Tag: GeoVax Labs

Research News and Market Data on GOVX

Former Georgia Life Sciences Chair Selected for CEO Spotlight and Private Global Health Policy Roundtable With U.S. Rep. Rich McCormick

ATLANTA, Ga., August 20, 2026 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today announced that Chairman, President and Chief Executive Officer David Dodd will participate in two leadership and policy events associated with the 2026 Georgia Life Sciences Summit, August 25–26, at the Performing Arts Center in Sandy Springs, Georgia.

Dodd, a former Chair of Georgia Life Sciences, has been selected as one of four biotechnology CEOs participating in “CEO Spotlights: Decisions That Define a Company,” presented by BioSpark Labs, on August 26. The CEO Spotlights feature 10-minute, TED-style presentations focused on pivotal decisions, challenges and inflection points that have shaped the trajectory of each participating company.

Dodd will draw upon GeoVax’s evolution to discuss the leadership and strategic decisions involved in building and advancing a biotechnology company through changing scientific, financial, regulatory and public-health environments. The presentation will offer a candid perspective on navigating uncertainty, allocating resources, advancing innovative technologies and maintaining a long-term strategic vision while confronting the realities inherent in building a clinical-stage biotechnology company.

GeoVax today is advancing a diversified portfolio built around its Modified Vaccinia Ankara (MVA) vaccine platform and novel oncology technologies. Its programs include GEO-MVA, the Company’s vaccine candidate for mpox and smallpox; MVA-based vaccine candidates targeting Ebola, Sudan Ebola and Marburg viruses; and Gedeptin^®, a novel gene-directed therapy for solid tumors.

“Building a biotechnology company is rarely a straight line,” said Dodd. “It requires making consequential decisions with incomplete information, adapting to changing circumstances and remaining focused on the scientific and strategic opportunities that can ultimately create meaningful value. I look forward to sharing some of the decisions and lessons that have shaped GeoVax’s journey with Georgia’s life sciences community.”

Dodd will be joined in the CEO Spotlight program by Samir Patel, President and CEO of Moonlight Therapeutics; Dr. Nikhil L. Shah, CEO and Co-Founder of Nephrodite; and Gareth Sheridan, Founder and CEO of Nutriband.

Private Roundtable with Congressman Rich McCormick

On August 25, Dodd will also participate in a private roundtable discussion with U.S. Representative Rich McCormick (GA-07), convened by Georgia Life Sciences, the Global Health Technologies Coalition and The Kyle House Group.

The roundtable will bring together leaders from Georgia’s global health, biotechnology, nonprofit and private sectors to discuss the state’s leadership in advancing global health and development through innovation, research and public-private partnerships. Participants will also have the opportunity to discuss key policy priorities and issues before Congress directly with Congressman McCormick.

For GeoVax, the discussion provides an opportunity to contribute perspectives informed by the Company’s work in infectious disease vaccines, medical countermeasures and global health preparedness, as well as the challenges faced by emerging biotechnology companies working to translate scientific innovation into products addressing significant public-health needs.

“Georgia has developed an increasingly important life sciences and global health ecosystem that brings together scientific innovation, entrepreneurship, academic expertise, public policy and investment,” Dodd said. “Having previously served as Chair of Georgia Life Sciences, I am especially pleased to participate in this year’s Summit and to engage with Congressman McCormick and other leaders on how we can further strengthen Georgia’s – and America’s – capacity for biotechnology innovation, health security and global health leadership.”

The Georgia Life Sciences Summit is the organization’s flagship annual gathering, bringing together leaders from industry, academia, government and the investment community to address major issues affecting scientific research, product development, financing, business development and public policy while showcasing innovation across Georgia’s life sciences sector.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Research News and Market Data on GOVX

FDA Approval of Replimune’s Intratumoral Therapy in Combination with Checkpoint Inhibition Reinforces Growing Momentum Behind Tumor-Directed Approaches Designed to Enhance Anti-Tumor Immune Response

ATLANTA, GA – August 11, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and solid tumors, today highlighted the recent U.S. Food and Drug Administration (FDA) accelerated approval of Replimune Group, Inc.’s TUDRIQEV^™ (formerly RP1) in combination with nivolumab as an important milestone in the evolution of intratumoral cancer immunotherapy.

The FDA approved TUDRIQEV in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease has progressed following prior anti-PD-1 therapy. The approval followed a favorable FDA Advisory Committee recommendation and represents an important regulatory milestone for localized tumor-directed therapies used in combination with immune checkpoint inhibitors (ICIs).

While TUDRIQEV and GeoVax’s investigational solid tumor therapy Gedeptin^® employ different mechanisms of action to achieve tumor cell killing, GeoVax believes the approval reinforces a broader therapeutic paradigm: local destruction of tumor masses may modify the tumor microenvironment and potentially enhance immune responses both within directly treated tumors and at distant tumor sites.

“This approval represents an important milestone that extends well beyond any individual product,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “It provides clinical and regulatory precedent for locally administered therapies used in combination with checkpoint inhibition. We believe this represents an increasingly important direction for cancer immunotherapy.”

Overcoming the “Cold Tumor” Barrier

Earlier this year, Mr. Dodd outlined this emerging concept in an Onco’Zine commentary entitled The Cold Tumor Barrier: Why Promising Oncology Therapies Fail In Vivo – and What It Will Take to Overcome It (Onco’Zine Cold Tumor Barrier). The article describes immunologically “cold” tumors – characterized by limited T-cell infiltration, poor antigen presentation and an immunosuppressive tumor microenvironment – as a fundamental barrier limiting the effectiveness of checkpoint inhibitors and other immunotherapies.

The article argues that durable advances in immuno-oncology may increasingly depend upon therapies capable of priming the tumor microenvironment and converting immunologically “cold” tumors into immune-responsive “hot” tumors, thereby creating the biological conditions necessary for checkpoint inhibitors to function more effectively.

GeoVax believes Gedeptin^® represents a differentiated approach to this emerging therapeutic paradigm. Unlike replication-dependent oncolytic viruses, Gedeptin utilizes a gene-directed enzyme prodrug therapy (GDEPT) approach in which a replication-deficient adenoviral vector delivers a bacterial enzyme, purine nucleoside phosphorylase (PNP), directly into tumor tissue. Following administration of fludarabine phosphate, the enzyme converts the inactive prodrug into a potent cytotoxic metabolite within the tumor microenvironment, producing localized tumor destruction and a demonstrated preclinical bystander effect extending beyond directly transduced tumor cells, while promoting anti-tumor immune responses. Importantly, GeoVax believes Gedeptin’s potential therapeutic value extends beyond localized cytotoxicity. 

Published Evidence Supporting Tumor Priming and Checkpoint Inhibitor Synergy

In recently published research in JCI Insight, Gedeptin combined with anti-PD-1 therapy in an immunocompetent preclinical model demonstrated enhanced anti-tumor immune responses, increased CD8+ T-cell infiltration, systemic anti-tumor activity and improved therapeutic outcomes compared with checkpoint inhibition alone.

These findings provide scientific support for the thesis that Gedeptin may function as a tumor-priming immunotherapy, using localized tumor destruction and immune activation to help transform immunologically resistant tumors into tumors more responsive to checkpoint inhibition.

“The objective is not simply to destroy tumor cells locally,” said Kelly McKee, M.D., Chief Medical Officer of GeoVax. “The greater opportunity is to initiate the immune recognition necessary for checkpoint inhibitors to work more effectively. These findings demonstrate Gedeptin’s potential to combine extensive localized tumor killing with immune activation, creating a more favorable tumor microenvironment for checkpoint inhibition.” 

A Converging Immuno-Oncology Strategy

GeoVax believes several recent developments now point toward a converging therapeutic strategy within immuno-oncology:

• Regulatory precedent: FDA accelerated approval of TUDRIQEV plus nivolumab establishes an approved intratumoral immunotherapy/checkpoint inhibitor combination for patients with advanced melanoma following anti-PD-1 therapy.
• Scientific evidence: The JCI Insight publication provides preclinical evidence that Gedeptin can enhance anti-tumor immune activity and checkpoint inhibitor responsiveness.
• Tumor-priming strategy: Growing scientific understanding of the “cold tumor” barrier supports approaches designed to modify the tumor microenvironment before or in conjunction with checkpoint inhibition.

Gedeptin is mechanistically distinct from TUDRIQEV. Rather than relying on viral replication and oncolysis, Gedeptin is designed to generate potent cytotoxic activity directly within the tumor through enzyme-directed prodrug activation, with a substantial bystander effect capable of extending tumor killing beyond cells directly reached by the vector.

GeoVax believes this differentiated mechanism has the potential to position Gedeptin as a tumor-priming immunotherapy designed to enhance the effectiveness of established immunotherapies, rather than simply as another intratumoral therapy. The Company is continuing preparations for the next phase of Gedeptin’s clinical development in combination with pembrolizumab for patients with head and neck squamous cell carcinoma. The planned study is expected to evaluate clinical activity together with biomarkers of immune activation, tumor microenvironment modulation and pathological tumor response.

“The FDA approval of an intratumoral therapy combined with checkpoint inhibition reinforces a therapeutic direction that we believe has significant potential,” concluded Mr. Dodd. “Our objective with Gedeptin is to address one of the fundamental barriers limiting immunotherapy – the inability of immunologically cold tumors to generate an effective anti-tumor immune response. Our published science provides an important foundation for that strategy, and we believe Gedeptin’s differentiated mechanism warrants continued clinical development.” 

About Gedeptin®

Gedeptin® is GeoVax’s investigational gene-directed enzyme prodrug therapy (GDEPT) for the treatment of solid tumors. The therapy utilizes a replication-deficient adenoviral vector to deliver the bacterial enzyme purine nucleoside phosphorylase (PNP) directly into tumors. Following administration of fludarabine phosphate, the PNP enzyme converts the inactive prodrug into a potent cytotoxic metabolite within the tumor microenvironment, producing localized tumor cell death while promoting anti-tumor immune responses. Gedeptin is being developed in combination with immune checkpoint inhibitors for the treatment of solid tumors.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Research News and Market Data on GOVX

Recent Third-Party Research Reinforces Scientific Rationale for Evaluating Broad-Spectrum Filovirus Preparedness Approaches

ATLANTA, GA – August 3, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and solid tumors, today highlighted recently published independent scientific research that reinforces growing interest in vaccine strategies capable of providing broader protection across multiple ebolavirus species.

A recent independent study, discussed by MedPage Today (July 23, 2026) and released as a scientific preprint by independent investigators, reported that immune responses generated by licensed vaccines against Zaire ebolavirus (EBOV) recognized Bundibugyo ebolavirus (BDBV), an emerging ebolavirus species responsible for recent outbreaks in Central Africa. The investigators concluded that these findings support further evaluation of existing and next-generation vaccine strategies against Bundibugyo virus and other related filoviruses.

While the vaccines included in the study do not demonstrate protection against Bundibugyo virus, it provides additional scientific support for the concept that vaccine-induced immune responses may extend across related ebolavirus species and underscores the importance of developing broadly applicable filovirus vaccine platforms.

GeoVax has previously demonstrated significant protective efficacy in published non-human primate studies with separate Modified Vaccinia Ankara (MVA)-based vaccine candidates targeting both Zaire Ebola virus (EBOV) and Sudan Ebola virus (SUDV). Together with the Company’s Marburg virus vaccine program, these vaccine candidates comprise a differentiated filovirus vaccine portfolio built upon GeoVax’s proprietary MVA platform.

David A. Dodd, Chairman and Chief Executive Officer of GeoVax, commented: “Independent scientific validation plays an important role in advancing preparedness strategies for emerging infectious diseases. These newly reported findings reinforce the growing recognition that future outbreak preparedness will benefit from platform technologies capable of addressing multiple related pathogens rather than individual viruses. GeoVax has extensive institutional experience in developing MVA-based vaccines against several of the world’s highest-consequence filoviruses, and we believe our technology platform is well positioned to support future preparedness initiatives.”

Mark J. Newman, Ph.D., Chief Scientific Officer of GeoVax, added: “The recently published findings provide encouraging support for an important scientific hypothesis – that immune responses against one ebolavirus may extend to related viruses. GeoVax’s MVA-VLP, multi-antigen experimental vaccines, which have been evaluated in animal models and shown to provide significant protective efficacy, are designed to induce broadly protective immune responses, invoking both the antibody and cellular arms of the immune system. These independent findings demonstrate the potential of the GeoVax MVA-VLP platform.”

GeoVax’s filovirus vaccine portfolio currently includes vaccine candidates targeting:

• Zaire Ebola virus (EBOV)
• Sudan Ebola virus (SUDV)
• Marburg virus (MARV)

Each program utilizes the Company’s Modified Vaccinia Ankara (MVA) platform, providing a common development and manufacturing foundation for addressing multiple high-consequence infectious diseases.

As governments and global health organizations continue strengthening preparedness against emerging infectious diseases, GeoVax believes platform technologies capable of supporting multiple biodefense and public health applications will become increasingly important.

The Company will continue evaluating strategic opportunities for its filovirus vaccine portfolio, including government collaborations, global health partnerships, and potential licensing opportunities, while maintaining its primary strategic focus on advancing GEO-MVA, its lead vaccine candidate for the prevention of mpox and smallpox, and Gedeptin®, its clinical-stage immuno-oncology program.

Reference

The scientific findings discussed in this release are based on recent independent research evaluating cross-reactive immune responses following licensed Ebola vaccination, as reported by MedPage Today (July 23, 2026) and described in a 2026 scientific preprint in The New England Journal of Medicine by the study investigators. GeoVax was not involved in conducting the study, and the findings should not be interpreted as demonstrating efficacy of GeoVax vaccine candidates against Bundibugyo ebolavirus.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Research News and Market Data on GOVX

ASPR Report Reinforces National Priorities for Domestic Manufacturing, Platform Technologies, Strategic National Stockpile Modernization, and Pandemic Preparedness

ATLANTA, GA – July 21, 2026  – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing next-generation vaccines and immunotherapies, today highlighted the strong alignment between its GEO-MVA vaccine platform strategy and the priorities outlined in the U.S. Department of Health and Human Services Administration for Strategic Preparedness and Response’s (ASPR) newly released Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Multiyear Budget: Fiscal Years 2025–2029.

The report provides the federal government’s five-year roadmap for investments in medical countermeasures, advanced manufacturing, Strategic National Stockpile (SNS) modernization, and preparedness against emerging infectious disease and biological threats.

According to the report, approximately 65% of future medical countermeasure investment is expected to focus on threat-agnostic and multi-threat technologies, while emphasizing domestic manufacturing capability, scalable vaccine platforms, and sustained preparedness infrastructure. The report also projects a total five-year medical countermeasure investment need of approximately $66.9 billion, underscoring the growing strategic importance of resilient domestic biodefense capabilities.

“The release of ASPR’s five-year preparedness strategy reinforces many of the strategic priorities that have guided our GEO-MVA program,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “The report recognizes that future preparedness requires more than individual vaccines – it requires flexible platform technologies, domestic manufacturing capability, resilient supply chains, and sustainable medical countermeasure infrastructure. GEO-MVA has been developed with these national priorities in mind.”

ASPR Priorities Closely Align with the GEO-MVA Strategy

GeoVax believes several priorities identified in the ASPR strategy directly support the long-term strategic rationale underlying the GEO-MVA program.

Domestic Manufacturing

The ASPR report identifies sustaining and expanding domestic commercial manufacturing capability as one of the nation’s principal preparedness challenges.

GeoVax’s GEO-MVA program is designed to establish a U.S.-based source of Modified Vaccinia Ankara (MVA) vaccine manufacturing, supporting domestic supply-chain resilience while reducing dependence on limited global manufacturing capacity.

Platform Technologies

The report emphasizes investments in threat-agnostic and multi-threat technologies capable of responding rapidly to future public health emergencies.

The MVA vector represents a well-established vaccine platform with demonstrated applicability across multiple infectious disease targets, providing flexibility beyond any single indication.

Strategic National Stockpile

The ASPR strategy calls for continued modernization of the Strategic National Stockpile while addressing lifecycle management, replenishment, and transition of new medical countermeasures into long-term preparedness programs.

GeoVax believes the GEO-MVA program aligns with these objectives by supporting future U.S. preparedness capacity for orthopoxvirus threats.

Emerging Infectious Diseases

The report identifies emerging infectious diseases as among the nation’s highest preparedness priorities while emphasizing investments that enable rapid response to evolving threats.

GeoVax’s clinical development strategy for GEO-MVA is intended to support preparedness against mpox and smallpox while leveraging the broader capabilities of the MVA platform.

Independent Validation of Long-Term Preparedness Trends

The ASPR report reflects a continuing evolution in federal preparedness strategy – from investing primarily in individual products toward investing in strategic capabilities, including manufacturing infrastructure, platform technologies, and sustainable preparedness systems.

GeoVax believes these evolving priorities reinforce the long-term strategic value of domestic vaccine manufacturing capabilities that can support future public health emergency response.

“Preparedness is increasingly being viewed as a strategic national capability rather than simply a collection of products,” added Mr. Dodd. “We believe this evolution supports the importance of maintaining flexible vaccine platforms and domestic manufacturing infrastructure capable of responding to future biological threats.”

About GEO-MVA

GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA) vaccine candidate being developed to support protection against mpox and smallpox. The program is advancing through an immunobridging regulatory strategy following positive Scientific Advice from the European Medicines Agency (EMA) and is intended to provide an additional source of MVA vaccine manufacturing capacity supporting future public health preparedness initiatives.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Research News and Market Data on GOVX

Company Expands Strategic Immuno-Oncology Positioning Around Tumor Microenvironment Modulation, Checkpoint Enhancement, and Multi-Tumor Development Potential

ATLANTA, GA – May 13, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines for solid tumors and infectious diseases, today highlighted the expanding strategic relevance of its Gedeptin^® immuno-oncology program within the rapidly evolving landscape of combination immunotherapy and checkpoint inhibitor enhancement strategies.

GeoVax believes Gedeptin’s unique mechanism of localized tumor destruction combined with immune activation positions the program within a growing area of oncology focus: therapies designed to overcome immune resistance and enhance responsiveness to checkpoint inhibitors in immunologically “cold” tumors.

Checkpoint inhibitors targeting PD-1 and PD-L1 have transformed cancer treatment across multiple tumor types; however, many solid tumors remain insufficiently responsive due to immune-suppressive tumor microenvironments, inadequate immune-cell infiltration, and incomplete tumor antigen recognition. As a result, oncologists are increasingly focused on combination approaches capable of improving checkpoint inhibitor response rates and extending durability of benefit.

“Modern immuno-oncology is increasingly shifting toward combination strategies designed to improve the effectiveness of checkpoint inhibitors across broader patient populations,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “We believe Gedeptin aligns directly with this trend by functioning not simply as a localized tumor therapy, but as a potential immune-sensitization platform capable of enhancing anti-tumor immune responses in tumors where checkpoint inhibitors alone may be insufficient.”

Key characteristics of the Gedeptin platform include:

• Tumor-agnostic mechanism of action independent of tumor histology or proliferation rate;
• Strong bystander effect, allowing destruction of neighboring tumor cells even when only a fraction are directly transduced;
• Tumor microenvironment remodeling and immune activation, potentially enhancing tumor recognition by the immune system;
• Potential checkpoint sensitization, supporting combination strategies with PD-1 and PD-L1 inhibitors;
• Compatibility with image-guided and intratumoral delivery approaches across multiple solid tumor settings.

GeoVax’s lead development focus for Gedeptin is a planned neoadjuvant combination study in recurrent head and neck squamous cell carcinoma (HNSCC), evaluating intratumoral Gedeptin together with PD-1 targeting immunotherapy in patients eligible for curative-intent surgery. The study is expected to evaluate pathologic response, immune biomarker modulation, and early event-free survival signals.

“The oncology field is increasingly recognizing that durable checkpoint inhibitor responses may require direct modulation of the tumor microenvironment in addition to checkpoint blockade alone,” continued Mr. Dodd. “We believe Gedeptin’s ability to induce localized tumor destruction while simultaneously promoting immune activation creates a compelling rationale for combination development approaches designed to broaden and deepen immunotherapy responses. Importantly, we believe this mechanism may ultimately extend beyond localized disease settings and support broader applicability across metastatic solid tumors where immune resistance remains a major therapeutic challenge.”

Beyond head and neck cancer, GeoVax believes Gedeptin may have broader applicability across solid tumors characterized by:

• established checkpoint inhibitor treatment paradigms,
• incomplete response durability,
• immunologically suppressed tumor microenvironments,
• and at least one lesion amenable to intratumoral or image-guided delivery.

Potential future tumor targets under evaluation include melanoma, triple-negative breast cancer, cutaneous malignancies, and additional metastatic solid tumor settings.

“As the oncology landscape evolves beyond single-agent checkpoint inhibition toward increasingly sophisticated combination approaches, we believe therapies capable of enhancing immune recognition and overcoming tumor resistance mechanisms may become increasingly important,” added Mr. Dodd. “Our objective is to position Gedeptin within that emerging therapeutic landscape as a differentiated immune-enabling platform with potential applicability across multiple solid tumor indications.”

About Gedeptin^®

Gedeptin^® is GeoVax’s proprietary gene-directed enzyme prodrug therapy (GDEPT) platform under development for the treatment of solid tumors. The therapy is designed for intratumoral administration and utilizes a non-replicating adenoviral vector to deliver purine nucleoside phosphorylase (PNP) directly into tumor tissue. Following administration of fludarabine, the PNP enzyme converts the prodrug into a potent localized cytotoxic agent that destroys tumor cells while simultaneously generating immune-activating signals within the tumor microenvironment.

GeoVax is advancing development plans to evaluate Gedeptin in combination with immune checkpoint inhibitors, including pembrolizumab, with the goal of amplifying anti-tumor immune activation and broadening therapeutic applicability across multiple solid tumor indications.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin^®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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:

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Media Contact:

Jessica Starman

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