Biopharmaceutical Archives

Release – Greenwich LifeSciences Provides Update on Increased Patient Screen Rate in FLAMINGO-01

Posted on March 3, 2026March 3, 2026 by aweinsoff@channelchek.com

Download as PDFMarch 03, 2026 6:00am EST

STAFFORD, Texas, March 03, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided an update on the increased patient screen rate in FLAMINGO-01.

FLAMINGO-01 Annual Patient Screen Rate Increases to Over 800 Patients per Year

Over the past 6 months, the Company achieved its highest screening rate of approximately 200 patients per quarter or the equivalent of over 800 patients per year in the US and EU sites, which is an approximately 33% increase over the prior reported annual screen rate of 600 patients per year. This increase is attributable to the new sites activated in 2025 and the increased patient driven momentum at existing sites.

CEO Snehal Patel commented, “While the approximately 33% increase to over 800 patients screened per year is impressive, marking our success in optimizing and expanding our clinical operations in 2025, we may have yet to see the peak screen rate for the study.”

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

Forward-Looking Statement Disclaimer

Statements in this press release contain “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 Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com

Source: Greenwich LifeSciences, Inc.

Released March 3, 2026

Release – Gyre Therapeutics Enters into Agreement to Acquire Cullgen to Gain Targeted Protein Degradation Platform and Pipeline

Posted on March 2, 2026March 2, 2026 by aweinsoff@channelchek.com

Research News and Market Data on GYRE

March 2, 2026

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Acquisition will create a U.S.- and China-based fully integrated biopharmaceutical company with revenue-producing commercial assets and a robust pipeline of degraders, targeting inflammatory diseases and cancers.
Access to degrader-antibody conjugates (DACs) platform technology for future discovery engine.
Strengthened leadership team designed to support future global growth.
Transaction is anticipated to close early in the second quarter of 2026.
An updated corporate presentation has been posted to the Gyre and Cullgen websites.

SAN DIEGO, March 02, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic diseases, today announced its agreement to acquire Cullgen Inc. (Cullgen), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader (TPD) and degrader antibody conjugate (DAC) therapies, in an all-stock transaction valued at approximately $300 million. Following the closure of the acquisition, the new combined entity will be a fully integrated biopharmaceutical company with U.S.- and China-based capabilities spanning from discovery to manufacturing and commercialization and covering multiple therapeutic areas including inflammatory diseases, cancers, and pain.

Under the terms of the definitive agreement, Cullgen will become a wholly owned subsidiary of Gyre. Upon the completion of the acquisition, the interim Chief Executive Officer and Executive Chairman of Gyre, Ping Zhang, will remain as the Executive Chairman. The current Chief Executive Officer of Cullgen, Dr. Ying Luo, is expected to become the President and Chief Executive Officer and a member of the board of directors of Gyre.

Dr. Luo, the expected President and Chief Executive Officer of Gyre, commented, “We are thrilled about the synergistic coalescing of our companies. Cullgen brings strong drug discovery capabilities and a solid preclinical and clinical pipeline to complement Gyre’s existing and highly efficient China-based manufacturing capabilities and sales team. Gyre is already a commercial-stage company with ETUARY® on the market in China for the treatment of lung fibrosis and a second product for liver fibrosis, Hydronidone (F351), nearing New Drug Application (NDA), submission in China. Gyre is also exploring the expansion of F351’s development in ex-China territories. Following the acquisition, we will have a fully integrated biopharmaceutical company that will be capable of leveraging emerging drug discovery capabilities in China and strong clinical development in the United States to address unmet medical needs worldwide. I am excited for the potential of TPDs and DACs to drive this Company’s future growth globally.”

Mr. Zhang, Chairman of Gyre, commented, “Recently, Gyre, through its majority owned subsidiary, Gyre Pharmaceuticals, had a pre-NDA meeting with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) which supported a conditional approval and priority review eligibility filing for Gyre Pharmaceuticals’ first-in-class anti-liver fibrosis candidate, Hydronidone, subject to formal approval. As a result, Gyre Pharmaceuticals plans to submit an NDA for Hydronidone for conditional approval in the first half of 2026 and conduct a Phase 3c confirmatory trial to support full approval in China. The addition of Cullgen’s TPD/DAC platform and pipeline is expected to enhance our long-term growth prospects. We are excited to have Cullgen colleagues join our team in both the United States and China.”

The transaction is expected to close early in the second quarter of 2026, subject to customary closing conditions, including necessary regulatory approvals in the United States.

Prior to entering into this transaction, Cullgen’s proposed merger with Pulmatrix was terminated.

Updated Corporate Presentation

In connection with this announcement, a new presentation has been posted on each company’s respective website. Visit http://www.cullgen.com or http://www.gyretx.com.

About Cullgen Inc.

Cullgen is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and DAC therapies designed to improve the lives of patients suffering from critical conditions such as pain, cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients. By leveraging its expertise in targeted protein degraders, Cullgen believes its product candidates have many distinct advantages over other therapeutic modalities, including higher selectivity, improved therapeutic profile and avoidance of known toxicities.

Cullgen’s lead product candidate, CG001419, is an oral pan-tropomyosin receptor kinase (TRK) degrader that previously completed a Phase 1 trial for the treatment of acute post-operative pain and Cullgen released positive top-line results from the study in late 2025. Cullgen recently submitted an IND for the molecule, and pending FDA allowance, expects to initiate a Phase 2 trial in acute pain in bunionectomy patients in the United States. The molecule is also being studied in a Phase 1 trial for the treatment of solid tumors. Cullgen’s second product candidate, CG009301, is a GSPT1 degrader being studied in a Phase 1 trial for the treatment of blood cancers, including relapsed/refractory acute myeloid leukemia, higher-risk myelodysplastic syndrome and acute lymphoblastic leukemia. In addition to CG001419 and CG009301, Cullgen is also progressing a number of preclinical programs including next-generation degrader-antibody conjugates.

For more information, please visit www.cullgen.com.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY^® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. Hydronidone received Breakthrough Therapy designation by the CDE of the NMPA in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. As of the third quarter of 2025, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.

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 PRC, Gyre is advancing a broad pipeline through its controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.

Advisory and Legal Counsel

Moelis & Company LLC is acting as financial advisor to the special committee to Gyre’s Board of Directors, and Gyre’s legal counsel is Gibson, Dunn & Crutcher LLP.

Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. is serving as legal counsel to Cullgen.

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 structure, timing and completion of the proposed acquisition; the anticipated timing of closing; the expected executive officers and directors of the combined entity; the future operations of the combined entity; the nature, strategy and focus of the combined entity; the development and commercial potential and potential benefits of any product candidates of the combined entity; and anticipated clinical drug development activities and related timelines, including the anticipated timing of the filing of Gyre’s NDA with the NMPA for the conditional approval of Hydronidone and the initiation of the confirmatory Phase 3c clinical trial of Hydronidone to support full approval in China and the anticipated timing of Cullgen’s Phase 2 trial of its TRK degrader in acute pain. 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: the risk that the conditions to the closing of the acquisition are not satisfied; uncertainties as to the timing of the consummation of the acquisition and the ability of each of Gyre and Cullgen to consummate the acquisition; risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the acquisition; unexpected costs, charges or expenses resulting from the acquisition; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; the uncertainties associated with Gyre’s and Cullgen’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined entity to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. 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 with the Securities and Exchange Commission.

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.

CONTACTS:

Gyre Therapeutics, Inc.
Ping Zhang, interim CEO and executive chairman
ping.zhang@gyretx.com

Cullgen Inc.
Thomas Eastling, CFO
ir@cullgen.com

Investors
Chuck Padala
Managing Director, LifeSci Advisors
chuck@lifesciadvisors.com

Release – Cadrenal Therapeutics Highlights Recent 12-LOX Inhibitor Platform Expansion

Posted on March 2, 2026March 2, 2026 by aweinsoff@channelchek.com

Research News and Market Data on CVKD

Encouraging data for CAD-1005 in Phase 2 HIT Study

EOP2 scheduled for Q1 for top-priority indication

Additional acute and chronic opportunities for 12-LOX inhibition beyond HIT

PONTE VEDRA, Fla., March 02, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company developing therapies for life-threatening immune and thrombotic disorders, today provided additional perspectives on development opportunities following its recent pipeline expansion with the addition of 12-LOX inhibitors.

As previously announced, Cadrenal recently acquired a portfolio of selective 12-LOX inhibitors, including oral candidates. Encouraging recent data from a blinded, placebo-controlled Phase 2 study of CAD-1005, a parenteral 12-LOX inhibitor, in heparin-induced thrombocytopenia (HIT) demonstrated a reduction in thrombotic events on a background of standard anticoagulants, with an End-of-Phase 2 (EOP-2) meeting scheduled for later this month.

While HIT remains Cadrenal’s near-term regulatory priority with CAD-1005, an ever-growing body of scientific research supports the central role that 12-LOX also plays in inflammatory signaling across multiple high-impact disease areas. Published studies have highlighted its role in atherosclerosis and vascular inflammation, microvascular thrombosis, ischemia-reperfusion injury, and immune-mediated metabolic conditions, including beta-cell stress pathways associated with type 1 diabetes and obesity.

Collectively, these therapeutic areas represent multi-billion-dollar potential global markets and opportunities to address novel pathways and potentially improve otherwise poor patient outcomes. Cadrenal’s new 12-LOX inhibitor portfolio is a differentiated platform approach across a range of thrombotic and inflammatory conditions, with both acute and chronic potential applications.

“We are very excited to have the only selective 12-LOX inhibitor currently in clinical-stage development and continue to move forward with HIT as our lead indication and regulatory priority,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “We also appreciate that 12-LOX inhibition represents an entirely new – and exciting – therapeutic approach and are optimistic that safely and selectively targeting 12-LOX can have far-reaching therapeutic implications in multiple disease areas.”

About 12-LOX

Lipoxygenases are a family of enzymes involved in lipid metabolism that stimulate the incorporation of oxygen into polyunsaturated fatty acids. The enzymatic action of 12-LOX ultimately leads to the formation of 12-HETE, a lipid molecule that easily crosses cell membranes. Intracellularly, 12-HETE promotes oxidative stress, while extracellularly, 12-HETE modulates a variety of signaling pathways to regulate inflammatory activity and elicit pro-inflammatory effects. In human blood, 12-LOX is found primarily in platelets and leukocytes; it is also found within the pancreas of diabetics and in certain cancer cells. In HIT, 12-LOX is a critical link in platelet activation via the IgG receptor. Early attempts to develop 12-LOX inhibitors failed because they were not 12-LOX specific. CAD-1005 is the first successful selective 12-LOX inhibitor and the only one to advance to clinical-stage development.

About CAD-1005

CAD-1005 is an investigational therapy being evaluated for the treatment of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms driving HIT. Unlike existing therapies for HIT, which are only directed at preventing thrombotic complications, this approach addresses the primary underlying cause of HIT. In preclinical models of HIT, CAD-1005 has been shown to prevent or treat HIT and halt the development of both thrombocytopenia and blood clots. The drug has not been associated with increased bleeding in animals or healthy human volunteers. CAD-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency.

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 includes tecarfarin, a Phase 3-ready oral vitamin K antagonist for patients with end-stage kidney diseases and left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor designed 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 Cadrenal’s development opportunities following its acquisition of a 12-LOX inhibitor portfolio; the EOP-2 meeting being scheduled with the FDA for later this month; HIT remaining Cadrenal’s near-term regulatory priority with CAD-1005; the therapeutic areas for Cadrenal’s 12-LOX inhibitor portfolio representing multi-billion-dollar potential global markets and opportunities to address novel pathways and potentially improve otherwise poor patient outcomes; and being optimistic that safely and selectively targeting 12-LOX can have far-reaching therapeutic implications in multiple disease areas. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Cadrenal’s ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; Cadrenal’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; Cadrenal’s ability to obtain or maintain the capital or grants necessary to fund its research and development activities; regulatory limitations relating to Cadrenal’s ability to promote or commercialize its product candidates for specific indications; acceptance of Cadrenal’s product candidates in the marketplace and the successful development, marketing or sale of its products; Cadrenal’s ability to maintain its license agreements; Cadrenal’s ability to retain its key employees or maintain its Nasdaq listing 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.

For more information, please contact:

Cadrenal Therapeutics:

Matthew Szot, CFO

press@cadrenal.com

Investors:

Lytham Partners, LLC

Robert Blum, Managing Partner

602-889-9700

CVKD@lythampartners.com

Release – Cadrenal Therapeutics Announces Phase 2 Results with Encouraging Reductions in Thrombotic Events for CAD-1005 in HIT, Supporting Clinical Advancement

Posted on February 24, 2026February 24, 2026 by aweinsoff@channelchek.com

Research News and Market Data on CVKD

Greater than 25% absolute reduction in thrombotic events with CAD-1005 versus placebo on a background of standard anticoagulant therapy, despite no difference in platelet count recovery

End-of-Phase 2 Meeting Scheduled for March 2026

PONTE VEDRA, Fla., Feb. 24, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced encouraging results from a Phase 2 trial evaluating CAD-1005 (formerly VLX-1005) in patients with heparin-induced thrombocytopenia (HIT), a severe pro-thrombotic reaction to heparin, the most commonly used parenteral anticoagulant.

This randomized, blinded, placebo-controlled trial evaluated the safety and efficacy of CAD-1005, a selective inhibitor of 12-lipoxygenase (12-LOX), a critical immune signaling pathway implicated in HIT, in patients receiving standard anticoagulant therapy. To potentially validate a new surrogate endpoint, the previous investigational new drug sponsor, Veralox Therapeutics, selected platelet count recovery rate as the primary endpoint. Their trial did not meet this primary endpoint. The secondary endpoint was the incidence of new or worsening thrombotic events, including radiologic progression, which showed encouraging results. The study concluded in December 2025 following the transfer of program ownership from Veralox to Cadrenal. Although CAD-1005 did not significantly affect platelet recovery rate, CAD-1005-treated patients had fewer thrombotic events.

Highlights:

Primary Endpoint: Thrombotic events continued to occur even after platelet count recovery in both groups. Platelet recovery rates were similar between the CAD-1005 and placebo arms. Platelet count recovery did not appear to be a surrogate marker for clinical efficacy.
Key Secondary Endpoint: A high rate of thrombotic events (>75%) was observed in the placebo group, with fewer thrombotic events in the CAD-1005 group (50%), although the study was not powered to detect statistical significance. Adding an inhibitor of 12-LOX to standard anticoagulants to block the immunological mechanisms driving HIT may be more effective than anticoagulants alone in preventing thrombotic events.

Building on these secondary endpoint results, Cadrenal has been granted an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to align on a Phase 3 registration path. The Company considers this meeting a significant milestone in the development of CAD-1005, the only 12-LOX inhibitor in clinical development worldwide.

“The encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm is strong support for the company’s decision to acquire this asset and rapidly progress its development,” said Quang X. Pham, CEO of Cadrenal Therapeutics. “Inhibition of 12-LOX is an exciting therapeutic frontier, potentially targeting numerous inflammatory, thrombotic, and metabolic conditions.”

“We learned two very important things from this study, the only blinded placebo-controlled trial ever conducted in HIT,” said James Ferguson, MD, Chief Medical Officer of Cadrenal Therapeutics. “First, platelet count recovery was not an appropriate surrogate endpoint for clinical efficacy in a trial in which standard therapy event rates were strikingly high. Secondly, despite the relatively small number of patients, the reduction in thrombotic events with CAD-1005 is extremely encouraging. CAD-1005 could represent a major step forward as the only first-line therapy targeting the immune mechanisms responsible for HIT.”

“Our field (HIT) is full of anticoagulant use in the absence of randomized prospective trials,” said Steven E. McKenzie, MD, PhD, Professor of Medicine at Thomas Jefferson University and a member of the study steering committee. “We are enthusiastic about CAD-1005 in addressing both the underlying immune mechanism and the unmet medical need for this serious thrombotic disorder.”

Detailed trial results will be presented at a future scientific meeting.

About Heparin-Induced Thrombocytopenia (HIT)

Heparin is the most widely used in-hospital anticoagulant, with over 12 million patients receiving it in the United States each year. Heparin-induced thrombocytopenia (HIT) is a potentially life-threatening immune-mediated complication of heparin administration that occurs when antibodies to heparin activate platelets, leading to clots throughout the circulatory system, dramatically lowering platelet counts, and increasing the risk of bleeding. Complications of HIT include deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, amputation, and death, with mortality rates for HIT exceeding 20% in some studies. CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT.

About CAD-1005

CAD-1005 is an investigational therapy being evaluated for the treatment of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms driving HIT. Unlike existing therapies for HIT, which are only directed at preventing thrombotic complications, this approach addresses the primary underlying cause of HIT. In preclinical models of HIT, CAD-1005 has been shown to prevent or treat HIT and halt the development of both thrombocytopenia and blood clots. The drug has not been associated with increased bleeding in animals or healthy human volunteers. CAD-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency.

About the Study

The study was originally planned to enroll 60 patients, but was stopped in December 2025 after program ownership transferred to Cadrenal. Analysis of all existing trial data was recently completed. The final dataset includes 24 patients with a presumptive diagnosis of HIT, randomized to receive either CAD-1005 or a matching placebo; all patients received concomitant standard anticoagulant therapy, either argatroban or bivalirudin. The primary endpoint was the rate of platelet count recovery; a key secondary endpoint was the development of new or worsening thrombotic events, the composite of death, stroke, systemic embolism, myocardial infarction, deep venous thrombosis, superficial vein thrombosis, or skin necrosis. Primary analyses focused on 17 patients in whom HIT was confirmed by a central lab functional assay.

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, as well as orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also under development.

The Company’s broader pipeline includes tecarfarin, a Phase 3-ready oral vitamin K antagonist for the treatment of patients with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral, clinical-stage Factor XIa inhibitor designed 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 adding an inhibitor of 12-LOX to standard anticoagulants to block the immunological mechanisms driving HIT being more effective than anticoagulants alone in preventing thrombotic events; the encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm being strong support for the Cadrenal’s decision to acquire this asset and rapidly progress its clinical development; full trial results being presented at a future scientific meeting; the reduction in thrombotic events with CAD-1005 being extremely encouraging, despite the relatively small number of patients; CAD-1005 representing a major step forward as the only first-line therapy targeting the immune mechanisms responsible for HIT; The EOP2 meeting being a significant milestone in the development of CAD-1005; CAD-1005 addressing both the underlying immune mechanism and the unmet medical need for this serious thrombotic disorder; the encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm being strong support for Cadrenal’s decision to acquire this asset and rapidly progress its development; CAD -1005 addressing the underlying immune drivers of HIT; and presenting detailed trial results at a future scientific meeting. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Cadrenal’s ability to advance the clinical development of CAD-1005 for the treatment of HIT, including designing a pivotal Phase 3 registration study acceptable to the FDA; CAD-1005 having the ability to address the underlying immune mechanism and the unmet medical need for the serious thrombotic disorder; Cadrenal’s ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; Cadrenal’s ability to successfully complete clinical trials on time and achieve desired results and benefits as expected including support for CAD-1005’s potential to be a treatment option for HIT, Cadrenal’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Release – Greenwich LifeSciences Announces Acceptance of Two Abstracts at AACR Annual Meeting 2026

Posted on February 24, 2026February 24, 2026 by aweinsoff@channelchek.com

Research News and Market Data on GLSI

Download as PDF

February 24, 2026 6:00am EST

STAFFORD, Texas, Feb. 24, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that two abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026, including two corresponding posters.

The AACR 2026 conference will be held from April 17-22, 2026. The AACR plans to publish the abstract titles on March 17, 2026 at 4:30 pm EST, the abstracts on April 17, 2026 at 3:00 pm EST, and the posters on the date of the presentation at the conference.

CEO Snehal Patel commented, “One of these abstracts will be the first abstract co-authored by the Company and the full Steering Committee of FLAMINGO-01.”

About the AACR Annual Meeting 2026

The AACR is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 61,000 members residing in 143 countries and territories. The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

About GLSI-100 Phase IIb Study

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

About Breast Cancer and HER2/neu Positivity

About Greenwich LifeSciences, Inc.

Forward-Looking Statement Disclaimer

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com

Source: Greenwich LifeSciences, Inc.

Released February 24, 2026

Release – Nutriband Inc. provides summary of Annual Shareholder Meeting Key Discussion Points

Posted on January 30, 2026January 30, 2026 by aweinsoff@channelchek.com

Research News and Market Data on NTRB

January 30, 2026 07:00 ET | Source: Nutriband Inc.

ORLANDO, Fla., Jan. 30, 2026 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) has provided an update to shareholders on the key milestones and discussions from this years Annual Shareholders Meeting, held on Jan 24, 2026 in Orlando, Florida. Details and highlights may be found below.

Addition of Two New Directors

Allesandro Puddu
Alessandro Puddu is an Italian Chartered Accountant and Statutory Auditor with over 10 years of experience in audit, corporate advisory and financial reporting for industrial groups and listed companies.

He advises companies on tax and corporate matters, company valuations, extraordinary corporate transactions and IAS/IFRS reporting, including consolidated financial statements. He has supported the design and implementation of accounting and administrative procedures and regularly serves as statutory auditor and member of statutory boards of Italian companies.

He currently serves as Group Internal Auditor for a company listed on the STAR segment of the Italian Stock Exchange, overseeing internal control and audit activities, including those related to the Group’s United States subsidiaries. At the beginning of his career, he worked at PricewaterhouseCoopers as a Senior Auditor, reviewing Italian and multinational companies operating in various industrial sectors, including the pharmaceutical sector, and coordinating audit teams across multiple jurisdictions.

Alessandro Puddu is enrolled in the Italian Register of Chartered Accountants (Dottori Commercialisti), the Register of Statutory Auditors held by the Italian Ministry of Economy and Finance, and the Register of Crisis & Insolvency Practitioners, and holds a Master’s Degree in Economics and Management.

Viorica Carlig
Viorica Carlig is a senior executive with over a decade of leadership experience across service-based companies. She currently provides executive and strategic oversight for multiple multinational organizations, leading operations, governance, compliance, budgeting, and growth initiatives in complex regulatory environments. With a background spanning business administration, law, and economics—including a Ph.D. in Economics—Viorica combines strong commercial judgment with rigorous operational and risk management expertise. Earlier in her career, she practiced commercial and corporate law as a member of the Bucharest Bar, advising companies on contracts, governance, and regulatory compliance. She is a multilingual leader experienced in managing diverse teams and stakeholders across Europe and beyond.

2025 AVERSA™ FENTANYL Development Summary

Strengthened collaboration with Kindeva for AVERSA™ FENTANYL through an exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments
Granted patent protecting its AVERSA™ abuse deterrent platform technology in Macao, a Special Administrative Region of the People’s Republic of China
Completed commercial manufacturing process scale-up with partner Kindeva for Aversa™ Fentanyl
Issued new US patent which further expands Nutriband’s intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products
Held Type C meeting with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL through commercialization
Filed a new provisional patent application with the U.S. Patent and Trademark Office (USPTO) covering improved aversive formulations and coating application methods to enhance the abuse deterrent properties and further strengthen Nutriband’s intellectual property protection for its AVERSA™ technology
Initiated development of the worldwide commercial brand name and visual identity for AVERSA™ FENTANYL with Brand Institute, Inc.

2026 AVERSA™ FENTANYL Focus on Development Towards NDA Filing

File nonprovisional patent application to potentially extend patent protection of AVERSA™ technology-based products to 2046
Manufacture clinical supplies for the Human Abuse Liability (HAL) clinical trial
File Investigational New Drug (IND) application with the US FDA
Initiate Human Abuse Liability (HAL) clinical study

EarthVision Bio Purchase of Pocono Pharma

The full purchase price and closing for the proposed sale of our Pocono subsidiary has not been received as of the shareholder meeting on Jan 24, 2026. However, the Company is collecting on the agreed nonrefundable $10,000 USD weekly penalty and has so far collected $30,000 USD of payments to extend the closing date.

Company Complaint Filed with FINRA

The Company, has filed a complaint with the Financial Industry Regulatory Authority (FINRA) on behalf of our shareholders to look into suspected naked short selling. The information was collected and prepared with a specialist analyst in the area of naked short selling.

Warrant Expiration in 2026

The Company is reminding shareholders that the warrants issued in our uplisting to NASDAQ on October 1, 2021 will expire on October 1, 2026. Currently there are 91,0904 warrants set to expire with a strike price of $6.43 totaling $5,856,112 if exercised.

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, including opioids and stimulant drugs, 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 periodic and current reports on Form 10-K, Forms 10-Q and 8-K 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.

Contact Information:

Nutriband Inc.
Phone: 407-377-6695
Email: info@nutriband.com

SOURCE: Nutriband Inc.

Release – Cadrenal Therapeutics Acquires VLX-1005, a First-in-Class Phase 2 12-LOX Inhibitor for Patients with Heparin-Induced Thrombocytopenia (HIT)

Posted on December 11, 2025December 11, 2025 by aweinsoff@channelchek.com

Research News and Market Data on CVKD

Novel first-in-class therapeutic targeting a key immune signaling pathway and the underlying cause of HIT
It is the first and only potent, highly selective inhibitor of human 12-LOX in clinical testing, distinguishing it from related compounds.
Orphan Drug and Fast Track designations from the FDA

PONTE VEDRA, Fla., Dec. 11, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today announced the acquisition of VLX-1005 and related 12-lipoxygenase (12-LOX) assets from Veralox Therapeutics (“Veralox”). The acquisition immediately strengthens Cadrenal’s pipeline with a late-stage, first-in-class drug candidate targeting a critical immune signaling pathway. This acquisition addresses yet another underserved therapeutic opportunity in the $40 billion global anticoagulation market.

VLX-1005 is a novel, potent, selective small-molecule inhibitor of 12-LOX, a key pathway driving immune platelet-mediated inflammation and a contributor to the pathogenesis of HIT. This potentially life-threatening complication can occur in up to 5% of patients exposed to heparin – the most commonly used parenteral anticoagulant – regardless of dose, schedule, or route of administration. HIT antibodies can cause catastrophic and life-threatening arterial and venous thrombosis. Approximately 300,000 patients in the United States are evaluated each year for suspected HIT, and an estimated 56,000 confirmed diagnoses occur each year. Mortality and thromboembolic event (TE) rates remain high despite currently available therapies.

Two Phase 1 studies of VLX-1005 in healthy participants have demonstrated that VLX-1005 was well tolerated, with no deaths, no serious adverse events, and no trend in adverse event reporting with increasing doses. A recent Phase 2 study (VLX-1005-003) evaluated VLX-1005 in individuals with suspected HIT, and interim results demonstrated encouraging reductions in thromboembolic events. These events have become a preferred, clinically meaningful endpoint for regulators, clinicians, and payers, given the rising rates observed in current HIT populations.

VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation therapeutics targeting 12-LOX are also under development for type 1 diabetes and other immune-mediated and inflammatory diseases.

“We are pleased the advancement of VLX-1005 for the treatment of HIT will continue under the leadership of Cadrenal,” said Matthew Boxer, Co-Founder of Veralox Therapeutics. “The program has found a home in Cadrenal, where it aligns with a shared vision and excitement regarding the promise 12-LOX technology may offer patients.”

“With the acquisition of VLX-1005, Cadrenal continues to advance novel therapeutics to treat or prevent thrombosis in high-risk patients,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “HIT remains a dangerous condition without a therapy that addresses its immune-driven biology. The emerging data from VLX-1005 suggest meaningful potential to improve patient outcomes while maintaining favorable tolerability. We believe this is a compelling strategic addition to our pipeline, with the market size for HIT reaching $1 billion in the US and EU.”

Under the terms of the acquisition agreement, Veralox is eligible to receive upfront and milestone payments contingent on the achievement of specified future clinical and regulatory milestones. Additionally, Veralox will be entitled to royalties on global sales of the acquired assets upon future commercialization. The structure and terms of the agreement enable Cadrenal to allocate capital to advancing the clinical development of VLX-1005.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding advancing VLX-1005 for the treatment of HIT; continuing to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the emerging data from VLX-1005 suggesting meaningful potential to improve patient outcomes while maintaining a favorable safety profile; VLX-1005 being a compelling strategic addition to Cadrenal’s pipeline; the payment to Veralox of milestone payments contingent upon the achievement of certain future clinical and regulatory milestones as well as royalties on global sales of the acquired assets upon future commercialization; the structure and terms of the agreement enabling Cadrenal to allocate capital to advancing the clinical development of VLX-1005; and developing transformative therapeutics to overcome the limitations of current anticoagulation therapy. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Release – Greenwich LifeSciences Announces Completion of Enrollment in the Open Label Arm of FLAMINGO-01

Posted on December 8, 2025December 8, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GLSI

Download as PDFDecember 08, 2025 6:00am EST

STAFFORD, Texas, Dec. 08, 2025 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the completion of enrollment in the open label non-HLA-A*02 arm of FLAMINGO-01.

In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are currently planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types (non-HLA-A*02) are planned to be treated with GLSI-100 in a third open label arm. The non-HLA-A*02 patients do not have the HLA-A*02 allele from either parent and represent about 55% of the patient population in FLAMINGO-01.

FLAMINGO-01 has achieved a major milestone by completing enrollment in the 250 patient open label non-HLA-A*02 arm of the Phase III trial, which is a result of the high screen rate and ensuing enrollment rate. The Company is continuing its review of the most recent data of this arm, including recurrence rates, which can be updated and/or published at any time.
The Company stopped enrolling in this arm earlier this year and is now approaching regulatory agencies to seek approval to continue enrollment of new non-HLA-A*02 patients in a randomized manner with a control arm. The Company has continued to screen a large number of these patients so that rapid enrollment of these screened patients can commence if regulatory approval is received.
The Company previously reported promising observations earlier this year showing that the immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the primary immunization series, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study, where breast cancer recurrences were reduced up to 80% or more and no metastatic breast cancer recurrences were reported. A preliminary analysis suggests that these promising trends are continuing.

CEO Snehal Patel commented, “As we continue to analyze the immune response, safety, and recurrence rate data of the 250 patient non-HLA-A*02 data set, it is important to remember that all 250 patients received GLSI-100, which is 5 times more than the approximately 50 patients treated in the Phase IIb trial. We can compare the open label recurrence rate data of these 250 treated patients to the expected historical recurrence rate for this population, which is well known and recently reported, to the HLA-A*02 arms of FLAMINGO-01, and to the Phase IIb study. In addition, we may be able to compare the recurrence rate during the first 6 months of vaccination, also called the primary immunization series or PIS, to the recurrence rate after the PIS is completed and after peak immunity is achieved. We look forward to providing updates on this analysis at any time, including publications at conferences as we have previously done for the Phase IIb trial from 2020-2022.”

Mr. Patel added, “The use of GLSI-100 in the non-HLA-A*02 patient population is an invention by the Company, and the Company believes that any patent claims related to this invention are not subject to any license, royalties, or milestone payments. These patent claims should complement other patent claims that the Company has recently filed to potentially extend patent protection of GLSI-100 beyond 2040. The Company believes that this patient population could double the number of US and European patients eligible for GLSI-100 treatment to approximately 88,000 new patients per year with a market potential using the drug prices per year of Kadcyla or Enhertu in the range of $8-10 billion per year.”

Additional updates:

The non-HLA-A*02 types that are most commonly being enrolled in FLAMINGO-01 continue to be HLA-A*03, HLA-A*24, HLA-A*01, HLA-A*11, HLA-A*68, HLA-A*29, HLA-A*30, HLA-A*23, and HLA-A*33.
The enrollment of HLA-A*02 patients in the 500 patient randomized arms continues, unaffected by the end of enrollment in the non-HLA-A*02 arm, while the Company also seeks to increase the size of these HLA-A*02 arms such that enrollment is not stopped prior to any interim analyses.
Enhertu (trastuzumab Deruxtecan [T-DXd]) treated patients continue to be eligible for enrollment in FLAMINGO-01. The Company believes that GLSI-100 will synergize with any trastuzumab based treatment in the neoadjuvant or adjuvant settings, including Enhertu.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

About Breast Cancer and HER2/neu Positivity

About Greenwich LifeSciences, Inc.

Forward-Looking Statement Disclaimer

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com

Source: Greenwich LifeSciences, Inc.

Released December 8, 2025

Release – Greenwich LifeSciences Provides Global Update on FLAMINGO-01, Screening Over 1,000 Patients to Date

Posted on December 3, 2025December 3, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GLSI

Download as PDF

December 03, 2025 6:00am EST

STAFFORD, Texas, Dec. 03, 2025 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following global update on FLAMINGO-01.

Flamingo-01 Progress to Date

The Company has achieved a major milestone by screening over 1,000 patients in Flamingo-01, continuing its screening rate of approximately 150 patients per quarter or the equivalent of 600 patients per year in approximately 40 US sites and 100 EU sites for a total of 140 active sites. The Company is considering a strategy to continue enrolling in both the HLA-A*02 and non-HLA-A*02 arms until interim analyses are conducted and the appropriate size of each arm can be further assessed.

CEO Snehal Patel commented, “Reaching 1,000 screened patients confirms that the interest from doctors and patients is high. The clinical site start-up activities in Europe in 2025 have further increased the momentum in the study. We are also receiving interest from other countries to join FLAMINGO-01, driven by patient interest. The high screening rate will give the Company many options, including the opportunity to continue enrollment through multiple interim analyses, the potential to realize higher enrollment rates and event rates, and the potential to maximize indications by analyzing efficacy across multiple HLA types in larger patient populations.”

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

About Breast Cancer and HER2/neu Positivity

About Greenwich LifeSciences, Inc.

Forward-Looking Statement Disclaimer

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com

Source: Greenwich LifeSciences, Inc.

Released December 3, 2025

Release – Cadrenal Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Posted on November 10, 2025November 10, 2025 by aweinsoff@channelchek.com

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Nov. 10, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome current gaps in anticoagulation therapy, today reported its financial results for the third quarter ended September 30, 2025, and provided an update on the clinical development of tecarfarin and the acquisition and development of frunexian.

Highlights

Progressed clinical development of tecarfarin.
- Completed the manufacturing of tecarfarin drug product in accordance with current good manufacturing practices (cGMP).
- Ongoing activities in support of a single-site U.S. Phase 2 study of tecarfarin in LVAD patients as part of the collaboration agreement with Abbott.
- Investigator discussions for a potential multi-site Phase 2 study of tecarfarin in dialysis patients already treated with warfarin.
Expanded Cadrenal’s portfolio through the acquisition of the assets of eXIthera Pharmaceuticals, including its proprietary portfolio of investigational intravenous (IV) and oral Factor XIa inhibitors, in September 2025.
- The lead asset, frunexian, is a first-in-class, Phase 2-ready IV Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices plays a significant role, such as cardiopulmonary bypass, catheter thrombosis, and other blood-contacting implanted cardiac devices.

“We have uniquely positioned ourselves to address gaps in anticoagulation treatment of multiple indications through the development of two differentiated anticoagulants (tecarfarin and frunexian) while benefitting from pathways that provide clear regulatory designations,” commented Quang X. Pham, Chairman & CEO. “Having multiple pathways has allowed us to be prudent and flexible in our strategic approach to achieving critical development milestones as we look to advance our therapies for patients where conventional anticoagulation does not provide sufficient safety or efficacy.”

“Our focus as we finish 2025 is the progression of tecarfarin into clinical applications where significant anticoagulation challenges exist,” Pham continued. “We are in discussions with key partners to move forward a development strategy which we believe is critical to the broader anticoagulation industry to address gaps in care and unlock key value for shareholders.”

Third Quarter 2025 Financial Highlights

Research and development expenses for the quarter ended September 30, 2025, were $0.7 million compared to $0.8 million for the same period in 2024. General and administrative expenses for the quarter ended September 30, 2025, were $2.0 million compared to $1.7 million for the same period in 2024. Cadrenal reported a net loss of $2.7 million for the quarter ending September 30, 2025, compared to $2.4 million for the same period in 2024.

On September 30, 2025, Cadrenal had cash and cash equivalents of $3.9 million. The Company had approximately 2.1 million shares of common stock outstanding as of September 30, 2025.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a biopharmaceutical company with a mission to develop novel and differentiated biopharmaceutical products that bridge critical gaps in current acute and chronic anticoagulant therapy. We bridge these gaps by developing novel and differentiated anticoagulants, or blood thinners, designed to provide greater predictability, increased stability, more precise control, and fewer bleeding complications. We currently have two clinical-stage assets: tecarfarin, an oral vitamin K antagonist (VKA) for chronic use, and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. By targeting underserved patient populations and advancing therapies designed for both chronic and acute use, we aim to reshape standards of care in anticoagulation. 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 the Company’s ability to develop transformative therapeutics to overcome current gaps in anticoagulation therapy, the Company’s ongoing activities supporting a single-site U.S. Phase 2 study of tecarfarin in LVAD patients as part of the collaboration agreement with Abbott; the potential initiation of a multi-site Phase 2 study of tecarfarin in dialysis patients already treated with warfarin; the Company being uniquely positioned to address gaps in anticoagulation treatment of multiple indications through development of two differentiated anticoagulants (tecarfarin and frunexian); the Company achieving critical development milestones; the progression of tecarfarin into clinical applications where significant anticoagulation challenges exist; moving forward with a development strategy with key partners; addressing gaps in care and unlocking key value for shareholders. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to develop novel and differentiated biopharmaceutical products that bridge critical gaps in current acute and chronic anticoagulant therapy; the Company’s ability to achieve critical development milestones and commence clinical trials as anticipated; the Company having sufficient funding to achieve its clinical goals; the Company’s ability to target underserved patient populations and advance therapies designed for both chronic and acute use and to reshape standards of care in anticoagulation 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.

For more information, please contact:

Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Release – MAIA Biotechnology Presents Trial in Progress Poster at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Posted on October 27, 2025October 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

October 27, 2025 10:45am EDT Download as PDF

First five patients in Part C (expansion) of THIO-101 Phase 2 clinical trial enrolled in Taiwan and Turkey

CHICAGO, Oct. 27, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced its recent attendance at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The Conference, held October 22-26, 2025, in Boston, MA, was hosted by the American Association for Cancer Research (AACR), the National Cancer Institute (NIC), and the European Organisation for Research and Treatment of Cancer (EORTC).

MAIA’s Sr. Medical Director, Victor Zaporojan, M.D., presented a Trial in Progress poster titled “A Phase 2 Study of Ateganosine (THIO; 6-thio-2′-deoxyguanosine) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress.”

Dr. Zaporojan stated, “It was a pleasure to engage with many oncologists and scientists at the AACR-NCI-EORTC Conference and share updates from Part C of our expanded Phase 2 trial. As enrollment continues, we’re seeing a safety profile well aligned with Parts A and B, and momentum is building. Our expert investigators are eager to bring this opportunity to more patients in more countries as new sites come online in the weeks ahead.”

MAIA also announced that it has enrolled five patients from Taiwan and Turkey in the expansion phase of its THIO-101 Phase 2 trial. Screening for the trial is ongoing in Europe and Asia. With multi-continental trial locations, MAIA investigators can draw from a significantly larger patient pool for its third-line studies of ateganosine.

Dr. Saadettin Kiliçkap, Scientific Advisor to MAIA and key investigator for THIO-101 Part C in Turkey, commented, “It’s exciting to see ateganosine develop into what could be a promising treatment option for the large and underserved NSCLC patient population in our region. Lung cancer remains a major public health challenge here—it is the most common cancer and the leading cause of cancer-related death, particularly among men. While public health efforts have helped reduce incidence in men, rates among women continue to rise. Our medical community would welcome a breakthrough therapy that could meaningfully extend and improve the quality of life for patients with late-stage NSCLC.”

Dr. Kiliçkap has served as principal or sub-investigator in more than 100 national and international multi-center phase 2 and phase 3 clinical studies, many of which were related to lung cancer. His research focuses on medical oncology and cancer epidemiology, including solid tumors such as lung cancer, breast cancer, melanoma, and gastrointestinal system cancers, as well as targeted therapies and immunotherapy.

The high prevalence of smoking, compounded by air pollution, is the key driver of NSCLC in Turkey. A 2018 study reported that tobacco smoking accounted for 89.6% of lung cancer cases in Turkey.¹ Subsequent research in 2019 suggested that prolonged exposure to ambient air pollution—particularly PM2.5 particulate matter—may have contributed to around 15% of lung cancer-related deaths, highlighting a significant additional risk when combined with smoking.²

MAIA’s Trial in Progress poster is available 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
ir@maiabiotech.com

¹ Tobacco Induced Diseases, 14th Annual Conference of the International Society for the Prevention of Tobacco Induced Diseases (TID)
² Department of Public Health, Trakya University, Faculty of Medicine, Türkiye

Source: MAIA Biotechnology, Inc.

Released October 27, 2025

Release – MAIA Biotechnology Details 30-Month Patient Survival in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung Cancer

Posted on October 23, 2025October 23, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

October 23, 2025 8:36am EDT Download as PDF

Outstanding measure of efficacy relative to high-risk cancers with limited treatment options

CHICAGO, Oct. 23, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from a recent presentation at the European Society for Medical Oncology (ESMO) Congress 2025 held in Berlin, Germany. Starting October 19, 2025, MAIA showcased two e-posters at ESMO detailing its ongoing Phase 2 and Phase 3 clinical trials of ateganosine in non-small cell lung cancer (NSCLC).

“The posters showcased at ESMO 2025 featured exceptional extended survival in third-line NSCLC patients. In addition, as of September 17, 2025, a patient that began therapy in March 2023 has shown survival of 30 months, or 912 days, an outstanding measure relative to many of the high-risk cancers,” said MAIA CEO Vlad Vitoc, M.D. “Very few options exist for patients who are refractory or resistant to immune checkpoint inhibitors (ICI). We believe that a survival of over two years is a clear signal of ateganosine’s role in effectively targeting and eliminating NSCLC tumor cells.”

The THIO-101 patient with 30-month survival received therapy every three weeks, and concluded treatment upon reaching the maximum treatment duration of 2 years based on protocol requirements.

MAIA’s newest posters featured at ESMO 205 are now available on MAIA’s website at maiabiotech.com/publications.

Presentation 1: A Phase 2 Study of Ateganosine (THIO; 6-thio-2′-deoxyguanosine) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress
Presentation 2: A Phase 3 Study of Ateganosine (THIO) Sequenced with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress

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
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released October 23, 2025

Trump Administration’s Pharma Policy Shift: A New Landscape for Small Cap Biotechs

Posted on October 21, 2025October 21, 2025 by slightbourne@noblecapitalmarkets.com

The evolving relationship between the Trump administration and major pharmaceutical giants like Pfizer and Eli Lilly is reshaping the U.S. biotech and pharmaceutical sectors in unexpected ways. As President Trump’s approach to drug pricing and distribution intensifies, investors are watching closely to see whether these changes will threaten Big Pharma’s profit margins—or set the stage for a new era of growth for smaller, more innovative companies.

One of the most notable policy shifts has been the Trump administration’s overt encouragement—or at least acceptance—of large pharmaceutical firms selling directly to consumers. This “TrumpRx” strategy is a radical departure from the conventional system involving intermediaries and pharmacy benefit managers. On one hand, such a model could potentially drive efficiency and lower costs for some patients. On the other hand, it stirs up considerable uncertainty about how much profit large firms like Pfizer and Eli Lilly can preserve in an environment where pricing pressure and regulatory scrutiny are rising.

For investors focused on the biotech sector, the uncertain impact on Big Pharma profits is neither an all-out negative nor a clear positive. Recent developments, including public negotiations between the Trump administration and pharmaceutical leaders, have left markets feeling neutral in their outlook. There’s a sense that the sector may finally be heading into a period of relative stability after years of headlines about aggressive price controls and disruptive policy threats.

But questions linger: If legislative and regulatory changes ultimately compress profit margins for giants like Pfizer and Eli Lilly, how much will these incumbents be willing to invest in breakthrough innovation? Big Pharma’s research budgets have long been a cornerstone of biotech progress, underwriting everything from gene therapies to next-generation cancer drugs. If these resources dwindle, will smaller players have to pick up the slack—or could this shift clear the runway for young, ambitious biotech companies to rise?

Some analysts argue that a direct-to-consumer environment and tighter financial discipline for industry leaders could empower small and mid-cap biotech firms. Unlike their larger rivals, these companies are often leaner, faster-moving, and more reliant on outside partnerships and licensing deals to bring new therapies to market. With Big Pharma potentially becoming more selective in its investments, nimble startups may find themselves with new opportunities to innovate, collaborate, and even become acquisition targets.

Ultimately, the Trump administration’s evolving stance toward pharmaceutical profits and the direct selling model may serve as a stabilizing force in the sector—at least in the short term. Investors will need to monitor how major policy decisions translate to bottom-line impacts, R&D spending, and future innovation. While uncertainty remains, the potential for small-cap biotech firms to thrive in the coming years has rarely looked more compelling. For patient investors, this environment could prove fertile ground for discovering the next generation of biotech trailblazers.

Take a moment to take a look at some emerging growth biotechnology companies by taking a look at Noble Capital Markets Research Analyst Robert LeBoyer’s coverage list.