Biopharmaceuticals Archives

Release – Greenwich LifeSciences Extends Lock-up of Directors and Officers to January 31, 2027

Posted on August 10, 2026August 10, 2026 by [email protected]

Download as PDFAugust 10, 2026 6:00am EDT

STAFFORD, Texas, Aug. 10, 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 its Board of Directors has extended the lock-up of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to January 31, 2027 which is approximately 76 months from the date of the Company’s IPO. During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company’s common stock unless otherwise modified by the Board of Directors. After January 31, 2027, the quantity of these locked-up shares that can be sold daily and over various periods of time will be restricted under a leak-out plan unless otherwise modified by the Board of Directors.

The Board could choose to end all or a small percentage of the 100% lock-up at any time for any reason, including prior to any data announcements, interim analyses, strategic transactions, such as an acquisition or partnership, or financial transactions, such as royalty or strategic investor transactions that provide a potential bridge to commercialization. The Board could also choose to implement a pre-determined leak-out plan and/or a 10b5-1 selling program at any time for any reason that allows for the organized independent selling of some of the locked-up shares by a third party over a specified period of time. Such decisions may or may not be announced at the time of the board’s decision.

CEO Snehal Patel commented, “We attended and presented at the BIO conference in June 2026 and plan to attend the BIO-Europe conference later this year, where strategic and financing transactions can be originated or concluded. With the further derisking of the Phase III clinical trial, more than doubling of enrollment and event rate, interest from leading clinicians and hospitals in up to 200 sites in the US and Europe, screening of over 1,500 patients, and the transformation of the interim analysis into a big pharma like study similar in design to recent large breast cancer studies, we are expecting a continued up-tick in the quantity and seriousness of such discussions.”

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, 2025, 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: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

Source: Greenwich LifeSciences, Inc.

Released August 10, 2026

Release – Greenwich LifeSciences Announces Receipt of Nasdaq Notice Regarding Late Form 10-K Filing

Posted on April 22, 2026April 23, 2026 by [email protected]

Research News and Market Data on GLSI

Download as PDF

April 22, 2026 5:00pm EDT

STAFFORD, Texas, April 22, 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 on April 16, 2026, the Company received notification from the Listing Qualifications Department of The Nasdaq Stock Market LLC notifying the Company that, because it has not yet filed its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, the Company is not currently in compliance with Nasdaq Listing Rule 5250(c)(1), which requires timely filing of periodic financial reports with the Securities and Exchange Commission. The notice has no immediate effect on the listing or trading of the Company’s common stock, which continues to trade on the Nasdaq Capital Market under the symbol “GLSI.”

The Company plans to file its Form 10-K for the fiscal year ended December 31, 2025 as soon as possible, working with both of its auditors where each auditor is responsible for their own periods ending in 2024 and 2025.

About Greenwich LifeSciences, Inc.

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: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

Source: Greenwich LifeSciences, Inc.

Released April 22, 2026

Release – Cadrenal Therapeutics Highlights Research Supporting 12-LOX Inhibition in Reducing Inflammation in Obesity and Type 2 Diabetes

Posted on March 12, 2026March 12, 2026 by [email protected]

Research News and Market Data on CVKD

PONTE VEDRA, Fla., March 12, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing innovative treatments for life-threatening immune and thrombotic conditions, today highlighted recent scientific findings demonstrating the potential of its first-in-class 12-lipoxygenase (12-LOX) inhibitor, CAD-1005, to target inflammatory consequences of obesity and Type 2 diabetes.

The study builds on prior animal research showing that inhibiting 12-LOX with CAD-1005 delays the onset of autoimmune diabetes in non-obese diabetic mice. The findings highlight 12-LOX as a key factor in obesity-associated inflammation and suggest that 12-LOX inhibition could be a therapeutic strategy to improve glucose homeostasis and peripheral inflammation in the setting of obesity and type 2 diabetes.

In the setting of obesity, 12-LOX overexpression leads to:

Adipocyte dysfunction following recruitment of pro-inflammatory macrophages into adipose tissue triggering an inflammatory reaction that impairs tissue insulin sensitivity.
Elevated 12-LOX activity in the pancreas causes oxidative stress and -cell dedifferentiation, hallmarks of Type 2 Diabetes progression.

In preclinical models, oral administration of CAD-1005 (formerly VLX-1005) demonstrated significant therapeutic benefits, including improved glycemic control, reduced pancreatic β-cell loss, reduced numbers of inflammatory cells in adipose (fat) and pancreatic tissues, and lower levels of pro-inflammatory cytokines in adipose tissues. Inhibiting 12-LOX acts as a selective “switch” to deactivate these pathways and interrupts a cycle of chronic inflammation, providing a dual benefit of restoring healthy metabolic signaling and protecting tissues from inflammatory damage.

Link to publication: https://link.edgepilot.com/s/ca8ee2a3/c_cA13QyP0eg7_nCqlb4HQ?u=https://pubmed.ncbi.nlm.nih.gov/40186458/

Selective 12-LOX inhibition specifically targets important inflammatory signaling pathways that were previously difficult to reach, with potential applications across multiple areas. Unlike other treatments for obesity and diabetes, Cadrenal’s 12-LOX inhibitor is designed to block inflammatory signals in adipose tissues and the pancreas – key drivers of the metabolic derangements that accompany adiposity and diabetes. Cadrenal believes that CAD-1005 is the only product in clinical development that uses this mechanism to inhibit adipo-inflammatory signaling and potentially add to the benefits of existing GLP-1 obesity medications.

Cadrenal acquired the 12-LOX portfolio in December 2025. CAD-1005 is also being evaluated for suspected Heparin-Induced Thrombocytopenia (HIT), a severe pro-thrombotic reaction to heparin. The results of a recent Phase 2 trial demonstrated a reduction in thrombotic events in patients with HIT. Next-generation development includes CAD-2000, an orally bioavailable 12-LOX inhibitor.

“While our near-term priority remains the clinical development of CAD-1005 for HIT, these findings highlight the broader potential of 12-LOX inhibition in other inflammatory conditions,” said Quang X. Pham, CEO of Cadrenal Therapeutics. “We look forward to sharing our findings about 12-LOX in other disease areas with interested partners.”

About 12-LOX

Lipoxygenases are a family of enzymes involved in lipid metabolism that facilitate the incorporation of oxygen into polyunsaturated fatty acids. The enzymatic activity of 12-LOX ultimately produces 12-HETE, a lipid molecule that easily crosses cell membranes. Inside cells, 12-HETE promotes oxidative stress, while outside cells, it modulates various signaling pathways to regulate inflammation and provoke pro-inflammatory effects. In human blood, 12-LOX is primarily found in platelets and leukocytes; it is also overexpressed in the pancreas of patients with diabetes and in certain cancer cells. In HIT, 12-LOX plays a key role in platelet activation via the IgG receptor. Early efforts to develop 12-LOX inhibitors struggled because they lacked specificity for 12-LOX.

About CAD-1005

CAD-1005, an investigational therapy being evaluated for suspected HIT, is a potent, highly selective small molecule inhibitor of human 12-LOX. It is currently the only selective 12-LOX inhibitor in clinical development. CAD-1005 is designed to target 12-LOX specifically, a pathway crucial to the primary immune mechanisms that cause HIT. Unlike existing therapies for HIT, which mainly focus on preventing blood clots, this approach addresses the root cause of HIT. In preclinical models, CAD-1005 has been shown to prevent or treat HIT and stop the development of thrombocytopenia and blood clots. The drug has not been linked to 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 Cadrenal Therapeutics, Inc.

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

The Company’s broader pipeline features tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation, including for patients with end-stage kidney disease and left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include Cadrenal developing innovative treatments for life-threatening immune and thrombotic conditions; CAD-1005 targeting inflammatory consequences of obesity and Type 2 diabetes; 12-LOX inhibition improving glucose homeostasis and peripheral inflammation in the setting of obesity and type 2 diabetes; 12-LOX inhibition having potential applications across multiple areas; Cadrenal’s 12-LOX inhibitor blocking inflammatory signals in adipose tissues and the pancreas – key drivers of the metabolic derangements that accompany adiposity and diabetes; CAD-1005 inhibiting adipo-inflammatory signaling and potentially add to the benefits of existing GLP-1 obesity medications; advancing the clinical development of CAD-1005 for the treatment of HIT; the development of CAD-2000, an orally bioavailable 12-LOX inhibitor; the broader potential of 12-LOX inhibition in other inflammatory conditions; sharing findings about 12-LOX in other disease areas with interested partners; CAD-1005 targeting 12-LOX specifically, a pathway crucial to the primary immune mechanisms that cause HIT, and addressing the root cause of HIT; CAD-1005 successfully preventing or treating HIT and stopping the development of thrombocytopenia and blood clots; Cadrenal advancing novel therapies for life-threatening immune and thrombotic conditions; Cadrenal developing second-generation 12-LOX oral therapeutics for chronic indications; tecarfarin preventing heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation, including for patients with end-stage kidney disease and left ventricular assist devices; and frunexian being used in acute hospital settings. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Cadrenal developing innovative treatments for life-threatening immune and thrombotic conditions; advancing the clinical development of CAD-1005 for the treatment of HIT; Cadrenal advancing novel therapies for life-threatening immune and thrombotic conditions; Cadrenal developing second-generation 12-LOX oral therapeutics for chronic indications; tecarfarin preventing heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation, including for patients with end-stage kidney disease and left ventricular assist devices; frunexian being used in acute hospital settings; 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
[email protected]

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

Release – Cadrenal Therapeutics Highlights High Incidence of Thrombotic Complications in Heparin-Induced Thrombocytopenia (HIT) at the J.P. Morgan Healthcare Conference and VLX-1005 as a Potential Therapeutic Solution as the First and Only Selective 12-LOX Inhibitor

Posted on January 12, 2026January 12, 2026 by [email protected]

Research News and Market Data on CVKD

Company to also participate in Fireside Chat at Lytham Partners 2026 Investor Healthcare Summit on Thursday, January 15, 2026

SAN FRANCISCO, Jan. 12, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today highlighted the significant and persistent unmet medical need in heparin-induced thrombocytopenia (HIT) and underscored the promise of its recently acquired investigational drug candidate, VLX-1005, the first and only potent, highly selective 12-LOX inhibitor in clinical testing as a potential new treatment option.

Cadrenal Therapeutics acquired VLX-1005 in December 2025, recognizing its potential to transform the treatment landscape for HIT and other immune-mediated thrombotic disorders.

Emerging data from a recent Phase 2 clinical trial evaluating VLX-1005 in individuals with suspected HIT suggest that VLX-1005 may reduce thrombotic complications, supporting its further development as a novel, mechanism-based therapy. Early trial results suggest that selective 12-LOX inhibition may offer a differentiated approach by addressing the immune thrombotic drivers of disease rather than solely suppressing coagulation.

HIT is a serious immune-mediated reaction to heparin that paradoxically increases the risk of thrombosis despite a drop in platelet count. It occurs when antibodies activate platelets, triggering widespread clot formation in veins and arteries. Thrombotic complications affect a large proportion of patients and are the primary cause of illness and death in HIT. Recent clinical and translational research continues to reinforce the urgent need for safer, more targeted therapies that address the immune-driven platelet activation underlying this disease.

Recent findings reported in a 2025 American Society of Hematology (ASH) abstract by Shatzel et al. and in a 2025 publication by Ramadan et al. highlight the high incidence and clinical burden of thrombotic complications in HIT, even with current standard-of-care anticoagulation. These data emphasize the limitations of existing therapies, which primarily inhibit coagulation pathways but do not directly modulate the platelet immune responses central to HIT pathophysiology.

Growing scientific evidence has identified 12-lipoxygenase (12-LOX) as a key mediator of platelet activation and immune thrombotic responses. Foundational work by McKenzie et al. (2022) significantly advanced the understanding of 12-LOX signaling in platelet-driven immune thrombosis, including in HIT, supporting the enzyme as a compelling therapeutic target.

Historically, however, drug development efforts targeting 12-LOX have been hindered by a lack of selectivity, raising concerns about off-target effects and safety. This challenge has limited the clinical translation of earlier 12-LOX inhibitors.

VLX-1005 represents a breakthrough in this area. Supported by preclinical and translational studies (Tourdot et al., 2017; Renna et al., 2023), VLX-1005 is the first and only highly selective 12-LOX inhibitor in clinical development. Its selectivity profile is designed to specifically modulate immune-mediated platelet activation while minimizing off-target inhibition of related lipid signaling pathways.

Cadrenal is moving forward rapidly to engage with the U.S. Food and Drug Administration (FDA) to discuss the design of a potential pivotal Phase 3 registration study for VLX-1005 in HIT.

“HIT remains a life-threatening condition with a strikingly high risk of thrombosis despite available therapies,” said Quang X. Pham, CEO of Cadrenal Therapeutics. “By selectively targeting 12-LOX, VLX-1005 has the potential to address a core disease mechanism in HIT. We believe this program represents a meaningful opportunity to improve outcomes for patients who currently have limited options.”

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 oral therapeutics targeting 12-LOX are also under development for type 1 diabetes and other chronic immune-mediated and inflammatory diseases.

Lytham Partners 2026 Investor Healthcare Summit

Cadrenal will participate in a webcast fireside chat at the Lytham Partners 2026 Investor Healthcare Summit, which will be held virtually at 4:30 p.m. ET on Thursday, January 15, 2026.

The webcast can be accessed via the conference home page at https://lythampartners.com/hc2026/ or at https://lythampartners.com/hc2026/cvkd. A replay will also be available through the same links.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products designed to 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 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 VLX-1005 as a potential therapeutic solution, the promise of VLX-1005 as a potential new treatment option for HIT, VLX-1005’s potential to transform the treatment landscape for HIT and other immune-mediated thrombotic disorders, VLX-1005 reducing thrombotic complications in patients with HIT, selective 12-LOX inhibition offering a differentiated approach by addressing the immune thrombotic drivers of disease rather than solely suppressing coagulation, 12-LOX inhibitor in clinical development advancing into human clinical development, 12-LOX being able to modulate immune-mediated platelet activation while minimizing off-target inhibition of related lipid signaling pathways, Cadrenal moving forward to engage with the FDA to discuss the design of a potential pivotal Phase 3 registration study for VLX-1005 in HIT, the program representing a meaningful opportunity to improve outcomes for patients who currently have limited options. 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, including designing a pivotal Phase 3 registration study acceptable to the FDA; 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 VLX-1005’s potential to be a treatment option for HIT and transform the treatment landscape for HIT and other immune-mediated thrombotic disorders, 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
[email protected]

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

Release – Greenwich LifeSciences Extends Lock-up of Directors and Officers to September 30, 2026

Posted on December 29, 2025December 29, 2025 by [email protected]

Research News and Market Data on GLSI

Download as PDF December 29, 2025 6:00am EST

STAFFORD, Texas, Dec. 29, 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 Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to September 30, 2026 which is approximately 72 months from the date of the Company’s IPO. During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company’s common stock unless otherwise modified by the Board of Directors. After September 30, 2026, the quantity of these locked-up shares that can be sold daily and over various periods of time will be restricted under a leak-out plan unless otherwise modified by the Board of Directors.

CEO Snehal Patel commented, “This unprecedented 6 years lock-up is controlled by the Board and is designed to align the locked-up shareholders with the Company’s long term investors and to support the FLAMINGO-01 Phase III trial. The Board could choose to end the 100% lock-up at any time and could then implement a pre-determined leak-out plan and/or a 10b5-1 trading plan that allows for the organized independent selling of some of the locked-up shares by a third party over a specified period of time. One example of how the Board could proceed in the future might be to continue to keep 95% or 99% or a higher or lower percentage of the locked-up shares locked up for longer periods of time after September 30, 2026, while allowing 5% or 1% or a lower or higher percentage of the locked-up shares to be sold within a 10b5-1 trading plan over a specified period of time. Any interim analyses or strategic transactions, such as an acquisition or partnership, which could occur at any time, could also affect the Board’s lock-up and leak-out plans.”

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.

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: [email protected]

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.

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: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

Source: Greenwich LifeSciences, Inc.

Released December 29, 2025

Release – Greenwich LifeSciences Provides Additional Updates on FLAMINGO-01 and Corporate Strategy

Posted on December 22, 2025December 22, 2025 by [email protected]

Research News and Market Data on GLSI

Download as PDFDecember 22, 2025 6:00am EST

STAFFORD, Texas, Dec. 22, 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 Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided additional updates on FLAMINGO-01 and the Company’s corporate strategy.

Corporate Strategy

The Company recently attended a Noble Capital conference on December 3, 2025, where further details of the Company’s FLAMINGO-01 clinical strategy, financing strategy, and partnering strategy were discussed in a fireside chat with the Noble analyst. The video is now available on the Company’s website at the bottom of the Welcome page: https://greenwichlifesciences.com/

Below are highlights from the discussion with additional information:

Clinical strategy – The FLAMINGO-01 clinical strategy continues to evolve with various options to further reduce risk and increase the chances of marketing approval supported by the current financing strategy that is supporting the current burn rate, the increasing interest from investigators and patients, cost reduction activities, and continued interest to add additional sites and countries to the study.
- Approximately 140 sites are actively enrolling patients, and there are plans to activate an additional 10 already approved sites in 2026 and additional EU countries.
- Quality improvement and cost reduction may be realized by moving more clinical trial operations internally and ending the use of a CRO for the US operations and global management.
- The study has transitioned from strong interest from principal investigators to patient driven interest, including the formation of wait lists at certain sites.
- The Company has entered into discussions with leading clinical sites in the United Kingdom and Canada regarding joining the study, which would require regulatory approval in each country, independent from the FDA and EMA regulatory approval that the Company has already received.
Financing strategy – The ATM financing is being used judiciously and efficiently to keep up with the burn rate in 2025, potentially exceeding the burn rate by year end. This ATM strategy reduces the likelihood of the Company doing a near term financing, increasing the chances for non-dilutive strategic partnerships at any time before or after an interim analysis.
- The Company’s annual burn rate was approximately $7 million in 2024 and 2023. The income statements for these periods have been reported as losses of $16 million and $9 million respectively, but the cash flow used for operations is much lower at $7 million due to the non-cash stock and options expenses added to the income statements.
- For the first three quarters of 2025, the burn rate is approximately $7 million, representing a gradual increase in burn rate over 2024, but not a substantial increase due to the Company’s lean structure and ongoing cost saving initiatives. In addition, a large part of the clinical expenses is from the upfront costs and the first 6 months of monthly vaccinations or Primary Immunization Series, after which the cost per patient should be lower when boosters are given once every 6 months.
Partnering strategy – The Company continues to attend partnering conferences.
- Large pharma dominates the breast cancer drug market, including acquiring or partnering with smaller biotechs who have promising new breast cancer drugs.
- We believe patent filings for treating non-HLA-A*02 patients with GLSI-100 will strengthen the patent portfolio for GLSI-100, in addition to the biologics data exclusivity available to GLSI-100 in the US.

FLAMINGO-01 Data Safety Monitoring Board (DSMB) & Steering Committee

The FLAMINGO-01 DSMB met twice in 2025, most recently in December 2025, and recommended to continue the study as is without modification. The Steering Committee also met at SABCS 2025 and discussed the clinical strategy, endorsing the planned modifications to FLAMINGO-01. The planned modifications subject to regulatory approval include:

increasing the size of the study, which would increase the power of the study thus decreasing the risk by designing the study to assume more recurrences even though fewer recurrences may be anticipated and observed,
doubling or quadrupling the enrollment rate, which will increase the patient years in the study more rapidly thus proportionately increase the event rate, which may shorten the time to reach an interim analysis or milestone,
continuing to enroll past the interim analyses so that the current momentum at the clinical sites continues,
using the interim analysis to potentially resize the study or to change the subsequent interim analysis, to change the number of events triggering an analysis, or to change the timing of the study based on recommendations by an independent committee, and
using a recently manufactured GP2 commercial drug product lot in FLAMINGO-01

CEO Snehal Patel commented, “We are looking forward to continuing our financing strategy and implementing the planned Phase III trial derisking modifications, pending regulatory approvals. The discussions with clinicians at SABCS 2025 were encouraging, as the study has become more widely recognized by the breast cancer community, leading to patient and investigator driven interest to expand FLAMINGO-01 into the United Kingdom and Canada. The potential for GLSI-100 to save lives by preventing metastatic breast cancer recurrences and thus reduce overall healthcare costs was also highlighted at the Noble conference. The open label data of FLAMINGO-01 in the non-HLA-A*02 arm has helped to increase the probability of success, while potentially doubling the market for GLSI-100, and will continue to be analyzed as we may provide updates or publications at any time.”

About FLAMINGO-01 Open Label Phase III Data

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

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: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

Release – Nutriband Inc. Signs Letter of Intent with Qvanta Group of Companies to Explore Advanced Technology Solutions for Abuse-Deterrent Pharmaceutical Innovation Strategic Exploration

Posted on December 18, 2025December 18, 2025 by [email protected]

Research News and Market Data on NTRB

The LOI Aligns with Federal Priorities on Fentanyl Crisis, Artificial Intelligence, and Quantum Technology

December 18, 2025 08:00 ET | Source: Nutriband Inc.

ORLANDO, Fla., Dec. 18, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) (“Nutriband” or the “Company”), a developer of transdermal pharmaceutical products including abuse-deterrent technologies, today announced the signing of a non-binding Letter of Intent (“LOI”) with the Qvanta Group of Companies.

The Qvanta Group comprises Qvanta LLC and its subsidiaries, Qvanta Foundry LLC and Qvanta Capital LLC (collectively, “Qvanta”). Qvanta is a U.S.-based advanced technology organization developing the BigΔx Quantum Defense Fabric, an integrated quantum-AI cybersecurity and computing platform designed to support enterprise, government, and high-security research environments.

The announcement comes amid heightened federal focus on three converging national priorities. On December 15, 2025 President Trump signed an Executive Order designating illicit fentanyl as a Weapon of Mass Destruction, recognizing the substance as a direct threat to U.S. national security (https://www.whitehouse.gov/presidential-actions/2025/12/designating-fentanyl-as-a-weapon-of-mass-destruction/).

In parallel, the Administration’s America’s AI Action Plan emphasizes accelerating the responsible adoption of artificial intelligence across regulated sectors, including healthcare and pharmaceuticals (https://www.whitehouse.gov/articles/2025/07/white-house-unveils-americas-ai-action-plan/).

Additionally, the Genesis Mission Executive Order establishes quantum information science as a national priority, underscoring the strategic importance of advanced computing technologies in addressing complex national challenges (https://www.whitehouse.gov/presidential-actions/2025/11/launching-the-genesis-mission/).

Nutriband believes that Qvanta’s quantum-AI simulation capabilities, secure high-performance computing infrastructure, and advanced cybersecurity technologies may provide meaningful support for Nutriband’s research, innovation efforts, and long-term product development initiatives.

Under the LOI, the parties plan to explore potential collaboration areas including secure AI and analytics platforms for regulated pharmaceutical data, cybersecurity and data-integrity frameworks that support abuse-deterrent technologies, and advanced modeling and simulation capabilities enabled by quantum-ready infrastructure. Any discussions would emphasize regulatory compliance, strong data protection, and responsible technology use.

The LOI is non-binding and does not establish a partnership, joint venture, equity investment, licensing arrangement, or other binding commercial relationship. Any future collaboration would be subject to additional technical and regulatory review, due diligence, and the execution of definitive agreements. There can be no assurance that a definitive agreement will be reached or that any transaction will ultimately occur.

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ technology directly addresses the fentanyl crisis by incorporating aversive agents into transdermal patches designed to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The Company’s lead product under development is an abuse-deterrent fentanyl transdermal system, protected 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.

Nutriband Inc. (NASDAQ: NTRB) develops transdermal pharmaceutical products, with its lead product being an abuse-deterrent fentanyl patch incorporating proprietary AVERSA™ technology. For more information, visit www.nutriband.com.

About Qvanta Group of Companies

The Qvanta Group of Companies (https://qvanta.io) develops AI-driven and quantum-ready infrastructure solutions for national security, enterprise resilience, and regulated industries. The group comprises Qvanta LLC (operating entity), Qvanta Foundry LLC (R&D), and Qvanta Capital LLC (investment solutions).

Forward-Looking Statements

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

Contact Information:

Nutriband Inc.
Phone: 407-377-6695
Email: [email protected]

SOURCE: Nutriband Inc.

Release – Greenwich LifeSciences Announces Preliminary Analysis Showing 80% Recurrence Rate Reduction in the Open Label Arm of FLAMINGO-01

Posted on December 15, 2025December 15, 2025 by [email protected]

Research News and Market Data on GLSI

Download as PDF

December 15, 2025 6:00am EST

STAFFORD, Texas, Dec. 15, 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 an approximately 80% recurrence rate reduction in the open label non-HLA-A*02 arm of FLAMINGO-01.

A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate shows an approximately 80% reduction in recurrence rate in the fully enrolled, 250 patient non-HLA-A*02 arm of FLAMINGO-01. This arm does not have a direct placebo comparator arm, thus these two methods were used.
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. See the summary of the Phase IIb results below.
The first non-HLA-A*02 patient has completed the 11 primary and booster vaccinations over the first 3 years.

In addition to announcing this first analysis of the recurrence rate data in the open label non-HLA-A*02 arm of FLAMINGO-01, the Company previously reported promising observations 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.

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 250 patient non-HLA-A*02 data set, 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. Since the 250 non-HLA-A*02 patients do not have a placebo arm for a direct comparison, the following two methods were used, yielding the 80% reduction in recurrence rate observation:

Method 1: The recurrence rate of these 250 treated patients after completing the PIS was compared to the expected historical recurrence rate per year reported for this population in the Katherine study who received TDM1 (Kadcyla), which is about 3.5-4% recurrences per year or higher in the initial years of the Katherine study. The majority of the treated patients in FLAMINGO-01 also received TDM1 followed by GLSI-100. The data suggests an approximately 80% reduction in recurrence rate after the GLSI-100 PIS is completed as compared to the TDM1 arm of the Katherine study at a similar timepoint.
Method 2: The recurrence rate during the first 6 months of vaccination or PIS period when the patient may not be fully protected or protected at all, which covered an exposure period of 100 patient years, was compared to the recurrence rate after the PIS is completed and after peak immunity is believed to be achieved, which covered an exposure period of 132 patient years. The exposure period (patient years) is defined as the cumulative number of years all patients are followed in a period. The data suggests that the peak immunity is lowering the recurrence rate by approximately 80% after the PIS is completed as compared to the recurrence rate during the PIS period.
- For the first 6 months of vaccination or PIS, the theoretical maximum patient years would be 250 patients at 0.5 years each or 125 patient years. Thus 100 completed patient years represents 80% of the maximum potential patient years and within 3 to 6 months all vaccinations during this period may be completed.
- For the period after the PIS is completed, the theoretical maximum patient years would be 250 patients at 3.5 years of follow-up each or 875 patient years. Thus 132 completed patient years represents 15% of the maximum potential patient years and represents an average of 9 months of follow-up time after the PIS for patients who have completed the PIS.

CEO Snehal Patel commented, “We are very excited to announce in our 100^th press release since going public that the first patient has completed the full primary and booster vaccination series in FLAMINGO-01. We are equally excited to see a positive trend in the recurrence rate in the non-HLA-A*02 arm of FLAMINGO-01, as assessed multiple ways, that is trending similarly to the Phase IIb trial results where HLA-A*02 patients were treated. Despite these being preliminary results that will mature and can change with time, seeing a reduction in expected recurrence rates that is trending towards a low HR of 0.2, which represents an 80% reduction in recurrence rate, is very encouraging and which is why along with the similarly promising safety and immune response data to date, we will seek to continue to treat non-HLA-A*02 patients in a placebo controlled manner in the study. We will continue to analyze the data and may provide updates at any time.”

Previously Published Phase IIb Data

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 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

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: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

Source: Greenwich LifeSciences, Inc.

Released December 15, 2025

Release – Cadrenal Therapeutics CEO, Quang X. Pham, Receives BioFlorida’s Executive of the Year Award

Posted on November 19, 2025November 19, 2025 by [email protected]

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Nov. 19, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome current gaps in anticoagulation therapy, today announced its Chairman and Chief Executive Officer, Quang X. Pham, received the prestigious BioFlorida, Inc. “Executive of the Year Award,” at the recently held Florida Innovation Conference, powered by BioFlorida, in Orlando.

As the voice of Florida’s life-science ecosystem, BioFlorida represents biotechnology, medical-technology, digital health and health system organizations across the state and is committed to advancing innovation, economic growth and patient-impacting therapies.

“Our Executive of the Year Award underscores the remarkable leadership and vision that Quang has brought to Cadrenal and to Florida’s biotech sector,” said Mark A. Glickman, CEO of BioFlorida. “He exemplifies the entrepreneurial spirit and patient-centric innovation that our state’s life sciences community stands for.”

Under Pham’s leadership, Cadrenal has uniquely positioned itself to address gaps in anticoagulation treatment of multiple indications through the development of two differentiated anticoagulants (tecarfarin and frunexian). He founded Cadrenal after a distinguished career that includes founding other life-science and digital-health firms, as well as service as a U.S. Marine Corps officer.

“I am deeply honored to receive this recognition from BioFlorida,” said Pham. “BioFlorida has been by our side from day one. Our team is motivated every day by the patients who have few options for safe and effective anticoagulation. This award is a tribute to all of them.”

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

For more information, please contact:

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

Release – Gyre Therapeutics Reports Third Quarter 2025 and Year-to-Date Financial Results and Provides Business Update

Posted on November 7, 2025November 7, 2025 by [email protected]

Research News and Market Data on GYRE

November 7, 2025

PDF Version

Net income of $5.9 million and $11.2 million for the three and nine months ended September 30, 2025, respectively

Full-year revenue guidance revised to $115-118 million (from $118 – $128 million previously) due to delayed Etorel® (Nintedanib) rollout and government procurement-related uncertainty

Q3 2025 vs Q3 2024 Highlights

Quarterly revenue of $30.6 million, up 20% year-over-year, driven by ETUARY® growth and contributions from sales of Etorel® and Contiva®.
GAAP net income doubled to $5.9 million and adjusted net income rose to $8.8 million, reflecting commercial execution and disciplined cost control.
Operating income increased 64% to $6.9 million, as operating expenses grew at a slower pace than revenue.
Basic EPS improved to $0.04, compared to $0.01 year-over-year.

Nine-Month 2025 Highlights

Revenue of $79.4 million, moderately above the prior-year period, supported by steady Q3 growth of Etorel® and Contiva®, after earlier supply chain and distribution delays related to new product launches.
Basic EPS down from $0.14 to $0.08, reflecting higher operating expenses related to the dual product launches in the first half of 2025, partially offset by the strong Q3 profit recovery.
$80.3 million in cash, cash equivalents, and short and long-term deposits, up 57% year-to-date, as of Sept 30, 2025.

Business Update

Hydronidone New Drug Application (NDA) progressing in China, with Priority Review discussions ongoing and targeted submission following completion of regulatory interactions.
Completed patient enrollment in the 52-week Phase 3 pirfenidone pneumoconiosis (PD) trial (272 patients, 18 sites).
Plan to initiate an adaptive Phase 2/3 trial of pirfenidone in oncology-related pulmonary complications (RILI/immune-related pneumonitis) in Q4 2025.
U.S. MASH IND anticipated timeline adjusted to 2026 to allow for (i) the incorporation of the complete Phase 2 and 3 CHB-associated liver fibrosis clinical data from China; and (ii) planning and expected initiation of a hepatic impairment study under the existing U.S. IND to further inform safety, dose optimization, and regulatory discussions.

SAN DIEGO, Nov. 07, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced financial results for the third quarter ended September 30, 2025 and provided a business update.

“Following the positive results from our pivotal Phase 3 trial in the PRC evaluating Hydronidone for the treatment of CHB-associated liver fibrosis, we are working diligently toward our NDA submission and are leveraging Hydronidone’s Breakthrough Therapy designation to bring this much-needed therapy to patients in China,” said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics. “With enrollment now completed in our 52-week Phase 3 trial of pirfenidone for the treatment of pneumoconiosis, we continue to advance our pipeline in China. We are also preparing for U.S. clinical activities and expect to file the U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis in 2026, supported by the translation and regulatory-quality review of our China Phase 2 and Phase 3 trial data and an upcoming hepatic impairment study.”

Third Quarter Business Highlights and Upcoming Milestones

Commercial Portfolio

ETUARY® (pirfenidone): Generated $27.7 million in sales of ETUARY® for the quarter ended September 30, 2025, compared to $25.3 million for the same period in 2024.

Etorel® (nintedanib ethanesulfonate soft capsules): Generated $1.5 million in sales of Etorel® for the quarter ended September 30, 2025, the first full quarter of launch.

Contiva® (avatrombopag maleate tablets): Generated $1.2 million in sales of Contiva® for the quarter ended September 30, 2025.

Pipeline Development Updates

Hydronidone:

New Drug Application (NDA) in China:

Building on the positive Phase 3 trial results, Gyre Pharmaceuticals is actively engaging with China’s National Medical Products Administration (NMPA) to confirm Priority Review eligibility for Hydronidone’s New Drug Application (NDA).
The Company remains on track to advance regulatory filing activities and intends to proceed with the NDA submission for Hydronidone in China upon completion of ongoing regulatory interactions and resolution of any outstanding requirements.

Hydronidone U.S. IND Timing Update:

The anticipated timeline for submitting the U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis has been adjusted due to the delayed availability of the full Phase 3 trial data set from the completed trial of Hydronidone for the treatment of CHB-associated liver fibrosis in China. The Phase 2 and Phase 3 trial data form the core clinical safety package supporting the U.S. program, and the translation and regulatory-quality review of the Clinical Study Reports are currently in progress.
In parallel, Gyre plans to conduct a hepatic impairment study in U.S. subjects under its active U.S. IND. In light of the shifting market dynamics in the MASH landscape, this study is expected to help determine dose selection and appropriate enrollment criteria in populations with reduced hepatic function, thereby supporting a more robust Phase 2 development strategy.
With these activities underway, Gyre expects to file the U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis in 2026, and, subject to U.S. IND clearance, initiate a Phase 2 trial.

Pirfenidone Development and Indication Expansion:

In the third quarter of 2025, Gyre Pharmaceuticals completed patient enrollment in the 52-week Phase 3 clinical trial evaluating pirfenidone for the treatment of pneumoconiosis. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 272 patients across 18 clinical research centers in China. The trial is designed to evaluate the efficacy and safety of 52 weeks of pirfenidone treatment in patients with pneumoconiosis, a chronic occupational lung disease characterized by progressive pulmonary fibrosis.
Following the NMPA’s approval in March 2025 of Gyre Pharmaceuticals’ clinical trial application for pirfenidone in oncology-related pulmonary complications, Gyre Pharmaceuticals plans to initiate an adaptive Phase 2/3 trial in the fourth quarter of 2025 in the PRC, targeting radiation-induced lung injury (RILI) including cases complicated by immune-related pneumonitis across leading oncology centers.

Financial Results

Cash Position

As of September 30, 2025, Gyre held $40.4 million in cash and cash equivalents, $19.6 million in short-term bank deposits, and $20.3 million in long-term certificates of deposit, totaling $80.3 million.

Financial Results for the Three Months Ended September 30, 2025

Revenues: Revenues for the three months ended September 30, 2025 were $30.6 million, compared to $25.5 million for the same period in 2024. The $5.1 million increase was primarily due to $1.5 million from Etorel® sales, $1.2 million from Contiva® sales and a $2.4 million increase in revenue from ETUARY® sales. The increase in ETUARY® sales was mainly driven by a shift in marketing focus in the third quarter. We continue to anticipate revenue growth over the remainder of the year, driven by the growth of ETUARY® sales and supplemented by the commercialization of Etorel® and Contiva® in 2025.
Cost of Revenues: For the three months ended September 30, 2025, cost of revenues was $1.6 million, compared to $1.0 million for the same period in 2024. The $0.6 million increase was primarily attributable to a $0.2 million increase in the costs associated with Contiva® and Etorel®, in line with the corresponding increase in their sales, and a $0.5 million increase in costs associated with ETUARY® due to the higher sales and increased production costs for the product batch related to such sales, partially offset by a $0.1 million decrease in costs associated with generic drugs due to the decrease of sales.
Selling and Marketing Expense: For the three months ended September 30, 2025, selling and marketing expense was $15.3 million, compared to $13.7 million for the same period in 2024. The $1.6 million increase was primarily attributable to a $0.5 million increase in payroll costs, driven by higher headcount and an increase of sales in the three months ended September 30, 2025 and a $1.1 million increase in promotion and conference expenses.
Research and Development Expense: For the three months ended September 30, 2025, research and development expense was $2.4 million, compared to $2.8 million for the same period in 2024. The decrease was primarily attributable to a $0.4 million decrease in clinical trial costs resulting from the completion of the Phase 3 trial of Hydronidone in the second quarter of 2025, and a $0.2 million decrease in pre-clinical research expenses, partially offset by $0.2 million increase in staff costs.
General and Administrative Expense: For the three months ended September 30, 2025, general and administrative expense was $4.3 million, compared to $3.8 million for the same period in 2024. The $0.5 million increase was primarily driven by a $1.1 million increase in functional and administrative department’s personnel and stock compensation costs and a $0.2 million increase in miscellaneous expenses, partially offset by a $0.8 million decrease in professional fees.
Income from Operations: For the three months ended September 30, 2025, income from operations was $6.9 million, compared to $4.2 million for the same period in 2024. The $2.7 million increase was primarily driven by a $5.1 million increase in revenue, partially offset by a $2.4 million increase in total operating expenses.
Net Income: For the three months ended September 30, 2025, net income was $5.9 million, compared to $2.9 million for the same period in 2024. The increase was primarily driven by an increase in revenue of $5.1 million and an increase in other income of $0.8 million, partially offset by an increase in operating expenses of $2.4 million and an increase in income tax expense of $0.6 million.
Non-GAAP Adjusted Net Income: For the three months ended September 30, 2025, non-GAAP adjusted net income was $8.8 million, compared to $4.4 million for the same period in 2024. The increase was primarily driven by an increase in revenue of $5.1 million and an increase in other income of $0.8 million, partially offset by an increase in operating expenses of $1.5 million.

Financial Results for the Nine Months Ended September 30, 2025

Revenues: Revenues for the nine months ended September 30, 2025 were $79.4 million, compared to $77.9 million for the same period in 2024. The $1.5 million increase was primarily driven by the increase in new product sales of Contiva® by $3.0 million and Etorel® by $3.1 million, partially offset by a $4.4 million decline in ETUARY® sales and a $0.2 million decrease in generic drug revenue. The decrease in ETUARY® sales was primarily due to the allocation of marketing resources towards the launches of two new products during the first half of the year. In the third quarter, Gyre refocused marketing efforts on ETUARY® in response to market uncertainties related to Etorel® and Contiva®, both of which were included in the latest national volume-based procurement catalog. For the three months ended September 30, 2025, Gyre recorded an increase in ETUARY® sales compared to the same period in 2024, and Gyre expects ETUARY® sales will continue to grow in the three months ended December 31, 2025 compared to the same period in 2024.

We revised our full-year revenue guidance (see “Revised Full Year 2025 Financial Guidance” section below) primarily due to lower-than-expected sales of Contiva® and Etorel® relative to internal budget expectations. While both products continue to expand their commercial presence, initial rollout challenges and external market dynamics have resulted in lower than-expected sales.

For Etorel®, early-year supply chain and distribution delays moderated launch uptake, and uncertainty related to government volume-based procurement led customers to cautious purchasing behavior. While the underlying demand has started to improve, current performance remains below our original expectations for the year.

Cost of Revenues: For the nine months ended September 30, 2025, cost of revenues was $3.7 million, compared to $2.7 million for the same period in 2024. The $1.0 million increase was primarily driven by a $0.1 million increase in stock-based compensation and a $0.4 million increase in the costs of Etorel® and Contiva®, in line with the corresponding increase in their sales, as well as a $0.8 million increase in ETUARY®’s cost due to the higher plant, property and equipment depreciation from a plant renovation in 2025, partially offset by a $0.3 million decrease in costs related to generic drugs due to the decrease of sales.
Selling and Marketing Expense: For the nine months ended September 30, 2025, selling and marketing expense was $41.4 million, compared to $40.7 million for the same period in 2024. The $0.7 million increase was primarily driven by a $0.9 million increase in conference expenses and a $0.1 million increase in stock compensation costs, partially offset by a $0.3 million reduction in staff costs.
Research and Development Expense: For the nine months ended September 30, 2025, research and development expense was $8.9 million, compared to $8.3 million for the same period in 2024. The $0.6 million increase was primarily attributable to a $1.0 million increase in clinical trial costs, primarily as a result of data analysis costs for Hydronidone in the first half of 2025. This increase was offset by a $0.2 million decrease in materials and utilities expenses and a $0.2 million decrease in pre-clinical research expenses.
General and Administrative Expense: For the nine months ended September 30, 2025, general and administrative expense was $14.1 million, compared to $10.6 million for the same period in 2024. The $3.5 million increase was primarily driven by a $2.8 million increase in functional and administrative department’s personnel and stock compensation costs and a $0.9 million increase in miscellaneous expense, mainly due to the increase in expenses related to Gyre Pharmaceuticals’ annual employee appreciation event, partially offset by a $0.2 million decrease in professional fees.
Income from Operations: For the nine months ended September 30, 2025, income from operations was $11.4 million, compared to $15.5 million for the same period in 2024. The $4.1 million decrease was primarily driven by a $5.6 million increase in total operating expenses, partially offset by a $1.5 million increase in revenue.
Net Income: For the nine months ended September 30, 2025, net income was $11.2 million, compared to $17.3 million for the same period in 2024. The decrease was primarily driven by the increase in operating expenses of $5.6 million and decrease in change in fair value of warrant liability of $4.5 million, partially offset by an increase in revenue of $1.5 million, an increase in other income of $0.7 million, and a decrease of income tax expense of $1.9 million.
Non-GAAP Adjusted Net Income: For the nine months ended September 30, 2025, non-GAAP adjusted net income was $14.6 million, compared to $15.7 million for the same period in 2024. The decrease was primarily driven by the increase in operating expenses of $3.3 million, partially offset by an increase in revenue of $1.5 million and an increase in other income of $0.7 million.

Revised Full Year 2025 Financial Guidance

Full-year revenue guidance revised from $118–128 million to $115–118 million, reflecting slower-than-expected commercialization of Etorel® (nintedanib) due to early supply chain and distribution challenges, as well as increased market uncertainty related to China’s centralized procurement policy leading to more cautious purchasing behavior in the second half of the year, partially offset by stronger-than-expected ETUARY® sales.

Please note that the revenue guidance assumes a constant foreign currency rate and no significant economic disruption or downturn.

Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.

Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.

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 NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest of 65.2% in Gyre Pharmaceuticals. In the third quarter of 2025, this indirect interest was increased from 65.2% to 69.7% through the increased capital contribution from BJContinent Pharmaceuticals Limited to 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 United States Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY®, and development programs for F573, F528, and F230.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including the anticipated timing of the submission of Gyre’s U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis, a hepatic impairment study of Hydronidone in U.S. subjects under Gyre’s active IND, the initiation of Gyre’s Phase 2/3 trial in the PRC for pirfenidone capsules for the treatment of RILI, including cases complicated by immune-related pneumonitis, the filing of an NDA with the NMPA and timing for potential commercial approval for Hydronidone for the treatment of CHB-associated liver fibrosis and trial design of Gyre’s Phase 3 clinical trial evaluating pirfenidone for the treatment of pneumoconiosis, the expectations regarding commercial revenues from the sales of Etorel® and Contiva® maleate tablets, interactions with regulators, expectations regarding future product sales, Gyre’s ability to meet its expected revenue guidance and Gyre’s financial position and cash resources. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital; supply chain and distribution delays and challenges. 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.

For Investors:
David Zhang
Gyre Therapeutics
[email protected]

View full release here.

Lilly and Novo Slash Obesity Drug Prices in Landmark Deal With Trump Administration

Posted on November 6, 2025November 6, 2025 by [email protected]

Eli Lilly & Co. and Novo Nordisk A/S have reached a sweeping agreement with the Trump administration to cut the prices of their blockbuster obesity drugs in exchange for tariff relief and expanded Medicare access — a move poised to reshape both the weight-loss market and broader healthcare policy in the U.S.

Under the deal, the two pharmaceutical giants will lower prices on their popular medications, Zepbound and Wegovy, bringing the monthly cost for eligible Medicare and Medicaid patients with obesity and related conditions down to roughly $245, with co-pays for Medicare users capped near $50. Both companies will also offer discounted direct-purchase programs: Eli Lilly will sell Zepbound’s lowest dose for about $299 a month via its LillyDirect platform, while Novo Nordisk’s Wegovy will be available at $499 through NovoCare. That’s less than half their current U.S. list prices, which exceed $1,000 per month.

In return, the companies receive a three-year exemption from new import tariffs on pharmaceutical products and fast-track regulatory reviews for upcoming weight-loss pills, which could reach the market next year at introductory prices near $149 per month. Both Lilly and Novo have pledged to manufacture these new products in the U.S., aligning with the administration’s push to onshore critical drug production.

The timing of the announcement, coming just days after midterm election losses for the Republican Party, underscores the political weight behind lowering healthcare costs. The White House framed the move as part of a broader effort to ease cost-of-living pressures, a theme that has dominated recent public sentiment.

For the pharmaceutical industry, the agreement signals a new era of negotiation — one in which pricing concessions may secure favorable trade treatment and regulatory acceleration. Rival firms including Pfizer, AstraZeneca, and Germany’s Merck KGaA have reportedly pursued similar arrangements to avoid heavier restrictions or penalties.

The deal also reflects growing momentum toward allowing Medicare coverage for anti-obesity drugs — something long prohibited under federal law. Beginning next year, patients with qualifying health conditions such as prediabetes or heart failure will gain access to these treatments under government plans, marking a significant policy shift that could expand the addressable market for weight-loss medications to millions of new patients.

From an investment standpoint, the move could reverberate across healthcare and biotech stocks. Large-cap players like Lilly and Novo may face slimmer margins on price-controlled drugs but stand to gain from much higher volume and broader insurance access. Small-cap biotech firms developing next-generation metabolic or appetite-control treatments could benefit from renewed investor attention and potential partnership opportunities as major pharmaceutical companies look to diversify pipelines and defend market share.

While the announcement temporarily weighed on Lilly’s shares and lifted Novo’s, analysts expect the broader obesity-drug market to continue expanding rapidly — particularly if upcoming oral treatments deliver similar efficacy at lower costs. For investors, the balance between pricing pressure and explosive demand could define one of the most lucrative — and politically charged — healthcare themes heading into 2026.

Release – Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Belgium

Posted on October 2, 2025October 2, 2025 by [email protected]

Research News and Market Data on GLSI

Download as PDFOctober 02, 2025 6:00am EDT

STAFFORD, Texas, Oct. 02, 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 expansion of FLAMINGO-01 clinical trial to Belgium.

The Company’s application to European regulators has been formally approved, adding Belgium as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, and the US.

According to the latest data collected by the European Cancer Information System (click here), a total of 11,366 new cases of breast cancer were diagnosed in Belgium in 2022, which is the most common cancer diagnosed in women, representing approximately 33% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Belgium with 2,324 deaths in 2022.

The Company is collaborating with Patrick Neven, MD, PhD, at UZ Leuven, who will be serving as the national principal investigator in Belgium for FLAMINGO-01. Dr Neven is Full Professor at the Department of Gynecological Oncology, University Hospitals Leuven, and is a staff member of the Multidisciplinary Breast Centre. His research focuses on breast oncology, particularly endocrine therapy and quality of life. He has served as principal investigator in multiple clinical trials, published over 300 peer-reviewed papers, and lectured widely at international meetings. He is president of the Belgian Society of Senology, active in several scientific societies, and has mentored numerous doctors and PhD students in breast cancer care.

CEO Snehal Patel commented, “We thank our steering committee for introducing us to Dr. Neven and look forward to working with him and his colleagues. We are planning start-up activities in Leuven in the coming month. Leuven is centrally located in Belgium and is an ideal location to cover large parts of the country, including Brussels and Antwerp.”

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

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: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

Source: Greenwich LifeSciences, Inc.

Released October 2, 2025

Release – Greenwich LifeSciences Announces Addition of Portugal to Flamingo-01 Clinical Trial

Posted on September 30, 2025September 30, 2025 by [email protected]

Research News and Market Data on GLSI

Download as PDF

September 30, 2025 6:00am EDT

STAFFORD, Texas, Sept. 30, 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 expansion of FLAMINGO-01 clinical trial to Portugal.

The Company’s application to European regulators has been formally approved, adding Portugal as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US.

According to the latest data collected by the European Cancer Information System (click here), a total of 9,065 new cases of breast cancer were diagnosed in Portugal in 2022, which is the most common cancer diagnosed in women, representing approximately 30% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Portugal with 2,211 deaths in 2022.

Luís António Marques da Costa, MD, PhD, will be serving as the national principal investigator in Portugal for FLAMINGO-01. Dr. Costa is an Associate Professor of Medicine, Oncology & Oncobiology, FML-UL, Lisbon, Portugal, and Head of the Clinical Translational Oncology Research Unit at the Institute of Molecular Medicine. He has also served as Director of the Oncology Department at Hospital de Santa Maria in Lisbon since 2005. At the School of Medicine, he is the Coordinator Professor of “Oncobiologia” a new teaching unit that aims to teach the understanding of clinical oncology through molecular medicine. He is involved in multiple clinical trials in breast cancer and other solid tumors, and his research interests have long centered on the area of bone metastases. In recent years, his research has focused on understanding the molecular mechanisms of tumor progression at metastatic sites using bone metastases as a paradigm.

CEO Snehal Patel commented, “We look forward to collaborating with Dr. Costa and his colleagues. We were introduced to Dr. Costa by a member of our steering committee. We recently visited Lisbon to begin start-up activities and to meet our investigators to develop a strategy for Portugal. We are in the process of activating sites in Lisbon and are reviewing additional sites in central and northern Portugal.”

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

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: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

Source: Greenwich LifeSciences, Inc.

Released September 30, 2025