• 100-day primary evaluation period completed for last participant in Phase 2 aGvHD trial
• Primary endpoint is Overall Response Rate at Day 28, with results anticipated in June 2026
• CYP-001 designed to modulate immune system and improve response rates and survival in aGvHD

Cynata Therapeutics Limited (ASX: 'CYP', 'Cynata', or the 'Company'), a clinical-stage biotechnology company specialising in cell therapeutics, has announced that the 100-day primary evaluation period has been completed for the last participant enrolled in its Phase 2 clinical trial of CYP-001 in adults with acute graft versus host disease (aGvHD). A total of 65 participants were enrolled in the randomised, double-blind, placebo-controlled trial, across clinical centres in Australia, the USA and Europe. Each participant was randomised to receive either steroids plus CYP-001, or steroids plus placebo. With the 100-day primary evaluation period now complete for all participants, the trial data is being compiled and analysed. The primary endpoint is Overall Response Rate at Day 28, with results anticipated in June 2026. aGvHD is a serious and often life-threatening complication of bone marrow transplantation and similar procedures, where the donor's immune cells (the graft) attack the recipient's tissues (the host). Cynata's Cymerus™ iPSC-derived MSC product for intravenous use, CYP-001, is designed to modulate the immune system and improve both response rates and survival outcomes in aGvHD. In a successful Phase 1 trial in patients with steroid-resistant aGvHD, 87% of patients showed an Overall Response, 53% showed a Complete Response, and 60% survived for at least two years. The US FDA has granted Orphan Drug Designation to CYP-001 for the treatment of aGvHD.