Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Shareholder Meeting (November 2019)
25 slides from Paradigm Biopharmaceuticals's shareholder meeting presentation, Nov 7, 2019
Slide 1: Annual General Meeting (AGM) Investor Update
PARADIGM BIOPHARMACEUTICALS LTD (ASX: PAR) ANNUAL GENERAL MEETING (AGM) INVESTOR UPDATE Paul Rennie, CEO & MD 7 November 2019
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: Executive Summary
EXECUTIVE SUMMARY Paradigm Biopharmaceuticals Ltd (PAR.ASX) is a late stage ASX-listed biotechnology company focused on repurposing Pentosan Polysulfate Sodium (PPS), an FDA-approved drug that has a long track record of safely treating inflammation over sixty years Our main focus is on repurposi
Slide 4: Executive Summary
EXECUTIVE SUMMARY Zilosul has also been granted FDA approval under the Expanded Access Program (EAP) to treat 10 patients First 10 patients are all ex-NFL players suffering OA – treatment begins Dec 2019 In Australia we are seeking Provisional Approval with the TGA prior to completing phase 3
Slide 5: Corporate Snapshot
CORPORATE SNAPSHOT Financial information Top Shareholders Volume Shares (m) % Share price (6-NOV-2019) A$2.80 Paul Rennie 23.4m 12.12% Number of shares 193m Number of Options 5.2m Other Board and Management 7.45m 3.86% Market capitalisation A$538m Citicorp Nominees 7.78m 4.03% Cash Mar-19 A$75.4m JP
Slide 6: Background on Pentosan Polysulfate Sodium (PPS) / Zilosul
BACKGROUND ON PENTOSAN POLYSULFATE SODIUM (PPS) / ZILOSUL Pentosan Polysulfate Sodium Excellent Safety Profile Pentosan polysulfate sodium (PPS) is a semi-synthetic drug PPS has a well established safety profile with no reported manufactured from beech-wood hemicellulose serious adverse events
Slide 7: Strong Patents & IP Position
STRONG PATENTS & IP POSITION 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 EU patents granted for BMEL, respiratory diseases Minimum life on patents is 2030 an
Slide 8: Exclusive Supply & Manufacturing
EXCLUSIVE SUPPLY & MANUFACTURING Exclusive Supply PPS Buy per/kg License Exclusivity Royalty Paradigm has executed a long term exclusive supply Agreement grants exclusive supply of only FDA agreement with bene pharmaChem Gmbh & Co. KG approved PPS for Paradigm’s orthopaedic and Bene pharmaChem
Slide 9: Market Demand – OA Stages and Treatments
MARKET DEMAND – OA STAGES AND TREATMENTS There are no effective treatments for Moderate to Severe OA Effective Non-validated Ineffective Analgesics, NSAIDS, Corticosteroids Opioids *Platelet-rich Plasma, *Stem Cells, *Royal Australian College of General Practitioners hold a ‘strong against’ recommen
Slide 10: Blockbuster Potential Revenue p.a.
BLOCKBUSTER POTENTIAL REVENUE P.A US MARKET – aiming for approval 2021 Key Assumptions: 10% 20% 30% 31m OA sufferers in the US Market Penetration Market Penetration Market Penetration 3m OA sufferers in Aus US$1.5k p.a US$6.2bn p.a US$12.4bn p.a US$18.6bn p.a INDICITATIVE Annual dosing/treatme
Slide 11: Deals – Global Big Pharma Interest in OA
DEALS – GLOBAL BIG PHARMA INTEREST IN OA Recent transactions highlight big pharma interest in OA Safety Issues COMPANIES COMPOUND REGION UPFRONT TOTAL VALUE STATUS Anti-NGF Global US$200m US$1.8bn Phase 3 (Failed) Anti-NGF Global US$250m US$1.25bn Phase 3 Corticosteroid Global Take-over* US$1.0bn* C
Slide 12: Successful Re-purposed Drugs
SUCCESSFUL RE-PURPOSED DRUGS Re-purposed drugs have become true blockbusters BRAND ORIGINAL PHARMA PEAK ANNUAL NEW INDICATION NAME INDICATION COMPANY SALES SPRAVATO Anaesthetic (Ketamine) Treatment Resistant Depression Janssen/J&J Approved March 2019 Structural Analogue of REVLIMID Multiple Myeloma
Slide 13: OA Phase 2b Trial Results Primary & Secondary Endpoints Met
OA PHASE 2B TRIAL RESULTS PRIMARY & SECONDARY ENDPOINTS MET ASX: PAR CORPORATE UPDATE & AGM 7/11/2019
Slide 14: Summary Phase 2b Data – PPP NRS 4-6
SUMMARY PHASE 2B DATA – PPP NRS 4-6 CLINICALLY MEANINGFUL - % of subjects with >50% reduction STRUCTURAL CHANGES - Median % Change from Baseline: in KOOS pain from BL- (PPP NRS 4-6) BMEL Volume in Knee (PPP NRS 4-6) 60 40.0% Percentage of Subjects 30.0% 50 P<0.026 P<0.021 20.0% 40 P<0.0496 10.0% 30
Slide 15: Bone Marrow Lesions (BML): Clinical Implications for Knee OA
BONE MARROW LESIONS (BML): CLINICAL IMPLICATIONS FOR KNEE OA AND DISEASE REGRESSION WITH iPPS THERAPY BML appear as increased signal intensity within the bone marrow INCREASING PAIN1 INCREASED CARTILAGE LOSS2 HIGH RISK OF JOINT DESTRUCTION3 Grade 3 medial tibial BML at baseline HIGH RISK OF TOTAL KN
Slide 16: iPPS as a cartilage-protective agent potentially blocks progression of KOA
iPPS as a cartilage-protective agent potentially blocks the progression of KOA: Reduction in serum COMP and ADAMTS-5 in KOA Mean % change of biomarker levels from • COMP: mean percentage reduction of 11.9% baseline at Day 53 from baseline at Day 1 to Day 53 in the iPPS 15 treatment group vs increase
Slide 17: Phase 2b OA/BML Clinical Trial – Primary and Secondary Endpoints
PHASE 2B OA/BML CLINICAL TRIAL – PRIMARY AND SECONDARY ENDPOINTS • Clinical trial met the primary endpoint - change in the KOOS pain score from baseline at Day 53 for the total trial population (p < 0.0001); • Number of subjects with a >50% Reduction from Baseline in KOOS Pain Score at Day 53 – Clin
Slide 18: Mechanism of Action: Reduction of NGF as mediator of Pain
Mechanism of Action: Reduction of NGF as mediator of Pain PPS downregulate NGF expression in Osteocytes Knee OA patients Confocal microscopy images showing NGF protein A: untreated B: +TNF-α expression (red) by freshly harvested human osteocytes compared (A, B, C) with isotype control IgG immunostai
Slide 19: MPS
MPS ASX: PAR CORPORATE UPDATE & AGM 7/11/2019 AGM INVESTOR UPDATE NOVEMBER 2019
Slide 20: Achievements Since $77M Capital Raising in April 2019
ACHIEVEMENTS SINCE $77M CAPITAL RAISING IN APRIL 2019 Mechanism of Action established and peer reviewed in scientific journal Release of exploratory endpoints from phase 2b trial – reduction in key OA biomarkers Expansion of team for regulatory approvals and pivotal trials – 5 new staff hired
Slide 21: Catalysts & News Flow
CATALYSTS & NEWS FLOW Further release of patient results for treatment of OA under the TGA special access scheme - imminent Results of meeting for provisional approval of Zilosul with TGA – end 2019 Potential for approval to begin selling in Australia Potential for first revenues in Q3 2020
Slide 22: AGM Business
AGM BUSINESS ASX: PAR CORPORATE UPDATE & AGM 7/11/2019 AGM INVESTOR UPDATE NOVEMBER 2019
Slide 23: The AGM – the Company Scoreboard
The AGM – the Company Scoreboard ASX: PAR CORPORATE UPDATE & AGM 7/11/2019
Slide 24: 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…
Slide 25: Milestones for CY2020
Milestones for CY2020 Milestones for CY2020 Initiate Compassionate Use program with NFL ‘Pro Players Elite Network’ Peer review publication of Phase 2a Viral Arthritis clinical trial. Phase 3 OA/BMEL Clinical Trial: • Commence Phase 3 Clinical Trial in USA Phase 2/3 MPS Clinical Trial: • Commence Ph
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