Ann: Quarterly Activity Report & Appendix 4C, page-4

FDA approves Cynata’s IND application for Phase 2 trial in aGvHD

In a major milestone achieved this quarter, the US FDA cleared Cynata’s IND application for a Phase 2 clinical trial
of CYP-001, Cynata’s lead product, in patients with aGvHD.

This is a major value catalyst for the Company as it provides a development and commercialisation gateway into the USA, not only for aGvHD but potentially for further clinical targets.

It is a critical validation step for Cynata’s ongoing commercial partnering activities.

The proposed Phase 2 clinical trial is expected to commence later this year, subsequent to the completion of negotiations with study centres and receipt of relevant ethical and administrative approvals.

The results of the primary evaluation are expected in early 2024.

The trial aims to recruit 60 patients with high risk aGvHD across a number of countries including the USA and Australia with patient Overall Response Rate (ORR) evaluated at Day 28. Participants will be randomised and will receive either CYP-001 or a placebo, in addition to corticosteroids, the current standard-of-care.