Greenwich Life Sciences, Inc. (GLSI) provided additional updates on its Phase 3 FLAMINGO-01 trial and outlined corporate strategy initiatives, including financing and partnering plans.
The Phase 3 FLAMINGO-01 trial is evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.
Breast cancer remains one of the most common cancers worldwide, with approximately 300,000 new patients diagnosed annually in the U.S. and more than 4 million survivors. Despite advances in surgery and trastuzumab-based therapy, many patients remain at risk of recurrence, underscoring the need for novel immunotherapies.
GLSI-100 (GP2+GM-CSF) is a HER2-directed peptide immunotherapy that has received Fast Track designation from the FDA. It is designed to elicit a potent immune response to prevent metastatic breast cancer recurrences.
In the Phase 2b trial, GLSI-100 reduced recurrence rates by 80% in HER2/neu 3+ patients compared to placebo.
The ongoing FLAMINGO-01 Phase 3 trial is enrolling patients across approximately 140 sites, with plans to expand to additional U.S, European, Canadian, and U.K. centers. More than 1,000 patients have been screened, and the 250-patient non-HLA-A*02 arm is fully enrolled.
Preliminary open-label data showed an approximately 80% reduction in recurrence rates after the Primary Immunization Series, consistent with Phase 2b results.
Corporate strategy updates include cost-reduction measures, transitioning U.S. trial operations in-house, and judicious use of ATM financing to maintain a lean burn rate of approximately $7 million annually. The company is also pursuing strategic partnerships, with large pharma dominating the breast cancer drug market.
Patent filings for treating non- HLA-A*02 patients are expected to strengthen GLSI-100's portfolio.
The Data Safety Monitoring Board met twice in 2025 and recommended continuation of the study without modification. Planned trial adjustments, subject to size to regulatory approval, include increasing study size, accelerating enrolment, and using a newly manufactured commercial drug product lot.
CEO Snehal Patel commented that the potential for GLSI-100 to save lives by preventing metastatic breast cancer recurrences and reducing healthcare costs was highlighted at the Noble conference. He added that expanding FLAMINGO-01 into the U.K. and Canada reflects growing patient and investigator interest.
GLSI has traded in the range of $7.78 to $14.47 over the past year. The stock is currently trading in the pre-market at $13.32, up 2.38%.
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December 19, 2025 15:10 ET U.S. inflation data and interest rate decisions by major central banks were the highlights of this busy week for economics news flow. Employment data and survey results on the housing markets also gained attention in the U.S. In Europe, the European Central Bank and Bank of England announced their policy decisions and macroeconomic projections.