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 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 - 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]

Core Viewpoint - Greenwich LifeSciences, Inc. has announced an extension of the lock-up period for shares owned by its directors, officers, and pre-IPO investors to September 30, 2026, to align interests with long-term investors and support the ongoing Phase III clinical trial, FLAMINGO-01, for its immunotherapy GLSI-100 aimed at preventing breast cancer recurrences [1][2] Group 1: Lock-Up Extension - The lock-up period for shares owned by directors, officers, and pre-IPO investors has been extended to approximately 72 months from the IPO date [1] - The Board of Directors retains the authority to modify the lock-up terms and implement a leak-out plan for share sales after the lock-up period [2] Group 2: FLAMINGO-01 Clinical Trial - FLAMINGO-01 is a Phase III clinical trial evaluating GLSI-100 in HER2 positive breast cancer patients, with over 1,000 patients screened and a current screening rate of about 600 patients per year [3][7] - The trial includes a fully enrolled non-HLA-A*02 arm with 250 patients receiving GLSI-100, which has shown a recurrence rate reduction similar to the Phase IIb trial results [3][6] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [7] Group 3: Clinical Data and Efficacy - Preliminary data from the FLAMINGO-01 trial indicates an approximately 80% reduction in recurrence rates after the Primary Immunization Series (PIS) [6] - 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][11] - The immune response and safety profile in the non-HLA-A*02 arm are trending similarly to the HLA-A*02 arm and Phase IIb study results [6]

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, with updates on clinical, financing, and partnering strategies [1][2]. Clinical Strategy - The FLAMINGO-01 clinical strategy is evolving to reduce risk and enhance marketing approval chances, supported by financing strategies and cost reduction activities [2] - Approximately 140 sites are currently enrolling patients, with plans to activate an additional 10 sites in 2026 and expand to more EU countries [2] - The study has shifted from principal investigator interest to patient-driven interest, with wait lists forming at certain sites [2] - Discussions are ongoing with clinical sites in the UK and Canada for potential study participation, pending regulatory approvals [2] Financing Strategy - The company is utilizing an At-The-Market (ATM) financing strategy to manage its burn rate, which was approximately $7 million annually in 2023 and 2024 [2] - The burn rate for the first three quarters of 2025 remains around $7 million, indicating a gradual increase but not substantial due to cost-saving initiatives [2] - The upfront costs of clinical expenses are expected to decrease after the initial six months of vaccinations, as booster shots will be administered every six months [2] Partnering Strategy - The company is actively attending partnering conferences to explore collaborations with larger pharmaceutical companies in the breast cancer drug market [2] - Patent filings for GLSI-100 are expected to strengthen its patent portfolio, enhancing its market position [2] FLAMINGO-01 Data Monitoring - The Data Safety Monitoring Board (DSMB) has recommended continuing the FLAMINGO-01 study without modifications, indicating confidence in the current trial design [3] - The Steering Committee has endorsed planned modifications to the study, pending regulatory approval [3] Open Label Phase III Data - Over 1,000 patients have been screened, with a current screening rate of approximately 600 patients per year [4] - The non-HLA-A*02 arm is fully enrolled with 250 patients, significantly increasing the treated patient data compared to the Phase IIb trial [4] - The Primary Immunization Series (PIS) consists of six initial injections followed by five booster injections every six months to maintain immune response [4] Preliminary Analysis - Preliminary analysis shows an approximately 80% reduction in recurrence rates in the non-HLA-A*02 arm after completing the PIS, aligning with Phase IIb trial results [7] - The immune response and safety profile in the non-HLA-A*02 patients are trending similarly to the HLA-A*02 arms of FLAMINGO-01 [7] About GLSI-100 - GLSI-100 is designed for HER2 positive breast cancer patients who have undergone surgery, with the trial led by Baylor College of Medicine and plans to expand to 150 sites globally [9] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [9]

Core Insights - Greenwich LifeSciences, Inc. announced an approximately 80% reduction in breast cancer recurrence rates in the non-HLA-A*02 arm of its Phase III clinical trial, FLAMINGO-01 [1][4][7] Group 1: Clinical Trial Results - The open label non-HLA-A*02 arm of FLAMINGO-01 showed an 80% reduction in recurrence rates compared to historical data from the Katherine study, which reported recurrence rates of about 3.5-4% per year [4][5] - The trial included 250 non-HLA-A*02 patients, significantly larger than the approximately 50 patients in the Phase IIb trial, allowing for more robust data [4] - The immune response and safety profile in non-HLA-A*02 patients are trending similarly to those in the HLA-A*02 arms of FLAMINGO-01 and the Phase IIb study [2][7] Group 2: Immunization Series - The Primary Immunization Series (PIS) consists of 6 GLSI-100 injections over the first 6 months, followed by 5 booster injections every 6 months to enhance long-term immune response [3] - The data suggests that peak immunity is achieved after the completion of the PIS, leading to an 80% reduction in recurrence rates compared to the initial 6 months of vaccination [5] Group 3: Future Directions - The company plans to continue treating non-HLA-A*02 patients in a placebo-controlled manner within the study, with ongoing data analysis and potential updates [7] - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients, with plans to expand to 150 clinical sites globally [9]