Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Evans & Partners 4th Annual Small Cap Healthcare Conference 2025
19 slides from Paradigm Biopharmaceuticals's conference presentation, Sep 9, 2025
Slide 1: Paradigm to Present at the Evans & Partners Small Cap Healthcare Conference
ASX RELEASE 9 September 2025 Paradigm to Present at the Evans & Partners Small Cap Healthcare Conference 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, today announced
Slide 2: For further information please contact
FOR FURTHER INFORMATION PLEASE CONTACT: Simon White Director of Investor Relations Tel: +61 404 216 467 Paradigm Biopharmaceuticals Ltd ABN: 94 169 346 963 Level 15, 500 Collins St, Melbourne, VIC, 3000, AUSTRALIA Email: investorrelations@paradigmbiopharma.com For personal use only
Slide 3: Evans & Partners 4th Annual Small Cap Healthcare Conference
For personal use only Evans & Partners 4 th A n n u a l S m a l l C a p Healthcare Conference MD | Paul Rennie
Slide 4: Disclaimer
Paradigm Biopharma Sep 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 5: What is Osteoarthritis
Paradigm Biopharma Sep 2025 What is Osteoarthritis Kellgren and Lawrence Grade For personal use only Risk Factors & Overview Impact Management • A degenerative joint • Restricts movement, • Age, sex, obesity, disease causing pain, daily activities, and joint injury, overuse, swelling, and stiffness.
Slide 6: Osteoarthritis By Numbers
Paradigm Biopharma Sep 2025 4 Osteoarthritis People affected by OA Globally1 Moderate – to – Severe OA3 For personal use only By Numbers Zilosul® is a non-opioid subcutaneous 528m+ 65 % of all OA injectable aimed to treat OA patients dissatisfied with current Knee OA most prevalent2 treatments4: pai
Slide 7: Unmet Need
Paradigm Biopharma Sep 2025 5 Unmet Effective Non-validated Ineffective Invasive Need • Daily use Analgesics, • GI, CV risk with NSAIDS For personal use only prolonged use. • Severe side-effects Opioids • Addictive • Limited treatment options: Current • Limited pain relief treatments (NSAIDs, *Hyalu
Slide 8: Advancing iPPS Toward a Differentiated OA Therapy
Paradigm Biopharma Sep 2025 29/12/20 6 The picture can’t be displayed. SAFTEY & 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 symptom
Slide 9: Confidence in iPPS Clinical & Real-World Evidence
Paradigm Biopharma Sep 2025 7 Confidence in IPPS Clinical & Real-World Evidence For personal use only iPPS Study Study Type Dosing Regimen Key Findings Randomised, double-blind, 3 mg/kg IM once weekly for 4 Significant pain reduction at rest (out to 24 weeks); Ghosh et al. (2005) placebo-controlled
Slide 10: Phase 2: PARA_OA_008
Paradigm Biopharma Sep 2025 8 Phase 2: PARA_OA_008 2 mg/kg IBW SC twice weekly v placebo for 6 weeks, followed up for 12 months (n=61) A single 6-week course of twice-weekly iPPS demonstrates durable clinical outcomes out to 12 months For personal use only Pain Reduction WOMAC least squares adjusted
Slide 11: PARA_OA_008 Top-Line Data: Quantitative MRI Results
Paradigm Biopharma Sep 2025 9 PARA_OA_008 Top-Line Day 168 Quantitative MRI Results For personal use only Changes in Cartilage Thickness from baseline • Twice weekly iPPS arm, demonstrated a consistent pattern of improvement in cartilage thickness across all key regions of medial and lateral compart
Slide 12: Osteoarthritis Pivotal PH3 Trial
For personal use only Osteoarthritis Pivotal PH3 Trial
Slide 13: Phase 3 Objectives
Paradigm Biopharma Sep 2025 11 29/12/20 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 ev
Slide 14: PARA_OA_012 Phase 3 Trial Design and Interim Analysis
Paradigm Biopharma. Sep 2025 12 PARA_OA_012 Interim Analysis (IA) • Conducted once 50% of subjects (~233) reach Day 112. Phase 3 trial design • Plan assess efficacy and possible early For personal use only conclusion of trial based on target effect size. • DSMB to conduct Interim Analysis. Treatment
Slide 15: PARA_OA_012 – Powered for Success
Paradigm Biopharma 29/12/20 Sep 2025 13 The picture can’t be displayed. PARA_OA_012 – Powered for Success Statistical Power Based on Phase 2 Data Validates For personal use only The table summarises modelled power at effect sizes established in Phase 2 studies. Estimated Power • High statistical pow
Slide 16: Valuation: ASX Phase 3 Comparison Table
Paradigm Biopharma Sep 2025 14 Valuation (Market Capitalisation $Am) FDA Company P3 Trial Indication Designations At IND Clearance Current For personal use only GVHD (paediatric ASX PH3 Mesoblast Ltd (MSB) refractory to standard of care) ~A$1,500 ~A$2,931 Comparison Immutep Ltd (IMM) Metastatic non-
Slide 17: Investment Highlights
Paradigm Biopharma Sep 2025 15 29/12/20 The picture can’t be displayed. Investment Highlights For personal use only ü Multiple Positive Phase 2 Trials: Consistent efficacy and safety demonstrated across studies, with signals of disease-modifying activity on MRI and biomarkers. ü Real-World Evidence:
Slide 18: News flow & catalysts
Paradigm Biopharma Sep 2025 16 News flow & catalysts For personal use only Event Target Date PARA_OA_012 – First participant dosed. Q3 2025 Upcoming PARA_OA_012 – 50% Recruitment of participants 2H 2025* Catalysts Regional licensing agreement(s) in OA Ongoing End of PARA_OA_008 – Phase 2 clinical tr
Slide 19: Contact
For personal use only Paradigm Biopharma Sep 2025 17 Paul Rennie Managing Director Email: prennie@paradigmbiopharma.com Simon White Director IR Investor and Media Enquiries For more information please visit: Email: swhite@paradigmbiopharma.com https://investors.paradigmbiopharma.com