Greenwich LifeSciences (GLSI) Provides Update on Commercial Manufacturing

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the commercial manufacturing of GP2.

Preparation for Filing of BLA in the US

In addition to the submission of the Phase III clinical data, submitting commercial manufacturing data will be critical to the filing of a Biological License Application (BLA) for GLSI-100 in the US and for regulatory filings in other countries.

Commercial Manufacturing

The first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In addition, drug stability programs have been initiated. Data on these commercial lots were submitted to the FDA in the US and European regulators (EMA) in Europe and will continue to be reviewed.

In 2024, the first of three commercial lots filling GP2 into vials for commercial sale or for clinical use was manufactured in an approved commercial facility, and final testing of this first lot is nearing completion. The Company may choose to use these finished commercial vials in FLAMINGO-01, subject to regulatory review.

CEO Snehal Patel commented, "We are pleased to have made substantial progress in the commercial manufacturing of GP2 in 2023 and 2024. We have now manufactured GP2 vials that can be stored in preparation for commercial launch or used in clinical trials. We will be manufacturing at least two more lots of finished GP2 product. Our plan is to complete these activities in parallel to conducting FLAMINGO-01 so that both clinical and manufacturing data are available for review by the biologics division of the FDA prior to potentially being granted a marketing license with up to 12 years of market exclusivity based on current law."

Mr. Patel further added, "Establishing a trade name for GP2 and a strategy for packaging of GP2 or GLSI-100 for commercial sale by country will be an upcoming priority as we near the filing of a BLA in the US. Furthermore, with the expansion of clinical sites into Europe and the on-going regulatory review of the manufacturing of GP2 by EMA, an additional priority will be to discuss the marketing license pathway in Europe with EMA. The objective is to manufacture GP2 and to conduct FLAMINGO-01 in a manner that is acceptable to both US and European regulators, even where regulatory standards may differ. Our manufacturing partners, who can ramp up manufacturing scale as needed, and the up to 150 participating clinical sites in the US and Europe at some of the most prominent institutions and teaching hospitals, who are becoming familiar with the use of GLSI-100 in the clinic, may provide for an efficient transition to product launch and commercial sales if GLSI-100 is approved."

New Intellectual Property

In 2024, additional refinements were made towards finalizing the manufacturing of GP2, the reconstitution of GLSI-100 in the pharmacy, and the injection of GLSI-100 in the clinic. As a result, the Company may potentially file additional patent applications.

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