Greenwich LifeSciences Announces Noble Capital Markets' Equity Research Coverage Initiation

Greenwich LifeSciences has announced that Noble Capital Markets has initiated company-sponsored equity research coverage. The coverage is focused on the company's Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences. The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival in approximately 500 HLA-A*02 patients. The company's shares are listed on the Nasdaq stock exchange under the ticker symbol GLSI.

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) has announced that Noble Capital Markets has initiated company-sponsored equity research coverage. The coverage is focused on the company's Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences.

FLAMINGO-01 is a Phase III clinical trial designed to assess the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery. The trial is led by Baylor College of Medicine and includes clinical sites in the US and Europe, with plans to expand to up to 150 sites globally. Approximately 500 HLA-A*02 patients will be randomized to receive GLSI-100 or placebo, while up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm.

The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival. An interim analysis for superiority and futility will be conducted once at least half of the required 28 events have occurred, providing 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

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 protein, a cell surface receptor protein expressed in a variety of common cancers, including breast cancer. The company's shares are listed on the Nasdaq stock exchange under the ticker symbol GLSI.

The equity research report by Noble Capital Markets Research Analyst Robert LeBoyer is available on the company's website. For more information on FLAMINGO-01, please visit the Company's website or clinicaltrials.gov.

References:
[1] https://www.globenewswire.com/news-release/2025/08/20/3136494/0/en/Noble-Capital-Markets-Initiates-Equity-Research-Coverage-on-Greenwich-LifeSciences.html
[2] https://www.marketscreener.com/news/greenwich-lifesciences-announces-plan-to-build-out-internal-clinical-operations-team-ce7c51ddd889f126