STAFFORD, Texas, Jan. 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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the expansion of the clinical trial into Europe. The Company's application to add an additional 11 sites in Spain, Germany, and Poland has been formally approved by EMA. The academ ...

STAFFORD, Texas, Jan. 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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the expansion of the clinical trial into Europe. The Company's application to add an additional 11 sites in Spain, Germany, and Poland has been formally approved by EMA. The acade ...

STAFFORD, Texas, Jan. 27, 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 Poland. According to the latest data collected by the European Cancer Information System (click here), a total of 24,599 new cases of breast cancer were diagnosed in ...

STAFFORD, Texas, Jan. 23, 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 initiation of new clinical sites in the US. Both Harvard University and Johns Hopkins University sites were recently added as participating sites in FLAMINGO-01 in the US and both principal investig ...

STAFFORD, Texas, Jan. 22, 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 provided the following update on the commercial manufacturing of GP2. Preparation for Filing of BLA in the US In addition to the submission of the Phase III clinical data, submitting commercial manufacturing data ...

STAFFORD, Texas, Jan. 14, 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 initiation of clinical sites in Germany. The Company has partnered with GBG (German Breast Group), the largest academic breast cancer research network in Germany, where approximately 38 sites have a ...

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 ...