Greenwich LifeSciences, Inc. (Nasdaq: GLSI) announced that the European Medicines Agency (EMA) has completed its review and approved the use of a commercially manufactured GP2 lot in the company's Phase III breast cancer trial, FLAMINGO-01.

The approval means all clinical sites in the United States and Europe — now numbering approximately 170 to 180, up from 160 — will use the same commercially manufactured GP2 lot. Shipments to European pharmacies are already under way, according to a company press release. Greenwich LifeSciences said it is separately seeking approval to use the same lot in the United Kingdom and Canada.

The commercial GP2 lot was previously approved by the U.S. Food and Drug Administration for use in FLAMINGO-01 in early 2026. All approximately 40 to 50 U.S. sites have been supplied with the vials and have begun treating patients. The first three commercial lots of GP2 active ingredient were manufactured in 2023, with capacity to prepare approximately 200,000 doses.

The company also provided a preliminary update on open-label Phase III data. More than 1,300 patients have been screened, with a current screening rate of approximately 800 patients per year. The 250-patient non-HLA-A*02 arm is fully enrolled. A preliminary analysis of that arm showed an approximately 70% to 80% reduction in recurrence rate after completion of the Primary Immunization Series, which the company noted is consistent with trends observed in its earlier Phase IIb trial. The company cautioned that the data is preliminary and not a prediction of final results.

FLAMINGO-01 is evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrences in HER2-positive patients who had residual disease or high-risk pathologic complete response at surgery. The trial is led by Baylor College of Medicine.