Greenwich LifeSciences Provides Update on Phase III Clinical Trial for Breast Cancer Immunotherapy; Shares Surge

New York, February 15, 2024 - PRISM MarketView - Greenwich LifeSciences, Inc. (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, provided an update on its Phase III clinical trial, Flamingo-01, focusing on GLSI-100, an immunotherapy aimed at preventing breast cancer recurrence post-surgery. The Flamingo-01 Data Safety Monitoring Board (DSMB) has met twice in 2023, advising the trial to proceed without modifications, noting no serious adverse events related to GLSI-100.

Currently, around 30 U.S. clinical sites with 87 locations are actively recruiting patients for Flamingo-01, with expectations to increase to 35-40 sites by 2024. In Europe, pending regulatory approval expected in 2024, plans are underway to add approximately 105-120 sites across several countries, potentially increasing the total sites to 140-160 in the U.S. and Europe combined.

The Flamingo-01 Steering Committee, during the 2023 San Antonio Breast Cancer Symposium (SABCS) and ASCO Annual Meeting, discussed expanding the third arm of the trial to include 250 patients, based on new research suggesting broader applicability of GP2 across various HLA types. This amendment aims to encompass a wider patient demographic.

CEO Snehal Patel shared optimism about the trial’s progress and the expansion into Europe, noting the potential to reach peak enrollment rates by the end of 2024. Patel highlighted the significance of the trial’s design and its potential impact, drawing parallels to Roche’s successful Herceptin and Kadcyla, which significantly reduced recurrences in HER2 positive patients.

The company is also focusing on commercial manufacturing and regulatory submissions, including the preparation of a comprehensive Phase II clinical trial study report for the FDA, to support the filing of a Biologics License Application (BLA) for GLSI-100.

Greenwich LifeSciences is considering additional trials to extend the follow-up period of prior studies and to potentially treat a broader range of HER2 positive patients. New patent applications related to GLSI-100 and its manufacturing process have been filed, with further innovations in development.

GLSI shares traded higher 30.6% to $10.85 Wednesday afternoon. The company is today’s intraday leader in the PRISM Emerging Women’s Health Index with an 11% increase in its stock.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, 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/neu protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, Flamingo-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

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