STAFFORD, Texas - Greenwich LifeSciences, Inc. (NASDAQ:GLSI), a clinical-stage biopharmaceutical company, announced Monday that its Board of Directors has approved an extension of the lock-up period for shares held by directors, officers, and pre-IPO investors until June 30, 2025.
This lock-up extension, which spans approximately 57 months from the company's IPO date, restricts these stakeholders from selling their common stock during the designated timeframe, with potential modifications at the discretion of the Board.
The company is currently advancing its Phase III clinical trial, FLAMINGO-01, which is assessing the immunotherapy candidate GLSI-100 for the prevention of breast cancer recurrences. The trial is focused on HER2/neu positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatments and involves multiple clinical sites across the United States, with plans to expand into Europe.
Approximately 500 HLA-A02 patients will be randomized to receive either GLSI-100 or a placebo in the double-blinded portion of the trial, while up to 250 patients of other HLA types will receive GLSI-100 in an open-label arm. The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival and will conduct an interim analysis for superiority and futility after at least 14 of the required 28 events have occurred.
Breast cancer affects one in eight U.S. women over their lifetime, with HER2/neu protein overexpression observed in a significant portion of these cases. GLSI-100, Greenwich LifeSciences' lead candidate, is a 9 amino acid transmembrane peptide of the HER2/neu protein designed to prevent recurrences in patients post-surgery.
The information provided in this report is based on a press release statement from Greenwich LifeSciences, Inc. The company has not provided any further comments on the financial implications of the lock-up extension or the ongoing trial. Investors and interested parties can find more details on the company's website and the clinical trial at clinicaltrials.gov.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.