Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Shareholder Meeting (November 2018)
23 slides from Paradigm Biopharmaceuticals's shareholder meeting presentation, Nov 26, 2018
Slide 1: 2018 AGM Presentation
2018 AGM Presentation Paul Rennie, CEO & MD 26 November 2018
Slide 2: Disclaimer
Disclaimer 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 has been prepared by th
Slide 3: Corporate Overview
Corporate Overview Paradigm Biopharmaceuticals Ltd is an ASX-listed Financial information - post $9m placement biotechnology company focused on repurposing Share price (21-November-2018) A$0.88 pentosan polysulfate sodium (PPS), an FDA-approved Number of shares (post $9m placement) 136.4m drug tha
Slide 4: Investment Highlights
Investment Highlights • Focus on repurposing PPS (under the name ZILOSUL®) to treat Osteoarthritis (OA) – 31 million sufferers in the US alone – Large Market with unmet Need for new treatments • iPPS is expected to be a more effective, safer, lower cost and longer term alternative to steroids and op
Slide 5: Drug Repurposing Strategy
Drug Repurposing Strategy Much lower cost, accelerated timeline, lower risk and with higher rates of success 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, which accelerates th
Slide 6: Board and Management
Board and Management High quality Board and management, with top-tier pharmaceutical experience 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.ASX) Extensive expe
Slide 7: Pentosan Polysulfate Sodium – Supply & License
Pentosan Polysulfate Sodium – Supply & License 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 orthopaedic (inc. alphavirus
Slide 8: IP Protection
IP Protection Multi-faceted IP protection increases barriers to entry for potential competitors 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 - i.e. 2035 BMEL patent granted
Slide 9: Broad Product Pipeline
Broad Product Pipeline 9 AGM Presentation November 2018
Slide 10: The AGM – The Company Scoreboard
The AGM – The Company Scoreboard 10 AGM Presentation November 2018
Slide 11: Milestones achieved - CY2017
Milestones achieved - CY2017 BME Milestones for CY2017 Additional Milestones Achieved CY2017 Close-out open-labelled acute BME study Q2 Twenty-Four Doctor’s patients with advanced 2017. ✓ Results Q4 CY2017 or Q1 CY 2018 OA treated with PPS under the TGA SAS. ✓ 83% response rate to reduction in pain;
Slide 12: Milestones achieved - CY2018
Milestones achieved - CY2018 OA/BMEL Milestones for CY2018 Additional Milestones Achieved CY2018 Complete Phase 2b randomised, double-blind Successfully treated AFL stars: Andrew Walker placebo-controlled clinical trial in subjects with and Greg ‘Diesel’ Williams ✓ osteoarthritis and concurrent BMEL
Slide 13: Milestones for CY2019
Milestones for CY2019 Milestones for CY2019 Phase 3 OA/BMEL Clinical Trial: • Plan/Design • File Investigational New Drug (IND) Application • Activate multiple sites (across US) • Initiate recruitment (Assuming Phase 2b success) Initiate Compassionate Use program with NFL ‘Pro Players Elite Network’
Slide 14: Opioid Epidemic – Demand for New Treatments
Opioid Epidemic – Demand for New Treatments What is the Opioid Epidemic? The opioid epidemic is a crisis throughout North America and now in Australia, that involves the widespread use of prescription painkillers and subsequent popularity of illegal opioids, resulting in Prescription opioid overdo
Slide 15: Osteoarthritis with BMEL: The Market for ZILOSUL®
Osteoarthritis with BMEL: The Market for ZILOSUL® ZILOSUL® has the potential to fill the current gap in osteoarthritis treatment options There is currently no effective treatment for osteoarthritis and BMELs that treats the underlying pathology of the disease. Current therapies treat the symptom
Slide 16: 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 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% improvement in knee
Slide 17: Paradigm to Treat Elite Athletes in the US
Paradigm to Treat Elite Athletes in the US Heads of Agreement with the Pro Players Elite Network Paradigm has executed a Heads of Agreement (HoA) to form a partnership with the Pro Players Elite Network (PPEN) to assist with commencing treatment of US based sportspeople under the FDA Expanded Access
Slide 18: OA with BMEL: Clinical Timeline
OA with BMEL: Clinical Timeline Comprehensive clinical pathway to commercialisation 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 ZILOSUL® in patients
Slide 19: Viral Arthritis: Clinical Timeline
Viral Arthritis: Clinical Timeline Potential to gain Orphan status, resulting in fast-tracked clinical development Pre-clinical studies have been conducted by the Institute of Glycomics at Griffith University. The results suggested that: − PPS significantly alleviated the severity of disease and r
Slide 20: Global Big Pharma Interest
Global Big Pharma Interest Recent transactions highlight big pharma interest in BMEL/OA and Heart failure Date ↓ Target Acquirer Deal value (US$) Relevance Galapagos licensed GLPG1972, a potential disease- $346m modifying oral therapy for osteoarthritis to Servier Jul - 17 GLPG1972 is a potent a
Slide 21: 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. • 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 Talks to $570 per Dos
Slide 22: Potential Share Price Catalysts / Newsflow
Potential Share Price Catalysts / Newsflow There is potential for significant news flow in the 1-12 months OA Phase 2b trial results released – mid/late December 2018 Further release of up to 50 patients OA data under the TGA special access scheme (by end of CY18) Progression of the newly in-l
Slide 23: Contacts
Contacts 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 23 AGM Presentation November 2018
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