Greenwich LifeSciences (GLSI) Company Report

Greenwich LifeSciences announced that the FDA has reviewed and approved the use of the first commercial lot of GP2 vials for its Phase III FLAMINGO-01 trial, which evaluates GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.
Preliminary analysis from the non-HLA-A*02 arm of the trial shows an approximate 80% reduction in recurrence rate, trending similarly to Phase IIb trial results.
The 250-patient non-HLA-A*02 arm is now fully enrolled, and the company plans to start using these new GP2 vials in the coming weeks at all 40 US sites.
This FDA approval, along with manufacturing investments made in 2023 and 2024, is considered a major step to de-risk the filing of a Biologics License Application (BLA) in the US.

8 days ago

Greenwich LifeSciences Updates on Financing Strategy and FLAMINGO-01 Trial Progress

GLSI

Guidance Update

New Projects/Investments

Greenwich LifeSciences reported a year-end cash balance of approximately $6 million as of December 31, 2025, and increased its cash balance to approximately $12.5 million by January 23, 2026, after raising approximately $7 million through its ATM financing vehicle in the first three weeks of January 2026.
The company's 2025 cash burn rate was approximately $9.5 million, which was higher than the $7 million annual burn rates in 2023 and 2024. The current cash balance of $12.5 million could potentially cover cash needs for all of 2026.
The ongoing use of the ATM is expected to sustain or grow the cash balance, potentially reducing the need for a large near-term financing in 2026 or 2027, and may provide a bridge to non-dilutive funding options.
In its FLAMINGO-01 Phase III clinical trial, the 250-patient non-HLA-A*02 arm is now fully enrolled, and preliminary analysis shows an approximately 80% reduction in recurrence rate after the Primary Immunization Series, trending similarly to Phase IIb results.

Jan 27, 2026, 11:00 AM

Greenwich LifeSciences receives FDA approval for commercial GP2 lot in Phase III trial

GLSI

Product Launch

New Projects/Investments

The U.S. Food and Drug Administration (FDA) has approved the use of the first commercially manufactured GP2 lot for Greenwich LifeSciences' Phase III FLAMINGO-01 trial of GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.
This FDA clearance significantly reduces regulatory risk for a planned Biologics License Application (BLA) in the U.S., with the same manufacturing data to be submitted to regulators in Europe, the U.K., and Canada.
The company manufactured three commercial GP2 active-ingredient lots in 2023, sufficient for approximately 200,000 doses, and filled the first vial lot in 2024, with drug stability programs supporting a three-year vial expiration.
Preliminary analysis from the fully enrolled non-HLA-A02 trial arm indicates an approximate 80% reduction in recurrence after primary immunization.
Following the news, the company's stock experienced significant premarket gains, with reports of surges up to 54%.

Jan 22, 2026, 6:08 PM

Greenwich LifeSciences Announces FDA Approval for Commercial GP2 Use in FLAMINGO-01 Trial

GLSI

New Projects/Investments

Product Launch

The FDA has approved the use of the first commercial lot of GP2 vials in Greenwich LifeSciences' FLAMINGO-01 Phase III clinical trial in the US.
This approval, following manufacturing investments in 2023 and 2024, is a major step to de-risk the filing of a Biological License Application (BLA) for GLSI-100 in the US.
The company plans to begin using these new GP2 vials at 40 US sites in the coming weeks and will submit manufacturing data to regulatory agencies in Europe, the UK, and Canada.
Preliminary analysis from the fully enrolled non-HLA-A*02 arm of FLAMINGO-01 indicates an approximately 80% reduction in breast cancer recurrence rate, trending similarly to Phase IIb trial results.

Jan 22, 2026, 11:00 AM

Greenwich LifeSciences Extends Share Lock-up for Directors and Officers

GLSI

Greenwich LifeSciences' Board of Directors has extended the lock-up period for shares owned by its directors, officers, and existing pre-IPO investors until September 30, 2026.
This extension represents an approximately 72-month lock-up from the Company's IPO date, during which these shareholders cannot sell their common stock unless the Board modifies the terms.
CEO Snehal Patel stated that this 6-year lock-up is designed to align locked-up shareholders with the Company’s long-term investors and to support the FLAMINGO-01 Phase III trial.
After September 30, 2026, the quantity of these locked-up shares that can be sold will be restricted under a leak-out plan, unless otherwise modified by the Board of Directors.

Dec 29, 2025, 11:00 AM

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

GLSI

New Projects/Investments

Guidance Update

Greenwich LifeSciences' FLAMINGO-01 Phase III clinical trial is actively enrolling patients at approximately 140 sites, with plans to activate an additional 10 approved sites in 2026 and expand to the United Kingdom and Canada. The Data Safety Monitoring Board (DSMB) recommended continuing the study without modification in December 2025, and the Steering Committee endorsed planned modifications to increase study size and enrollment rate.
Preliminary analysis of the 250-patient non-HLA-A*02 arm of FLAMINGO-01 shows an approximately 80% reduction in recurrence rate after the Primary Immunization Series, trending similarly to Phase IIb trial results.
The company's annual burn rate was approximately $7 million in 2024 and 2023, and approximately $7 million for the first three quarters of 2025. ATM financing is being used to manage this burn rate, aiming to reduce the need for near-term financing and increase opportunities for non-dilutive partnerships.

Dec 22, 2025, 11:00 AM

Greenwich LifeSciences Reports Preliminary 80% Recurrence Rate Reduction in FLAMINGO-01 Trial

GLSI

New Projects/Investments

Greenwich LifeSciences announced a preliminary analysis showing an approximately 80% recurrence rate reduction in the open label non-HLA-A*02 arm of its Phase III clinical trial, FLAMINGO-01.
This observation, based on 250 fully enrolled patients, is trending similarly to previous Phase IIb trial results where breast cancer recurrences were reduced up to 80%.
The recurrence rate reduction was estimated using two methods, including a comparison to historical recurrence rates and a comparison of recurrence rates before and after the Primary Immunization Series.
The company emphasizes that this analysis is preliminary and based on data that is not yet fully reviewed, and future results may differ.

Dec 15, 2025, 11:00 AM

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