Greenwich LifeSciences Provides Update Regarding Form 10-K Filing

Greenwich LifeSciences reported delays in filing its Form 10-K for fiscal year 2025 due to coordination issues between dual auditors regarding accounts payable adjustments related to its Phase III FLAMINGO-01 clinical trial. The company maintains a cash balance of approximately $10.5 million as of March 31, 2026, and reported preliminary positive data from the trial showing a 70-80% reduction in breast cancer recurrence rates in the non-HLA-A*02 patient arm.

06/01/2026, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Announces Acceptance of Abstract at ASCO 2026

Greenwich LifeSciences announced that an abstract presenting preliminary data from its Phase III FLAMINGO-01 trial of GLSI-100 immunotherapy has been accepted for presentation at the 2026 ASCO Annual Meeting (May 28-June 2). The non-HLA-A*02 open-label arm, now fully enrolled with 250 patients, shows approximately 70-80% reduction in breast cancer recurrence rates after the Primary Immunization Series, consistent with Phase IIb results. The company plans to attend multiple oncology conferences in coming months.

04/23/2026, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Announces Receipt of Nasdaq Notice Regarding Late Form 10-K Filing

Greenwich LifeSciences received a notification from Nasdaq on April 16, 2026, indicating non-compliance with listing rules due to failure to timely file its Annual Report on Form 10-K for fiscal year 2025. The company's stock continues to trade on Nasdaq Capital Market under ticker GLSI with no immediate effect on listing status. The company is working with auditors to file the report as soon as possible.

04/22/2026, 5:00 PM • GlobeNewswire

Greenwich LifeSciences Presents FLAMINGO-01 Phase III Trial Open Label Data Published at AACR Meeting 2026

Greenwich LifeSciences presented preliminary immune response data from the Phase III FLAMINGO-01 trial of GLSI-100, an immunotherapy for breast cancer recurrence prevention. The non-HLA-A*02 open label arm (247 patients) showed a statistically significant 4-fold increase in delayed-type-hypersensitivity (DTH) immune reactions from 5.2% at baseline to 20.4% at months 4-6 (p<0.001). Preliminary recurrence rate analysis showed approximately 70-80% reduction in recurrence rates after the primary immunization series, supporting the drug's mechanism of action. Over 1,300 patients have been screened for the trial to date.

04/20/2026, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Provides Update on Patent Claims Potentially Doubling GP2 Market Potential

Greenwich LifeSciences announced new patent claims for GLSI-100 based on Phase III FLAMINGO-01 trial data showing statistically significant immune response and approximately 80% recurrence rate reduction in non-HLA-A*02 breast cancer patients. The claims potentially double the addressable market by an additional 100% (88,000 new patients annually in US and Europe) and could provide patent protection through 2045. The company has begun enrolling both HLA-A*02 and non-HLA-A*02 patients in the same randomized arms following FDA approval of protocol changes.

04/07/2026, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Announces Addition of City of Hope to FLAMINGO-01

Greenwich LifeSciences announced the activation of new FLAMINGO-01 Phase III clinical trial sites at City of Hope across multiple U.S. locations, with renowned breast cancer expert Dr. Hope Rugo joining as principal investigator. The trial evaluating GLSI-100 immunotherapy for breast cancer recurrence prevention has expanded from 160 to potentially 190-200 sites, with preliminary data from the non-HLA-A*02 arm showing approximately 70-80% reduction in recurrence rates, consistent with Phase IIb results.

03/19/2026, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Provides Update on Upcoming AACR Meeting

Greenwich LifeSciences announced that two abstracts and two posters were accepted for presentation at the AACR Meeting 2026. The company reported preliminary data from the open-label arm of FLAMINGO-01 Phase III trial showing statistically significant immune response results for GLSI-100, an immunotherapy designed to prevent breast cancer recurrences. The non-HLA-A*02 arm showed approximately 70-80% reduction in recurrence rates after the Primary Immunization Series, consistent with Phase IIb trial results.

03/18/2026, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Announces Use of Commercially Manufactured GP2 in FLAMINGO-01

Greenwich LifeSciences announced that all 40 US sites in its Phase III FLAMINGO-01 trial are now treating patients with commercially manufactured GP2 vials following FDA approval. The company is expanding manufacturing capacity to 500,000-1 million vials annually and plans to submit manufacturing data to European, UK, and Canadian regulators. Preliminary data from the non-HLA-A*02 arm shows approximately 80% reduction in breast cancer recurrence rates, consistent with Phase IIb results.

03/16/2026, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Provides Update on Increased Patient Screen Rate in FLAMINGO-01

Greenwich LifeSciences announced a significant 33% increase in patient screening rates for its Phase III FLAMINGO-01 trial, reaching over 800 patients per year. The non-HLA-A*02 arm is fully enrolled with 250 patients, showing preliminary recurrence rate reductions of approximately 80%, consistent with Phase IIb results. The company continues expanding clinical sites globally.

03/03/2026, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Announces Acceptance of Two Abstracts at AACR Annual Meeting 2026

Greenwich LifeSciences announced that two abstracts have been accepted for presentation at the AACR Annual Meeting 2026 (April 17-22), including the first abstract co-authored with the full FLAMINGO-01 Steering Committee. The Phase III trial's non-HLA-A*02 arm is fully enrolled with 250 patients, showing preliminary results of approximately 80% reduction in recurrence rates after the Primary Immunization Series, consistent with Phase IIb trial outcomes.

02/24/2026, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Provides Update on FLAMINGO-01 Cash Burn Rate and Financing Strategy

Greenwich LifeSciences reported a cash burn rate of approximately $9.5 million in 2025 and raised $7 million through its ATM offering in early January 2026, bringing cash balance to $12.5 million. The company believes this may be sufficient to cover 2026 operations. The Phase III FLAMINGO-01 trial for GLSI-100 immunotherapy continues with over 1,000 patients screened, and preliminary data shows approximately 80% reduction in breast cancer recurrence rates in the non-HLA-A*02 arm.

01/27/2026, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Provides Additional Updates on FLAMINGO-01 and Corporate Strategy

Greenwich LifeSciences provided updates on its Phase III FLAMINGO-01 clinical trial for GLSI-100, an immunotherapy to prevent breast cancer recurrences. The company reported that the 250-patient non-HLA-A*02 arm is fully enrolled with preliminary data showing approximately 80% reduction in recurrence rates. The company is implementing cost reduction measures, expanding to additional sites and countries, and pursuing strategic partnerships while maintaining its ATM financing strategy with a burn rate of approximately $7 million annually.

12/22/2025, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Announces Preliminary Analysis Showing 80% Recurrence Rate Reduction in the Open Label Arm of FLAMINGO-01

Greenwich LifeSciences reported an approximately 80% reduction in breast cancer recurrence rates in the non-HLA-A*02 arm of its FLAMINGO-01 Phase III clinical trial, using two estimation methods for its GLSI-100 immunotherapy treatment.

12/15/2025, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Announces Completion of Enrollment in the Open Label Arm of FLAMINGO-01

Greenwich LifeSciences completed enrollment in the non-HLA-A*02 arm of its Phase III FLAMINGO-01 clinical trial, evaluating GLSI-100 immunotherapy for preventing breast cancer recurrences. The company is seeking regulatory approval to continue enrollment and believes the treatment could potentially serve approximately 88,000 new patients annually.

12/08/2025, 6:00 AM • GlobeNewswire

Greenwich LifeSciences Announces Addition of Austria to Flamingo-01 Clinical Trial

Greenwich LifeSciences expanded its Phase III clinical trial FLAMINGO-01 to Austria, focusing on an immunotherapy to prevent breast cancer recurrences. The trial will include up to 150 global sites and aims to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients.

10/09/2025, 6:00 AM • GlobeNewswire