Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Non-Deal Roadshow (June 2016)
22 slides from Paradigm Biopharmaceuticals's roadshow presentation, Jun 20, 2016
Slide 1: ASX Release: Investor roadshow presentation
ASX RELEASE For personal use only Investor roadshow presentation 20 June 2016, Melbourne, Australia: Paradigm Biopharmaceuticals Limited (ASX: PAR) (Paradigm or Company) wishes to advise that the following investor roadshow presentation will be shared with investor groups in Australia this week. - E
Slide 2: Investor roadshow presentation
For personal use only Investor roadshow presentation Paul Rennie, CEO & MD 20 June 2016
Slide 3: Drug repurposing strategy
Drug repurposing strategy For personal use only Much lower cost, accelerated timeline, lower risk and with higher rates of success Lower cost: average development cost of US$8-41m compared to US$1.3bn for “de novo” development1 Faster: FDA 505(b)(2) pathway leveraging previous clinical efforts,
Slide 4: Company highlights
Company highlights For personal use only Repurposing a pre-approved drug to reduce clinical costs and accelerate commercialisation Pentosan Polysulfate Sodium is a new, multi-acting treatment for bone bruising and hay fever, both of which have very large addressable markets (US$13.5bn+) Highly
Slide 5: Operational milestones
Operational milestones For personal use only Paradigm has met all short term deliverables since IPO 18-Aug-15: IPO 23-Nov-15: Bone bruising 15-Dec-15: Respiratory 26-Feb-16: First patient enrolled clinical trial approved patents granted in bone bruising trial Paradigm lists on the ASX Ethics approva
Slide 6: Company overview
Company overview For personal use only Financial information Top shareholders2,3 Shares (m) % Share price (17-Jun-16) A$0.33 Paul Rennie (Managing Director) 21.2 24.6% Number of shares1 87.6m MJGD Nominees (technology vendor) 7.1 8.1% Market capitalisation A$28.9m Other Board and management 7.1 8.1%
Slide 7: Board and management
Board and management For personal use only 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
Slide 8: Pentosan Polysulfate Sodium
Pentosan Polysulfate Sodium For personal use only PPS has a long safety history and is currently being sold in the US and Europe Pentosan Polysulfate Sodium Ideal biological characteristics Pentosan Polysulfate Sodium (PPS) has been used in humans for PPS is an anti-inflammatory and an anti-hist
Slide 9: IP protection
IP protection For personal use only Multi-faceted IP protection increases barriers to entry for potential competitors Valuable patent portfolio Paradigm has patent protection because it is using PPS for BME patent granted in EU patents granted for respiratory diseases incl. new indications USA AR,
Slide 10: Hay fever
Hay fever For personal use only Hay fever is a very common condition that is poorly treated at present What is hay fever (allergic rhinitis)? Allergic inflammation of the nasal airways, when an allergen is Addressable market for hay fever: inhaled by a sensitised individual Why focus on hay fever?
Slide 11: Hay fever: the market for RHINOSUL
Hay fever: the market for RHINOSUL® For personal use only RHINOSUL® has the potential to fill the current gap in hay fever treatment options The hay fever market is changing with new players, like Meda (MEDA.STO, A$9.0bn market cap), developing a new class of dual acting treatments RHINOSUL® is
Slide 12: Hay fever: clinical timeline
Hay fever: clinical timeline For personal use only Paradigm is on track with clinical development timeline and expenditure Paradigm is developing RHINOSUL®, the first intra-nasally applied PPS product to be used humans — Since this would be the first time PPS would be delivered intra-nasally, Para
Slide 13: Bone marrow edema (BME)
Bone marrow edema (BME) For personal use only Currently no approved treatments for bone marrow edema, growing market opportunity What is bone marrow edema (BME or bone bruising)? Bone marrow edema or bone bruising is the accumulation of Addressable market based on acute interstitial fluid or infla
Slide 14: BME: the market for ZILOSUL
BME: the market for ZILOSUL® For personal use only Multi-acting treatment that addresses the underlying pathology of bone bruising Why focus on bone bruising? Untreated BME lesions are 10x more likely to lead to osteoarthritis ‒ BME lesions restrict blood supply to the cartilage in the joint, caus
Slide 15: BME: clinical timeline
BME: clinical timeline For personal use only Opportunity to further accelerate clinical trial development timeline Currently conducting an open label clinical trial investigating the safety, tolerability and efficacy of ZILOSUL® in patients with a bone marrow edema from a recent ACL injury — Open
Slide 16: Bone bruising: elite athlete case study
Bone bruising: elite athlete case study For personal use only Potential to open new market opportunities by treating chronic BME with ZILOSUL® Overview Elite athlete in a major Australian sporting code successfully treated for a chronic orthopaedic injury by ZILOSUL® ‒ Successfully completed pre-s
Slide 17: Undervalued compared to peers
Undervalued compared to peers For personal use only Attractive investment given low risk development and large market opportunity Paradigm appears undervalued compared to similar stage, drug repurposing peers given its platform for successful development, secure industrial scale manufacturing and
Slide 18: Global interest in respiratory and BME
Global interest in respiratory and BME For personal use only Recent transactions highlight big pharma interest in respiratory and BME spaces Mylan’s takeover offer of Meda earlier this year was at a 92% premium to last close and Dymista® is RHINOSUL®’s closest comparative product AstraZeneca’s t
Slide 19: Partnering with Big Pharma
Partnering with Big Pharma For personal use only Paradigm will likely seek to partner with a Big Pharma company in the future Big Pharma continues to acquire and partner with junior biotechs to replenish its R&D pipeline and transactions are done increasingly in the earlier R&D stages Phase I Phas
Slide 20: Enhancing shareholder returns
Enhancing shareholder returns For personal use only Strong ongoing focus on prudent cash management Paradigm maintains a highly specialised and nimble team through effective outsourcing Paradigm’s focus is to use cash for clinical development rather than administration and overheads Paradigm’s
Slide 21: Share price catalysts
Share price catalysts For personal use only Upcoming milestones should drive strong shareholder returns Open label trial anticipated to confirm efficacy together with optimal dosing of BME TRIAL ZILOSUL® and clinical endpoints Phase II(a) trial Potential to bring forward next clinical trial to 3
Slide 22: 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
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