Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — Shareholder Meeting (November 2016)
23 slides from Paradigm Biopharmaceuticals's shareholder meeting presentation, Nov 30, 2016
Slide 1: AGM
For personal use only AGM Paul Rennie, CEO & MD 30 November, 2016
Slide 2: 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 3: Company Overview
Company Overview For personal use only Financial information Top shareholders2,3 Shares (m) % Share price (29-Nov-16) A$0.42 Paul Rennie (Managing Director) 21.24 21.1% Number of shares1 100.3m MJGD Nominees (technology vendor) 6.9 6.9% Market capitalisation A$42.1m Other Board and management 7.1 7.
Slide 4: 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 5: 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 6: 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 7: The AGM – the Company Scoreboard
The AGM – the Company Scoreboard For personal use only 7 AGM 30 November, 2016
Slide 8: Company Scoreboard – Milestones achieved for 2016
Company Scoreboard – Milestones achieved for 2016 For personal use only Milestones Achieved 1. US Patent granted for treatment of Bone Marrow Edema with PPS; 2. Ethics Approval for Open Label Pilot Phase 2 Bone Marrow Edema clinical trial; 3. 1st Patient treated under the Open Label Pilot Bone Marro
Slide 9: Company Scoreboard – Bonus Runs: Additional Milestones Achieved 2016
Company Scoreboard – Bonus Runs: Additional Milestones Achieved 2016 For personal use only Additional Milestones Achieved New acute injury BME clinical trial centre initiated. Ten BME patients treated under Therapeutic Goods Administration (TGA) Special Access Scheme (SAS). This has created interest
Slide 10: 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 11: 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; Ten participants treated under the Phase 2 clinical trial; C
Slide 12: Company Scoreboard – BME Milestones for 2017
Company Scoreboard – BME Milestones for 2017 For personal use only BME Milestones for 2017 Close-out open-labelled acute BME study Q2 2017 Commence pilot randomised, double-blind placebo-controlled osteoarthritis study (total n=20) Commence pilot randomised, double-blind placebo-controlled rheumatoi
Slide 13: 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 14: Hay Fever: Clinical Timeline
Hay Fever: Clinical Timeline For personal use only Paradigm is on track with clinical development timeline and expenditure Nasal formulation, intra-nasal toxicology and Phase 1 clinical trial complete. Ethics and Swedish Regulatory approval. Participant screening and recruitment has commenced.
Slide 15: Company Scoreboard – Respiratory Milestones for 2017
Company Scoreboard – Respiratory Milestones for 2017. For personal use only Respiratory Milestones for 2017 Complete Phase 2 clinical trial with read-out Q3 2017. Commence commercial partnership opportunities. Product development for a new product to treat other allergic conditions. 15 AGM 30 Novemb
Slide 16: 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 17: Viral Arthritis – Alphavirus
Viral Arthritis – Alphavirus For personal use only Chikungunya: The Agony Virus A mosquito-borne virus has made the jump from Africa to the Americas, and it combines rapid transmission with searing pain. So swat that skeeter—or you may live to regret it Laura Beil September 11, 2014 Chikungunya viru
Slide 18: Viral Arthritis – Alphavirus
Viral Arthritis – Alphavirus For personal use only Global emergence of Alphaviruses that cause arthritis in humans. • Lwande OW et al . Infect Ecol Epidemiol. 2015 Dec 18;5:29853. doi: 10.3402/iee.v5.29853. Pentosan Polysulphate: A Novel Glycosaminoglycan-Like Molecule for Effective Treatment of Alp
Slide 19: Viral Arthritis: Clinical Timeline
Viral Arthritis: Clinical Timeline For personal use only Potential to gain Orphan status, resulting in fast-tracked clinical development Preclinical studies have been conducted by the Institute of Glycomics at Griffith University. The results suggested that: PPS significantly alleviated the seve
Slide 20: Company Scoreboard – Alphavirus Milestones for 2017
Company Scoreboard – Alphavirus Milestones for 2017 For personal use only Alphavirus Milestones for 2017 Commence Ross River Phase 2 clinical trial (Planning has commenced) Commence Chikungunya Phase 2 clinical trial (Brazil) (Planning has commenced). 20 AGM 30 November, 2016
Slide 21: 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 22: 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 2 trial Potential to expand to OA and RA HAY FEVER Publicatio
Slide 23: 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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