Syntara Limited · ASX:SNT
Syntara — Investor Presentation (December 2023)
44 slides from Syntara's investor presentation, Dec 19, 2023
Slide 1: Equity Raising Presentation
For personal use only ™ Equity Raising Presentation Gary Phillips, CEO 19 December 2023 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 13 December 2023. 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 and New Zealand may be restricted by law. Please refer to the Geographical Restrictions section of this presentation. This presentation may not be released to US wire services or distributed
Slide 4: For personal use only
For personal use only A clinical stage drug development company Pipeline of pre-clinical and clinical stage A$10.0m Equity Raising via a two-tranche assets in fibrosis and inflammation institutional placement provides funding required to deliver: Myelofibrosis combination clinical trial Prioritising
Slide 5: Executive Summary
For personal use only Executive Summary
Slide 6: Pharmaxis evolves to Syntara: cost savings and clear clinical focus
Pharmaxis evolves to Syntara1: Cost savings and clear clinical focus For personal use only The main factors impacting cash from separation of the mannitol business unit are: Proforma Cash Expenses 2023 • Employee numbers dropping from ~67 to ~26 FTE’s 35,000 • Much reduced space requirement - resear
Slide 7: Syntara is the global leader in lysyl oxidase chemistry and biology
Syntara is the global leader in lysyl oxidase chemistry and biology Multi year research program leveraged with extensive scientific For personal use only collaborations worldwide has delivered 3 drugs now in phase 1c/2 studies Lysyl oxidases mediate the final stage in fibrosis SNT-5505 in Oncology T
Slide 8: Preclinical science and collaborations validated in high impact publications
Preclinical science and collaborations validated in high impact publications For personal use only Myelofibrosis Myelodysplastic • Treatment with lysyl Syndrome oxidase inhibitor • In xenograft mouse significantly reduced model that closely reticulin fibrosis and resembles human megakaryocyte cell d
Slide 9: Potential to deliver near term value
Potential to deliver near term value Pipeline creates multiple opportunities in high value markets Upcoming Addressable market For personal use only Drug Candidate Indication Phase Trial design Status Milestones (US$) • Open label 12 month study (n=15) First patient H2 2024: Interim Myelofibrosis (M
Slide 10: Recent and anticipated news flow
News flow Recent and anticipated news flow Strong and growing pipeline with advancement in studies expected For personal use only to provide value inflection points Q4 2023 H1 2024 H2 2024 • SNT-5505 phase 2a myelofibrosis • Pan-LOX scar prevention for burn injuries- • SNT-5505 phase 2a myelofibrosi
Slide 11: Syntara Board under new leadership and downsized
Syntara Board under new leadership and downsized Significant international pharmaceutical experience For personal use only 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 •
Slide 12: 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 For personal use only Chief Executive Officer Chief Medical Officer
Slide 13: Equity Raising
For personal use only Equity Raising
Slide 14: Equity Raising Summary
Equity Raising Summary • $10.0m two tranche placement (Placement) comprising the issue of 454.5 million new fully paid ordinary shares (New Shares): - Tranche 1 to raise approximately A$2.4m utilising the Company’s existing placement capacity under ASX Listing Rule 7.1; and For personal use only - T
Slide 15: Sources and Use of Funds
Sources and Use of Funds Funds including proceeds raising under the Placement will be Anticipated Sources of Funds1 A$m used to fund: For personal use only Existing cash as at 30 September 2023 $7.1 MF combination clinical trial R&D tax credits (FY24 & FY25) $7.6 • Phase 2 study to deliver results H
Slide 16: Indicative Timetable
Indicative Timetable Event Time (AEST) / Date For personal use only SPP Record Date 7pm, Monday, 18th December 2023 Tuesday, 19th December 2023 Announce completion of Placement, trading halt lifted and recommencement of trading Friday, 22nd December 2023 Settlement of Tranche 1 Thursday, 28th Decemb
Slide 17: Program Update
For personal use only Program Update
Slide 18: Myelofibrosis (MF)
For personal use only Myelofibrosis (MF)
Slide 19: Myelofibrosis
Myelofibrosis A rare type of bone marrow cancer that disrupts the body's normal production of blood cells For personal use only 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
Slide 20: Myelofibrosis - SNT-5505 phase 1/2a trial
Myelofibrosis - SNT-5505 phase 1/2a trial 6 month monotherapy study with meaningful safety and efficacy endpoints For personal use only • Phase 1c: dose escalation in patients (complete) • Phase 2a: cohort expansion (currently ongoing) Study Design Treatment Endpoints Population Cohort JAK-Inhibitor
Slide 21: SNT-5505 Phase 2a trial (interim results)
SNT-5505 Phase 2a trial (INTERIM results) For personal use only Study status Efficacy • 100% of target (24 pts) enrolled • 5/ 10 evaluable patients* had improved bone marrow fibrosis • 11 patients having completed 24 weeks scores of ≥1 grade of treatment - 4 out of 5 fibrosis responders demonstratin
Slide 22: Potential place in MF therapy for SNT-5505
Potential place in MF therapy for SNT-5505 Key features / background environment For personal use only • Ruxolitinib is discontinued by most patients during the first 5 years (~50% at 3 years) mainly due to either a loss of response or adverse events such as cytopenias - an unmet need exists in pati
Slide 23: Clinical development plan: FDA feedback
Clinical development plan: FDA feedback Fastest For personal use only route to meaningful data FDA reviewed all safety and efficacy data available at that time Protocol subsequently submitted to FDA • Provided guidance on and accepted without change Q3 23 the number of patients, treatment dosage, •
Slide 24: Phase 2a study cohort added to trial SNT-5505 in patients on a stable dose of JAK inhibitor
Phase 2a study cohort added to trial SNT-5505 in patients on a stable dose of JAK inhibitor Fastest route to meaningful data with no dose escalation and utilizing existing trial infrastructure Study Plan For personal use only • 19 clinical trial sites scheduled to be open for recruitment by end Stud
Slide 25: Strong interest in myelofibrosis assets from strategics
Strong interest in myelofibrosis assets from strategics For personal use only Target / Acquiror / / / / / / Date of Announcement June-2023 July-2022 December-2020 November-2022 September-2020 January-2018 Combination of Ruxolitinib Drug Name Pacritinib Momelotinib Bomedemstat AVID200 Fedratinib & CK
Slide 26: Myelodysplastic Syndromes (MDS)
For personal use only Myelodysplastic Syndromes (MDS)
Slide 27: Myelodysplastic syndrome (MDS) is a blood cancer
Myelodysplastic syndrome (MDS) is a blood cancer Diverse bone marrow disorders characterized by inadequate production of healthy blood cells Key Facts 12–20k new cases are reported every year in the US Treatment of High Risk MDS For personal use only (87k p.a. worldwide) Current standard of care (So
Slide 28: SNT-5505 in high-risk MDS/CMML study
SNT-5505 in high-risk MDS/CMML study • Clinician designed multicenter open-label study in Germany evaluating the safety and efficacy of escalating doses of For personal use only SNT-5505 for pan lysyl oxidase inhibition in combination with 5-AZA in patients diagnosed with MDS or CMML1 Study Design T
Slide 29: Skin Scarring
For personal use only Skin Scarring
Slide 30: Hypertrophic and keloid scarring
Hypertrophic and keloid scarring Cutaneous scarring following skin trauma or a wound is a major cause of morbidity and disfigurement For personal use only Key Facts • Mechanisms underlying scar formation• Pre clinical evidence are not well established; prophylactic and treatment strategies remain -
Slide 31: SNT-6302 phase 1c trial in established skin scars (Solaria); top line results
SNT-6302 phase 1c Trial in established skin scars (Solaria 2); Top line results For personal use only SNT-6302 well tolerated and Mean inhibition of LOX activity 66% Meaningful changes in the Longer study required to show demonstrated a good safety compared to baseline and placebo composition of the
Slide 32: Syntara skin scarring clinical development plan
Syntara skin scarring clinical development plan For personal use only Incidences of skin rash with Unprecedented structural Scar prevention with oral Update on plans for SNT-6302 in Solaria trial changes effected by 3 pan-LOX inhibitor topical treatment for suggest potential months treatment with pr
Slide 33: Appendix
For personal use only APPENDIX
Slide 34: 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. For personal use only As such, potential investors should be aware that investing in the Company’s securities involves
Slide 35: 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- For personal use only 4728 in a timely manner. There is a risk that the cl
Slide 36: 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 37: 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 38: Key business risks
Key business risks h) Mannitol business unit In October 2023 the Company sold its mannitol business unit. Notwithstanding the sale, the Company has certain residual risks associated with the mannitol business unit. The Company maintains the For personal use only risks for liabilities arising from th
Slide 39: 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 40: 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 For personal use only can be no assurances that the C
Slide 41: Foreign jurisdiction selling restrictions
Foreign jurisdiction selling restrictions International Offer 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 For personal use only to a
Slide 42: Foreign jurisdiction selling restrictions
Foreign jurisdiction selling restrictions New Zealand This document has not been registered, filed with or approved by any New Zealand regulatory authority under the Financial Markets Conduct Act 2013 (the “FMC Act”). For personal use only The New Shares are not being offered or sold in New Zealand
Slide 43: Foreign jurisdiction selling restrictions
Foreign jurisdiction selling restrictions United Kingdom Neither this document nor any other document relating to the offer has been delivered for approval to the Financial Conduct Authority in the United Kingdom and no prospectus (within the meaning of For personal use only section 85 of the Financ
Slide 44: Gary Phillips, David McGarvey contact details
For personal use only Gary Phillips Syntara Limited ABN 75 082 811 630 Chief Executive Officer gary.phillips@syntaraTX.com.au David McGarvey Chief Financial Officer david.mcgarvey@syntaraTX.com.au www.syntaraTX.com.au