Tag: GOVX

Research News and Market Data on GOVX

GeoVax Advances GEO-MVA to Strengthen U.S. and Global Readiness

ATLANTA, GA, February 19, 2025 – The confirmation of a fourth case of Clade 1 Mpox in New York underscores the urgent need for a stronger and more diversified vaccine supply chain. GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in developing vaccines and immunotherapies for infectious diseases and cancer, is calling for immediate action to expand vaccine production and ensure timely distribution.

The spread of Clade 1 Mpox, a highly virulent and transmissible strain with a fatality rate ranging from 3% – 10%, is raising alarms across the public health community. While the virus has been a persistent threat in Africa, its increasing presence in Europe and the United States signals a critical moment in the fight against the disease. Over the last 4 months, confirmed cases of Clade 1 Mpox have been reported in California, Georgia, New Hampshire, and New York. However, the nation remains heavily dependent on a single non-U.S. vaccine manufacturer of the preferred Mpox vaccine, based on Modified Vaccinia Ankara (MVA), leaving the U.S. and global markets vulnerable to supply chain disruptions, limited accessibility, and potential vaccine shortages at a time when demand is surging.

Current Supply Chain Inadequate for Global Mpox Response

The current reliance on a single supplier for the preferred Mpox vaccine presents numerous challenges, particularly as the outbreak grows:

• Supply chain instability – Depending on a single foreign manufacturer introduces geopolitical and logistical risks that could delay vaccine availability during critical outbreaks.
• Insufficient production capacity – African health agencies have requested 20 million doses in 2025 to curb the spread of the virus, yet only 2–5 million doses are expected to be available.
• High costs and limited access – At as much as $270 per dose in the U.S., the preferred product for vaccination against Mpox can be prohibitively expensive for many, creating a barrier to widespread vaccination efforts.
• Inability to respond swiftly to emerging strains – Current stockpiles, which were depleted during the 2022 outbreak, are likely inadequate to combat the increasing spread of Clade 1, leaving public health officials struggling to contain the outbreak.

GeoVax’s GEO-MVA: A Critical Additional-Source Solution

In response to these pressing concerns, GeoVax is advancing development of GEO-MVA, an alternative MVA based vaccine in the fight against Mpox. GeoVax is also further addressing vaccine availability with plans to transition manufacturing of GEO-MVA, once authorized, to an advanced MVA manufacturing platform with the potential to offer significant advantages over the currently utilized Chicken Embryo Fibroblast (CEF) manufacturing platform, a complicated manufacturing process highly dependent on the availability of Specific Pathogen Free (SPF) chicken eggs. GEO-MVA’s innovative MVA production process, once implemented, should enable:

• Scalability for global demand – Rapid, high-volume manufacturing to meet urgent vaccination needs.
• Flexibility to utilize existing vaccine manufacturing facilities vs need to construct new ones.
• Lower cost and increased accessibility – The advanced technology behind GeoVax’s MVA manufacturing platform should help reduce production costs, making vaccination programs more affordable worldwide.
• Eliminate the need for SPF eggs whose availability can be negatively impacted by supply disruptions such as those related to avian flu outbreaks.
• Strengthening U.S. biosecurity – Unlike the current MVA vaccine, which is produced overseas, GEO-MVA can be manufactured within the U.S., reducing reliance on foreign supply chains.
• Enhanced pandemic preparedness – A diversified vaccine supply ensures greater resilience in response to future outbreaks, preventing disruptions in availability.

GeoVax has established strategic partnerships with OXB (France) and ProBioGen (Berlin) to support production scale up, while also actively engaging with U.S. and international health agencies to potentially expedite regulatory approvals and secure funding to bring GEO-MVA to market and eventually transition production to the next generation MVA manufacturing process. GeoVax recently completed cGMP (current Good Manufacturing Practice) manufacturing of the GEO-MVA drug substance and is currently in the process of fill-finish, with anticipated availability of clinical vialed material by mid-year.

A Call to Action: Strengthening the Global Response

With the growing threat of Clade 1 Mpox, it is imperative to diversify vaccine manufacturing capabilities and ensure the U.S. and global health agencies have access to multiple suppliers. GeoVax urges policymakers and regulators to take decisive action:

• Increase federal funding and policy support to expedite the availability of GEO-MVA as an alternative Mpox vaccine.
• Expedite regulatory approvals to bring GEO-MVA to market as quickly as possible.
• Enhance collaboration with global health organizations to ensure equitable vaccine distribution, particularly in underserved regions.

“We cannot afford to wait for another pandemic-level crisis before addressing vaccine shortages and supply chain vulnerabilities,” said David Dodd, Chairman & CEO of GeoVax. “The emergence of Clade 1 Mpox in the U.S. is a clear warning sign. Immediate action is needed to strengthen vaccine supply and access.  GEO-MVA, along with our efforts towards establishing our next generation MVA manufacturing platform, represents critical solutions to ensure we are better prepared for future outbreaks.”

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

Research News and Market Data on GOVX

GeoVax’s Vaccine Development Programs Align with Anticipated HHS Focus on Vaccine Safety, Diversification and Domestic Biosecurity

ATLANTA, GA, February 18, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in vaccine and immunotherapy development, congratulates Robert F. Kennedy, Jr. on his confirmation as Secretary of the U.S. Department of Health and Human Services (HHS). RFK Jr.’s appointment provides a significant opportunity for healthcare innovation, transparency, and public trust, reinforcing national priorities such as vaccine safety, diversified vaccine platforms, and strengthened domestic manufacturing. GeoVax stands ready to support these initiatives by delivering next-generation vaccines and advanced vaccine manufacturing technology that enhance biosecurity, public health resilience, and vaccine confidence.

GeoVax’s Commitment to a Robust, Transparent and Secure Vaccine Future

GeoVax’s mission aligns closely with the new administration’s policy priorities, particularly in reducing reliance on foreign pharmaceutical supply chains, increasing vaccine safety and durability, and ensuring access for underserved populations. The Company’s proprietary Modified Vaccinia Ankara (MVA) platform offers a promising alternative to other vaccine technologies such as mRNA, providing broad-spectrum, durable immunity across multiple infectious diseases via a recognized safe vaccine platform.

Key initiatives supporting the goals for vaccine safety and transparency include:

• Diversified Vaccine Development – GeoVax’s GEO-CM04S1, a next-generation COVID-19 vaccine, and GEO-MVA, a dual-purpose Mpox and smallpox vaccine, align with the advocacy for alternative vaccine platforms beyond mRNA. These vaccines are designed to offer long-term immunity with a well-documented safety profile.
• Transparency as a Pillar of Public Trust – As David Dodd, Chairman and CEO of GeoVax, has emphasized, restoring trust in vaccines requires clear communication, open regulatory processes, and full transparency regarding safety, efficacy, and potential risks. GeoVax supports the call for greater industry accountability and public engagement, ensuring that vaccine development aligns with the highest standards of ethical science.
• Strengthening U.S. Biosecurity – GeoVax’s anticipated domestic vaccine manufacturing capabilities reinforce the bipartisan legislative commitment to reducing dependence on foreign pharmaceutical supply chains, thereby enhancing national pandemic preparedness.
• Ethical Vaccine Development & Public Confidence – GeoVax embraces open regulatory processes, rigorous safety standards, and public access to data, ensuring confidence in its vaccines. These principles align with the call for increased scrutiny and transparency in vaccine development and approval.
• Equitable Access & Global Preparedness – With cost-effective, scalable technology that does not require ultra-cold storage, GeoVax’s vaccines are well-suited for domestic and global distribution, ensuring broad access to critical immunizations, particularly for immunocompromised and underserved communities.

David Dodd: “Transparency is the Key to Restoring Vaccine Trust”

Reflecting on the challenges of vaccine hesitancy, David Dodd has been a vocal advocate for transparency in vaccine development and regulatory processes. In a recent op-ed, he emphasized: “Trust in vaccines has become a critical battleground for public health. Addressing public concerns openly and honestly is the only way to bridge the growing divide between science and skepticism. Transparency is a necessity, not an option. GeoVax remains committed to clear communication, scientific integrity, and ensuring that public confidence in vaccines is based on facts, not fear.” (https://www.genengnews.com/topics/translational-medicine/a-call-to-action-building-vaccine-trust-through-transparency/)

This perspective directly supports the stated goals of strengthening public trust, reducing regulatory opacity, and ensuring vaccine safety through independent oversight. GeoVax’s proactive approach to transparent vaccine development is a model for responsible biotech leadership.

A New Era for U.S. Healthcare and Pandemic Preparedness

RFK Jr.’s confirmation as HHS Secretary provides a renewed opportunity in support of vaccine diversification, transparency, and strategic biomanufacturing initiatives. GeoVax’s innovative vaccine pipeline supports these goals, positioning the Company as a vital partner in safeguarding national and global public health.

GeoVax’s vaccine development strategy builds upon successful national initiatives, such as Operation Warp Speed and Project NextGen, by prioritizing pandemic preparedness and biosecurity resilience. Through continued engagement with federal agencies and global health organizations, the Company seeks to accelerate vaccine development, expand domestic manufacturing, and enhance pandemic response efforts.

David Dodd, Chairman and CEO of GeoVax, stated: “Secretary Kennedy’s confirmation presents an opportunity to redefine public health with greater emphasis on safety, accessibility, and innovation. GeoVax proudly supports the commitment to reducing dependence on foreign pharmaceutical supply chains, diversifying vaccine technology, and restoring trust in public health solutions. We stand ready to collaborate with HHS and other healthcare stakeholders to advance a safer, more resilient healthcare future.”

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:		Investor Relations Contact:		Media Contact:
info@geovax.com		austin.murtagh@precisionaq.com		sr@roberts-communications.com
678-384-7220		212-698-8696		202-779-0929

Research News and Market Data on GOVX

Strategic Progress Across COVID-19, Mpox, Oncology Therapies and AI Integration Positions GeoVax for Strong Momentum

Atlanta, GA – February 5, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today outlined its 2025 strategic milestones and business outlook. Building on a history of delivering on key commitments, GeoVax enters 2025 with a robust pipeline, a catalyst-rich milestone schedule, and an unwavering commitment to addressing unmet medical needs on a global scale.

An Important Year Ahead for GEO-CM04S1, a Next-Generation COVID-19 Vaccine

GEO-CM04S1 continues to demonstrate potential for both immunocompromised patients and as a booster vaccine for those previously inoculated with mRNA vaccines. In 2025, the Company anticipates completion of the evaluation trial among Chronic Lymphocytic Leukemia (CLL) patients, a patient population recognized to currently have minimal COVID-19 vaccine options. Interim data reported in Q4 2024 suggest GEO-CM04S1 may offer superior immune responses to CLL patients compared to an mRNA vaccine.

GeoVax also expects to report final results from its healthy adults booster trial, offering valuable data on the vaccine’s safety and immunogenicity profile. Another pivotal milestone for GEO-CM04S1 in 2025 is the anticipated initiation of patient enrollment in the BARDA-funded Project NextGen Phase 2b trial, which will evaluate GEO-CM04S1 compared to an authorized mRNA vaccine within a 10,000-patient study. As both a booster and a primary vaccine for immune-compromised patient populations, GEO-CM04S1 remains central to GeoVax’s mission to address the ongoing and evolving challenges of COVID-19.

As part of its strategy, GeoVax will continue to explore and establish strategic partnerships and collaborations to accelerate the development, commercialization, and global accessibility of GEO-CM04S1.

GEO-MVA: Addressing Biosecurity and Global Health Gaps

GEO-MVA, a vaccine designed to combat Mpox and Smallpox, has emerged as a critical solution amid rising global biosecurity concerns. In 2025, the Company plans to initiate clinical evaluations for GEO-MVA while continuing discussions with various stakeholders regarding the opportunity to utilize GEO-MVA among underserved populations in regions including Africa. With ongoing geopolitical and logistical challenges limiting vaccine availability, GEO-MVA’s ability to offer multi-disease protection, minimal refrigeration needs, and scalability through implementation of an advanced MVA manufacturing process, GEO-MVA represents a potential transformative resource for both national biosecurity strategies and global health initiatives.

GeoVax recognizes that addressing these critical global challenges requires collaborative efforts. In 2025, the Company will actively pursue strategic partnerships with governments, NGOs, and private-sector stakeholders to maximize the impact and reach of its GEO-MVA platform.

Gedeptin: Unlocking Potential in Solid Tumor Cancer Therapy

GeoVax’s oncology program, centered around Gedeptin^®, continues to progress in addressing unmet medical needs in solid tumor therapies. Following encouraging results from Phase 1 and Phase 1/2 trials, Gedeptin is advancing into a Phase 2 clinical trial in 2025, where it will be evaluated in combination with an immune checkpoint inhibitor, targeting first recurrent head and neck cancer. This trial aims to validate the potential synergy between Gedeptin’s targeted gene-directed enzyme prodrug therapy and the powerful immune responses activated by checkpoint inhibitors.

As an FDA-designated Orphan Drug for anatomically accessible oral and pharyngeal cancers, Gedeptin is strategically positioned to address not only head and neck cancers but also other solid tumor indications, such as triple-negative breast cancer, soft tissue sarcoma and melanoma. GeoVax’s clinical roadmap for Gedeptin represents a significant market opportunity, with the potential to reshape how these cancers are treated worldwide.

GeoVax remains open to collaborations with oncology leaders, academic research institutions, and industry partners to further enhance the clinical impact and commercial success of Gedeptin.

Next-Generation Manufacturing: Pioneering Scalable Vaccine Production

To amplify the value of its clinical programs, GeoVax is also focused on advancing MVA vaccine manufacturing through validation of continuous cell line manufacturing processes, ensuring consistent, high-quality vaccine production capabilities. These advancements address long-standing challenges in vaccine scalability and cost-effectiveness, positioning GeoVax as a leader in MVA-based vaccine manufacturing solutions, potentially implementing a proprietary MVA manufacturing process supporting more flexible, localized MVA manufacturing at lower production cost, specifically enabling vaccine self-sufficiency manufacturing in low-middle income regions such as Africa.

GeoVax recognizes that strong manufacturing partnerships are vital to bringing these innovations to market efficiently and cost-effectively. The Company plans to collaborate with manufacturing partners worldwide to scale up production capabilities and meet the growing global demand for MVA-based vaccines.

AI Integration: Optimizing Processes and Driving Innovation

In alignment with its 2025 objectives, GeoVax has expanded the integration of Artificial Intelligence (AI) across its vaccine development and cancer immunotherapy activities. Leveraging AI is anticipated to accelerate vaccine development, optimize cancer therapies, streamline clinical trials, and enhance manufacturing processes, potentially in the following manners:

• Vaccine and Therapy Innovation: Predicting pathogen mutations and optimizing GEO-CM04S1 and Gedeptin^® design, ensuring effectiveness in variant-proof vaccines and cancer therapies.
• Clinical Trial Optimization: Refining patient selection, accelerating recruitment, and enhancing diversity for trials targeting high-risk and underserved populations.
• Streamlined Manufacturing: Enhancing scalability and logistics, enabling efficient production and distribution, particularly in underserved regions.

Addressing a $55+ Billion Pipeline Market Opportunity

GeoVax’s pipeline addresses significant unmet and underserved medical needs worldwide in both infectious disease vaccines and oncology, representing a collective potential global market opportunity in excess of $55 billion. Each program—GEO-CM04S1, GEO-MVA, and Gedeptin—addresses significant gaps in existing treatment and prevention strategies, backed by emerging clinical data and a focus towards achieving the necessary regulatory milestones in support of product registration.

David Dodd, Chairman & CEO of GeoVax, commented: “2024 was a transformative year for GeoVax, and our focus and commitment in 2025 is unwavering, focused on critically needed unmet medical needs. Our pipeline, enriched with value-driven milestones, positions us well for successful growth and development.  Collaborations and partnerships remain core to our strategy, ensuring our innovations reach those who need them most. With GEO-CM04S1, GEO-MVA, Gedeptin, our MVA manufacturing advancements, and leveraging AI to optimize our processes and drive innovation, we are prepared to make meaningful contributions to global health, delivering value to our fellow shareholders, various stakeholders and, providing compelling career development opportunities to our staff colleagues.”

For further details on GeoVax’s pipeline and strategic initiatives, please visit www.geovax.com.

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 to initiate during the first half of 2025. 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:		Investor Relations Contact:		Media Contact:
info@geovax.com		austin.murtagh@precisionaq.com		sr@roberts-communications.com
678-384-7220		212-698-8696		202-779-0929

Research News and Market Data on GOVX

Harnessing AI to Revolutionize Vaccine and Therapy Development

ATLANTA, GA, February 3, 2025 — GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in vaccine and immunotherapy development, announced today its endorsement of President Donald J. Trump’s Stargate Initiative, which aims to harness advanced technologies including Artificial Intelligence (AI) to strengthen U.S. healthcare, biosecurity, and global innovation leadership. This announcement aligns with GeoVax’s commitment to leveraging AI across its vaccine and cancer immunotherapy programs to accelerate research, optimize operations, and deliver life-saving solutions.

Revolutionizing Healthcare with AI

GeoVax has embedded AI into its platforms for vaccine development and cancer immunotherapy, enabling groundbreaking advances:

• Vaccine Development: AI drives target discovery and design for vaccines using the Modified Vaccinia Ankara (MVA) platform, including GEO-CM04S1, GeoVax’s next-generation vaccine for COVID-19, and vaccines for Mpox and Smallpox. AI predicts pathogen mutations, ensuring long-lasting and variant-proof vaccines.
• Cancer Immunotherapy: AI optimizes GeoVax’s Gene-Directed Enzyme Prodrug Therapy (GDEPT) for solid tumors, including predictive modeling of tumor microenvironments, real-time adjustment of protocols to maximize therapeutic efficacy, and identifying synergistic combinations with immune checkpoint inhibitors.
• Clinical Targeting: AI-powered analytics will refine patient stratification, ensuring that GeoVax’s therapies reach underserved populations most in need, aligning with the initiative’s national focus to maximize therapeutic efficacy.
• Manufacturing and Operations: AI improves GeoVax’s vaccine production scalability and supply chain management, ensuring timely delivery to strategic stockpiles.

Aligned with the Stargate Vision

President Trump’s Stargate Initiative, supported by up to $500 billion in private-sector investment, represents a bold step forward in embracing transformative technologies. GeoVax proudly aligns with this vision, advancing U.S. healthcare innovation and pandemic preparedness.

David Dodd, GeoVax Chairman and CEO, stated: “President Trump’s Stargate Initiative exemplifies leadership in harnessing AI to address critical healthcare challenges. GeoVax is honored to support this initiative, highlighting its application of AI to develop vaccines and therapies that save lives and enhance biosecurity. We are proud to contribute to a future where the United States leads the world in healthcare innovation.”

Building on Operation Warp Speed’s Legacy

GeoVax’s efforts reflect the spirit of President Trump’s Operation Warp Speed, which accelerated COVID-19 vaccine development and deployment. By integrating AI into its research and operational strategies, GeoVax aims to continue pushing the boundaries of what is possible in medical science.

A Commitment to Life-Saving Innovation

GeoVax remains steadfast in its mission to develop innovative vaccines and immunotherapies, leveraging the power of AI to meet the healthcare needs of today and prepare for the challenges of tomorrow. With AI now embedded in its processes, GeoVax anticipates shorter development timelines, increased efficiency in clinical trials, and enhanced capacity to deliver life-saving therapies globally. Collaborations with academic institutions, industry partners and federal agencies will further amplify the reach and impact of GeoVax’s innovative programs under the Stargate framework. AI-enabled supply chain optimization will further ensure efficient vaccine distribution to high-priority populations and regions.

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 to initiate in mid-2025. 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:		Investor Relations Contact:		Media Contact:
info@geovax.com		austin.murtagh@precisionaq.com		sr@roberts-communications.com
678-384-7220		212-698-8696		202-779-0929

Research News and Market Data on GOVX

 

• Last updated: 29 January 2025
• Created: 29 January 2025
• Hits: 63

Addressing Critical U.S. Vulnerabilities in Vaccine Supply and National Preparedness

ATLANTA, GA, January 29, 2025 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, today highlighted that it is committed to playing a pivotal role in reinforcing America’s biosecurity through its GEO-MVA vaccine, designed to combat both smallpox and Mpox.  In light of recent global health challenges, the United States has recognized the critical need to reduce dependence on foreign vaccine suppliers and bolster domestic production capabilities.

The 2022 Mpox pandemic significantly depleted the U.S. Strategic National Stockpile (SNS) of vaccines, exposing vulnerabilities in the nation’s preparedness for emerging health threats. Compounding this issue is the nation’s reliance on a single foreign manufacturer for smallpox and Mpox vaccines. This dependency poses a strategic risk, especially considering the current Clade I Mpox outbreak in Africa, characterized by an estimated 5%-10% mortality rate, increasingly migrating to other regions worldwide.

GeoVax’s GEO-MVA vaccine is expected to offer a timely and strategic solution. Developed on the proven Modified Vaccinia Ankara (MVA) platform, a clinical batch of GEO-MVA has recently been produced under current Good Manufacturing Practice (cGMP) production.  Clinical evaluation of the vaccine is expected to begin this year.  The Company’s innovative advanced MVA manufacturing process is anticipated to provide scalable, flexible and cost-effective vaccine production, reducing reliance on foreign vaccine manufacturers and reinforcing domestic biosecurity.

America First – Bolstering U.S. Biomanufacturing Resilience

The importance of onshoring medical product manufacturing has garnered bipartisan support among U.S. legislators. Reps. Earl L. “Buddy” Carter (R-GA), Elissa Slotkin (D-MI), Chrissy Houlahan (D-PA), and Gus Bilirakis (R-FL) officially launched the bipartisan Domestic Pharmaceutical Manufacturing Caucus for the 118th Congress. (https://buddycarter.house.gov/news/documentsingle.aspx?DocumentID=11059)

Representatives Blake Moore (R-UT), August Pfluger (R-TX), Mark Green (R-TN), and former Representative Brad Wenstrup (R-OH) have also sought feedback on policy solutions to secure and enhance domestic medical supply chains. (https://blakemoore.house.gov/media/press-releases/moore-wenstrup-pfluger-and-green-release-request-for-information-on-policy-solutions-to-secure-and-enhance-domestic-medical-supply-chains)

In addition, John Crowley, President of the Biotechnology Innovation Organization (BIO), has underscored the urgency of reshoring biomanufacturing capacity to protect public health and national security. (https://bio.news/biosecurity/national-security-biosecurity-biomanufacturing-biotech-manufacturing-john-crowley-bio/)

GeoVax’s commitment to domestic vaccine production aligns seamlessly with these national initiatives, positioning GEO-MVA as a cornerstone in America’s strategy to achieve vaccine independence and enhance public health preparedness.

David Dodd, GeoVax’s Chairman and CEO, stated, “With GEO-MVA, we intend to create the first U.S.-based source for a Mpox vaccine, an important biodefense goal.”

Recent Conference Presentations

GeoVax CEO David Dodd recently presented the Company’s strategic initiatives and the potential of GEO-MVA at:

• Biotech Showcase: January 14, 2025
• Emerging Growth Conference: January 16, 2025

For additional details, visit www.geovax.com.

About GEO-MVA

GEO-MVA is a Mpox and smallpox vaccine candidate utilizing U.S. NIH rights acquired by GeoVax. Designed for robust immune responses, GEO-MVA is anticipated to offer a safe and effective solution for both immunocompromised and general populations​.

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 to initiate during the first half of 2025. 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:		Investor Relations Contact:		Media Contact:
info@geovax.com		austin.murtagh@precisionaq.com		sr@roberts-communications.com
678-384-7220		212-698-8696		202-779-0929

Research News and Market Data on GOVX

 

• Last updated: 27 January 2025
• Created: 27 January 2025
• Hits: 60

Process Expected to Increase Production Yield, Flexibility at Lower Cost

Atlanta, GA – January 27, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in vaccines and immunotherapies, has shared updates about its development-stage advanced Modified Vaccinia Ankara (MVA) vaccine manufacturing process. This anticipated process provides the potential to not only address today’s pressing health challenges but also paves the way for more efficient, flexible and lower-cost MVA-vaccine manufacturing.

The Power and Versatility of the MVA Platform

The MVA platform is uniquely designed to incorporate multiple antigens into a single vaccine. This versatility allows GeoVax to develop vaccines targeting multiple aspects of a single pathogen or several pathogens simultaneously. Originally developed as a safer smallpox vaccine, the MVA platform offers distinct advantages, including:

• Protection against diseases such as Mpox and smallpox.
• Multi-antigen vaccines like GEO-CM04S1, which targets both the Spike (S) and Nucleocapsid (N) antigens of SARS-CoV-2.
• Stability under minimal refrigeration and the potential for freeze-drying (lyophilization), simplifying distribution in resource-limited settings.

Advancing MVA Manufacturing

Current vaccine manufacturing methods rely on Chicken Embryo Fibroblast (CEF) cells, requiring pathogen-free eggs. This process is costly, time-consuming, and dependent on limited egg supplies, providing barriers to rapid, real-time MVA manufacturing, as well as hindering the flexibility necessary to establish local MVA manufacturing of critically important vaccines.  GeoVax is addressing these barriers through an advanced MVA Manufacturing process utilizing an avian cell line licensed from ProBioGen AG (Berlin). Key features include:

• A continuous avian suspension cell line process that eliminates the need for pathogen-free eggs.
• Compatibility with standard manufacturing equipment, reducing setup time, simplifying the MVA manufacturing process, increasing scalability and lowering manufacturing costs.

This advanced MVA manufacturing process is expected to significantly simplify vaccine production, particularly in middle- and low-income regions where supply chain issues often hinder access to critical vaccines.

Addressing Global Health Needs

“Our advanced MVA manufacturing process represents not only a transformative manufacturing advance but also addresses a public health imperative,” said David Dodd, Chairman and CEO of GeoVax. “By tackling disease protection, logistical hurdles, and manufacturing challenges, we aim to empower regions like Africa with the tools needed to combat current and future health crises.”

GeoVax’s MVA vaccines have demonstrated robust performance in clinical trials, with ongoing Phase 2 studies for GEO-CM04S1, its COVID-19 vaccine candidate, showing broad and durable immune responses. Supported by its BARDA Project NextGen Award and partnerships with leading manufacturing and development organizations, GeoVax is positioned to enhance vaccine access and delivery on a global scale.

Recent Conference Presentations

GeoVax CEO David Dodd recently presented the company’s strategic initiatives and the potential of GEO-MVA at:

• Biotech Showcase: January 14, 2025
• Emerging Growth Conference: January 16, 2025

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 to initiate in mid-2025. 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:		Investor Relations Contact:		Media Contact:
info@geovax.com		austin.murtagh@precisionaq.com		sr@roberts-communications.com
678-384-7220		212-698-8696		202-779-0929

Research News and Market Data on GOVX

Represents a Key Step Toward Validating Gedeptin Potential in Solid Tumor Therapy

Atlanta, GA, January 15, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing innovative immunotherapies and vaccines for cancer and infectious diseases, announced significant progress in advancing Gedeptin as a cancer therapy. Gedeptin, based on a Gene-Directed Enzyme Prodrug Therapy (GDEPT) platform, employs a targeted approach to deliver therapeutic agents directly to tumor sites. The result of this approach is the localized production of a potent anti-cancer agent(s) within the tumor microenvironment, while minimizing systemic exposure and the potential for associated side effects. 

Following a review of the data from the completed Phase 1 single-cycle and Phase 1/2 multi-cycle Gedeptin trials among patients with advanced Head & Neck (H&N) tumors, GeoVax has decided to initiate a Phase 2 clinical study, evaluating neoadjuvant Gedeptin therapy in combination with an approved immune check point inhibitor (ICI) in 1^st recurrent H&N cancer scheduled for resection with curative intent.

Therapy Potential and Market Opportunity

Gedeptin has been granted Orphan Drug Designation by the U.S. FDA for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, underscoring its potential to address significant unmet medical needs.

“Preclinical data suggest that Gedeptin/fludarabine can enhance the activity of ICIs in treatment of solid tumors.  Our upcoming Phase 2 trial will investigate this approach as a neoadjuvant therapy for patients with first recurrence head and neck cancer. We believe this will lead to increased tumor response and decreased recurrence rates in these patients,” said David Dodd, Chairman and CEO of GeoVax. “Based on the data generated to date, this combination has the potential to address multiple solid tumor indications, and represents a significant medical and commercial opportunity, if approved.”

David Dodd added, “We are entering an exciting phase of clinical development with Gedeptin, and our team remains committed to advancing this innovative therapy to deliver life-changing benefits for cancer patients worldwide.”

Advancing Clinical Development

The upcoming Phase 2 trial will evaluate the efficacy of Gedeptin in combination with ICIs in patients with first-recurrence head and neck cancer. Key endpoints will include pathologic response rates and overall treatment outcomes. GeoVax plans to initiate trial activities mid-year and partner with leading academic oncology centers.

A Transformative Year Ahead

GeoVax projects significant milestones in 2025, with Gedeptin expected to play a key role in delivering transformative cancer therapies. Beyond head and neck cancers, the company plans to explore Gedeptin’s potential applications across other solid tumor types.

GeoVax’s CEO, David Dodd, will present the Company’s 2024 progress and outlook for 2025 at the Emerging Growth Conference: January 16, 2025, at 2:35 PM ET.

For more information on GeoVax’s portfolio and developments, please visit www.geovax.com.

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 to initiate during the first half of 2025. 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:		Investor Relations Contact:		Media Contact:
info@geovax.com		austin.murtagh@precisionaq.com		sr@roberts-communications.com
678-384-7220		212-698-8696		202-779-0929

Research News and Market Data on GOVX

 Advancements Position GEO-CM04S1 as a Leading Vaccine Candidate Addressing Unmet Medical Needs, Especially Among Immunocompromised Patients

ATLANTA, GA, January 13, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in immunotherapies and vaccines against infectious diseases and cancers, is pleased to announce substantial progress in the clinical development of its COVID-19 vaccine portfolio during 2024. These achievements underscore the potential of GEO-CM04S1 to address critical public health needs, particularly among immunocompromised populations.

Project NextGen (PNG) Award

In June 2024, GeoVax received a significant award through the Rapid Response Partnership Vehicle (RRPV), funded by the Biomedical Advanced Research and Development Authority (BARDA) as part of PNG. This award supports a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 compared to an approved COVID-19 vaccine. The study is set to commence in the second half of 2025, with Allucent, a global clinical research organization, selected to conduct and manage the trial.

Chronic Lymphocytic Leukemia (CLL) Interim Study Results

In November 2024, the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1 as a booster vaccine for patients with CLL conducted an interim data review of the study. Following its review, the DSMB recommended that the study should continue enrollment of the experimental arm utilizing GEO-CM04S1, but that the mRNA control arm of the study should be halted as it failed to meet the predetermined primary immune endpoint. This suggests a potentially superior immune response in this vulnerable population. Further enrollment of the remaining patient participants is expected to be completed during 2025.

Completion of Enrollment in Booster Vaccine Study for Healthy Adult Volunteers

GeoVax has successfully completed enrollment in its Phase 2 clinical trial evaluating GEO-CM04S1 as a booster vaccine in healthy adults who previously received COVID-19 vaccines. This study aims to assess the vaccine’s safety and immunogenicity at two different dose levels, with data readouts anticipated in the first half of 2025.

Ongoing Stem Cell Transplant Study

The Company continues to advance its Phase 2 clinical trial of GEO-CM04S1 as a primary vaccine for immunocompromised patients undergoing stem cell transplantation. This study addresses a critical need for effective vaccination strategies in populations that may not respond adequately to existing vaccines.

Potential Benefits of GEO-CM04S1 Over Existing Authorized COVID-19 Vaccines

GEO-CM04S1 offers several potential benefits compared to currently authorized COVID-19 vaccines:

• Public Health Impact: By providing robust protection for immunocompromised individuals, GEO-CM04S1 could significantly reduce COVID-19-related risks of morbidity and mortality among such high-risk patient populations.
• Durability: Preliminary data suggest that GEO-CM04S1 may offer longer-lasting immunity, potentially reducing the frequency of booster doses required.
• Breadth of Protection: The inclusion of both Spike (S) and Nucleocapsid (N) antigens in GEO-CM04S1 may confer broader immunity, making it more effective against a range of variants without the need for frequent reformulation.
• Primary Vaccine for Immunocompromised Patients: With approximately 40 million immunocompromised individuals in the U.S. and an estimated 400+ million worldwide, many of whom may not respond adequately to current vaccines, GEO-CM04S1 has the potential to become the preferred vaccine for this population.
• Safety. The safety profile of MVA as the platform for GEO-CM04S1 is well-established, with decades of data supporting its use as a smallpox vaccine, as well as its use as a platform with diverse vaccine candidates. This robust safety record is particularly important as the new HHS administration prioritizes transparency and rigorous oversight in vaccine safety evaluation. GEO-CM04S1 aligns with these priorities, offering a scientifically validated platform backed by comprehensive safety data.

Market Potential and Partnering Opportunities

GEO-CM04S1 offers an alternative approach to boosting existing COVID-19 vaccines, providing enhanced and more durable immunity. Its applicability for immunocompromised patients further broadens its public health and commercial value. GeoVax estimates the annual market potential for GEO-CM04S1 to be approximately $30 billion, reflecting the critical medical need to better address high-risk immunocompromised patients. The global need for a next-generation COVID-19 vaccine with the advantages offered by GEO-CM04S1 creates multiple partnering opportunities for GeoVax.

Looking Ahead to 2025

The continued development of GEO-CM04S1 is a key component of GeoVax’s catalyst-rich agenda for 2025. The Company anticipates multiple data readouts and regulatory milestones that will further define the vaccine’s role in combating COVID-19.

“Our progress in 2024 has been remarkable, particularly in advancing GEO-CM04S1 as a next-generation COVID-19 vaccine,” said David Dodd, Chairman & CEO of GeoVax. “The MVA platform underlying our vaccine offers unique advantages, including the potential for broader and more durable protection, which is especially critical for immunocompromised individuals. We are committed to delivering solutions that address unmet medical needs and improve public health outcomes.”

Upcoming Presentations

GeoVax’s CEO, David Dodd, will present the Company’s 2024 progress and future outlook at the following conferences:

• Biotech Showcase: January 14, 2025, at 10:30 AM PST
• Emerging Growth Conference: January 16, 2025, at 2:35 PM ET

For more information on GeoVax’s portfolio and developments, please visit www.geovax.com

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 to initiate during the first half of 2025. 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:		Investor Relations Contact:		Media Contact:
info@geovax.com		austin.murtagh@precisionaq.com		sr@roberts-communications.com
678-384-7220		212-698-8696		202-779-0929

Research News and Market Data on GOVX

 

• Last updated: 19 November 2024
• Created: 19 November 2024
• Hits: 158

GEO-CM04S1 Improved Immune Response vs mRNA Vaccine

ATLANTA, GA, November 19, 2024 — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the completion of an interim data review by the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, as a booster vaccine for patients with chronic lymphocytic leukemia (CLL).

Based on the interim analysis of immune responses from the patients enrolled to date, the DSMB determined that, while the mRNA control arm of the study failed to meet the predetermined primary endpoint, the study should continue enrollment of the experimental arm utilizing GeoVax’s Next-Generation GEO-CM04S1 vaccine. The Phase 2 trial is an investigator-initiated clinical study (ClinicalTrials.gov Identifier: NCT05672355) being conducted at City of Hope National Medical Center. The study is examining the use of two injections of GEO-CM04S1, three months apart, to assess immune responses in CLL patients, with an mRNA vaccine as the control arm. Thus far, participants have been randomized 1:1 to receive two boosters with either the GEO-CM04S1 or the mRNA control vaccine.

“This is very exciting news,” commented David Dodd, GeoVax President and CEO, “The outcome of the DSMB interim review appears to support our view of GEO-CM04S1 as a potentially superior COVID-19 vaccine booster within the CLL patient population. Within the CLL and other immune-compromised patient populations, more robust and durable protective immunity is needed, as provided by potential next-generation vaccines such as GEO-CM04S1 that induce both strong T cell and antibody responses.”

Individuals with CLL, regardless of their treatment status, typically exhibit less predictable and often insufficient immune responses to the currently authorized COVID-19 vaccines; therefore, such patients may be at higher risk of a lethal COVID-19 infection. GEO-CM04S1 uses a modified vaccinia virus (MVA) viral vector backbone, containing both the Spike (S) and Nucleocapsid (N) antigens of the SARS-CoV-2 virus.  Inclusion of both the S and N antigens may be more effective at inducing COVID-19 immunity in patients exhibiting poor antibody responses following receipt of an mRNA vaccine containing only the S antigen as MVA also induces strong T cell expansion, even in the background of immunosuppression. By targeting both the S and N protein antigens, GEO-CM04S1 offers the potential to both broaden the specificity of the immune responses as well as protect against the loss of efficacy associated with current vaccines due to the significant sequence variation observed within the S antigen.

Dodd continued, “This ongoing trial is providing important information about the potential use of GEO-CM04S1 in one of many immune-compromised patient populations. It is also complementary to the pending start of a BARDA-funded 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine as a booster in healthy individuals. We look forward to sharing further progress reports on each of these programs.”

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 to initiate during the first half of 2025. 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:		Investor Relations Contact:		Media Contact:
info@geovax.com		austin.murtagh@precisionaq.com		sr@roberts-communications.com
678-384-7220		212-698-8696		202-779-0929