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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) updated investors on new patent claims tied to FLAMINGO-01 data for GLSI-100. The company says claims, based on statistically significant open‑label immune response and recurrence-rate data, could expand the GP2 market by 100% to 88,000 patients/year and enable combined approvals.
The invention is solely owned by the company; if granted after prosecution, the patent could provide protection through 2045. The company may sequence GP2-specific T cells to deepen immune-response analysis.
Greenwich LifeSciences (Nasdaq: GLSI) activated City of Hope network sites in its Phase III trial FLAMINGO-01 testing Fast Track-designated immunotherapy GLSI-100 to prevent breast cancer recurrence. City of Hope sites include Los Angeles and Orange counties, Arizona, Atlanta, and Illinois, with Dr. Hope S. Rugo joining the Steering Committee. The company said these additions expand U.S. coverage and could increase total FLAMINGO-01 sites from the current 160 to 190–200.
Greenwich LifeSciences (Nasdaq: GLSI) announced two accepted abstracts/posters for AACR Meeting 2026, including a FLAMINGO-01 poster (CT138) on April 20, 2026 with statistically significant delayed-type-hypersensitivity (DTH) immune response data from the open-label arm. A second poster (CT227) on April 21, 2026 updates the Phase III study design.
The update highlights Fast Track designated GLSI-100 (GP2 + GM-CSF) being evaluated in breast cancer patients with residual disease or high-risk PCR after anti-HER2 therapy.
Greenwich LifeSciences (Nasdaq: GLSI) reported a preliminary update from the fully enrolled 250‑patient open label non‑HLA‑A*02 arm of Phase III FLAMINGO‑01. Following completion of the primary immunization series, the observed recurrence rate is <1% per year (0.7% over 1.2 patient‑years), versus ~4% per year in the Katherine study, an ~83% reduction (Chi‑Square p < 0.005). Data are preliminary, based on site reports, and may change as data are cleaned and follow‑up continues.
Most non‑HLA‑A*02 patients completed the six‑month PIS; ~110 patient‑years are added every six months.
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.