Greenwich LifeSciences Takes Flight As FLAMINGO 01 Breast Cancer Trial Progresses

Core Viewpoint - Shares of Greenwich LifeSciences Inc. (GLSI) have seen significant gains as the company advances its financing strategy and prepares to implement modifications to its phase III trial for the breast cancer immunotherapy GLSI-100, pending regulatory approval [1] Company Overview - GLSI-100 is a combination of GP2 peptide vaccine and GM-CSF, aimed at helping the immune system recognize and combat cancer cells expressing the HER2/neu protein, which is present in 75% of breast cancer cases [2] - The drug is targeted at high-risk breast cancer patients post-surgery and standard treatments [2] Clinical Trial Details - The ongoing phase 3 trial, FLAMINGO-01, involves HLA-A02-positive and HER2/neu-positive breast cancer patients at high risk for recurrence, with about 500 patients planned for random assignment to receive either GLSI-100 or a placebo [3] - A preliminary analysis of the 250-patient open-label non-HLA-A02 arm showed an approximately 80% reduction in recurrence rate [4] Planned Modifications to the Trial - The company plans to increase the study size to enhance statistical power and reduce risk, despite potentially fewer recurrences being anticipated [4] - Strategies include doubling or quadrupling the enrollment rate to increase patient-years in the study and maintain momentum at clinical sites [5] - The trial's projected completion date is December 31, 2026 [6] Industry Context - Breast cancer is the most common cancer among women in the U.S., with over 4 million survivors [7] - Major pharmaceutical companies like Roche, AstraZeneca, and Pfizer are actively involved in developing HER2-targeted therapies, shaping the breast cancer treatment landscape [9] Financing Strategy - As of September 30, 2025, the company held $3.81 million in cash and is utilizing an At-the-Market (ATM) offering strategy to manage cash efficiently and minimize shareholder dilution [10] - Between January 1, 2025, and September 30, 2025, the company completed ATM offerings, generating gross proceeds of $6.49 million from the sale of 621,674 shares at an average price of $10.44 per share [11] Insider Share Lock-Up - The Board of Directors has extended the lock-up period for shares held by directors, officers, and pre-IPO investors until September 30, 2026, approximately 72 months post-IPO [12] Stock Performance - GLSI shares began trading on the Nasdaq Capital Market at $5.75 on September 25, 2020, and reached a 52-week intraday high of $22.31 on December 26, 2025, closing at $20.68 [13]