Tag: GOVX

Research News and Market Data on GOVX

GEO-CM04S1 Offers Solution to Overcome HHS-Cited mRNA Deficiencies – Potentially Offering Broader, More Durable Protection

ATLANTA, GA – August 7, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen, MVA-based vaccines and solid tumor immunotherapies, today issued a statement in response to the U.S. Department of Health and Human Services’ (HHS) decision to terminate nearly $500 million in BARDA-funded mRNA vaccine development contracts.

This action reflects a policy shift, underscored by HHS Secretary Kennedy addressing fundamental concerns around mRNA vaccines. In a post on X, Secretary Kennedy stated: “mRNA vaccines don’t perform well against viruses that infect the upper respiratory tract”. The Secretary added that this is due to a concept known as “antigenic shift, meaning that the vaccine paradoxically encourages new mutations and can actually prolong pandemics as the virus constantly mutates”. GeoVax’s vaccine candidates, including GEO-CM04S1 for COVID-19, are designed to induce immunity using multiple antigens. GEO-CM04S1 expresses both the Spike (S) and Nucleocapsid (N) proteins of SARS-CoV-2, enabling broader and more durable protection – even as the virus mutates. Data from clinical studies have demonstrated that GEO-CM04S1 induces immune responses across variants, from the original Wuhan strain through Omicron, even in immunocompromised patients.

“Secretary Kennedy’s remarks spotlight the exact issue our platform was designed to overcome,” said David Dodd, Chairman and CEO of GeoVax. “The mRNA approach, with its single-target design, appears limited relative to durability and antigenic shift. GEO-CM04S1’s multi-antigen construct represents a promising solution – with clinical data demonstrating broader immunity and addressing the mRNA shortcomings Kennedy described, including among the most vulnerable immunocompromised patients.”

Why GeoVax’s MVA-Based Vaccines Align with U.S. Priorities

• Multi‑antigen breadth and durability – GeoVax’s COVID-19 vaccine candidate, GEO‑CM04S1, expresses both SARS‑CoV‑2 Spike and Nucleocapsid proteins – inducing robust and durable antibody and T‑cell immunity in Phase 2 trials. Notably, in a trial among Chronic Lymphocytic Leukemia (CLL) patients, the mRNA comparator arm was halted for failing to meet immune‑response benchmarks, while GEO‑CM04S1 exceeded interim endpoints, with the remainder of the ongoing study only including the GEO-CM04S1 arm. 
• Safety for vulnerable populations – MVA does not replicate in human cells and has been FDA‑approved for use in immunocompromised individuals, pregnant women, and children. This makes it a validated vaccine platform with broad safety.
• Manufacturing innovation and U.S. resilience – GeoVax is advancing AGE.1 manufacturing processes for MVA-based vaccines such as GEO-CM04S1 which is expected to support scalable, decentralized U.S. vaccine manufacturing, providing faster production, higher yield at a reduced cost – a strategic advantage for public health resilience.
• Broad infectious-disease pipeline – Beyond COVID‑19, GeoVax is pursuing MVA‑based vaccines targeting hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg), Zika, and Mpox/Smallpox. This diversified pipeline aligns with HHS, NIH, FDA, and WHO priorities for pandemic preparedness and biodefense.

GeoVax: Delivering on the “Safer, Broader” Vision

GeoVax applauds the call to shift toward multi-antigen vaccine designs with validated safety profiles and resilience to viral mutation. The MVA‑based platform delivers on these goals:

• Evidence‑backed safety for immunocompromised, pediatric, and pregnant populations.
• Broader immune responses with Spike plus Nucleocapsid antigens.
• Strategic manufacturing design for domestic scale and surge capacity.
• Multi‑disease readiness across COVID‑19, hemorrhagic fevers, Zika, and Mpox/Smallpox.

Next Steps: Turning Rhetoric into Resilience

GeoVax urges HHS to proactively support robust, evidence-backed alternatives – including multi-antigen platforms like MVA as part of a diversified, resilient biomedical countermeasure arsenal.

GeoVax invites HHS and other federal partners to collaborate under the FDA’s Commissioner’s National Priority Voucher (CNPV) program and other mechanisms to accelerate regulatory and funding support for GEO-CM04S1 and GEO-MVA, both of which are uniquely positioned to protect high-risk populations and enhance U.S. biomanufacturing self-sufficiency.

Dodd added: “We must now invest in platforms that reflect what we’ve learned. GeoVax stands ready to lead this transition. Our MVA platform already has a safety track record and is delivering early efficacy where mRNA appears to have fallen short. We stand ready and prepared to assist in supporting HHS’s bold reset into a long-term strategy for national immunization security.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com 

Research News and Market Data on GOVX

With Mpox spreading globally, COVID-19 variants evading immunity, and bipartisan leaders demanding U.S.-based solutions, GeoVax calls for urgent investment in domestic manufacturing and vaccine diversification

Atlanta, GA – July 30, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies, today renewed its call for decisive U.S. action on pandemic preparedness and biodefense. With escalating outbreak risks, public health system strain, and growing bipartisan consensus for domestic solutions, GeoVax underscored the urgent need to modernize the nation’s countermeasure infrastructure and end foreign vaccine dependency.

“The warning signs are multiplying,” said David Dodd, Chairman and CEO of GeoVax. “We are facing the global expansion of virulent Mpox strains, immune-evasive COVID variants, and a national stockpile reliant on outdated, offshore platforms. Pandemic readiness must be built at home – with modern, American-made solutions and proactive government-industry leadership.”

GeoVax’s Domestic Platform for Emerging and Endemic Threats

GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine platform anchors two front-line candidates:

• GEO-MVA for Mpox/smallpox, designed to protect against both Clade I and II Mpox strains.
• GEO-CM04S1, a multi-antigen, next-generation COVID-19 vaccine targeting the 40 million U.S. immunocompromised through robust, durable, antibody and T-cell–driven immune protection.

The vaccine candidates are supported by Phase 2 clinical data (GEO-CM04S1) and favorable clinical development guidance from the European Medicines Agency (GEO-MVA) and current development plans include the implementation of an advanced MVA continuous avian cell line manufacturing process for U.S.-based, scalable production.

New Health Threats Demand Immediate Preparedness

• Mpox: The World Health Organization maintains Mpox as a Public Health Emergency of International Concern. Clade I outbreaks have now spread to numerous continents, including sustained transmission in China and wastewater detection in the U.S. New data from the Democratic Republic of the Congo confirmed vertical transmission during pregnancy, raising fresh concerns for maternal and neonatal health.
• COVID-19: The NB.1.8.1 (“Nimbus”) variant continues to gain dominance, prompting updated CDC guidance recommending boosters for vulnerable groups, including older adults and the immunocompromised. However, mRNA vaccine uptake remains low in these populations, reinforcing the need for broader, longer-lasting immunity options like GEO-CM04S1.

Alarmingly, the Strategic National Stockpile (SNS) remains overly dependent on a single foreign supplier for Mpox/smallpox MVA vaccine, which is reportedly unable to supply the current estimated global needs.  Most concerning, the U.S. government has had to continuously shift MVA vaccine from the SNS, which is primarily intended for biosecurity purposes, resulting in a vicious cycle of SNS replenishment, followed by further reduction of the SNS as Mpox outbreaks continue.

“The cost of delay is steep, and the status quo is unacceptable,” said Dodd. “The United States needs increased MVA vaccine competition – not complacency and dependency on a foreign, monopolistic supplier.”

Bipartisan Momentum and Federal Mandate for Action

Policymakers across the aisle are rallying behind a more secure biodefense posture:

• At BIO 2025, Administration for Strategic Preparedness and Response (ASPR) Chief of Staff Mark O’Neill emphasized the need for onshoring, platform diversification, and public-private partnerships to strengthen domestic pandemic response capabilities.
• In Congress, Democrats and Republicans alike are advancing legislation to reduce foreign dependency and prioritize U.S.-based manufacturing and procurement for pandemic countermeasures.

“GeoVax supports and welcomes this emerging consensus,” Dodd added. “We’re aligned with ASPR and BARDA priorities – and we’re ready to deliver. Swift, decisive government action is needed.”

Preparedness Requires Investment – Before the Next Crisis

More than 120 nations have signed the new WHO Pandemic Agreement, and the U.S. is scaling its biodefense footprint through mobile biocontainment units, genomic surveillance, and expanded diagnostics. Yet, without domestically produced, next-generation vaccines and a diversified stockpile, those efforts will fall short.

“We commend HHS, BARDA, ASPR, and congressional leaders for sounding the alarm,” concluded Dodd. “Now is the time to fund, procure, and manufacture domestically – before the next emergency hits.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com 

Research News and Market Data on GOVX

EMA Scientific Guidance, Global Surge in Clade I Mpox, and Aid Shortfalls Drive Urgent Need for Scalable, Equitable Vaccine Solutions

Atlanta, GA – July 29, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today announced an expedited development strategy for its GEO-MVA Mpox vaccine candidate, following newly reaffirmed global emergency status by the World Health Organization (WHO), a record-setting surge in Mpox cases across Africa, and recent favorable scientific advice from the European Medicines Agency (EMA) supporting an expedited development path for GEO-MVA.

These developments reinforce the urgent global need for diversified, scalable vaccine platforms amid critical shortages and growing international spread of more virulent Mpox strains.

Global Mpox Cases Surge Beyond 2024 Totals; Africa’s Health Systems Overwhelmed

More than 21,000 confirmed Mpox cases have been reported in 13 African countries so far in 2025 – exceeding the total case count for all of 2024 – with numbers expected to double by year-end. Sierra Leone, Malawi, and the Democratic Republic of the Congo (DRC) are among the most heavily impacted, with healthcare systems under severe strain due to significant U.S. and European aid reductions.

Only 700,000 Mpox vaccine doses have been administered across 11 countries, and key nations like Sierra Leone are still awaiting most of their requested supply. In the DRC alone, over 60,000 suspected cases and nearly 1,800 deaths have been reported. The crisis is being further complicated by armed conflict, collapsing infrastructure, and the emergence of Clade I and Clade 1a Mpox variants, which exhibit greater severity and transmissibility.

Global Spillover and WHO Emergency Status Highlight Urgency

The WHO’s International Health Regulations (IHR) Emergency Committee reconvened on July 5, 2025, and officially reaffirmed Mpox as a Public Health Emergency of International Concern (PHEIC). The WHO’s Situation Report #55, released July 11, underscores the worsening multi-country outbreak and mounting strain on surveillance, laboratory, and response systems.

International spread is accelerating. Clade I Mpox cases have now been confirmed in China, the United Kingdom, Italy, and the United States. U.S. health officials have identified five travel-related Clade I cases since late 2024, including a confirmed case in Massachusetts in June 2025, while wastewater testing confirms silent community transmission.

The CDC continues to emphasize surveillance efforts – including wastewater and diagnostic testing – but warns that current tools are insufficient to contain a broader outbreak without expanded vaccine access and supply.

EMA Guidance Supports Expedited GEO-MVA Pathway

GeoVax has received favorable scientific advice from the European Medicines Agency (EMA) regarding the development of GEO-MVA. The EMA guidance supports a streamlined regulatory pathway, enabling GeoVax to pursue expedited development and potential conditional approval of GEO-MVA as an additional Mpox vaccine candidate in the EU. This guidance strengthens the GEO-MVA development program’s relevance to global procurement programs, including those of WHO and UNICEF.

GeoVax Response: Acceleration, Scalability, and Equitable Access

In light of these developments, GeoVax is implementing a comprehensive, expedited development strategy:

• Clinical Development Acceleration: Finalizing fill-finish manufacturing and initiating human trials to evaluate safety and immunogenicity against both Clade I and Clade II variants. Regulatory planning includes immuno-bridging studies for global deployment.
• Advanced MVA Manufacturing Platform: Development is underway for GEO-MVA’s production using a continuous avian cell line system, enabling rapid, large-scale, and cost-effective production – addressing a key shortfall of the incumbent egg-based method.
• International Collaboration: Engaging health authorities, NGOs, and regional partners across Africa to ensure vaccine readiness and coordinated deployment to underserved and high-risk populations.
• Policy Engagement: Advocating for vaccine platform diversification and calling on governments and international donors to break the global reliance on a single supplier for Mpox vaccines.

David Dodd, Chairman & CEO of GeoVax, commented: “With Mpox cases rapidly rising across Africa and the WHO reaffirming global emergency status, the world must act urgently. The emergence of Clade I across multiple continents and the persistent lack of vaccine access underscore the need for scalable and diversified solutions. GEO-MVA is designed to meet this moment – leveraging our regulatory momentum from the EMA, efforts to accelerate implementation of our continuous manufacturing platform and an unwavering commitment to equitable access. We stand ready to be part of the solution, both scientifically and humanely.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com 

Research News and Market Data on GOVX

Study Aims to Validate Thermostable, Self-Administered MVA-Vaccine Platform for Pandemic Preparedness and Global Immunization

Atlanta, GA – July 28, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today announced the initiation of a research program to evaluate the immunogenicity and stability of GEO-MVA delivered via Vaxxas’ proprietary high-density microarray patch (HD-MAP) platform in preclinical models.

The proof-of-concept study, conducted at the University of Queensland (UQ) under a research agreement between GeoVax and UniQuest Pty Limited (UQ’s commercialization company), will assess the immune responses, delivery efficiency, and thermostability of GEO-MVA formulated and dried onto HD-MAPs for administration in mice. HD-MAPs offer a needle-free, skin-targeted delivery approach with the potential to enhance immunogenicity and enable distribution without refrigeration.

“This program represents a potential major step forward in our strategy to expand the versatility of GeoVax’s MVA platform and meet global needs for more accessible, ruggedized, and effective vaccines,” said David Dodd, Chairman and CEO of GeoVax. “Demonstrating that GEO-MVA can be delivered via HD-MAP could lead to more potent immune responses at lower doses, greater thermostability, and eliminate the need for needles – a very compelling profile for both routine immunization and rapid deployment during outbreaks.”

If successful, the study results will support the development of a thermostable, needle-free GEO-MVA vaccine for pandemic response, biodefense stockpiling, and immunization programs in low- and middle-income countries.

The HD-MAP platform offers several potential advantages over traditional needle-and-syringe delivery, including:

• Self-administration in the home, pharmacy, or vaccination hubs;
• Increased patient acceptance, especially among needle-phobic individuals;
• Higher immunogenicity, enabling dose-sparing;
• Thermostability, reducing cold chain reliance;
• Elimination of sharps waste and needle-stick injuries;
• Faster deployment in emergency settings with minimal training requirements.

The Vaxxas HD-MAP platform has demonstrated enhanced immunogenicity in multiple animal model and clinical studies and is being advanced in partnerships with leading pharmaceutical, government entities and foundations. GeoVax recently received favorable scientific advice from the European Medicines Agency (EMA) regarding the development of GEO-MVA. The EMA guidance supports a streamlined regulatory pathway, enabling GeoVax to pursue potential expedited development and approval pathways for GEO-MVA as an additional Mpox vaccine candidate in the EU.

The current study is supported by GeoVax and conducted by researchers led by A/Prof David Muller and Dr. Chris McMillan at the University of Queensland.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com 

Research News and Market Data on GOVX

Revised Phase 2 Strategy Targets Event-Free Survival in Primary Head and Neck Cancer through Checkpoint Inhibitor Combination

ATLANTA, GA, July 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced a strategic shift in its Gedeptin® clinical development program, with a new emphasis on evaluating Gedeptin as a neoadjuvant therapy in combination with pembrolizumab for patients with primary, resectable head and neck squamous cell carcinoma (HNSCC).

The revised strategy follows the landmark results of the KEYNOTE-689 Phase 3 trial, published in the New England Journal of Medicine on June 18, 2025, which demonstrated a significant improvement in event-free survival (EFS) with the addition of perioperative pembrolizumab in resectable, locally advanced HNSCC patients. These data represent the first validated use of PD-1 inhibition in curative-intent HNSCC and have catalyzed a major shift in treatment paradigms toward neoadjuvant immunotherapy.

GeoVax’s new Phase 2 trial (AdPNP-203) will evaluate the addition of intra-tumoral Gedeptin®, intravenous fludarabine, and pembrolizumab in patients eligible for curative surgery. The trial is designed to assess major pathological response (MPR) and associated immunologic and biomarker outcomes following two pre-surgical cycles of therapy as well as event-free survival over a one-year period. Gedeptin’s tumor-targeting, immune-sensitizing mechanism may help overcome the limitations of checkpoint monotherapy by enhancing immune activation within the tumor microenvironment. Trial initiation is planned for 2026.

“The KEYNOTE-689 results support our view that neoadjuvant checkpoint inhibition can transform the treatment of head and neck cancer,” said Dr. Kelly McKee, Chief Medical Officer at GeoVax. “By integrating Gedeptin into this emerging standard, we hope to improve both local tumor clearance and event-free survival, especially for high-risk or PD-L1-low patients.”

“This is a strategic shift in our program,” added David Dodd, Chairman and CEO of GeoVax. “We believe Gedeptin’s localized cytotoxic mechanism, when combined with systemic checkpoint inhibition for first-line treatment, can meaningfully improve therapeutic outcomes in patients with resectable HNSCC.”

Rationale for Combination Strategy

As highlighted in the NEJM editorial, the benefit in KEYNOTE-689 may be driven primarily by the neoadjuvant component of immunotherapy. However, many patients still experience local or distant relapse, underscoring the need for intensified strategies in the perioperative window. Gedeptin, with its dual cytotoxic and immune-priming mechanism, may serve as an ideal partner to checkpoint inhibitors by converting “cold” tumors into “hot” immunogenic targets.

About Gedeptin®

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) using a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP). Once delivered directly into tumors and followed by fludarabine, PNP enzymatically converts the prodrug into a cytotoxic compound, selectively targeting tumor cells while sparing healthy tissue. This localized approach aims to reduce toxicity, enhance immune visibility, and enable immune checkpoint synergy.

Gedeptin has received Orphan Drug Designation for oral and pharyngeal cancers and is backed by a robust intellectual property portfolio. GeoVax’s ongoing innovation in immune-sensitizing therapies supports a broader strategy to complement checkpoint inhibitors and overcome tumor immune resistance across solid tumor types.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com

Research News and Market Data on GOVX

GeoVax to Host Conference Call at 4:30 PM ET

Atlanta, GA, July 22, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today announced that it will report second quarter 2025 financial results on Monday, July 28, 2025, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

Conference Call Details

To access the live conference call, participants may register here. The live audio webcast of the call will be available under “Events and Presentations” in the Investor Relations section of the GeoVax website at geovax.com/investors. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archive of the audio webcast will be available on GeoVax’s website approximately two hours after the conference call and will remain available for at least 90 days following the event.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com 

Research News and Market Data on GOVX

Positive EMA Scientific Advice Positions GeoVax for Expedited European Approval

ATLANTA, GA – July 21, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today reinforced the strategic and commercial significance of the recent positive Scientific Advice (SA) received from the European Medicines Agency (EMA) for its GEO-MVA vaccine targeting Mpox and smallpox.

The EMA’s feedback indicated that a single Phase 3 immuno-bridging trial—bypassing the need for Phase 1 and 2 studies—may be sufficient to support a Marketing Authorization Application (MAA) under the EU’s centralized procedure. The ability to proceed without Phase 1 and 2 clinical trials substantially reduces development risk and timelines, positioning GeoVax to achieve product commercialization and revenue generation significantly earlier than previously anticipated.

Immuno-bridging studies allow for vaccine approval by the immune response elicited by a candidate vaccine comparable to that of an already approved vaccine. This approach, when accepted by regulatory authorities, can reduce the need for large-scale efficacy trials, thereby reducing development time while maintaining regulatory standards for safety and immunogenicity.

“This EMA guidance is more than a regulatory milestone—it represents a potential commercial inflection point,” said David Dodd, Chairman and CEO of GeoVax. “We now have a clear, expedited path to commercialization in one of the world’s largest vaccine markets. With the Phase 3 trial in operational preparation, we are entering a potential revenue acceleration phase supported by growing global demand, regulatory momentum, and our progressing advanced MVA manufacturing platform.”

Key Investor Highlights:

• Expedited Approval Path: EMA confirmed that one Phase 3 immuno-bridging trial—if successful—meets criteria for market authorization in all 27 EU countries.
• De-Risked Development:  Moving directly to a Phase 3 immuno-bridging trial significantly reduces development timelines, cost, and clinical execution risk.
• Market Timing Advantage: EMA guidance coincides with the WHO’s fourth Mpox PHEIC declaration and Clade I outbreaks across multiple continents.
• First-Mover Opportunity: GEO-MVA would be the only MVA-based Mpox vaccine alternative to Bavarian Nordic’s Imvanex/Imvamune, addressing global supply constraints and monopolistic risk.
• Revenue Visibility: GeoVax expects to initiate its Phase 3 trial in 2H 2026.
• Manufacturing Readiness: Current CEF-based production supports near-term supply; transition to AGE1 cell line to enable scalable, cost-efficient output for global procurement.

GeoVax is actively engaging with European regulatory bodies, public health stakeholders, and procurement agencies to advance GEO-MVA access and funding partnerships in support of both public health and commercial goals.

“From an investor perspective, this EMA development potentially shortens our path to revenue generation and significantly enhances our strategic value,” said Dodd. “GeoVax is now on the radar as a viable near-term commercial vaccine company, not just a development-stage biotech.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com 

Research News and Market Data on GOVX

European Medicines Agency Supports Streamlined Development Pathway for GEO-MVA Vaccine Candidate via a Single Phase 3 Immuno-bridging Trial

ATLANTA, GA – July 16, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today issued a statement underscoring the increasing urgency of expanding global Mpox vaccine access, as recent data from the Airfinity July 2025 Mpox Report highlight significant new outbreaks and rising global transmission of Clade I and Clade II Mpox.

The company previously announced favorable Scientific Advice from the European Medicines Agency (EMA) supporting the company’s proposed expedited development pathway for GEO-MVA. EMA confirmed that a single Phase 3 immuno-bridging trial, combined with proposed preclinical data, would be sufficient to support a Marketing Authorisation Application (MAA) via the centralized procedure. Immuno-bridging studies allow for vaccine approval by demonstrating comparable immune responses—rather than requiring traditional large-scale efficacy trials—thereby reducing development time while maintaining regulatory rigor.  GeoVax is now accelerating engagement with global and regional health authorities as Mpox re-emerges with more virulent and transmissible strains in vulnerable populations.

“The global Mpox situation is expanding in both scope and severity, especially with the silent spread of Clade I in China, Europe, and the United States,” said David Dodd, Chairman and CEO of GeoVax. “The increasing number of breakthrough infections, pregnancy-related complications, and international importation threats make the need for second-source MVA-based vaccines not only strategic—but urgent. We are encouraged by EMA’s endorsement of a streamlined regulatory approach, which enables us to accelerate clinical development and scale-up planning for GEO-MVA.”

Global Spread of Clade I Mpox Highlights Need for Vaccine Diversification

The Airfinity report shows:

• Clade I Mpox cases now span all continents, with new detections confirmed in China, United Kingdom, Italy and the U.S., including wastewater tracing.
• Local Clade I transmission in China raises concern of sustained spread in one of the world’s most populous regions.
• Travel-linked cases from Ethiopia and the Democratic Republic of the Congo (DRC) indicate high exportation risk to G7 countries, including the U.S. and France.
• New data from the DRC confirmed vertical transmission of Mpox—meaning the virus was passed from mother to child during pregnancy—prompting renewed calls for next-generation vaccines with broader safety data and global availability.

GEO-MVA Positioned as Scalable, Strategic Alternative

GeoVax’s GEO-MVA vaccine candidate is being positioned as a second source MVA-based vaccine to address emerging global needs with:

• EMA Scientific Advice concurrence on the company’s proposed expedited development pathway offering a near-term alternative MVA supply option.
• Planned transition to a modernized AGE1 continuous cell-line-based manufacturing system, offering the potential for scalable, lower-cost, and U.S.-based production.

“As the global MVA vaccine stockpile is stretched and a single supplier model becomes increasingly untenable, GEO-MVA offers both immediate and long-term solutions to expand access, improve durability, and restore resilience to the world’s Mpox vaccine infrastructure,” added Dodd.

GeoVax is actively engaging with global stakeholders, including the World Health Organization (WHO), Africa CDC, and Gavi, as well as the U.S. Administration for Strategic Preparedness and Response (ASPR) to explore advance purchase agreements, regional partnerships, and manufacturing alliances to enable rapid deployment of GEO-MVA in current and emerging hotspots.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com 

Research News and Market Data on GOVX

• Last updated: 02 July 2025
• Created: 02 July 2025

With global cases rising and bipartisan momentum for pandemic preparedness, GeoVax’s GEO-MVA vaccine advances on an expedited development track toward commercialization and revenue generation

ATLANTA, GA — July 2, 2025 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and cancer, today emphasized the growing global public health importance of its GEO-MVA Mpox/smallpox vaccine in response to rising public health threats and a rapidly evolving regulatory environment.

With favorable regulatory input from the European Medicines Agency (EMA), GEO-MVA is on an expedited path toward market access—accelerating GeoVax’s focus toward regulatory approval and commercialization.

“GeoVax is entering a value inflection phase,” said David Dodd, Chairman and CEO. “The EMA’s expedited development path brings us closer to regulatory registration and commercial readiness, providing the opportunity to address urgent public health needs, expanding the critically needed supply option of MVA-vaccine, addressing both expanding outbreak needs and stockpile opportunities.”

Modern Platform for Variant-Responsive Stockpiling

GeoVax’s development-stage continuous avian cell line process is anticipated to provide increased production of MVA-based vaccines, the ability to quickly respond to epidemics and pandemics, local implementation of MVA-based vaccine manufacturing and overall reduced production costs. 

With confirmed Mpox cases across multiple U.S. states, throughout Europe and new clade Ib outbreaks in West and Central Africa, the urgency for additional MVA-vaccine supply options is increasingly, critically important. 

“There is a clear need for diversity in stockpile planning,” Dodd added. “GEO-MVA is well-positioned to serve as a complementary or alternative solution where current, single-source options fall short.  Ending the current monopoly of MVA-vaccine will benefit public health worldwide, providing an expanded supply option of this critically needed vaccine.”

EMA Scientific Advice and BARDA RRPV Proposal Expedite Readiness

GeoVax recently received favorable Scientific Advice from the EMA, confirming an expedited regulatory development path for GEO-MVA. This milestone enhances the product’s standing with international regulatory bodies and opens pathways to revenue-generating opportunities across Europe and beyond.

In parallel, GeoVax’s advanced MVA-based vaccine manufacturing proposal under BARDA’s Rapid Response Partnership Vehicle (RRPV) remains under active review. The program is designed to fund scalable vaccine platforms, eliminating the dependency for stockpiling of MVA-based vaccines relative to high-consequence threats such as smallpox.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com 

Research News and Market Data on GOVX

• Last updated: 01 July 2025

Atlanta, GA, July 1, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into definitive securities purchase agreements with several institutional and individual investors for the purchase and sale of approximately 9.2 million units, each comprised of one share of the Company’s common stock and warrants, as described below, to purchase shares of the Company’s common stock, at a price of $0.65 per unit in a public offering. The Company will issue warrants to purchase up to approximately 18.5 million shares of common stock. The warrants will have an exercise price of $0.65 per share, will be exercisable immediately following the date of issuance and will have a term of five years following the date of issuance.

Roth Capital Partners is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $6 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. The closing of the offering is expected to occur on or about July 2, 2025, subject to the satisfaction of customary closing conditions.

The shares in the offering described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-288085) previously filed with the Securities and Exchange Commission (the ‘SEC’) and declared effective by the SEC on June 30, 2025. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach, CA 92660, by phone at (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com 

Research News and Market Data on GOVX

Patent Supports Multi‑Antigenic VLP-MVA Vaccine Design for Products Used Against Endemic and Emerging Infectious Diseases

ATLANTA, GA, June 25, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and cancers, today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 12,329,808, from patent application No.18,394,580, titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria.”

The patent covers compositions comprising GeoVax’s recombinant Modified Vaccinia Ankara (MVA) viral vector expressing immunogenic proteins from Plasmodium falciparum (the causative agent of malaria). The novel construct supports expression of virus-like particles (VLPs) assembled from P. falciparum circumsporozoite protein (CSP) or gametocyte surface protein Pfs230 fused to a Marburg virus glycoprotein transmembrane domain, together with the Marburg VP40 matrix protein. The expressed proteins are assembled in vivo as VLPs, which is an antigen presentation design used to enhance vaccine potency and induce both humoral and T-cell responses.

David Dodd, GeoVax President and CEO, commented, “This new patent further demonstrates our commitment to advancing critically important vaccines that address both globally persistent and emerging high-consequence pathogens. The vaccine construct exemplifies our multi-antigenic platform strategy that is critical to pandemic preparedness and global health security. While our clinical-stage programs remain our immediate focus, protecting our innovation pipeline through issued patents supports long-term value creation and future public health impact.”

GeoVax’s intellectual property estate now encompasses over 135 granted or pending patent applications across 23 distinct patent families, reinforcing the company’s strategic position across oncology, infectious diseases, and biodefense platforms. This broad portfolio includes strong protection for its Gedeptin® oncolytic cancer therapy, recently expanded to cover synergistic combinations with radiation, and multiple MVA‑based vaccine constructs targeting SARS‑CoV‑2, Mpox/smallpox, Zika, Ebola, Sudan, and Marburg viruses.

Malaria remains a persistent global health threat, causing over 600,000 deaths yearly, primarily in sub-Saharan Africa. The use of GeoVax’s versatile MVA-based platform offers the potential for inducing durable immunity against both such latent and emerging pathogens.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.

Company Contact:                                                                             

info@geovax.com                                                                               

678-384-7220                                                                                      

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com 

Research News and Market Data on GOVX

 

Supports Advancement of GeoVax’s Phase 2 Gedeptin® Trial in Recurrent Head and Neck Cancer

ATLANTA, GA, June 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today commented on the U.S. Food and Drug Administration’s recent approval of Keytruda® (pembrolizumab) for use in resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) tumors expressing PD-L1 as determined by an FDA approved test. This regulatory milestone marks a significant advancement in the curative-intent treatment landscape for head and neck cancer and affirms the therapeutic strategy underlying GeoVax’s Gedeptin® development program.

An editorial by Rosenberg and Vokes in New England Journal of Medicine (NEJM) noted that the study forming the basis of FDA’s approval represents the first demonstration of benefit for PD-1 inhibition in the curative setting for HNSCC, with implications for evolving neoadjuvant immunotherapy paradigms.

GeoVax is planning to initiate a Phase 2 clinical trial of Gedeptin® in combination with a checkpoint inhibitor, such as pembrolizumab, in patients with locally advanced HNSCC scheduled for curative-intent surgery. The trial aims to improve tumor clearance and reduce relapse by combining the immune-priming effect of Gedeptin’s targeted cytotoxicity with the systemic immune activation of checkpoint inhibition.

The Phase 2 study, expected to launch in 2026, will evaluate pathologic response, recurrence rates, and biomarker-defined immunologic changes when Gedeptin is used as neoadjuvant therapy with checkpoint inhibitors. Importantly, the NEJM editorial emphasized the need to optimize patient selection and treatment duration in the immunotherapy era, aligning with GeoVax’s biomarker-driven approach.

“The NEJM publication and FDA approval of Keytruda in resectable HNSCC signals a new era in curative-intent cancer therapy,” said David Dodd, Chairman and CEO of GeoVax. “By combining Gedeptin therapy with pembrolizumab, we aim to enhance local tumor eradication while unlocking systemic anti-tumor immunity, potentially reducing both local and distant recurrence.”

“We believe Gedeptin’s tumor-targeted cytotoxicity can enhance immunotherapy efficacy, particularly in the perioperative window where anti-tumor immunity can be primed,” added Dr. Kelly McKee, GeoVax’s Chief Medical Officer. “We are excited to embark on the next phase of Gedeptin development as we attempt to build on the important advances being made in this disease”.

For more information about the KEYNOTE-689 study, see the June 18, 2025 publication in the New England Journal of Medicine.

About Gedeptin

Gedeptin® is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally via an adenoviral vector encoding purine nucleoside phosphorylase (PNP). Upon systemic administration of fludarabine, the enzyme catalyzes the generation of a cytotoxic agent selectively within the tumor microenvironment. This mechanism provides dual cytotoxicity and immune modulation with minimal systemic exposure.

Gedeptin has been granted Orphan Drug Designation by the FDA for the treatment of oral and pharyngeal cancers and is protected by a growing intellectual property portfolio. GeoVax’s ongoing innovation in immune-sensitizing therapies supports a broader strategy to complement checkpoint inhibitors and overcome tumor immune resistance across solid tumor types.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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.

Company Contact:                                                                             

info@geovax.com                                                                               

678-384-7220                                                                                      

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com