Greenwich LifeSciences, Inc. provided the following update on the Phase III clinical trial, Flamingo-01. Data Safety Monitoring Board (DSMB) The Flamingo-01 DSMB met twice in 2023 and recommended to continue the study as is without modification. Data on these commercial lots will be submitted to the FDA in the US and other regulatory agencies in Europe or elsewhere when a marketing application is filed seeking approval to sell GP2 in these respective markets.

Phase II Clinical Trial Study Report: The Company is preparing a comprehensive study report of the Phase II trial for the FDA prior to the filing of a BLA. This report will include the patients with breast cancer recurrences, the last known date of patients who did not recur (censoring data), the adverse events, immune responses, and other final study report analyses. This report will serve to complement the Phase III data and to provide a drug product dossier that can also be submitted to regulatory agencies in other countries for marketing approval.

After the trial had already started, the Company received the rights to the Phase II trial data pursuant to a license agreement with the Henry Jackson Foundation (HJF) that entitled the Company to all of the GP2 data from the Phase II trial and all prior trials, but did not provide the Company with the ability to participate in the Phase II trial as a regulatory clinical sponsor. The lead clinicians and HJF were responsible for project and site management, medical monitoring, data monitoring of case report forms (CRFs), correspondence with the FDA, and creation, data entry and management of the database. The Company was provided study updates but was not provided an opportunity to participate in any of the above activities or to review the publications of the 3 and 4 year follow-up data by the lead clinicians.

Thus, the comprehensive study report will rely on cooperation from HJF and the clinical sites who are responsible for providing the final data accurately to the Company. The Company is currently comparing the final CRFs and database provided by HJF and has noted the following agencies as the comprehensive study report is being prepared. The lead clinicians reported in an annual report to the FDA and in their publication of 4 year follow-up data a 6th recurrence in the HER2 positive control arm of the study.

The Company is developing an assay that may be applicable to the manufacturing of GP2 and is exploring alternative formulations to minimize the reconstitution process in the pharmacy, both of which may provide additional patent opportunities.