Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Investor Presentation (October 2018)
29 slides from Paradigm Biopharmaceuticals's investor presentation, Oct 25, 2018
Slide 1: Investor Presentation
For personal use only Investor Presentation Paul Rennie, CEO & MD 25 October 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: Executive Summary
Executive Summary • Paradigm Biopharmaceuticals Ltd (PAR) is an ASX-listed biotechnology company focused on For personal use only repurposing Pentosan Polysulfate Sodium (PPS), an FDA-approved drug that has a long track record of safely treating inflammation and dissolving blood clots over sixty yea
Slide 4: Potential Share Price Catalysts / Newsflow
Potential Share Price Catalysts / Newsflow There is potential for significant news flow in the short term (<6 months) post capital raising For personal use only OA Phase 2b trial results released – mid December 2018 Further release of up to 75 patients OA data under the TGA special access scheme
Slide 5: Corporate Snapshot
Corporate Snapshot For personal use only Financial information Share price (22-October-2018) A$0.73 Number of shares 126.2m 1.10 12 Month Share Price Performance Market capitalisation A$92.1m 0.90 Pro-forma Cash (Sept) inc R&D Rebate* ~A$10.5m Pro-forma Enterprise value ~A$81.6m 0.70 *September cash
Slide 6: 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 7: 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 8: Pentosan Polysulfate Sodium (PPS)
Pentosan Polysulfate Sodium (PPS) 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
Slide 9: Opioid Epidemic – Demand for New Treatments
Opioid Epidemic – Demand for New Treatments For personal use only What is the Opioid Epidemic? The opioid epidemic is a crisis throughout North America that involves the widespread use of prescription painkillers and subsequent popularity of illegal opioids, resulting in unprecedented addiction an
Slide 10: 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 11: Osteoarthritis with BMEL: The Market for ZILOSUL
Osteoarthritis with BMEL: The Market for ZILOSUL® ZILOSUL® (the renamed PPS) has the potential to fill the current gap in osteoarthritis treatment For personal use only options There is currently no effective treatment for osteoarthritis and BMELs that treats the underlying pathology of the diseas
Slide 12: 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 13: Long Term IP Protection
Long Term 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 recent patents
Slide 14: Osteoarthritis with Bone Marrow Edema Lesions
Osteoarthritis with Bone Marrow Edema Lesions For personal use only TGA Special Access Scheme – Real World Evidence – 125 patients treated All patients (median age of 57.8 years - range 31 to 84 years) had pain and failed current standard of care - analgesics, NSAIDs or corticosteroids. At six weeks
Slide 15: OA/BML – First Patients treated via TGA SAS
OA/BML – First 125 Patients treated via TGA SAS A Paired t-test was used to compare the before and after scores for knee For personal use only pain (NRS) and knee function (LKS). Pain (NRS) Before – After = 3.2 p<0.0001 Function (LKS) Before – After = 25.1 p<0.0001 51.5 % reduction in knee pain 69.1
Slide 16: Peer Comparison
Peer Comparison Attractive investment given low risk development and large market opportunity For personal use only Ticker and Market Clinical stage of key Addressable market Peer exchange cap (A$m) Rationale product size Marketing a slow release corticosteroid that is US$4.6bn+ injected into the kn
Slide 17: Global Big Pharma Interest
Global Big Pharma Interest Recent transactions highlight big pharma interest in BMEL/OA and Heart failure For personal use only Date ↓ Target Acquirer Deal value (US$) Relevance Galapagos licensed GLPG1972, a potential disease- $346m modifying oral therapy for osteoarthritis to Servier Jul - 17
Slide 18: Flexion Case Study (FLXN.NASDAQ)
Flexion Case Study (FLXN.NASDAQ) Flexion is marketing a slow-release corticosteroid for the treatment of OA in the knee. For personal use only • • 6x increase in valuation to A$1.4bn post meeting Ph2 endpoints in April 2016. Also received big pharma interest. $1.30b Win FDA approval expect Sanofi in
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: 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 21: Capital Raising Details
For personal use only CAPITAL RAISING DETAILS 21 Investor Presentation August 2018
Slide 22: Capital Raising Use Of Funds
Capital Raising Use Of Funds Two Tranche Placement to Professional and Sophisticated investors of A$9.0m at $0.68 per For personal use only share which represents a 19.2% discount to the 30 day VWAP. Amount Comments • Engage consultants early for IND submission to FDA for Osteoarthritis – regulatory
Slide 23: Offer Timetable
Offer Timetable For personal use only Trading halt Tuesday, 23 October 2018 Placement bids due 5pm Tuesday, 23 October 2018 Offer announced and Company resumes trading Thursday, 25 October 2018 Settlement of New Shares issued under Placement Tranche 1 Wednesday, 31 October 2018 Allotment of New Shar
Slide 24: Appendix
For personal use only APPENDIX 24 Investor Presentation August 2018
Slide 25: Orthopaedic – Bone Marrow Edema Lesions
Orthopaedic – Bone Marrow Edema Lesions PPS – The first effective treatment for bone marrow edema lesions For personal use only What are bone marrow edema lesions (BMELs)? Bone marrow edema lesions are the accumulation of interstitial fluid or inflammation within the bone marrow Typically occur
Slide 26: Acute Injuries – Bone Marrow Edema Lesions
Acute Injuries – Bone Marrow Edema Lesions For personal use only Bone marrow edema lesions as a result of an acute injury BMELs 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 BMEL, reduces in
Slide 27: Osteoarthritis with Bone Marrow Edema Lesions
Osteoarthritis with Bone Marrow Edema Lesions Osteoarthritis - A blockbuster indication with no effective treatments For personal use only Osteoarthritis and bone marrow edema lesions BMEL are commonly associated with OA and have been linked to early onset of OA and joint cartilage degeneration. 1
Slide 28: 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 Safety and efficacy confirmed in IL-1RA Peptide Cancer-related cachexia Phase 1/2 clinical trial (n:26) Medicine
Slide 29: Contacts
Contacts For personal use only Office Level 2, 517 Flinders Lane, Melbourne, VIC, 3000 +61 3 9629 5566 info@paradigmbiopharma.com Managing Director & CEO Paul Rennie - prennie@paradigmbiopharma.com Chief Scientific Officer Dr Ravi Krishnan – rkrishnan@paradigmbiopharma.com 29 Investor Presentation A
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