Latest news with #GeoVax
Associated Press
29-07-2025
- Business
- Associated Press
GeoVax Reports Second Quarter 2025 Financial Results and Provides Business Update
GEO-MVA received favorable European regulatory guidance supporting streamlined development pathway GEO-CM04S1 demonstrates superior robust immune responses in CLL patients; data presented at EHA 2025 Gedeptin(R) highlighted strong safety and efficacy for the treatment of solid tumors; data presented at AACR 2025 Company to host conference call today at 4:30 p.m. ET ATLANTA, GA - July 28, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies for infectious diseases and cancer, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. 'The second quarter marked a pivotal period for GeoVax, with compelling clinical data and regulatory milestones reinforcing the strength of our pipeline and our focus on accelerating to commercial status,' said David Dodd, GeoVax's Chairman and CEO. 'The favorable European regulatory guidance for GEO-MVA, robust immune responses demonstrated by GEO-CM04S1 in immunocompromised patients, particularly those with Chronic Lymphocytic Leukemia (CLL), and the continued progress towards initiation of the Gedeptin(R) Phase 2 trial highlight our expanding footprint in oncology and global infectious disease preparedness. These achievements reflect our commitment to advancing innovative, vaccines and immunotherapies that address urgent and underserved medical needs.' Clinical Trial Progress and Operational Developments GEO-MVA GEO-CM04S1 Gedeptin(R) Other Corporate Updates Second Quarter 2025 Financial Results Net Loss: Net loss for the three-month period ended June 30, 2025, was $5,369,783, or $0.35 per share, as compared to $5,064,042, or $1.99 per share, for the comparable period in 2024. For the six-month period ended June 30, 2025, the Company's net loss was $10,727,434, or $0.79 per share, as compared to $10,914,174, or $4.68 per share, in 2024. Revenue: During the three-month and six-month periods ending June 30, 2025, the Company reported $852,282 and $2,489,145 of government contract revenues associated with the BARDA/RRPV Project NextGen award, compared to $300,677 and $300,677 for the comparable periods in 2024. During the second quarter of 2025 GeoVax received notification that BARDA determined to terminate the contract for convenience to the government. R&D Expenses: Research and development expenses were $4,728,998 and $10,083,586 for the three-month and six-month periods ended June 30, 2025, compared with $4,276,868 and $8,702,596 for the comparable period in 2024, with the overall increase primarily due to program-specific costs associated with the BARDA/RRPV contract and GEO-MVA, partially offset by lower costs for the GEO-CM04S1 clinical trials and manufacturing costs not covered by the BARDA/RRPV contract. G&A Expenses: General and administrative expenses were $1,542,190 and $3,229,635 for the three-month and six-month periods ended June 30, 2025, compared to $1,086,030 and $2,543,383 for the comparable periods in 2024, with the overall increase primarily due to higher investor relations consulting costs and stock-based compensation expense. Cash Position: GeoVax reported cash balances of $3,093,862 at June 30, 2025, as compared to $5,506,941 at December 31, 2024. During July 2025, the Company completed a public offering of common stock and warrants with net proceeds of approximately $5.6 million. Summarized financial information is attached. Further information is included in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Conference Call Details Management will host a conference call and live audio webcast today, July 28, 2025, at 4:30 p.m. ET to review financial results and provide an update on corporate developments. A question-and-answer session will follow management's formal remarks. 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 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(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: 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 Investor Relations Contact: [email protected] 212-698-8696 Media Contact: Jessica Starman [email protected] FINANCIAL TABLES FOLLOW View the original release on
Yahoo
09-07-2025
- Health
- Yahoo
GeoVax Highlights Critical Role of Multi-Antigen COVID-19 Vaccines as Nimbus Variant Underscores Persistent and Evolving Public Health Threat
With COVID-19 continuing to mutate and over 40 million immunocompromised Americans still at risk, GeoVax's GEO-CM04S1 vaccine offers potential broader, more durable protection through a unique multi-antigen approach ATLANTA, GA - July 3, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today emphasized the urgent need for innovation in COVID-19 vaccination as the NB.1.8.1 variant - commonly known as "Nimbus" - spreads rapidly across the globe. Nimbus, a highly transmissible Omicron subvariant classified by the World Health Organization as a "Variant Under Monitoring," is now dominant in multiple U.S. states and surging across Europe and Asia. Though not more severe, its rapid spread and potential for immune escape reflect an increasingly clear reality: COVID-19 is not going away, and it will continue to evolve. "The emergence of the Nimbus variant is a stark reminder that we need smarter' vaccines, not just newer ones," said David Dodd, Chairman and CEO of GeoVax. "Our GEO-CM04S1 vaccine was designed for this purpose and is built to potentially provide broader and longer-lasting protection, especially for the immunocompromised patients most at risk." GEO-CM04S1: Multi-Antigen Protection for the Immunocompromised Unlike mRNA vaccines that rely solely on the Spike protein, GEO-CM04S1 delivers both Spike (S) and Nucleocapsid (N) antigens, stimulating an immune response that includes not only an antibody response, but also robust T-cell activity. This is believed to be critical for cross-variant protection and extended durability, particularly in individuals with weakened immune systems. GEO-CM04S1 is currently being evaluated in two Phase 2 clinical trials, focused on populations at greatest risk from COVID-19 complications, including blood cancer patients scheduled to receive stem cell transplant therapy. In one of the ongoing Phase 2 trials, the mRNA control arm was discontinued due to poor immunogenicity with the remainder of the trial only including GEO-CM04S1 which surpassed the immunogenicity target, reinforcing the limitations of monovalent vaccines and the important value of a multi-antigen vaccine approach in such high-risk patient populations. "There are more than 40 million immunocompromised individuals in the U.S. alone," said Dodd. "They are underserved by the current, FDA-approved vaccine options that deliver only an antibody response and require a better solution with both breadth and longevity of protection." Public Vaccine Policy and Regulatory Changes Support Platform Diversification Recent guidance from the U.S. Food and Drug Administration (FDA) calls for diversified vaccine platforms and risk-based regulatory pathways. Additionally, the CDC's narrowed 20252026 booster recommendations - now focused on adults 65+ and immunocompromised individuals - closely mirror GeoVax's clinical strategy and target population. GEO-CM04S1 has been proposed under BARDA's Rapid Response Partnership Vehicle (RRPV) for surge manufacturing support and integration into long-term public health preparedness efforts. The proposal, "Innovation in Clinical Manufacturing of MVA-Vectored COVID-19 Vaccines", was selected by the RRPV, pending funding availability. "As public health moves toward more targeted, durable, and inclusive vaccination strategies, GEO-CM04S1 is positioned to deliver where first generation COVID-19 vaccines fall short," Dodd added. In addition to targeting today's variants, GEO-CM04S1 is structurally designed to adapt to future mutations and serve as a platform for multi-pathogen preparedness. As part of GeoVax's broader MVA-based portfolio, the platform underpins vaccine candidates for Mpox, smallpox, and hemorrhagic fever viruses, offering scale and flexibility across infectious disease threats. 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(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: 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@ Investor Relations Contact:geovax@ Media Contact:Jessica Starmanmedia@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
03-07-2025
- Health
- Associated Press
GeoVax Highlights Critical Role of Multi-Antigen COVID-19 Vaccines as Nimbus Variant Underscores Persistent and Evolving Public Health Threat
With COVID-19 continuing to mutate and over 40 million immunocompromised Americans still at risk, GeoVax's GEO-CM04S1 vaccine offers potential broader, more durable protection through a unique multi-antigen approach ATLANTA, GA - July 3, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today emphasized the urgent need for innovation in COVID-19 vaccination as the NB.1.8.1 variant - commonly known as 'Nimbus' - spreads rapidly across the globe. Nimbus, a highly transmissible Omicron subvariant classified by the World Health Organization as a 'Variant Under Monitoring,' is now dominant in multiple U.S. states and surging across Europe and Asia. Though not more severe, its rapid spread and potential for immune escape reflect an increasingly clear reality: COVID-19 is not going away, and it will continue to evolve. 'The emergence of the Nimbus variant is a stark reminder that we need 'smarter' vaccines, not just newer ones,' said David Dodd, Chairman and CEO of GeoVax. 'Our GEO-CM04S1 vaccine was designed for this purpose and is built to potentially provide broader and longer-lasting protection, especially for the immunocompromised patients most at risk.' GEO-CM04S1: Multi-Antigen Protection for the Immunocompromised Unlike mRNA vaccines that rely solely on the Spike protein, GEO-CM04S1 delivers both Spike (S) and Nucleocapsid (N) antigens, stimulating an immune response that includes not only an antibody response, but also robust T-cell activity. This is believed to be critical for cross-variant protection and extended durability, particularly in individuals with weakened immune systems. GEO-CM04S1 is currently being evaluated in two Phase 2 clinical trials, focused on populations at greatest risk from COVID-19 complications, including blood cancer patients scheduled to receive stem cell transplant therapy. In one of the ongoing Phase 2 trials, the mRNA control arm was discontinued due to poor immunogenicity with the remainder of the trial only including GEO-CM04S1 which surpassed the immunogenicity target, reinforcing the limitations of monovalent vaccines and the important value of a multi-antigen vaccine approach in such high-risk patient populations. 'There are more than 40 million immunocompromised individuals in the U.S. alone,' said Dodd. 'They are underserved by the current, FDA-approved vaccine options that deliver only an antibody response and require a better solution with both breadth and longevity of protection.' Public Vaccine Policy and Regulatory Changes Support Platform Diversification Recent guidance from the U.S. Food and Drug Administration (FDA) calls for diversified vaccine platforms and risk-based regulatory pathways. Additionally, the CDC's narrowed 2025–2026 booster recommendations - now focused on adults 65+ and immunocompromised individuals - closely mirror GeoVax's clinical strategy and target population. GEO-CM04S1 has been proposed under BARDA's Rapid Response Partnership Vehicle (RRPV) for surge manufacturing support and integration into long-term public health preparedness efforts. The proposal, 'Innovation in Clinical Manufacturing of MVA-Vectored COVID-19 Vaccines', was selected by the RRPV, pending funding availability. 'As public health moves toward more targeted, durable, and inclusive vaccination strategies, GEO-CM04S1 is positioned to deliver where first generation COVID-19 vaccines fall short,' Dodd added. In addition to targeting today's variants, GEO-CM04S1 is structurally designed to adapt to future mutations and serve as a platform for multi-pathogen preparedness. As part of GeoVax's broader MVA-based portfolio, the platform underpins vaccine candidates for Mpox, smallpox, and hemorrhagic fever viruses, offering scale and flexibility across infectious disease threats. 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(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: 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 Investor Relations Contact: [email protected] 212-698-8696 Media Contact: Jessica Starman [email protected]
Associated Press
02-07-2025
- Business
- Associated Press
GeoVax Responds to Growing Mpox Threat With Expedited EU Pathway and Platform Aligned to U.S. Biodefense Objectives
With global cases rising and bipartisan momentum for pandemic preparedness, GeoVax's GEO-MVA vaccine advances on an expedited development track toward commercialization and revenue generation ATLANTA, GA - July 2, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and cancer, today emphasized the growing global public health importance of its GEO-MVA Mpox/smallpox vaccine in response to rising public health threats and a rapidly evolving regulatory environment. With favorable regulatory input from the European Medicines Agency (EMA), GEO-MVA is on an expedited path toward market access, accelerating GeoVax's focus toward regulatory approval and commercialization. 'GeoVax is entering a value inflection phase,' said David Dodd, Chairman and CEO. 'The EMA's expedited development path brings us closer to regulatory registration and commercial readiness, providing the opportunity to address urgent public health needs, expanding the critically needed supply option of MVA-vaccine, addressing both expanding outbreak needs and stockpile opportunities.' Modern Platform for Variant-Responsive Stockpiling GeoVax's development-stage continuous avian cell line process is anticipated to provide increased production of MVA-based vaccines, the ability to quickly respond to epidemics and pandemics, local implementation of MVA-based vaccine manufacturing and overall reduced production costs. With confirmed Mpox cases across multiple U.S. states, throughout Europe and new clade Ib outbreaks in West and Central Africa, the urgency for additional MVA-vaccine supply options is increasingly, critically important. 'There is a clear need for diversity in stockpile planning,' Dodd added. 'GEO-MVA is well-positioned to serve as a complementary or alternative solution where current, single-source options fall short. Ending the current monopoly of MVA-vaccine will benefit public health worldwide, providing an expanded supply option of this critically needed vaccine.' EMA Scientific Advice and BARDA RRPV Proposal Expedite Readiness GeoVax recently received favorable Scientific Advice from the EMA, confirming an expedited regulatory development path for GEO-MVA. This milestone enhances the product's standing with international regulatory bodies and opens pathways to revenue-generating opportunities across Europe and beyond. In parallel, GeoVax's advanced MVA-based vaccine manufacturing proposal under BARDA's Rapid Response Partnership Vehicle (RRPV) remains under active review. The program is designed to fund scalable vaccine platforms, eliminating the dependency for stockpiling of MVA-based vaccines relative to high-consequence threats such as smallpox. About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: 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 Investor Relations Contact: [email protected] 212-698-8696 Media Contact: Jessica Starman [email protected] View the original release on
Associated Press
24-06-2025
- Business
- Associated Press
GeoVax Comments on FDA Approval of Keytruda(R) in Head and Neck Cancer, Underscoring Potential for Gedeptin(R) Combination Therapy
Supports Advancement of GeoVax's Phase 2 Gedeptin(R) Trial in Recurrent Head and Neck Cancer ATLANTA, GA - June 24, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today commented on the U.S. Food and Drug Administration's recent approval of Keytruda(R) (pembrolizumab) for use in resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) tumors expressing PD-L1 as determined by an FDA approved test. This regulatory milestone marks a significant advancement in the curative-intent treatment landscape for head and neck cancer and affirms the therapeutic strategy underlying GeoVax's Gedeptin(R) development program. An editorial by Rosenberg and Vokes in New England Journal of Medicine (NEJM) noted that the study forming the basis of FDA's approval represents the first demonstration of benefit for PD-1 inhibition in the curative setting for HNSCC, with implications for evolving neoadjuvant immunotherapy paradigms. GeoVax is planning to initiate a Phase 2 clinical trial of Gedeptin(R) in combination with a checkpoint inhibitor, such as pembrolizumab, in patients with locally advanced HNSCC scheduled for curative-intent surgery. The trial aims to improve tumor clearance and reduce relapse by combining the immune-priming effect of Gedeptin's targeted cytotoxicity with the systemic immune activation of checkpoint inhibition. The Phase 2 study, expected to launch in 2026, will evaluate pathologic response, recurrence rates, and biomarker-defined immunologic changes when Gedeptin is used as neoadjuvant therapy with checkpoint inhibitors. Importantly, the NEJM editorial emphasized the need to optimize patient selection and treatment duration in the immunotherapy era, aligning with GeoVax's biomarker-driven approach. 'The NEJM publication and FDA approval of Keytruda in resectable HNSCC signals a new era in curative-intent cancer therapy,' said David Dodd, Chairman and CEO of GeoVax. 'By combining Gedeptin therapy with pembrolizumab, we aim to enhance local tumor eradication while unlocking systemic anti-tumor immunity, potentially reducing both local and distant recurrence.' 'We believe Gedeptin's tumor-targeted cytotoxicity can enhance immunotherapy efficacy, particularly in the perioperative window where anti-tumor immunity can be primed,' added Dr. Kelly McKee, GeoVax's Chief Medical Officer. 'We are excited to embark on the next phase of Gedeptin development as we attempt to build on the important advances being made in this disease.' For more information about the KEYNOTE-689 study, see the June 18, 2025 publication in the New England Journal of Medicine. About Gedeptin Gedeptin(R) is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally via an adenoviral vector encoding purine nucleoside phosphorylase (PNP). Upon systemic administration of fludarabine, the enzyme catalyzes the generation of a cytotoxic agent selectively within the tumor microenvironment. This mechanism provides dual cytotoxicity and immune modulation with minimal systemic exposure. Gedeptin has been granted Orphan Drug Designation by the FDA for the treatment of oral and pharyngeal cancers and is protected by a growing intellectual property portfolio. GeoVax's ongoing innovation in immune-sensitizing therapies supports a broader strategy to complement checkpoint inhibitors and overcome tumor immune resistance across solid tumor types. About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: 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 Investor Relations Contact: [email protected] 212-698-8696 Media Contact: Jessica Starman [email protected]
