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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) said its Form 10-K for fiscal 2025 remains under audit; auditors expect to complete audits before the end of May and file alongside the Form 10-Q for period ending March 31, 2026. Final adjustments focus on accounts payable tied to its global Phase III trial. The company reported an unaudited cash balance of ~$10.5 million as of March 31, 2026, subject to change after the Q1 financial review.
Greenwich LifeSciences (Nasdaq: GLSI) announced that an abstract has been accepted for publication and poster presentation at the 2026 ASCO Annual Meeting, May 28–June 2, 2026. The full abstract and poster will be available on June 1, 2026. The submission presents preliminary injection site reaction immune response data from the non-HLA-A*02 open-label arm of Phase III FLAMINGO-01 evaluating Fast Track designated GLSI-100. Management said the abstract is co-authored with the FLAMINGO-01 Steering Committee. The company also plans to attend upcoming ESMO Breast, BIO partnering, and investor conferences.
Greenwich LifeSciences (Nasdaq: GLSI) received a notice from Nasdaq on April 16, 2026, for noncompliance with Nasdaq Listing Rule 5250(c)(1) because it has not yet filed its Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
The notice does not affect the current listing or trading of GLSI common stock. The company says it will file the Form 10-K as soon as possible, coordinating with two auditors who are each responsible for their respective periods in 2024 and 2025.
Greenwich LifeSciences (Nasdaq: GLSI) presented FLAMINGO-01 Phase III open-label immune response data at AACR 2026 on April 20, 2026. In 247 non-HLA-A*02 patients vaccinated with GLSI-100, delayed-type-hypersensitivity (DTH) reactions rose from 5.2% to 20.4% (≈+290%, McNemar p < 0.001).
Study remains ongoing, with over 1,300 patients screened and data collection/cleaning continuing; recurrence-event counts remain very low, so final results may vary.
Greenwich LifeSciences (Nasdaq: GLSI) provided a financing update for Q1 2026 related to its Phase III trial FLAMINGO-01 and investigational immunotherapy GLSI-100.
The company said its ATM program sold common stock into the market and raised more than the company's Q1 2026 cash burn, resulting in an approximate cash balance of $10.5 million as of March 31, 2026; these figures are preliminary and unaudited.
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.