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Biotechnology: Pharmaceutical Preparations
Clinical TrialApr 30, 2026, 06:02 AM

GLSI Phase III GLSI-100 Shows 70-80% Recurrence Reduction

AI Summary

Greenwich LifeSciences provided an update on its Phase III FLAMINGO-01 clinical trial for GLSI-100, an immunotherapy to prevent breast cancer recurrences. Preliminary analysis in the fully enrolled 250-patient non-HLA-A*02 arm showed an approximately 70-80% reduction in recurrence rate, trending similarly to Phase IIb results. The company also noted its Form 10-K for FY2025 is still being audited, with completion expected by the end of May, and reported an unaudited cash balance of approximately $10.5 million as of March 31, 2026.

Key Highlights

  • Preliminary Phase III FLAMINGO-01 data shows ~70-80% reduction in breast cancer recurrence rate in non-HLA-A*02 arm.
  • The 250-patient non-HLA-A*02 arm of the FLAMINGO-01 Phase III trial is now fully enrolled.
  • DTH reactions in non-HLA-A*02 arm increased ~4x (290%), from 5.2% at baseline to 20.4% at month 4/6.
  • FY2025 Form 10-K filing is delayed due to ongoing audit, expected by end of May 2026.
  • Unaudited cash balance as of March 31, 2026, is approximately $10.5 million.