Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Investor Presentation (July 2025)
22 slides from Paradigm Biopharmaceuticals's investor presentation, Jul 31, 2025
Slide 1: Investor Webinar Presentation: Phase 3 Update and Probability of Success
ASX RELEASE 31st July 2025 Investor Webinar Presentation: Phase 3 Update and Probability of Success 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, advises that the inv
Slide 2: Phase 3 Clinical Trial Webinar July 2025
For personal use only PHASE 3 CLINICAL TRIAL WEBINAR JULY 2025 DR. DONNA SKERRETT | CMO MR PAUL RENNIE | MD
Slide 3: Disclaimer
Paradigm Biopharma JUL 2025 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, For personal use only
Slide 4: Executive Summary
Paradigm Biopharma JUL 2025 3 Executive Summary For personal use only Paradigm Biopharmaceuticals (ASX: PAR) is a late-stage drug development company focused on delivering new treatments for diseases with high unmet medical need. Our lead program, injectable pentosan polysulfate sodium (iPPS), is be
Slide 5: Recent News Flow
Paradigm Biopharma JUL 2025 4 For personal use only Phase 3 OA program commencement – Site Activation, First Participant Consent Australia First Participant Consented in US 2025 New IP Acquisition – Building out Paradigm OA portfolio. Recent News- Funding Secured to provide runway through many Flow
Slide 6: Advancing iPPS Toward a Differentiated OA Therapy
Paradigm Biopharma JUL JUL2005 2025 5 SAFETY & EFFICACY PROFILE 01 • Strong efficacy and safety shown across a broad dataset • Durable benefits sustained to 12 months in Phase 2 studies For personal use only • Imaging and biomarker data suggest effects beyond Advancing symptom relief iPPS Toward a P
Slide 7: Drug Development Phase Success Rates
Paradigm Biopharma 02/12/21 JUL 2025 6 Drug Drug Development Phase Success Rate Development For personal use only 86.5 Phase Success Rates 62 62.5 Success Rate % • Only about 12% of drugs entering Phase I ultimately receive regulatory approval, highlighting the high attrition rate in drug developmen
Slide 8: Osteoarthritis Pivotal Phase 3 Trial
For personal use only Osteoarthritis Pivotal PH3 Trial
Slide 9: Study Overview
Paradigm Biopharma 29/12/20 JUL 2025 8 Trial Type: Phase 3 For personal use only Study Overview Study Drug: Pentosan Polysulfate Sodium (PPS) - Injectable A Phase 3, Double- blind, Placebo- Patient controlled, Multicenter Adults with moderate to severe knee osteoarthritis with pain Population: Study
Slide 10: Phase 3 Objectives
Paradigm Biopharma JUL29/12/20 2025 9 Phase 3 Objectives For personal use only Key objectives for the Phase 3 PARA_OA_012 study Primary Objectives • To evaluate the treatment effect of PPS on knee pain in participants with knee OA pain. (Weekly Average ADP Day 112) Key Secondary Objectives • To eval
Slide 11: Optimised Endpoint Design and Pain Scoring
Paradigm Biopharma 29/12/20 JUL 2025 10 PARA_OA_012 Optimised Endpoint Design and Pain Scoring For personal use only • Following FDA discussions, the primary efficacy endpoint is now assessed 8 weeks post-final injection, aligning with recent OA and chronic pain studies and reflecting the durable th
Slide 12: PARA_OA_012 Phase 3 Trial Design
Paradigm Biopharma. JUL 2025 11 PARA_OA_012 Phase 3 trial design For personal use only Treatment Period: Follow-up Period: 6 weeks 52 weeks PPS 2 mg/kg N = 233* Screening Placebo N = 233* Day 1 39 56 84 112 140 168 224 280 336 404 First Injection Last Inj. Interim End of Study Analysis Primary endpo
Slide 13: PARA_OA_012 Phase 3 Site Locations by State
Paradigm Biopharma. JUL 2025 12 PARA_OA_012 Phase 3 Site Locations by State United States Australia For personal use only 50 sites 15 sites
Slide 14: Considerations in Evaluating Probability of Success
Paradigm Biopharma JUL JUL2005 2025 13 PARA_OA_012 Considerations in Evaluating Probability of Success For personal use only NRS 0-10 endpoint, average daily pain • What is a meaningful difference – statistical or clinical (anchor to PRO) • FDA recommended endpoint to ”reduce recall bias and capture
Slide 15: PARA_OA_005 Magnitude of Effect
Paradigm Biopharma 29/12/20 JUL 2025 14 PARA_OA_005 Magnitude: NRS 0-10, absolute and %Change from Baseline For personal use only iPPS iPPS Day 53 Day 81 NRS -33.33 -16.67 NRS-valid and reliable measure of pain intensity Med % CBL 4-6 -36.67 -8.33 • NRS assessed for prior 48 hours 7-8 -14.29 -28.57
Slide 16: PARA_OA_008 Magnitude of Effect
Paradigm Biopharma 29/12/20 JUL 2025 15 PARA_OA_008 • Sustained improvements in both pain and function Magnitude: WOMAC, scores were observed in the iPPS twice-weekly For personal use only treatment group %Change from Baseline1 • These improvements* exceeded the Minimum Clinically Important Improvem
Slide 17: Observed Effect Size for Pain Scores
Paradigm Biopharma 29/12/20 JUL 2025 16 PARA_OA_012 Endpoint: Observed effect size for Pain Scores (Scale 0-10) For personal use only Pooled- Time Para_005 Para_OA_008 weighted Study Population Considerations • SC 2mg/kg twice weekly x 6 Day 39 0.33 0.38 0.34 Patient Populations • 005 BML 95%, KL 3-
Slide 18: PARA_OA_012 – Probability of Success
Paradigm Paradigm Biopharma Biopharma JUL JUL2005 2025 17 PARA_OA_012 – Probability of Success Clinically Important response on NRS Scale For personal use only • Sample Size: ~466 participants with moderate to severe knee OA (KL Grade 2–4), randomised 1:1 • Primary Endpoint: Change from baseline in
Slide 19: Interim & Final Analysis
Paradigm Biopharma 29/12/20 JUL 2025 18 PARA_OA_012 Interim & Final For personal use only Analysis Interim analysis (IA) is planned after pain intensity data are available from 50% of total planned sample size 466 (randomised 1:1). Outcomes of IA could be: • Early conclusion of futility if an observ
Slide 20: News flow & catalysts
Paradigm Biopharma JUL 2025 19 News flow & catalysts For personal use only Event Target Date PARA_OA_012 – First participant dosed US and Aus Q3 CY2025 Upcoming Clinical PARA_OA_012 – 50% Recruitment of participants 2H CY2025* Catalysts PARA_OA_012 – 100% Recruitment 1H 2026* PARA_OA_012 Interim Ana
Slide 21: Contact
For personal use only Paradigm Biopharma JUL 2025 20 Paul Rennie Managing Director Email: prennie@paradigmbiopharma.com Simon White Director IR Email: swhite@paradigmbiopharma.com For more information please visit: paradigmbiopharma.com
Slide 22: References
References: For personal use only 1. Robert H. Dworkin, Dennis C. Turk, Kathleen W. Wyrwich,, Dorcas Beaton. Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations https://www.jpain.org/issue/S1526- 5900(07)X0083-X 2. Angst F, Aeschlimann
Paradigm Biopharmaceuticals — Investor Presentation (July 2025) on 6ix