Greenwich LifeSciences, Inc. announced the Phase III clinical trial, Flamingo-01, has officially started; Multiple sites have begun the screening and enrolling process; Flamingo-01 is evaluating 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. The commencement of the Phase III trial transitions the Company into pre-commercialization activities, which include: Working with the FDA in preparation for a BLA submission and commercial launch; Implementing a global strategy for launching GP2 in international markets outside the US and Europe; Initiating large scale manufacturing, packaging, and marketing. The Company anticipates the following additional activities/milestones: Phase III clinical trial progress and open label data will be presented at major conferences.

Licensing discussions may accelerate as the interim analysis approaches. Other assets may be developed by acquisition or internal research, including T cell therapies that may be discovered in the Phase III trial by studying GP2's robust immunogenicity. Additional patents for GP2 based on the Phase III trial findings, manufacturing, and pharmacy procedures are planned to be filed to extend patent life.