Slide 1: Interim data; ASH 2024
™ Interim data; ASH 2024 SNT-5505 in myelofibrosis phase 2a trial Gary Phillips, CEO December 2024
Slide 2: Forward looking statement
Forward looking statement This document contains involve known and unknown forward-looking statements, risks, uncertainties and other including statements factors, many of which are concerning Syntara’s future beyond our control, and which financial position, plans, and the potential of its products
Slide 3: Investment Highlights
Investment Highlights Australian-founded clinical Clinical Backed by specialist Focus on first-in-class and Funded to mid-2025 with stage drug developer. stage drug developer. healthcare investors – best-in-class drugs backed near term data to drive 52% institutional. by in house long-life value ove
Slide 4: Shareholders & cash
Shareholders & cash Financial Information (ASX: SNT) Share Price & Volume - YTD Share price – 9 December 2024 $0.067 Price (AUD) Market cap A$92m 0.08 0.07 Proforma cash balance (30 Sep 2024)1 A$10.4m 0.06 0.05 Enterprise value A$81.6m 0.04 0.03 Note: 0.02 1. Proforma cash of $10.4m includes: cash (
Slide 5: Oral Presentation #1001
Multicenter, Open-Label Phase 1/2a Study of PXS-5505 and Ruxolitinib in Patients With Primary, Post-Polycythemia Vera (PV) or Post-Essential Thrombocythemia (ET) Myelofibrosis (NCT04676529) Oral Presentation #1001 presented on Monday 9th December at ASH 2024 Contributing Investigators: Peter Tan1, R
Slide 6: Myelofibrosis
Myelofibrosis A rare type of bone marrow cancer that disrupts the body's normal production of blood cells Key Facts Primary Myelofibrosis is Current standard SNT-5505 characterised by a build up of scar of care (SoC): JAK inhibition In contrast to SoC tissue (fibrosis) in bone marrow SNT-5505 interv
Slide 7: The role of lysyl oxidases in myelofibrosis
The role of lysyl oxidases in myelofibrosis SNT-5505 designed to improve the bone marrow microenvironment • Lysyl oxidase gene family upregulated in the bone marrow (BM) of myelofibrosis patients1 • Increased lysyl oxidase activity1: • Catalyzes the formation of stabilizing crosslinks leading to a s
Slide 8: Elevated LOX in MF targeted by SNT-5505
Elevated LOX in MF targeted by SNT-5505 SNT-5505 demonstrates >90% target inhibition1 LOX and LOXL2 are upregulated Very consistent SNT-5505 High target engagement in MF patients (plasma) plasma levels across patients even at trough (pre-dose) ✱ ✱✱✱✱ Plasma concentration [ng/mL] 10000 100 LOX activi
Slide 9: Aims/Methods
Aims/Methods SNT-5505-MF-101 Add-on to RUX (study in progress)1 • This add-on phase aims to further evaluate the safety and efficacy of SNT-5505 (200 mg BID) in patients with MF on stable background regimens of ruxolitinib (RUX) over a 52-week period STUDY POPULATION DESIGN ENDPOINTS PRIMARY Phase 2
Slide 10: Baseline characteristics
Baseline characteristics Heterogenous population with a high disease burden1 • Study is ongoing – data extracted 14 Characteristic N=16 Age, median (range), years 71 (46-82) Nov 2024 Sex, male, n (%) 7 (44) • 13 patients (pts) reached 12 week visit Time since MF diagnosis, median (range), 60 (7–134)
Slide 11: Safety
Safety SNT-5505 has been well tolerated with no treatment related SAEs1 • Majority of AEs were mild, 44/61 Pts with Grade 3/4 AEs Regardless of Causality# (72%) ≤ Grade 2 Grade 3 Grade 4 • 82% of AEs considered not related Adverse Event N=16 N=16 to treatment Anemia 4 • 11 possibly related AEs* Plat
Slide 12: Total symptom score
Total symptom score Improvements seen in TSS from Baseline to Week 121 100 • 6/13 pts (46%) achieved TSS50 10 • Median absolute change 50 TSS Change from Baseline (%) was -10 11 • Median % change was -41% Baseline TSS 37 52 51 45 22 16 18 32 19 23 10 0 -50 TSS50 -100 TSS50 is widely used in clinical
Slide 13: Total symptom score over time
Total symptom score over time Substantial reduction in TSS observed in the majority of patients1 100 Week 12 • 8/13 pts (62%) reached TSS50 up Week 24 to Week 38 Week 38 • Improvement in TSS continue 50 TSS Change from Baseline (%) over time 11 • TSS improvement despite a prior Baseline TSS RUX dura
Slide 14: Spleen volume over time
Spleen volume over time Additional reductions seen with longer treatment1 50 45 Week 12 40 * Week 24 • 11/13 pts had spleen volumes at 35 Week 38 baseline > 450 cm3 30 * 25 Spleen Volume Change % • 9/11 pts (82%) had either stable or 20 15 reduced spleen volume 10 1353 Baseline Spleen Volume (cm3) 3
Slide 15: Hematology parameters
Hematology parameters Stable with some observed decreases in transfusion burden1 • Of the 13 pts with ≥3 months treatment, at baseline: • 2 transfusion dependent • 4 receiving transfusions • 7 not receiving transfusions • 1/2 transfusion dependent pts had over 50% reduction in RBC transfusions • 5/7
Slide 16: Efficacy outcomes at Week 38
Efficacy outcomes at Week 38 Longer duration of therapy leads to additional improvements1 Baseline TSS 10 Baseline Spleen Volume (cm3) 52 22 45 18 23 0 5 602 478 3832 3050 2153 Pt # 1 Pt # 2 Pt # 3 Pt # 4 Pt # 5 0 Pt # 4 Pt # 2 Pt # 5 Pt # 1 Pt # 3 Spleen Volume Change (%) -5 -10 SVR10 TSS Change (%
Slide 17: Competitive landscape
Competitive landscape Data from comparative open label phase 2 studies for drugs currently under late stage development in MF Drug Latest Program Phase 2 Open Label Trial results in suboptimal patient population Status N Baseline characteristics Safety TSS50 SVR35 (median, range) Grade 3/4 events ≥
Slide 18: Strong interest in myelofibrosis assets from strategics
Strong interest in myelofibrosis assets from strategics Target / Acquiror / / Date of Feb-2024 June-2023 July-2022 Announcement Drug Name Pelabresib Pacritinib Momelotinib Lead Indication / Myelofibrosis Myelofibrosis Myelofibrosis Phase (Successful Phase 3 (Marketed) (FDA Filed – June) (at transact
Slide 19: Conclusions
Conclusions Interim data1 suggests SNT-5505 combined with ruxolitinib may deliver deep and long lasting benefit to patients who are sub-optimally controlled on ruxolitinib alone Consistent with Despite the relatively Reductions in Additional data from monotherapy data2, small sample size the symptom
Slide 20: Gary Phillips
Gary Phillips Syntara Limited ABN 75 082 811 630 Chief Executive Officer gary.phillips@syntaraTX.com.au www.syntaraTX.com.au