Greenwich LifeSciences Extends Lock-up of Directors and Officers to September 30, 2026

Core Viewpoint - Greenwich LifeSciences, Inc. has announced an extension of the lock-up period for shares owned by its directors, officers, and pre-IPO investors to September 30, 2026, to align interests with long-term investors and support the ongoing Phase III clinical trial, FLAMINGO-01, for its immunotherapy GLSI-100 aimed at preventing breast cancer recurrences [1][2] Group 1: Lock-Up Extension - The lock-up period for shares owned by directors, officers, and pre-IPO investors has been extended to approximately 72 months from the IPO date [1] - The Board of Directors retains the authority to modify the lock-up terms and implement a leak-out plan for share sales after the lock-up period [2] Group 2: FLAMINGO-01 Clinical Trial - FLAMINGO-01 is a Phase III clinical trial evaluating GLSI-100 in HER2 positive breast cancer patients, with over 1,000 patients screened and a current screening rate of about 600 patients per year [3][7] - The trial includes a fully enrolled non-HLA-A02 arm with 250 patients receiving GLSI-100, which has shown a recurrence rate reduction similar to the Phase IIb trial results [3][6] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [7] Group 3: Clinical Data and Efficacy - Preliminary data from the FLAMINGO-01 trial indicates an approximately 80% reduction in recurrence rates after the Primary Immunization Series (PIS) [6] - The Phase IIb trial demonstrated an 80% or greater reduction in cancer recurrences among HER2/neu 3+ patients treated with GLSI-100 after 5 years of follow-up [5][11] - The immune response and safety profile in the non-HLA-A02 arm are trending similarly to the HLA-A*02 arm and Phase IIb study results [6]