Greenwich Lifesciences Inc

Greenwich LifeSciences announced its board has extended the lock-up of shares owned by directors, officers, and pre-IPO investors to January 31, 2027, roughly 76 months from its IPO. During this period, those insiders cannot sell their common stock unless the board modifies the restriction. After the lock-up expires, daily and periodic sales will be governed by a leak-out plan, though the board may end the lock-up early for strategic or financial transactions. CEO Snehal Patel noted the company expects increased interest in partnership and financing discussions following progress in its Phase III FLAMINGO-01 trial for the GLSI-100 immunotherapy.

Greenwich LifeSciences announced that the European Medicines Agency has approved combining both HLA-A*02 and non-HLA-A*02 patients in the randomized arms of its Phase III FLAMINGO-01 trial for GLSI-100, an immunotherapy to prevent breast cancer recurrences. This decision aligns European sites with US sites, where the FDA previously allowed the combination, effectively more than doubling the enrollment rate of the pivotal arm and making non-HLA-A*02 patients, who represent about 55% of the population, eligible for enrollment. All 170 to 180 clinical sites in the US and Europe are now operating under the same protocol and could continue enrolling up to the first interim analysis, with data analyzable by individual HLA types. The company also reported that the 250-patient non-HLA-A*02 open-label arm is fully enrolled, and a preliminary analysis shows an approximately 70 to 80 percent reduction in recurrence rate after the primary immunization series, trending similarly to the Phase IIb trial where HLA-A*02 patients saw up to an 80 percent reduction. Greenwich LifeSciences plans to pursue approval for both patient groups using a combined analysis, potentially doubling the market for GP2.

Greenwich LifeSciences announced that the European Medicines Agency has approved the use of its commercially manufactured GP2 in the Phase III FLAMINGO-01 breast cancer trial. The same commercial lot of GP2 vials was already approved by the FDA for US sites earlier in 2026, and all approximately 40 to 50 US sites have been supplied and are treating patients. With the EMA decision, all clinical sites in the US and Europe, now totaling approximately 170 to 180 sites, are expected to use the same lot, and shipments to European pharmacies are already under way. The company is also seeking approval to use this lot in the UK and Canada through separate regulatory processes. The open-label non-HLA-A*02 arm of the trial is fully enrolled with 250 patients, and preliminary data shows an approximately 70 to 80 percent reduction in recurrence rate after the primary immunization series, trending similarly to the Phase IIb results where treated HLA-A*02 patients saw up to an 80 percent reduction.