Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Bell Potter Virtual Healthcare Conference 2022
16 slides from Paradigm Biopharmaceuticals's conference presentation, Nov 9, 2022
Slide 1: Paradigm Presentation to the Bell Potter Virtual Healthcare Conference
ASX RELEASE 9 November 2022 Paradigm Presentation to the Bell Potter Virtual Healthcare Conference For personal use only Paradigm Biopharmaceuticals Ltd (ASX:PAR, “Paradigm” or “the Company”), a late-stage drug development company focused on delivering new therapies to address unmet medical needs, i
Slide 2: Authorised for release and investor contact
Authorised for release by the Paradigm Board of Directors. To learn more please visit: www.paradigmbiopharma.com FOR FURTHER INFORMATION PLEASE CONTACT: For personal use only Simon White Director of Investor Relations Tel: +61 404 216 467 Paradigm Biopharmaceuticals Ltd. ABN: 94 169 346 963 Level 15
Slide 3: Bell Potter Healthcare Conference 2022
For personal use only Bell Potter Healthcare Conference 2022
Slide 4: Disclaimer
For personal use only Paradigm Biopharma OCT 2022 2 Disclaimer This document, together with any information communicated by Paradigm Biopharmaceuticals Ltd ASX:PAR (known as “Paradigm”, “Paradigm Biopharma” or “the Company”), in any presentation or discussion relating to this document (collectively,
Slide 5: About Paradigm
Paradigm Biopharma OCT 2022 3 Pentosan polysulfate sodium for subcutaneous use (PPS, iPPS) Proven For personal use only • PPS is a non-opioid with a 60-year track record treating pain, inflammation and About Molecule thrombosis in humans. Paradigm Osteoarthritis (OA) ZILOSUL® Paradigm • Zilosul® is
Slide 6: Extensive market protection
Paradigm Biopharma AUG 2022 4 5 Extensive market protection For personal use only Exclusive Complex supply molecule Alphavirus • Molecular platform technology and a Heart ? Failure complex trade-secret manufacturing process makes it extremely difficult to replicate Severe OA Arthroplasty Pain • The
Slide 7: Recent Company Milestones
Paradigm Biopharma OCT 2022 5 Recent Company Milestones For personal use only • FDA Fast Track designation granted for OA program • Canada regulatory and ethics approval for phase 3 OA trial • Research partnership with NFL Alumni Health • MPS clinical program update – safety review of phase 2 clinic
Slide 8: Lead Programs
Paradigm Biopharma OCT 2022 6 Lead Programs For personal use only 2021 2022 2023 2024 2025 2026 OA_002 Pivotal & Confirmatory OA_003 NDA OA_006 Duration of effect OA_007 OA Label OA_009 Extension OA_010 MPS I phase 2 Safety and Efficacy MPS VI phase 2 Proposed MPS VI phase 3 002 OA NDA Pivotal First
Slide 9: Osteoarthritis
For personal use only Paradigm Biopharma 01/04/21 OCT 2022 77 Osteoarthritis OA
Slide 10: Osteoarthritis - Global Phase PARA_OA_002 Global Progress
Paradigm Biopharma 01/04/21 OCT 2022 99 Osteoarthritis - Global Phase 3 PARA_OA_002 Global Progress For personal use only United States • Fast Track Designation • 50+ sites activated • Enrolling participants • DSMB review December Australia • 8 sites activated • Enrolling participants UK and Europe
Slide 11: PARA_OA_008 – Top-Line Results
Paradigm Biopharma 01/04/21 OCT 2022 1010 PARA_OA_008 – Top-Line Results For personal use only Day 56 Top-Line Results – Changes in Synovial Fluid Biomarkers • iPPS impacted multiple biomarkers measured in the synovial fluid: o NGF reduction indicates mechanisms relating to pain reduction; o Reducti
Slide 12: PARA_OA_008 - Clinical Outcomes
Paradigm Biopharma 01/04/21 OCT 2022 1111 PARA_OA_008 - Clinical Outcomes For personal use only Day 56 Top-Line Results – Changes in WOMAC Pain and Function from Baseline • Participants in the study were asked to provide baseline pain scores using the WOMAC Osteoarthritis Index. • iPPS treatment sho
Slide 13: Mucopolysaccharidosis
For personal use only 01/04/21 12 Mucopolysaccharidosis MPS
Slide 14: Mucopolysaccharidosis (MPS)
Paradigm Biopharma AUG 2022 13 Mucopolysaccharidosis (MPS) MPS I - Australia For personal use only Phase 2 asset in rare disease associated with inflammation and • Open-label trial dosing subjects weekly SC for 12 weeks, then every ongoing musculoskeletal pain – PPS has FDA and EMA orphan other week
Slide 15: Upcoming Milestones
Paradigm Biopharma OCT 2022 14 Upcoming Milestones For personal use only Upcoming near-term news flow • PARA_OA_002 – first data safety monitoring board review Q4 CY2022 • FY22 tax rebate Q4 CY2022 circa ~A$7m • Further IP generation and protection • MPS-VI – 100% recruitment expected Q4 CY2022 • MP
Slide 16: For personal use only
For personal use only Paradigm Biopharma OCT 2022 15 For more information please visit: paradigmbiopharma.com
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