Greenwich LifeSciences, Inc. provided the following update on the expansion of the clinical trial into Europe. The Company's application to expand Flamingo-01 into Europe has been reviewed by European Medicines Agency (EMA) through EMA's Clinical Trials Information System (CTIS). The Company was informed that the manufacturing, non-clinical, clinical, statistical, and regulatory sections of its application are acceptable and the regulators' requests for information have been addressed.

The regulators have thus approved the clinical trial, marking a major milestone for the Company. The 5 individual countries in Europe will now make a final determination, and if acceptable, they will allow the first group of approximately 105 sites in Europe to begin initiation and activation. Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment.

The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required.

An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. GLSI 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.