Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Investor Presentation (April 2018)
24 slides from Paradigm Biopharmaceuticals's investor presentation, Apr 17, 2018
Slide 1: Investor Presentation
For personal use only Investor Presentation Paul Rennie, CEO & MD April 2018
Slide 2: Disclaimer
Disclaimer For personal use only This document, together with any information communicated by Paradigm Biopharmaceuticals Ltd (known as “Paradigm”, “Paradigm Biopharma” or “the Company”), in any presentation or discussion relating to this document (collectively, “Information”) is confidential, and h
Slide 3: Corporate Overview
Corporate Overview For personal use only Financial information Paradigm Biopharmaceuticals Ltd is an ASX-listed Share price (13-April-18) A$0.33 biotechnology company focused on repurposing pentosan polysulfate sodium (PPS), an FDA-approved Number of shares 120.6m drug that has a long track record
Slide 4: Investment Proposition
Investment Proposition For personal use only Reduce clinical costs and accelerate commercialisation by repurposing a pre-approved drug - 505(b)(2) Very large addressable markets (combined US$37bn+) - Pentosan Polysulfate Sodium (PPS) is a new, multi-acting treatment for osteoarthritis (associate
Slide 5: Board and Management
Board and Management High quality Board and management, with top-tier pharmaceutical experience For personal use only Board and management are renowned leaders in the biopharmaceutical industry, having held senior management positions with top ASX-listed companies, CSL (CSL.ASX) and Mesoblast (MSB
Slide 6: Drug Repurposing Strategy
Drug Repurposing Strategy Much lower cost, accelerated timeline, lower risk and with higher rates of success For personal use only Lower cost: average development cost of ~US$30-50m compared to US$1.3bn for “de novo” development1 Faster: FDA 505(b)(2) pathway leveraging previous clinical efforts
Slide 7: Pentosan Polysulfate Sodium
Pentosan Polysulfate Sodium PPS has a long safety history and is currently being sold in the US and Europe For personal use only Pentosan Polysulfate Sodium Excellent Safety Profile Pentosan polysulfate sodium (PPS) is a semi-synthetic drug PPS has a well established safety profile with no repor
Slide 8: Pentosan Polysulfate Sodium – Supply & License
Pentosan Polysulfate Sodium – Supply & License For personal use only Exclusive Supply PPS Buy per/kg License Exclusivity Royalty Paradigm has executed a 20 year exclusive supply Agreement grants exclusive supply of only FDA agreement with bene PharmaChem Gmbh & Co. KG approved PPS for all orthop
Slide 9: IP Protection
IP Protection Multi-faceted IP protection increases barriers to entry for potential competitors For personal use only Valuable patent portfolio Paradigm has patent protection because it is using PPS for new indications Minimum life on patents is 2030 and beyond for more EU patents granted for re
Slide 10: Broad Product Pipeline
Broad Product Pipeline For personal use only 10 Investor Presentation April 2018
Slide 11: Orthopaedic – Bone Marrow Lesions
Orthopaedic – Bone Marrow Lesions PPS – The first effective treatment for bone marrow lesions For personal use only What are bone marrow lesions (BMLs)? Bone marrow lesions are the accumulation of interstitial fluid or inflammation within the bone marrow Typically occur as a consequence of a dir
Slide 12: Acute Injuries – Bone Marrow Lesions
Acute Injuries – Bone Marrow Lesions For personal use only Bone marrow lesions as a result of an acute injury BMLs occur as a consequence acute injuries where the bone sustains strong impact, such as a ruptured ACL Addressable market based on acute Resolution of the BML, reduces inflammation and
Slide 13: Osteoarthritis with Bone Marrow Lesions
Osteoarthritis with Bone Marrow Lesions Osteoarthritis - A blockbuster indication with no effective treatments For personal use only Osteoarthritis and bone marrow lesions BML are commonly associated with OA and have been linked to early onset of OA and joint cartilage degeneration. 1 OA Market Fa
Slide 14: Osteoarthritis with BML: The Market for ZILOSUL
Osteoarthritis with BML: The Market for ZILOSUL® ZILOSUL® has the potential to fill the current gap in osteoarthritis treatment options For personal use only There is currently no effective treatment for osteoarthritis and BMLs that treats the underlying pathology of the disease. Current therapi
Slide 15: TGA Special Access Scheme – Real World Evidence – 45 patients treated
Osteoarthritis with Bone Marrow Lesions For personal use only TGA Special Access Scheme – Real World Evidence – 45 patients treated All patients (median age of 57.6 years - range 31 to 84 years) had pain and failed current standard of care - analgesics, NSAIDs or corticosteroids. At six weeks after
Slide 16: OA/BML – Patients treated via TGA SAS
OA/BML – 45 Patients treated via TGA SAS Before and after scores for knee pain (NRS) and knee function (LKS) For personal use only Pain (NRS) Before – After = 3.1 p<0.0001 Function (LKS) Before – After = 23.5 p<0.0001 50% reduction in knee pain 64% improvement in knee function Paired Profiles for (N
Slide 17: OA with BML: Clinical Timeline
OA with BML: Clinical Timeline Comprehensive clinical pathway to commercialisation For personal use only OA/BMEL case study published in peer reviewed scientific journal Successful completion of the Phase 2a open label clinical trial Trial demonstrated the safety, tolerability and efficacy of
Slide 18: Viral Arthritis – Alphavirus
Viral Arthritis – Alphavirus No approved treatment for severely debilitating viral infection For personal use only Viral Arthritis Alphavirus infections result in the clinical symptoms of joint and muscle pain, fever and joint inflammation. Ross River Virus (RRV) and Chikungunya (CHIKV) are mosq
Slide 19: Viral Arthritis: Clinical Timeline
Viral Arthritis: Clinical Timeline Potential to gain Orphan status, resulting in fast-tracked clinical development For personal use only Pre-clinical studies have been conducted by the Institute of Glycomics at Griffith University. The results suggested that: PPS significantly alleviated the sev
Slide 20: Clinical Pipeline
Clinical Pipeline Paradigm hosts a deep clinical pipeline For personal use only Indication(s) Clinical Status Market Size Inflammatory bowel disease (“IBD”) Inflammatory Bowel Disease Cancer-related cachexia Safety and efficacy confirmed in IL-1RA Peptide Phase 1/2 clinical trial (n:26) Medicine
Slide 21: Peer Comparison
Peer Comparison Attractive investment given low risk development and large market opportunity For personal use only Paradigm appears undervalued compared to similar stage, drug repurposing peers given its platform for successful development, secure industrial scale manufacturing and the size of it
Slide 22: Global Big Pharma Interest
Global Big Pharma Interest Recent transactions highlight big pharma interest in BMEL/OA, Heart failure and IBD For personal use only Date ↓ Target Acquirer Deal value (US$) Relevance Galapagos licensed GLPG1972, a potential disease- $346m modifying oral therapy for osteoarthritis to Servier Jul -
Slide 23: Share Price Catalysts
Share Price Catalysts Upcoming milestones should drive strong shareholder returns For personal use only Additional OA with BML RWE results ACL/BMEL Complete Phase 2b placebo controlled OA clinical trial (100 patients) with trial results OA/BMEL Read Out targeted for Q4 CY2018 Phase 2 trials Ad
Slide 24: Contacts
Contacts For personal use only Office Level 2, 517 Flinders Lane, Melbourne, VIC, 3000 info@paradigmbiopharma.com Managing Director & CEO Paul Rennie - prennie@paradigmbiopharma.com Chief Scientific Officer Dr Ravi Krishnan – rkrishnan@paradigmbiopharma.com Corporate Advisor Baker Young Stockbrokers
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