Syntara Limited · ASX:SNT
Syntara — Investor Presentation (October 2022)
43 slides from Syntara's investor presentation, Oct 19, 2022
Slide 1: Capital Raising Presentation
Capital Raising Presentation Investor Presentation | October 2022 Gary Phillips CEO developing breakthrough treatments for fibrosis and inflammation 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 Pharmaxis Ltd [ABN 75 082 811 630] (the Company) and is dated [insert date]. The Company is under no obligation to update or keep the information represented in this presentation current past the date of
Slide 3: Disclaimer
Disclaimer Use of third party information Any information or views expressed in this presentation were prepared by the Company. Information contained may have been obtained from publicly available sources that have not been independently verified. No warranty or representation is made to the accurac
Slide 4: Disclaimer
Disclaimer No offer of securities Information contained in this presentation does not constitute an offer to sell or a solicitation of an offer to buy or sell Company securities in any jurisdiction. This presentation is not a prospectus, product disclosure document, or other offering document or con
Slide 5: Key Highlights
Key Highlights Phase 2a Myelofibrosis Interim Data from 8 Three novel drugs across PXS-5505 Interim Data patients treated with PXS- five indications with from 6 patients has shown 6302 shows a high level of multiple key catalysts encouraging signs of inhibition of enzymes and over the next 6-9 month
Slide 6: Pharmaxis Overview
Pharmaxis Overview Not for release to US wire services or distribution in the United States 6
Slide 7: Executive Summary
Overview Executive Summary • Pharmaxis is a clinical stage drug development company Pipeline creates multiple opportunities in high value markets targeting inflammation, fibrosis and selected cancer indications with first in class or best in class small 1. Lead asset PXS-5505 is in a multinational p
Slide 8: Pharmaxis is the global leader in lysyl oxidase chemistry and biology
Overview Pharmaxis is the global leader in lysyl oxidase chemistry and biology Multi year research program leveraged with extensive scientific collaborations worldwide has delivered 2 drugs in the clinic Lysyl oxidases are the final stage in fibrosis PXS-5505 – Oral dosage form – four capsules twi
Slide 9: Program Update
Program Update Not for release to US wire services or distribution in the United States 9
Slide 10: Myelofibrosis
Program Update Myelofibrosis A rare type of bone marrow cancer that disrupts the body's normal production of blood cells Primary Myelofibrosis is caused by a build up of scar tissue (fibrosis) in bone marrow reducing the production of blood cells: KEY FACTS • Reduced red blood cells can cause extrem
Slide 11: Myelofibrosis - PXS-5505; an effective and safe inhibitor of LOX in myelofibrosis patients
Program Update Myelofibrosis - PXS-5505; an effective and safe inhibitor of LOX in myelofibrosis patients Pre clinical and clinical studies strongly support entry into long term phase 2 patient studies PXS-5505 attenuates hallmarks of primary myelofibrosis in mice3 PXS-5505 – Phase 1c dose escalatio
Slide 12: Myelofibrosis - PXS-5505 Phase 1/2a Trial
Program Update Myelofibrosis - PXS-5505 Phase 1/2a Trial 6 month monotherapy study with meaningful safety and efficacy endpoints DESIGN TREATMENT COHORT ENDPOINTS Phase 2a open label Cohort expansion: Primary: study to evaluate safety, PXS-5505 Safety and tolerability PK/PD, and efficacy (n = 24 sub
Slide 13: Myelofibrosis - PXS-5505 Phase 2a Trial (INTERIM DATA)
Program Update Myelofibrosis - PXS-5505 Phase 2a Trial (INTERIM DATA) Very well tolerated with encouraging signs of clinical efficacy in JAK inhibitor unsuitable patients DESIGN TREATMENT COHORT ENDPOINTS Phase 2a open label study Cohort expansion: Primary: to evaluate safety, PK/PD, PXS-5505 PXS550
Slide 14: Hepatocellular Carcinoma (HCC)
Program Update Hepatocellular Carcinoma (HCC) 4th leading cause of cancer-related mortality worldwide with a 19.6% 5-year relative survival Primary liver malignancies have Normal tissue Pre-clinical data (Rochester Uni; Aug doubled in incidence over the last two decades. 2021) Collagen – Tumour
Slide 15: Hepatocellular carcinoma - PXS-5505 Phase 1b/2a Trial
Program Update Hepatocellular carcinoma - PXS-5505 Phase 1b/2a Trial First line combination treatment with standard of care to assess safety and efficacy endpoints DESIGN TREATMENT COHORT ENDPOINTS Open label phase 1b/2a of Phase 1b: Primary: PXS-5505 combined with • Dose escalation design atezolizu
Slide 16: Hypertrophic and keloid scarring
Program Update Hypertrophic and keloid scarring Cutaneous scarring following skin trauma or a wound is a major cause of morbidity and disfigurement Mechanisms underlying scar formation are not well established; prophylactic and treatment strategies KEY FACTS remain unsatisfactory 100m patients dev
Slide 17: Established Hypertrophic Scarring – PXS-6302 Phase 1c Trial (Solaria 2)
Program Update Established Hypertrophic Scarring – PXS-6302 Phase 1c Trial (Solaria 2) 3 month monotherapy study to assess dosage, tolerability and efficacy endpoints DESIGN TREATMENT COHORT ENDPOINTS Phase 1c 3 month placebo Cohort 1: Primary: controlled study Safety and tolerability (n = 8 subject
Slide 18: Established Hypertrophic Scarring – PXS-6302 Phase 1c Trial (Solaria 2)
Program Update Established Hypertrophic Scarring – PXS-6302 Phase 1c Trial (Solaria 2) 3 month monotherapy study to assess dosage, tolerability and efficacy endpoints DESIGN TREATMENT COHORT ENDPOINTS Phase 1c 3-month placebo Cohort 1: Cohort 1: controlled study • Skin biopsies show skin penetration
Slide 19: iRBD & Neuro Inflammation - Using a sleep disorder to target Parkinson’s Disease
Program Update iRBD & Neuro Inflammation - Using a sleep disorder to target Parkinson’s Disease SSAO inhibition proven effective mechanism against neuro inflammation and is neuro protective in pre clinical models PXS-4728 and neuro inflammation • PXS-4728 has already undergone extensive development
Slide 20: iRDB and Neuro Inflammation – Parkinson’s UK Funding
Program Update iRDB and Neuro Inflammation – Parkinson’s UK Funding PXS-4728 to proceed to phase 2 trial Short and longer term commercial opportunities • Current standard of care for iRBD is melatonin. There Parkinson’s UK Funding Agreement remains a high unmet need. Clinical trial in precursor to P
Slide 21: Mannitol respiratory business (Bronchitol and Aridol)
Program Update Mannitol respiratory business (Bronchitol® and Aridol®) Sales growth expected from Bronchitol sales in US and Russia Sales Bronchitol in US Bronchitol > 75% of sales Strong short term growth from Russia • US CF market >65% of global market Sales growth expected in approved in value
Slide 22: Upcoming News Flow
Upcoming News Flow Not for release to US wire services or distribution in the United States 22
Slide 23: Five trials to deliver near term value
Upcoming News Flow Five trials to deliver near term value Pipeline creates multiple opportunities in high value markets Addressable Indication Trial design # patients Status Data market (US$) Interim data Phase 2 open label 6 month study in JAK intolerant / ineligible released Myelofibrosis (MF) $1
Slide 24: News flow
Upcoming News Flow News flow Q4 2022 and H1 2023 anticipated news flow Strong and growing pipeline with advancement in studies expected to provide value inflection points in FY23 Q4 2022 Q1 2023 Q2 2023 • PXS-5505 phase 2a myelofibrosis study – • LOX topical drug PXS-6302 commences independent • PXS
Slide 25: Capital Raising
Capital Raising Not for release to US wire services or distribution in the United States 25
Slide 26: Details of the Offer
Capital Raising Details of the Offer Pharmaxis is undertaking a capital raising of approximately A$10 million, funding the company’s clinical programs into early 2024 • A two tranche placement to institutional, sophisticated and professional investors of A$10m, comprising: • Tranche 1 – placement of
Slide 27: Indicative Timetable
Capital Raising Indicative Timetable Indicative capital raising timetable Trading halt Tuesday, 18 October 2022 Capital raising announced and trading halt lifted – Shares recommence trading on ASX Wednesday, 19 October 2022 Settlement of first tranche Placement Tuesday, 25 October 2022 Allotment and
Slide 28: Capital Structure
Capital Raising Capital Structure Pharmaxis Capital Structure Institutional Ownership 30 June 22 Capital Structure (17 October 2022) $m BVF Partners LP 18.7% ASX Code PXS Karst Peak Capital Limited 12.4% Share price $0.078 Liquidity (turnover last 12 months) 100m shares D&A Income Limited 7.4% Marke
Slide 29: Appendix
Appendix Not for release to US wire services or distribution in the United States 29
Slide 30: Board
Board Significant international pharmaceutical experience Malcolm McComas – Chair Gary Phillips – Chief Executive Officer Former investment banker and commercial lawyer 30+ years’ of operational management experience in the pharmaceutical Former MD Citi Group and healthcare industry in Europe,
Slide 31: Experienced senior management team
Experienced senior management team Significant global experience in drug development, commercialisation and partnering Gary Phillips – CEO and Managing Director Jana Baskar – Chief Medical Officer 30+ years’ of operational management experience in the 20+ years’ experience both in clinical medic
Slide 32: Financials
Financials Income statement highlights Twelve months Periods ended (A$’000) - unaudited Jun-22 Jun-21 Segment Financials New drug development Oral LOX (external costs) (5,431) (2,521) Other program external costs (net of grants) (1,712) (1,850) Employee costs (2,943) (3,270) Overhead (374) (396) R&D
Slide 33: Cash
Financials Cash Twelve months Periods ended (A$’000) Jun-22 Jun-21 Cash Cash at period end 8,937 18,712 Cash received/receivable post period end 2022 R&D tax credit - expected H2 CF 2022 4,900 Exercise of Orbital option by Aptar - August 2022 7,031 Proforma cash at period end 20,868 Cash Flow Statem
Slide 34: Risks
Risks Pharmaxis is developing drugs targeting inflammation, fibrosis and cancer indications and whilst some of these activities have passed pre-clinical testing and phase 1 clinical studies they have not yet demonstrated clinical proof of concept in patients. Pharmaxis’ business is subject to a numb
Slide 35: Key business risks
Key business risks (a) Overview Pharmaxis’ business success is currently substantially dependent on its ability to successfully advance the clinical development of PXS-5505, PXS-6302 and PXS-4728 in a timely manner. Five clinical trials with respect to these product candidates have or will soon comm
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) Pharmaxis may not be successful in developing or securing new product candidates Although the Company already has an extensive product candidate pipeline, its continues to spend limited resources developing new product candidates. From time to time it also considers in-licensi
Slide 38: Key business risks
Key business risks (h) Dependence on distributors for sales of Aridol and Bronchitol Pharmaxis currently relies on distributors to perform sales, marketing, distribution and supply activities for Aridol and Bronchitol. As a result, Pharmaxis has a lower degree of control over these activities than i
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 Pharmaxis is developing and future product candidates, even if they receive regulatory approval may not gain a
Slide 40: Key business risks
Key business risks (p) Patents and trade secrets Pharmaxis 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 Pharmaxis’ patents will affor
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 to any person, and the New
Slide 42: 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 section 85 of the Financial Services and Marke
Slide 43: Contacts
Contacts Gary Phillips Chief Executive Officer developing breakthrough treatments for fibrosis and inflammation gary.phillips@pharmaxis.com.au Pharmaxis Ltd ABN 75 082 811 630 David McGarvey www.pharmaxis.com.au Chief Financial Officer david.mcgarvey@pharmaxis.com.au Not for release to US wire servi