Syntara Limited · ASX:SNT
Syntara — Investor Presentation (December 2024)
40 slides from Syntara's investor presentation, Dec 12, 2024
Slide 1: Equity Raising Presentation
™ Equity Raising Presentation Gary Phillips, CEO December 2024 Not for release to US wire services or distribution in the United States
Slide 2: Disclaimer
Disclaimer Disclaimer This presentation has been prepared by, and is the sole responsibility of Syntara Limited ABN 75 082 811 630 (the Company or Syntara) and is dated 12 December 2024. The Company is under no obligation to update or keep the information represented in this presentation current pas
Slide 3: Disclaimer
Disclaimer Geographical restrictions The distribution of this presentation in jurisdictions outside Australia may be restricted by law. Please refer to the Foreign jurisdiction selling restrictions section of this presentation. This presentation may not be released to US wire services or distributed
Slide 4: Investment Highlights
Investment Highlights Australian-founded clinical stage Backed by specialist Focus on first-in-class and best-in- Currently funded to mid-2025 Clinical stage drug developer. drug developer. healthcare investors – 52% class drugs backed by in house with near term data to drive institutional. long-lif
Slide 5: Syntara Board
Syntara Board Significant international pharmaceutical experience Dr Kathleen Metters Dr Simon Green Gary Phillips Hashan De Silva Chair Non-Executive Director Chief Executive Officer Non-Executive Director • Former Senior Vice President and • Experienced senior global pharma executive • 30+ years’
Slide 6: Experienced senior management team
Experienced senior management team Scientific excellence Significant global experience in drug development, commercialisation and partnering • Global leaders in amine oxidase chemistry Gary Phillips Jana Baskar and biology – key to Chief Executive Officer Chief Medical Officer inflammatory and fibro
Slide 7: SNT-5505; Lead asset and a key driver of value
• FDA IND and orphan drug designation in myelofibrosis • First and best in class pan-LOX inhibitor • Long patent life SNT-5505; Lead asset • Multiple Nature publications and a key driver of value • Phase 2 trial data as a monotherapy and interim data in combination with ruxolitinib presented at ASH
Slide 8: Oral Presentation #1001
Not for release to US wire services or distribution in the United States 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
Slide 9: Myelofibrosis
Myelofibrosis A rare type of bone marrow cancer that disrupts the body's normal production of blood cells Key Facts Primary Myelofibrosis is characterised by a Current standard of SNT-5505 build up of scar tissue (fibrosis) in bone care (SoC): JAK inhibition In contrast to SoC SNT- marrow reducing t
Slide 10: 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 11: 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 in MF Very consistent SNT-5505 plasma levels High target engagement even at patients (plasma) across patients trough (pre-dose) ✱ Plasma concentration [ng/mL] ✱✱✱✱ 10000 100 LOX activi
Slide 12: 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 13: Baseline characteristics
Baseline characteristics Heterogenous population with a high disease burden1 • Study is ongoing – data extracted 14 Nov Characteristic N=16 Age, median (range), years 71 (46-82) 2024 Sex, male, n (%) 7 (44) • 13 patients (pts) reached 12 week visit Time since MF diagnosis, median (range), months 60
Slide 14: Safety
Safety SNT-5505 has been well tolerated with no treatment related SAEs1 • Majority of AEs were mild, 44/61 (72%) ≤ Pts with Grade 3/4 AEs Regardless of Causality# Grade 2 Grade 3 Grade 4 • 82% of AEs considered not related to Adverse Event N=16 N=16 treatment Anemia 4 • 11 possibly related AEs* Plat
Slide 15: Total symptom score
Total symptom score Improvements seen in TSS from Baseline to Week 121 100 • 6/13 pts (46%) achieved TSS50 • Median absolute change was -10 10 • Median % change was -41% 50 11 TSS Change from Baseline (%) Baseline TSS 37 52 51 45 22 16 18 32 19 23 10 0 -50 TSS50 -100 TSS50 is widely used in clinical
Slide 16: Total symptom score over time
Not for release to US wire services or distribution in the United States 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 to Week Week 24 Week 38 38 • Improvement in TSS continue over time 50 11 TSS Change
Slide 17: Spleen volume over time
Not for release to US wire services or distribution in the United States Spleen volume over time Additional reductions seen with longer treatment1 50 45 Week 12 40 Week 24 • 11/13 pts had spleen volumes at baseline 35 * Week 38 > 450 cm3 30 * 25 Spleen Volume Change % • 9/11 pts (82%) had either sta
Slide 18: 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 19: Efficacy outcomes at Week 38
Not for release to US wire services or distribution in the United States 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
Slide 20: Competitive landscape
Competitive landscape Data from comparative open label phase 2 studies for drugs currently under later stage development in MF Drug Latest Program Status Phase 2 Open Label Trial results in suboptimal patient population N Baseline characteristics (median, Safety TSS50 SVR35 range) Grade 3/4 events ≥
Slide 21: Strong interest in myelofibrosis assets from strategics
Strong interest in myelofibrosis assets from strategics Target / Acquiror / / Date of Announcement Feb-2024 June-2023 July-2022 Drug Name Pelabresib Pacritinib Momelotinib Lead Indication / Phase Myelofibrosis Myelofibrosis Myelofibrosis (at transaction) (Successful Phase 3 studies) (Marketed) (FDA
Slide 22: ASH interim data: Conclusions and outlook
ASH interim data1: Conclusions and outlook Interim data 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 small Reductions in symptoms and Additional data from
Slide 23: Multiple milestones targeted
Multiple milestones targeted A$15.0m Equity Raising via a two-tranche institutional placement provides funding required to deliver: MF combination clinical trial • Phase 2 study to deliver additional interim data from patients completing 12 months treatment H1 2025. Final data Q3 2025 • FDA discussi
Slide 24: Equity Raising
>| SYNTARA Equity Raising
Slide 25: 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 0.02 Note: 1. Proforma cash of $10.4m includes: cash (
Slide 26: Equity Raising Summary
Equity Raising Summary • Two tranche placement to raise $15.0m (Placement) comprising the issue of approximately 250.0 million new fully paid ordinary shares (New Shares) in the following tranches: - Tranche 1: to raise approximately A$12.4m utilising the Company’s existing placement capacity under
Slide 27: Sources and Use of Funds
Not for release to US wire services or distribution in the United States Sources and Use of Funds Funds including proceeds raising under the $15m Placement provides a cash runway to June 20261 and will be used to fund the following targeted milestones: Anticipated Sources of Funds1 A$m MF combinatio
Slide 28: Indicative Timetable
Indicative Timetable Event Date Announce completion of Placement, trading halt lifted and recommencement of trading Thursday, 12th December 2024 Settlement of Tranche 1 Wednesday, 18th December 2024 Tranche 1 New Shares allotted Thursday, 19th December 2024 Expected EGM approval to issue Tranche 2 N
Slide 29: Gary Phillips, Chief Executive Officer
Gary Phillips Syntara Limited ABN 75 082 811 630 Chief Executive Officer gary.phillips@syntaraTX.com.au www.syntaraTX.com.au
Slide 30: APPENDIX
4| SYNTARA APPENDIX
Slide 31: Risks
Risks The Company’s business is subject to a number of significant risks and uncertainties both specific to its business and of a general nature, some of which are summarised below. As such, potential investors should be aware that investing in the Company’s securities involves a high degree of risk
Slide 32: Key business risks
Key business risks (a) Overview The Company’ business success is currently substantially dependent on its ability to successfully advance the clinical development of SNT-5505, SNT-6302 (and related back up compounds) and SNT- 4728 in a timely manner. There is a risk that the clinical development of
Slide 33: Key business risks
Key business risks (c) The time and cost to undertake clinical trials and obtain regulatory approval may be significantly more than expected The length of time and the cost necessary to complete clinical trials and to submit an application for marketing approval may vary significantly based on the t
Slide 34: Key business risks
Key business risks (e) The Company may not be successful in developing or securing new product candidates Although the Company already has an extensive product candidate pipeline, it continues to spend limited resources developing new product candidates. From time to time it also considers in-licens
Slide 35: Key business risks
Key business risks h) Mannitol business unit In October 2023, the Company sold its mannitol business unit. As at 9 December 2024, the Company’s estimates that the acquiror owes the Company ~$3.1m. While the Company is confident in its contractual position, and although the acquiror has made some pay
Slide 36: Key business risks
Key business risks (k) Even if a product is approved, the product may not warrant launch or even if launched, may not be successful in the market There is a risk that the product candidates the Company is developing and future product candidates, even if they receive regulatory approval may not gain
Slide 37: Key business risks
Key business risks (p) Patents and trade secrets The Company uses patents or trade secrets to protect its technologies from unauthorised use by third parties. The term of patents may expire or may be challenged, invalidated or circumvented. There can be no assurances that the Company’ patents will a
Slide 38: Foreign jurisdiction selling restrictions
Foreign jurisdiction selling restrictions This document does not constitute an offer of new ordinary shares (New Shares) of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares may not be offered or sold,
Slide 39: Foreign jurisdiction selling restrictions
Foreign jurisdiction selling restrictions Singapore This document and any other materials relating to the New Shares have not been, and will not be, lodged or registered as a prospectus in Singapore with the Monetary Authority of Singapore. Accordingly, this document and any other document or materi
Slide 40: Foreign jurisdiction selling restrictions
Foreign jurisdiction selling restrictions United States This document does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States. The New Shares have not been, and will not be, registered under the US Securities Act of 1933 or the securities laws of a