Purchases reflect strong confidence in the scientific differentiation and commercial potential of ateganosine
CHICAGO, Dec. 24, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that independent directors including Adelina Louie Ngar Yee and Stan V. Smith, Ph.D. purchased common stock and warrants in the recent private placement offering which closed on December 22, 2025.
Three directors purchased a total of 179,737 shares and 179,737 warrants with an average purchase price of $1.224. Dr. Smith has invested in all of MAIA’s funding rounds since the Company’s inception in 2018, and Ms. Adelina Louie is a top investor in MAIA. Gross proceeds from the offering totaled approximately $1.51 million.
To date, directors and officers hold 5,019,857 shares or 13.43% of MAIA.
“Ongoing support from our directors reflects their strong conviction in the commercial potential of ateganosine, our first-in-class anticancer treatment for advanced non-small cell lung cancer (NSCLC),” said Vlad Vitoc, M.D., founder and CEO of MAIA. “Consistent insider participation in our 2025 financings strengthens our ability to execute as we advance our pivotal Phase 3 international trial launched this month with first patient dosing.”
Dr. Smith commented, “Our continued support reflects our strong confidence in the scientific differentiation and commercial promise of ateganosine. The initiation of the pivotal Phase 3 trial marks an important value-creation milestone for MAIA.”
Ms. Adelina Louie stated, “I believe MAIA has reached a pivotal stage in advancing life-changing therapies to broad populations of patients with cancer, and I am proud continue to support the Company in my capacity as both an investor and a member of the Board.”
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine for the treatment of NSCLC. Statistical assessments of the Phase 3 trial point to a very high probability of technical success for regulatory approval of ateganosine.
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
Atlanta, GA, December 19, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into definitive securities purchase agreements with several institutional and individual investors for the purchase and sale of approximately 13.2 million units, each comprised of one share of the Company’s common stock and warrants, as described below, to purchase shares of the Company’s common stock, at a price of $0.245 per unit in a public offering. The Company will issue warrants to purchase up to approximately 26.5 million shares of common stock. The warrants will have an exercise price of $0.245 per share, will be exercisable immediately following the date of issuance and will have a term of five years following the date of issuance.
Roth Capital Partners is acting as the exclusive placement agent for the offering.
The gross proceeds to the Company from this offering are expected to be approximately $3.2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. The closing of the offering is expected to occur on or about December 22, 2025, subject to the satisfaction of customary closing conditions.
The shares in the offering described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-292127) previously filed with the Securities and Exchange Commission (the ‘SEC’) and declared effective by the SEC on December 19, 2025. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA 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: 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.
EMA Concurrence Enables Acceleration Toward Phase 3 Initiation and Represents a Major Milestone on GeoVax’s Path to Commercialization
ATLANTA, GA – December 18, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today announced that it has received formal Scientific Advice (SA) from the European Medicines Agency (EMA) confirming regulatory alignment on the Company’s proposed pivotal Phase 3 immunobridging trial design for GEO-MVA, its Modified Vaccinia Ankara (MVA)-based vaccine candidate for the prevention of Mpox and smallpox.
The EMA’s feedback concurs with GeoVax’s proposed strategy to evaluate GEO-MVA through a single, pivotal Phase 3 immuno-bridging study versus the approved MVA vaccine, Imvanex®, and supports the Company’s plan to proceed directly into this trial without the need for additional Phase 1 or Phase 2 clinical studies. Receipt of this formal Scientific Advice represents a significant regulatory milestone and enables GeoVax to accelerate operational planning toward implementation and initiation of the Phase 3 program, currently projected to begin in the second half of 2026.
“This formal Scientific Advice from EMA represents a pivotal step forward for GEO-MVA and meaningfully de-risks our regulatory path in Europe,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “EMA’s concurrence positions GeoVax to move efficiently toward a single, registrational Phase 3 study. This is a major milestone on our path toward commercialization.”
The Scientific Advice confirms that non-inferiority immunogenicity endpoints are acceptable to support a future Marketing Authorization Application (MAA) and that GeoVax’s proposed clinical safety database is sufficient to support registration, assuming successful trial outcomes. Importantly, EMA’s feedback provides clarity and confidence across proposed clinical and quality dimensions, allowing the Company to focus on execution rather than redesign of its development strategy.
The receipt of this advice follows GeoVax’s previous announcement of favorable preliminary EMA guidance announced in June 2025 and marks the transition from regulatory alignment to regulatory execution. Together, these milestones substantially strengthen GEO-MVA’s development profile and reinforce its potential role in expanding global Mpox and smallpox vaccine supply beyond the current single-supplier paradigm.
“With formal EMA Scientific Advice now in hand, GEO-MVA moves from a conceptual regulatory pathway to a clearly defined and executable development plan,” Dodd added. “As global health authorities continue to emphasize preparedness, resilience, and diversification of vaccine supply, we believe GEO-MVA is well positioned to play an important role.”
About GEO-MVA
GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine candidate being developed for the prevention of Mpox and smallpox. GEO-MVA leverages the well-characterized MVA platform and is designed to support both civilian public health needs and broader preparedness objectives.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA 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: 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.
Animal Models Show Full Protection Against Omicron Variant Despite Absence of Neutralizing Antibodies, Highlighting Critical Importance of T-cell Immunity for Next-generation COVID-19 Vaccines
ATLANTA, GA – December 18, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and cancer, today announced the publication of a peer-reviewed article in Frontiers in Immunology titled: “Multi-antigen MVA-vectored SARS-CoV-2 vaccine, GEO-CM04S1, induces cross-protective immune responses to ancestral and Omicron variants.”
The study provides definitive preclinical evidence that GeoVax’s multi-antigen COVID-19 vaccine candidate, GEO-CM04S1, delivers full cross-variant protection, driven predominantly by robust T-cell responses, even in the absence of neutralizing antibodies.
The findings reinforce the design philosophy behind GeoVax’s MVA-based, multi-antigen platform and provide mechanistic insight that is increasingly relevant for immunocompromised individuals, who often fail to respond optimally to the first-generation COVID-19 vaccines.
Study Highlights: Multi-Antigen Breadth and T-Cell Immunity Drive Protection
The study evaluated GEO-CM04S1 in the K18-hACE2 lethal mouse model, comparing immune responses and efficacy to experimental MVA-vectored vaccine constructs expressing spike alone (S) or nucleocapsid alone (N). Key findings include:
Full protection against both ancestral B.1 and Omicron XBB.1.5: Only GEO-CM04S1 (S+N) maintained 100% survival, preventing weight loss, severe lung inflammation, and virus replication in both upper and lower airways.
Protection against XBB.1.5 occurred despite no detectable neutralizing antibodies: Neutralization assays showed zero detectable neutralizing activity against XBB.1.5 in any group – yet GEO-CM04S1-vaccinated animals were fully protected. This indicates immunity was not antibody-dependent.
CD4+ T cells were identified as the critical effector of protection: Antibody-mediated depletion studies showed:
Loss of CD4+ T cells eliminated vaccine protection, leading to high viral loads and severe lung pathology.
Depletion of CD8+ T cells or B cells had minimal impact on vaccine efficacy.
These results confirm T cell responses as the critical component of vaccine-induced immune responses capable of providing cross-variant protection.
Multi-antigen design (Spike + Nucleocapsid) outperformed spike-only vaccines: GEO-CM04S1 delivered broader and more durable immunity than spike-only MVA vaccines – especially when spike was mismatched to circulating variants.
“This publication provides significant evidence supporting the unique value of a multi-antigen designed to induce high levels of T-cell responses and validates the core design principles that differentiate our vaccine from first-generation, spike-only approaches,” said Mark Newman, PhD, Chief Scientific Officer of GeoVax.
Dr. Newman added: “These findings support the belief that the GEO-CM04S1 vaccine could be a highly relevant product for use in immunocompromised patients, because of the ability to protect through strong, multi-antigen T-cell immunity.”
“This peer-reviewed study provides a compelling scientific foundation for the ongoing clinical advancement of GEO-CM04S1,” stated David Dodd, Chairman & CEO of GeoVax. “As SARS-CoV-2 continues to evolve, it is increasingly clear that next-generation vaccines must move beyond spike-only strategies. GEO-CM04S1 demonstrates the breadth, durability, and variant-proof characteristics that global public-health leaders have been calling for.”
Dodd continued: “More than 40 million immunocompromised individuals in the U.S. alone remain underserved by existing vaccines. The results published in Frontiers in Immunology strengthen the rationale behind our multiple ongoing Phase 2 studies in immunocompromised patient populations.”
About GEO-CM04S1
GEO-CM04S1 is an MVA-vectored vaccine encoding both the Spike (S) and Nucleocapsid (N) proteins from SARS-CoV-2, designed to induce:
Strong CD4+ and CD8+ T-cell responses
Durable immunity supported by conserved N-protein recognition
Multi-antigen breadth that mitigates loss of protection as the virus mutates
GEO-CM04S1 is currently being evaluated in multiple Phase 2 clinical trials in immunocompromised patients, including individuals with hematologic cancers and chronic lymphocytic leukemia.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA 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: 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.
CDI-988 is the first oral broad-spectrum antiviral drug candidate for potential prevention of norovirus outbreaks and treatment of acute viral gastroenteritis caused by norovirus infection
There are no approved treatments or vaccines currently available for norovirus infection
BOTHELL, Wash., Dec. 18, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the approval from the Institutional Review Board (IRB) at Emory University School of Medicine to initiate a Phase 1b human challenge study with CDI-988. This study aims to evaluate CDI-988 as both a preventive and treatment for norovirus infections. Initial screening of study subjects is currently underway, with enrollment expected to begin in the first quarter of 2026. The IRB approval from Emory University School of Medicine follows Cocrystal’s prior regulatory milestones, including U.S. Food and Drug Administration (FDA) clearance of its investigational New Drug (IND) application.
CDI-988 is the first oral antiviral drug candidate developed for the prevention and treatment of norovirus acute gastroenteritis. It was specifically designed as a broad-spectrum inhibitor by targeting a highly conserved region of the viral 3CL protease of all noroviruses, including GII.4 and recently re-emerging GII.17.
The randomized, double-blind, placebo-controlled Phase 1b study will be conducted at Emory University and involve up to 40 healthy subjects ages 18-49. Participants will be screened and infected with the norovirus GII.2 (Snow Mountain Virus). The study’s primary efficacy endpoint is to assess the reduction in incidence of clinical symptoms, while the secondary efficacy endpoint focuses on the reduction in viral shedding and disease severity. The study will also assess the safety and pharmacokinetic profile of CDI-988. Additional information is available on clinicaltrials.gov.
“This approval from the Emory IRB marks a significant milestone in advancing our Phase 1b norovirus challenge study,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are very excited about collaborating with the Emory team, given their exceptional expertise in norovirus and experience in human challenge studies.
“Cocrystal’s norovirus challenge study is a critical step in addressing the global burden of norovirus outbreaks, which account for an estimated 700 million cases each year worldwide. We are committed to delivering innovative medicine for norovirus outbreaks and chronic norovirus infection among immunocompromised patients,” added Dr. Lee.
“CDI-988 may revolutionize the management of the highly contagious norovirus, which is known for quickly spreading in hospitals, nursing homes, cruise ships, schools, disaster relief sites, military settings and other semi-closed environments,” said James Martin, CFO and co-CEO. “Used as a prophylaxis, oral CDI-988 could offer a potential solution and add a new layer of defense.”
CDI-988 was designed with Cocrystal’s proprietary structure-based drug discovery platform technology. In August 2025 Cocrystal announced favorable Phase 1 safety and tolerability data from all CDI-988 dose cohorts including the highest dose of 1200 mg. In September 2025 the Company received a Study May Proceed Letter from the FDA for the Phase 1b challenge study.
About Norovirus
Norovirus is a common and highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. This debilitating illness causes an estimated 200,000 deaths worldwide each year, with a societal cost of approximately $60 billion. In the U.S., norovirus is responsible for about 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, with an estimated annual economic burden of $10.6 billion.
Cocrystal Pharma’s Structure-Based Drug Discovery Platform Technology
Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of novel broad-spectrum antivirals for the treatment of acute, chronic and potentially pandemic viral diseases.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our initiation of the norovirus study in the first quarter of 2026 and the potential of CDI-988 for norovirus infections. The words “believe,” “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. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, the possibility of a recession, the impact of future interest rate changes on the economy, tariffs and the resulting litigation, and geopolitical conflicts including those in Ukraine and Middle East on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with the planned norovirus study or subsequent studies as well as similar problems with our vendors and our current and any future clinical research organizations (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes and any adverse developments which may arise therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 and the Prospectus dated September 25, 2025. 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.
Milestone Advances Clinical Readiness and Reinforces Urgent U.S. Need for Domestic MVA Vaccine Capacity
ATLANTA, GA – December 17, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today announced the successful completion of fill-finish for the initial clinical batch of GEO-MVA, its next-generation Mpox/smallpox vaccine. The product has now entered final release evaluation, the concluding quality-control and compliance process required before shipment for clinical use, positioning the Company for Phase 3 immunobridging trial start-up activities in Q1 2026.
Clinical and Regulatory Milestone
Fill-finish – the sterile, cGMP-regulated process of filling, sealing, and packaging vaccine vials – marks the last manufacturing step before a vaccine may enter clinical study supply channels. With fill-finish complete and GEO-MVA now undergoing final release evaluation, GeoVax has moved into the final pre-clinical-deployment phase of its EMA-aligned clinical program.
In June 2025, the European Medicines Agency (EMA) Scientific Advice confirmed that a single Phase 3 immunobridging study demonstrating immune comparability to the approved MVA vaccine, Imvanex®, would be sufficient to evaluate GEO-MVA’s efficacy. This provides a clear, accelerated regulatory path to licensure.
Strengthening U.S. and Global Pandemic Preparedness
This milestone coincides with increasing Mpox activity globally – including expanding Clade I outbreaks in Africa and emerging cases in the United States – exposing vulnerabilities associated with global dependence on a sole foreign MVA vaccine supplier. GEO-MVA is designed to expand supply, diversify sources, and strengthen biodefense infrastructure.
David Dodd, Chairman & CEO of GeoVax, commented: “Completion of fill-finish for GEO-MVA and progression into final release evaluation represent critical steps toward Phase 3 initiation and a pivotal advancement in our mission to support U.S. and global health security. America cannot remain dependent on a single foreign manufacturer for MVA-based biodefense vaccines. GEO-MVA provides a clear path toward a diversified and domestically controlled second-source supply – an essential component of modern pandemic preparedness. This milestone also underscores the strong operational progress we are delivering for our shareholders and partners.”
About GEO-MVA
GEO-MVA is a Modified Vaccinia Ankara (MVA)-based Mpox/smallpox vaccine designed to expand global vaccine availability at a time of constrained stockpiles and growing demand for resilient, scalable, and geographically diversified manufacturing capacity. GEO-MVA is a core asset within GeoVax’s broader MVA platform, which also includes next-generation COVID-19 and other infectious disease programs.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA 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: 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.
After several challenging years marked by higher interest rates, tighter capital markets, and depressed valuations, signs are emerging that the biotech sector may be on the cusp of a meaningful turnaround. One of the clearest indicators is the renewed pickup in mergers and acquisitions activity across biotech and pharmaceutical companies. Historically, periods of rising M&A have often preceded broader recoveries in biotech equities, particularly among small- and mid-cap names that have been trading at discounted valuations.
Large pharmaceutical companies are once again stepping up as active acquirers. Many face looming patent expirations that threaten billions of dollars in revenue over the next several years, creating urgency to replenish drug pipelines. Rather than relying solely on in-house research and development, big pharma is increasingly turning to acquisitions and strategic partnerships with innovative biotech firms that already have promising assets in development. This dynamic disproportionately benefits smaller biotech companies, which often lack the capital to fully commercialize therapies on their own but possess highly valuable intellectual property.
The macroeconomic backdrop is also becoming more supportive. Expectations around interest rate cuts play a critical role in driving this renewed activity. Biotech companies are capital-intensive by nature, frequently operating for years without meaningful revenue while funding clinical trials and regulatory processes. When interest rates are high, the cost of capital rises, making financing more difficult and suppressing valuations. As rates begin to fall—or even as markets anticipate easing—capital becomes cheaper and more accessible, enabling both buyers and sellers to transact more confidently.
Lower interest rates also have a powerful effect on biotech valuations. Because many biotech companies derive much of their value from future potential cash flows rather than current earnings, they are particularly sensitive to discount rates used in valuation models. When rates decline, the present value of future earnings increases, supporting higher valuations across the sector. This dynamic can help reverse the multiple compression biotech stocks experienced during the tightening cycle.
In addition, rate cuts tend to shift investor behavior toward a more “risk-on” environment. As yields on safer assets like bonds decline, investors are more inclined to seek growth opportunities in sectors such as biotech, where innovation and breakthrough therapies can drive outsized returns. Rising equity prices and improved sentiment, in turn, make biotech companies more attractive acquisition targets, reinforcing the M&A cycle.
For small-cap biotech investors, this combination of increased deal activity and improving macro conditions is particularly significant. M&A announcements often come with substantial acquisition premiums, providing immediate upside for shareholders and helping reprice comparable companies across the sector. Even firms that are not direct acquisition targets can benefit as investors reassess the strategic value of underappreciated pipelines and platforms.
While risks remain and selectivity is still critical, the resurgence of biotech M&A alongside a more favorable interest rate environment suggests that the sector’s prolonged downturn may be nearing its end. If rate cuts materialize and deal momentum continues, biotech—especially at the small-cap level—could be positioned for a sustained recovery rather than just a short-term bounce.
CHICAGO, IL, Dec. 16, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,233,488 shares of common stock at a purchase price of $1.224 per share, in a private placement to accredited investors and a Company director. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.36 per share, which price represents the “Minimum Price” as defined under NYSE American Rule 713 (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six-months following issuance and have a term of three years from the issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about December 18, 2025, subject to the satisfaction of customary closing conditions.
The gross proceeds from the offering are expected to be approximately $1.51 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the execution of Step 1 of Part C of the Phase II trial THIO -101 and for working capital.
The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) completion of the private placement, (ii) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (iii) our ability to advance product candidates into, and successfully complete, clinical studies, (iv) the timing or likelihood of regulatory filings and approvals, (v) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (vi) the rate and degree of market acceptance of our product candidates, (vii) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (viii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
Non-opioid analgesic shows efficacy in several animal pain models, including diabetic and chemotherapy-induced neuropathic pain
Compelling safety and pharmacokinetic profiles in animals support IND-enabling studies
CHATHAM, N.J., Dec. 16, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced licensing exclusive worldwide rights to TNX-4900 (formerly known as PW507), a highly selective small-molecule Sigma-1 receptor (S1R) antagonist with demonstrated analgesic activity in multiple models of neuropathic pain.
“Sigma-1 receptor antagonism has generated considerable scientific interest as a promising class of non-opioid, non-addictive analgesics,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “With our extensive experience studying and developing an FDA approved non-opioid analgesic we are well-positioned to oversee this new development program. We believe TNX-4900 has the potential to be best-in-class.”
Dr. Youyi Peng, co-inventor of TNX-4900, formerly a Senior Bioinformatics Specialist at the Rutgers Cancer Institute of New Jersey and now a consultant to Tonix, added, “We used computer-aided and AI-driven approaches to design this new class of selective Sigma-1 receptor antagonists. TNX-4900 showed robust analgesic efficacy in multiple pain models and an encouraging safety profile, supporting its potential as a new non-opioid approach to treating neuropathic pain.”
TNX-4900 was created from a structure-based drug design program led by Dr. Youyi Peng and Dr. William Welsh at Rutgers University that produced a series of potent and selective triazole-based S1R antagonists. The compound binds the human Sigma-1 receptor with nanomolar affinity (Ki = 7.5 nM), demonstrates > 100-fold selectivity over the Sigma-2 receptor, and exhibits high blood-brain barrier penetration and favorable adsorption, distribution, metabolism and elimination (ADME) properties, including oral bioavailability of approximately 28%.
“Our foundational research into TNX-4900 represents an important step toward developing non-opioid solutions for chronic pain. We are pleased to see this innovation progress toward potential clinical application, which could address a critical need for safer pain management options,” said Dr. William Welsh, Distinguished Professor in the Department of Pharmacology at Rutgers Robert Wood Johnson Medical School (RWJMS).
In preclinical models of diabetic and chemotherapy-induced neuropathic pain, TNX-4900 produced significant and durable reductions in pain behaviors after both acute and chronic dosing without evidence of tolerance or motor impairment. Tonix plans to advance TNX-4900 through expanded pharmacokinetic, formulation, and safety studies to support IND-enabling development.
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYATM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the-art infectious disease research facility in Frederick, Md.
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication under development.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DSMB Ends Comparator Arm; Trial Proceeds Exclusively With GEO-CM04S1 Following mRNA Vaccine’s Failure to Meet Primary Endpoint
Phase 2 Data Reinforce GEO-CM04S1 as an Important Next-generation Vaccine Candidate for the 40 Million U.S. and 400 Million Global Immunocompromised Patients Underserved by First-generation COVID-19 Vaccines
ATLANTA, GA – December 15, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today announced the publication of interim Phase 2 clinical data on its next-generation COVID-19 vaccine in patients with chronic lymphocytic leukemia (CLL).
The Research Letter in the British Journal of Haematology reports that GEO-CM04S1 met the study’s primary immunologic endpoint, generating significantly stronger and more durable SARS-CoV-2–specific T-cell responses than BNT162b2 (Pfizer-BioNTech) in patients with chronic lymphocytic leukemia (CLL) – a population known for poor vaccine responsiveness.
Importantly, following interim analysis, the trial’s Data and Safety Monitoring Board (DSMB) ruled to discontinue the randomized, double-blind comparator arm after the mRNA vaccine failed to meet the predefined primary immunogenicity endpoint. Enrollment is now proceeding exclusively in a single-arm cohort receiving GEO-CM04S1, as previously described in GeoVax’s clinical update at the European Hematology Association (EHA) 2025 Conference.
GEO-CM04S1’s superior performance in enhancing cellular immune response against SARS-CoV-2 in individuals with CLL, a patient population that generally responds sub optimally to vaccines designed to induce humoral (antibody) responses, underscores its potential to fill a protection gap for profoundly immunocompromised patients. More than 40 million adults in the U.S. and 400 million globally have some degree of compromised immunity, many of whom fail to mount meaningful responses to currently authorized COVID-19 vaccines. GEO-CM04S1 is specifically designed to address this gap through its dual-antigen (Spike + Nucleocapsid), MVA-based platform, which promotes robust, durable T-cell responses that are less impacted by immune dysfunction and viral variation.
Phase 2 Study Overview (NCT05672355)
CLL patients previously vaccinated with mRNA vaccines
31 enrolled; 27 evaluable for primary analysis
Primary endpoint: ≥3-fold rise in antigen-specific IFN-γ–secreting T cells at Day 56
40% of GEO-CM04S1 recipients met the primary endpoint vs. 14.3% for BNT162b2
Higher Spike-specific IFN-γ responses at Days 28, 56, and 84
2. Durable activation of Nucleocapsid-specific T cells
~10-fold higher N-specific CD4 T-cell activation vs. BNT162b2
Responses maintained through Day 180
3. Broader immune engagement in spite of CLL-associated humoral defects
GEO-CM04S1 generated sustained N-IgG and a correlation between N-specific antibodies and T-cell activation
mRNA vaccination produced higher early RBD-IgG titers but limited cellular immunity
Kelly T. McKee, MD, MPH, Chief Medical Officer, stated: “These results demonstrate GEO-CM04S1’s ability to address the immune limitations of CLL patients by inducing strong, durable T-cell responses to both spike and nucleocapsid proteins of SARS-CoV-2. The DSMB’s decision to discontinue the comparator arm further validates the vaccine’s clinical relevance for immunocompromised individuals.”
David Dodd, Chairman & CEO, added: “With more than 40 million immunocompromised Americans, many of whom lack durable protection from first-generation vaccines, GEO-CM04S1 represents a purpose-built solution for high-risk patients. This peer-reviewed publication strengthens our regulatory and partnering strategy as we advance toward potential commercialization.”
Medical and Commercial Significance
The findings published in BJH, combined with the DSMB’s action, reinforce the value of the differentiated profile of GEO-CM04S1 across multiple dimensions:
Critical unmet need: Immunocompromised individuals remain vulnerable and, in many cases, sub optimally protected from the threat of SARS-CoV-2.
Multi-antigen design: GEO-CM04S1’s dual-antigen design stimulates immune responses that appear to be more durable and variant-resilient than single-antigen mRNA approaches.
These segments represent a $30B+ annual potential commercial market.
About GEO-CM04S1
GEO-CM04S1 is a dual-antigen MVA-vectored COVID-19 vaccine being evaluated in multiple Phase 2 trials, including a primary vaccination for immunocompromised individuals, and a booster vaccination for CLL patients.
The vaccine has generated robust immune responses in difficult-to-vaccinate populations including CAR-T and stem-cell transplant recipients, who typically fail to respond well to first-generation vaccines.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA 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: 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.
PONTE VEDRA, FL / ACCESS Newswire / December 12, 2025 / Cadrenal Therapeutics (NASDAQ:CVKD) believes it continues to be misread by the market. Yes, the Company is intentionally narrowly focused. However, the lane it occupies is among the most undertreated areas in medicine. Anticoagulation for difficult-to-treat patients has not seen meaningful reinvention in decades. Warfarin persists due to a lack of innovation. DOACs dominate because alternatives have not evolved. Cadrenal is stepping into that void with therapeutics being designed for the specific patient groups who struggle most with a 70-year-old drug (warfarin).
Tecarfarin, the Company’s late-stage asset, is the kind of drug candidate you notice only after you understand how fragile the current standard really is. Patients with end-stage kidney disease plus atrial fibrillation and advanced comorbidities do not get predictable outcomes from existing anticoagulants. Tecarfarin was engineered to solve that problem. Stable. Controlled. Reversible. The design reflects clinical demands that have gone unanswered for years. This is where Cadrenal begins to differ. It is not trying to win a popularity contest. It is trying to find a better solution to the shortcomings of current therapies.
That shift has been visible since August. Cadrenal advanced manufacturing readiness. It added clinical depth inside the leadership ranks. And it expanded the pipeline in a way that instantly upgraded the company’s strategic position. The acquisition of VLX-1005, a Phase 2 program with Orphan Drug and Fast Track designations for Heparin-Induced Thrombocytopenia (“HIT”), is expected to be a game changer. It is a signal that Cadrenal intends to play on a larger scale.
Expansion That Changes the Stakes
With that, Cadrenal no longer behaves like a one-asset microcap. It behaves like a company constructing a multi-shot clinical platform inside the $40 billion anticoagulation market. The acquisition of a Factor XIa portfolio opened the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed. When you combine that with tecarfarin’s chronic-care positioning, you get a company with meaningful reach across multiple high-value treatment environments.
The addition of VLX-1005 further expands the pipeline. HIT is one of the most dangerous complications in hospital care, and treatment options remain limited. A Phase 2 asset with existing regulatory advantages gives Cadrenal an immediate foothold in a space where clinicians are hungry for better solutions. This kind of diversification is not common among companies of this size. It changes the conversation about Cadrenal’s potential.
The valuation does not appear to have kept pace with the expansion. The stock still appears to trade as if the Company is a single-asset story with a narrow path ahead. Meanwhile, Cadrenal sits on a portfolio with three mechanistic approaches and multiple clinical catalysts. That gap between perception and reality is where opportunity usually forms. It does not stay open forever.
Underdog Periods Have an Expiration Date
Investors are beginning to rediscover the story. Still, it appears the market continues to price Cadrenal for what it was, not for what it is building. Companies that solve real problems in anticoagulation do not stay in microcap territory. Not when they have differentiated assets, expanding clinical programs, and designations that potentially derisk the regulatory pathway. Cadrenal has put all those elements in motion.
This could be the last period during which anyone can underestimate the Company. Tecarfarin is approaching Phase 3 trial readiness. VLX-1005 is entering a phase where clinical data becomes increasingly important. The Factor XIa platform gives the company hospital relevance that most microcaps never achieve. These are not theoretical advantages. They exist today. And bigger companies are hungry to add late-stage assets to their portfolios, and many of their drugs are coming off patent in this decade.
The underdog label still fits, but potentially not for long. Cadrenal is preparing for a set of milestones that are expected to lead to a reevaluation upon their arrival. The market has been slow to adjust, but pipelines like this eventually speak loudly. When Cadrenal’s data hits, the story could flip from overlooked to obvious, and the window for catching the mispricing could close fast.
About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.
Safe Harbor
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the Company being misread by the market; Warfarin persisting due to a lack of innovation; designing therapeutics for patient groups who struggle most with a 70-year-old drug; finding a better solution to the shortcomings of current therapies; the acquisition of VLX-1005, a Phase 2 program with Orphan Drug and Fast Track designations for HIT being a game changer; signaling Cadrenal intends to play on a larger scale; the acquisition of a Factor XIa portfolio opening the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed; the conversation about Cadrenal’s potential; the gap between perception and reality being where opportunity usually forms; investors beginning to rediscover the story; this being the last period during which anyone can underestimate the Company; Tecarfarin approaching Phase 3 trial readiness; the underdog label still fitting, but potentially not for long; preparing for a set of milestones that are expected to lead to a reevaluation upon their arrival, and the story flipping from overlooked to obvious; and the window for catching the mispricing closing fast when Cadrenal’s data hits. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to use the acquisition of a Factor XIa portfolio to open the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Accuracy & Disclosure Statement: Hawk Point Media Group, LLC (HPM) has been retained by IR Agency, Inc. to provide press releases, editorial insights, and digital media production for Cadrenal Therapeutics. This content is sponsored. For services rendered from December 12, 2025 through December 16, 2025, HPM has been compensated ten thousand dollars (USD) via wire transfer for content creation and syndication related to Cadrenal Therapeutics. The information contained herein is based on sources believed to be accurate and reliable at the time of creation, including publicly available filings, company disclosures, and direct website content. This material is provided for informational purposes only and should not be interpreted as investment advice, a recommendation, or an offer to buy or sell any security.
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CHICAGO, Dec. 11, 2025 (GLOBE NEWSWIRE) — Ateganosine (THIO, 6-thio-2′-deoxyguanosine), a first-in-class telomere-targeting therapy under development by MAIA Biotechnology (NYSE American: MAIA), appears to be gaining increasing attention in the oncology community as emerging clinical results continue to surpass expectations in advanced non-small cell lung cancer (NSCLC). With the therapy’s Phase 2 trial ongoing and a pivotal Phase 3 program initiated this week, ateganosine is being closely watched as one of the most distinctive investigational approaches in solid-tumor treatment today.
We believe that MAIA has positioned itself at the forefront of a new scientific category in oncology. To our knowledge, Ateganosine remains the only direct telomere-targeting anticancer agent currently in clinical development anywhere—a key distinction in a treatment landscape where most therapeutic advances build upon established mechanisms rather than introduce entirely new ones.
According to management, statistical assessments of the Phase 3 trial points to a very high probability of technical success for regulatory approval of ateganosine.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine for the treatment of NSCLC.
A Dual Mechanism Unlike Existing Therapies
Ateganosine works through a dual mechanism of action that we believe differentiates it from existing chemotherapies, targeted agents, and immunotherapies.
First, the molecule is selectively incorporated into cancer-cell telomeres by telomerase, an enzyme active in more than 80% of human cancers. This incorporation disrupts telomeric structure and function, driving selective cancer-cell death.
Simultaneously, this disruption generates micronuclei carrying ateganosine-modified telomeric DNA fragments. These fragments interact with immune cells and trigger a potent immunogenic response involving both the cGAS/STING innate pathway and adaptive T-cell activation, further promoting tumor regression.
This integrated telomere-targeting–plus–immune-activation model represents a mechanism that to our knowledge is not seen in current NSCLC treatments and may hold implications for broader solid-tumor indications.
Phase 3 Outcomes are the Next Step
The launch of a Phase 3 trial reflects growing confidence in the maturing clinical profile. With NSCLC remaining one of the largest and most challenging oncology markets globally, in our opinion, the commercial opportunity for a first-in-class therapy with this level of early performance is substantial.
As the only telomere-targeting agent in clinical development that we are aware of, ateganosine could mark the start of a new therapeutic category. Should its results to date translate into later-stage confirmation, we believe the therapy could emerge as a major entrant in next-generation cancer treatment.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
Continued Mpox Evolution Underscores Dependence on a Single Global Supplier, Reinforcing the Critical Importance of GeoVax’s Accelerated GEO-MVA Program
Atlanta, GA – December 11, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today addressed reports from UK health authorities confirming the emergence of a newly evolved “recombinant” Mpox strain. Early analysis indicates the variant contains genetic elements from both Clade I and Clade II Mpox viruses, highlighting the ongoing evolution of the pathogen and the potential implications for disease severity, transmissibility, and vaccine readiness.
The discovery of this recombinant strain comes at a time when global Mpox vaccine supply remains concentrated in a single manufacturer – creating risks around preparedness, surge capacity, and geopolitical access. GEO-MVA is uniquely positioned in developing an expanded supply of MVA vaccine, bolstering domestic and global resilience.
GeoVax Highlights Strategic and Public Health Implications
The virus continues to evolve. Simultaneous circulation of multiple Mpox clades creates ongoing risk for recombination and changing outbreak behavior.
Global supply remains dangerously concentrated. A single-vendor global supply model heightens vulnerability for stockpile readiness and equitable vaccine distribution.
GEO-MVA is progressing as the first U.S.-based Mpox/smallpox vaccine. GeoVax aims to deliver a scalable, domestically manufactured solution that supports national biodefense and global supply diversification.
Clinical and manufacturing progress advancing: Final fill-finish activities of GEO-MVA are scheduled to be completed by year-end, with first-in-human studies planned upon regulatory clearance.
“The emergence of a recombinant Mpox strain is a timely reminder that viral evolution does not pause,” said David Dodd, Chairman & CEO of GeoVax. “With global vaccine supply dependent on a single provider, the risks to preparedness, national security, and market stability are clear. We are developing GEO-MVA to meet this strategic need – a U.S.-manufactured Mpox vaccine capable of supporting both domestic requirements and global demand.”
Favorable EMA Development Pathway Accelerates GEO-MVA
GeoVax recently received positive Scientific Advice from the European Medicines Agency (EMA) confirming that the Company may proceed directly to a single Phase 3 immuno-bridging trial with no Phase 1 or Phase 2 trials required to support a Marketing Authorization Application (MAA) for GEO-MVA. The EMA’s Committee for Medicinal Products for Human Use (CHMP) also affirmed the adequacy of GeoVax’s proposed nonclinical package and agreed with the Company’s immunogenicity endpoints for demonstrating non-inferiority to the licensed comparator vaccine.
This guidance provides a significant acceleration of the regulatory timeline, a de-risked development path, and a potentially earlier commercialization opportunity across all 27 EU member states. As reinforced in a subsequent regulatory communication, the EMA’s pathway positions GeoVax for expedited approval, reduced development cost, and earlier revenue generation as the Company advances GEO-MVA toward Phase 3.
About GEO-MVA
GEO-MVA is GeoVax’s next-generation Modified Vaccinia Ankara (MVA)-based Mpox/smallpox vaccine, engineered to provide a durable, broad immune response with both civilian and biodefense (“dual-use”) applicability. Key attributes include:
U.S.-Based Manufacturing Pathway: GEO-MVA is being developed as the first U.S.-manufactured Mpox/Smallpox vaccine, reducing reliance on foreign suppliers and supporting national security priorities.
Dual-Use Capability: Designed to meet both public health needs and Strategic National Stockpile requirements.
Robust Multi-Antigen Immunity: MVA enables broad antigen presentation to support strong humoral and T-cell responses.
Scalable Modern Production: GeoVax’s planned transition to AGE1 continuous cell-line manufacturing is expected to expand output, reduce cost, and support global self-sufficiency.
Regulatory Momentum: EMA’s streamlined approach provides a clear, accelerated pathway for clinical advancement and commercialization.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA 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: 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.
