• Positive Type C meeting outcome with US FDA supporting the Phase 2b design for Amsulostat
• Amsulostat on target to advance into late-stage clinical development with a ~100 patient, placebo-controlled Phase 2b study in myelofibrosis
• Competitive and differentiated drug profile with near term potential for indication extension

Syntara Limited (ASX: SNT), a clinical-stage drug development company, has received positive feedback from the U.S. Food and Drug Administration (FDA) following a constructive in-person Type C meeting regarding the planned Phase 2b clinical trial of its lead candidate, amsulostat, for the treatment of patients with myelofibrosis (MF) who have had an inadequate response to standard of care. Following a review of amsulostat's development to date, the FDA supported the proposed Phase 2b study design and provided guidance on the detail of the study and overall development pathway for amsulostat. This feedback represents a major milestone for the company, enabling progression into late-stage clinical development and creating opportunity for further engagement with potential commercial partners. The Phase 2b study will be a double-blind, placebo-controlled study of amsulostat added to standard of care (JAK inhibition) for patients who have had an inadequate response. The primary endpoint will be achievement of 50% reduction in total symptom score (TSS50) after 9 months of treatment. Subject to final protocol review, the number of patients to be studied is expected to be approximately 100. Amsulostat has a differentiated and competitive safety and efficacy profile, with strong potential as a breakthrough therapy for MF patients with an inadequate response to standard of care. Syntara is also advancing amsulostat's development into myelodysplastic syndrome (MDS), where two clinical studies are currently ongoing. With additional clinical milestones expected over the next 12 months, including top-line data from the Phase 2 study of SNT-4728 for isolated REM sleep behaviour disorder (iRBD), a prodromal feature of Parkinson's disease, and results from a placebo-controlled study of SNT-9465, a topical pan-LOX inhibitor for hypertrophic scarring, 2026 is shaping up to be a landmark year for Syntara.

Syntara is expected to deliver further near-term catalysts in CY2026 including top-line data from its Phase 2 iRBD/Parkinson's trial, and two sets of results from its Phase 1b skin scarring studies.