Key Points: – Supernus to acquire Sage for up to $12.00 per share, combining upfront cash and milestone-based CVRs. – Deal adds FDA-approved ZURZUVAE® for postpartum depression to Supernus’ growing CNS portfolio. – Transaction expected to be accretive by 2026, with $200M in annual cost synergies forecast.
Supernus Pharmaceuticals (NASDAQ: SUPN) has announced a strategic acquisition of Sage Therapeutics (NASDAQ: SAGE) in a deal worth up to $795 million, signaling a bold expansion into the neuropsychiatric space. This all-cash transaction, set to close in Q3 2025, brings to Supernus a key commercial asset—ZURZUVAE® (zuranolone)—as well as access to Sage’s central nervous system (CNS) discovery platform.
The proposed deal includes an upfront payment of $8.50 per share in cash, representing approximately $561 million, and a non-tradable contingent value right (CVR) worth up to an additional $3.50 per share. The CVR milestones are tied to commercial performance of ZURZUVAE in the U.S. and its future launch in Japan.
This acquisition is a transformative step for Supernus, best known for CNS products such as Qelbree®, GOCOVRI®, and ONAPGO™. With the addition of ZURZUVAE—the first and only FDA-approved oral treatment for postpartum depression—the company further solidifies its footprint in the growing neuropsychiatry market. Supernus CEO Jack Khattar stated that the move “adds a fourth growth product” and “diversifies our sources of future growth.”
ZURZUVAE was developed by Sage and commercialized in partnership with Biogen. Under the collaboration, Supernus will recognize revenue equal to 50% of U.S. net sales. In 2024, that share amounted to $36.1 million, with $13.8 million already reported in Q1 2025—indicating an accelerating ramp that Supernus is now positioned to capitalize on.
From a financial perspective, the deal is expected to be significantly accretive starting in 2026, supported by estimated annual cost synergies of up to $200 million. Supernus will fund the transaction entirely through its existing cash reserves, avoiding equity dilution or new debt issuance. For investors, this adds a layer of financial discipline and long-term earnings potential.
Sage’s leadership, including CEO Barry Greene, called the deal the result of a comprehensive strategic review aimed at maximizing shareholder value. Greene highlighted the company’s mission in brain health and praised the Sage team’s work in delivering two first-in-class therapies for postpartum depression.
In terms of integration, Sage’s R&D pipeline and commercial operations will fold into Supernus’ existing infrastructure—a move expected to streamline costs and accelerate product development. The combined entity will also benefit from a strengthened CNS platform and expanded market reach.
While the deal is subject to customary closing conditions, including regulatory approvals and a majority tender of Sage’s outstanding shares, both companies anticipate a smooth closing process. Supernus plans to provide revised financial guidance following deal completion in Q3.
This acquisition reflects a strategic shift in mid-cap biopharma, where clinical differentiation and near-term revenue growth are prioritized. For small- and micro-cap investors, it also signals continued consolidation in the CNS space—where innovation, reimbursement potential, and strong commercialization strategy drive M&A activity.
Mr. Hunter brings more than 40 years of experience building and leading commercial organizations in the biopharmaceutical industry, including leadership roles at Validus Pharmaceuticals, Relialab and Novartis
Led launch of Tonix Medicines, acquisition of migraine assets Zembrace® SymTouch® and Tosymra®, and recruitment of commercial leadership team
Appointment strengthens commercial strategy and governance as Tonix prepares for potential launch of TNX-102 SL for fibromyalgia this year
CHATHAM, N.J., June 13, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the appointment of James “Jim” Hunter to its Board of Directors, effective June 12, 2025. Mr. Hunter most recently served as Executive Vice President, Commercial at Tonix, where he was responsible for building the Company’s commercial subsidiary, Tonix Medicines, and successfully executing its entry into the migraine market.
“Jim’s appointment to our Board comes at a pivotal moment as we continue to expand our commercial footprint and intensify our pre-commercial efforts for the potential launch of TNX-102 SL for fibromyalgia later this year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Having successfully built Tonix Medicines from the ground up, Jim brings a unique operational perspective and deep commercial expertise that will be invaluable as we advance our commercial strategy and long-term growth.”
In his role as Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines from June 2023 to December 2024, Mr. Hunter was responsible for managing all aspects of Tonix’s commercial efforts, including sales, marketing, market access and other operational and strategic initiatives. In addition to its ongoing commercial activities with respect Tosymra and Zembrace, Tonix Medicines is actively involved in TNX-SL 102 pre-launch activities including launch strategy, market analysis, product positioning, and market access initiatives.
Previously, Mr. Hunter was CEO and Co-founder of Validus Pharmaceuticals from 2007 to 2018, where he was responsible for more than two dozen successful product acquisitions from companies such as Shire, Roche, Novartis and Sanofi. Jim was also Co-Founder of Relialab, a diagnostics company focused on CLIA-waived, point-of-care psychiatric testing. Prior to these ventures, Mr. Hunter was Executive Director of Neuroscience Sales at Novartis Pharmaceuticals, where he launched and supported products in schizophrenia, epilepsy, migraine, Parkinson’s and Alzheimer’s. Mr. Hunter also served as Executive Director of the Northeast Business Unit at Ciba Geigy Pharmaceuticals, where he was responsible for the General Practice and hospital sales force and Regional Managed Care. Mr. Hunter received his B.S. at Seton Hall University and earned his M.B.A at Fairleigh Dickinson University.
“I’m honored to join Tonix’s Board at such an exciting juncture,” said Mr. Hunter. “It’s been a privilege to help build Tonix Medicines and launch the Company’s commercial capabilities. I look forward to continuing to support Tonix’s mission as a member of the Board and contributing to its next phase of growth.”
“I’m grateful to Jim for creating and building our commercial department which has positioned us well to launch TNX-102 SL for the management of fibromyalgia,” said Thomas Englese, EVP of Commercial Operations and leader of Tonix Medicines. “Jim’s continued strategic involvement as we prepare for the launch and continue to build our commercial infrastructure will be incredibly valuable.”
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* 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. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
LVAD patients face a high risk of bleeding events associated with oral anticoagulation alongside increased risk of cardiovascular (CV) events such as stroke
Hospitalization costs for patients following a major bleeding event associated with oral anticoagulation use averages $39,000 per event
Tecarfarin, with its novel metabolic pathway, potentially may offer an alternative to warfarin in this vulnerable population
PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing novel therapeutics for patients with cardiovascular disease, today announced new findings from third-party research on the economic and medical burdens faced by advanced heart failure patients with left ventricular assist devices (LVAD) requiring chronic anticoagulation.
The research recently conducted by Guidehouse, an AI-led professional services firm delivering advisory, technology, and managed services to the commercial and government sectors, underscores the significant clinical and economic burden for LVAD patients who require chronic oral anticoagulation. Key findings include:
Major bleeds remain a primary cost driver, with average hospitalization costs (per event) of $54,100 for intracranial hemorrhage, $26,900 for gastrointestinal bleeds, and $36,600 for other major bleeds.
Guidehouse’s analysis also identified tecarfarin – a novel, Phase 3-ready oral anticoagulant being developed by Cadrenal – as a potential alternative to warfarin to address the current unmet need in this patient population. Tecarfarin is designed to provide more consistent anticoagulation control by avoiding the multiple metabolic pathways associated with warfarin. Its unique metabolism via a single enzyme (CES2) may reduce the risk of drug interactions, dietary complications, and adverse bleeding or thrombotic events.
“Despite decades of use, warfarin has significant limitations – especially in complex patients with LVADs,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “This research reinforces our conviction that tecarfarin has the potential to transform anticoagulation management for this high-risk population who currently has no alternative options.”
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for a number of indications, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of warfarin and capture value in a market with high demand for safer, more manageable treatment options.
Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).
Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/and connect with us on LinkedIn.
Safe Harbor
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding Tecarfarin offering an alternative to warfarin for LVAD patients requiring chronic anticoagulation; providing more consistent anticoagulation control by avoiding the multiple metabolic pathways associated with warfarin; Tecarfarin’s metabolism via a single enzyme (CES2) reducing the risk of drug interactions, dietary complications, and adverse bleeding or thrombotic events; transforming anticoagulation management for LVAD patients who currently have no alternative options; preventing heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation; addressing the unmet needs in anticoagulation therapy; reducing the clinical complexities of warfarin; and capturing value in a market with high demand for safer, more manageable treatment options. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to provide clinical benefits for LVAD patients who require anticoagulation; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
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.
Approval May Come After The PDUFA Date Of June 28. Unicycive announced that an FDA inspection has found deficiencies with the cGMP (certified Good Manufacturing Practice) compliance at a third-party manufacturing subcontractor. The company’s product, OLC, is manufactured by a contract manufacturer with other subcontractors. The deficiency does not involve the active pharmaceutical compound (APC) and may be related to final finishing and packaging operations.
Good News and Bad News. The FDA stated that the manufacturing deficiencies must be resolved before product label discussions can proceed. We interpret this to mean that the FDA review of the clinical data has been completed, the manufacturing inspection was conducted, and product labeling remains as the final step before approval. Although the manufacturing deficiencies have stopped the labeling discussion, we expect NDA approval when corrected.
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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.
ATLANTA, GA, June 10, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and solid tumors, today announced that clinical data for its next-generation COVID-19 multi-antigen vaccine candidate, GEO-CM04S1, will be presented at the European Hematology Association (EHA) 2025 Hybrid Congress, taking place June 12–15, 2025, in Milan, Italy and online.
Alexey V. Danilov, M.D., Ph.D., Associate Director of the Toni Stephenson Lymphoma Center and Professor in the Department of Hematology and Hematopoietic Cell Transplantation at the City of Hope Comprehensive Cancer Center in Duarte, California, will present a poster titled: “MVA-Based GEO-CM04S1 Vaccine Results in Improved Cellular Immune Response in Patients with Chronic Lymphocytic Leukemia (CLL) Compared with mRNA-Based Vaccine: Initial Results of a Phase II Randomized Study”. The poster will be featured on Saturday, June 14, 2025, from 18:30 to 18:30 CEST in the Poster Hall, as part of the session on Infections in Hematology (including supportive care/therapy).
The presentation will highlight initial results from a Phase II randomized clinical trial highlighting the superior cellular immune response of GEO-CM04S1 compared to an authorized mRNA-based COVID-19 vaccine in CLL patients—a population known to exhibit suboptimal protective responses to COVID-19 and other vaccines due to immune dysfunction. The findings will underscore the differentiated mechanism and clinical potential of the GeoVax MVA multi-antigen platform, particularly in immunocompromised individuals.
“GEO-CM04S1 continues to show promise as a vaccine option for populations with suboptimal protection from existing COVID-19 vaccines,” said Kelly T. McKee, Jr., M.D., Chief Medical Officer of GeoVax. “We are proud to have these important data showcased at EHA2025, reflecting the real-world needs of patients with hematologic malignancies.”
About GEO-CM04S1
GEO-CM04S1 is a multi-antigen COVID-19 vaccine designed using a synthetic Modified Vaccinia Ankara (MVA) vector platform. The vaccine expresses both spike (S) and nucleocapsid (N) antigens of SARS-CoV-2, aiming to provide broader and more durable immune protection. It is currently being evaluated in Phase 2 clinical trials in both immunocompromised and healthy adults.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
SAN DIEGO, June 10, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A (“ETA”) receptor antagonist, for the treatment of pulmonary arterial hypertension (“PAH”).
This milestone marks Gyre’s entry into the PAH field, a rare, progressive, and high-mortality cardiovascular condition with limited treatment options. PAH is recognized in China’s National Rare Disease Catalog, underscoring its significance in public health. According to Frost & Sullivan, China’s PAH market was valued at $370 million in 2023 and is projected to grow to $480 million by 2031.
F230, originally discovered by Eisai Co., Ltd. and exclusively licensed by GNI Group Ltd. to Gyre, is a fully synthetic small molecule designed to selectively block the ETA receptor. By targeting this pathway, F230 is designed to reduce pulmonary vascular remodeling and lower pulmonary pressure, key contributors to PAH progression.
The Phase 1 trial is designed to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers. The trial represents the latest expansion of Gyre’s fibrosis-first strategy beyond the liver, leveraging a robust clinical development platform and commercial infrastructure in China.
F230 joins Gyre’s pipeline alongside lead candidate Hydronidone (F351), which met the primary endpoint in a pivotal Phase 3 trial for CHB-fibrosis. A New Drug Application (“NDA”) submission to China’s National Medical Products Administration (“NMPA”) is planned for the third quarter of 2025, and a pre-IND meeting with the U.S. Food and Drug Administration is being planned for an expected Phase 2 trial in metabolic dysfunction-associated steatohepatitis (“MASH”) fibrosis.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning the expectations regarding Gyre’s research and development efforts and timing of expected clinical trials, including an NDA submission to the NMPA for F351, the expected clinical benefits of F230 and expectations regarding interactions with regulators. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings Gyre may make with the SEC.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact: David Zhang Gyre Therapeutics david.zhang@gyretx.com
Distribution agreement in Canada under MustGrow’s sales and distribution division NexusBioAg.
RhizoSorb® releases nutrients in the soil more efficiently to reduce phosphorus use by up to 50% while maximizing crop yield.
Sustainable production and responsible use of phosphorus is critical to support global food demands.
SASKATOON, Saskatchewan, Canada, June 10, 2025 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”), a leading provider of biological and regenerative agriculture solutions, is pleased to announce the addition of Phospholutions Inc.’s (“Phospholutions”) RhizoSorb® phosphorous efficiency product. MustGrow and Phospholutions have signed a distribution agreement whereby MustGrow will sell RhizoSorb®through its Canadian sales and distribution division, NexusBioAg (website: NexusBioAg).
Traditionally, the majority of applied phosphates are quickly tied up in soil, making them unavailable for plant uptake. As little as 10% of conventional phosphorus fertilizer is used by the crop. RhizoSorb® offers a controlled release, avoiding tie up while decreasing nutrient leaching.
RhizoSorb® Product Highlights1
RhizoSorb® patented technology is designed to replace conventional commodity fertilizers like monoammonium phosphate (“MAP”) and diammonium phosphate (“DAP”), by enhancing nutrient use efficiency through its integration into dry-granule phosphate production. It offers the same ease of application as traditional granular fertilizers, requiring no changes to existing equipment or practices.
RhizoSorb® increases phosphorus efficiency by up to 50%, allowing farmers to apply half the applied phosphorus of their traditional fertilizer while maintaining, and even improving yield. This efficiency translates to better grower return on investment, with potential savings of up to US$20 per acre by optimizing fertilizer inputs and reducing costs without sacrificing yield.
In addition to economic benefits, RhizoSorb® delivers meaningful environmental advantages, reducing CO₂e emissions by 45.2%, phosphorus runoff by 78%, and leaching by 84% compared to conventional MAP fertilizer.
“With approximately 94.5 million acres of crop production that depend on phosphate, Canada is a key market,” said Craig Dick, VP Sales and Marketing. “We are proud to partner with MustGrow to deliver RhizoSorb® to retailers and growers across Canada.”
“This partnership marks another major milestone in Phospholutions’ journey,” added Hunter Swisher, CEO of Phospholutions. “Partnering to bring more cost-effective fertilizer solutions to the Canadian market supports our broader global expansion efforts.”
“MustGrow and Phospholutions share a common mission to improve the global food system through sustainable production solutions,” said Colin Bletsky, COO of MustGrow. “Phosphorus is the second-most-used nutrient in global food production, making its efficient and responsible use a top priority for both our companies and the growers we serve.”
Benefits of Reduced-Rate Phosphate
RhizoSorb® features a 38% lower salt index, promoting healthier soils and long-term productivity. Growers benefit from lower application rates, reduced input costs, and sustained yields. For retailers, it offers reduced storage and logistics costs along with stronger margins. Environmentally, RhizoSorb® cuts CO₂ emissions by reducing carbon-intensive ingredients during manufacturing, reducing logistics across import, retail, and farm.
About Phospholutions Inc.
Phospholutions’ mission is to enhance global phosphorus use. It believes that sustainable production and responsible use of phosphorus is critical to support global food demands. RhizoSorb® was developed to cut costs and reduce the environmental impact of fertilizer use by releasing nutrients in the soil more efficiently. Phospholutions’ patented fertilizer is incorporated into production to create higher efficiency products that maximize the use of phosphate resources. For further details, please visit www.phospholutions.com.
About MustGrow
MustGrow is a fully-integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers. In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products. These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers. Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 112 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg. MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 52.4 million common shares issued and outstanding and 59.4 million shares fully diluted. For further details, please visit www.mustgrow.ca.
Contact Information
Corey Giasson Director & CEO Phone: +1-306-668-2652 info@mustgrow.ca
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 press release, including statements about the ability of RhizoSorb® to reduce costs, environmental impacts, and strengthen retailer profit margins, are subject to a number of risks and uncertainties that may cause the actual results of MustGrow and its distributed products 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 the accuracy of the information provided by Phospholutions Inc. regarding RhizoSorb® as well as 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.
1 All statements contained in this press release about product efficacy of RhizoSorb® and conventional phosphorus fertilizer are based on information from Phospholutions about their field testing RhizoSorb® in over 500 trials across 14 states for four years.
Key Points: – Concentra Biosciences is acquiring Elevation Oncology for $0.36 per share in cash plus a CVR tied to future financial milestones. – Elevation’s board supports the deal; insiders holding 5.1% have committed to tender their shares. – Shareholders could earn additional payouts based on net cash reserves and proceeds from potential asset sales.
In a strategic move within the biotech sector, Concentra Biosciences has announced plans to acquire Elevation Oncology, a clinical-stage oncology firm known for its targeted cancer therapies. The transaction, which was unveiled Monday, values Elevation at $0.36 per share in cash. In addition to the upfront payment, shareholders will receive a contingent value right (CVR) tied to future financial outcomes.
This acquisition marks a significant shift for Elevation Oncology, which has focused its efforts on developing precision treatments for solid tumors with limited current treatment options. The deal aligns with Concentra’s expansion strategy in oncology innovation, particularly in addressing high-need patient populations.
Under the terms of the agreement, Elevation stockholders will receive a cash payout of $0.36 per share, with an additional CVR providing potential future compensation. The CVR includes two main components: shareholders could benefit from any closing cash above $26.4 million and from a share of future net proceeds related to the disposition of EO-1022, a clinical asset, if sold within a year of closing. The CVR will remain active for up to five years following the merger.
Elevation’s board of directors has unanimously backed the agreement, emphasizing that the proposed terms serve the best interest of shareholders. A wholly owned subsidiary of Concentra is expected to begin a formal tender offer by June 23, 2025. For the acquisition to proceed, a majority of Elevation’s outstanding shares must be tendered, and at least $26.4 million in net cash must remain on hand after deducting liabilities, transaction costs, and specific payments.
Support for the deal is already emerging. Elevation’s leadership and certain insiders, who collectively own about 5.1% of the company’s shares, have signed agreements to support and tender their holdings. If all conditions are met, the merger is expected to finalize by July 2025.
The acquisition arrives at a pivotal moment for Elevation Oncology. The company has faced challenges navigating the complex landscape of cancer drug development and commercialization. Partnering with Concentra provides a pathway to both secure value for current shareholders and potentially advance EO-1022 and other clinical assets under stronger financial and operational support.
Legal counsel for Elevation Oncology is being provided by Fenwick & West LLP, while Gibson, Dunn & Crutcher LLP is advising Concentra.
This merger is part of a broader trend in the biotech sector, where companies with innovative pipelines seek strategic partnerships or acquisitions to accelerate growth and mitigate risk. For Concentra, the deal expands its reach into solid tumor therapeutics—a market with both high clinical need and strong commercial potential.
As the healthcare sector continues to evolve, this acquisition underscores the importance of collaboration in bringing forward novel cancer treatments and delivering shareholder value in a highly competitive and capital-intensive industry.
– The U.S. Food and Drug Administration (FDA) identified deficiencies at a third-party manufacturing vendor
– FDA to provide final decision by PDUFA action date of June 28, 2025
LOS ALTOS, Calif., June 10, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY or the “Company”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced an update on its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
The FDA communicated to the Company that it had identified deficiencies in cGMP compliance at a third-party manufacturing vendor (one of its CDMO’s third-party subcontractors and not its Drug Substance vendor) following an FDA inspection.
The FDA indicated that, given the identified deficiencies, any label discussions between the FDA and the Company are precluded. The Company has responded to all FDA information requests and expects a final decision from the FDA by the PDUFA action date of June 28, 2025.
“We are discussing with our partners to help resolve FDA’s concerns and remain confident in the promise of OLC based on the extensive clinical and preclinical data we’ve generated,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “We believe OLC is a promising new treatment option and we are eager to bring it as quickly as we can to patients with CKD on dialysis who are living with hyperphosphatemia.”
About Oxylanthanum Carbonate (OLC) OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.2 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
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; 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; 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, 2024, 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.
1 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307. 2 Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145. Epub 2023 Jun 29. PMID: 37229723; PMCID: PMC10371371.
Patent issuance expands United States patent coverage for AVERSA™ transdermal abuse deterrent technology
AVERSA™ transdermal 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.
ORLANDO, Fla., June 09, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that the United States Patent and Trademark Office (USPTO) issued patent number 12,318,492 on June 3, 2025, entitled “Abuse and Misuse Deterrent Transdermal Systems.” The issuance of this patent further expands Nutriband’s intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products based on its proprietary Aversa™ abuse deterrent technology. This technology can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential.
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.
Nutriband’s lead product under development is Aversa™ Fentanyl, an abuse deterrent fentanyl transdermal system, with the potential to become the first abuse deterrent pain patch on the market with peak annual US sales estimated to be$80 million to $200 million.1
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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.
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 and 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.
Preclinical Studies Demonstrate Durable Protection Against SARS-CoV-2 Variants, Including Omicron XBB.1.5, Driven by T-Cell Responses
ATLANTA, GA, June 9, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and multi-antigen vaccines against infectious diseases and solid tumors, today recapped two scientific poster presentations delivered at the Keystone Symposia on Vaccinology: Horizons Across Disease, Demography and Technology, held June 4–7, 2025, in Washington, D.C.
The presentations, titled MVA-Vectored Multi-Antigen COVID-19 Vaccines Induce Protective Immunity Against SARS-CoV-2 Variants Spanning Alpha to Omicron in Preclinical Animal Models, and GEO-CM04S1 Vaccine Candidate Maintains Potent Cross-Reactivity Against Original SARS-CoV-2 B.1 and Omicron Subvariant XBB.1.5, were delivered by Drs. Pratima Kumari and Amany Elsharkawy, respectively, members of GeoVax’s scientific team and its collaborators, during the June 5 and June 6 poster sessions. The presentations spotlight the Company’s Modified Vaccinia Ankara (MVA)-vectored COVID-19 vaccine candidates, GEO-CM04S1 and GEO-CM02, and their ability to induce durable, cross-reactive immunity against SARS-CoV-2 variants in preclinical animal models. These studies underscore the immunologic breadth, durability, and cross-variant protection of GeoVax’s multi-antigen design strategy—especially important for addressing variant evasion and suboptimal immune response in vulnerable patient populations.
Key Findings from Studies
GEO-CM02 Study – Poster #1050 | Presenter: Dr. Pratima Kumari, GeoVax Scientist
This presentation detailed findings for GEO-CM02, a multi-antigen MVA-based vaccine expressing the spike (S), membrane (M), and envelope (E) proteins.
In hACE2 mouse models, a single dose provided complete protection against both the original Wuhan strain and the Omicron BA.1 variant.
Two-dose regimens generated high neutralizing antibody levels, reduced viral loads in lung and brain tissues, and lowered inflammatory markers- indicating enhanced immune memory.
Notably, early protection was achieved prior to detectable neutralizing antibodies, further supporting the role of innate and cellular immune responses in viral control. This underscores the value of the multi-antigen MVA-based vaccine platform, particularly as the virus continues to mutate.
GEO-CM04S1 Study – Poster #2047 | Presenter: Dr. Amany Elsharkawy, Georgia State University Scientist
This study evaluated the immunogenicity and protective efficacy of GEO-CM04S1, an MVA-vectored vaccine co-expressing spike (S) and nucleocapsid (N) proteins, in a K18-hACE2 mouse model. Mice were challenged intranasally with either the original B.1 strain or the Omicron XBB.1.5 subvariant.
GEO-CM04S1 conferred full protection against clinical disease, lung injury, and inflammation in both viral challenge models.
Despite the absence of detectable neutralizing antibodies against XBB.1.5, vaccinated animals were fully protected, suggesting antibody-independent protection.
Immune cell depletion studies revealed that CD4+ T cells, not B cells or CD8+ T cells, were critical for protection, highlighting the vaccine’s ability to drive T cell–mediated immunity across variants.
“These experimental findings document the value of inducing broadly specific immune responses to protect against evolving SARS-CoV-2 variants,” said Mark Newman, PhD, Chief Scientific Officer of GeoVax. “We believe the use of multi-antigen vaccines could provide significant benefit by limiting the need to continually update COVID vaccines and by limiting the need for yearly booster doses.”
GeoVax’s MVA vaccine platform is designed to address gaps in pandemic preparedness and public health resilience, with lead vaccine candidate GEO-CM04S1 currently being evaluated in multiple Phase 2 clinical trials for COVID-19.
About GEO-CM04S1
GEO-CM04S1 is a synthetic next-generation, multi-antigen MVA-vectored COVID-19 vaccine co-expressing spike (S) and nucleocapsid (N) antigens, designed to induce both broad antibody and T-cell responses. It is being evaluated in three ongoing Phase 2 clinical trials:
A primary vaccine for immunocompromised individuals (e.g., post-transplant, CAR-T, or hematologic cancers)
A booster for patients with chronic lymphocytic leukemia (CLL)
A booster for healthy adults previously immunized with mRNA vaccines
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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 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.
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.
New THIO-101 Update Presented AT ASCO. MAIA presented updated data from its THIO-101 trial showing median overall survival increased as more patients advanced through treatment. Data presented showed a median overall survival of 17.8 months for patients receiving the combination of THIO and the PD-1 inhibitor, Libtayo (cemiplimab, a checkpoint inhibitor from Regeneron), an increase from 16.9 months reported in January 2025.
Survival Improved As More Patients Completed The Study. Updated data was presented at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting, with more patients treated for longer periods. The median overall survival reported was 17.8 months compared with the expected survival of 5.8 months for standard of care therapy. This was an improvement from 16.9 months (n=22 patients) reported in January 2025 and 10.6 months (n=19 patients) reported in August 2024.
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*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.
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced a new partial response (PR) was identified in a patient after 20 months of treatment in its Phase 2 THIO-101 clinical trial evaluating ateganosine (THIO), sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who are resistant to immune therapy and chemotherapy. A partial response is defined as a decrease in tumor size of at least 30%.
“The patient remained on treatment and we observed stable disease for more than twenty months before the partial response was identified, highlighting the efficacy, safety and low toxicity of the treatment. Extended-term responses like this are not often seen in heavily pretreated patients in hard-to-treat diseases such as NSCLC, where the prognosis for the advanced-stage of the disease is typically poor,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “We confirmed this response with a second scan, and we are highly confident that ateganosine could become an outstanding therapeutic alternative for third-line NSCLC patients.”
THIO-101 third line (3L) data cutoff from May 15, 2025, showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine in parts A and B of the trial. At the data cutoff, the patient with the longest survival in the trial had completed 32 cycles of therapy and had 24.3 months survival. Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.1
MAIA has announced the trial design for an expansion of its THIO-101 pivotal Phase 2 trial in NSCLC to assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous CPI treatment and chemotherapy.
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
1 Girard N, et al. J Thorac Onc 2009;12:1544-1549.
