September 2025 Quarterly Activity Report and Appendix 4C

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Stock Cynata Therapeutics Ltd (CYP.ASX)
Release Time 31 Oct 2025, 1:36 p.m.
Price Sensitive Yes
 Cynata Therapeutics Provides Quarterly Activity Report
Key Points
  • Major clinical trial results expected in 2026 for acute Graft versus Host Disease and Osteoarthritis
  • Kidney transplant trial progressing with DSMB review of first cohort expected in Q4 2025
  • Funding runway extended to mid-2026 through R&D tax incentive and reduced cash outflows
Full Summary

Cynata Therapeutics Limited, a clinical-stage biotechnology company specialising in cell therapeutics, has provided its Quarterly Activity Report for the three-month period ended 30 September 2025. The key highlights include:- The company is entering a defining phase with results of two randomised, controlled efficacy clinical trials expected in the next 6-9 months. The Phase 2 trial in acute Graft versus Host Disease (aGvHD) is nearing completion, with primary results anticipated during Q2 2026. The final patient visit in the 321-patient Phase 3 trial in Osteoarthritis is expected in November 2025, with results also anticipated during Q2 2026.- The Phase 1/2 kidney transplantation trial is progressing, with the enrolment and treatment of the three patients in Cohort 1 now complete. The outcome of a review of this cohort by the study's independent Data and Safety Monitoring Board (DSMB) is anticipated during Q4 2025.- Cynata ended the quarter with $3.2 million in cash, and expects to receive an R&D tax incentive rebate of approximately $1.7 million imminently, providing a funding runway through mid-2026 to cover all key clinical readouts. Quarterly cash outflows are expected to decrease, as the company is now only funding the Phase 2 aGvHD trial.- Cynata remains focused on value-driving milestones, advancing regulatory engagement, and preparing for potential partnerships or licensing opportunities. The company is well positioned to translate its scientific achievements into sustainable commercial outcomes and long-term shareholder value.

Outlook

Cynata is entering one of the most defining phases in its development, with two late-stage clinical programs approaching major data readouts that will define the Company's next chapter. The Phase 3 osteoarthritis and Phase 2 aGvHD trials are both on track to report results over the next 6-9 months -- key milestones designed to demonstrate the consistency, scalability, and clinical potential of Cynata's Cymerus platform. Beyond these trials, Cynata's broader outlook remains positive, with regulatory tailwinds accelerating and a favourable environment for companies with validated technologies and late-stage clinical assets.