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Company Profile

Business Description: Greenwich LifeSciences (the “Company”) is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu (human epidermal growth factor receptor 2) protein, a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or “over-expressor”) levels. 

Substantial Unmet Need: 1 in 8 U.S. women will develop invasive breast cancer over her lifetime. There are approximately 700,000 new breast cancer patients and 9.5 million breast cancer survivors in the US and EU in 2025. In the adjuvant setting, a HER2/neu positive patient typically receives Herceptin in the first year following breast cancer surgery, with the hope that their breast cancer will not recur, and with the odds of recurrence slowly decreasing over the first 5 years following surgery. Herceptin has been shown to reduce recurrence rates by 50%, from 25% to 12%, in the adjuvant setting. In the neoadjuvant setting, a HER2/neu 3+ patient receives treatment before surgery and based on the results of a biopsy at surgery, will receive Herceptin or Kadcyla, a more potent form of Herceptin, following surgery. Kadcyla has been shown to reduce recurrence rates by 50%, from 22% to 11%, in the neoadjuvant setting. Accordingly, the Company believes that GP2 immunotherapy may be effective in safely addressing the 50% of recurring patients who do not respond to either Herceptin or Kadcyla.

Phase IIb Clinical Data in HER2/neu 3+ Over-Expressors: In a prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites) Phase IIb clinical trial led by MD Anderson and completed in 2018, an 80% or greater reduction in recurrences was observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient was treated, followed, and remained disease free over the first 6 months, which is the time required to reach peak immunity and thus maximum efficacy and protection. Furthermore, the GP2 immunotherapy elicited a potent immune response measured by local skin tests and immunological assays. Of the 146 patients who have been treated with GP2 immunotherapy to date over 4 clinical trials, no serious adverse events were reported related to GP2 immunotherapy, and GP2 immunotherapy was well tolerated. The Phase IIb clinical trial results can be summarized as:

Ongoing Phase III Clinical Trial: Greenwich LifeSciences is currently advancing GLSI-100 through its global Phase III clinical trial, called Flamingo-01, in which up to 750 patients are planned to be treated. In alignment with top-tier research networks — US (US Oncology), Spain (GEICAM), Italy (GIM), France (Unicancer), Germany (GBG), and Polish network— and prestigious institutions across 150 clinical sites, Greenwich LifeSciences is striving to build on the promising results of the Phase IIb clinical trial.