Greenwich Lifesciences Inc. Completes Enrollment in the Open‑Label Arm of FLAMINGO‑01

Greenwich Lifesciences Inc. (Nasdaq: GLSI), a clinical‑stage biopharmaceutical company headquartered in Stafford, Texas, announced on 8 December 2025 that it has completed enrollment in the open‑label, non‑HLA‑A*02 arm of its Phase III clinical trial, FLAMINGO‑01. The trial evaluates GLSI‑100, an investigational immunotherapy designed to prevent breast‑cancer recurrence.

Trial Structure and Enrollment Milestones

  • Double‑blind, randomized component – Approximately 500 patients who are HLA‑A*02 positive will be randomized to receive either GLSI‑100 or placebo.
  • Open‑label, non‑HLA‑A*02 component – Up to 250 patients who do not possess the HLA‑A*02 allele from either parent are enrolled in a third open‑label arm and receive GLSI‑100. This arm represents roughly 55 % of the total FLAMINGO‑01 population.
  • Completion status – On 8 December 2025, the company reported that the enrollment of the 250 non‑HLA‑A*02 patients has been finalized, marking the conclusion of the first enrollment phase for the entire study.

Executive Commentary

CEO Snehal Patel emphasized the importance of the non‑HLA‑A*02 data set, stating that analysis of immune response, safety, and recurrence rates among these 250 patients will provide critical insights into the broader applicability of GLSI‑100. Patel noted that the open‑label design allows for detailed safety monitoring while the randomized component offers robust efficacy data.

Market Context

  • Stock performance – At the close on 4 December 2025, GLSI traded at $8.94 per share, within a 52‑week range of $7.78 to $14.47.
  • Market capitalization – The company’s market cap is approximately $123.9 million USD.
  • Sector positioning – Greenwich Lifesciences operates in the health‑care biotechnology sector and focuses on developing cancer treatments, primarily serving patients in Texas.

Sources

The completion of enrollment was reported by multiple outlets on 8 December 2025, including:

  • Investing.com (News ID 2)
  • Investing.com (News ID 1)
  • Wallstreet‑online.de (News ID 3)
  • GlobeNewswire (News ID 4)

These reports collectively confirm the milestone and provide details on the trial’s structure and executive remarks.