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 approxi ...

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]

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 s ...

Core Viewpoint - Greenwich LifeSciences, Inc. is making significant progress in its Phase III clinical trial, FLAMINGO-01, aimed at evaluating GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Group 1: FLAMINGO-01 Progress - The company has screened over 1,000 patients in the FLAMINGO-01 trial, maintaining a screening rate of approximately 150 patients per quarter, equating to 600 patients annually across 140 active sites [2][3]. - The company is considering a strategy to continue enrolling patients in both HLA-A*02 and non-HLA-A*02 arms until interim analyses are conducted [2]. Group 2: Clinical Trial Details - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have residual disease or high-risk pathologic complete response after surgery [4]. - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [4]. - An interim analysis for superiority and futility will be conducted after at least 14 events have occurred, with the trial designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival [4]. Group 3: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy aimed at preventing breast cancer recurrences in patients post-surgery [6]. - The company is actively expanding its clinical trial sites, with plans to open up to 150 sites globally [4].

Core Insights - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial FLAMINGO-01 to Austria, which is aimed at evaluating GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2] Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy targeting breast cancer recurrences in patients post-surgery [6] - The company has initiated the FLAMINGO-01 trial, which is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [4][6] Clinical Trial Details - FLAMINGO-01 is a Phase III trial that includes sites in the US and Europe, with plans to expand to 150 sites globally [4] - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [4] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [4] Market Context - In Austria, breast cancer is the most common cancer among women, accounting for about 28% of all female cancers, with 6,070 new cases diagnosed in 2022 [3] - Breast cancer was the leading cause of cancer-related deaths in women in Austria, with 1,789 deaths reported in 2022 [3] Collaboration and Expansion - The company is collaborating with principal investigators at Ordensklinikum Linz in Upper Austria, with plans to activate this site within the year and explore additional sites in Vienna and Salzburg [4]

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, to Belgium, which aims to evaluate GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Group 1: Clinical Trial Expansion - The FLAMINGO-01 trial has received formal approval from European regulators to include Belgium, adding to its existing sites in Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, and the US [2]. - The trial is led by Baylor College of Medicine and plans to open up to 150 sites globally, with a focus on university-based hospitals and academic networks [5]. Group 2: Breast Cancer Statistics in Belgium - In 2022, Belgium reported 11,366 new cases of breast cancer, making it the most common cancer among women, accounting for approximately 33% of all female cancers [3]. - Breast cancer was the leading cause of cancer-related deaths in women in Belgium, with 2,324 deaths recorded in 2022 [3]. Group 3: Principal Investigator and Collaboration - The company is collaborating with Dr. Patrick Neven, a prominent figure in breast oncology, who will serve as the national principal investigator for FLAMINGO-01 in Belgium [4]. - Dr. Neven has extensive experience in clinical trials and has published over 300 peer-reviewed papers, contributing significantly to breast cancer research [4]. Group 4: Trial Design and Objectives - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [5]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [5].

Core Insights - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, to Portugal, focusing on GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2] Group 1: Clinical Trial Expansion - The FLAMINGO-01 trial has received formal approval from European regulators to include Portugal, joining other countries such as Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US [2] - The trial is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [5] Group 2: Breast Cancer Statistics in Portugal - In 2022, there were 9,065 new cases of breast cancer diagnosed in Portugal, making it the most common cancer among women, accounting for approximately 30% of all cancers in this demographic [3] - Breast cancer was the leading cause of cancer-related deaths in women in Portugal, with 2,211 deaths reported in 2022 [3] Group 3: Principal Investigator and Collaboration - Dr. Luís António Marques da Costa has been appointed as the national principal investigator for FLAMINGO-01 in Portugal, bringing extensive experience in oncology and clinical trials [4] - The CEO of Greenwich LifeSciences expressed enthusiasm for collaborating with Dr. Costa and his team, indicating ongoing efforts to activate clinical trial sites in Lisbon and other regions of Portugal [5] Group 4: Trial Design and Objectives - FLAMINGO-01 aims to randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [5] - 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 [5]

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial FLAMINGO-01 to Ireland, which aims to evaluate GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy designed to prevent breast cancer recurrences in patients who have previously undergone surgery [7][8]. Clinical Trial Details - FLAMINGO-01 (NCT05232916) is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery [5]. - The trial is led by Baylor College of Medicine and includes clinical sites in the US and Europe, with plans to open up to 150 sites globally [5]. - Approximately 500 HLA-A*02 patients will be randomized to receive GLSI-100 or placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [5]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [5]. Expansion to Ireland - The application to European regulators for including Ireland in the FLAMINGO-01 trial has been formally approved, adding to existing sites in Spain, France, Germany, Italy, Poland, Romania, and the US [2]. - Dr. Janice Walshe will serve as the national principal investigator in Ireland, collaborating with Cancer Trials Ireland to provide access to novel agents for Irish women affected by breast cancer [4]. Breast Cancer Statistics - In 2022, Ireland reported 3,723 new cases of breast cancer, making it the most common cancer diagnosed in women, accounting for approximately 30% of all cancers in women [3]. - Breast cancer is the second leading cause of cancer-related deaths among women in Ireland, with 883 deaths recorded in 2022 [3].

Core Viewpoint - Greenwich LifeSciences, Inc. has received Fast Track designation from the FDA for its immunotherapy GLSI-100, aimed at preventing breast cancer recurrences in HLA-A*02 positive patients who have completed standard HER2/neu targeted therapy [1][2] Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy designed to prevent breast cancer recurrences in patients post-surgery [9][11] - The company is currently conducting a Phase III clinical trial named FLAMINGO-01, which evaluates the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [7][11] Fast Track Designation - The Fast Track designation allows for more frequent communication between the FDA and the company, potentially leading to earlier drug approval and the ability to submit parts of the Biologic License Application (BLA) as they are completed [2][5] - The designation is granted to drugs that address serious conditions and fill unmet medical needs, with GLSI-100 showing potential to improve invasive breast cancer-free survival [2][4] Clinical Trial Details - FLAMINGO-01 is designed to include approximately 500 HLA-A*02 patients randomized to receive GLSI-100 or placebo, with an interim analysis planned after 14 events of invasive breast cancer [7] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, providing 80% power if the annual event rate in placebo-treated subjects is 2.4% or greater [7] Previous Clinical Data - In a Phase IIb trial, GLSI-100 demonstrated an 80% or greater reduction in cancer recurrences over five years in HER2/neu 3+ patients, with no serious adverse events reported [6][10] - The immunotherapy was well tolerated, and booster injections every six months prolonged the immune response, indicating a strong safety profile [6][10]

Core Viewpoint - Greenwich LifeSciences, Inc. has announced the initiation of company-sponsored equity research coverage by Noble Capital Markets, focusing on its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100 as an immunotherapy for preventing breast cancer recurrences [1] Group 1: Clinical Trial Details - FLAMINGO-01 is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients with residual disease or high-risk pathologic complete response after surgery [2] - The trial will involve approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types receiving GLSI-100 [2] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [2] Group 2: Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy aimed at preventing breast cancer recurrences in patients post-surgery [4] - GP2 is a 9 amino acid transmembrane peptide derived from the HER2 protein, which is expressed in 75% of breast cancers at varying levels [4] - The company is actively conducting the FLAMINGO-01 trial, with plans to expand to 150 clinical sites globally [2][4] Group 3: Breast Cancer Statistics - One in eight U.S. women will develop invasive breast cancer in their lifetime, with around 300,000 new cases and 4 million survivors annually [3] - HER2 protein is expressed in 75% of breast cancers, indicating its significance in treatment strategies [3][4]