Welcome to our dedicated page for Greenwich Lifesciences news (Ticker: GLSI), a resource for investors and traders seeking the latest updates and insights on Greenwich Lifesciences stock.
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 new open-label immune response data from the non-HLA-A*02 arm (n=247) of the Phase III FLAMINGO-01 trial of Fast Track GLSI-100 in HER2-positive breast cancer.
Erythema ISRs increased from 20.2% after dose 1 to 55.3% after doses 4–6, and induration from 14.9% to 34.6% (both McNemar p<0.001). The company links these immune responses and earlier preliminary data suggesting a 70–80% recurrence reduction in this arm to GLSI-100’s proposed mechanism of action. The trial remains ongoing and final results may change.
Greenwich LifeSciences (Nasdaq: GLSI) updated investors on its delayed Form 10-K for the year ended December 31, 2025, which is still under audit by a new auditor and includes the 2024 audit from the prior auditor.
The company links accounts payable adjustments to its global Phase III FLAMINGO-01 trial and higher-than-expected European screening and enrollment. It reports unaudited cash of about $10.5 million as of March 31, 2026, exceeding 2025 net cash used in operations of approximately $9.9 million, and says over 75% of 2025 accounts payable has been retired.
Greenwich LifeSciences (Nasdaq: GLSI), a clinical-stage biopharma company running the Phase III FLAMINGO-01 trial of Fast Track-designated GLSI-100, received a Nasdaq notice on May 20, 2026.
The company is not in compliance with Nasdaq Listing Rule 5250(c)(1) due to a late Form 10-Q for Q1 2026, but there is no immediate effect on GLSI’s Nasdaq Capital Market listing or trading.
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.