GLSI News & Events

Greenwich LifeSciences announced the initiation of new clinical sites in the US. The Phase III clinical trial has recently been activated at City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States - specifically at its network sites in Los Angeles and Orange counties, Arizona, Atlanta, and Illinois. Principal investigator at City of Hope, Hope S. Rugo, M.D., continues her participation on the Steering Committee. Her prior site at University of California San Francisco, where she is Professor Emeritus, is still participating in the study.

Greenwich LifeSciences, focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, provided a preliminary update showing a continued reduction in the recurrence rate in the fully enrolled, 250 patient, open label non-HLA-A*02 arm of FLAMINGO-01. 6 months of additional patient data since last update shows recurrence rate of less than1% per year in non-HLA-A*02 patients treated with GLSI-100. This less than1% Annual Recurrence Rate observed in non-HLA-A*02 Patients is statistically significantly sThan a 4% annual recurrence rate over a similar time period observed in the Katherine study yielding an spproximately 70-80% teduction in tecurrence tate as explained below. Final results may vary. Future updates may be presented at upcoming conferences. This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.

Greenwich LifeSciences provided the following update on the use of commercially manufactured GP2 in FLAMINGO-01. The Company previously announced that the first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first of three commercial lots filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was recently submitted to the FDA, and after review, the first commercial lot of GP2 vials was approved for use in FLAMINGO-01 in the US. Within weeks following the FDA review, all approximately 40 US sites were supplied with commercially manufactured GP2 vials and these sites began treating patients with these vials immediately. We were able to efficiently distribute the GP2 vials and communicate with the US pharmacists working with our warehouse partners and through our clinical team, which we internalized in Q4 2025.