Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Investor Presentation (December 2024)
34 slides from Paradigm Biopharmaceuticals's investor presentation, Dec 9, 2024
Slide 1: Capital Raising Presentation
December 2024 Capital Raising Presentation Not for release to US wire services or distribution in the United States
Slide 2: Disclaimer
Paradigm Biopharma DEC 2024 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, “Information”) is con
Slide 3: Executive Summary
Paradigm Biopharma DEC 2024 3 Executive Summary Background • Paradigm Biopharmaceuticals Limited (Paradigm, PAR or Company) is a late-stage clinical biotech company developing Pentosan Polysulfate Sodium (PPS, iPPS,Zilosul®) for the treatment of Osteoarthritis (OA). • Molecule is a non-opioid with 6
Slide 4: Blockbuster market opportunity
Paradigm Biopharma DEC 2024 4 Blockbuster People affected by OA in 20203 Knee and Hip (Global) market opportunity 72m+ 69 % of all OA Zilosul® is a non-opioid OA patients dissatisfied with current subcutaneous People affected by OA by 20303 treatments1 injectable aimed to treat m+ 81 pain and functi
Slide 5: Market Demand
Paradigm Biopharma DEC 2024 5 “Most patients with OA of the hip and/or knee either initiate on or switch to opioids for long-term management of OA-related pain despite known risks. This highlights the need for new treatments that delay or prevent use of opioids1”. Effective Non-validated Ineffective
Slide 6: Phase 3 derisked by multiple Phase 2 trials
Paradigm Biopharma DEC 2024 6 Phase 3 derisked by multiple Phase 2 trials PARA_005 Phase 2 PARA_OA_008 Phase 2 PARA_OA_002 Phase 2 Pain & Function Pain, Function, mechanism of action Safety & Dose Optimisation • 6-week treatment, 46-week follow-up, n=61 • 6-week treatment, 18-week • 6-week treatment
Slide 7: Recap of PH2 results
Osteoarthritis Recap of PH2 results
Slide 8: Phase 2: PARA_005
Paradigm Biopharma DEC 2024 8 Phase 2: PARA_005 2 mg/kg SC twice weekly v placebo for 6 weeks, followed up for 6 months Pain Reduction KOOS adjusted least squares mean change from baseline. FAS. Function ADL KOOS adjusted least squares mean change from baseline. FAS. LS Mean Change +/- Standard Erro
Slide 9: Phase 2: PARA_OA_008
Paradigm Biopharma DEC 2024 9 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 Pain Reduction WOMAC least squares adjusted mean change from base
Slide 10: iPPS Durability Compared to Current OA Therapies
Paradigm Biopharma 01/04/21 DEC 2024 1010 Market Demand iPPS Durability Compared to Current OA Therapies Current OA medication effect duration. Representative infographic reflecting current Phase 2 Data literature on the timing of the peak and estimated duration of treatment effect of currently avai
Slide 11: Para_OA_005 Exploratory Endpoints
Paradigm Biopharma DEC 2024 11 Para_OA_005 • 2 mg/kg SC twice-weekly v placebo • PPS showed significantly reduced serum levels of cartilage degradation biomarkers and Exploratory significant reduction in BML size as compared with placebo controls. Endpoints Reduction in size of bone marrow lesions R
Slide 12: Molecular Biomarkers PARA_OA_008
Paradigm Biopharma 01/04/21 DEC 2024 1212 Day 168 Top-Line Results – Changes in Synovial Fluid, Serum, and Urinary Biomarkers • Molecular biomarkers of cartilage degradation in iPPS-treated subjects were favourable compared to placebo control. Molecular Biomarker Day 168 iPPS v placebo C2C (Se) Redu
Slide 13: PARA_OA_008 Top-Line Quantitative MRI Results
Paradigm Biopharma DEC 2024 13 PARA_OA_008 Top-Line Day 168 Quantitative MRI Results 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 compartments at 6 months • P
Slide 14: Pivotal PH3 Trial
Osteoarthritis Pivotal PH3 Trial
Slide 15: FDA approval to commence PH3 at 2mg/kg dose
Paradigm Biopharma DEC 2024 15 Positive FDA Update FDA review completed and PAR can proceed with PH3 trial as per company desired FDA protocol: approval to o 2mg/kg twice weekly for 6-weeks dose regimen. o 466 patients randomised 1:1, double blinded, placebo control. commence o Primary endpoint: Cha
Slide 16: PARA_OA_012 Phase 3 trial design and timeline
Paradigm Biopharma DEC 2024 16 PARA_OA_012 Phase 3 Treatment Period 6 weeks Follow-up Period 46 weeks PPS 2mg/kg (max 200 mg) N = 233* Screening Placebo N = 233* 39 56 84 112 140 168 224 280 336 404 Day 1 Interim First Injection Last Inj. End of Study Analysis Projected Time Objective Interim Analys
Slide 17: ASX PH3 Comparison Table
Paradigm Biopharma DEC 2024 17 Valuation (Market Capitalisation ($Am) FDA Company P3 Trial Indication Designations At IND Clearance Current Wet age-related macular ASX PH3 Opthea Ltd (OPT) degeneration (Wet AMD) Fast track ~A$500 ~A$880 Comparison Mesoblast Ltd (MSB) Chronic heart failure ~A$1,500 ~
Slide 18: Current Partnering Activity
Paradigm Biopharma DEC 2024 18 Current status Non- Confidential Non-binding Board Dataroom Binding Board Final confidential CDA Deal Information offer approval access offer approval negotiations information Ongoing Commercial Partnering Efforts • Active engagement with key potential partners to supp
Slide 19: Funding position and use of funds
Paradigm Biopharma DEC 2024 19 Funding position and use of funds • Capital raising of A$16.0 million funds initiation of Phase 3 activities and early enrolment in Australia and the US. • A$26.9m December pro forma cash balance post capital raising1. Non-dilutive funding from partnering or regional l
Slide 20: TGA Feedback on Provisional Pathway
Paradigm Biopharma DEC 2024 20 Paradigm received feedback from the TGA acknowledging that preliminary clinical results for PPS show potential benefits for patients with moderate to severe knee TGA osteoarthritis (OA), although the TGA noted, OA at the milder end is not considered seriously debilitat
Slide 21: News flow & catalysts
Paradigm Biopharma DEC 2024 21 News flow & catalysts Event Target Date FDA 30-day review completion, proceed to Pivotal Phase 3 PARA_OA_012 trial Complete Australian Ethics Submission – Phase 3 PARA_OA_012 Q4 CY2024 Regional licensing agreement(s) in OA and MPS. CY2025 Upcoming PARA_OA_012 – First A
Slide 22: Offer Summary
Paradigm Biopharma DEC 2024 22 • Placement to institutional, sophisticated and professional investors to raise A$16.0 million (Placement or Offer). Offer Offer Structure • 40.0 million new fully paid ordinary shares (New Shares) to be issued under the Offer, representing and Size approximately 11.5%
Slide 23: Indicative Offer Timetable
Paradigm Biopharma DEC 2024 23 Indicative Offer Timetable Event Date Trading halt Thursday, 5 December 2024 Announcement of completion of Placement and recommencement of trading Monday, 9 December 2024 Settlement of Placement Thursday, 12 December 2024 Allotment and normal trading of New Shares issu
Slide 24: Appendix
Appendix
Slide 25: Mechanism of action
Paradigm Biopharma DEC 2024 25 Mechanism Pentosan Polysulfate Sodium (PPS) of action • Multiple modes of action NF-κB • Previous phase 2B, SAS, and EAP experience • New phase 2 data Inflammation Pain Tissue Preservation Improved Blood OA TNF-α, IL-1β, IL-6 Flow NGF, Prostanoids ADAMTS-4 & -5, MMPs C
Slide 26: Extensive market protection
Paradigm Biopharma DEC 2024 26 26 Complex Extensive Alphavirus Exclusive molecule Heart supply Failure ? market protection Severe Arthroplasty OA Pain • Multiple method of use patents, Allergic ARDS Rhinitis continually refined and expanded with additional patents being PPS universe of protection pu
Slide 27: Achievable price range (USD year)
Paradigm Biopharma DEC 2024 27 Target pricing Pricing potential of Zilosul in P&F and DM compared to price benchmark Price points for comparators Weak opioids CS IA HA IA 8000 • Achievable for P&F Achievable price range (USD year) label with PAR 7000 $6K+ 6000 current clinical 5000 program 4000 $2-3
Slide 28: Risk Factors
Paradigm Biopharma DEC 2024 28 Risk Factors Shareholders should consider the investment in the context of their individual risk profile for speculative investments, investment objectives and individual financial circumstances. Each Shareholder should consult their own stockbroker, solicitor, account
Slide 29: Risk Factors Continued
Paradigm Biopharma DEC 2024 29 Risk Factors Continued Research and Development Activities: Paradigm’s future success is dependent on the performance of Paradigm in current and planned future clinical trials using Pentosan Polysulfate Sodium (PPS) and whether it proves to be a safe and effective trea
Slide 30: Risk Factors Continued
Paradigm Biopharma DEC 2024 30 Risk Factors Continued Manufacturing: There is a risk that scale-up of commercial supplies of Pentosan Polysulfate Sodium (PPS) may present technical and supply difficulties. Any unforeseen difficulty relating to manufacturing or supply of commercial GMP quantities of
Slide 31: Risk Factors Continued
Paradigm Biopharma DEC 2024 31 Risk Factors Continued Economic Risks: General economic conditions, movements in interest and inflation rates and currency exchange rates may have an adverse effect on the Company’s activities, as well as on its ability to fund those activities. Taxation: The acquisiti
Slide 32: International Offer Restrictions
Paradigm Biopharma DEC 2024 32 International Offer Restrictions This document does not constitute an offer of new ordinary shares (“New Shares”) and Options of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the Ne
Slide 33: International Offer Restrictions Continued
Paradigm Biopharma DEC 2024 33 International Offer Restrictions Continued Singapore This document and any other materials relating to the New Shares and Options have not been, and will not be, lodged or registered as a prospectus in Singapore with the Monetary Authority of Singapore. Accordingly, th
Slide 34: Paul Rennie, Simon White
Paradigm Biopharma DEC 2024 34 Paul Rennie Managing Director Email: prennie@paradigmbiopharma.com Simon White Director IR Email: swhite@paradigmbiopharma.com For more information please visit: paradigmbiopharma.com
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