Tag: Biotechnology

Release – Cadrenal’s Anticoagulation Platform Is Expanding in a $40 Billion Market

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

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.

At the time of publication, HPM does not own, buy, sell, or trade securities of the companies covered. However, individuals or organizations that have retained HPM may hold shares of Cadrenal Therapeutics and may sell those shares during the coverage period. Such sales could place downward pressure on the stock price and result in financial loss for investors.

Any reproduction, redistribution, or syndication of this content must include this disclosure in full. This statement is provided in accordance with Section 17(b) of the Securities Act of 1933, the Federal Trade Commission’s Endorsement Guides, and other applicable laws governing sponsored communications and paid investor content.

Contact for this content:

info@hawkpointmedia.com

SOURCE: Cadrenal Therapeutics

Release – MAIA’s Ateganosine Surges Ahead with Breakthrough Momentum as Pivotal Phase 3 Trial Initiates

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

December 11, 2025 1:00pm EST Download as PDF

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.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

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Source: MAIA Biotechnology, Inc.

Released December 11, 2025

Release – GeoVax Addresses Identification of New Mpox Variant

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

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.

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com 

Release – MAIA Biotechnology Announces First Patient Dosed in THIO-104 Phase 3 Pivotal Trial Evaluating Ateganosine as Third-Line Treatment for Advanced Non-Small Cell Lung Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

December 11, 2025 9:00am EST Download as PDF

Key milestone achieved as Company advances clinical program to full approval trial of ateganosine sequenced with a checkpoint inhibitor in comparison to chemotherapy

CHICAGO, Dec. 11, 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 the first patient has been dosed in the Company’s THIO-104 Phase 3 pivotal trial evaluating the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) as a third-line treatment for advanced non-small cell lung cancer (NSCLC).

The multicenter, open-label trial of patients who are resistant to CPI and chemotherapy treatments, is designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 patients. MAIA has received regulatory approval to screen patients in Taiwan, Turkey, select European Medicines Agency (EMA) countries, and Georgia. Screening and enrollment are now underway.

“Our strategy to bring our telomere-targeting treatment to market is proceeding according to plan as we advance our ateganosine program to a Phase 3 trial. This larger trial will provide us a robust dataset to support our case for commercial approval by the U.S. FDA,” said Vlad Vitoc, M.D., CEO of MAIA. “We have many sites in several countries already screening patients, and with our first patient dosed, we have achieved a key milestone along our path to potential FDA commercial approval. We expect to see Phase 3 results consistent with Phase 2 trial data showing median survival of 17.8 months compared to approximately six months of survival from chemotherapy. We are confident that ateganosine could become the new treatment standard for patients suffering from this devastating disease.”

Ateganosine sequenced with a CPI has shown exceptional efficacy in third-line NSCLC patients. As of September 17, 2025, the observed progression free survival (PFS) in THIO-101 was 5.6 months, more than double the standard of care PFS of 2.5 months. One patient that began therapy in March 2023 has shown survival of 30 months, or 912 days. 

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine for the treatment of NSCLC.

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 THIO-104 Phase 3 Clinical Trial

THIO-104 is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine’s telomere-targeting anti-tumor activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives: (1) to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival (OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.

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.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Primary Logo

Source: MAIA Biotechnology, Inc.

Released December 11, 2025

Release – MAIA Leadership Continues Insider Buying in 2025 and Trial Data Signals Breakout Potential

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

December 11, 2025 8:00am EST Download as PDF

CHICAGO, Dec. 11, 2025 (GLOBE NEWSWIRE) — A recent round of open-market purchases marks another display of confidence as the small molecule telomere-targeting cancer therapy by MAIA Biotechnology, Inc. (NYSE American: MAIA) advances through mid- to late-stage clinical development. Newly filed disclosures show that CEO Dr. Vlad Vitoc and other board members acquired approximately 182,445 shares between November 21 and 28, 2025. Insiders’ participation has been viewed by the market as a strong signal of alignment, conviction, and belief in the long-term value creation potential of the ateganosine platform.

The latest insider buying arrives as ateganosine continues to deliver encouraging results. These outcomes have strengthened internal and external confidence that MAIA’s novel telomere-targeting approach may represent a meaningful new therapeutic pathway for patients with advanced non-small cell lung cancer (NSCLC).

Taken together—material insider buying at market prices, sustained insider participation across 2025 financings, and strengthening clinical signals—MAIA’s leadership continues to demonstrate a unified stance: confidence in the company’s strategy, confidence in ateganosine’s growing body of clinical evidence, and confidence in the opportunity ahead as the program advances toward later-stage development. To date, Directors and Officers hold 4,480,120 shares or 12.95% of the company.

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.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Primary Logo

Source: MAIA Biotechnology, Inc.

Released December 11, 2025

Release – MAIA Takes Aim at a $50B Immunotherapy Market with Breakthrough Telomere-Targeting Approach

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

December 10, 2025 2:00pm EST Download as PDF

CHICAGO, Dec. 10, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology (NYSE American: MAIA) – The treatment paradigm for advanced non-small cell lung cancer (NSCLC) is undergoing another shift. After a decade of targeted therapies and checkpoint inhibitors (CPIs) dominating headlines, MAIA believes that a new therapeutic class—telomere-targeting agents—is emerging for the population with substantial unmet medical need: patients without actionable mutations and who no longer respond to CPIs or chemotherapy.

This is a segment that existing therapies leave behind. And it is the segment where we believe that ateganosine, developed by MAIA, may soon become one of the most consequential entrants in years.

A Market Dominated by Checkpoint Inhibitors—But Vulnerable at Its Edges

CPI therapies remain the backbone of NSCLC treatment in patients who don’t have an actionable mutation. Collectively, the category generated approximately $50 billion in global sales in 2024, anchored by five major agents approved for NSCLC. The therapeutic concentration in lung cancer is striking:

  • >30% of all NSCLC drug sales come from CPIs
  • >40% of all CPI global sales originate from NSCLC alone

Merck’s Keytruda, the category-defining CPI, reported $29.5 billion in revenue in 2024, with NSCLC representing an estimated 30% of its total sales. Keytruda is expected to approach $35 billion by 2027—just before biosimilars begin entering the market in 2028.

While CPIs have transformed outcomes for some patients, in our opinion their limitations remain clear: patients without actionable mutations, and those who become CPI-refractory, still experience extremely poor prognosis and limited therapeutic benefit. We believe this treatment gap has become one of the industry’s largest unmet needs.

Telomere-Targeting: A New Pathway for a Hard-to-Treat Population

We believe that MAIA’s ateganosine represents the first drug in a new class. Unlike targeted therapies requiring EGFR, ALK, KRAS, or other mutations—and unlike immunotherapies dependent on PD-1/PD-L1 dynamics—ateganosine has been designed to exploit a universal feature of cancer cells: telomerase activity, present in more than 80% of human tumors.

Its dual mechanism has been designed to disrupt telomeres to trigger direct cancer cell death while simultaneously enabling the immune system to respond to cancer. MAIA was recently awarded Fast Track Designation by the U.S. FDA for the treatment of NSCLC in patients resistant to immunotherapy and chemotherapy, and is initiating a Phase 3 THIO-104 trial.

A Commercial Opportunity That Extends Across Oncology

With the NSCLC market now valued at $34.1 billion—projected to nearly double to $68.8 billion by 2033—the implications of a first-in-class therapy are substantial. In the United States alone, roughly 180,000 patients enter the NSCLC treatment ecosystem every year.

But ateganosine’s opportunity does not end with lung cancer. The candidate already carries FDA Orphan Drug Designations (ODDs) for:

  • Glioblastoma (market: $2.2B → $3.2B growth expected)
  • Hepatocellular carcinoma (HCC) (mortality: 0.8M; sales: $3.8B)
  • Small cell lung cancer (SCLC) (mortality: 0.3M; sales: $2.8B)

Each ODD offers seven years of U.S. market exclusivity upon regulatory FDA approval and access to tax credits—advantages that strengthen MAIA’s long-term market positioning.

A Strategic Inflection Point for the Entire NSCLC Treatment Landscape

The oncology market is poised for a shift as developers seek to fill in gaps in the treatment landscape. The next decade is expected to reward novel mechanisms, and in our opinioin advanced NSCLC represents the clearest example of that gap.

Telomere-targeting therapeutics may be the next foundation in that evolution. If ateganosine’s outcomes are successful, the therapy could become a defining entrant in a space where treatment failure has long been accepted as inevitable. Statistical assessments points to a high probability of technical success for regulatory approval of ateganosine.

In our opinion, MAIA is now positioned at the center of this turning point—scientifically and strategically.

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.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

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Source: MAIA Biotechnology, Inc.

Released December 10, 2025

Release – GeoVax Announces Addition of Renowned Global Experts to its Scientific Advisory Board

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Newly Appointed Members Include Leaders in Vaccine Immunology, T-Cell Science, and Clinical Research

Atlanta, GA -December 10, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancers, today announced an update to its Scientific Advisory Board (SAB), welcoming internationally recognized experts whose work spans vaccine design, T-cell immunology, viral pathogenesis, and immunocompromised-host medicine.

This strategic expansion is designed to support GeoVax’s current and future development efforts with MVA and its multi-antigen MVA vector platform for vaccines targeting biothreat pathogens and vulnerable or currently underserved populations such as those from low- and middle-income countries, and immunocompromised patients. Future additions to the GeoVax SAB will support its oncology immunotherapy pipeline.

Newly Announced SAB Members

Joining Prof. Teresa Lambe, PhD, OBE, FMedSci – Calleva Head of Vaccine Immunology, Oxford Vaccine Group / Jenner Institute, University of Oxford, whose appointment to the GeoVax SAB was previously announced, are the following:

  • Dr. Alessandro Sette, Dr of Biological Sciences – Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology

An authority in T-cell epitope mapping and immune correlates of protection, Dr. Sette leads the NIH Immune Epitope Database (IEDB) and is widely recognized by defining T-cell immunity across SARS-CoV-2, Mpox, and Ebola.

  • Prof. Lance Turtle, PhD, MBBS, FRCP, DTMH – Chair in Immunity and Infectious Diseases, University of Liverpool / Royal Liverpool Hospital

A clinician-scientist specializing in viral pathogenesis and post-infection immune recovery, Prof. Turtle’s research provides key translational insights into long-term immunity and emerging pathogen preparedness.

  • Prof. Thushan I. de Silva, MBBS, PhD, MRCP – Professor of Infectious Diseases and Immunology, University of Sheffield

An expert in human viral immunology, vaccine responses, and global immunosurveillance, Prof. de Silva leads studies across Europe, Asia, and Africa evaluating population-level vaccine immunity and viral evolution.

  • Dr. Joshua A. Hill, MD, FIDSA – Associate Professor, University of Washington School of Medicine / Fred Hutchinson Cancer Center

A leading infectious-disease expert focusing on vaccine response in immunocompromised and transplant patients, Dr. Hill’s work aligns with GeoVax’s emphasis on protecting high-risk, under-served populations.

David Dodd, GeoVax Chairman & CEO, commented: “By assembling this exceptional team of global experts, we are further strengthening GeoVax’s position at the forefront of vaccine innovation. Their combined experience – from antigen design to human immunology and clinical translation – perfectly aligns with our mission to deliver durable, broad-spectrum protection to both global and immunocompromised populations.”

Dr. Kelly McKee, Chief Medical Officer, added: “The addition of these renowned experts ensures that our clinical strategy is guided by cutting-edge immunology insight and global research expertise. Their collaboration will be instrumental as GeoVax advances vaccines and immunotherapies designed to protect those who remain most vulnerable – particularly those in low and middle income countries (LMICs), and immunocompromised patients who have been underserved by traditional approaches or currently available vaccines”

Dr. Mark Newman, Chief Scientific Officer, stated: “This expanded SAB strengthens multiple aspects of our R&D platform. With direct input from some of the world’s most respected scientific leaders, we can ensure that our vaccine and immunotherapy candidates deliver real-world impact.”

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.

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com 

Release – GeoVax Announces Issuance of U.S. Patent Covering Enhanced Therapeutic Use of Gedeptin® Gene Therapy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

  • Last updated: 09 December 2025
  • Created: 09 December 2025
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Patent Protects Novel Application of Gedeptin Therapy Across Multiple Solid Tumor Types; Supports Expansion of Gedeptin Product Platform 

ATLANTA, GA – December 9, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against cancers and infectious diseases, today announced the issuance of U.S. Patent No. 12,453,760, titled “Enhanced Therapeutic Usage of a Purine Nucleoside Phosphorylase or Nucleoside Hydrolase Prodrug”, by the United States Patent and Trademark Office (USPTO). The patent provides composition-of-matter and method-of-use protection for GeoVax’s Gedeptin® platform in combination with targeted delivery approaches for solid tumors, including head and neck cancer.

The newly issued patent, which extends through 2045, enhances the Company’s intellectual property estate for Gedeptin and its use across a range of solid tumor cancers — consolidating GeoVax’s leadership in the field of targeted gene therapies and supporting ongoing clinical development plans.

“The issuance of this patent marks an important milestone in the advancement and protection of GeoVax’s oncology pipeline,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “It underscores our commitment to progressing Gedeptin, both as a monotherapy and in synergistic combination with other oncology treatment approaches as we work to deliver meaningful treatment options for patients with difficult-to-treat solid tumors.”

The Company is actively preparing for a Phase 2 clinical trial evaluating Gedeptin as a first-line therapy in combination with pembrolizumab (Keytruda®) in resectable head and neck cancer, in line with the recent shift toward neoadjuvant checkpoint strategies. Additional preclinical programs are assessing Gedeptin across other tumor types, including breast and cutaneous cancers.

About Gedeptin®

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) designed for targeted use in solid tumors. Delivered via a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP) and followed by systemic fludarabine, Gedeptin generates localized cytotoxic activity within tumors while minimizing systemic toxicity. The therapy has demonstrated safety and disease control in a multi-center Phase 1/2 trial in patients with advanced head and neck cancer and has received FDA Orphan Drug Designation for oral and pharyngeal cancers.

GeoVax plans to advance Gedeptin into a Phase 2 trial in combination with pembrolizumab (Keytruda®) as a neoadjuvant regimen for resectable head and neck squamous cell carcinoma, supported by recent clinical data validating the role of immune checkpoint inhibitors in perioperative settings. Additional preclinical work is underway to assess Gedeptin combinations across other solid tumors.

Key Advantages of Gedeptin

  • Localized, tumor-selective cytotoxicity
  • Tumor agnostic – expansion potential across multiple solid tumors
  • Synergistic potential with checkpoint inhibitors
  • Favorable safety profile and orphan drug designation
  • Strong patent protection through 2045

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.

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com 

Release – Tonix Pharmaceuticals Appoints Irina Ishak as General Counsel

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

December 09, 2025 7:00am EST Download as PDF

Ms. Ishak brings more than 25 years of corporate legal and strategic leadership experience in the life sciences industry

CHATHAM, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated commercial-stage biotechnology company today announced the appointment of Irina Ishak as General Counsel, effective December 8, 2025. Ms. Ishak will lead Tonix’s legal, corporate governance, and compliance functions.

“Irina is a highly accomplished corporate and commercial attorney whose experience spans public and private life sciences companies, as well as advising life sciences investors,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “Her deep background in complex transactions, public company matters, and governance will be a significant asset as we commercialize our marketed products, advance our pipeline, manage our partnerships, and continue to execute on Tonix’s long-term strategy.”

Ms. Ishak joins Tonix from Lowenstein Sandler LLP, where she served since 2013 as Senior Counsel, and has advised Tonix since 2017 in structuring and negotiating financings, licensing and other strategic transactions, key commercial agreements, and employment-related contracts, and advising senior management and the Board of Directors on corporate strategy, governance, risk, and securities offerings and filings. In addition to Tonix, Ms. Ishak acted as outside general counsel, corporate secretary, and advisor to certain other public and private life sciences companies, as well as to investors. Previously, she was Senior Director, Legal and Assistant Corporate Secretary at Savient Pharmaceuticals, Inc., which developed, won US Food and Drug Administration (FDA) approval for, and launched KRYSTEXXA® (pegloticase), a biologic treatment for chronic gout in adults. Earlier in her career Ms. Ishak was a corporate associate at Fried, Frank, Harris, Shriver & Jacobson LLP. She received her J.D. from New York University School of Law and her B.A., with highest honors, from Rutgers College in New Brunswick, N.J.

“I am honored to join Tonix as General Counsel at such a pivotal moment in the Company’s evolution,” said Ms. Ishak. “Tonix has just launched the first therapy approved by the FDA for treating fibromyalgia in more than 15 years. Now the company is maximizing that science to expand into other conditions. It’s an exciting time at Tonix and there is immense opportunity to make a valuable contribution. I look forward to working closely with Seth, the leadership team, and the Board to support the Company’s next phase of growth.”

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 TONMYA™, 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.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals 
investor.relations@tonixpharma.com 
(862) 799-8599 

Brian Korb 
astr partners 
(917) 653-5122 
brian.korb@astrpartners.com 

Media Contacts
Mary Ann Ondish
Tonix Pharmaceuticals
maryann.ondish@tonixpharma.com

Ray Jordan 
Putnam Insights 
ray@putnaminsights.com 

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.

Indication and Usage
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released December 9, 2025

Release – GeoVax Announces JCO Oncology Advances Publication Highlighting Favorable Safety and Evidence of Disease Stability of Gedeptin® in Recurrent Head & Neck Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

  • Last updated: 08 December 2025
  • Created: 08 December 2025
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Phase 1/2 trial confirms safety with repeated dosing supporting further development in early-stage disease and combination treatment settings

ATLANTA, GA – December 8, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing novel immunotherapies and vaccines for solid tumor cancers and infectious diseases, today announced the publication of a peer-reviewed article in JCO Oncology Advances, the American Society of Clinical Oncology’s (ASCO) open-access journal.

The manuscript, titled “A Phase 1/2 Study of Intratumoral Ad/PNP (Gedeptin) with Fludarabine Phosphate in Subjects with Recurrent Head and Neck Cancer”, reports findings from a multi-center clinical trial evaluating repeated cycles of Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT), administered via intratumoral injection followed by systemic fludarabine.

Study Overview: Evaluating Repeated Dosing in a Highly Refractory Population

The Phase 1/2 trial enrolled patients with recurrent head and neck cancers who had exhausted all standard treatment options and had undergone a median of four prior lines of systemic therapy. Patients received therapy on a 28 day schedule, each consisting of intratumoral Gedeptin injections followed by intravenous fludarabine.

Key results from the publication include:

  • Acceptable safety profile with no new safety signals: Serious adverse events were uncommon and generally unrelated to treatment. No deaths were attributed to study therapy.
  • Clinical evidence of disease stability: Three of eight patients (37.5%) in this cohort of patients with end-stage disease achieved stable disease.
  • Successful tumor transduction and PNP transgene expression: Tumor biopsies confirmed uptake and expression of the therapeutic E. coli PNP transgene in all evaluable patients, supporting the mechanistic foundation of the Gedeptin platform.

Study results suggest that earlier intervention, higher vector dosing, improved tumor transduction, or combination therapy (e.g., with immune checkpoint inhibitors) may further increase efficacy. Preclinical findings cited in the manuscript show that Gedeptin-mediated tumor destruction may sensitize tumors to checkpoint inhibitors, offering a promising path forward.

J. Marc Pipas, MD, Executive Medical Director, Oncology of GeoVax, stated: “This publication reinforces the strong scientific rationale underpinning the Gedeptin platform. Even in a highly refractory patient population with extensive prior treatment, repeated intratumoral dosing of Gedeptin demonstrated a favorable safety profile and evidence of disease stability. Importantly, correlative analyses confirmed robust tumor transduction and PNP expression, a critical mechanistic milestone for gene-directed enzyme prodrug therapy.”

Kelly T. McKee, MD, MPH, Chief Medical Officer of GeoVax, added: “These results support the continued development of Gedeptin in settings where tumor burden is lower, patients are less heavily pretreated, or where combination strategies, particularly with immune checkpoint inhibitors, may amplify therapeutic benefit. This aligns with our strategy to advance Gedeptin into neoadjuvant studies for surgically resectable recurrent head and neck cancers.”

David Dodd, Chairman & CEO of GeoVax, stated: “The publication in the ASCO journal underscores both the scientific significance of this trial and the need for new approaches to treat recurrent head and neck cancers. Gedeptin’s targeted mechanism, combined with its repeat-dosing feasibility, offers a promising therapeutic option for patients. We look forward to expanding development into earlier disease settings and into rational combination regimens.”

About the Gedeptin® Platform

Gedeptin is a non-replicating adenoviral vector delivering the E. coli purine nucleoside phosphorylase (PNP) gene directly into tumor tissue. Following intratumoral injection, patients receive systemic fludarabine, which is converted in PNP-expressing tumor cells into a potent cytotoxic metabolite (2-fluoroadenine, F-Ade).

Key characteristics include:

  • Tumor-agnostic mechanism of action, driven by localized intratumoral activation of fludarabine into the potent cytotoxin F-Ade, enabling activity independent of tumor histology or proliferation rate.
  • Strong bystander effect, in which the activated F-Ade diffuses to neighboring cancer cells – allowing Gedeptin to kill tumor cells even when only a small fraction is directly transduced.
  • Immune-sensitizing properties that enhance tumor antigen visibility and may improve responses to immune checkpoint inhibitors.
  • Favorable safety profile, demonstrated across early Phase 1 and Phase 1/2 studies and supported by consistent tolerability in heavily pretreated solid tumor patients.

Gedeptin is now progressing toward combination-therapy in a neoadjuvant clinical program. Building on robust preclinical data showing that Gedeptin enhances tumor sensitivity to immune checkpoint blockade, GeoVax is advancing plans to evaluate Gedeptin with agents such as pembrolizumab aiming to strengthen antitumor immune activation.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumors. 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  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  our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com 

Release – NeuroSense to Hold Pre-NDS Meeting with Health Canada in April 2026

Posted on by aweinsoff@channelchek.com

Research News and Market Data on NRSN

CAMBRIDGE, Mass., Dec. 4, 2025 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that following a productive discussion with Health Canada (“Agency”), the Company is resuming its regulatory advancement in Canada for PrimeC in amyotrophic lateral sclerosis (ALS).

After outlining the remaining requirements, Health Canada confirmed that NeuroSense’s proposed next steps align with the Agency’s expectations. With additional clinical data recently generated and further supportive analyses underway, NeuroSense is now preparing for a pre-NDS meeting with Health Canada currently contemplated in April 2026.

Pending a successful outcome of this meeting and completion of the final submission components, the Company currently anticipates a potential NDS submission by mid-2026.

“This positive engagement reinforces our confidence in the regulatory pathway in Canada,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “We appreciate the constructive dialogue with Health Canada as we work to bring PrimeC to people living with ALS.”

Additional details regarding the Canadian submission and contemplated timelines will be provided during NeuroSense’s upcoming investor webinar on December 8th, 2025. Registration for the webinar is available here.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and Alzheimer’s Disease (AD) that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations, and include statements regarding the timing of a pre-NDA meeting with Health Canada and the timing of a potential NDS submission, and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of commencement of the Phase 3 trial. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk that the pre-NDA meeting with Health Canada will be delayed or not occur; that the potential NDS submission will be delayed or not occur; Phase 3 trial for PrimeC in ALS will not occur, or if it occurs, will be delayed; that the trial will not be successful; uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

SOURCE NeuroSense

For further information: For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183

Release – NeuroSense Receives FDA Clearance to Initiate Pivotal Phase 3 Trial for PrimeC in ALS

Posted on by aweinsoff@channelchek.com

Research News and Market Data on NRSN

CAMBRIDGE, Mass., Nov. 24, 2025 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed the review of the Investigational New Drug (IND) amendment application and authorized the Company to initiate the pivotal Phase 3 clinical trial for the evaluation of its lead drug candidate, PrimeC, for the treatment of amyotrophic lateral sclerosis (ALS).

With the FDA’s clearance, NeuroSense is preparing for trial initiation and aims to have its first patient enrolled in the coming months upon securing the strategic resources needed to launch the trial.

The global pivotal Phase 3 trial, PARAGON, is powered at over 95% to achieve its primary endpoint and to expand upon the results of NeuroSense’s Phase 2b PARADIGM trial, which demonstrated promising clinical and biomarker outcomes and a favorable safety and tolerability profile.

“This FDA clearance marks a meaningful advancement for NeuroSense and for people living with ALS. We believe this progress lays a strong foundation for additional achievements across several fronts in the near future,” stated Alon Ben-Noon, Chief Executive Officer of NeuroSense. “We recognize the significant unmet need of people living with ALS and remain committed to delivering a meaningful therapy through our efforts.” 

Based on prior successful discussions with the FDA and in line with its recent comments and recommendations, PARAGON is expected to be conducted in the U.S. and EU and include 300 people living with ALS randomized in a ratio of 2:1 (PrimeC : Placebo). The prospective, double-blind, 12-month placebo-controlled trial, has an open label extension to evaluate safety and efficacy of PrimeC. The trial will employ an adaptive design allowing for interim analyses to optimize sample size and assess early efficacy and futility boundaries.

Additional details regarding the PARAGON trial design and timelines will be provided in NeuroSense’s upcoming investor webinar on December 8th, 2025 and on NeuroSense’s website. Registration to the webinar is available here.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and Alzheimer’s Disease (AD) that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of commencement of the Phase 3 trial. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk that the Phase 3 trial for PrimeC in ALS will not occur, or if it occurs, will be delayed; that the trial will not be successful; uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

Logo – https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

SOURCE NeuroSense

For further information: For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183

Release – Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

November 24, 2025 7:00am EST Download as PDF

Tonix plans to initiate potential pivotal Phase 2 HORIZON study of TNX-102 SL in adults with major depressive disorder in mid-2026

More than 21 million US adults experience a major depressive episode each year

CHATHAM, N.J., Nov. 24, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support clinical development of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of major depressive disorder (MDD) in adults.

“There is a clear need for innovative therapies that address depression,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe TNX-102 SL offers a promising approach for individuals suffering from MDD. The unique pharmacological profile of TNX-102 SL is designed to target the disruptive sleep which is often associated with depression. Prior studies of TNX-102 SL in fibromyalgia and post-traumatic stress disorder (PTSD) showed promising signals for improvement of depressive symptoms on the Beck Depression Inventory-II and the Montgomery-Asberg Depression Rating Scale (MADRS), respectively. We are excited to advance TNX-102 SL and look forward to evaluating its potential as a new treatment option for those affected by depression.”

The IND clearance enables Tonix to proceed with the potentially pivotal Phase 2 HORIZON study, a 6-week, randomized, double-blind, placebo-controlled study of TNX-102 SL as a first-line monotherapy in adults with MDD. About 360 patients will be enrolled at approximately 30 U.S. sites. Eligible participants are 18 years or older and currently experiencing a moderate to severe major depressive episode. The study will compare TNX-102 SL 5.6 mg, taken sublingually at bedtime to placebo, with the primary endpoint being the MADRS total score change from baseline at Week 6. Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep disturbance. Tonix plans to initiate enrollment of the study in mid-year 2026.

“TNX-102 SL is designed to target the disturbed sleep of depression, which is a novel mechanism of action,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “TNX-102 SL has been generally well tolerated in registrational studies of fibromyalgia patients. In the fibromyalgia studies, TNX-102 SL treatment was associated with a low incidence of side effects common with traditional antidepressants like weight gain, blood pressure changes, sexual dysfunction and cognitive issues.”

About Major Depressive Disorder
Major Depressive Disorder (MDD) is a prevalent and serious psychiatric illness that affects adults of all ages, races, and backgrounds. It is characterized by persistent feelings of sadness or loss of interest, along with symptoms such as sleep and appetite disturbances, fatigue, difficulty concentrating, and thoughts of worthlessness or suicide. These symptoms must last at least two weeks and significantly impair daily functioning. In the United States, more than 21 million adults experience a major depressive episode each year. While several antidepressant medications are available, many individuals do not achieve adequate relief or discontinue treatment due to side effects like weight gain, sleep disruption, and sexual dysfunction. MDD is associated with increased risk of suicide and substantial impairment in quality of life, underscoring the urgent need for new, first-line therapies that are both effective and well-tolerated.

About TNX-102 SL
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride that enables rapid transmucosal absorption and reduces production of the persistent active metabolite, norcyclobenzaprine, by bypassing first-pass hepatic metabolism. TNX-102 SL is a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. It is currently FDA approved in the U.S. as a once-daily bedtime treatment for fibromyalgia in adults under the brand name TONMYATM (cyclobenzaprine HCl sublingual tablets). TNX-102 SL is also in development as a daily bedtime treatment for acute stress reaction/acute stress disorder under an Investigator-initiated IND. In addition to MDD, Tonix also holds active INDs for the following indications for TNX-102 SL: Long COVID (post-acute sequelae of COVID-19), PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patents are important elements of Tonix’s proprietary composition. These patents are expected to provide TNX-102 SL U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.

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 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.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals 
investor.relations@tonixpharma.com 
(862) 799-8599 

Brian Korb 
astr partners 
(917) 653-5122 
brian.korb@astrpartners.com 

Media Contacts
Mary Ann Ondish
Tonix Pharmaceuticals
maryann.ondish@tonixpharma.com

Ray Jordan 
Putnam Insights 
ray@putnaminsights.com 

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.

Indication and Usage
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Source: Tonix Pharmaceuticals Holding Corp.

Released November 24, 2025