SNT-5505 awarded US FDA Fast Track designation

• SNT-5505 granted Fast Track designation by US FDA for treatment of myelofibrosis
• Fast Track designation enables more frequent FDA interaction, eligibility for Priority Review and discussions on accelerated approval
• Reflects significant unmet medical need in myelofibrosis, a serious blood cancer with limited treatment options

Syntara Limited (ASX: SNT), a clinical-stage biotechnology company, announced that its lead candidate, SNT-5505, has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of myelofibrosis in patients with an inadequate response to JAK inhibitor therapy. Fast Track designation can be awarded by the FDA after its review of data demonstrating potential benefit, a mechanistic rationale for efficacy and early clinical evidence. The Fast Track designation aims to expedite the review and development of therapies that address serious conditions and unmet medical needs, facilitating earlier drug approval and patient access. Benefits include more frequent meetings and communication with the FDA, eligibility for Accelerated Approval and Priority Review, and potential for Rolling Review in support of a New Drug Application (NDA). Myelofibrosis is a rare and serious type of bone marrow cancer affecting approximately 15 per 1 million people worldwide, with about 20,000 patients in the US alone. Current standard of care, primarily JAK inhibitors, are often associated with significant side effects leading to high discontinuation rates. SNT-5505 represents a novel therapeutic approach by inhibiting lysyl oxidases, key enzymes in fibrosis and growth factor signalling pathways. Clinical studies to date have demonstrated SNT-5505's ability to significantly enhance patient quality of life by improving symptom scores together with an excellent safety and tolerability profile.

Syntara continues to advance SNT-5505 through its Phase 2 clinical trial, with additional interim data to be presented at the European Hematology Association meeting on Saturday 14 June 2025 (Sunday 15 June AEST).