Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Investor Presentation (April 2019)
40 slides from Paradigm Biopharmaceuticals's investor presentation, Apr 15, 2019
Slide 1: Phase 2b Secondary Endpoints Met & $77.9M Capital Raising
PHASE 2B SECONDARY ENDPOINTS MET & $77.9M CAPITAL RAISING • OBJECTIVE MRI/BML DATA • ACTIVITIES OF DAILY LIVING • KOOS PAIN DAY 165 Paul Rennie, CEO & MD 15 April 2019
Slide 2: Disclaimer
DISCLAIMER IMPORTANT: Confidential information This document has been prepared by Paradigm Biopharmaceuticals Ltd (known as “Paradigm”, “Paradigm Biopharma” or the “Company”) in relation to the Company's proposed placement of new ordinary shares in Paradigm (the “New Shares”) as further described in
Slide 3: Disclaimer: Forward-looking statements
DISCLAIMER Forward-looking statements Certain statements made in this document are forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements are not historical facts but rather a
Slide 4: Disclaimer: International offer restrictions
DISCLAIMER International offer restrictions The distribution of this document (including an electronic copy) in the United States and other jurisdictions outside Australia may also be restricted by law and any such restrictions should be observed. Persons who come into possession of this document wh
Slide 5: Executive Summary
EXECUTIVE SUMMARY Paradigm Biopharmaceuticals Ltd (PAR.ASX) is an 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. Initial focus is on repurposing PPS (un
Slide 6: Corporate Snapshot
CORPORATE SNAPSHOT Financial information Top Shareholders Shares (m) % Share price (8-April-2019) A$1.98 Paul Rennie (Managing Director) 21.6 15.4% Number of shares 140m Other Board and management 7.1 5.1% Number of Options 6.2m Irwin Biotech (technology vendor) 6.3 4.5% Market capitalisation MJGD N
Slide 7: Background on Pentosan Polysulfate Sodium (PPS)
BACKGROUND ON PENTOSAN POLYSULFATE SODIUM (PPS) PPS has a long safety history and is currently being sold in the US and Europe Pentosan Polysulfate Sodium Excellent Safety Profile Pentosan polysulfate sodium (PPS) is a semi-synthetic drug PPS has a well established safety profile with no reporte
Slide 8: 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 Minimum life on patents is 2030 and beyond for more recent patents - i.e. BMEL paten
Slide 9: 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 10: 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 11: Blockbuster Potential US Market Revenue p.a.
BLOCKBUSTER POTENTIAL US MARKET REVENUE P.A Key Assumptions: 31m OA sufferers in the US Annual dosing/treatment – assumed 12 month duration of effect as observed in TGA special access scheme Indicative and potential pricing of US$2-3k per treatment MARKET PENETRATION (31m OA sufferers) 10% 20%
Slide 12: 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 Anti-NGF Global US$250m US$1.25bn Phase 3 Corticosteroid Global Take-over* US$1.0bn* Commercial
Slide 13: 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 14: OA Phase 2b Trial Results Primary & Secondary Endpoints Met
OA PHASE 2B TRIAL RESULTS PRIMARY & SECONDARY ENDPOINTS MET 14 Secondary Endpoints and Capital Raising Presentation – April 2019
Slide 15: Phase 2b OA/BML Clinical Trial – Secondary Endpoints
PHASE 2B OA/BML CLINICAL TRIAL – SECONDARY ENDPOINTS iPPS demonstrated efficacy on both Objective and Subjective and Measures OBJECTIVE DATA MEASURES OUTCOME 1. Reduction in Bone Marrow Edema lesions determined by MRI – NEW DATA Achieved SUBJECTIVE DATA MEASURES OUTCOME 2. A mean change in KOOS pa
Slide 16: Summary – Phase 2b Data – PPP NRS 4-6
SUMMARY – PHASE 2B DATA – PPP NRS 4-6 (PHASE 3 TARGET POPULATION) 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<0.0
Slide 17: Bone Marrow Lesions: 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 18: Phase 2b Objective Data – Reduction in BML Volume (Total Population)
PHASE 2B OBJECTIVE DATA – REDUCTION IN BML VOLUME (TOTAL POPULATION) PPP Total Population: The median of the percentage change from Baseline: BML Volume in Knee BML Volume in Knee (PPP Total Population) 10% The median of the % Change 5% in Volume from Baseline 0% BML Volume is a 3D -5% analysis of t
Slide 19: Phase 2b Objective Data – Reduction in BML Area (Total Population)
PHASE 2B OBJECTIVE DATA – REDUCTION IN BML AREA (TOTAL POPULATION) PPP Total Population: The median of the percentage change from Baseline: BML Area in Knee BML Area in Knee (PPP Total Population) 15% The median of the % Change 10% 5% BML Area in Knee is in Area from Baseline 0% a 2D analysis of a -
Slide 20: Phase 2b Objective Data – Reduction in BML Volume (PPP NRS 4-6)
PHASE 2B OBJECTIVE DATA – REDUCTION IN BML VOLUME (PPP NRS 4-6) PPP NRS 4-6 – The median of the percentage change from Baseline: BML Volume in Knee BML Volume in Knee (PPP NRS 4-6) 40.0% 30.0% 20.0% The median of the % Change in Volume from Baseline BML Volume is a 3D 10.0% analysis of the total 0.0
Slide 21: Phase 2b Objective Data – Reduction in BML Area (PPP NRS 4-6)
PHASE 2B OBJECTIVE DATA – REDUCTION IN BML AREA (PPP NRS 4-6) PPP NRS 4-6 – The median of the percentage change from Baseline: BML Area in Knee BML Area in Knee (PPP NRS 4-6) 20.0% 15.0% The median of the % Change 10.0% BML Area in Knee is in Area from Baseline 5.0% a 2D analysis of a MRI, to determ
Slide 22: Mean Change in KOOS Pain Score from Baseline
MEAN CHANGE IN KOOS PAIN SCORE FROM BASELINE Improvement In the PPP Total Population and PPP NRS 4-6 Stratum Paradigm demonstrated a statistically significant mean change in KOOS Pain from Baseline versus Placebo at day 39 and day 53 A mean change in KOOS Pain from Baseline greater than 10 is
Slide 23: Greater Than 50% Reduction in KOOS Pain from Baseline (PPP NRS 4-6)
GREATER THAN 50% REDUCTION IN KOOS PAIN FROM BASELINE (PPP NRS 4-6) PPP NRS 4-6: Proportion of subjects with at least 50% reduction in KOOS pain score from Baseline 60 50 Treatment Period P<0.026 Percentage of Subjects P<0.021 40 P<0.0496 30 20 10 0 11 25 39 53 81 109 165 Days iPPS Placebo Statist
Slide 24: Clinically Meaningful Improvement in Physical Function – KOOS ADL
CLINICALLY MEANINGFUL IMPROVEMENT IN PHYSICAL FUNCTION – KOOS ACTIVITIES OF DAILY LIVING What is KOOS Activities of Daily Living (Secondary Endpoint)? KOOS Activities of Daily Living (ADL) is a secondary endpoint and measures physical function while performing daily activities. It includes 17 di
Slide 25: KOOS Activities of Daily Living (PPP Total Population)
CLINICALLY MEANINGFUL IMPROVEMENT IN PHYSICAL FUNCTION – KOOS ACTIVITIES OF DAILY LIVING (PPP TOTAL POPULATION) PPP Total Population - iPPS shows improvement in Activities of Daily Living compared to Placebo p = 0.006 In PPP Total Population iPPS demonstrated a statistically significant mean perce
Slide 26: KOOS Activities of Daily Living (PPP NRS 4-6)
CLINICALLY MEANINGFUL IMPROVEMENT IN PHYSICAL FUNCTION – KOOS ACTIVITIES OF DAILY LIVING (PPP NRS 4-6) PPP NRS 4-6 - iPPS shows improvement in Activities of Daily Living compared to Placebo Mean % Change in ADL from Baseline Mean from Day 11 to Day 165 (PPP NRS 4-6) 50 45 p=0.0001 Mean % Change from
Slide 27: Phase 2b OA/BML Trial – Primary Endpoints Previously Reported
PHASE 2B OA/BML CLINICAL TRIAL – PRIMARY ENDPOINTS PREVIOUSLY REPORTED 18 DECEMBER 2018. 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); Mean Change in KOOS pain score from Baseline – Total Population an
Slide 28: Capital Raising & Potential Newsflow
CAPITAL RAISING & POTENTIAL NEWSFLOW 28 Secondary Endpoints and Capital Raising Presentation – April 2019
Slide 29: Capital Raising Structure
CAPITAL RAISING STRUCTURE A$77.9m capital raising at A$1.50 per share comprising A$51.6m Placement to Sophisticated and Professional investors under Listing Rule 7.1 and 7.1a A$26.3m 1 for 8 Fully Underwritten Accelerated Entitlement Offer to existing eligible shareholders. Placement shares will
Slide 30: Use of Funds
USE OF FUNDS A$77.9m anticipated to fund the Company’s OA and MPS programs through to end of their pivotal phase 3 studies and new drug applications. A$82.0m cash position post capital raising will put the Company in a strong negotiating position on commercial transaction. $ Amount Comments • Comp
Slide 31: Anticipated and Potential Catalysts & News Flow
ANTICIPATED AND POTENTIAL CATALYSTS & NEWS FLOW Successful OA Phase 2b trial secondary endpoints released with capital raising Ongoing partnering discussions with big pharma Release of scientific journal detailing mechanism of action via NGF – Q2 2019 Appointment of highly regarded US based
Slide 32: Indicative Timetable
INDICATIVE TIMETABLE Release of OA Phase2b Secondary Endpoints Pre-Market Monday 15 April 2019 Trading Halt Monday 15 April – Tuesday 16 April 2019 Company resumes trading and Offer announced Wednesday 17 April 2019 Record date for eligibility under the Entitlement Offer Settlement of New Shares iss
Slide 33: Risk Factors
Risk Factors This section outlines some (but not all) of the key risks associated with an investment in Paradigm. Paradigm’s assets and business is subject to a number of risk factors both specific to its assets / business and of a general nature which may impact on its future performance and foreca
Slide 34: Risk Factors Continued
Risk Factor Continued Economic Risks: Paradigm is exposed to economic factors in the ordinary course of business. A number of economic factors / conditions, both domestic and global, affect the performance of financial markets generally, which could affect the price at which Paradigm Shares trade on
Slide 35: Risk Factors Continued
Risk Factors Continued Intellectual Property risks: Securing rights in technology and patents is an integral part of securing potential product value in the outcomes of biotechnology research and development. Competition in retaining and sustaining protection of technology and the complex nature of
Slide 36: Risk Factors Continued
Risk Factors Continued Commercial Risk: Paradigm may, from time to time, consider acquisition, licensing, partnership or other corporate opportunities for Paradigm’s product development programs. There can be no assurance that any such acquisition, licensing, partnership or corporate opportunities c
Slide 37: International Offer Restrictions
INTERNATIONAL OFFER RESTRICTIONS This document does not constitute an offer of New Shares 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 New Shares may not be offered or sold, in any country outside Austral
Slide 38: International Offer Restrictions
INTERNATIONAL OFFER RESTRICTIONS Singapore This document and any other materials relating to the New Shares have not been, and will not be, lodged or registered as a prospectus in Singapore with the Monetary Authority of Singapore. Accordingly, this document and any other document or materials in co
Slide 39: International Offer Restrictions
INTERNATIONAL OFFER RESTRICTIONS United States This document does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States. The New Shares have not been, and will not be, registered under the US Securities Act of 1933 and may not be offered or sold in th
Slide 40: Thank You
THANK YOU 40 Results Presentation Secondary Endpoints and Capital Raising Presentation – April 2019
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