• Greenwich LifeSciences' Flamingo-01 Phase III trial, evaluating GLSI-100 for breast cancer recurrence prevention, has been approved for expansion into Europe, including Spain, France, Germany, Italy, and Poland.
• The Flamingo-01 trial will activate 105 sites in Europe, with site initiation visits starting as early as March 4, 2024, aiming to enroll more patients and accelerate the study.
• The trial's steering committee has agreed to expand the third arm of the study to enroll up to 250 patients with non-HLA-A*02 types, potentially broadening the patient population who could benefit from GLSI-100.
• Greenwich LifeSciences is preparing for a BLA filing in the US, including commercial manufacturing data and study reports from prior clinical trials, marking progress toward potential commercialization of GLSI-100.