Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Non-Deal Roadshow (May 2017)
24 slides from Paradigm Biopharmaceuticals's roadshow presentation, May 15, 2017
Slide 1: Paradigm Non-Deal Roadshow Presentation (ASX Release)
For personal use only ASX RELEASE 15 May2017 Paradigm Non-Deal Roadshow Presentation Paradigm Biopharmaceuticals Ltd (ASX:PAR) updates its Corporate Presentation. Over the next few weeks, Paradigm management will be conducting a number of investor meetings, the updated presentation can be found belo
Slide 2: Non-deal Roadshow Presentation
For personal use only Non-deal Roadshow Presentation Paul Rennie, CEO & MD 15 May, 2017
Slide 3: Company Highlights
Company Highlights For personal use only Repurposing a pre-approved drug to treat conditions associated with inflammation in a safer way Repurposing reduces clinical risk and costs, whilst accelerating commercialisation Pentosan Polysulfate Sodium (PPS) is a new, multi-acting treatment for hay
Slide 4: 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$28m compared to US$1.3bn for “de novo” development1 Faster: FDA 505(b)(2) pathway leveraging previous clinical efforts, wh
Slide 5: Company Overview
Company Overview For personal use only Financial information Top shareholders2,3 Shares (m) % Share price (15-May-17) A$0.585 Paul Rennie (Managing Director) 21.2 21.1% Number of shares1 101.5m MJGD Nominees (technology vendor) 6.9 6.9% Market capitalisation A$59.4m Other Board and management 7.1 7.
Slide 6: 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 7: 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 8: 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 Addressable market for hay fever: allergen is inhaled by a sensitised individual Why focus on hay fever?
Slide 9: 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 acquired by Mylan for US$7.2B/A$9.5B), developing a new class of dual acting treatment
Slide 10: Peer Reviewed Scientific Publication - In vitro studies
Peer Reviewed Scientific Publication - In vitro studies showing PPS binds to key inflammatory Th2 cytokines For personal use only PPS shown as a potent Th2 cytokine-binding molecule with biological neutralization capacity and broad anti-inflammatory effects PPS demonstrated a strong binding affi
Slide 11: Peer Reviewed Scientific Publication - Preclinical Model
Peer Reviewed Scientific Publication - Preclinical (Guinea Pig / Astra Zeneca) Model For personal use only After OVA challenge (allergen), total leukocyte, eosinophil and neutrophil numbers in the nasal lavage fluid were inhibited by PPS and budesonide (Astra Zeneca Rhinocort) PPS significantly
Slide 12: Phase 2 Hay Fever Challenge Study
Phase 2 Hay Fever Challenge Study For personal use only Lund University Sweden (ex-Astra Zeneca Respiratory Facility) Established model for AR – used by Big Pharma Nasal Symptom Scores (am, pm, 10 including Astra Zeneca to trial AR drugs minute) AR Patients (pollen) in “Off Season” Peak Insp
Slide 13: Hay Fever: Clinical Timeline
Hay Fever: Clinical Timeline Paradigm is on track with clinical development timeline For personal use only and expenditure Nasal formulation, intra-nasal toxicology and Phase 1 clinical trial – complete Ethics and Swedish Regulatory approval – complete Participant screening and recruitment – c
Slide 14: 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 15: BME: Clinical Timeline
BME: Clinical Timeline For personal use only Status update 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; 10 participants already treated under the Phase 2 open label c
Slide 16: Preclinical study published in peer-reviewed journal
Preclinical study published in peer-reviewed journal (Journal of Virology) For personal use only 15 Non-deal Roadshow Presentation 15 May, 2017
Slide 17: Viral Arthritis – Alphavirus
Viral Arthritis – Alphavirus No approved treatment for severely debilitating virus infection For personal use only What is 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) a
Slide 18: Viral Arthritis – Alphavirus
Viral Arthritis – Alphavirus Ross River Virus For personal use only The Ross River virus could become a global epidemic on the same scale as the Zika virus, Australian researchers warn. APP February 22, 2017 Chikungunya: The Agony Virus A mosquito-borne virus has made the jump from Africa to the Ame
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 Preclinical studies have been conducted by the Institute of Glycomics at Griffith University. The results suggested that: − PPS significantly alleviated the seve
Slide 20: 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 21: 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 22: Global Interest in Respiratory and BME
Global Interest in Respiratory and BME Recent transactions highlight big pharma interest in respiratory and BME spaces For personal use only Merck & Co (MSD) acquisition of Afferent for US$1.25B (inc milestones) Mylan’s takeover offer of Meda in 2016 was at a 92% premium to last close and Dymist
Slide 23: Share Price Catalysts
Share Price Catalysts For personal use only Upcoming milestones should drive strong shareholder returns HAY FEVER Publication of comparator study in “Allergy” expected in Q2 CY17 Initiating human Phase 2 ‘allergen challenge’ results in late June 2017 trials Potential interest from Big Pharma p
Slide 24: 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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