Greenwich LifeSciences (NASDAQ:GLSI) provided a comprehensive year-end update on Monday for its pivotal Phase III clinical trial, FLAMINGO-01.
The trial is evaluating GLSI-100, a Fast Track-designated immunotherapy designed to prevent breast cancer recurrence in HER2-positive patients.
Highlighting both clinical progress and a lean fiscal approach, the company confirmed that the trial's Data Safety Monitoring Board (DSMB) met twice in 2025—most recently in December—and recommended the study continue without any modifications.
The FLAMINGO-01 trial has reached significant operational scale, with approximately 140 clinical sites currently active.
Looking toward 2026, Greenwich plans to activate an additional 10 approved sites and is in discussions to expand the study into the United Kingdom and Canada.
These expansions are paired with proposed protocol modifications, including resizing the study and increasing the enrollment rate, which the company believes will further de-risk the path toward potential regulatory approval.
Financially, Greenwich LifeSciences continues to operate under a highly disciplined model.
The company reported an annual cash burn rate of approximately $7 million, a figure it has maintained consistently since 2023.
This lean structure is supported by an "At-the-Market" (ATM) financing strategy, which management noted allows them to fund ongoing operations efficiently while actively pursuing non-dilutive strategic partnerships.
The update also highlighted preliminary data from the trial's non-HLA-A*02 arm, which recently reached full enrollment of 250 patients.
Initial analysis from this open-label group suggests an 80% reduction in recurrence rates for patients who completed the Primary Immunization Series.
While preliminary, these results mirror the strong efficacy signals seen in the company's prior Phase IIb studies and underscore GLSI-100’s potential to become a cornerstone in post-treatment breast cancer care.