Greenwich LifeSciences Announces Acceptance of Two Abstracts at AACR Annual Meeting 2026
Rhea-AI Summary
Greenwich LifeSciences (Nasdaq: GLSI) announced acceptance of two abstracts and two corresponding posters for presentation at the AACR Annual Meeting 2026, April 17-22, 2026. The company is a clinical-stage biopharmaceutical firm running the Phase III FLAMINGO-01 trial of Fast Track-designated GLSI-100 to prevent breast cancer recurrences.
The AACR will publish abstract titles on March 17, 2026 at 4:30 pm EST, abstracts on April 17, 2026 at 3:00 pm EST, and posters on their conference presentation dates. CEO Snehal Patel noted one abstract is the first co-authored with the full FLAMINGO-01 steering committee.
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Key Figures
Market Reality Check
Peers on Argus
GLSI fell 5.65% while peers showed mixed moves and the momentum scanner flagged only one biotech peer (KYTX) down 0.76% without news. This points to a stock-specific move rather than a broad sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 27 | Cash/ATM update | Neutral | +9.6% | Updated cash burn, 2025 ATM proceeds and early 2026 cash position. |
| Jan 22 | FDA trial supply | Positive | +5.7% | FDA approved use of commercially manufactured GP2 vials in FLAMINGO-01. |
| Dec 29 | Insider lock-up | Positive | +19.8% | Extended director and officer lock-up to support FLAMINGO-01 through 2026. |
| Dec 22 | Trial/corporate update | Positive | +2.7% | Expanded FLAMINGO-01 footprint, DSMB reviews, protocol and cash-burn commentary. |
| Dec 15 | Clinical data update | Positive | -3.9% | Preliminary ~80% reduction in recurrence in an open-label FLAMINGO-01 arm. |
GLSI has mostly traded higher on recent news, especially operational and regulatory updates, with one notable divergence on strong clinical data.
Over the last few months, GLSI updates have centered on the FLAMINGO-01 Phase III trial and financing. A Dec 15, 2025 preliminary analysis reported an ~80% recurrence rate reduction but saw a negative reaction. Subsequent news on trial operations, insider lock-up extension, and an FDA decision on commercial GP2 use all drew positive price moves. January’s cash burn and ATM update also lifted shares. Today’s AACR abstract acceptance continues this pattern of trial-focused milestones.
Market Pulse Summary
This announcement highlights acceptance of 2 abstracts and 2 posters on GLSI-100 and the Phase III FLAMINGO-01 program at the AACR 2026 meeting, reinforcing clinical visibility. In recent months, the company reported an FDA decision enabling commercial GP2 use in the trial and disclosed cash-burn and ATM activity. Investors may watch upcoming AACR data, future updates on enrollment and protocol changes, and how management addresses prior going-concern disclosures and capital needs.
Key Terms
phase iii medical
immunotherapy medical
fast track regulatory
AI-generated analysis. Not financial advice.
STAFFORD, Texas, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that two abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026, including two corresponding posters.
The AACR 2026 conference will be held from April 17-22, 2026. The AACR plans to publish the abstract titles on March 17, 2026 at 4:30 pm EST, the abstracts on April 17, 2026 at 3:00 pm EST, and the posters on the date of the presentation at the conference.
CEO Snehal Patel commented, "One of these abstracts will be the first abstract co-authored by the Company and the full Steering Committee of FLAMINGO-01."
About the AACR Annual Meeting 2026
The AACR is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 61,000 members residing in 143 countries and territories. The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.
About FLAMINGO-01 Open Label Phase III Data
More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
- In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately
80% reduction in recurrence rate. - This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to
80% compared to a 20-50% reduction in recurrence rate by other approved products. - The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
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 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
For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in
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
Forward-Looking Statement Disclaimer
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com
FAQ
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