GLSI News & Events

Greenwich LifeSciences, focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, provided an update on the increased patient screen rate in FLAMINGO-01. Over the past 6 months, the company achieved its highest screening rate of approximately 200 patients per quarter or the equivalent of over 800 patients per year in the US and EU sites, which is an approximately 33% increase over the prior reported annual screen rate of 600 patients per year. This increase is attributable to the new sites activated in 2025 and the increased patient driven momentum at existing sites. CEO Snehal Patel commented, "While the approximately 33% increase to over 800 patients screened per year is impressive, marking our success in optimizing and expanding our clinical operations in 2025, we may have yet to see the peak screen rate for the study."

Greenwich LifeSciences provided additional updates on its cash burn rate and financing strategy for its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences. The company's ATM financing vehicle allows the company to sell its common stock directly into the trading market at market price. The amount raised through the ATM for 2025 exceeded the company's 2025 cash burn rate of approximately $9.5M, leading to a year end cash balance of approximately $6M as of December 31, 2025. Furthermore, the company more than doubled its cash balance as of the close of business on January 23, 2026, to approximately $12.5M, having raised approximately $7M in the first three weeks of January 2026 through the ATM.

Greenwich LifeSciences provided an update on the use of commercially manufactured GP2 in its Phase 3 clinical trial FLAMINGO-01. GP2 is an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including 75% of breast cancers. The first three commercial lots of GP2 active ingredient were manufactured in 2023 and 2024. In addition to the submission of the Phase III clinical data, submitting commercial manufacturing data for three lots will be critical to the filing of a Biological License Application for GLSI-100 in the US and for regulatory filings in other countries. At least two more lots of finished GP2 product will be manufactured so that both clinical and manufacturing data are available for review by the biologics division of the FDA prior to potentially being granted a marketing license with up to 12 years of market exclusivity. A preliminary analysis of recurrence rates after the Primary Immunization Series is completed shows an approximately 80% reduction in recurrence rate. The Phase IIb results can be summarized as follows: 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.