Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Shareholder Meeting (November 2020)
17 slides from Paradigm Biopharmaceuticals's shareholder meeting presentation, Nov 19, 2020
Slide 1: 2020 Annual General Meeting (AGM) Presentation
For personal use only Paradigm Biopharmaceuticals LTD (ASX:PAR) 2020 Annual General Meeting (AGM) Presentation PARADIGM BIOPHARMA 1 ANNUAL GENERAL MEETING 2020
Slide 2: Disclaimer
DISCLAIMER For personal use only This document, together with any information communicated by Paradigm Biopharmaceuticals Ltd (known as “Paradigm”, “Paradigm Biopharma” or “the Company”), in any presentation or discussion relating to this document (collectively, “Information”) is confidential, and h
Slide 3: Paradigm's Mission
PARADIGM’S MISSION For personal use only Paradigm Biopharmaceuticals Limited (PAR) is a late-stage drug development company To develop and commercialise pentosan polysulphate sodium (PPS) for the treatment of arthralgia driven by injury, inflammation, aging, degenerative disease, infection or geneti
Slide 4: Corporate Snapshot
CORPORATE SNAPSHOT Key Financial Details Paradigm 12-Month Share Price Performance For personal use only Ticker Symbol ASX:PAR Share Price (17th Nov, 2020) ~A$3.07 Total Ordinary Shares on Issue 228,019,548 Market Capitalisation ~A$700m (17th Nov, 2020) Trading Range (12month) A$1.08 – $4.50 Cash Ba
Slide 5: Osteoarthritis Market
For personal use only OSTEOARTHRITIS MARKET PARADIGM BIOPHARMA 5 ANNUAL GENERAL MEETING 2020
Slide 6: Blockbuster Market Opportunity
BLOCKBUSTER MARKET OPPORTUNITY SIGNIFICANT MARKET SIZE WITH UNMET NEED For personal use only 81% A PARADIGM SHIFT IN THE Number of OA TREATMENT MARKET FOR patients dissatisfied OA with current treatments1 ~72M+ US$15B+3 Total prevalence of OA in these Conservative Estimate AUS markets. Target uptake
Slide 7: Goal: Harmonised Global Registration
GOAL: HARMONISED GLOBAL REGISTRATION EUROPE For personal use only USA EMA meeting September 2020 Pre IND meeting February 2020 • Agree with Clinical Trial design and • Bene pharmaChem product endpoints • Additional pre-clinical studies • Confirmation no-comparator arm • Western PK • Ability to recru
Slide 8: Confidence: Phase Study Design
CONFIDENCE: PHASE 3 STUDY DESIGN CONSISTENT RESULTS ACROSS MULTIPLE PROGRAMS IN PAIN REDUCTION FOR KNEE OA For personal use only Phase 2B OA/BML Clinical Trial Ø Double-Blinded Placebo Controlled study (n=112) Ø Met primary endpoint – Change in KOOS pain score from baseline Ø Secondary Endpoint of P
Slide 9: Competitor Field Update
COMPETITOR FIELD UPDATE For personal use only COMPANIES DRUG MECHANISM OF ACTION TARGET STATUS GLPG1972, ADAMTS-5 Inhibitor • Cartilage Degradation • Discontinued. S201086 • Multiple clinical holds due to Tanezamub Anti-NGF • Pain Reduction Adverse Events • Submitted for Registration • Reduction of
Slide 10: Protection: Achieved Secure Supply
PROTECTION: ACHIEVED SECURE SUPPLY PARADIGM STRENGTHENED IP IN 2020 Secure manufacturing and supply – Extension For personal use only § Includes all major pharmaceutical markets (excluding Japan which is covered under a separate arrangement). Exclusive Supply Agreement with only FDA § 25 years from
Slide 11: Mucopolysaccharidoses (MPS)
MUCOPOLYSACCHARIDOSES (MPS) For personal use only Paradigm’s investigation of PPS for MPS seeks to establish whether PPS may be an effective combination therapy with current Enzyme Replacement Therapy treatments Ø Orphan Designations for MPS-I and MPS-VI in the US and EU Ø Parallel Scientific Advice
Slide 12: Preparation for Commercialisation
PREPARATION FOR COMMERCIALISATION For personal use only Ø Gathering and consolidating feedback from US, EU and AU regulators Aim: To have a pivotal protocol acceptable to all major jurisdictions Benefit: Faster approval globally Ø Assembled high calibre and experienced globally focussed team in USA
Slide 13: Paradigm Key Events in 2020
EMA PROVIDES PARADIGM KEY EVENTS IN 2020 KEY PATH TOWARD PHASE 3 BRIEFING BOOK SUBMITTED FOR TRIALS AND TYPE-C MEETING WOMAC REGISTRATION WITH FDA SAS DATA PAR REPORTS 65% For personal use only 34 MEAN PAIN PATIENTS REDUCTION RRV MANUSCRIPT PHASE 2B OA ADDITIONAL PRE IND- SUBMITTED FOR MANUSCRIPT AC
Slide 14: Key Appointments
KEY APPOINTMENTS For personal use only Team Additions in 2020 Strategic Partners Ø Dr Donna Skerrett - Executive Director Ø Bene pharmaChem Ø Dr Jeannie Joughin – Chief Operating Officer Ø Siegfried Ø Justin Cahill – Chief Financial Officer Ø Premier Research Ø Dr Michael Imperiale – Global Head of
Slide 15: Upcoming Presentation for Investors
UPCOMING PRESENTATION FOR INVESTORS R&D DAY, 21ST / 22ND DEC 2020 (DATE TBC) For personal use only PRESENTATIONS FROM, DR DONNA SKERRETT (CMO) AND DR RAVI KRISHNAN (CSO) Ø Share feedback from Type-C Meeting written response Ø Detail on OA and MPS trial designs and timelines Ø Update on scientific re
Slide 16: Outlook for Remainder of FY21
OUTLOOK FOR REMAINDER OF FY21 For personal use only § Feedback from Type-C meeting with US FDA § Paradigm to host R&D Day detailing all clinical programs the company is planning to undertake § Additional TGA SAS patient WOMAC data § Commence Phase 3 Clinical Trial Osteoarthritis § Peer reviewed publ
Slide 17: For personal use only
For personal use only For more information please visit: www.paradgimbiopharma.com or email any queries to investorrelations@paradigmbiopharma.com PARADIGM BIOPHARMA 17 ANNUAL GENERAL MEETING 2020
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