4 - Greenwich LifeSciences, Inc. (0001799788) (Issuer)

4 - Greenwich LifeSciences, Inc. (0001799788) (Issuer)

4 - Greenwich LifeSciences, Inc. (0001799788) (Issuer)

4 - Greenwich LifeSciences, Inc. (0001799788) (Issuer)

4 - Greenwich LifeSciences, Inc. (0001799788) (Issuer)

4 - Greenwich LifeSciences, Inc. (0001799788) (Issuer)

4 - Greenwich LifeSciences, Inc. (0001799788) (Issuer)

4 - Greenwich LifeSciences, Inc. (0001799788) (Issuer)

4 - Greenwich LifeSciences, Inc. (0001799788) (Issuer)

4 - Greenwich LifeSciences, Inc. (0001799788) (Issuer)

STAFFORD, Texas, April 03, 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 global update on FLAMINGO-01. Flamingo-01 Progress to Date & Future Plans The Company recently confirmed that the preliminary HLA prevalence, safety, and immune response data in FLAMINGO-01 patients is trending as expected in both HLA-A*02 and non-HLA-A*02 arms. The non-HLA-A*02 arm was expanded to 250 patients in 2024 with approval from both EU and US regulators. With t

STAFFORD, Texas, April 02, 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 following update on FLAMINGO-01 open label immune response data. FLAMINGO-01 Immune Response Data Summary The Company has analyzed the preliminary immune response data from FLAMINGO-01. Immune response data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types (non- HLA-A*02), show that GLSI-100 is creating an immune response over tim

STAFFORD, Texas, March 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 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 March 31, 2026 which is approximately 66 months from date of the Company's IPO. During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modif

STAFFORD, Texas, March 17, 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 following update on FLAMINGO-01 open label safety data. FLAMINGO-01 Data Safety Monitoring Board (DSMB) The FLAMINGO-01 DSMB met twice in 2024, most recently in December 2024, and recommended to continue the study as is without modification. No serious adverse events related to GLSI-100 have been reported to date in FLAMINGO-01. Additional safety updates and comparison to the Pha

STAFFORD, Texas, Feb. 10, 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 following update on FLAMINGO-01 open label HLA data. Analysis of the open label data from FLAMINGO-01 has commenced and has been conducted in a manner that maintains the study blind. A preliminary review of FLAMINGO-01 HLA data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types, shows that approximately 46% of all screened patients h

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 academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. With this additional approval, regulators ha

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 Poland in 2022, which is the most common cancer diagnosed in women, representing approximately 25% of all cancers in women. Breast cancer is the second leading cause of death from cancer

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 investigators, Dr. Laura Spring and Dr. Cesar Santa-Maria have joined the Steering Committee. The Steering Committee is now comprised of the following experts in the field of breast cancer onco

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 will be critical to the filing of a Biological License Application (BLA) for GLSI-100 in the US and for regulatory filings in other countries. Commercial Manufacturing The first thre

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 agreed to participate in FLAMINGO-01. Most of the sites have been approved by German authorities which has led to start-up activity in 2024, and the remaining sites are currently under re

SC 13G - Greenwich LifeSciences, Inc. (0001799788) (Subject)