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 new clinical sites activated in Poland [1][3]. Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy for breast cancer recurrence prevention in patients post-surgery [10]. - The company is collaborating with Dr. Piotr Wysocki, a prominent figure in breast cancer research in Poland, to facilitate the trial [3][4]. 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 [7][8]. - The trial will include approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [8]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [8]. Market Context - In 2022, Poland reported 24,599 new breast cancer cases, making it the most common cancer among women, accounting for about 25% of all female cancers [2]. - Breast cancer was the second leading cause of cancer-related deaths in women in Poland, with 8,723 deaths recorded in 2022 [2]. Clinical Site Activation - The activation of clinical sites in Poland includes 9 to 11 locations approved by Polish authorities, with the first patient treated in 2024 [3][5]. - Notable participating sites include major oncology centers in cities like Kraków, Opole, and Poznań [6].

Core Viewpoint - Greenwich LifeSciences, Inc. has initiated new clinical sites in the US for its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][8] Group 1: Clinical Trial Details - FLAMINGO-01 is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [8] - The trial will include 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 treated with GLSI-100 [8] - 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 [8] Group 2: Key Personnel and Institutions - Harvard University and Johns Hopkins University have been added as participating sites, with Dr. Laura Spring and Dr. Cesar Santa-Maria joining the Steering Committee [2][7] - Dr. Spring is a breast medical oncologist at Massachusetts General Hospital and has a focus on novel therapeutic strategies for breast cancer [3][4] - Dr. Santa-Maria is a recognized researcher in breast immunotherapy and will also contribute to the trial at Johns Hopkins [6][7] Group 3: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy targeting breast cancer recurrences, particularly in patients who have undergone surgery [10] - The company is expanding its clinical trial network globally, with plans to open up to 150 sites [8]

Core Viewpoint - Greenwich LifeSciences, Inc. is making significant progress in the commercial manufacturing of GP2, an immunotherapy aimed at preventing breast cancer recurrences, as it prepares for the filing of a Biological License Application (BLA) in the US and other countries [1][5]. Group 1: Commercial Manufacturing - The first three commercial lots of GP2 active ingredient were manufactured in 2023, capable of preparing approximately 200,000 doses [3]. - In 2024, the first commercial lot of GP2 was filled into vials for sale or clinical use, with final testing nearing completion [4]. - The company plans to manufacture at least two more lots of finished GP2 product while conducting the FLAMINGO-01 clinical trial [5]. Group 2: Regulatory and Filing Updates - Submission of commercial manufacturing data is critical for the BLA filing for GLSI-100 in the US and for regulatory filings in other countries [2]. - The company is expanding clinical sites into Europe and discussing the marketing license pathway with the European Medicines Agency (EMA) [5]. Group 3: Clinical Trial Information - FLAMINGO-01 is a Phase III clinical trial evaluating GLSI-100 in HER2 positive breast cancer patients, with plans to include up to 150 clinical sites globally [7]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [7]. Group 4: Intellectual Property Developments - In 2024, the company made refinements in the manufacturing of GP2 and may file additional patent applications [6]. Group 5: Company Overview - Greenwich LifeSciences is focused on developing GP2, a 9 amino acid peptide of the HER2 protein, to prevent breast cancer recurrences in patients post-surgery [9].

Core Viewpoint - Greenwich LifeSciences, Inc. has initiated clinical sites in Germany for its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2]. Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy for breast cancer recurrence prevention in patients post-surgery [14]. - The company is conducting the FLAMINGO-01 trial, which is designed to assess the safety and efficacy of GLSI-100 in HER2-positive breast cancer patients [12]. Clinical Trial Details - FLAMINGO-01 is a Phase III trial that includes approximately 500 HLA-A*02 patients randomized to receive GLSI-100 or a placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [12]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [12]. Partnership and Collaboration - The company has partnered with GBG (German Breast Group), the largest academic breast cancer research network in Germany, with around 38 sites participating in the trial [2][3]. - GBG is recognized for its extensive research capabilities, having published 64 research articles in 2023 with a cumulative impact factor of 1,291 [3]. Significance of Breast Cancer Research - In 2022, Germany reported 75,267 new breast cancer cases, making it the most common cancer among women, accounting for approximately 29% of all female cancers [4]. - Breast cancer was the leading cause of cancer-related deaths in women in Germany, with 20,601 deaths recorded in 2022 [4]. Expert Commentary - Professor Sibylle Loibl, a key figure in the FLAMINGO-01 Steering Committee, emphasized the trial's potential to enhance understanding of breast cancer recurrence prevention [5]. - Dr. Marcus Schmidt, the national Principal Investigator for Germany, highlighted the trial's unique opportunity to evaluate GLSI-100's efficacy in preventing recurrence among HER2-positive patients [6].

Partnership and Clinical Trial Activation - The company has partnered with Unicancer and its breast cancer group (UCBG), the largest academic breast cancer research network in France, to activate the FLAMINGO-01 study in approximately 19 French sites [1] - The UCBG network includes over 100 investigating centers across France, covering various types of institutions, and is internationally recognized for its role in breast cancer research [2] - The FLAMINGO-01 study will be conducted in collaboration with UCBG, with 15 sites initiated in Q2-Q4 2024 and the remaining 4 sites scheduled for start-up activities in Q1-Q2 2025 [1] Unicancer's Role and Network - Unicancer is the only hospital network in France entirely dedicated to oncology, with 18 Cancer Centers (CLCC) and two affiliated member institutions, caring for nearly 530,000 patients annually [6] - Unicancer is the leading academic sponsor of clinical trials in oncology in Europe, with 106 active clinical trials sponsored in 2020 and nearly 7,600 patients enrolled [6] - The Unicancer network contributes to a third of the internationally significant French publications in oncology and is ISO 9001:2015 certified for clinical research [6][10] FLAMINGO-01 Trial Details - FLAMINGO-01 is a Phase III clinical trial evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences in HER2-positive breast cancer patients [5][13] - The trial is designed to enroll approximately 500 HLA-A*02 patients randomized to GLSI-100 or placebo, with up to 250 patients of other HLA types treated with GLSI-100 in a third arm [13] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, with an interim analysis planned after 14 events [13] Breast Cancer Statistics in France - In 2022, 66,328 new cases of breast cancer were diagnosed in France, representing approximately 33% of all cancers in women [9] - Breast cancer is the leading cause of cancer-related deaths in women in France, with 14,739 deaths reported in 2022 [9] Key Figures and Leadership - Dr. F.C. Bidard, a Medical Oncologist and Head of Breast Cancer Group at Institut Curie, serves as the national Principal Investigator for FLAMINGO-01 in France and is a member of the trial's Steering Committee [11] - Dr. T. Bachelot, President of UCBG, emphasized the importance of the FLAMINGO study in advancing clinical research in cancer vaccination [7] - CEO Snehal Patel highlighted the partnership with Unicancer and the involvement of Dr. Bidard in the Steering Committee as key factors in the trial's development [8]

STAFFORD, Texas, Jan. 13, 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 activation of clinical sites in France. According to the latest data collected by the European Cancer Information System (click here), a total of 66,328 new cases of breast cancer were diagnosed in F ...

STAFFORD, Texas, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provided the following update on corporate events. The Company's 2024 events to date are listed below: Feb 29 - Mar 1, 2024 – GBG Annual Scientific Meeting (German clinical network conference)Jun 1 - 4, 202 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class: Trading Symbol(s) Name of each exchange on which registered: Common Stock GLSI Nasdaq Capital Market Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 ☐ TRANSITION REPORT UNDER SECTION 13 OR ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-39555 GREENWICH LIFESCIENCES, INC. (Exact Name of registrant as specified in its charter) Delaware 20-5473709 (State or other jurisdiction (I.R. ...

STAFFORD, Texas, Aug. 01, 2024 (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 following update of the expansion of clinical sites into Spain. As previously announced, the Company has partnered with GEICAM, the largest academic breast cancer research network in Spain, where 38 ...