Greenwich LifeSciences reports 70% reduction in recurrence rate

• Greenwich LifeSciences amended FLAMINGO-01 to combine all HLA types, potentially increasing enrollment speed by 2.22 times.
• The company estimated a preliminary June 30 cash balance of $8.9 million after an expected $2 million quarterly cash burn.
• Greenwich said the revised trial design provides interim analyses at 28 and 56 recurrence events.

Greenwich LifeSciences (NASDAQ:GSLI) expanded FLAMINGO-01 to include up to 2,000 patients after FDA and EMA review of its amended design.

Combining all HLA types in the blinded arms allows the 55% non-HLA-A*02 population to enter randomization, potentially increasing enrollment 2.22 times.

The trial targets a 0.55 hazard ratio with interim analyses at 28 and 56 events, while preliminary June cash was estimated at $8.9 million.

Greenwich has screened over 1,500 patients across 170–180 sites in 11 countries and fully enrolled the 250-patient non-HLA-A*02 arm.

The company said preliminary open-label analysis suggested a 70–80% recurrence reduction, or a 0.2–0.3 hazard ratio, but cautioned that the data remain early.