Syntara (SNT) investor relations material

FDA Feedback and Clinical Development Pathway

• Achieved formal FDA alignment on the Phase 2b trial protocol for amsulostat/imsulostat in myelofibrosis, de-risking the regulatory path and validating the clinical strategy.

• FDA supports TSS50 (50% reduction in Total Symptom Score) as the primary endpoint after 9 months, with secondary endpoints including spleen volume, overall survival, and safety.

• The Phase 2b study will enroll about 100 patients in a double-blind, placebo-controlled format, targeting those with inadequate response to standard care.

• Trial preparation is underway, with commencement targeted for Q4 2026 and recruitment over 18 months.

• FDA alignment enhances the asset's attractiveness for potential partners and supports ongoing licensing and commercial partnership discussions.

Clinical Data and Competitive Positioning

• Phase 2a data showed rapid and sustained symptom improvement, with 73% of patients achieving TSS50 at 24 weeks or beyond.

• Meaningful spleen volume reductions were observed, and several patients continued treatment beyond 52 weeks.

• Amsulostat/imsulostat offers a distinct mode of action, improved tolerability, and potential for disease modification compared to current JAK inhibitor standard of care.

• Fast Track and Orphan Drug Designations have been secured, reinforcing its differentiated position.

• Strong differentiation from competitors due to significant symptom improvement, a key factor for both regulators and partners.

Capital Raising and Financial Position

• Raised AUD 8 million via institutional placement and targeting an additional AUD 2 million through a Share Purchase Plan, extending cash runway to Q3 2027.

• The raise was timed to leverage the de-risked FDA pathway, providing funding for five key clinical trial readouts in 2026.

• Strong support from existing and new specialist healthcare investors, maintaining a robust investor base.

• Phase 2b trial estimated to cost $20–25 million; company is exploring both partnerships and non-dilutive funding options.