WHO Selects Proposed INN for Cymerus MSCs

Cynata Therapeutics Limited ABN – 98 104 037 372 Level 3, 100 Cubitt Street Cremorne VIC 3121 Australia T: +613 7067 6940 E: [email protected] www.cynata.com ASX ANNOUNCEMENT 29 May 2026 World Health Organization Selects Proposed International Nonproprietary Name for Cymerus™ MSCs Melbourne, Australia; 29 May 2026: Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, has been informed by the World Health Organization (WHO) that it has s elected “pixenstrocel” as the p roposed International Nonproprietary Name (INN) for Cymerus™ iPSC1-derived MSCs2. The selection was made following an application by the Company, which included a number of suggested INNs for consideration by the WHO Expert Advisory Panel. The proposed INN is expected to be published early in 2027 in the WHO Drug Information List 136 of Proposed INN. There will then be a period of four months during which interested parties may comment on the proposed INN, and the final confirmation of the INN is expected around May 2027. Once confirmed, the INN (also known as the generic name) will be used to describe Cymerus™ iPSC-derived MSCs in regulatory documents, scientific literature, promotional material, product labelling and information leaflets. Cynata currently uses codes to identify different products Cymerus™ iPSC-derived MSCs – including CYP-001 (for intravenous infusion), CYP-004 (for intra-articular injection) and CYP-006TK (topical wound dressing). These codes represent the final product, whereas the INN represents the active agent. Therefore, the INN will not replace these codes, it will be used in addition to them. In due course, trade names will be selected for our different products, and at that time the trade names will be used alongside the INN, instead of the existing product codes. Nuket Desem, Cynata’s Director of Regulatory and Scientific Affairs, said: "As we await the results of the Australian Phase 3 trial of CYP-004 in osteoarthritis and the multinational Phase 2 trial of CYP-001 in acute graft versus host disease, in parallel we are pursuing a number of important activities to progress towards our ultimate goal of seeking regulatory approval to market our products. Selection of an INN is one of these important activities, and we look forward to the final confirmation from the WHO next year." -ENDS- Authorised for release by Dr Kilian Kelly, CEO & Managing Director CONTACTS: Dr Kilian Kelly, CEO & MD, Cynata Therapeutics, +61 (03) 7067 6940, [email protected] Lauren Nowak, Media Contact, +61 (0)400 434 299, [email protected] About Cynata Therapeutics (ASX: CYP) Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical -stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus ™, a proprietary therapeutic stem cell platform technology. Cymerus ™ overcomes the challenges and limitations of conventional MSC production by using induced pluripotent stem cells (iPSCs) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the necessity to obtain t issue from multiple donors on an ongoing basis, and without the complexity and product inconsistency resulting from conventional methods. Cynata has demonstrated positive safety and efficacy data for its Cymerus™ product candidates CYP-001 and CYP-006TK in Phase 1 clinical trials in steroid-resistant acute graft versus host disease (GvHD) and diabetic foot ulcers (DFU), respectively. Further clinical trials are now ongoing: a Phase 2 trial of CYP-001 in GvHD under a cleared US FDA IND; a Phase 1/2 trial of CYP-001 in patients undergoing kidney transplantation; and a Phase 3 trial of CYP -004 in osteoarthritis. In addition, Cynata has demonstra ted utility of its Cymerus ™ technology in preclinical models of numerous other diseases, including critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome. 1 iPSC = induced pluripotent stem cell. 2 MSC = mesenchymal stem (or stromal) cell.

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