

GeoVax Responds to WHO's Fourth Declaration of Mpox as a Global Public Health Emergency

GEO-MVA Provides Potential Opportunity to Expand Mpox Vaccine Supply Amid Growing U.S.and Global Clade 1 Threat

ATLANTA, GA - June 11, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today issued a statement in response to the World Health Organization's (WHO) fourth declaration of Mpox as a Public Health Emergency of International Concern (PHEIC). The WHO's decision reflects the ongoing global spread of the highly virulent Clade 1 strain of the Mpox virus, which has prompted heightened international concern and a call to action for more robust vaccine strategies.

Mpox continues to pose a significant threat to global health, with WHO reporting rising case counts in endemic and non-endemic regions alike. In particular, Clade 1 Mpox - previously confined to Central Africa - is now appearing in Europe, Asia, and North America. In the United States, multiple confirmed Clade 1 cases have been reported across New York, California, Georgia, and New Hampshire. Additionally, Clade 1 viral particles have been detected in wastewater in North Carolina, California, Alabama and Iowa, suggesting silent transmission may be occurring even before symptomatic cases emerge.

U.S. and Global Reliance on a Single Supplier Threatens Response Capacity

Despite the urgency, the world remains dangerously dependent on a single manufacturer for the preferred Mpox vaccine, based on the Modified Vaccinia Ankara (MVA) platform. This presents significant risks to biosecurity, affordability, and equitable distribution. African nations alone have requested 20 million doses for 2025; global capacity is estimated at only 2-5 million doses annually.

GEO-MVA: America's Strategic Vaccine Alternative

GeoVax is actively developing GEO-MVA, a U.S.-based MVA vaccine for Mpox and smallpox. GEO-MVA is engineered as an alternative to the existing global supply and has been recognized at global forums as a pivotal component of future pandemic resilience.

GeoVax has completed cGMP drug substance manufacturing of GEO-MVA, with fill/finish processes underway. Clinical vials are expected to be available in Q4 '25, enabling clinical trials to begin in 2026.

GEO-MVA is also being developed using an advanced continuous avian cell line manufacturing process, intended to:

  • Increase production yield and scalability.
  • Eliminate reliance on pathogen-free chicken eggs.
  • Reduce cost and streamline use of existing manufacturing infrastructure.
  • Enable U.S.-based rapid deployment in future outbreaks.

"WHO's latest declaration underscores that the Mpox crisis is not behind us - it is escalating," said David Dodd, Chairman & CEO of GeoVax. "As Clade 1 spreads in the U.S. and globally, we must act now to expand domestic vaccine capacity. Single-source dependency threatens access during geopolitical or logistical disruptions. GEO-MVA offers a scalable, cost-effective, and onshore alternative that supports national security, global equity, and pandemic preparedness."

Strengthening Biosecurity and Public Health Readiness

GeoVax is engaged with U.S. federal agencies to align GEO-MVA with government initiatives aimed at onshoring critical pharmaceutical manufacturing and strengthening national pandemic readiness. The company's proposal under BARDA's Rapid Response Partnership Vehicle (RRPV) was selected for award, pending funding, to scale MVA-based vaccine production using advanced U.S. biomanufacturing technologies.

GeoVax is calling on global and national policymakers to:

  • Accelerate regulatory pathways for GEO-MVA and next-generation MVA manufacturing.
  • Expand federal funding to ensure rapid scale-up and stockpiling.
  • Preserve early warning surveillance systems such as wastewater monitoring.

GeoVax Reports First Quarter 2025 Financial Results and Provides Business Update

COVID-19 vaccine program progressing with additional data evaluating GEO-CM04S1 as booster to mRNA vaccines in healthy adults expected in second quarter of 2025

Clinical evaluation of GEO-MVA, vaccine candidate for protection against Mpox and Smallpox, expected to initiate in second half of 2025

Gedeptin® advancing into Phase 2 clinical trial of as treatment for first recurrent head and neck cancer in combination with immune checkpoint inhibitor

ATLANTA, GA - May 1, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer, today announced its financial results and key operational accomplishments for the quarter ended March 31, 2025.

"Despite the recent and unexpected termination of our Project NextGen award by BARDA, our commitment to advancing GEO-CM04S1 remains unwavering. This next-generation, multi-antigen COVID-19 vaccine is highly differentiated and continues to show promise, particularly for the over 40 million immunocompromised individuals in the U.S. who remain vulnerable to current variants. Our ongoing Phase 2 trials, including studies in chronic lymphocytic leukemia patients and stem cell transplant recipients, are progressing well, with key data readouts anticipated in the first half of 2025," stated David Dodd, GeoVax's Chairman and CEO.

Dodd continued, "Concurrently, we are preparing to initiate the clinical evaluation of GEO-MVA during the second half 2025, while a Phase 2 trial of Gedeptin in combination with an immune checkpoint inhibitor for recurrent head and neck cancer is advancing towards trial initiation These efforts underscore GeoVax's strategic focus on delivering innovative immunotherapies and vaccines that address critical unmet needs across oncology, infectious diseases and biodefense."

Clinical Trial Progress and Operational Developments

GEO-CM04S1

  • GEO-CM04S1 continues to demonstrate potential as both a primary and booster vaccine, especially in immunocompromised patients. Key milestones anticipated during 2025 include:
    • Healthy Adult Booster Trial - Enrollment is complete, with data readout expected in the second quarter of 2025.
    • Chronic Lymphocytic Leukemia (CLL) Patient Study (Immunocompromised patient study) - Enrollment ongoing in Phase 2 study evaluating GEO-CM04S1 as a COVID-19 booster vaccine for immunocompromised patients; interim data resulted in continuation of the GEO-CM04S1 arm, whereas the Data Safety Review Board recommended early termination of the mRNA arm, which was subsequently implemented.
    • Stem Cell Transplant/CAR-T Trial (Immunocompromised patient study) - Enrollment and evaluation continue among hematological patients receiving stem cell transplantation or CAR-T therapy, comparing GEO-CM04S1 to mRNA COVID-19 vaccines.
  • GEO-CM04S1 is a multi-antigen COVID-19 vaccine, utilizing a synthetic-MVA platform, expressing both S and N antigens, offering the potential for broader, more durable protection than current mRNA vaccines.
  • Published peer-reviewed article in Vaccines (MDPI) - In April 2025, a peer-reviewed article titled "Preclinical Evaluation of a Multi-Antigen SARS-CoV-2 Vaccine Candidate GEO-CM02" was published in Vaccines (MDPI), which highlights the potential benefits of GeoVax's multi-antigen COVID-19 vaccine approach and further validates the Company's approach for developing GEO-CM04S1 utilizing the MVA platform. The publication supports the rationale for advancing next-generation COVID-19 vaccines capable of delivering broader, more durable immune responses.
  • GEO-CMO4S1 addresses a significant medical need worldwide reflected in an estimated market potential at $30B+.

Gedeptin®

  • Advancing into Phase 2 in Solid Tumors - GeoVax's oncology program, utilizing the Gedeptin® technology, is planned to progress to a Phase 2 trial in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer. Gedeptin has received Orphan Drug designation for use among advanced head & neck cancer patients.  The Gedeptin technology provides potential for expansion into other solid tumors including triple-negative breast cancer, melanoma, and soft tissue sarcoma.
  • Gedeptin addresses a significant medical need worldwide reflected in an estimated market potential for use addressing Head & Neck cancer at $15B+.

GEO-MVA  

  • Mpox and Smallpox Vaccine Platform Addressing Biosecurity and Global Vaccine Equity -GeoVax anticipates initiating clinical trials in 2025 for GEO-MVA, its Mpox/smallpox vaccine candidate. The Company has successfully produced cGMP clinical product and is focused on completing the vaccine vialing in support of initiating clinical evaluation during the second half of 2025.  GEO-MVA positions GeoVax to offer a U.S.-developed alternative to foreign-sourced vaccines amid rising global biosecurity threats and constrained supply.
  • GEO-MVA addresses a significant medical need worldwide reflected in an estimated market potential at $10B+.

Vaccine Manufacturing Process Development

  • Scaling MVA for Global Reach - GeoVax is advancing continuous cell line manufacturing for MVA-based vaccines, offering a path to scalable, cost-effective production - including localized manufacturing for low- and middle-income countries. This innovation addresses critical gaps in vaccine self-sufficiency and supply resilience.

Corporate Updates

  • Announced plan to establish strategic presence in the United Kingdom to advance manufacturing partnerships, European collaborations with service providers and academic partners, technology licensing opportunities and scientific expertise.
  • Senthil Ranganathan, Ph.D., joined GeoVax on April 21, 2025, as Vice President, Technical Development & CMC Operations, reflecting significant progress in the Company focus on product authorization and commercialization activities.

First Quarter 2025 Financial Results

Net Loss: Net loss for the three months ended March 31, 2025, was $5.4 million, as compared to $5.9 million for the three months ended March 31, 2024.

Revenue:  For the three months ended March 31, 2025, the Company reported $1.6 million of government contract revenues associated with the BARDA/RRPV Project NextGen award. There were no revenues reported during the comparable 2024 period.

R&D Expenses: Research and development expenses were $5.4 million for the three months ended March 31, 2025, compared to $4.4 million for the three months ended March 31, 2024, with the increase primarily due to costs associated with the BARDA/RRPV Project NextGen award and the Gedeptin and GEO-MVA programs.

G&A Expenses: General and administrative expenses were $1.7 million for the three months ended March 31, 2025, compared to $1.5 million for the three months ended March 31, 2024, with the increase primarily due to higher investor relations consulting costs and stock-based compensation expense.

Cash Position: GeoVax reported cash balances of $7.4 million at March 31, 2025, as compared to $5.5 million at December 31, 2024.

Summarized financial information is attached. Further information is included in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.

MVA TECHNOLOGY OVERVIEW

GeoVax’s vaccines are constructed to induce broader immunity through inclusion of multiple antigens into a single virus/vaccine platform. This is possible through the use of the company’s MVA vaccine platform, a large virus capable of incorporating multiple antigens into a vaccine platform.

Utilizing MVA, as a vaccine vector, allows for the targeting of multiple sites on a pathogen or cancer cell. Doing this is intended to result in a more robust and durable protective immune response. In addition, using MVA as a vaccine platform allows for the construction of vaccines which are capable of generating virus-like particles (VLPs) in the person receiving the vaccine.

The production of VLPs in the person being vaccinated is intended to mimic viral production that occurs in a natural infection, stimulating both the humoral (antibody) and cellular (T-cell) arms of the immune system to recognize, prevent, and control future infections.

MVA vectored vaccines can elicit durable (long-acting) immune responses while also possessing an excellent safety profile. MVA-VLP vaccines are designed to mimic authentic viruses in form but are not infectious or capable of replicating. As a result, VLPs can cause the body’s immune system to recognize and kill targeted infectious agents to prevent an infection or can be designed to target cancerous cells resulting in inhibited growth or destruction of tumors. VLPs can also train the immune system to recognize and kill virus-infected cells to control infection and reduce the length and severity of disease.

GEDEPTIN TECHNOLOGY OVERVIEW

A Phase 1/2 trial (NCT03754933), evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options recently completed enrollment at the Stanford University Cancer Institute, the Emory University Winship Cancer Institute, and the Thomas Jefferson University Sidney Kimmel Cancer Center.

The trial design involved repeat administration using Gedeptin followed by systemic fludarabine (prodrug). Expansion towards a larger, Phase 2 patient trial is anticipated. The FDA has granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities. Also, the initial Phase 1/2 clinical study was funded by the FDA pursuant to its Orphan Products Clinical Trials Grants Program.

240125 Gedeptin image white v2

GeoVax Highlights Broad Cross-Protective Immunity of Multi-Antigen COVID-19 Vaccine Candidates at Keystone Symposia

Preclinical Studies Demonstrate Durable Protection Against SARS-CoV-2 Variants, Including Omicron XBB.1.5, Driven by T-Cell Responses

ATLANTA, GA - June 9, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and multi-antigen vaccines against infectious diseases and solid tumors, today recapped two scientific poster presentations delivered at the Keystone Symposia on Vaccinology: Horizons Across Disease, Demography and Technology, held June 4-7, 2025, in Washington, D.C.

The presentations, titled MVA-Vectored Multi-Antigen COVID-19 Vaccines Induce Protective Immunity Against SARS-CoV-2 Variants Spanning Alpha to Omicron in Preclinical Animal Models, and GEO-CM04S1 Vaccine Candidate Maintains Potent Cross-Reactivity Against Original SARS-CoV-2 B.1 and Omicron Subvariant XBB.1.5, were delivered by Drs. Pratima Kumari and Amany Elsharkawy, respectively, members of GeoVax's scientific team and its collaborators, during the June 5 and June 6 poster sessions. The presentations spotlight the Company's Modified Vaccinia Ankara (MVA)-vectored COVID-19 vaccine candidates, GEO-CM04S1 and GEO-CM02, and their ability to induce durable, cross-reactive immunity against SARS-CoV-2 variants in preclinical animal models. These studies underscore the immunologic breadth, durability, and cross-variant protection of GeoVax's multi-antigen design strategy, especially important for addressing variant evasion and suboptimal immune response in vulnerable patient populations.

Key Findings from Studies

GEO-CM02 Study - Poster #1050 - Presenter: Dr. Pratima Kumari, GeoVax Scientist

This presentation detailed findings for GEO-CM02, a multi-antigen MVA-based vaccine expressing the spike (S), membrane (M), and envelope (E) proteins.

  • In hACE2 mouse models, a single dose provided complete protection against both the original Wuhan strain and the Omicron BA.1 variant.
  • Two-dose regimens generated high neutralizing antibody levels, reduced viral loads in lung and brain tissues, and lowered inflammatory markers- indicating enhanced immune memory.
  • Notably, early protection was achieved prior to detectable neutralizing antibodies, further supporting the role of innate and cellular immune responses in viral control. This underscores the value of the multi-antigen MVA-based vaccine platform, particularly as the virus continues to mutate.

GEO-CM04S1 Study - Poster #2047 - Presenter: Dr. Amany Elsharkawy, Georgia State University Scientist

This study evaluated the immunogenicity and protective efficacy of GEO-CM04S1, an MVA-vectored vaccine co-expressing spike (S) and nucleocapsid (N) proteins, in a K18-hACE2 mouse model. Mice were challenged intranasally with either the original B.1 strain or the Omicron XBB.1.5 subvariant.

  • GEO-CM04S1 conferred full protection against clinical disease, lung injury, and inflammation in both viral challenge models.
  • Despite the absence of detectable neutralizing antibodies against XBB.1.5, vaccinated animals were fully protected, suggesting antibody-independent protection.
  • Immune cell depletion studies revealed that CD4+ T cells, not B cells or CD8+ T cells, were critical for protection, highlighting the vaccine's ability to drive T cell-mediated immunity across variants.

"These experimental findings document the value of inducing broadly specific immune responses to protect against evolving SARS-CoV-2 variants," said Mark Newman, PhD, Chief Scientific Officer of GeoVax. "We believe the use of multi-antigen vaccines could provide significant benefit by limiting the need to continually update COVID vaccines and by limiting the need for yearly booster doses."

GeoVax's MVA vaccine platform is designed to address gaps in pandemic preparedness and public health resilience, with lead vaccine candidate GEO-CM04S1 currently being evaluated in multiple Phase 2 clinical trials for COVID-19.

About GEO-CM04S1

GEO-CM04S1 is a synthetic next-generation, multi-antigen MVA-vectored COVID-19 vaccine co-expressing spike (S) and nucleocapsid (N) antigens, designed to induce both broad antibody and T-cell responses. It is being evaluated in three ongoing Phase 2 clinical trials:

  1. A primary vaccine for immunocompromised individuals (e.g., post-transplant, CAR-T, or hematologic cancers)
  2. A booster for patients with chronic lymphocytic leukemia (CLL)
  3. A booster for healthy adults previously immunized with mRNA vaccines

NEWS


GeoVax to Participate in BIO International Convention 2025

4 days ago

GeoVax Responds to WHO's Fourth Declaration of Mpox as a Global Public Health Emergency

5 days ago

GeoVax Announces Upcoming Presentation at the European Hematology Association 2025 Congress Highlighting Positive Immune Response Data for GEO-CM04S1 in CLL Patients

6 days ago

GeoVax Highlights Broad Cross-Protective Immunity of Multi-Antigen COVID-19 Vaccine Candidates at Keystone Symposia

7 days ago

GeoVax to Showcase Innovative COVID 19 Vaccine Data at the Keystone Symposia on Vaccinology

Jun 4, 2025

GeoVax Congratulates Bipartisan Senate Action to Onshore Critical Medical Manufacturing

May 29, 2025

GeoVax Commends FDA's Shift to Risk-Based COVID-19 Vaccination Guidance

May 27, 2025

GeoVax Applauds EQUIP-A-Pharma Initiative, Reinforces Commitment to Domestic Vaccine Manufacturing and Biodefense Innovation

May 21, 2025

GeoVax Reaffirms Urgent Need for Multi-Antigen COVID-19 Vaccines as CDC Shifts Recommendations

May 20, 2025

GeoVax Highlights Dual Protective Potential of GEO-CM04S1 Following Presentation at the AAI Annual Meeting 2025

May 8, 2025

GeoVax Expands Gedeptin(R) Patent Portfolio

May 7, 2025

GeoVax Applauds White House Executive Order Supporting U.S. Pharmaceutical Manufacturing; Highlights Progress in Domestic MVA Vaccine Production

May 6, 2025

GeoVax Reports First Quarter 2025 Financial Results and Provides Business Update

May 1, 2025

GeoVax Presents Gedeptin(R) Clinical Data at the American Association for Cancer Research Annual Meeting

Apr 29, 2025

GeoVax Responds to Detection of Clade I Mpox in North Carolina Wastewater

Apr 24, 2025

GeoVax Highlights Strong Clinical Results Following Presentation of Multi-Antigen COVID-19 Vaccine at the 25th Annual World Vaccine Congress

Apr 24, 2025

GeoVax to Report First Quarter 2025 Financial Results and Provide Corporate Update on May 1, 2025

Apr 23, 2025

GeoVax Appoints Dr. Senthil Ranganathan as Vice President, Technical Development and CMC Operations

Apr 22, 2025

GeoVax Highlights New Study Demonstrating the Strength of Multi-Antigen COVID-19 Vaccine Candidates

Apr 16, 2025

GeoVax Provides Update on BARDA Project NextGen and Outlines 2025 Business Momentum

Apr 16, 2025

MANAGEMENT

Sincerely,

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