Invion Ltd. · ASX:IVX
Invion — Investor Presentation (September 2012)
27 slides from Invion's investor presentation, Sep 11, 2012
Slide 1: ASX Media Announcement: Investor Presentation September 2012
ASX / MEDIA ANNOUNCEMENT 11 September 2012 For personal use only INVESTOR PRESENTATION – SEPTEMBER 2012 Australian drug development company Invion Limited (ASX:IVX) is pleased to provide the attached company presentation to investors. About Invion Limited Invion Limited is a clinical-stage drug deve
Slide 2: Clinical-stage drug development company targeting chronic inflammation
ASX:IVX For personal use only Clinical-stage drug development company targeting chronic inflammation Dr William Garner, CEO 11 September 2012 Disclaimer: This presentation does not constitute an offer to sell or a solicitation of an offer to buy any interests in Invion Limited. Any such offering wil
Slide 3: Invion: a merger of peers
Invion: a merger of peers For personal use only 30 August 2012, shareholders approve scrip-based merger of CBio Limited and Inverseon Inc. to create Invion Limited ASX-listed, Brisbane-based Private, San Francisco-based ~ $5.5M cash and commitments ~ $4.4M NIH grant at merger close Cpn10 IP and clin
Slide 4: Invion business model mitigates risk
Invion business model mitigates risk For personal use only • Two phase II proprietary therapeutic candidates that target chronic inflammation From Inverseon: INV102 (repurposed inverse beta agonist) From CBio: Cpn10 (modified natural immunomodulator) • Clinical-stage company with risk significan
Slide 5: Complementary approaches to chronic inflammation: INV102
Complementary approaches to chronic inflammation For personal use only INV102: existing drug repurposed for a new target • Scientific founder defined the field of (beta adrenergic) Inverse Agonism • Issued patent with new IP applications • Chemistry and toxicology complete for oral delivery (lead pr
Slide 6: Complementary approaches to chronic inflammation: Cpn10
Complementary approaches to chronic inflammation For personal use only Cpn10: immunomodulator • Strong IP position with issued patents for Cpn10 composition • Pre-clinical proof of concept in industry-standard models of chronic inflammatory diseases • Chemistry (CMC) and toxicology support 3 months
Slide 7: Invion pipeline 2012
Invion pipeline 2012 For personal use only Research Phase I Phase II Oral INV102 Smoking cessation* Asthma NIH funded Cpn10 Lupus (SLE) Inhaled INV102 Chronic bronchitis Cystic fibrosis NCE development Beta-2 adrenergic inverse agonist Academic alliance *Smoking cessation in patients with chronic br
Slide 8: Invion pipeline 2012-2015
Invion pipeline 2012-2015 For personal use only 2012 2013 2014 2015 Oral INV102 Smoking cessation Phase IIa Proof of principle Phase IIb/phase III NDA submission Asthma Phase II Phase II Partner Phase III (partner) Cpn10 Lupus (SLE) Submit IND to FDA Phase IIa Partner Phase IIb/phase III Inhaled INV
Slide 9: Experienced Board and Management
Experienced Board and Management For personal use only William J. Garner MD, CEO EGB Advisors, Roche, Founder of Urigen and DelMar Pharmaceuticals Serially successful founder and executive Mitchell Glass MD, EVP R&D and CMO 24 year veteran of Pharma (AZ, GSK) and Biotech (AGIX) Managed more
Slide 10: INV102 (nadolol)
INV102 (nadolol) A beta blocker repurposed for obstructive inflammatory lung disorders For personal use only • Nadolol: An inverse -agonist non-selective beta blocker (1 and 2) indicated for the treatment of high blood pressure, migraine headaches and chest pain INV102 (nadolol) is a syntheti
Slide 11: INV102 intellectual property
INV102 intellectual property For personal use only • First patent issued 2009 • Airway Disease Issued Patent: “ Method of Treating Airway Diseases with Beta Adrenergic Inverse Agonists” US Patent #7,528,175 Issued May 5, 2009 divisional filing in 2009 for additional claims covers inhaled and
Slide 12: INV102 precedent: parallel pharmacology of heart failure and obstructive lung disease
INV102 precedent: Parallel pharmacology of congestive heart failure and obstructive lung disease use only Congestive Heart Failure COPD (asthma and chronic bronchitis) β-Inverse Agonist β-Inverse Agonist β-Agonist Contraindicated β-Agonist Contraindicated For personal for >25 years for >25 years ACU
Slide 13: Metaplasia of lung epithelial cells
Metaplasia of lung epithelial cells For personal use only • Healthy airway consists of mostly Airspace ciliated epithelial cells with Airway surface smaller numbers of (secretory) liquid goblet cells • With chronic insults, the proportion of goblet cells Ciliated epithelia Goblet cell increases, lin
Slide 14: Airway healing: effect of oral INV102
Airway healing: effect of oral INV102 For personal use only Control lung tissue Lung tissue of ‘asthmatic’ mice - Lung tissue of asthmatic mice epithelial cells have been treated with -adrenergic converted to mucus producing inverse agonist INV102 for goblet cells 28days: restored epithelium No ef
Slide 15: Demonstrated positive dose response in phase IIa trial
Demonstrated positive dose response in phase IIa trial For personal use only Objective: proof-of-concept to evaluate safety and effects on airway with escalating doses administered to 19 subjects with mild asthma Primary endpoint: objective measure of airway hyper- responsiveness (PC20 MeChFEV1), th
Slide 16: Development strategy
Development strategy For personal use only • Oral INV102 could be approved/partnered in < 36 months chronic bronchitis (COPD) patients with chronic cough have difficulty quitting smoking (indication) and increased post-operative complications (indication) INV102 can be added to standard of care
Slide 17: Oral INV102 for patients with chronic bronchitis
Oral INV102 for patients with chronic bronchitis: smoking cessation and reduced peri-operative complications For personal use only • Rationale: INV102 can treat underlying cause of chronic cough and mucus secretion which are a major barrier to smoking cessation and cause of peri-operative complicati
Slide 18: Respiratory inflammation market
1. Respiratory Inflammation market $64B+ For personal use only • Smoking-Cessation Drug Market worth $2.4B in 20122. • Large COPD /Asthma drug market, valued at ~$34B1. ® • Advair Diskus , approved for asthma and COPD, ($8.1B peak annual sales) 3. ® • Singulair , approved for asthma ($5.5B peak annu
Slide 19: Cpn10 overview
Cpn10 overview For personal use only • Potential new anti-inflammatory biologic therapeutic • Strong patent position covering composition of matter and trade secrets • Novel mechanism: effect on inflammatory markers is different to current leading therapies, i.e. immune response is dampened not abla
Slide 20: Cpn10 intellectual property
Cpn10 intellectual property For personal use only • Composition of matter patent granted drug candidate human Ala-Cpn10 2026 in USA, 2023 in Europe, Japan, etc potential extension up to 5 years in most jurisdictions • Composition of matter claims on numerous Cpn10 variants pending in all maj
Slide 21: Cpn10 in systemic lupus erythematosus
Cpn10 in systemic lupus erythematosus (“lupus”) For personal use only • As a molecule that reduces pro-inflammatory cytokine production Cpn10 has potential utility across a range of indications • Analysis of therapeutic potential, clinical need and commercial attractiveness identified lupus as appro
Slide 22: Cpn10: lupus development plan
Cpn10: lupus development plan For personal use only • Target: Under-served lupus market, only 1 drug approved by FDA in 50 years • Regulatory: file US IND (2H12) • Plan: Chemistry: re-qualify existing material for IND IV formulation • Assessment: Toxicology: package adequate for lupus IV dosing • Cl
Slide 23: Potential value drivers
Potential value drivers For personal use only Oral INV102: Asthma phase II results (and potential phase III program) Approvable package in chronic bronchitis (smoking cessation & peri-operative complications) Oral INV102: Proof of concept results in short Inhaled INV102: term use in chronic bronchit
Slide 24: Company Snapshot
Company Snapshot For personal use only Sector Biotechnology Principal activities Clinical-stage drug development ASX code IVX Last trade (7 Sep 2012) $0.063 (6.3cents) Shares on issue 384,531,941 Market cap (7 Sep 2012) $24.2 million Major shareholders Dr William Garner 16.4% Dr Mitchell Glass 3.6%
Slide 25: Activities to watch
Activities to watch For personal use only 2H 2012 ― Initiation of phase II study in asthma ― Initiation of phase II study in patients with chronic bronchitis undergoing smoking cessation ― Pre-IND meeting with FDA re: Cpn10 in lupus ― Filing of IND for Cpn10 in lupus* 1Q 2013 ― Initiation of lupus c
Slide 26: Invion: summary
Invion: summary For personal use only 1. Clinical-stage company targeting inflammation 2. Two primary clinical assets: INV102 and Cpn10 and multiple clinical-stage programs 3. Management team who have taken drugs through FDA 4. Opportunities for expansion within three years 5. Mitigated risk 25
Slide 27: For personal use only
For personal use only Managing Director & CEO Investor & Media Relations Dr William Garner Buchan Consulting william.garner@invion.com.au rwilson@buchanwe.com.au tdonovan@buchanwe.com.au Corporate and Financial Melanie Farris, Company Secretary Invion Limited melanie.farris@invion.com.au 2/120 Blues