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Greenwich LifeSciences, Inc. reports developments as a clinical-stage biopharmaceutical company focused on FLAMINGO-01, a Phase III clinical trial evaluating GLSI-100 as an immunotherapy intended to prevent breast cancer recurrences. GLSI-100 combines the GP2 peptide with GM-CSF and is described by the company as a Fast Track designated program.
Recurring news includes FLAMINGO-01 clinical-site activity, oncology conference abstracts and posters, open-label immune-response and recurrence-rate data, patent-claim updates tied to GP2, at-the-market equity financing activity, and SEC reporting or Nasdaq compliance matters related to periodic filings.
Greenwich LifeSciences (Nasdaq: GLSI) reported that the first commercial lot of GP2 vials was approved by the FDA for use in FLAMINGO-01 and that all ~40 US sites were supplied and began treating patients with commercially manufactured GP2.
The company noted prior manufacture of GP2 active ingredient (sufficient for ~200,000 doses), ongoing stability programs, submission of data to other regulators, and plans to target 500,000–1,000,000 vials per year capacity.
Greenwich LifeSciences (Nasdaq: GLSI) reported an increased patient screen rate in its Phase III trial FLAMINGO-01 for GLSI-100. The annualized screening rate rose to over 800 patients per year, a ~33% increase from the prior 600 per year.
The company recorded ~200 patients screened per quarter across US and EU sites, attributing the rise to new sites activated in 2025 and stronger momentum at existing sites.
Greenwich LifeSciences (Nasdaq: GLSI) announced acceptance of two abstracts and two corresponding posters for presentation at the AACR Annual Meeting 2026, April 17-22, 2026. The company is a clinical-stage biopharmaceutical firm running the Phase III FLAMINGO-01 trial of Fast Track-designated GLSI-100 to prevent breast cancer recurrences.
The AACR will publish abstract titles on March 17, 2026 at 4:30 pm EST, abstracts on April 17, 2026 at 3:00 pm EST, and posters on their conference presentation dates. CEO Snehal Patel noted one abstract is the first co-authored with the full FLAMINGO-01 steering committee.
Greenwich LifeSciences (Nasdaq: GLSI) updated investors on cash burn and financing for its Phase III FLAMINGO-01 trial of GLSI-100. The company said ATM sales in 2025 exceeded its 2025 cash burn of approximately $9.5M, leaving ~$6M at 12/31/2025. Through the first three weeks of January 2026 the ATM raised ~$7M, bringing cash to ~$12.5M as of 1/23/2026. Figures are preliminary and unaudited. Management said 2026–2027 burn rates are expected to rise and ongoing ATM use may reduce need for a large near-term financing, but no assurance exists.
Greenwich LifeSciences (Nasdaq: GLSI) said the FDA approved use of the first commercially manufactured lot of GP2 vials in the Phase III FLAMINGO-01 trial of GLSI-100 to prevent breast cancer recurrence. The company noted three commercial active-ingredient lots made in 2023 (enough for ~200,000 doses), one finished vial lot filled in 2024, and stability programs yielding 3 years of stability data supporting vial expiration. GLSI plans to start using the new vials at 40 US sites in the coming weeks and expects to submit commercial manufacturing data to support a US BLA filing under Fast Track.
Greenwich LifeSciences (Nasdaq: GLSI) said its Board extended the lock-up on shares held by directors, officers and certain pre-IPO investors to September 30, 2026, approximately 72 months from the IPO. During this period those holders cannot sell common stock unless the Board modifies the restriction.
After September 30, 2026, sales will be limited under a Board-controlled leak-out plan unless modified; the Board may instead end the 100% lock-up earlier and implement a 10b5-1 trading plan or other staged release options. Management said the lock-up is intended to align insiders with long-term investors and support the FLAMINGO-01 Phase III trial of GLSI-100.
Greenwich LifeSciences (Nasdaq: GLSI) provided updates on its Phase III trial FLAMINGO-01 evaluating Fast Track designated GLSI-100 to prevent breast cancer recurrence and on corporate strategy on Dec 22, 2025.
Key points: the FLAMINGO-01 DSMB met twice in 2025 and recommended continuing the study without modification; ~140 sites are actively enrolling with plans to activate ~10 additional approved sites in 2026 and to pursue sites in the UK and Canada; planned protocol modifications (subject to regulatory approval) include resizing the study and increasing enrollment rate; the company reports an annual cash burn of approximately $7 million (2023–2025) and is using an ATM financing strategy to support operations while pursuing partnerships.
Greenwich LifeSciences (Nasdaq: GLSI) reported a preliminary analysis from the open-label non-HLA-A*02 arm of FLAMINGO-01 showing an approximately 80% reduction in recurrence rate in the fully enrolled 250-patient arm by two analytic methods. Method 1 compared treated patients after the Primary Immunization Series to historical T-DM1 (KATHERINE) recurrence rates; Method 2 compared recurrence during the 6-month PIS (100 patient-years) to post-PIS follow-up (132 patient-years). The first patient completed all primary and booster vaccinations. Results are preliminary, the arm has no direct placebo comparator, and data are not completed or fully reviewed.
Greenwich LifeSciences (Nasdaq: GLSI) announced completion of enrollment in the 250-patient open-label non-HLA-A*02 arm of its Phase III FLAMINGO-01 trial of GLSI-100 to prevent breast cancer recurrence on Dec 8, 2025. The company said non-HLA-A*02 patients represent about 55% of the trial population and about 250 non-HLA-A*02 patients have now been treated. Approximately 500 HLA-A*02 patients remain planned for randomization to GLSI-100 or placebo. Greenwich is reviewing immune response, safety, and recurrence-rate data from the 250-patient cohort and may seek regulatory approval to resume randomized enrollment of non-HLA-A*02 patients. The company reiterated prior Phase IIb comparisons and cited patent and market-potential estimates.
Greenwich LifeSciences (Nasdaq: GLSI) provided a global update on its Phase III trial FLAMINGO-01 evaluating GLSI-100 to prevent breast cancer recurrence. The company has screened over 1,000 patients to date across 140 active sites (about 40 US sites and 100 EU sites).
Screening is progressing at ~150 patients per quarter (~600 per year). Management is considering continuing enrollment in both the HLA-A*02 and non-HLA-A*02 arms until interim analyses define appropriate arm sizes, and reports interest from additional countries to join the study.