Category: Health

Release – Nutriband Selects Commercial Brand Name for Its Abuse Deterrent Fentanyl Patch

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Research News and Market Data on NTRB

Nutriband has selected the commercial worldwide brand name for its lead product, an abuse deterrent fentanyl transdermal system, and will submit to the FDA for approval per FDA Guidance.

Nutriband partnered with Brand Institute, Inc, the global leader in pharmaceutical and healthcare-related brand name and identity development.

ORLANDO, Fla., March 30, 2026 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has selected the commercial worldwide brand name candidate for its lead product, an abuse deterrent fentanyl transdermal system. The proposed brand name and product labeling will be submitted to the FDA and other international regulatory agencies for review and approval. In addition, the selected name is being submitted to the United States Patent and Trademark Office for trademark registration and to secure full intellectual property rights in the United States and internationally.

The company engaged Brand Institute, Inc, the global leader in pharmaceutical and healthcare-related brand name and identity development services to develop the worldwide commercial brand name and visual identity for the product. This product utilizes Nutriband’s AVERSA™ abuse deterrent transdermal technology and has the potential to be the world’s first abuse-deterrent patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl.

Nutriband’s abuse deterrent fentanyl transdermal system has the potential to reach peak annual US sales of $80 million to $200 million.1 While initially concentrating on the US market, the unmet medical need for adequate pain management is a global problem, and the product is in development for all major medical markets worldwide.

Developing a proprietary brand name for a prescription drug product is a critical element in drug product development because the end users (doctors, pharmacists, patients) must be able to easily distinguish a proprietary name from other drug names that are phonetically similar (sound-alike names) or similar in their spelling or appearance (look-alike names). In addition, if the drug name is otherwise confusing or misleading, the patient might receive the wrong product and the subsequent medication error could lead to significant harm to the patient.

Brand Institute has been leading the market for over 20 years with a 75% share of drug name approvals globally, including 87% of FDA approved names in 2024. In addition, Brand Institute has been responsible for many of the opioid chronic pain product brand names and specifically a majority of the abuse deterrent opioid product brand names approved by FDA for sale in the United States.

Drug Safety Institute (DSI), a wholly owned regulatory subsidiary of Brand Institute, will provide regulatory services, solutions and support on the project. DSI is led by former officials from US Food & Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), United States Adopted Name Council (USAN), and World Health Organization (WHO) who co-authored the naming guidance documents while with their former respective agencies.

Nutriband’s AVERSA™ abuse-deterrent technology is utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

1 Health Advances Aversa Fentanyl market analysis report 2022

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband, Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

About Brand Institute, Inc., and wholly owned regulatory subsidiary, Drug Safety Institute

Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 5,000 marketed healthcare brand names and 1,800 USAN/INN nonproprietary names for nearly 1,600 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers. Drug Safety Institute is composed of former naming regulatory officials from global government health agencies, including Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines while with their former respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications to ensure safety and prevent medication errors. To learn more about Brand Institute’s capabilities and experience, please visit www.brandinstitute.com and contact your local Brand Institute representative.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Forms 10-K’s and Forms 10-Q’s, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Nutriband is a registered trademark of Nutriband, Inc. AVERSA is a trademark of Nutriband, Inc.

Brand Institute and Drug Safety Institute are registered trademarks of Brand Institute, Inc.

Release – NeuroSense Therapeutics Reports Year End 2025 Financial Results and Provides Business Update

Posted on by [email protected]

Research News and Market Data on NRSN

  • 2025 marked transition of PrimeC into a late-stage clinical asset with FDA-cleared Phase 3 program in ALS
  • Statistically significant survival benefit demonstrated, including 65% reduction in risk of death and >14-month median survival advantage
  • Results published in JAMA Neurology, providing high-level peer-reviewed validation of clinical and biological activity
  • Advancing toward key regulatory milestones with planned pre-NDS meeting in Canada and near-term Alzheimer’s readout

CAMBRIDGE, Mass., March 31, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense” or the “Company”), a late-stage clinical biotechnology company developing treatments for severe neurodegenerative diseases, today reported its financial results for the year ended December 31, 2025 and provided a business update.

“2025 was a transformational year for NeuroSense, as we advanced PrimeC from a successful Phase 2b program into a late-stage clinical asset with a clear regulatory path forward,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “As we entered 2026, we further strengthened our clinical and scientific foundation with statistically significant survival data and publication of our results in JAMA Neurology. Together, these milestones position PrimeC as a differentiated therapeutic candidate with the potential to meaningfully impact people with ALS and potentially other neurodegenerative diseases.”

Business Highlights from 2025

2025 marked a transformative year for NeuroSense, as the Company advanced PrimeC from a successful Phase 2b program into a late-stage clinical asset with a clearly defined regulatory and development pathway. Results from the Phase 2b PARADIGM study demonstrated approximately 33% slowing in disease progression over 18 months, alongside a substantial reduction in ALS-related complications. During the year, NeuroSense further strengthened its data package through additional biomarker analyses, including microRNA data, supporting the biological activity of PrimeC, supporting PrimeC’s potential as a disease-modifying therapy.

The Company also completed commercial-scale manufacturing and advanced its regulatory strategy, including engagement with Health Canada and ongoing partnership discussions.

Importantly, in November 2025, NeuroSense received FDA clearance to initiate the PARAGON Phase 3 trial in ALS, marking a key inflection point in the Company’s development trajectory.

NeuroSense also reported early signals of biological activity and statistically significant reductions in key biomarkers associated with Alzheimer’s disease, supporting broader potential across neurodegenerative diseases.

Recent Developments and First Quarter 2026 Highlights

Since the beginning of 2026, NeuroSense has continued to strengthen PrimeC’s position through significant clinical and scientific milestones. The Company reported statistically significant survival data from its Phase 2b study, demonstrating a 65% reduction in the risk of death and a greater than 14-month median survival benefit.

Further reinforcing the strength of its clinical package, results from the PARADIGM trial were published in JAMA Neurology, highlighting meaningful clinical outcomes and biological activity, including biomarker changes consistent with the proposed mechanism of action.

NeuroSense also expanded its scientific visibility through presentations at leading international conferences and strengthened its intellectual property portfolio with newly granted patents in the United States and internationally. In addition, the Company enhanced its Scientific Advisory Board with leading experts to support continued development in ALS and Alzheimer’s disease.

Upcoming Expected Milestones

  • Additional biomarkers readouts from PARADIGM
  • Readouts from the Phase 2 Alzheimer’s study
  • Planned pre-NDS meeting with Health Canada in May 2026
  • Potential NDS submission in Canada, subject to regulatory feedback
  • Continued preparation for initiation of the Phase 3 PARAGON trial in ALS

Financial Results

Research and development expenses for the years ended December 31, 2025 and 2024 were $6.2 million and $5.7 million, respectively. The increase of $0.5 million, or 8.8%, was mainly attributed to an increase in share-based payment expenses and increase in our salaries and social benefits expenses which were partly offset by a decrease of our expenses to subcontractors and consultants.

General and administrative expenses for the years ended December 31, 2025 and 2024 were $4.9 million and $4.2 million, respectively. The increase of $0.7 million, or 16.6%, was mainly attributed to an increase in share-based compensation.

As of December 31, 2025, NeuroSense had cash of approximately $0.2 million.

A summary of NeuroSense’s consolidated financial results is included in the tables below.

A copy of the Company’s annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company’s investor relations website at https://neurosense.investorroom.com/sec-filings. The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at [email protected].

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.

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 AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

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.

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 regulatory filings, reporting of data, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding future development of PrimeC, 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 uncertainty regarding the timing of regulatory filings, meetings and regulatory decisions; outcomes and the timing of current and future clinical trials; the risk the PrimeC will not advance towards later-stage development, timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; 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 March 31, 2026 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.

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SOURCE NeuroSense

For further information: For further information: Email: [email protected] | Tel: +972 (0)9 799 6183

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Release – MAIA Biotechnology Reports Overall Survival Exceeding Two Years for Eight Patients in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung Cancer

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Research News and Market Data on MAIA

March 31, 2026 9:15am EDTDownload as PDF

Potential breakthrough therapeutic targets $50B+ global immunotherapy market1

CHICAGO, March 31, 2026 (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 highlights from a poster presented on March 27, 2026, at the European Lung Cancer Congress 2026 (ELCC), a premier thoracic oncology forum held March 25-28, 2026, in Copenhagen, Denmark.

MAIA reports overall survival (OS) beyond two years for eight patients treated with ateganosine sequenced with cemiplimab in Parts A and B of its ongoing Phase 2 THIO-101 clinical trial in non-small cell lung cancer (NSCLC). The patients did not receive subsequent lines of therapy.

The eight patients featured in the poster include:

  • 1 patient in third-line (3L) therapy with survival of 33 months. Expected survival in this heavily pre-treated population is 5.8 months.2
  • 4 patients in 2L therapy with survival over 30 months. Documented OS for standard of care treatment (chemotherapy or checkpoint inhibitors alone) in second-line (2L) therapy is 10.5 months.3
  • All patients have failed previous treatment (prior to THIO-101) with a checkpoint inhibitor (CPI) alone.
  • All patients completed 29-34 cycles of therapy, except for 1 patient who completed 2 cycles of therapy with survival follow-up of 725 off therapy.
  • 5 of the 8 patients have survival follow-up ongoing.

“It’s very encouraging to see such outstanding survival from these patients extending beyond our 24-month trial protocol and without any subsequent treatment. OS surpassing two-years bodes well as we continue to monitor patients in our ongoing Phase 3 pivotal trial and in THIO-101 Part C,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “These results illuminate ateganosine’s valuable role in targeting telomeres to eliminate NSCLC tumor cells and support this treatment—ateganosine sequenced by a CPI—as a potential breakthrough therapeutic option for NSCLC.”

THIO-101 treated 79 patients in Parts A and B of the trial. The Part C expansion is currently enrolling up to 48 participants in Asia and Europe. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population.

MAIA’s ELCC poster is available on MAIA’s website at maiabiotech.com/publications. 

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-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

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
[email protected]

1 Immune Checkpoint Inhibitors Market Analysis by Mordor Intelligence, July 2025
2 Girard N, et al. J Thorac Onc 2009;12:1544-1549
3 https://clinicaltrials.gov/study/NCT01168973?tab=results

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Source: MAIA Biotechnology, Inc.

Released March 31, 2026

Release – Cadrenal Therapeutics Reports Fourth Quarter 2025 Financial Results; Provides Corporate Update on CAD-1005 Program for HIT Following End-of-Phase 2 FDA Meeting

Posted on by [email protected]

Research News and Market Data on CVKD

Encouraging Phase 2 HIT data and recent FDA feedback support continued advancement of CAD-1005 as Cadrenal’s near-term development priority; broader 12-LOX platform remains a longer-term opportunity

PONTE VEDRA, Fla., March 31, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update highlighting recent progress across its CAD-1005 program for HIT and broader 12-LOX inhibitor platform. The update reflects continued progress for CAD-1005, Cadrenal’s first-in-class 12-LOX inhibitor for suspected heparin-induced thrombocytopenia (HIT), including completion of its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) on March 26, 2026, to align on the proposed Phase 3 pivotal trial of CAD-1005 in patients with HIT.

Recent Highlights

  • Reported encouraging results from a randomized, blinded, placebo-controlled Phase 2 study of CAD-1005 in HIT, with fewer new or worsening thrombotic events observed in patients treated with CAD-1005 on a background of standard anticoagulant therapy.
  • Observed a greater than 25% absolute reduction in thrombotic events in the CAD-1005 treatment arm versus placebo, while also gaining important insight that platelet count recovery may not be an appropriate surrogate endpoint for clinical efficacy in HIT.
  • On March 26, 2026, the Company completed its End-of-Phase 2 meeting with the FDA and clarified a potential registrational path for its planned Phase 3 pivotal trial.
  • Incorporation of FDA feedback into Phase 3 protocol is currently underway.
  • Continued to position CAD-1005 as the only selective 12-LOX inhibitor currently in clinical development, supported by Orphan Drug and Fast Track designations from the FDA and orphan drug status from the European Medicines Agency.
  • While HIT remains the Company’s near-term development priority, it continues to see additional scientific support for 12-LOX inhibition beyond HIT, including research in obesity and type 2 diabetes showing potential improvements in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling.

“CAD-1005 continues to reinforce our conviction that selective 12-LOX inhibition may offer a differentiated approach for patients with HIT, a life-threatening, immune-mediated prothrombotic disorder, and a serious condition with substantial unmet need,” commented Quang X. Pham, Chairman & CEO. “Despite modern care, mortality remains high (up to 18-20% in some groups), with many survivors facing limb amputations. The encouraging Phase 2 results, including the reduction in thrombotic events observed on top of standard anticoagulant therapy, further strengthen our confidence in the program and in the decision to make CAD-1005 our lead development priority.”

“The recent End-of-Phase 2 meeting with the FDA is an important milestone in clarifying the regulatory path forward for CAD-1005. As we incorporate FDA feedback and prepare for the next stage of development, we remain focused on advancing CAD-1005 as our lead priority in HIT. At the same time, we continue to evaluate longer-term opportunities across our broader 12-LOX platform and other pipeline assets to support future value creation.”

Fourth Quarter 2025 Financial Highlights
Research and development expenses for the quarter ended December 31, 2025, were $0.7 million compared to $1.5 million for the same period in 2024. General and administrative expenses for the quarter ended December 31, 2025, were $2.4 million compared to $2.7 million for the same period in 2024. Cadrenal reported a net loss of $3.0 million for the quarter ending December 31, 2025, compared to $4.2 million for the same period in 2024.

On December 31, 2025, Cadrenal had cash and cash equivalents of $4.0 million. The Company is evaluating financing and strategic alternatives to support its planned clinical development activities. The Company had approximately 2.3 million shares of common stock outstanding as of December 31, 2025.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor for the treatment of heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also under development for chronic indications.

The Company’s broader pipeline features tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation, including for patients with end-stage kidney disease and left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended 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, without limitation, statements regarding the continued progress for CAD-1005 for suspected heparin-induced thrombocytopenia; a potential registrational path for the Company’s planned Phase 3 pivotal trial; additional scientific support for 12-LOX inhibition beyond HIT; research in obesity and type 2 diabetes showing potential improvements in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling; selective 12-LOX inhibition offering a differentiated approach for patients with HIT, a serious condition with substantial unmet need; continuing to evaluate longer-term opportunities across the Company’s broader 12-LOX platform and other pipeline assets to support future value creation; the Company’s clinical development plans and timing, regulatory pathway and potential registration strategy for CAD-1005; the design and initiation of its planned Phase 3 trial, the potential therapeutic and commercial opportunity for CAD-1005 and the Company’s broader pipeline, and the Company’s capital requirements and potential financing or strategic alternatives. 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 progress CAD-1005; the ability to successfully plan a registrational path for the Company’s planned Phase 3 pivotal trial; the ability for 12-LOX inhibition to provide improvements in obesity and type 2 diabetes in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling and support future value creation; the Company’s ability to raise sufficient funding to commence and complete its planned Phase 3 trial, and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, 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.

For more information, please contact:

Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
[email protected]

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Release – Tonix Pharmaceuticals Announces Presentation of Phase 1 Data and Outlines Planned Adaptive Phase 2 Field Study of TNX-4800 for the Prevention of Lyme Disease, at the World Vaccine Congress Washington 2026

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Research News and Market Data on TNXP

March 31, 2026 7:00am EDTDownload as PDF

TNX-4800 is a long-acting anti-Borrelia burgdorferi OspA human monoclonal antibody in development as a single-dose Lyme prophylactic
 
Phase 1 study of TNX-4800 demonstrated safety, tolerability, and pharmacokinetics supportive of approximately four months protection
 
Company expects to initiate a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study in the first half of 2027, pending FDA clearance
 

BERKELEY HEIGHTS, N.J., March 31, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced Phase 1 data of TNX-4800 (formerly known as mAb 2217LS)1,2 was presented by Mark S. Klempner, MD, professor of medicine at UMass Chan Medical School, an inventor of TNX-4800 and principal investigator of the study, on March 30, 2026, at the World Vaccine Congress Washington 2026. Tonix also announced its planned strategy for an adaptive Phase 2 field study expected to initiate in the first half of 2027, pending FDA clearance.

TNX-4800 is a long-acting borreliacidal (or bactericidal), human monoclonal antibody (mAb) with an engineered crystallizable fragment (Fc) domain for an extended half-life that targets the outer surface protein A (OspA) of Borrelia burgdorferi, which causes 99.9% of Lyme disease cases in the U.S.3,4 Tonix is developing TNX-4800, which the Company in-licensed from UMass Chan Medical School in 2025, as a prophylactic that is administered in a single subcutaneous (SC) dose expected to provide approximately four months protection to people in endemic areas during the U.S. tick season. There are currently no marketed U.S. Food and Drug Administration (FDA)-approved vaccines or prophylactics to protect against Lyme disease.

“TNX-4800 is expected to provide a preventative option to the 87 million5 people in the United States who are at high risk of contracting the disease because they live, work, or vacation in a tick-endemic area,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “As a monoclonal antibody, we believe TNX-4800 offers significant advantages over vaccines in development. Lyme disease vaccines that elicit antibodies to OspA currently in development take more than six months to offer protection and require complex immunization schedules. A previously approved anti-OspA vaccine was withdrawn due to poor uptake,6 potentially relating to its complex immunization schedule.”

Dr. Lederman continued, “TNX-4800, targeting Borrelia burgdorferi, the serotype that causes 99.9% of Lyme disease in the U.S., is a single dose subcutaneous administration that potentially offers immunity within two days for a duration of approximately four months. We believe TNX-4800’s differentiating characteristics could offer meaningful improvements for people seeking protection from Lyme disease. We believe the Phase 1 pharmacokinetic (PK) data support our plan to conduct an adaptive field study in the first half of 2027, pending FDA clearance, in which protection at four months is the primary endpoint, and protection at six months is a key secondary endpoint.”

Phase 1 Results

“Our study demonstrated potentially protective blood levels of TNX-4800 at two days, with protective blood levels sustained for at least four months due to its extended half-life design,” said Dr. Klempner. “Additionally, with its differentiated mechanism of action, TNX-4800 has the potential to provide passive immunity by directly supplying neutralizing antibodies, bypassing the need for a vaccine to induce a patient’s immune system to generate its own antibodies, which can be associated with other issues. We look forward to further clinical investigation of TNX-4800 as we strive to overcome this major public health challenge.”

The primary objective of the Phase 1 study was to evaluate the safety and tolerability of a SC injection of TNX-4800 when administered to healthy male and female subjects ages 19-65 years old. The secondary objective was to evaluate the PK of a SC dose of TNX-4800 when administered to healthy subjects. 44 subjects were enrolled, with 41 subjects completing the study. Subjects received a single SC administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg.

Results showed no significant clinical or laboratory safety signals, with most adverse events mild or moderate. Peak serum concentration (Cmax) increased by ~25-fold for a 20-times increase in dose. Serum TNX-4800 was measurable at earliest sampling time of two days, indicating rapid systemic absorption. TNX-4800 levels remained quantifiable for >200 days in 80% of subjects at the lowest dose, and for up to 350 days in the majority of subjects at higher doses (i.e., ≥ 1.5 mg/kg). The mean half-life ranged from 62-69 days across TNX-4800 cohorts. Serum concentrations were quantifiable for up to 12 months in most subjects.

  • Mean exposure for the 10 mg/kg cohort had <17% of the highest exposures in a nonclinical toxicology study.
  • The maximum half-life ranged from 81-104 days, with the 10mg/kg cohort at 97 days and 5mg/kg cohort at 87 days.
  • In the 5mg/kg dose cohort, mean serum TNX-4800 concentration was approximately 10 μg/ml at four months, which was approximately twice the minimum effective concentration, or MEC, calculated from in vitro bactericidal activity, and approximately the MEC from in vitro tick-feeding experiments. These data support Tonix’s planned evaluation of protection at four months as the proposed primary endpoint.

Adaptive Phase 2 Field Study Plans

Pending FDA clearance, the Company plans to initiate an adaptive field study in the first half of 2027. TNX-4800 will be studied in a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a single SC dose of TNX-4800, 350 mg, in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 4 following administration). Based on the Phase 1 PK data, a fixed dose of 350 mg was selected for the Phase 2 field study, which is expected to provide exposures comparable to the 5 mg/kg dose evaluated in Phase 1. Participants will include adolescents and adults 16 to 65 years of age in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease at four months (comparison of TNX-4800 group and placebo group). A key secondary endpoint will be the prevention of Lyme disease at six months (comparison of TNX-4800 and placebo).

The Company expects to have GMP investigational product available for clinical testing in early 2027. Additionally, if necessary and pending FDA clearance, the Company plans to initiate a controlled human infection model (CHIM) study in 2028.

A copy of Dr. Klempner’s World Vaccine Congress Washington 2026 presentation is available under the Scientific Presentations tab on the Tonix website at https://www.tonixpharma.com/scientific-presentations. The Company’s TNX-4800 specific presentation can be found under the Presentations tab on the Investors section of the Tonix website at https://ir.tonixpharma.com/presentations.

About TNX-4800
TNX-4800 (formerly known as mAb 2217LS) is a long-acting borreliacidal (or bactericidal), human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) on Lyme-causing Borrelia bacteria. When TNX-4800-containing blood is ingested by the tick, TNX-4800 kills and blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. The Company in-licensed TNX-4800 from UMass Chan Medical School in 2025. Published work in animals showed that TNX-4800 was 95% effective at preventing infection of non-human primates after six days of exposure to ticks infected with Borrelia burgdorferi.1 TNX-4800 was derived from mAb 2217 by amino acid substitutions in its Fc domain, which serve to prolong the serum half-life. A single administration is designed to potentially provide immunity against Lyme disease within two days and maintain protective antibody levels for approximately four months, without relying on the recipient’s immune system to generate antibodies. TNX-4800 also avoids the multidose priming schedules required for OspA vaccines in development7 and the FDA-approved vaccine that was withdrawn from the market.8 

About the TNX-4800 Phase 1 Study
TNX-4800 was studied in a randomized, double-blind, sequential dose-escalation study (NCT04863287) that evaluated safety, tolerability, PK, and immunogenicity of TNX-4800 in healthy adults. 44 subjects were randomized, and 41 completed the study. Subjects received a single SC administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg. Safety was assessed via clinical and lab evaluations. Drug exposure increased by approximately 25 times for a 20-times increase in dose. Serum TNX-4800 was measurable at the earliest sampling time of two days, indicating rapid systemic absorption. TNX-4800 concentrations remained quantifiable for >200 days in 80% of volunteers at the lowest dose and for up to 350 days in the majority of volunteers at higher doses (i.e., ≥ 1.5 mg/kg). Mean half-life ranged from 62-69 days across groups. Serum concentrations remained quantifiable for up to 12 months in most subjects. Mean exposure for the 10 mg/kg cohort was less than 17% of the highest exposures in a rat toxicology study. Anti-drug antibodies were detected in <10% of treated subjects, with no impact on PK. Most adverse events were mild or moderate. TNX-4800 was determined to be generally safe and well tolerated.

About Lyme Disease 
In the United States, Lyme disease is caused by the bacterium Borrelia burgdorferi. Lyme disease remains the most common vector-borne infection in the United States, and its incidence is climbing each year, due in part to global changes in climate expanding the habitat range for ticks.9 It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme disease bacteria are transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, heart, and nervous system. Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Although many cases of Lyme disease can be treated successfully with antibiotics, diagnosis and treatment are often delayed or missed. Chronic Lyme is considered an Infection Associated Chronic Illness (IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue, and other symptoms.10

Citations
1Schiller ZA, et al. J Clin Invest. 2021 131(11):e144843.
2Wang Y, et al. J Infect Dis. 2016. 214(2):205-11.
3Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017-2024.
4Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556-564.
5Kugeler KJ, et al. Emerg Infect Dis. 2021. 27(2):616-619.
6 Nigrovic LE, et al. Epidemiol Infect. 2006. Aug 8;135(1):1-8.
7Comstedt P, et al. Vaccine. 2015 33(44):5982-8.
8Connaught’s (ImuLyme™) and SmithKline Beecham’s (LYMErix™) Lyme disease vaccines were withdrawn. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8.
9Gomes-Solecki M, et. al. Clin Infect Dis. 2020 70(8):1768-1773.
10National Academies of Sciences, Engineering, and Medicine. 2025. Charting a Path Toward New Treatments for Lyme Infection-Associated Chronic Illnesses. Washington, DC: The National Academies Press. https://doi.org/10.17226/28578.

Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. In addition, the Company’s CNS portfolio includes TNX-2900 (intranasal oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.

*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.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

About UMass Chan Medical School
UMass Chan Medical School, one of five campuses of the University of Massachusetts system, comprises the T.H. Chan School of Medicine, the Morningside Graduate School of Biomedical Sciences, the Tan Chingfen Graduate School of Nursing, ForHealth Consulting at UMass Chan Medical School, MassBiologics, and a thriving Nobel-Prize-winning biomedical research enterprise. UMass Chan is advancing together to improve the health and wellness of our diverse communities throughout Massachusetts and across the world by leading and innovating in education, research, health care delivery and public service. It is ranked among the best medical schools in the nation for primary care education and biomedical research by U.S. News & World Report. Learn more at www.umassmed.edu.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. 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 in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. 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
[email protected]
(862) 799-8599

Brian Korb
astr partners
(917) 653-5122
[email protected]

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

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Source: Tonix Pharmaceuticals Holding Corp.

Released March 31, 2026

Release – MustGrow to Close NexusBioAg Canadian Distribution Arm to Focus on TerraSante™ Sales Growth in U.S.

Posted on by [email protected]

Research News and Market Data on MGROF

SASKATOON, Saskatchewan, Canada, March 31, 2026 – MustGrow Biologics Corp. (TSXV: MGRO; OTC: MGROF; FRA: 0C0) (the “Company” or “MustGrow“), announces it is to close its wholly-owned Canadian marketing and distribution business NexusBioAg effective April 15, 2026.  NexusBioAg had been re-selling and distributing third party products to Canadian farmers, a lower-margin and price-competitive business. Remaining inventory will be sold in subsequent months through existing distribution channels. MustGrow will focus its capital and resources on scaling inventory to meet accelerating demand for its mustard-derived organic biofertility product TerraSante™ in the U.S.

TerraSante™ Sales Growth

In 2025, sales demand from large U.S. commercial farmers outstripped MustGrow’s inventory production.  MustGrow’s decision to focus on its proprietary TerraSante™ product in the U.S. requires more focused capital and resources to scale inventory to meet the accelerating demand MustGrow experienced in 2025, and continues to see in 2026.

In January 2026, MustGrow closed a $2 million equity financing, and the proceeds are, in part, being used to build TerraSante™ inventory to meet growing demand for the product.  A $2 million credit facility via CIBC and guaranteed by Canada’s Export Development Canada (EDC) has also strengthened MustGrow’s ability to produce inventory.  MustGrow utilizes multiple international third-party manufacturers to produce TerraSante™, allowing MustGrow to ramp-up production to meet sales demand, while eliminating the need to build an expensive production plant.

Additionally, MustGrow is assessing multiple global partnership opportunities to expand TerraSante™ internationally.

TerraSante™ for Soil and Ecological Health

MustGrow’s mustard-derived TerraSante™ organic biofertilizer is a wettable powder containing nutritious plant proteins and carbohydrates that feed the soil and soil microbes.  TerraSante™ is currently registered and approved for sale in California, Florida, Arizona, Idaho, Oregon, and Washington State, under Organic OMRI Listed® certification and California’s Organic Input Material (OIM) Program.

MustGrow’s biofertility program focuses on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields.  Soil is a farmer’s most valuable asset, and MustGrow’s mustard plant-based technologies are being applied with the intention to improve the health of the soil and soil microbiome, and have a positive impact on root and plant health.

TerraSante™ contains nutritious plant proteins and carbohydrates that feed the soil and soil microbes, potentially improving beneficial microbial activity and ensuring long-term sustainable soil health.  These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress.  TerraSante™ has the potential to improve crop nutrient uptake and, hence, overall crop performance.  There are no artificial additives or preservatives used during its manufacturing.

To learn more about TerraSante™, visit TerraSante™ – MustGrow.

About MustGrow

MustGrow Biologics Corp. is a provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s technology is centered on harnessing the natural defense mechanisms and organic compounds found in mustard seed and formulating them into organic biofertility, biostimulant, and biocontrol products. These solutions are designed to protect soil health and the soil microbiome, support plant health, and contribute to global food security through more sustainable agricultural practices.  In the United States, MustGrow’s flagship biofertility product, TerraSante™, is registered, organically certified, and commercially sold in key agricultural states, including California. Outside of North America, MustGrow is focused on collaborating with leading global agriculture companies, such as Bayer AG in Europe, the Middle East, and Africa, to commercialize its wholly owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio, which includes approximately 110 issued and pending patents. MustGrow is publicly traded on the TSX Venture Exchange under the symbol MGRO and has approximately 62.9 million common shares issued and outstanding, and approximately 77.1 million shares on a fully diluted basis.

For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson Director & CEO
Phone: +1-306-668-2652
[email protected]

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”.  Forward-looking statements in this news release, including statements about: the impact and significance of performance data and field testing, the timing of the closing of NexusBioAg, if at all, the future demand for the Company’s products and the use of proceeds from past financings, and are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include: those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2024 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca.  Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2026 MustGrow Biologics Corp. All rights reserved.

Eli Lilly Invests $6.3 Billion on Sleep Science with Centessa Pharmaceuticals Acquisition

Posted on by [email protected]

Eli Lilly (NYSE: LLY) is making one of its boldest neuroscience moves yet, announcing a definitive agreement to acquire clinical-stage biotech Centessa Pharmaceuticals (Nasdaq: CNTA) in a deal valued at up to $47.00 per share — representing a total potential equity value approaching $7.8 billion when contingent payments are included.

The upfront cash consideration of $38.00 per share reflects an aggregate equity value of approximately $6.3 billion and carries a 40.5% premium to Centessa’s 30-day volume-weighted average trading price ended March 30, 2026. Shareholders will also receive one non-transferable contingent value right (CVR) worth up to an additional $9.00 per share, tied to three FDA approval milestones for Centessa’s lead drug candidates.

What Lilly Is Really Buying

The deal is fundamentally about orexin receptor 2 (OX2R) science — a mechanism that sits at the neurobiological center of how the brain regulates the sleep-wake cycle. Centessa has spent years building what it believes is a potential best-in-class pipeline of OX2R agonists, with its lead candidate cleminorexton (formerly ORX750) having already shown promising Phase 2a clinical data across three major sleep disorders: narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.

Beyond cleminorexton, Centessa’s portfolio includes additional clinical and preclinical-stage assets targeting neurological, neurodegenerative, and neuropsychiatric indications — giving Lilly a broader platform than a single drug acquisition would suggest.

The CVR Structure

The contingent value rights break down as follows: $2.00 per CVR upon FDA approval of cleminorexton or ORX142 for narcolepsy type 2 before the fifth anniversary of close; $5.00 per CVR upon FDA approval for idiopathic hypersomnia within the same window; and $2.00 per CVR upon the first FDA approval of either candidate for any indication before January 1, 2030.

CVR structures are increasingly common in biopharma M&A as a tool to bridge valuation gaps between buyers and sellers when clinical outcomes remain uncertain. For Centessa shareholders, the arrangement means meaningful upside if the pipeline delivers — but no guarantees.

Strategic Fit and Timing

The acquisition lands at a moment when sleep disorder therapeutics are gaining serious commercial momentum. The emergence of orexin-based therapies — like Idorsia’s daridorexant and Eisai and Biogen’s lemborexant — has validated the mechanism on the wake-promotion side of the equation. Centessa’s OX2R agonist approach works in the opposite direction, promoting wakefulness rather than suppressing it, which addresses a different and underserved patient population.

For Lilly, a company already navigating massive commercial demands from its GLP-1 and Alzheimer’s franchises, adding a differentiated neuroscience platform signals a commitment to diversifying its long-range pipeline.

The transaction is structured as a scheme of arrangement under English and Welsh law and is expected to close in the third quarter of 2026, pending Centessa shareholder approval, High Court sanction, and customary regulatory clearances. Approximately 24.1% of Centessa’s outstanding shares are already locked up through voting and support agreements signed by major investors including Medicxi Ventures, Index Ventures, and General Atlantic.

Unicycive Therapeutics (UNCY) – FY2025 Loss Reported With OLC PDUFA Data Approaching

Posted on by [email protected]


Tuesday, March 31, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

NDA Sumisssion Was Accepted In January. Unicycive reported loss for FYQ25 of $26.6 million or $(1.67) per share. Importantly, the resubmission of the NDA for oxylanthanum calcium (OLC), its phosphate binder for controlling high phosphate levels in renal dialysis patients, was accepted for filing by the FDA. The PDUFA data is June 19, 2026. Cash on December 31, 2026 was $54.9 million, which we estimate is sufficient to last through product launch and the first quarter of OLC sales.

We Believe Previous Issues Have Been Settled. The NDA was submitted in December 2025 and accepted for filing in January. FDA acceptance and notification of the PDUFA date signifies that the application is complete for review. There were no questions about the third-party manufacturing issue that stopped the review process in June 2025. We believe the corrective actions have addressed the problem, allowing for marketing approval by June 2026.


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Release – Unicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update

Posted on by [email protected]

Research News and Market Data on UNCY

March 30, 2026 7:05am EDT Download as PDF

  • Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026
  • Commercial readiness activities ongoing in anticipation of potential commercial launch of OLC in 3Q26
  • As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled $54.9 million, with expected runway into 2027

LOS ALTOS, Calif., March 30, 2026 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2025, and provided a business update.

“This year is shaping up to be pivotal for Unicycive, underscored by the U.S. Food and Drug Administration’s acceptance of our New Drug Application resubmission for OLC and the potential for approval and launch later this year,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With hyperphosphatemia still uncontrolled in nearly 75% of U.S. patients with chronic kidney disease undergoing dialysis, OLC, if approved, has the potential to offer a meaningful new treatment option characterized by a differentiated clinical profile and reduced pill burden compared to currently available phosphate binders.”

Key Highlights & Upcoming Milestones

  • In January 2026, the Company announced the FDA has accepted the resubmission of its NDA for OLC, an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a PDUFA target action date of June 29, 2026. The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers and a tolerability study in patients with CKD on dialysis), multiple preclinical studies and chemistry, manufacturing and controls (CMC) data. The FDA did not raise any concerns regarding the preclinical, clinical or safety data for OLC included in the original NDA submission. The resubmission in December 2025 was based on the progress made by the third-party manufacturing vendor responsible for the drug product (Drug Product).
  • As part of Unicycive’s continued preparation to support a potential launch of OLC later this year, the Company is continuing to strengthen its commercial infrastructure and advance market readiness initiatives.

Financial Results for the Year Ended December 31, 2025

Research and Development (R&D) expenses were $9.1 million for the year ended December 31, 2025, compared to $20.0 million for the same period in 2024. The decrease in research and development expenses was primarily due to a decrease in drug development as well as clinical trial costs.

General and Administrative (G&A) expenses were $20.4 million for the year ended December 31, 2025, compared to $12.1 million for the same period in 2024. The increase was primarily due to an increase in consulting, professional services, and commercial launch preparation costs.

Other income was $3.0 million for the year ended December 31, 2025 compared to Other expense of $4.6 million in the same period in 2024 due primarily to a decrease in the fair value of the Company’s warrant liability.

Net loss attributable to common stockholders for the year ended December 31, 2025 was $26.6 million, or $1.67 per share of common stock, compared to a net loss attributable to common stockholders of $37.8 million, or $5.65 per share of common stock for the same period in 2024. The decreased net loss for the year ended December 31, 2025, was attributable primarily to the decrease in drug development and clinical trial costs.

As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled $54.9 million. The Company believes that it has sufficient resources to fund planned operations into 2027.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
[email protected]

Media Contact:

Layne Litsinger
Real Chemistry
[email protected]

SOURCE: Unicycive Therapeutics, Inc.

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Release – Tonix Pharmaceuticals Announces First Participant Dosed in Phase 1 Investigator-Initiated Pharmacodynamic Study of TNX-1900 (Intranasal Potentiated Oxytocin) to Assess Potential for Treating Migraine and Craniofacial Pain

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Research News and Market Data on TNXP

March 26, 2026 7:00am EDT Download as PDF

Intranasal oxytocin blocks the release of calcitonin gene-related peptide (CGRP) in animal models and is the core technology of TNX-1900 for craniofacial pain conditions, including migraine and trigeminal neuralgia

TNX-1900 will be studied in the trigeminal neurovascular reactivity model, by measuring the forehead skin blood flow response to capsaicin and electrical stimulation by Laser Speckle Contrast Imaging (LSCI)

Oxytocin treatment affects a pathway distinct from the recently available CGRP migraine treatment drug class

BERKELEY HEIGHTS, N.J., March 26, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated, commercial biotechnology company, today announced that the first participant has been dosed in a Phase 1 investigator-initiated study to evaluate the effect of TNX-1900 (intranasal potentiated oxytocin) on trigeminal nerve-mediated vasodilation of the forehead using capsaicin as well as electrical stimulation, a model for trigeminal neurovascular reactivity, in healthy female human volunteers. Dr. Antoinette Maassen van den Brink, Professor of Neurovascular Pharmacology, Erasmus University Medical Center, is serving as principal investigator and sponsor for the study in a collaborative research agreement with Tonix.

In animal studies, intranasal oxytocin has been shown to bind to oxytocin receptors in the trigeminal ganglion, blocking the release of calcitonin gene-related peptide (CGRP), a potent vasodilator critically involved in the pathogenesis of migraine.1 Dr. Maassen van den Brink has previously found a CGRP inhibitor and a triptan to inhibit the forehead dermal blood flow response to capsaicin in migraineurs and healthy volunteers, respectively.2,3

“We are excited to collaborate with Professor Maassen van den Brink on this proof-of-concept study investigating the potential for TNX-1900 for treating migraine, craniofacial pain, and other related conditions,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “While there are several CGRP inhibitors approved for the treatment of migraine, TNX-1900’s oxytocin treatment affects a distinct pathway that could address unmet needs. The results of the new study will guide future development of this potential non-opioid treatment for migraine and other craniofacial pain conditions.”

As part of the preliminary work in support of this study, Dr. Maassen van den Brink’s team recently validated a newer detection method for dermal blood flow known as Laser Speckle Contrast Imaging (LSCI) in the trigeminal neurovascular reactivity model.4

“We are excited to be using LSCI in this study of TNX-1900, which adds to our established model by providing real-time and higher resolution dermal blood flow measurements, compared to Laser Doppler Perfusion Imaging used in earlier studies,” said Dr. Maassen van den Brink. “Oxytocin represents a potential new therapeutic option, targeting a pathway in migraine and craniofacial pain that is distinct from both the triptan and CGRP inhibitor migraine treatment drug classes.”

About Migraine

Migraine is a neurovascular condition that typically manifests in a throbbing moderate to severe headache which lasts at least four hours, often on one side of the head and aggravated by routine physical activity. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light and loud noises.5 Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually.6 In the U.S., approximately 39 million Americans suffer from migraines, and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month, at least eight of which are migraines).6

About TNX-1900

TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for the treatment of migraine and craniofacial pain. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system7 resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release.1 Blocking CGRP release is a distinct mechanism compared with CGRP receptor antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor, or bind to the peptide CGRP. The addition of magnesium to the oxytocin formulation in TNX-1900 enhances oxytocin receptor binding8 as well as having an inhibitory effect on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models.9 Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children.10 Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects, which could potentially occur with systemic CGRP receptor antagonists and anti-CGRP (receptor) antibodies.11 For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. This mechanism is being investigated in a Phase 1 study to evaluate the effect of TNX-1900 on trigeminal nerve-mediated vasodilation of the forehead model for craniofacial pain. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to craniofacial pain conditions, TNX-1900 is being developed for treatment of binge eating disorder, adolescent obesity, bone health in pediatric autism and arginine-vasopressin deficiency. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

Citations

1Tzabazis A, et al. Oxytocin receptor: Expression in the trigeminal nociceptive system and potential role in the treatment of headache disorders. Cephalalgia. 2016. 36(10):943-50.
2de Vries Lentsch S, et al. CGRP-mediated trigeminovascular reactivity in migraine patients treated with erenumab. J Neurol Neurosurg Psychiatry. 2022 Aug;93(8):911-912.
3Ibrahimi K, et al. A human trigeminovascular biomarker for antimigraine drugs: A randomized double-blind, placebo-controlled, crossover trial with sumatriptan. Cephalalgia. 2017 Jan;37(1):94-98.
4van Lohuizen et al. 2025. Trigeminovascular activity using a forehead dermal blood flow model: preliminary results of a validation study. J Headache and Pain 26 (Suppl 2): 138.
5The International Classification of Headache Disorders, 3rd Edition. Cephalalgia. 2018. 38(1):1-211.
6Burch et al. Migraine: Epidemiology, Burden, and Comorbidity. Neurol Clin 37 (2019):631–649.
7Yeomans DC, et al. Nasal oxytocin for the treatment of psychiatric disorders and pain: achieving meaningful brain concentrations. Transl Psychiatry. 2021. 11(1):388.
8Antoni FA and Chadio SE. Essential role of magnesium in oxytocin-receptor affinity and ligand specificity. Biochem J. 1989. 257(2):611-4.
9Cai Q, et al. Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. Psychiatry Clin Neurosci. 2018. 72(3):140-151.
10Yeomans, DC et al. 2017. US patent US2017368095.
11MaassenVanDenBrink A, et al. Wiping out CGRP: potential cardiovascular risks. Trends Pharmacol Sci. 2016. 37(9):779-788.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. In addition, the Company’s CNS portfolio includes TNX-2900 (intranasal oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including long-acting human monoclonal antibody TNX-4800 for Lyme disease prophylaxis, and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.

*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.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. 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 Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. 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
[email protected]
(862) 799-8599

Brian Korb
astr partners
(917) 653-5122
[email protected]

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
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Ray Jordan
Putnam Insights
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GeoVax Labs (GOVX) – MVA Vaccine Makes Progress Toward Phase 3 For Mpox

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Thursday, March 26, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Mpox Vaccine Clinical Supplies Expected To Be Ready Soon. GeoVax announced the completion of clinical supply testing of GEO-MVA, its modified vaccinia ankara (MVA) vaccine for Mpox/smallpox. The release of vaccine that can be used in clinical trials is expected in early April. This is an important milestone in preparation for the Phase 3 trial planned for late FY2026.

Preparation for Phase 3 Bridging Study and Commercialization. GeoVax is preparing for an immune bridging study to show GEO-MVA stimulates an immune response that is non-inferior to a commercial Mpox vaccine. The study was designed to meet requirements for the European Medicines Agency’s expedited development pathway for Marketing Authorization.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

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

Cardiff Oncology (CRDF) – KOL Discussion Of Onvansertib Supports Our Outperform Rating

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Thursday, March 26, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Cardiff Oncology Held A KOL Discussion. On March 25, Cardiff Oncology held a webcast with two world-renown oncologists with experience in drug development and patient treatment. The discussion began with a review of the Phase 2 data by Dr. Mani Mohindru, the Interim CEO. The discussion centered on aspects of the trial, including the outcome data, practical use, and competitive therapies.

The Discussion Included Significance Of Phase 2 Outcomes. The presentation began with a review of Phase 2 data announced in January 2026, with comments by the KOLs. They pointed to the response rate (RR) of 72.2% and the median progression-free survival (PFS) that has not yet been reached. Importantly, onvansertib did not cause additional toxicities to the combination chemotherapy regimen.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

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

Release – GeoVax Provides Update on GEO-MVA Program

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Research News and Market Data on GOVX

Clinical Product Release Testing Completed in Support of Pivotal Phase 3 Trial

Atlanta, GA – March 25, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today provided a development update on its GEO-MVA vaccine program for protection against mpox and smallpox, highlighting continued progress toward initiation of its planned pivotal Phase 3 clinical study.

GeoVax announced that GEO-MVA clinical supplies have completed the required release testing and final release of the product for clinical use is scheduled for early April.  Upon final release, sufficient clinical material will be available to fully support the planned immune bridging study designed in accordance with guidance from the European Medicines Agency (EMA).

This impending availability of GEO-MVA vaccine clinical material further advances the program towards initiation of the immune bridging study, a critical step toward regulatory Marketing Authorization under the EMA’s expedited development pathway, scheduled to initiate in the second-half of this year.

Advancing Toward a Pivotal Inflection Point

“The availability of GEO-MVA cGMP clinical material marks a significant advancement for the GEO-MVA program,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “With final product release expected shortly, we are entering the final preparatory phase ahead of initiating our immune bridging study positioning GeoVax at a pivotal inflection point, moving toward potential regulatory approval and subsequent commercialization.”

The planned immune bridging study is designed to demonstrate comparability to an approved MVA vaccine using immunological endpoints, consistent with EMA guidance supporting a streamlined development pathway.

Parallel Progress Toward Commercial Readiness

As recently announced, we have initiated outreach discussions in support of potential procurement and preparedness  contracting, positioning the Company for rapid GEO-MVA vaccine distribution upon regulatory and/or Emergency Use Licensing issuance. These discussions include organizations that influence or directly procure vaccines for national stockpiles, military preparedness programs, and international outbreak response initiatives.

“We are encouraged by the early engagement with global health and preparedness stakeholders,” Dodd added. “These discussions, alongside our clinical progress, underscore the increasing recognition of the critical need to expand global supply of MVA-based vaccines.”

Addressing a Critical Global Supply Gap

GEO-MVA is being developed to address a significant and well-recognized gap in global vaccine preparedness. Recent mpox outbreaks and evolving epidemiological patterns have reinforced the need for sustained preparedness, including expanded manufacturing capacity and diversified supply source. The current supply of MVA vaccine is concentrated in a single commercial manufacturer, limiting redundancy in a platform considered essential for protection against both mpox and smallpox. GeoVax believes GEO-MVA has the potential to serve as an important additional source of MVA vaccine supply supporting:

  • National stockpile programs
  • Global outbreak response efforts
  • Military and biodefense preparedness initiatives

About GEO-MVA

GEO-MVA is GeoVax’s candidate vaccine for protection against mpox and smallpox based on the Modified Vaccinia Ankara (MVA). The program is advancing under an expedited regulatory pathway supported by EMA scientific advice, which enables potential regulatory approval based on a single immune bridging study demonstrating non-inferiority to an approved MVA vaccine.

Following successful completion of the planned study, GEO-MVA is expected to advance toward regulatory submission and potential commercialization as an additional source of MVA vaccine supply for global preparedness and biodefense programs.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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.

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