Tag: GOVX

Research News and Market Data on GOVX

Company Aligns Resources with Programs Demonstrating Strong Clinical, Regulatory, and Market Momentum

ATLANTA, GA — May 26, 2026 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines, today announced a strategic prioritization of its development portfolio to concentrate resources on its lead programs, GEO-MVA and Gedeptin^®, reflecting increasing clinical, regulatory, and market alignment across these programs. As part of this decision, the Company has elected to discontinue active development activities related to its GEO-CM04S1 COVID-19 vaccine candidate.  This decision was not related to any safety concerns with the vaccine but reflects the continued evolution and contraction of the global COVID-19 vaccine market, and GeoVax’s focus on programs with clearer regulatory pathways, stronger demand visibility, and more immediate commercialization potential. GeoVax emphasized that portfolio prioritization is a standard and essential practice within the biotechnology industry, enabling companies to align resources with the highest-value opportunities as market conditions and scientific landscapes evolve.

“GeoVax is at an important inflection point, and this decision reflects a deliberate and disciplined focus on the programs we believe can deliver the greatest near-term and long-term value,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “As GEO-MVA advances toward clinical validation and potential commercialization, and as Gedeptin gains relevance within emerging immuno-oncology treatment paradigms, we are aligning our resources to support focused execution against these high-potential opportunities.”

GEO-MVA: Expedited Pathway and Near-Term Commercial Opportunity

GEO-MVA, GeoVax’s Modified Vaccinia Ankara (MVA) vaccine candidate targeting mpox and smallpox, is advancing under an expedited regulatory pathway supported by European Medicines Agency (EMA) scientific advice. This approach enables potential approval based on a single pivotal immunobridging study demonstrating non-inferiority to an approved MVA vaccine – significantly accelerating development timelines and reducing clinical risk.

The program has clinical-grade material manufactured and released in preparation for the planned Phase 3 immunobridging study. Following successful completion, GEO-MVA is expected to advance toward regulatory submission and potential commercialization within a streamlined timeframe, including potential Emergency Use Licensing.

GeoVax has initiated outreach with global procurement and preparedness stakeholders – including government agencies, international organizations, and biodefense programs – supporting potential vaccine supply agreements aligned with national stockpiling and outbreak response needs. These activities position GEO-MVA to serve as a critical additional supplier of MVA-vaccine supporting supply-chain resilience and biodefense preparedness.

Gedeptin^®: Aligned with Emerging Immuno-Oncology Treatment Paradigm

Gedeptin^®, GeoVax’s gene-directed enzyme prodrug therapy (GDEPT) platform, is being advanced in alignment with a rapidly evolving oncology landscape, highlighted by the landmark KEYNOTE-689 Phase 3 trial demonstrating improved event-free survival with neoadjuvant checkpoint inhibitor therapy in resectable head and neck cancers.

GeoVax’s planned Phase 2 study (AdPNP-203) will evaluate Gedeptin in combination with pembrolizumab and fludarabine in a neoadjuvant setting, with the objective of enhancing tumor immune visibility and improving clinical outcomes.

Gedeptin’s tumor-targeting mechanism is designed to significantly damage or destroy treated lesions through the localized, in situ generation of a potent chemotherapeutic agent. In addition, Gedeptin appears to sensitize tumors to checkpoint inhibitors, likely through the exposure and release of neoantigens from treated lesions, thereby enhancing responses in both treated and untreated lesions. This mechanism may expand response rates and improve durability of outcomes in patients who derive limited benefit from checkpoint inhibition alone. These developments underscore the growing relevance of Gedeptin within this evolving treatment paradigm and support GeoVax’s decision to prioritize its advancement within the Company’s portfolio.

“This is a strategic step forward for GeoVax,” Dodd added. “By concentrating our efforts on GEO-MVA and maintaining our oncology innovation with Gedeptin, we believe we are positioning the Company for a more focused, execution-driven path toward late-stage development, commercialization and long-term value creation”.

About GeoVax

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

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Research News and Market Data on GOVX

ATLANTA, GA – May 18, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, today announced that it has entered into a securities purchase agreement with existing institutional investors for the purchase and sale of 2,027,027 shares of common stock (or common stock equivalents in lieu thereof) together with (i) Series A warrants to purchase up to 2,027,027 shares of common stock with an exercise price of $1.48 per share and a five-year term, and (ii) Series B warrants to purchase up to 2,027,027 shares of common stock with an exercise price of $1.48 per share and an 18-month term, for aggregate gross proceeds of approximately $3 million, before deducting placement agent fees and other offering expenses.

The closing of the offering is expected to occur on or about May 19, 2026, subject to the satisfaction of customary closing conditions. The Company expects to use the net proceeds from the offering for working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as the sole placement agent in connection with the offering.

The offer and sale of the foregoing securities is being made in reliance on an exemption from the registration requirement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, and applicable state securities laws, and the securities have not been and will not initially be registered under the Securities Act, or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to the terms of the securities purchase agreement entered into with the investor, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) covering the resale of the shares of common stock and shares of common stock underlying common warrants sold in the offering.

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

About GeoVax

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

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. Forward-looking statements include, among other things, statements regarding the proposed closing of the transaction, the expected gross proceeds and the intended use of proceeds. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]   

Research News and Market Data on GOVX

Near-Term Clinical Milestones and Combination Strategy Position Program for Next Stage of Value Creation

ATLANTA, GA – April 29, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today outlined near-term development milestones and strategic priorities for its oncology program, Gedeptin^®, as the Company advances toward Phase 2 clinical initiation and potential partnership opportunities.

With oncology treatment increasingly defined by combination regimens, the ability to integrate into established therapeutic backbones is becoming a key factor in clinical and commercial success. GeoVax believes the convergence of upcoming clinical milestones and increasing industry focus on combination approaches creates a timely opportunity to advance Gedeptin’s development and strategic positioning.

Advancing Toward Phase 2 Clinical Execution

GeoVax is advancing Gedeptin with a focus on integration into combination treatment regimens, particularly alongside immune checkpoint inhibitors (ICIs) and other established oncology backbones.  The Company believes this approach aligns with the evolving treatment landscape and may support broader applicability across multiple tumor types. GeoVax is preparing to initiate a Phase 2 clinical trial evaluating Gedeptin, in combination with an ICI, as a first-line neoadjuvant treatment in patients with resectable locally advanced head and neck cancer, with trial initiation targeted for 2027.

The study is designed to evaluate:

• Tumor response in the neoadjuvant setting
• Biomarker-driven immune activation
• Event-free survival outcomes

This trial is expected to represent a key step in establishing clinical validation for Gedeptin in combination immuno-oncology strategies.

Expanding Development Across Additional Solid Tumors

In parallel with its lead clinical program, GeoVax is planning to advance preclinical and translational work evaluating Gedeptin across additional solid tumor indications.  These efforts are intended to (a) identify tumor settings where combination approaches may provide the greatest clinical benefit, (b) support expansion beyond head and neck cancer and, (c) inform future clinical development strategies.

Positioned for Strategic Collaboration

GeoVax is actively pursuing opportunities to advance Gedeptin through clinical development partnerships, combination-focused collaborations and potential licensing or co-development arrangements.

“We are entering an important phase of development for Gedeptin, with a focus on clinical execution and advancing discussions around potential partnerships,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “As combination therapy becomes more common across oncology, we believe Gedeptin is well positioned to be integrated into these regimens and contribute to improved treatment outcomes.”

Supported by an Established Clinical and Scientific Foundation

GeoVax has established a clinical and scientific foundation to support Gedeptin’s advancement into its next stage of development, including:

• Completed Phase 1/2 clinical experience in advanced head and neck cancer
• Engagement of an Oncology Advisory Board with deep immuno-oncology expertise
• Expanded intellectual property supporting combination use with checkpoint inhibitors

This foundation is intended to support both continued clinical progression and engagement with potential partners.

About Gedeptin^®

Gedeptin^® is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally using a non-replicating viral vector encoding purine nucleoside phosphorylase (PNP). Following administration of a systemically delivered prodrug, the encoded enzyme converts the prodrug into a cytotoxic agent directly within the tumor microenvironment.

About GeoVax

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

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Research News and Market Data on GOVX

Positioned to Enhance Efficacy of Checkpoint Inhibitors and Next-Generation Oncology Modalities Across Solid Tumors

ATLANTA, GA – April 27, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today highlighted the strategic positioning of its oncology asset, Gedeptin® (Ad/PNP), in the context of accelerating industry investment in next-generation in vivo cancer therapies.

Recent high-profile transactions and investments across the biopharmaceutical sector underscore a growing focus on therapies designed to simplify delivery, improve scalability, and expanding therapeutic reach. As these approaches advance, a central challenge remains: many tumors are immunologically “cold,” limiting the effectiveness of even the most advanced therapeutic modalities. GeoVax believes Gedeptin is uniquely positioned to address this challenge.

“While the industry is investing heavily in next-generation cell and gene therapies, the ability to positively modify the local tumor environment is believed to be one of the critical determinants of clinical success,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Gedeptin is designed to directly destroy both proliferating and non-proliferating tumors, while also demonstrating high bystander activity due to the ability of the in situ generated cytotoxic agent ability to diffuse into neighboring tumor cells.”

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT), delivered intratumorally, designed to generate PNP, selectively destroy both proliferating and non-proliferating tumor cells within the treated tumor. In vivo preclinical experiments have shown PNP treatment to be additive or synergistic with checkpoint blockade–type agents. For example, studies in preclinical in vivo tumor models of metastasis, have demonstrated treatment of a single lesion can robustly sensitize tumors to checkpoint blockade inhibitors, presumably by destroying tumor tissue (including the tumor microenvironment), exposing neoantigens, and enhancing immune response and activity of immune check point inhibitors (ICIs) at distant PNP-untreated lesions This dual mechanism – localized cytotoxicity combined with enhancing the immune response and activity of immune check point inhibitors against both Gedeptin treated and untreated tumors – has the potential to offer an improved therapeutic approach to addressing solid tumor metastatic disease.

GeoVax has generated preclinical, clinical and translational data supporting Gedeptin’s ability to:

• Induce localized tumor cell death against both proliferating and non-proliferating tumors, while minimizing systemic toxicity
• Potentially improve response rates when combined with immune checkpoint inhibitors

Aligned with the Next Phase of Immuno-Oncology Innovation

As checkpoint inhibitors continue to move earlier in treatment paradigms, including neoadjuvant and first-line settings, the need for complementary approaches that enhance response rates is becoming increasingly evident.

GeoVax is advancing Gedeptin in combination with checkpoint inhibition in a planned Phase 2 clinical trial in first-line head and neck cancer therapy, with additional solid tumor indications under evaluation.

“Checkpoint inhibitors have transformed cancer care, but many patients still do not achieve durable responses,” said Kelly T. McKee, M.D., Chief Medical Officer of GeoVax. “We believe Gedeptin is well positioned as a combination-enabling platform designed to enhance therapeutic response across checkpoint inhibitors and other emerging oncology modalities.”

About Gedeptin®

Gedeptin® is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally using a non-replicating viral vector encoding purine nucleoside phosphorylase (PNP). Following administration of a systemically delivered prodrug, the encoded enzyme converts the prodrug into a cytotoxic agent directly within the tumor microenvironment. This localized approach is designed to selectively destroy tumor cells while promoting immune recognition and minimizing systemic toxicity. Gedeptin has received Orphan Drug Designation for oral and pharyngeal cancers.

The Company continues to evaluate strategic partnerships and collaborations to advance the clinical development and potential commercialization of Gedeptin-based combination therapies.

About GeoVax

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

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Research News and Market Data on GOVX

Pivotal Phase 3 Trial for GEO-MVA (Mpox/Smallpox Vaccine)

Scheduled to Initiate During the Second Half of This Year

ATLANTA, GA, April 15, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today announced its financial results and key operational accomplishments for the year ended December 31, 2025.

“During 2025, we made significant progress advancing GEO-MVA toward late-stage clinical development, supported by regulatory alignment with the European Medicines Agency (EMA) and key manufacturing milestones,” stated David Dodd, Chairman and Chief Executive Officer of GeoVax. “We believe GEO-MVA represents a critically important opportunity to eliminate the current global supply constraint in orthopoxvirus vaccines, while supporting broader public health preparedness and biosecurity objectives. As such, we look forward to initiating the planned Phase 3 immuno-bridging study in the second half of this year, which represents the next key step in advancing GEO-MVA to regulatory approval and access, providing a critically needed supply source of MVA-vaccine.”

Mr. Dodd concluded, “As we look ahead, our priority is executing key GEO-MVA clinical and regulatory milestones, strengthening strategic partnerships, while selectively advancing other programs, addressing critical medical needs worldwide, while maximizing long-term value to shareholders and stakeholders.”

Corporate and Operational Highlights

Priority Program – GEO-MVA

GeoVax’s primary near-term strategic development focus is the advancement of GEO-MVA, its Modified Vaccinia Ankara (MVA)-based vaccine candidate targeting mpox and smallpox. GEO-MVA is the Company’s most advanced program and its most direct path to potential regulatory approval and commercialization. GEO-MVA is being developed on an expedited regulatory pathway to address a documented global supply constraint in orthopoxvirus vaccines, while supporting both public health preparedness and biosecurity needs, including diversification of supply beyond a single foreign manufacture.

During 2025, the Company achieved several key milestones, advancing GEO-MVA toward late-stage development and commercial readiness: 

• Regulatory Alignment: GeoVax received formal Scientific Advice from the European Medicines Agency (EMA), supporting a streamlined and accelerated development pathway for GEO-MVA, including a single Phase 3 immuno-bridging study without the need for prior Phase 1 or Phase 2 trials.
• Phase 3 Readiness: The Company is preparing to initiate a pivotal Phase 3 clinical trial in the second half of 2026, representing the critical next step toward potential regulatory approval and product distribution.
• Manufacturing Progress: GeoVax completed cGMP manufacturing and fill-finish of clinical-grade GEO-MVA, establishing readiness for clinical supply and potential commercialization.

GeoVax believes GEO-MVA is uniquely positioned at the intersection of:

• Recurring global mpox outbreaks and evolving viral strains
• Depleted government stockpiles following recent outbreaks
• Policy-driven demand for diversified and domestic vaccine supply

Given these dynamics, GEO-MVA is expected to play a central role in global orthopoxvirus preparedness strategies. The Company is actively aligning GEO-MVA with public health preparedness and biosecurity procurement frameworks, including engagement with international regulatory and governmental stakeholders.

Additional Progress Across Clinical Pipeline

Beyond GEO-MVA, GeoVax continues to advance a diversified pipeline spanning infectious diseases and oncology:

• GEO-CM04S1 (COVID-19 Vaccine):
  • Advancing through multiple Phase 2 clinical trials targeting immunocompromised populations, including stem cell transplant and CLL patients.
  • Data readouts expected in 2026, including from a completed booster trial in healthy adults.
  • Interim DSMB findings in the CLL study indicated superior immune responses versus mRNA comparator, supporting continued development.
• Gedeptin^® (Oncology):
  • Completed Phase 1/2 clinical evaluation in advanced head and neck cancer.
  • Entered into an exclusive license agreement with Emory University to support combination use with immune checkpoint inhibitors.
  • Planning Phase 2 trial for first-line treatment in locally advanced head and neck squamous cell carcinoma (2027).

2025 Full Year Financial Results

Net Loss: Net loss for the year ended December 31, 2025, was $21.5 million, or $22.40 per share, as compared to $25.0 million, or $120.46 per share, for the year ended December 31, 2024.

Revenue: For the year ended December 31, 2025, the Company reported $2.5 million of government contract revenues associated with the BARDA/RRPV Project NextGen award, compared to $4.0 million during 2024. In April 2025, GeoVax received notification that BARDA determined to terminate the contract for convenience to the government.

R&D Expenses: Research and development expenses were $18.1 million for 2025, compared to $23.7 million in 2024, with the overall decrease primarily related to discontinued costs associated with termination of the BARDA/RRPV contract, as well as lower costs for the GEO-CM04S1 clinical trials and manufacturing costs associated with the GEO-CM04S1 and Gedeptin programs.

G&A Expenses: General and administrative expenses were $6.0 million for 2025, compared to $5.4 million in 2024, with the overall increase primarily due to higher personnel costs, investor relations consulting and other programmatic expenses, patent costs, and stock-based compensation expense.

Cash Position: GeoVax reported cash balances of $3.1 million on December 31, 2025, as compared to $5.5 on December 31, 2024.

Summarized financial information is attached. Further information is included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission.

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 biosecurity preparedness. In oncology, GeoVax is developing Gedeptin^®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Research News and Market Data on GOVX

Highlights Critical Need for Additional MVA Vaccine Supply, Ending the Current Monopoly, Increasing Access and Supply Worldwide

ATLANTA, GA, April 14, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today highlighted the urgent challenges caused by the supply-constrained, global orthopoxvirus vaccine market and outlined the strategic positioning of its GEO-MVA vaccine candidate to address the limited supply and increasing global demand.

A Procurement-Driven Market with Recurring Global Demand

The global market for vaccines targeting mpox and smallpox (orthopoxviruses) has evolved into a recurring, procurement-driven market supported by:

• National stockpile programs across the United States, Europe and allied countries
• Ongoing purchasing by global health organizations and regional agencies
• Outbreak-driven surge demand tied to periodic global transmission events

Recent mpox outbreaks across multiple continents, including the emergence of more virulent strains, have reinforced the need for sustained vaccine supply beyond emergency response cycles.

Single-Supplier Market Structure and Limited Surge Capacity

The current global supply of MVA vaccines, the preferred vaccine for orthopoxvirus infections due to their recognized safety for use in vulnerable populations, is concentrated with a single commercial supplier.

This market structure has contributed to:

• Limited surge capacity during outbreaks
• Repeated depletion of government stockpiles
• Increased focus on supply chain resilience and diversification

As a result, governments and public health agencies are increasingly prioritizing:

• Establishment of additional sources of MVA vaccine supply
• Expansion of domestic and allied manufacturing capacity
• Reduced dependence on single-source providers for critical countermeasures

An Established Market Measured in Hundreds of Millions Annually

Public disclosures and procurement activity indicate that the mpox/smallpox vaccine market:

• Has generated hundreds of millions of dollars in annual procurement in recent years
• Includes multiyear purchasing frameworks and forward-looking supply agreements
• Is supported by both baseline stockpiling demand and outbreak-driven purchasing cycles

GeoVax believes these dynamics support a durable and expanding global market, rather than a one-time, pandemic-driven market opportunity.

GEO-MVA Positioned as a Second-Source MVA Vaccine Candidate

GeoVax’s GEO-MVA vaccine candidate is being developed to address the current supply-demand imbalance. The Company believes GEO-MVA is positioned as a potential second-source MVA vaccine, with key attributes including:

• Leverages the established MVA platform, widely used for immunocompromised and high-risk populations
• A defined regulatory pathway, based on immuno-bridging, to an approved MVA vaccine
• Late-stage development readiness, with Phase 3 initiation planned during 2026

GeoVax believes GEO-MVA has the potential to support:

• National stockpile replenishment programs
• Global outbreak response efforts
• Long-term preparedness and biodefense strategies

Alignment with Public Health and Biodefense Priorities

The mpox/smallpox vaccine market is increasingly shaped by the intersection of:

• Public health preparedness, driven by recurring mpox outbreaks and evolving viral threats
• National security and biodefense priorities, including protection against biological threats

Recent U.S. and international policy initiatives have emphasized:

• Strengthening biosecurity infrastructure
• Expanding domestic manufacturing capabilities
• Ensuring reliable access to critical medical countermeasures

GeoVax believes GEO-MVA is positioned for both civilian and biodefense procurement channels.

Development Timeline Synchronized with Procurement Cycles

GeoVax believes its planned development timeline for GEO-MVA corresponds with:

• Anticipated stockpile replenishment cycles following recent depletion
• Continued global procurement activity driven by outbreak preparedness
• Increasing policy emphasis on supply diversification initiatives

David Dodd, Chairman and Chief Executive Officer of GeoVax, commented, “The mpox and smallpox vaccine market is not a future construct, it is an active, procurement-driven market with recurring demand and increasing strategic importance. It is also a market currently defined by supply concentration and limited surge capacity.”

Mr. Dodd added, “We believe that, if approved, GEO-MVA, which is expected to begin a pivotal Phase 3 trial this year, is positioned to enter this market as a second-source MVA vaccine at a time when governments and global health organizations are actively seeking to diversify supply and strengthen preparedness. Our focus is on executing the next phase of development and aligning GEO-MVA with procurement frameworks that support both long-term stockpiling and rapid response 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’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]