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) 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.
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.