STAFFORD, Texas, March 19, 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 the initiation of new clinical sites in the US. The Phase III clinical trial has recently been activated at City of Hope, one of the largest and most advanced cancer research and ...

STAFFORD, Texas, March 18, 2026 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided an update on the upcoming AACR Meeting 2026. Two abstracts and two posters were accepted for presentation. The titles and authors of the abstracts are as follows: Abstract Number: ...

STAFFORD, Texas, March 17, 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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided a preliminary update showing a continued reduction in the recurrence rate in the fully enrolled, 250 patient, open label non-HLA-A*02 arm of FLAMINGO-01. 6 Months of Additional Patient Data Since Last U ...

STAFFORD, Texas, March 16, 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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the use of commercially manufactured GP2 in FLAMINGO-01. All US Sites Treating Patients with Commercially Manufactured GP2 The Company previously announced that the first three c ...

Core Viewpoint - Greenwich LifeSciences, Inc. has reported a significant increase in the patient screening rate for its Phase III clinical trial, FLAMINGO-01, evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2]. Group 1: Patient Screening and Trial Progress - The annual patient screening rate in FLAMINGO-01 has increased to over 800 patients per year, marking a 33% rise from the previous rate of 600 patients per year [2]. - The increase in screening is attributed to the activation of new sites in 2025 and heightened patient engagement at existing sites [2]. - Currently, more than 1,000 patients have been screened, with a focus on the 250 patient non-HLA-A*02 arm, which is now fully enrolled [3][4]. Group 2: Clinical Trial Details and Efficacy - The Phase IIb trial demonstrated an 80% or greater reduction in cancer recurrences among HER2/neu 3+ patients treated with GLSI-100 after 5 years of follow-up [5][8]. - In the non-HLA-A*02 arm, preliminary analysis indicates an approximately 80% reduction in recurrence rates, aligning with Phase IIb trial results [7]. - The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned once 14 events have occurred [9]. Group 3: Immunotherapy and Safety Profile - GLSI-100 is a 9 amino acid transmembrane peptide of the HER2 protein, which is expressed in 75% of breast cancers [11]. - The Primary Immunization Series (PIS) consists of 6 initial injections followed by 5 booster injections, aimed at achieving peak protection and prolonging the immune response [3][4]. - The safety profile of GLSI-100 has been well-tolerated, with immune responses trending positively in both HLA-A*02 and non-HLA-A*02 patient groups [7][8].

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 ...

Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, while also updating on its cash burn rate and financing strategy [1][2]. Financial Updates - The Company raised more than its 2025 cash burn rate of approximately $9.5 million through its ATM financing, resulting in a year-end cash balance of approximately $6 million as of December 31, 2025 [2]. - As of January 23, 2026, the cash balance increased to approximately $12.5 million after raising about $7 million in the first three weeks of January 2026 [2]. - The current cash balance may cover the Company's cash needs for all of 2026, considering the projected increase in cash needs over the previous years [3]. Clinical Trial Progress - FLAMINGO-01 has screened over 1,000 patients, with a current screening rate of approximately 600 patients per year [4]. - The non-HLA-A*02 arm is fully enrolled, with 250 patients receiving GLSI-100, which represents a significant increase in treated patients compared to the Phase IIb trial [4]. - Preliminary analysis indicates an approximately 80% reduction in recurrence rates after the Primary Immunization Series (PIS) is completed, aligning with Phase IIb trial results [7]. Immunotherapy Details - GLSI-100 is designed to elicit a potent immune response, with the PIS involving six injections over the first six months, followed by five booster injections every six months [4][13]. - The safety profile and immune response trends in non-HLA-A*02 patients are similar to those observed in HLA-A*02 patients from the FLAMINGO-01 trial and the Phase IIb study [7]. Future Financing Strategy - The Company plans to continue using the ATM to sustain or grow its cash balance, potentially reducing the need for large financing in the near term [3]. - Continued use of the ATM may facilitate access to non-dilutive funding options, such as strategic partnerships or debt financing, to support FLAMINGO-01 and future commercial activities [3].

Core Insights - The recent update from Greenwich LifeSciences, Inc. (GLSI) focuses on manufacturing validation and regulatory progress rather than solely on clinical results [1] Company Overview - Greenwich LifeSciences has received FDA approval, indicating progress in its regulatory journey [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis in the biotech sector [1] - The analyst has been active in the investment space for five years, with a focus on identifying promising biotechnology companies [1] Investment Focus - The analyst emphasizes evaluating the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities while balancing financial fundamentals [1] - The goal is to provide insights that help investors understand both opportunities and risks in the biotech sector [1]

Core Insights - Biotech shares experienced significant movements in after-hours trading, with Sarepta Therapeutics leading due to anticipated trial data and other companies benefiting from recent clinical and regulatory updates [1] Company Summaries - Sarepta Therapeutics Inc. (SRPT) saw a surge of 9.65% to $23.17, driven by anticipation for a webcast on January 26, 2026, where three-year topline results from its Phase 3 trial of ELEVIDYS for Duchenne muscular dystrophy will be presented, potentially pivotal for its gene therapy program [2] - Fractyl Health, Inc. (GUTS) increased by 7.66% to $2.25, indicating speculative interest despite no new company news, suggesting momentum-driven trading [3] - Greenwich LifeSciences, Inc. (GLSI) advanced 2.08% to $26.00 following FDA approval of the first commercial lot of GP2 vials for the FLAMINGO-01 trial, marking a significant step in its commercialization efforts with the potential to prepare approximately 200,000 doses [4] - Anebulo Pharmaceuticals, Inc. (ANEB) rose 8.41% to $1.16, attracting buyers despite no new updates, reflecting investor interest [5] - OmniAb, Inc. (OABI) gained 4.59% to $2.05, similar to Anebulo, indicating broader investor interest in the biotech sector without fresh news [6] - Trevi Therapeutics, Inc. (TRVI) added 3.40% to $10.33 after publishing results from its Phase 2b CORAL trial in a peer-reviewed journal, enhancing credibility and investor enthusiasm [7] - AEON Biopharma, Inc. (AEON) edged up 1.80% to $1.13, confirming a meeting with the FDA and securing shareholder approval for financing transactions, simplifying its capital structure ahead of a second PIPE financing closing expected around January 27, 2026 [8]

Core Viewpoint Greenwich LifeSciences, Inc. has made significant progress in its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with the FDA approving the first commercial lot of GP2 for use in the trial, which is a crucial step towards filing a Biological License Application (BLA) in the US. Group 1: Clinical Trial Updates - The first three commercial lots of GP2 were manufactured in 2023, capable of preparing approximately 200,000 doses [2] - The first commercial lot of GP2 vials has been approved for use in FLAMINGO-01 in the US [2][3] - More than 1,000 patients have been screened in FLAMINGO-01, with a current screening rate of approximately 600 patients per year [5] Group 2: Manufacturing and Regulatory Progress - The company plans to start using the new GP2 vials at all 40 US sites in the coming weeks [3] - The submission of commercial manufacturing data for three lots is critical for the BLA filing in the US and other countries [4] - At least two more lots of finished GP2 product will be manufactured to support clinical and manufacturing data review by the FDA [4] Group 3: Efficacy and Safety Data - Preliminary analysis shows an approximately 80% reduction in recurrence rates after the Primary Immunization Series (PIS) in the non-HLA-A*02 arm of FLAMINGO-01 [6] - The immune response and safety profile of non-HLA-A*02 patients are trending similarly to HLA-A*02 arms and the Phase IIb study [6] - The Phase IIb trial demonstrated an 80% or greater reduction in cancer recurrences in HER2/neu 3+ patients treated with GLSI-100 [8] Group 4: Future Plans and Market Potential - The company aims to conduct FLAMINGO-01 at 150 leading clinical sites in the US and Europe, facilitating a smooth transition to product launch if GLSI-100 is approved [5] - The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, with an interim analysis planned when at least 14 events have occurred [9] - The company is preparing to submit the same manufacturing data to regulatory agencies in Europe, the UK, and Canada [5]