Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with updates on clinical, financing, and partnering strategies [1][2]. Clinical Strategy - The FLAMINGO-01 clinical strategy is evolving to reduce risk and enhance marketing approval chances, supported by financing strategies and cost reduction activities [2] - Approximately 140 sites are currently enrolling patients, with plans to activate an additional 10 sites in 2026 and expand to more EU countries [2] - The study has shifted from principal investigator interest to patient-driven interest, with wait lists forming at certain sites [2] - Discussions are ongoing with clinical sites in the UK and Canada for potential study participation, pending regulatory approvals [2] Financing Strategy - The company is utilizing an At-The-Market (ATM) financing strategy to manage its burn rate, which was approximately $7 million annually in 2023 and 2024 [2] - The burn rate for the first three quarters of 2025 remains around $7 million, indicating a gradual increase but not substantial due to cost-saving initiatives [2] - The upfront costs of clinical expenses are expected to decrease after the initial six months of vaccinations, as booster shots will be administered every six months [2] Partnering Strategy - The company is actively attending partnering conferences to explore collaborations with larger pharmaceutical companies in the breast cancer drug market [2] - Patent filings for GLSI-100 are expected to strengthen its patent portfolio, enhancing its market position [2] FLAMINGO-01 Data Monitoring - The Data Safety Monitoring Board (DSMB) has recommended continuing the FLAMINGO-01 study without modifications, indicating confidence in the current trial design [3] - The Steering Committee has endorsed planned modifications to the study, pending regulatory approval [3] Open Label Phase III Data - Over 1,000 patients have been screened, with a current screening rate of approximately 600 patients per year [4] - The non-HLA-A*02 arm is fully enrolled with 250 patients, significantly increasing the treated patient data compared to the Phase IIb trial [4] - The Primary Immunization Series (PIS) consists of six initial injections followed by five booster injections every six months to maintain immune response [4] Preliminary Analysis - Preliminary analysis shows an approximately 80% reduction in recurrence rates in the non-HLA-A*02 arm after completing the PIS, aligning with Phase IIb trial results [7] - The immune response and safety profile in the non-HLA-A*02 patients are trending similarly to the HLA-A*02 arms of FLAMINGO-01 [7] About GLSI-100 - GLSI-100 is designed for HER2 positive breast cancer patients who have undergone surgery, with the trial led by Baylor College of Medicine and plans to expand to 150 sites globally [9] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [9]

Core Insights - The partnership between Susan G. Komen, Tokio Marine HCC (TMHCC), and Nelly Korda aims to raise awareness and funds for breast cancer research and support [1][5][6] Group 1: Partnership and Contributions - TMHCC will donate $5,000 for every birdie and $10,000 for every eagle scored by Nelly Korda during the tournament, with a guaranteed minimum donation of $50,000 [3] - Additional donations from TMHCC include $25,000 for a hole in one, $100,000 for a three-stroke win, $500,000 for a four-stroke win, and $1 million for a five or more stroke win [4] Group 2: Breast Cancer Statistics - An estimated 316,950 women in the U.S. will be diagnosed with invasive breast cancer for the first time in 2025, with 42,170 expected to succumb to the disease [2] Group 3: Organizational Background - TMHCC is part of the Tokio Marine Group, which has a market capitalization of $74 billion as of March 31, 2025, and holds strong financial ratings from S&P Global Ratings, AM Best, and Fitch Ratings [8] - Susan G. Komen is the leading nonprofit organization focused on breast cancer, providing comprehensive support and advocacy for patients while driving research for breakthroughs [10]