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. (Nasdaq: GLSI) generates news primarily around the clinical and regulatory progress of GLSI-100, its investigational immunotherapy to prevent breast cancer recurrences, and the Phase III FLAMINGO-01 trial. Company press releases highlight milestones in patient screening and enrollment, preliminary clinical observations, regulatory designations, and trial expansion across the United States and Europe.
Readers following GLSI news can expect updates on FLAMINGO-01, including the number of patients screened, enrollment status in the HLA-A*02 and non-HLA-A*02 arms, and preliminary analyses of recurrence rates, immune responses, and safety. The company has reported that more than 1,000 patients have been screened and that the 250-patient non-HLA-A*02 open label arm is fully enrolled, with early analyses suggesting an approximately 80% reduction in recurrence rate after completion of the primary immunization series. These observations are described by the company as preliminary and subject to change as the trial matures.
News items also cover regulatory developments, such as the U.S. FDA granting Fast Track designation for GLSI-100 in the HLA-A*02 genotype population, and geographic expansion of FLAMINGO-01 into additional European countries, including Ireland, Portugal, Belgium, and Austria, following approvals from European regulators. Corporate strategy communications discuss clinical strategy, financing approaches such as at-the-market offerings, partnering activities, and oversight by the Data Safety Monitoring Board and Steering Committee.
For investors, clinicians, and observers, the GLSI news feed offers a consolidated view of how Greenwich LifeSciences describes the evolution of its lead program, including trial design refinements, interactions with regulators, and key governance decisions disclosed through SEC filings and press releases. Regularly reviewing these updates can help track the company’s reported progress in developing GLSI-100 for HER2-positive breast cancer patients.
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.
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.