Tag: GOVX

Release – GeoVax Confirms Bundibugyo Ebola Vaccine Construct

Posted on by [email protected]
GeoVax, Inc.

Research News and Market Data on GOVX

BDBV-Specific Construct Developed Using GeoVax Proprietary Rapid Cloning Technology and Builds on Established Filovirus Vaccine Experience

GEO-MVA (Mpox/Smallpox Vaccine) Targeted for Phase 3 Initiation Remains Company Priority

ATLANTA, GA – September 16, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing vaccines and immunotherapies against infectious diseases and solid tumor cancers, today announced the development of a vaccine construct targeting Bundibugyo virus (BDBV), the cause of the ongoing Bundibugyo virus disease outbreak in the Democratic Republic of Congo.

The BDBV construct was generated using GeoVax’s proprietary MVA-based rapid-cloning technology, designed to enable rapid insertion or replacement of vaccine antigens in response to emerging infectious disease threats. The construct represents a milestone step toward a potential BDBV vaccine candidate.  Full characterization and animal evaluation are necessary prior to clinical evaluation.

The BDBV work builds upon GeoVax’s existing MVA-based developmental-stage filovirus vaccine portfolio targeting Zaire Ebola virus, Sudan Ebola virus and Marburg virus. These earlier programs have generated encouraging efficacy results in established preclinical models, including nonhuman primate challenge studies, with results presented publicly and published in peer-reviewed scientific journals. This body of work provides a scientific and technical foundation for applying GeoVax’s MVA platform to BDBV.

“While GEO-MVA remains our primary development focus, the ongoing, expanding BDBV outbreak represents an opportunity to apply capabilities developed through years of MVA and filovirus research,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “The successful generation of this BDBV-specific MVA construct demonstrates the responsiveness of our platform and builds on our published preclinical experience across Zaire Ebola, Sudan Ebola and Marburg, including encouraging results in nonhuman primate challenge studies. As global organizations advance multiple BDBV vaccine approaches, we believe this combination of filovirus experience, rapid construct generation and next-generation MVA technologies warrants further evaluation.”

Growing Global Focus on BDBV Vaccine Development

Bundibugyo virus disease is a severe filovirus infection for which there is currently no licensed BDBV-specific vaccine. The World Health Organization (WHO) has called for accelerated development and evaluation of BDBV-specific vaccines and other countermeasures and has established a target product profile to guide vaccine development.

The urgency surrounding BDBV has also prompted increased global investment in vaccine development. In August 2026, the Coalition for Epidemic Preparedness Innovations (CEPI) announced funding of up to $16.5 million to advance another MVA-based BDBV vaccine candidate through preclinical development and toward an early-stage clinical trial in Africa. The program is part of a broader CEPI strategy to advance multiple BDBV vaccine approaches.

GeoVax believes its BDBV construct and extensive body of MVA-based filovirus experience may warrant consideration within this expanding global development effort. In addition to its rapid-cloning technology, GeoVax is advancing MVA technologies directed toward single-dose vaccination, continuous cell-line manufacturing and alternative delivery approaches. The Company also recognizes the importance of regional manufacturing and is committed to evaluating manufacturing partnerships, including in Africa, as part of future MVA-based vaccine development programs.

“Our BDBV work provides another tangible example of how an adaptable vaccine platform and established scientific expertise can potentially contribute to outbreak preparedness,” Dodd concluded. “We look forward to exploring opportunities with global health, government and scientific partners to further evaluate the BDBV construct and our broader filovirus capabilities.”

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]

Release – GeoVax and CEPI Enter Agreement to Utilize CEPI Centralised Laboratory Network to Support GEO-MVA Phase 3 Trial

Posted on by [email protected]
GeoVax, Inc.

Research News and Market Data on GOVX

Independent Evaluation Supports GEO-MVA Pivotal Phase 3 Program

Advances GeoVax’s Strategy to Expand and Diversify MVA Vaccine Supply

ATLANTA, GA – September 14, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against high consequence infectious diseases and solid tumor cancers, today announced that it has entered into a Memorandum of Agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) providing GeoVax access to clinical trial sample testing services through the CEPI Centralised Laboratory Network in support of its planned pivotal GEO-MVA Phase 3 immune-bridging study.

The agreement represents an important step in the continued development of GEO-MVA, GeoVax’s MVA-based vaccine candidate targeting mpox and smallpox. It provides access to independent laboratory testing using standardized assays and reporting procedures established through CEPI’s global laboratory infrastructure. CEPI’s network is the largest global group of laboratories dedicated to harmonizing the immunological assessment of vaccines in development against infectious diseases with epidemic and pandemic potential. With network scientists assessing clinical trial samples using the same methods and validated assays, the possibility of variability in trial readouts is minimized, helping researchers and regulators consistently evaluate vaccine performance in clinical trials. For GeoVax, the agreement also supports a broader strategic objective: building independent scientific evidence necessary to establish GEO-MVA as a potential additional source of MVA-based mpox vaccine supply at a time when outbreaks and preparedness requirements continue to demonstrate the importance of resilient, diversified vaccine capacity.

GeoVax expects to initiate its approximately 500-participant pivotal Phase 3 immune-bridging study in the fourth quarter of 2026, with results expected in mid-2027.

Recent global mpox outbreaks have underscored the risks of constrained vaccine supply and the importance of expanding MVA vaccine capacity. GeoVax believes sustainable preparedness will increasingly require not only adequate vaccine stockpiles, but also multiple qualified sources of supply and manufacturing capacity capable of serving different regions of the world.

“Independent evaluation is an important step toward building confidence in GEO-MVA among regulators, public-health organizations, governments and potential strategic partners,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “Our agreement with CEPI provides access to a highly respected global laboratory network capable of testing and characterizing immune responses associated with GEO-MVA.”

Dodd continued, “But the larger objective extends beyond development of another mpox vaccine. The global preparedness community needs resilient MVA supply. We believe that the data produced by CEPI’s network could pave the way for an additional qualified supply source of mpox vaccine supply if we are successful in testing and licensure, reducing dependence on a single manufacturing infrastructure and ultimately enabling production capacity that can be deployed closer to the populations it is intended to protect.”

Independent Evaluation Supporting an Expanded-Source Strategy

Under the agreement, clinical samples provided by GeoVax will be evaluated through the CEPI Centralised Laboratory Network using assays specific to orthopoxviruses, the family of viruses to which mpox and smallpox belong.

The independent nature of the testing is particularly important as GeoVax advances GEO-MVA toward its pivotal Phase 3 study. Results generated through CEPI’s laboratory network will provide independently generated and standardized immunological data that will inform GeoVax’s ongoing clinical development and future regulatory interactions.

“CEPI’s Centralised Laboratory Network was set up during the COVID-19 pandemic to help reduce clinical testing differences that can emerge from independent laboratory review to instead ensure easy access and alignment to key data that could support vaccine approvals” said Dr Amy Shurtleff, Director of Laboratory Research and Innovation Department at CEPI. “It has rapidly expanded since then, with vaccine developers around the world using the service to evaluate thousands of their samples produced during trials of promising vaccine candidates against other deadly pathogens, including mpox. Our new agreement with GeoVax enables the company to access validated, high-quality mpox testing tools that could fast-track its promising GEO-MVA mpox vaccine through development and give the world further options to fight this harmful, recurring disease.”

The agreement also provides a framework under which CEPI may share anonymized summaries of sample-testing results with the World Health Organization (WHO), Gavi, the Vaccine Alliance and others to further CEPI’s mission to transform the world’s response to epidemic and pandemic threats, including diseases like mpox.

GeoVax will cover the full testing costs associated with the research carried out by CEPI’s Centralised Laboratory Network. CEPI has not provided specific funding for the development of GEO-MVA.

 About GEO-MVA

GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine being developed for protection against mpox and smallpox. Following Scientific Advice from the European Medicines Agency (EMA), GeoVax is pursuing an immune-bridging development strategy that is intended to compare immune responses generated by GEO-MVA with those generated by the licensed MVA-BN comparator.

GeoVax is developing GEO-MVA to expand global access to MVA vaccine supply, scalable production capabilities, and a capital-efficient regulatory pathway. The Company believes GEO-MVA has the potential to become an important strategic preparedness asset by providing governments and international public health organizations with an additional, reliable source of MVA vaccine to support biosecurity and orthopoxvirus preparedness.

About CEPI and the Centralised Laboratory Network

CEPI is an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. Central to CEPI’s pandemic-beating plan is the ‘100 Days Mission’ to develop safe, effective and accessible vaccines against new threats in just 100 days. CEPI is seeking $2.5 billion to execute CEPI 3.0, its 2027-2031 strategy which will systematically reduce the likelihood, impact and cost of epidemics and pandemics by driving the 100 Days Mission towards an operational reality. Learn more at CEPI.net.

The Centralised Laboratory Network focuses on the assessment of vaccines against CEPI’s priority list of pathogens including Lassa, Nipah, mpox, MERS, Ebola, Chikungunya, Rift Valley fever and COVID-19.

Laboratory members also support testing of vaccines for other viral threats with epidemic or pandemic potential, like Marburg, and are on standby to help fast-track the assessment of vaccine candidates against a Disease X – a novel or as-of-yet unidentified pathogen. To date, the network has served over 60 vaccine developers to assess their vaccine candidates at all stages of developments, processing over 120,000 samples.

CEPI’s Centralised Laboratory Network members are listed here. Laboratories are selected to join the network based on their capacity, experience and scientific expertise in testing clinical samples using high-quality systems. Since its launch in 2020, CEPI has provided up to US $59 million to fund capability building and collect immunogenicity data in the network.

Data produced by members of the network is sent back to the vaccine developer. Neither CEPI nor the laboratory who assessed the samples owns the data.

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, an investigational 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 fourth quarter 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]

Release – GeoVax Provides Nasdaq Listing Update and Reaffirms Focus on Advancing Strategic Priorities

Posted on by [email protected]
GeoVax, Inc.

Research News and Market Data on GOVX

ATLANTA, GA – September 10, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against high-consequence infectious diseases and solid tumor cancers, today provided an update regarding its Nasdaq listing status and reaffirmed its continued focus on advancing the Company’s key development and strategic priorities.

As previously disclosed, GeoVax requested a hearing before the Nasdaq Hearings Panel (the “Panel”) to appeal the delisting determination the Company received on August 27, 2026, relating to the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). The hearing has been scheduled for October 13, 2026.

The Company’s hearing request has stayed any suspension or delisting action pending the hearing and the expiration of any extension period that may be granted by the Panel following the hearing. Accordingly, GeoVax’s common stock is expected to continue to trade on The Nasdaq Capital Market under the symbol “GOVX” at least through that period. At the hearing, GeoVax intends to present its plan to regain and maintain compliance with the applicable Nasdaq listing standards.

David Dodd, Chairman and Chief Executive Officer of GeoVax, commented, “We remain committed to maintaining GeoVax’s Nasdaq listing and look forward to presenting our compliance plan to the Hearings Panel. Importantly, the Nasdaq process does not change our strategic priorities or our focus on execution. We continue to advance GEO-MVA toward its planned pivotal Phase 3 clinical program, pursue opportunities to strengthen our manufacturing and global preparedness capabilities, and engage potential strategic, funding and development partners across our portfolio.”

Mr. Dodd continued, “Our focus remains on building long-term value from GeoVax’s vaccine and immuno-oncology programs while addressing the Company’s near-term corporate and financing priorities. We believe the progress across our programs, together with the growing emphasis on vaccine supply resilience, biodefense preparedness and expanded global access, provides a strong foundation for our continued efforts.”

Continued Focus on Key Strategic Priorities

GeoVax’s priority program is GEO-MVA, an investigational 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 addressing the need for expanded orthopoxvirus vaccine supply and biodefense preparedness.

In parallel, GeoVax continues to pursue manufacturing and product innovations intended to support broader access and preparedness, while evaluating strategic partnerships and funding opportunities aligned with its development priorities.

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.

The Company also maintains a broader MVA-based vaccine platform and intellectual property portfolio addressing high-consequence infectious diseases and global health preparedness.

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 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 continue and 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]

Release – GeoVax Welcomes Launch of Global Mpox Vaccine Stockpile, Highlights GEO-MVA Readiness to Support Diversified Global Supply

Posted on by [email protected]
GeoVax, Inc.

Research News and Market Data on GOVX

Gavi-funded, ICG-Coordinated Initiative Establishes Long-Term Infrastructure for Timely and Equitable Mpox Vaccine Access During Outbreaks

New Stockpile Framework Supports Sustainable Supply and Long-Term Global Preparedness

ATLANTA, GA – September 9, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancers, today welcomed the launch of a new global mpox vaccine stockpile designed to provide countries with timely, equitable and sustainable access to vaccines during future outbreaks.

In a September 2 announcement, the World Health Organization (WHO) highlighted the initiative, which was launched on August 27 and is funded by Gavi (the Vaccine Alliance) and coordinated through the International Coordinating Group (ICG) on Vaccine Provision, whose partners include WHO, UNICEF, Médecins Sans Frontières (MSF) and the International Federation of Red Cross and Red Crescent Societies (IFRC). The stockpile is scheduled to begin operations later this month and establishes a long-term mechanism for global mpox vaccine access and outbreak response.

“Establishing a dedicated global mpox vaccine stockpile is an important step forward in moving from reactive outbreak response toward sustained preparedness,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Equitable access requires more than having vaccines available after an outbreak begins. It requires durable procurement infrastructure, sufficient vaccine supply, and the ability to rapidly deliver vaccine protection where it is needed. We applaud WHO, Gavi and the ICG partners for establishing this important mechanism and look forward to engaging with global health partners as our mpox vaccine candidate, GEO-MVA, advances toward pivotal Phase 3 evaluation and potential future supply.”

The new stockpile builds upon the Access and Allocation Mechanism established during the 2024 mpox public health emergency and responds to persistent barriers to vaccine access experienced during recent outbreaks. WHO has identified securing a robust product mix of vaccines and supplies and supporting market-shaping efforts to promote longer-term sustainable access to mpox vaccines among the stockpile’s strategic objectives. These objectives underscore the importance of reliable and diversified vaccine supply as part of sustained global preparedness.

The ICG mechanism has been used for decades to coordinate emergency vaccine supplies for epidemic-prone diseases. The addition of mpox establishes a durable framework through which international health organizations, donors, countries and vaccine manufacturers can support preparedness and rapid outbreak response.

GEO-MVA: Advancing Toward Pivotal Phase 3

GeoVax is developing GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine candidate for the prevention of mpox and smallpox. The Company has completed key manufacturing, regulatory, clinical and preclinical milestones supporting planned initiation of its pivotal Phase 3 immune-bridging study in the fourth quarter of 2026.

GEO-MVA program readiness includes:

  • Manufacturing Readiness: GMP clinical product has been manufactured, filled, packaged and released for use in the pivotal clinical study.
  • Regulatory Alignment: European Medicines Agency (EMA) Scientific Advice supports an expedited immune-bridging development pathway comparing GEO-MVA with the licensed MVA-BN vaccine.
  • Clinical Readiness: CRO engagement and clinical-site identification are advancing in support of the targeted approximately 500-participant pivotal study.
  • Preclinical Support: Comparative nonclinical studies have generated orthopoxvirus-specific immune responses and neutralizing-antibody data supporting the planned immune-bridging strategy.

As the new global stockpile infrastructure develops, GeoVax believes additional qualified MVA vaccine sources can help expand supply availability, manufacturing capacity and preparedness for future outbreaks. The Company is engaging government agencies and international preparedness organizations regarding future procurement requirements and the potential role of GEO-MVA as an additional source of MVA vaccine supply.

“Creating a sustainable procurement mechanism is an important part of preparedness, but preparedness also requires sufficient and reliable vaccine supply,” Dodd continued. “Our objective with GEO-MVA is to contribute a reliable additional source of MVA vaccine capacity that can strengthen global supply resilience and provide governments and international health organizations with greater supply flexibility.”

Extending Access Through Next-Generation MVA Technologies

Beyond advancing GEO-MVA toward potential registration and supply, GeoVax is pursuing technologies intended to address additional barriers to global vaccine access and administration. These efforts include development of MVA-X, a next-generation MVA vaccine approach targeting single-dose protection; advancement of continuous-cell-line manufacturing intended to support scalable production; and evaluation of microarray-based delivery technologies that could potentially simplify vaccine administration and facilitate broader deployment.

“The launch of this global stockpile represents a significant advance in the infrastructure for equitable mpox vaccine access and outbreak response,” Dodd said. “The next challenge is ensuring that the vaccines supporting that stockpile can be manufactured at scale and deployed as efficiently and broadly as possible. Our longer-term MVA strategy is focused on that entire continuum – from expanding supply, to pursuing single-dose protection, to simplifying how vaccines may ultimately be administered in the field.”

“As GEO-MVA progresses toward pivotal Phase 3 evaluation, we look forward to working with Gavi, WHO, the ICG and other international health organizations toward the shared objective of expanding sustainable and equitable access to mpox vaccines worldwide,” Dodd added.

About GEO-MVA

GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine being developed for protection against mpox and smallpox. Following Scientific Advice from the European Medicines Agency, GeoVax is pursuing an immune-bridging development strategy intended to compare immune responses generated by GEO-MVA with those generated by the licensed MVA-BN comparator.

GeoVax is developing GEO-MVA to expand global access to MVA vaccine supply and scalable production capabilities. The Company believes GEO-MVA has the potential to become an important strategic preparedness asset by providing governments and international public health organizations with an additional source of MVA vaccine supporting biosecurity and orthopoxvirus preparedness.

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 fourth quarter 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]

Release – GeoVax Advances GEO-MVA Toward Pivotal Phase 3 Study Implementation

Posted on by [email protected]
GeoVax, Inc.

Research News and Market Data on GOVX

Selections of CRO and European Clinical Sites Represent Significant Milestones Toward Initiation of the GEO-MVA Immunobridging Study

ATLANTA, GA – August 25, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and solid tumor cancers, today announced that it has selected the contract research organization (CRO) and European clinical trial sites planned to support the critical immunobridging portion of GEO-MVA-301, the Company’s pivotal Phase 3 clinical program evaluating GEO-MVA as a vaccine against mpox and smallpox.

The selections represent another important operational readiness milestone as GeoVax advances preparations for the European immunobridging study. The randomized, double-blind study is designed to compare the immunogenicity and safety of GEO-MVA with the licensed MVA vaccine in healthy adults.

The selected European clinical sites have extensive experience conducting late-stage vaccine studies and were evaluated for their ability to support timely recruitment across the study’s required adult age groups, intensive immunogenicity sampling, participant retention and high-quality clinical execution. GeoVax has also established contingency site capacity intended to provide additional recruitment flexibility if required.  The immunobridging study is designed to be completed within 8-12 weeks, initiated in Q4 2026, with results announced by mid-2027.

“Selection of our CRO and European clinical sites moves GEO-MVA another important step from development planning toward clinical execution,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “We now have critical components of the pivotal study infrastructure identified and aligned, and the program is increasingly taking shape as an execution-ready clinical program.”

Dodd continued, “These milestones are particularly important because they reflect progress across multiple workstreams – not simply clinical-site selection. Manufacturing readiness, regulatory planning, clinical operations, comparator strategy and site preparation are being brought together around a defined pivotal development pathway. We believe these activities position us to move efficiently toward study initiation as the remaining requirements are completed.”

A Focused Pivotal Development Strategy

The immunobridging study is planned to enroll 500 healthy adult participants at European clinical sites and evaluate whether immune responses generated by GEO-MVA are non-inferior to those generated by the licensed MVA comparator vaccine.  GeoVax expects meeting the non-inferiority criteria will form the basis for approval by the European Medicines Agency (EMA), providing eligibility for GEO-MVA procurement.

The study will evaluate neutralizing antibody responses and seroconversion against vaccinia and mpox viruses, together with additional immunogenicity and safety measures. Enrollment is planned across multiple adult age groups to support a representative clinical dataset.

The study design incorporates an initial safety lead-in cohort, followed by enrollment of the remaining immunobridging study participants. The CRO and site-selection process emphasized capabilities considered important for efficient execution of the pivotal program, including:

  • Experience conducting Phase 2 and Phase 3 vaccine trials;
  • Demonstrated ability to timely recruit healthy adult volunteers; Experience managing registration-enabling clinical programs;
  • Established clinical and regulatory infrastructure in Europe;
  • Ability to support intensive immunogenicity sampling and rigorous safety oversight; and
  • Recruitment capacity and contingency planning designed to protect program timelines.

“Our objective has been to systematically remove the operational dependencies between GEO-MVA and initiation of the pivotal study,” Dodd said. “With each readiness milestone, the program becomes more tangible: the clinical pathway is defined, the vaccine has been manufactured, and we are now putting the clinical execution infrastructure in place. There is still work ahead, including regulatory and financing requirements, but the pieces necessary to execute the program are increasingly coming together.”

About GEO-MVA

GEO-MVA is GeoVax’s MVA-based vaccine candidate being developed for prevention of mpox and smallpox. GEO-MVA is a highly attenuated, replication-deficient poxvirus vaccine derived from the same original MVA lineage as currently licensed MVA vaccines. The planned GEO-MVA-301 pivotal program is designed to evaluate the immunogenicity and safety of GEO-MVA relative to an approved MVA comparator vaccine and, if successful, support regulatory submissions seeking marketing authorization.

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]

Release – GeoVax Initiates Global Health Outreach to WHO, Africa CDC and Other Agencies Regarding Ebola Vaccine Portfolio Amid Expanding Outbreak

Posted on by [email protected]
GeoVax, Inc.

Research News and Market Data on GOVX

Emerging Evidence of Potential Protection From Authorized Ebola Zaire Vaccine Against Bundibugyo Virus Provides Rationale for Evaluating GeoVax’s MVA-Based Ebola Vaccine Candidates

ATLANTA, GA – August 24, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancers, today announced that it has expanded outreach to global and regional public health organizations regarding the potential relevance of its Modified Vaccinia Ankara (MVA)-based hemorrhagic fever vaccine portfolio amid the expanding Ebola disease outbreak caused by Bundibugyo virus (BDBV) in various regions of Africa.

The outreach follows GeoVax’s recent announcement highlighting its willingness to contribute vaccine candidates, materials and scientific expertise to the global response. GeoVax is seeking to determine whether its existing hemorrhagic fever vaccine candidates and MVA platform capabilities may warrant evaluation or could support broader Ebola preparedness and response efforts.

Of particular interest is GeoVax’s Zaire Ebola vaccine candidate, GEO-EM01, which previously demonstrated 100% protection following a single intramuscular dose in a non-human primate lethal-challenge study. All vaccinated rhesus macaques survived lethal Zaire Ebola virus challenge, with no live virus detected in tissues from vaccinated animals. The research, conducted in collaboration with scientists at the National Institute of Allergy and Infectious Diseases’ Rocky Mountain Laboratories, was originally published in Scientific Reports.

Recent scientific evidence has increased interest in whether vaccines developed against Zaire ebolavirus may also provide some degree of cross-protection against Bundibugyo virus. WHO’s Technical Advisory Group on Candidate Vaccine Prioritization recently recommended that the licensed Ebola Zaire vaccine Ervebo® be prioritized for inclusion in a Phase 3 study during the current Bundibugyo outbreak, based on an evolving body of animal, laboratory and human immune-response data suggesting potential cross-protection. Importantly, the extent of such protection remains uncertain and must be established through controlled clinical evaluation.

“The evolving science raises an important question that we believe warrants evaluation,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Our Ebola Zaire vaccine demonstrated compelling protection in a stringent non-human primate challenge model, including 100% survival following a single dose. We do not know whether that protection extends to Bundibugyo virus. However, emerging evidence that a Zaire-directed Ebola vaccine may provide some degree of protection against BDBV provides a scientific rationale for asking that question. We are reaching out to the appropriate global health organizations to determine whether our vaccine candidate, materials and MVA platform expertise warrant further evaluation.”

Seeking Various Paths for Evaluation and Development

GeoVax’s outreach is focused on organizations involved in global health security, epidemic preparedness, vaccine evaluation and outbreak response. The Company is exploring potential opportunities that could include independent evaluation of existing vaccine materials, scientific collaboration, public-private partnerships, licensing arrangements or other externally supported development pathways.

GeoVax believes this approach could provide a mechanism for assessing and potentially advancing its hemorrhagic fever vaccine portfolio while preserving the Company’s operational and capital focus on GEO-MVA, its lead infectious disease program targeting mpox and smallpox.

“We believe these assets represent strategic optionality for GeoVax, but our intention is not to divert resources from GEO-MVA,” Dodd continued. “The appropriate path is to determine whether public health organizations, development partners or other third parties see sufficient scientific and strategic value to support further evaluation. If so, we are prepared to explore collaborative structures capable of advancing these assets responsibly.”

GEO-MVA on Schedule for Pivotal Phase 3 Immunobridging Study Initiation in Q4 2026

GeoVax’s primary infectious disease development priority remains GEO-MVA, its MVA-based vaccine candidate for the prevention of mpox and smallpox. The Company is advancing toward a pivotal Phase 3 immunobridging clinical program designed to compare immune responses generated by GEO-MVA with those generated by an established MVA vaccine.

As part of its GEO-MVA activities, GeoVax is developing relationships with healthcare, research and public health organizations in regions confronting significant infectious disease challenges. The Company believes these relationships, together with its broader MVA expertise, provide a foundation for exploring collaborative opportunities involving other high-consequence infectious diseases.

“Our priority remains execution of the GEO-MVA program,” Dodd concluded. “At the same time, the current Ebola outbreak demonstrates why maintaining a portfolio of technologies addressing high-consequence pathogens can have strategic value. Where an opportunity exists to leverage external expertise and resources to evaluate those assets without distracting from our lead program, we believe it is appropriate – and potentially important – to pursue it.”

About GeoVax’s Hemorrhagic Fever Vaccine Portfolio

GeoVax has developed MVA-based vaccine candidates targeting Zaire ebolavirus, Sudan ebolavirus and Marburg virus. The programs have undergone preclinical evaluation, including lethal-challenge studies in non-human primates, and have demonstrated encouraging protective efficacy.

GeoVax’s Zaire Ebola vaccine candidate, GEO-EM01, utilizes the Company’s MVA-VLP technology and previously demonstrated 100% survival in a small rhesus macaque lethal-challenge study following either a single-dose or two-dose vaccination regimen. The single-dose study represented the first reported demonstration that a replication-deficient MVA vector could provide complete protection against lethal Zaire Ebola virus challenge following a single vaccination in rhesus macaques.

GeoVax is evaluating opportunities for collaboration, licensing, public-private partnerships and other externally supported structures that could enable further evaluation and development of these assets while maintaining the Company’s primary operational and capital focus on GEO-MVA.

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]

Release – GeoVax Chairman and CEO David Dodd to Participate in 2026 Georgia Life Sciences Summit

Posted on by [email protected]
GeoVax

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] 

Release – GeoVax Highlights Gedeptin® Tumor-Priming Strategy as Immuno-Oncology Enters New Phase

Posted on by [email protected]
GeoVax

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] 

Release – GeoVax Highlights Newly Published Independent Research Supporting Broader Filovirus Vaccine Strategies and Strategic Value of Its MVA-Based Vaccine Portfolio

Posted on by [email protected]
GeoVax

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] 

GeoVax Labs (GOVX) – GeoVax Reports 2Q26 With Clinical Study Plans Moving Forward

Posted on by [email protected]


Wednesday, July 29, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

GeoVax Reported 2Q26 With Updates For GEO-MVA and Oncology Programs. GeoVax reported a 2Q26 net loss of $4.4 million or $(0.97) per share, lower than our expected loss of $5.8 million. R&D expenses were lower than we projected due to strategic changes, with priority given to preparations for the upcoming Phase 3 trial of GEO-MVA in MPox and the Phase 2 trial of Gedeptin in oncology. Cash on June 30, 2026 was approximately $3.1 million.

Strategic Changes Lowered The 2Q26 Loss. As discussed in our Research Note on May 27, GeoVax will focus on GEO-MVA in infectious diseases and Gedeptin in oncology. These programs have established regulatory pathways, patient needs, and market potential.


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Release – GeoVax Highlights Strategic Alignment of GEO-MVA with HHS/ASPR’s Five-Year Medical Countermeasure Preparedness Strategy

Posted on by [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] 

Release – GeoVax Highlights Strategic Implications of Recent Gedeptin(R) Findings for Checkpoint-Resistant Cancers

Posted on by [email protected]
GeoVax

Research News and Market Data on GOVX

Recent Publication and Growing Industry Focus on Immune-Priming Strategies Support Continued Evaluation of Gedeptin® as a Potential Complement to Checkpoint Inhibitor Therapy

ATLANTA, GA – June 17, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines for solid tumors and infectious diseases, today highlighted the broader oncology and strategic implications of recently published research supporting the potential of its Gedeptin® platform to enhance immune checkpoint inhibitor activity and address one of the most significant challenges in modern cancer treatment: improving responses in checkpoint-resistant tumors.

The update follows publication of the peer-reviewed article, “Broadening Activity of Checkpoint Blockade Agents by Intratumoral Nucleoside Cleavage,” in JCI Insight. The study reported findings supporting the potential for Gene-Directed Enzyme-Prodrug Therapy (GDEPT) to enhance checkpoint inhibitor responses, activate systemic anti-tumor immunity, and generate anti-tumor effects in both treated and distant untreated tumors in preclinical models of checkpoint-resistant triple-negative breast cancer.

While the publication focused on the underlying scientific findings, GeoVax views the results as further validation of broader trends shaping the future of cancer immunotherapy, including increasing industry emphasis on immune-priming approaches designed to improve checkpoint inhibitor responsiveness and overcome treatment resistance.

Addressing the Challenge of Checkpoint Resistance

Checkpoint inhibitors targeting pathways, such as PD-1 and PD-L1, have transformed treatment paradigms across multiple cancer types and now represent foundational therapies in modern oncology. Despite their success, many tumors remain poorly responsive to checkpoint blockade due to limited immune-cell infiltration, poor antigen presentation, and immunosuppressive tumor microenvironments.

These so-called “cold” tumors represent one of the most significant barriers to effective immunotherapy. Without sufficient immune recognition and engagement, even highly active therapies may struggle to generate durable clinical responses.

GeoVax recently explored this challenge in an Onco’Zine commentary authored by Chairman and Chief Executive Officer David Dodd entitled, “The Cold Tumor Barrier: Why Promising Oncology Therapies Fail In Vivo – and What It Will Take to Overcome It”. The article discussed the growing recognition that future advances in immuno-oncology may depend not only on developing new therapies, but also on improving the responsiveness of tumors to existing treatments through immune activation and tumor microenvironment modulation.

As a result, substantial research and development efforts across the oncology sector are increasingly focused on identifying therapies capable of converting immunologically cold tumors into more responsive tumors, potentially expanding the number of patients who may benefit from immunotherapy and improving outcomes with established checkpoint inhibitor regimens.

“One of the most significant challenges in oncology today is the cold tumor barrier,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “Checkpoint inhibitors can be highly effective when sufficient immune activity already exists within a tumor. However, many tumors remain largely invisible to the immune system. The next major opportunity may lie in therapies capable of activating immune recognition and making these tumors more responsive to existing immunotherapies.”

Positioning Gedeptin Within an Emerging Immunotherapy Paradigm

GeoVax sees potential for Gedeptin to play a differentiated role within this evolving treatment landscape. The recently published findings suggest that localized treatment may not only destroy targeted tumor cells, but also remodel the tumor microenvironment, promote immune activation, and enhance responsiveness to checkpoint inhibitors. These characteristics are increasingly viewed as important components of next-generation combination immunotherapy strategies.

The Company views Gedeptin’s combination of localized tumor destruction, strong bystander killing effects, tumor microenvironment remodeling, and immune activation as a potentially differentiated approach to addressing treatment resistance.

“Importantly, Gedeptin is not necessarily intended to directly compete with checkpoint inhibitors, but rather to complement them,” continued Mr. Dodd. “The medical proposition is to improve responses where checkpoint inhibitors alone have not achieved their full potential; also representing a significant commercial opportunity with multiple partnering avenues.”

Focus on Neoadjuvant Combination Strategies

GeoVax’s lead clinical development focus for Gedeptin is a planned neoadjuvant study in recurrent head and neck squamous cell carcinoma (HNSCC), evaluating intratumoral Gedeptin in combination with PD-1-based immunotherapy and standard of care, in patients with first recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) eligible for curative-intent surgery.

The Company considers recurrent head and neck cancer an attractive initial development setting because tumors are frequently accessible for direct injection, checkpoint inhibitors are already integrated into standard of care treatment paradigms, and substantial unmet need remains despite advances in immunotherapy.

GeoVax also views the neoadjuvant setting as particularly well suited for immune-priming approaches because the intact tumor can serve as a source of tumor antigens capable of stimulating broader anti-tumor immune responses prior to surgical resection.

“As checkpoint inhibitors continue moving earlier in the treatment paradigm, opportunities are emerging for therapies designed to improve immune responsiveness before surgery and potentially improve long-term outcomes,” said Mr. Dodd. “Gedeptin’s biologic profile appears well aligned with this evolving treatment strategy.”

Broader Platform Opportunities

Beyond head and neck cancer, GeoVax sees potential applicability for Gedeptin across multiple solid tumor settings where checkpoint inhibitors are established standard of care but response rates remain suboptimal.

“The oncology community is increasingly focused on improving response rates to existing immunotherapies and overcoming the cold tumor barrier,” added Mr. Dodd. “The emerging data support continued evaluation of Gedeptin as a differentiated immune-priming platform designed to complement existing immunotherapies and potentially broaden the impact of checkpoint blockade across multiple tumor settings.”

About Gedeptin®

Gedeptin® is GeoVax’s proprietary gene-directed enzyme prodrug therapy (GDEPT) platform under development for the treatment of solid tumors. The therapy utilizes a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP). Following administration of fludarabine, the PNP enzyme converts the prodrug into a potent localized cytotoxic compound within the tumor microenvironment.

GeoVax is advancing development plans evaluating Gedeptin in combination with checkpoint inhibitors, including pembrolizumab-based regimens, with the goal of improving anti-tumor immune responsiveness 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 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] 

Release – GeoVax CEO Welcomes FIFA World Cup 2026 While Addressing Biothreat Readiness

Posted on by [email protected]
GeoVax

Research News and Market Data on GOVX

Largest FIFA Tournament in History Expected to Draw 6.5 Million Attendees Across North America and More Than 1.2 Million International Visitors to U.S. Host Cities Amid Growing Concerns Regarding Mpox, Ebola, Hantavirus, Measles, and Other Emerging Infectious Disease Threats

ATLANTA, GA – June 1, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today welcomed the upcoming FIFA World Cup 2026 and highlighted the importance of public health readiness, healthcare capacity, and biodefense capabilities as North America prepares to host the largest sporting event in history.

According to a recent economic impact analysis conducted by Oxford Economics and Tourism Economics, FIFA World Cup 2026 is expected to attract approximately 6.5 million attendees across the United States, Canada, and Mexico, including more than 1.2 million international visitors traveling to U.S. host cities alone. For public health authorities, healthcare systems, emergency management agencies, and national security planners, the tournament represents a real-world test of disease surveillance, healthcare capacity, emergency response coordination, vaccine availability, and critical public health infrastructure at a scale rarely encountered outside of a global crisis.

The event arrives amid a period of increasing infectious disease activity marked by ongoing Clade I mpox transmission, the escalating Bundibugyo Ebola outbreak in Central Africa, renewed concern surrounding zoonotic pathogens such as hantavirus and avian influenza, and growing measles outbreaks in multiple regions. Together, these developments reinforce a broader reality: biological threats are becoming more global, more interconnected, and increasingly simultaneous.

“FIFA 2026 represents more than a sporting event. It is a large-scale operational challenge occurring in an era of persistent biological risk,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “When millions of people move across borders, transportation networks, and densely populated urban environments over a compressed period of time, health security becomes an operational necessity. The ability to detect, monitor, and respond rapidly to emerging infectious disease threats will be as important as the infrastructure supporting the tournament itself.”

Mass gatherings do not create outbreaks. However, they can amplify the operational consequences of existing vulnerabilities. Millions of visitors moving through airports, public transportation systems, hotels, entertainment venues, and urban centers create conditions that test disease surveillance systems, laboratory capacity, healthcare surge capabilities, public communication networks, and cross-jurisdictional coordination.

Recent outbreaks have reinforced the reality that governments can no longer focus on a single pathogen at a time. The continued spread of mpox beyond historically endemic regions, the emergence of more virulent viral strains, and the ongoing Bundibugyo Ebola outbreak, which currently lacks a broadly licensed vaccine specifically approved for widespread deployment, underscore the need for flexible response capabilities able to address multiple evolving threats simultaneously.

“The central challenge is no longer responding to a single outbreak,” continued Dodd. “Governments and health systems increasingly require the ability to manage multiple biological threats at once. Health security today means more than surveillance. It requires manufacturing capacity, supply-chain diversification, stockpile availability, operational coordination, and the ability to rapidly deploy effective countermeasures when and where they are needed.”

GeoVax believes several priorities warrant increased attention as FIFA 2026 approaches:

  • Expanding domestic vaccine manufacturing capacity
  • Diversifying critical medical countermeasure supply chains
  • Enhancing disease surveillance and rapid-response capabilities
  • Supporting adaptable vaccine platform technologies
  • Strengthening public-private health security partnerships
  • Improving stockpile management and deployment logistics

A New Era of Biological Risk

The World Cup does not create vulnerabilities. It has the potential to expose them.

Recent mpox outbreaks demonstrated how rapidly demand for vaccines and medical countermeasures can outpace available supply. The Bundibugyo Ebola outbreak has highlighted continuing gaps in available tools for emerging pathogen variants. At the same time, concerns regarding zoonotic spillover events, international mobility, and supply-chain concentration have reinforced the importance of scalable manufacturing capacity, diversified sourcing, flexible vaccine technologies, and geographically distributed biodefense infrastructure.

The ongoing mpox environment has also highlighted the strategic importance of poxvirus vaccine availability. Today, global supply of MVA-based poxvirus vaccines remains concentrated among a single non-U.S. manufacturer, creating potential constraints during periods of heightened demand. Expanding manufacturing capacity and strengthening supply diversity may play an important role in future health security efforts.

GeoVax’s development portfolio is anchored by GEO-MVA, an MVA-based poxvirus vaccine candidate being advanced for protection against mpox and smallpox and intended to support a more diversified global poxvirus vaccine supply. GeoVax is also advancing Gedeptin®, an immuno-oncology program designed to enhance anti-tumor immune responses in solid tumors. The Company’s broader technology portfolio includes preclinical vaccine candidates targeting hemorrhagic fever pathogens, including Ebola and Marburg viruses, which have demonstrated encouraging efficacy in animal studies and may provide future strategic optionality for biodefense and global health applications.

“As the world comes together to celebrate FIFA World Cup 2026, we extend our congratulations to the athletes who have dedicated years to reaching this global stage and to the organizers responsible for bringing this remarkable event to life,” concluded Dodd. “The success of gatherings like these depends not only on what happens on the field, but also on the public health systems, healthcare infrastructure, and operational planning that support them behind the scenes. By investing in manufacturing capacity, disease surveillance, and biodefense capabilities today, we can help ensure that the world’s attention remains focused where it belongs – on the athletes, the competition, and the spirit of international cooperation.”

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]