Greenwich LifeSciences, Inc. (GLSI) announced that patient screening in its pivotal Phase 3 trial, FLAMINGO-01, has accelerated to more than 800 patients per year, marking a 33% increase over the prior rates. The study is evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.
The higher screening rate reflects new clinical sites activated in 2025 and growing patient momentum at existing centers. CEO Snehal Patel noted that the company "may have yet to see the peak screen rate for the study," underscoring optimism about continued enrolment growth.
FLAMINGO-01 has already screened over 1,000 patients. In the non-HLA-A*02 arm, preliminary analysis after the primary immunization series showed an approximately 80% reduction in recurrence rates, consistent with earlier Phase 2b results. GLSI-100 works by stimulating the immune system with a series of injections followed by boosters to prolong protection.
The trial, led by Baylor College of Medicine, is enrolling HER2-positive breast cancer patients across U.S. and European sites, with plans to expand globally. An interim analysis will assess efficacy once half of the required events have occurred.
GLSI has traded between $7.78 and $34.10 over the past year. The stock closed Monday's session at $27.39, down 1.19%. Shares fell 1.46% to $26.99 in premarket trading Tuesday.
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