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) 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.
Greenwich LifeSciences (Nasdaq: GLSI) reported a preliminary analysis from the open-label non-HLA-A*02 arm of FLAMINGO-01 showing an approximately 80% reduction in recurrence rate in the fully enrolled 250-patient arm by two analytic methods. Method 1 compared treated patients after the Primary Immunization Series to historical T-DM1 (KATHERINE) recurrence rates; Method 2 compared recurrence during the 6-month PIS (100 patient-years) to post-PIS follow-up (132 patient-years). The first patient completed all primary and booster vaccinations. Results are preliminary, the arm has no direct placebo comparator, and data are not completed or fully reviewed.
Greenwich LifeSciences (Nasdaq: GLSI) announced completion of enrollment in the 250-patient open-label non-HLA-A*02 arm of its Phase III FLAMINGO-01 trial of GLSI-100 to prevent breast cancer recurrence on Dec 8, 2025. The company said non-HLA-A*02 patients represent about 55% of the trial population and about 250 non-HLA-A*02 patients have now been treated. Approximately 500 HLA-A*02 patients remain planned for randomization to GLSI-100 or placebo. Greenwich is reviewing immune response, safety, and recurrence-rate data from the 250-patient cohort and may seek regulatory approval to resume randomized enrollment of non-HLA-A*02 patients. The company reiterated prior Phase IIb comparisons and cited patent and market-potential estimates.
Greenwich LifeSciences (Nasdaq: GLSI) provided a global update on its Phase III trial FLAMINGO-01 evaluating GLSI-100 to prevent breast cancer recurrence. The company has screened over 1,000 patients to date across 140 active sites (about 40 US sites and 100 EU sites).
Screening is progressing at ~150 patients per quarter (~600 per year). Management is considering continuing enrollment in both the HLA-A*02 and non-HLA-A*02 arms until interim analyses define appropriate arm sizes, and reports interest from additional countries to join the study.
Greenwich LifeSciences (Nasdaq: GLSI) announced expansion of its Phase III trial FLAMINGO-01 of GLSI-100 to Austria after formal European regulator approval on Oct 9, 2025. Austria is added to existing approved countries including Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, Belgium, and the US.
The company cited Austrian cancer data showing 6,070 new breast cancer cases in 2022 and 1,789 breast cancer deaths in 2022. Greenwich is collaborating with principal investigators at Ordensklinikum Linz, has begun site training, and said it hopes to activate the Linz site in 2025 while considering additional sites in Vienna and Salzburg.
Greenwich LifeSciences (NASDAQ:GLSI) has announced the expansion of its Phase III FLAMINGO-01 clinical trial to Belgium, marking the tenth country approval for the study. The trial evaluates GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.
The company will collaborate with Dr. Patrick Neven at UZ Leuven as the national principal investigator. Belgium reported 11,366 new breast cancer cases in 2022, representing 33% of all female cancers, with 2,324 deaths recorded. The strategic location of Leuven will facilitate coverage of major Belgian regions, including Brussels and Antwerp.
Greenwich LifeSciences (NASDAQ:GLSI) has received regulatory approval to expand its FLAMINGO-01 Phase III clinical trial to Portugal, joining existing trial locations in Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US. The trial evaluates GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.
Dr. Luís António Marques da Costa, Associate Professor of Medicine and Head of Clinical Translational Oncology Research Unit at the Institute of Molecular Medicine, will serve as Portugal's national principal investigator. According to recent data, Portugal reported 9,065 new breast cancer cases in 2022, accounting for 30% of all female cancers, with 2,211 deaths recorded.
The company is currently activating trial sites in Lisbon and evaluating additional locations in central and northern Portugal.