GeoVax Labs (GOVX) – 1Q25 Reported With Pipeline Strategy Updates


Friday, May 02, 2025

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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.

First Quarter Included Contract Revenues. GeoVax reported a 1Q25 loss of $5.4 million or $(0.45) per share, a smaller loss than we had expected. The quarter included $1.6 million in Contract Revenue from the BARDA contract in preparation for the Phase 2 trial. Since the contract was cancelled on April 11, 2025, the 2Q25 results will include some final contract work. Cash on March 31, 2025, was $7.4 million.

CM04S1 Continues Development With Focus On Immunocompromised Patients. The current focus of CM04S1 development is in immunocompromised patients, a population estimated at 40 million patients in the US alone. Data from the Phase 1 and Phase 2 clinical trials for CM04S1 was presented at the 25th World Vaccine Congress. The two Phase 2 trials in chronic lymphocytic leukemia and stem cell transplants continue to enroll patients, while the Phase 2 Healthy Adult Booster trial is expected to report data during 2Q25.


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

Research News and Market Data on GOVX

GEO-CM04S1 Demonstrates Durable T Cell and Antibody Responses in Healthy and Immunocompromised Populations

ATLANTA, GA, April 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today recapped the successful presentation of new clinical data on its multi-antigen SARS-CoV-2 vaccine candidate, GEO-CM04S1, delivered at the 25th Annual World Vaccine Congress in Washington, D.C.

The presentation, titled “Phase 2b Study Results That Evaluated and Compared GeoVax’s Multi-Antigen Vaccine Candidate (GEO-CM04S1) to an Approved Vaccine Against COVID-19,” was given by Don J. Diamond, Ph.D. on April 24, 2025. It highlighted results across several Phase 1 and 2 clinical trials, including studies involving healthy volunteers as well as immunocompromised patients such as stem cell transplant recipients and those with chronic lymphocytic leukemia (CLL).

GEO-CM04S1, based on the synthetic Modified Vaccinia Ankara (MVA) vector platform, uniquely expresses both the Spike (S) and Nucleocapsid (N) antigens of SARS-CoV-2—resulting in broad and durable immune responses even in populations that have historically responded poorly to mRNA vaccines.

Key Highlights from the Clinical Data Presented

Robust Immune Response in Healthy Adults

  • In a Phase 1 trial, 100% of participants (34/34) seroconverted (i.e., produced antibodies) for Spike IgG, and 94% (32/34) for Nucleocapsid IgG.
  • 98% (48/49) demonstrated a T cell response to either antigen following vaccination.
  • No serious safety concerns were reported across varying dose levels.

Comparable Immunogenicity at Lower Doses (Phase 2 Booster Trial)

  • Healthy volunteers who had previously received mRNA or protein-based COVID-19 vaccines were boosted with GEO-CM04S1 at two dose levels (10⁷ vs 10⁸ pfu).
  • Spike, RBD, and Nucleocapsid IgG antibody responses, as well as neutralization titers against multiple COVID-19 variants (including XBB.1.5), increased significantly at both dose levels with no meaningful differences between them.
  • T cell responses increased significantly post-vaccination, regardless of baseline immunity.

Superior Performance in Immunocompromised Populations

  • In stem cell transplant recipients, GEO-CM04S1 induced ELISA antibody titers and T cell responses that exceeded those observed in healthy volunteers.
  • In a randomized Phase 2 trial comparing GEO-CM04S1 to the Pfizer-BioNTech (Comirnaty®) vaccine in patients with Chronic Lymphocytic Leukemia, GEO-CM04S1 demonstrated a significantly higher T cell response rate.
    • At Day 56 of the study: 6 of 15 patients in the GEO-CM04S1 arm achieved ≥3-fold increases in Spike or Nucleocapsid-specific T cells versus 2 of 14 in the Comirnaty arm.
    • The Data and Safety Monitoring Board (DSMB) recommended halting enrollment in the Pfizer arm due to underperformance, while continuing enrollment of the GEO-CM04S1 arm.

“We were pleased to share these promising results with global leaders in vaccinology,” said Don J. Diamond, Ph.D. “The data underscore the value of our dual-antigen approach, particularly for patients underserved by existing single-antigen vaccines. GEO-CM04S1 not only drives strong antibody and T cell immunity in healthy adults, but also in the immunocompromised—a population historically underserved by single-antigen mRNA vaccines.”

David A. Dodd, Chairman, President, and CEO of GeoVax, added: “The clinical performance of GEO-CM04S1 across diverse and high-risk populations supports our mission to deliver broad and lasting protection through next-generation vaccines. Our data continues to demonstrate strong, durable immune responses in both healthy and immunocompromised populations—a critical feature of our vaccine for public health preparedness. As we continue to advance this program, these results reinforce our confidence in the MVA platform as a foundation for addressing future public health threats.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation COVID-19 vaccine based on the Modified Vaccinia Ankara (MVA) vector originally developed at City of Hope. Its multi-antigen design expresses both Spike and Nucleocapsid proteins of SARS-CoV-2, promoting broad, cross-reactive immunity. The vaccine is being evaluated in three ongoing Phase 2 clinical trials.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

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

Research News and Market Data on GOVX

GeoVax to Host Conference Call at 4:30 PM ET

Atlanta, GA, April 23, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report first quarter 2025 financial results on Thursday, May 1, 2025, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

Conference Call Details

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

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

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

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  • Last updated: 22 April 2025
  • Created: 22 April 2025
  • Hits: 49

Recognized Biologics Executive to Oversee Critical Expansion of U.S.-Based Development Capabilities

ATLANTA, GA, April 22, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today announced the appointment of Senthil Ranganathan, Ph.D. as Vice President, Technical Development and CMC Operations. Dr. Ranganathan brings over 20 years of experience in biologics development to commercialization across vaccines, cell and gene therapies, monoclonal antibodies, and viral vector products.

This appointment comes at a pivotal time for GeoVax as it advances a comprehensive portfolio of infectious disease vaccines and cancer therapies, positioning the Company to address significant unmet medical needs, contributing to biodefense readiness, and improving vaccine and therapeutic equity through innovation and onshoring.

David Dodd, Chairman & CEO of GeoVax, stated: “We are delighted to welcome Senthil to GeoVax. His track record and expertise in a breadth of biologics development and preparation for registration and subsequent commercialization will support and enhance our progress as we proceed towards the authorization and subsequent commercialization stages for our exciting development portfolio.”

Dr. Ranganathan has held senior leadership roles across industry-leading biopharmaceutical companies, most recently serving as Head of Process Development CMC for the Boston site of National Resilience. He previously led global CMC and manufacturing operations at Athersys, Zymeworks, and Alder Biopharmaceuticals (acquired by Lundbeck Biopharmaceuticals). His career has spanned the development and validation of cell and gene therapies, vaccines, bispecific antibodies, and other biologics—from pre-IND through licensure and commercialization.

He holds a Ph.D. in Biochemistry from Loyola University Chicago and has authored numerous regulatory submissions and publications in support of breakthrough vaccines, biologics, and therapies.

“I am honored to join GeoVax during such a critical stage of the Company’s growth and development,” said Dr. Ranganathan. “I look forward to working with the outstanding GeoVax team as we develop and execute the roadmap that will bring the GeoVax portfolio to benefit patients and communities worldwide.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

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

Research News and Market Data on GOVX

Company Reaffirms Commitment to Innovation in COVID-19, Oncology, and Biosecurity Amid Strategic Program Developments

ATLANTA, GA, April 16, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today addressed the termination of its Project NextGen (PNG) award by the Biomedical Advanced Research and Development Authority (BARDA), effective April 11, 2025. The Company also provided a comprehensive business update across its core programs, including the next-generation COVID-19 vaccine (GEO-CM04S1), cancer immunotherapy (Gedeptin®), Mpox/smallpox vaccine (GEO-MVA), and advanced MVA manufacturing process.

GeoVax expressed disappointment in the HHS/BARDA action but remains committed to the critical medical need addressed by GEO-CM04S1, particularly among the more than 40 million immunocompromised Americans—and over 400 million people globally—who remain inadequately protected by the current authorized COVID-19 vaccines.  Thus far, clinical data in support of GEO-CM04S1 demonstrate encouraging support of the potential of GEO-CM04S1 for providing (a) more robust immune response, (b) increased durability and (c) protective immunity for those patients with depleted immune systems inadequately responding to the current authorized COVID-19 vaccines.

The Company also noted recent public statements by HHS leadership acknowledging the potential enhanced value of multi-antigen vaccines addressing respiratory viruses.  Of special note is that GEO-CM04S1 was the only multi-antigen/polyvalent COVID-19 vaccine candidate selected under the PNG initiative.

“While the recent HHS/BARDA Stop Work Order action was disappointing and surprising, our commitment to protecting vulnerable populations remains unchanged, and our clinical momentum is strong in support of our ongoing Phase 2 GEO-CM04S1 programs,” said David Dodd, Chairman and CEO of GeoVax.

Continued Progress Across a Catalyst-Rich Pipeline

GEO-CM04S1: Advancing to Meet Unmet COVID-19 Needs

GEO-CM04S1 continues to demonstrate potential as both a primary and booster vaccine, especially in immunocompromised patients. Key milestones anticipated during 2025 include:

  • Healthy Adult Booster Trial – Enrollment is complete; data readout expected in H1 2025.
  • CLL Patient Study (Immunocompromised patient study) – Ongoing enrollment; interim results resulted in continuation of the GEO-CM04S1 arm, whereas the Data Safety Review Board recommended early termination of the mRNA arm, which was subsequently implemented.
  • Stem Cell Transplant/CAR-T Trial (Immunocompromised patient study) – Enrollment and evaluation continue among hematological patients receiving stem cell transplantation or CAR-T therapy, comparing GEO-CM04S1 to mRNA COVID-19 vaccines.

GEO-CM04S1 is a multi-antigen COVID-19 vaccine, utilizing a synthetic-MVA platform, expressing both S and N antigens, offering the potential for broader, more durable protection than current mRNA vaccines.

Gedeptin®: Advancing into Phase 2 in Solid Tumors

GeoVax’s oncology program, utilizing the Gedeptin® technology, is planned to progress to a Phase 2 trial in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer. Gedeptin has received Orphan Drug designation for use among advanced head & neck cancer patients.  The Gedeptin technology provides potential for expansion into other solid tumors including triple-negative breast cancer, melanoma, and soft tissue sarcoma.

GEO-MVA: Addressing Biosecurity and Global Vaccine Equity

GeoVax anticipates initiating clinical trials in 2025 for GEO-MVA, its Mpox/smallpox vaccine candidate. The Company has successfully produced cGMP clinical product and is focused on completing the vaccine vialing in support of initiating clinical evaluation during H2 2025.  GEO-MVA positions GeoVax to offer a U.S.-developed alternative to foreign-sourced vaccines amid rising global biosecurity threats and constrained supply.

Advanced Manufacturing: Scaling MVA for Global Reach

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

Outlook for 2025

Despite the PNG award termination, GeoVax anticipates a milestone-rich 2025 across its portfolio. The Company will continue to engage with government and industry partners, pursue clinical trial completions, and drive innovation through expanded AI integration to optimize development, trial operations, and manufacturing efficiency.

“Our scientific foundation is strong and our strategy is clear,” added Dodd. “GeoVax remains committed to delivering transformative solutions for unmet medical needs in infectious disease and cancer. We’re advancing with purpose and fully prepared to deliver on the promise of our development program.”

For further details on GeoVax’s programs and progress, visit www.geovax.com.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

GeoVax Labs (GOVX) – Stop Work Order Received For Project NextGen Trial – No Impact On Other Programs


Tuesday, April 15, 2025

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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 Has Received A Stop Work Order For The Phase 2b Trial. GeoVax has received a Stop Work order for its BARDA-sponsored Phase 2b trial testing of CM04S1 for COVID-19. We have known about other Project NextGen-funded COVID-19 trials that were halted, but hoped the CM04S1 program would continue.

Background On The Phase 2 Trial. In June 2024, BARDA (an office within HHS) selected CM04S1 for a Phase 2b trial to test efficacy, immunogenicity, and safety for protection against COVID-19 as part of Project NexGen. We had expected GeoVax to receive about $25 million for its work on trial design and supplies to be received over several years. During FY2024, GeoVax received payments of $4.0 million.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – GeoVax Receives USPTO Notice of Allowance for Marburg Hemorrhagic Fever Vaccine Patent

Research News and Market Data on GOVX

 

  • Last updated: 09 April 2025
  • Created: 09 April 2025
  • Hits: 71

Continues to Strengthen its Pandemic Preparedness and Biodefense Vaccine Portfolio

ATLANTA, GA, April 9, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Patent Application No. 18/394,555 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).” The allowed claims generally cover prevention of Marburg virus infection utilizing GeoVax’s proprietary MVA-based Marburg vaccine.

Previous presentations of data from nonhuman primate studies demonstrated that immunization with GeoVax’s vaccine candidate, GEO-MM01, conferred 80% survival in cynomolgus macaques following a lethal dose of Marburg virus. Vaccination protected from viremia, weight loss and death following challenge with a lethal Marburg virus dose. Evaluation of immune responses following vaccination demonstrated the presence of both neutralizing antibodies and functional T cells, indicating a breadth of responses that combine for optimal protection. GeoVax is currently evaluating study designs to assess the potential for administering different dose levels of the vaccine and different routes of vaccine delivery to optimize utility and efficacy.

David Dodd, GeoVax President and CEO, commented, “While our focus and development priorities continue to be our next-generation COVID-19 vaccine, our Mpox/smallpox vaccine and cancer immunotherapy programs, developing vaccines against lethal hemorrhagic fever viruses represents our commitment to addressing highly fatal endemic threats throughout the world. Such viruses have mortality rates between 50%-90% depending on the specific virus strain. Our team is committed to supporting the successful advancement of such a vaccine, as we recognize the critically important medical and biodefense need, reflected by the inclusion of Marburg virus in the FDA Priority Review Voucher program. Within the critically needed area of hemorrhagic fever viruses, GeoVax has successfully developed vaccine candidates addressing Ebola Zaire, Ebola Sudan and Marburg, all having demonstrated impressive results when evaluated in non-human primates. The USPTO’s recognition of our Marburg vaccine technology further validates our approach and underscores the growing value of our wholly owned, co-owned, and in-licensed intellectual property estate, now standing at over 135 granted or pending patent applications spread over 23 patent families.”

Dodd continued, “Our focus extends beyond individual product candidates—we are building a broad, durable defense platform against hemorrhagic fever viruses. We believe this strategy, supported by compelling preclinical data and prioritized by global health authorities, positions GeoVax to play a central role in pandemic preparedness and biodefense.”

About Marburg Virus

Marburg virus (MARV) is a hemorrhagic fever virus of the Filoviridae family, which also includes Ebola virus, and causes severe human disease with up to a 90% fatality rate. The Marburg virus is transmitted to people from fruit bats, and human-to-human transmission occurs through direct contact with bodily fluids, or contaminated surfaces and materials. MARV is rated by the World Health Organization (WHO) as a Risk Group 4 Pathogen. In the United States, the NIH/National Institute of Allergy and Infectious Diseases ranks it as a Category A Priority Pathogen and the Centers for Disease Control and Prevention lists it as a Category A Bioterrorism Agent. MARV typically appears in sporadic outbreaks throughout Africa and the virus continues to pose potential public health and biodefense threats. There are currently no licensed vaccines or therapeutics against the diseases caused by MARV.

About the GeoVax MVA Platform

GeoVax’s vaccine platform utilizes modified vaccinia Ankara (MVA), a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into virus-like particles (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated can mimic the virus production that occurs in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:                           

info@geovax.com                           

678-384-7220

Investor Relations Contact:           

geovax@precisionaq.com 

212-698-8696

GeoVax Labs (GOVX) – 4Q24 Reported With Updates On Upcoming Clinical Trials


Friday, March 28, 2025

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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.

4Q24 Meets Expectations As Pipeline Advances. GeoVax reported 4Q24 loss of $8.3 million or $(0.88) per share and a loss of $25.0 million or $(4.82) per share for FY2024. The company updated its three clinical programs with CM04S1, the Gedeptin Phase 2, and the MVA program, which continue to make progress as expected. On December 31, 2024, cash on hand was $5.5 million, excluding the proceeds of a $4.5 million offering completed in March 2025.

Clinical Supplies Were Made for the CM04S1 Phase 2b BARDA Trial. Geovax has manufactured clinical supplies for the Phase 2b trial, testing CM04S1 as a booster for healthy adults who have received an mRNA vaccine against COVID-19. This trial is sponsored by a BARDA grant, with estimated revenues of $25 to $45 million for the company, plus about $350 million allocated for direct clinical trial expenses. The trial is now expected to begin late in 2025 to early 2026.


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Release – GeoVax Labs Announces $4.5 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Research News and Market Data on GOVX

ATLANTA, GA, March 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into a securities purchase agreement with a single healthcare-focused institutional investor for the purchase and sale of 3,435,115 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 3,435,115 shares of common stock in a registered direct offering (the “Offering”) at a combined purchase price of $1.31 per share and accompanying warrant, priced at-the-market under Nasdaq rules. The warrants will have an exercise price of $1.31 per share, will be exercisable upon shareholder approval and will expire 5 years from shareholder approval.

The closing of the Offering is expected to occur on or about March 25, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $4.5 million, before deducting placement agent fees and other estimated offering expenses. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as sole placement agent for the Offering.

The Offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-277585) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). A prospectus supplement describing the terms of the proposed Offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com.

In connection with the offering, the Company also agreed to amend existing warrants to purchase up to 2,675,610 shares of the Company’s common stock, with an exercise price of $5.00 per share, that were previously issued to the investor participating in this offering. Effective upon closing of this Offering, such existing warrants will be amended to reduce the exercise price to $1.31 per share and the term of such existing warrants will be amended to 5 years from the closing date of 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 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 developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

sr@roberts-communications.com

202-779-0929

Release – GeoVax to Report Fourth Quarter and Full Year 2024 Financial Results and Provide Corporate Update on March 27, 2025

Research News and Market Data on GOVX

GeoVax to Host Conference Call at 4:30 PM ET

Atlanta, GA, March 17, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report 2024 financial results on Thursday, March 27, 2025, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

Conference Call Details

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

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin(R) combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

sr@roberts-communications.com

202-779-0929

Release -GeoVax Establishing Strategic Presence in Europe with Initial Footprint in the UK

Research News and Market Data on GOVX

Hub to Advance Global Vaccine and Immuno-Oncology Development

ATLANTA, GA, March 12, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in the development of immunotherapies and vaccines, today announced its initial steps toward establishing a strategic presence in Europe, with the UK as its initial footprint. This move aligns with the Company’s commitment to advancing its vaccine and immunotherapy pipeline through global collaborations.

Efforts are underway to identify a UK location best suited to align with GeoVax’s development and corporate strategy. The Company already has several established connections in the UK and broader European region, including:

  • Scientific Expertise: Professor Teresa Lambe, a principal investigator at the Oxford Vaccine Group, recently joined GeoVax’s Scientific Advisory Board. Professor Lambe played a pivotal role in the development of the Oxford/AstraZeneca COVID-19 vaccine and has extensive experience in vaccine design and evaluation.
  • Manufacturing Partnerships: GeoVax maintains an existing contract development and manufacturing organization (CDMO) relationship with Oxford Biomedica PLC (Oxford, UK), as well as additional collaborations with Oxford Biomedica (France), with facilities in Strasbourg and Lyon.
  • Technology Licensing: The Company has a broad licensing agreement with ProBioGen AG (Berlin, Germany) to utilize their AGE1 continuous avian cell line for the manufacture of MVA vaccines.
  • European Collaborations: GeoVax currently collaborates with multiple European-based service providers and UK academic partners, reinforcing the strategic rationale for establishing a presence within the region.

To support this initiative, GeoVax is working closely with Professor Teresa Lambe and clinical investigators and scientists in Oxford and other academic centers across the UK to develop preclinical, translational, and clinical projects supporting its pipeline. Additionally, Dr. Deborah Spencer, a highly regarded expert in industry-academic partnerships and public health development, has recently been retained to facilitate and coordinate initiatives in the UK and Europe.

Establishing a strategic presence in Europe will support GeoVax’s infectious disease vaccine development efforts and play a key role in advancing Gedeptin®, the Company’s lead immuno-oncology candidate. Currently in clinical development for the treatment of advanced head and neck cancers, Gedeptin is anticipated to be further developed for use with immune checkpoint inhibitors as a potential treatment for various other solid tumors. GeoVax holds worldwide rights to Gedeptin for all indications.

“Expanding our presence into Europe represents a critical milestone for GeoVax as we continue to develop innovative solutions for infectious diseases and oncology, especially in building upon our initial UK footprint,” said David Dodd, President and CEO of GeoVax. “The globally recognized expertise of our key European collaborators and partners will significantly enhance our research and development capabilities. This expansion underscores our commitment to global collaboration and innovation in both vaccine and immuno-oncology development. As we accelerate the development of our infectious disease vaccine candidates and Gedeptin, we look forward to providing continued updates.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:                               

info@geovax.com                                         

678-384-7220                                                            

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

sr@roberts-communications.com

202-779-0929

Release – GeoVax Highlights the Critical Role of MVA-Based Vaccines in U.S. Biodefense Strategy

Research News and Market Data on GOVX

 

GeoVax’s GEO-MVA: Strengthening U.S. Biodefense

ATLANTA, GA – March 3, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in developing vaccines and immunotherapies for infectious diseases and cancer, underscores the strategic importance of its Modified Vaccinia Ankara (MVA) vaccine platform in helping to bolster U.S. biodefense capabilities. Efforts in MVA vaccine design and manufacturing improvements align with key recommendations from the recent “Bolstering U.S. Biodefense: Recommendations For The New Administration” report, published by the Janne E. Nolan Center on Strategic Weapons at the Council on Strategic Risks, a respected think tank specializing in national security and biodefense policy. The report emphasizes the need for robust, diversified medical countermeasures to protect national and global security.

Addressing Biodefense Gaps with MVA-Based Solutions

The “Bolstering U.S. Biodefense” report highlights the urgency of strengthening U.S. preparedness against biological threats, including deliberate attacks, emerging infectious diseases, and supply chain vulnerabilities. GeoVax’s efforts towards the development of MVA-based vaccines, including GEO-MVA for vaccination against Mpox and smallpox, and efforts to transition to a next-generation manufacturing platform utilizing a continuous avian cell line, directly align with these national security objectives:

  • Vaccine Supply Chain Resilience: Current reliance on a single non-U.S. manufacturer for critical vaccines, such as MVA, poses a national security risk. GeoVax’s efforts to transition to a next generation manufacturing platform should allow for the use of existing domestic manufacturing facilities, leading to a reduced dependence on foreign suppliers and enhancing supply chain security.
  • Advanced Biomanufacturing for Scalability: The biodefense report calls for investment in next-generation biomanufacturing. GeoVax is developing a continuous cell line-based MVA manufacturing platform that it expects will result in rapid, high-volume vaccine production, which is currently not feasible utilizing existing MVA directed manufacturing platforms
  • Diverse Medical Countermeasures for Threat Readiness: The Department of Defense’s Biodefense Posture Review and National Biodefense Strategy emphasize the need for multiple vaccine approaches. GeoVax’s MVA platform complements mRNA and protein-based vaccines, ensuring a broader and more resilient national preparedness framework.
  • Strategic National Stockpile Shortfalls: The 2022 Mpox epidemic revealed significant vaccine shortages in the National Strategic Stockpile, leaving public health officials unable to meet urgent demand. The reliance on a single foreign supplier for any vaccine can further exacerbate these challenges, reinforcing the need for a diversified, U.S.-based vaccine supply.

Relevance to the New HHS Administration

The transition of leadership at the U.S. Department of Health and Human Services (HHS) presents a pivotal moment for vaccine policy and national preparedness. The Administration has emphasized transparency, safety, and domestic vaccine manufacturing, aligning closely with GeoVax’s mission.

  • Alignment with National Health Security Goals: GeoVax’s focus on U.S.-based vaccine production supports HHS’s priority of reducing dependency on foreign pharmaceutical supply chains, ensuring America’s self-sufficiency in pandemic preparedness.
  • Advancing a Diversified Vaccine Portfolio: With a growing consensus that a single vaccine platform is unable to address the breadth of infectious disease concerns, there is a clear recognition of the benefits of having multiple alternative vaccine platforms available. GeoVax’s MVA-based approach provides a proven, durable, and safe alternative, reinforcing a well-rounded immunization strategy.
  • Public Trust and Transparency: Given the call for increased scrutiny of vaccine development, GeoVax is committed to transparency, publishing full clinical trial results and working collaboratively with HHS to foster public confidence.

Policy Action to Strengthen U.S. Biodefense

GeoVax urges policymakers to act swiftly in supporting domestic vaccine production and biodefense innovation. Key recommendations include:

  1. Expanding Federal Investment in MVA-Based Vaccines: Increased funding from BARDA, the Department of Defense, and the NIH to accelerate the development, next-generation manufacturing scale up and deployment of GEO-MVA.
  2. Accelerating Regulatory Approvals: Streamlined pathways for emergency use authorization and priority review of MVA-based vaccines to strengthen national preparedness.
  3. Public-Private Partnerships: Enhanced collaboration between government agencies, biotechnology firms, and global health organizations to integrate MVA-based solutions into pandemic and biodefense planning.

A Call for Action

“The ‘Bolstering U.S. Biodefense’ report clearly articulates the vulnerabilities in our national health security framework. GeoVax is committed to helping address these gaps with our MVA-based vaccines and next-generation manufacturing capabilities,” said David Dodd, Chairman & CEO of GeoVax. “With a new HHS administration, there is a timely opportunity to strengthen domestic vaccine infrastructure and ensure greater national resilience against emerging threats.”

GeoVax remains dedicated to advancing innovative, scalable, and accessible vaccine solutions to safeguard public health and national security.

References:
Council on Strategic Risks. (2025). Bolstering U.S. Biodefense: Strengthening the Nation’s Response to Biological Threats. Janne E. Nolan Center on Strategic Weapons. Retrieved from https://www.councilonstrategicrisks.org.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:   

geovax@precisionaq.com      

212-698-8696                          

Media Contact:

sr@roberts-communications.com

202-779-0929

Release – GeoVax Highlights the Role of MVA-Based Vaccines in Advancing Public Health Preparedness

Research News and Market Data on GOVX

 

  • Last updated: 24 February 2025
  • Created: 24 February 2025
  • Hits: 46

Recent Studies Support Diversified Vaccine Strategies, Aligning with GeoVax’s MVA-Based GEO-CM04S1 for Enhanced Protection, Particularly for Immunocompromised Populations

ATLANTA, GA, February 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in immunotherapies and vaccines, today reaffirms the critical role that mRNA vaccines have played in combating the COVID-19 pandemic and highlights the growing recognition of the need for complementary vaccine platforms, particularly for immunocompromised patients and those requiring broader, more durable immunity.

The rapid development and deployment of mRNA vaccines were pivotal in mitigating the initial impact of the pandemic, offering a timely and effective response. However, the scientific literature continues to underscore the importance of a diversified vaccine strategy directed towards enhanced durability and expanded protection against variants for populations that may not mount a sufficiently strong immune response to a single vaccine platform. GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine candidates, such as GEO-CM04S1 (COVID-19), may complement other existing vaccine platforms by addressing specific challenges.

Building a More Resilient Vaccine Landscape

Recent scholarly analyses, including research from leading experts(1) and a strategic review by the Biomedical Advanced Research and Development Authority (BARDA)(2), stress the importance of broadening vaccine portfolios beyond mRNA. These publications highlight areas where alternative vaccine platforms, such as viral-vector and live-attenuated vaccines, may provide advantages in durability, cellular immunity, and accessibility.

GeoVax’s MVA-based vaccines may offer an alternative approach, by utilizing a well-established vaccine vector, particularly in high-risk populations. Unlike current mRNA COVID-19 vaccines, GEO-CM04S1 expresses both the Spike (S) and Nucleocapsid (N) antigens, to elicit a broader immune response. This enhanced immunogenicity may be especially valuable for immunocompromised individuals, including transplant recipients and cancer patients, who often exhibit suboptimal responses to mRNA vaccines.

GeoVax’s MVA-based COVID-19 vaccine can serve as an important addition to the global immunization strategy by offering:

  • Enhanced Immune Response: The inclusion of both Spike and Nucleocapsid antigens in GEO-CM04S1 is intended to elicit a more comprehensive immune response, potentially reducing the need for frequent boosters.
  • Durability and Broader Variant Protection: Studies suggest measures of T-cell responses induced by GEO-CM04S1 elicit protection against emerging variants, minimizing the need for frequent reformulation.
  • Better Suitability for Immunocompromised Populations: Clinical trials demonstrate that GEO-CM04S1 elicits robust T-cell responses in patients unable to generate adequate antibody responses to conventional (spike-only) COVID-19 vaccines. This is critical for individuals with immune systems compromised by disease (eg cancers, genetic defects) or immunosuppressive therapies.
  • Scalability and Global Accessibility: GeoVax is further addressing vaccine availability with plans to transition manufacturing to a Next-Generation MVA manufacturing platform, with the potential for improved production efficiency and reduced costs, facilitating global distribution.

A Proven Technology with a Strong Safety Record

MVA was originally developed as a safer smallpox vaccine. MVA-based vaccines have been safely administered for decades.  MVA’s extensive track record aligns with the U.S. Department of Health and Human Services’ (HHS) emphasis on vaccine safety, durability, and transparency. The well-documented safety and efficacy of MVA-based vaccines positions them as an important complement to existing mRNA-based approaches.

Government and Industry Support for Diversified Vaccine Strategies

Under BARDA’s $5 billion Project NextGen initiative, GeoVax was awarded a contract to conduct a 10,000-participant Phase 2b clinical trial evaluating an Omicron-updated version of GEO-CM04S1 in a comparison format against an approved mRNA COVID-19 vaccine. This study aims to validate the value of multi-antigen MVA-based COVID-19 vaccines in long-term pandemic preparedness and protection against future health threats.

Positioning for the Future of Vaccine Innovation

“The success of mRNA vaccines in responding to COVID-19 has been remarkable, but the evolving nature of infectious diseases calls for a diversified, complementary approach to immunization,” said David Dodd, Chairman & CEO of GeoVax. “Our MVA-based vaccines offer enhanced protection for those who need it most, including immunocompromised patients and populations requiring longer-lasting immunity. We are committed to advancing vaccine innovation in collaboration with public and private stakeholders.”

As the industry moves towards a more integrated and diversified vaccine ecosystem, GeoVax’s MVA-based vaccines should provide a scalable, durable, and globally accessible solution that enhances the existing landscape, ensuring broader protection for all populations.

References:

  1. Plotkin, S. A., Robinson, J. M., Fitchett, J. R. A., & Gershburg, E. (2024). Vaccine development should be polytheistic, not monotheistic. Clinical Infectious Diseases, 79(6), 1518–1520. https://doi.org/10.1093/cid/ciae460
  2. Parish, L. A., Rele, S., Hofmeyer, K. A., Luck, B. B., & Wolfe, D. N. (2025). Strategic and technical considerations in manufacturing viral vector vaccines for the Biomedical Advanced Research and Development Authority threats. Vaccines, 13(73). https://doi.org/10.3390/vaccines13010073

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:                                                                             

info@geovax.com                                                                               

678-384-7220                                                                                                    

Investor Relations Contact:

austin.murtagh@precisionaq.com

212-698-8696

Media Contact:

sr@roberts-communications.com

202-779-0929