Paradigm Biopharmaceuticals Ltd. · ASX:PAR

Paradigm Biopharmaceuticals — NWR Virtual Healthcare Conference (March 2023)

18 slides from Paradigm Biopharmaceuticals's conference presentation, Mar 22, 2023

  1. Slide 1: NWR Virtual Healthcare Conference

    For personal use only NWR Virtual Healthcare Conference

  2. Slide 2: Disclaimer

    For personal use only Paradigm Biopharma MAR 2023 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,

  3. Slide 3: About Pentosan polysulfate sodium for subcutaneous use (PPS, iPPS)

    For personal use only Paradigm Biopharma MAR 2023 3 About Pentosan polysulfate sodium for subcutaneous use (PPS, iPPS) • PPS is a non-opioid with a 60-year track record treating pain, inflammation, and Paradigm Proven Molecule thrombosis in humans. Paradigm Osteoarthritis (OA) ZILOSUL® Biopharmaceut

  4. Slide 4: Recent Company Milestones

    Paradigm Biopharma MAR 2023 4 Osteoarthritis (OA) For personal use only • Phase 2 disease modifying OA data presentations at OARSI World Congress 2023. • Parallel European Ethics and Regulatory approvals for phase 3 PARA_OA_002. • Positive top-line results in phase 2 trial exploring disease modifyin

  5. Slide 5: Osteoarthritis

    For personal use only Paradigm Biopharma 01/04/21 MAR 2023 55 Osteoarthritis OA

  6. Slide 6: Blockbuster market opportunity

    For personal use only Paradigm Biopharma MAR 2023 6 Blockbuster People affected by OA in 20203 Knee and Hip (Global) market opportunity 72m+ 69 % of all OA Zilosul® aims to OA patients dissatisfied with current People affected by OA by 20303 meet a significant treatments1 unmet need in osteoarthriti

  7. Slide 7: OA Clinical Development

    Paradigm Biopharma 01/04/21 MAR 2023 7 OA Clinical Development For personal use only 2017-2018 2021 2022 2023 2024 2025 OA_005 NDA Phase 2 OA OA_008 OA_002 Pivotal + duration of effect OA_006 (002 extension) Confirmatory + OA_003 duration of effect OA_007 (006 extension) OA_009 (retreatment) OA Labe

  8. Slide 8: Exploring the potential of iPPS as a disease modifying OA drug (DMOAD)

    Paradigm Biopharma 01/04/21 MAR 2023 88 EXPLORING THE POTENTIAL OF iPPS AS A For personal use only DISEASE MODIFYING OA DRUG (DMOAD) PARA_OA_008 • Biomarker study assessing change from baseline in multiple objective measures associated with disease progression of OA. • 60 participants received iPPS

  9. Slide 9: Day 56 Top-Line Results – Changes in Synovial Fluid Biomarkers

    For personal use only Paradigm Biopharma MAR 2023 9 DAY 56 TOP-LINE RESULTS – CHANGES IN SYNOVIAL FLUID BIOMARKERS In all cases, the synovial biomarker changes in iPPS-treated subjects at day 56 were favourable compared to placebo control. Synovial iPPS compared to Biomarker Biomarker placebo Functi

  10. Slide 10: Day 56 Top-Line Results PARA_OA_008

    Paradigm Biopharma MAR 2023 10 PPS once-weekly PPS twice-weekly PPS pooled Placebo Biomarker Statistics N=17 N=15 N=32 N=22 Top-Line COMP (µg/mL) For personal use only LS mean change from -25.56 9.47 -4.67 26.17 Results baseline (95% CI) LS mean difference1 (95% CI) (-67.31, 16.19) -51.73 (-100.62,

  11. Slide 11: PARA_OA_008: Clinical Endpoints

    Paradigm Biopharma MAR 2023 PARA_OA_008: Clinical Endpoints For personal use only Percentage Change from Baseline in WOMAC NRS 3.1 Index Pain and Function Subscale DAY 56 TOP-LINE RESULTS – CHANGES IN WOMAC PAIN, FUNCTION AND STIFFNESS FROM BASELINE WOMAC Pain PPS Placebo • Participants in the study

  12. Slide 12: Exploring the potential of iPPS as a DMOAD: upcoming 6-month data

    Paradigm Biopharma 01/04/21 MAR 2023 1212 EXPLORING THE POTENTIAL OF iPPS AS A For personal use only DISEASE MODIFYING OA DRUG (DMOAD) PARA_OA_008 • Upcoming 6-month Data to be reported in Q1 will include: • Changes in one or more synovial fluid biomarkers; • Changes and correlation between synovial

  13. Slide 13: Structural imaging biomarkers for potential disease modifying treatments for OA

    Paradigm Biopharma MAR 2023 Structural imaging biomarkers for potential disease modifying treatments for OA For personal use only Biomarker Biomarker Evaluated Pathology Subchondral BML MRI Pain and cartilage degeneration area and volume Joint synovitis / MRI Inflammation and pain effusion volume Im

  14. Slide 14: Phase 3 Program OA

    For personal use only 01/04/21 14 Phase 3 Program OA

  15. Slide 15: PARA_OA_002 Phase 3 Trial Design

    Paradigm Biopharma MAR 2023 PARA_OA_002 For personal use only Phase 3 Trial Design –Primary Endpoint: WOMAC Pain, Secondary: WOMAC Function STAGE STAGE Treatment Period 6 weeks Follow-Up Period 1 Treatment Period 6-weeks Follow-Up Period 2 1.5mg/kg SC twice weekly for 6 weeks (N=117) Selected PPS Do

  16. Slide 16: Osteoarthritis - Global Phase 3 Enrolment

    Paradigm Biopharma 01/04/21 MAR 2023 16 Osteoarthritis - Global Phase 3 Enrolment For personal use only Harmonised clinical protocol to achieve simultaneous registration in key jurisdictions PARA_OA_002 Global Progress USA • Fast Track Designation • 76 active sites • 14 sites selected • US enrolling

  17. Slide 17: Next 6 months: Expected Key News Flow Events

    For personal use only Paradigm Biopharma 01/04/21 MAR 2023 1717 • PARA_OA_008 – 6-month data March CY2023 • Canine OA model – 20-week follow-up (3-year human equivalent) data Q2 CY2023 Next 6 • PARA_OA_002 – Stage 1 100% recruitment 1H CY2023 months • Discussions with key regulatory bodies (FDA/EMA)

  18. Slide 18: For more information please visit

    For personal use only Paradigm Biopharma FEB 2023 18 For more information please visit: paradigmbiopharma.com

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