Syntara (SNT) investor relations material

FDA Feedback and Clinical Development Milestones

• Achieved positive FDA feedback and alignment on the Phase 2b trial protocol for amsulostat/imsulostat in myelofibrosis, with TSS50 as the primary endpoint and strong support for the study design and duration.

• The Phase 2b trial will enroll about 100 patients in a double-blind, placebo-controlled format, including cohorts with ruxolitinib and potentially momelotinib, targeting those with inadequate response to standard care.

• The primary endpoint is a 50% reduction in total symptom score after nine months; secondary endpoints include spleen size reduction, overall survival, and safety.

• FDA alignment de-risks the regulatory pathway, validates the clinical approach, and enhances attractiveness for potential partners.

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

Clinical Data and Competitive Positioning

• Phase 2a data showed significant 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.

• The drug holds Fast Track and Orphan Drug Designations, a long patent life to 2042, and is positioned as first- and best-in-class for its enzyme target.

• Differentiated safety and efficacy profile positions the drug as a potential breakthrough therapy.

Capital Raising and Financial Runway

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

• The capital raise was timed to leverage the de-risked FDA pathway, providing funding for five key clinical trial readouts and supporting ongoing licensing discussions.

• The raise was well supported by existing and new specialist healthcare investors, maintaining a strong investor base.

• Funds will be used for protocol finalization, CRO selection, site negotiations, formulation work, and clinical trial supplies for the Phase 2b study.