Greenwich LifeSciences Announces Activation of Clinical Sites and Commencement of Phase III Clinical Trial

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the following:

• 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

CEO Snehal Patel commented, “We are thrilled to begin what we hope will be a successful reproduction of our Phase IIb trial, in which GLSI-100 safely prevented metastatic breast cancer recurrences with 100% disease free survival. The hard work and effort of the GLSI team and our partners have led us to this major milestone. We look forward to sharing more site contact information with patients and their clinicians in the future as we activate more sites and some of the largest oncology networks in the US and Europe, making Flamingo-01 available to as many patients as possible.”

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

For Patients Seeking to Participate in Flamingo-01