Slide 1: Invion Limited Investor Presentation March 2015
For personal use only Invion Limited (ASX:IVX) Clinical-stage life sciences company targeting chronic inflammation Investor Presentation March | 2015
Slide 2: Overview
Overview For personal use only 1. Revised strategy > To position company for near term strategic partnership or trade sale 2. New funding arrangements > Conclusion of facility with The Australian Special Opportunity Fund > New R&D Tax rebate debt facility with Metamor Capital Partners > Further supp
Slide 3: Strategy update
Strategy update For personal use only Strategic streamlining of operations > Refocus on core activities required to achieve key near to mid-term milestones and value-drivers. > These include: > completion of enrolment and dosing and receipt of data in the phase II clinical trial of INV103 (ala-Cpn10
Slide 4: Funding arrangements
Funding arrangements For personal use only Share Purchase & Convertible Security agreement (SPCSA) with The Australian Special Opportunity Fund (ASOF) > As part of the update to strategy, the Company has mutually agreed to conclude the SPCSA with ASOF, effective on 24 March 2015. The existing conver
Slide 5: Capital raising overview
For personal use only Capital raising overview Placement and underwritten non-renounceable entitlement offer
Slide 6: Offer overview
Offer overview Offer Details For personal use only > A Placement to institutional and sophisticated investors of approximately 35.8 million shares at an Offer Price of 2.5 cents per new ordinary share to raise approximately $895,000 to be followed by Entitlement Offer to existing shareholders target
Slide 7: Estimated use of funds
Estimated use of funds $000’s For personal use only Mar-Aug 2015 Opening cash 1.009 Capital raising * 4.976 R&D Tax Rebate funding facility 1.489 Other income 0.405 Total funds available 7.880 Outflows Program spend in INV103 (ala-Cpn10) ** 0.628 Program spend in INV102 (nadolol) ** 2.625 Program sp
Slide 8: Timetable
Timetable For personal use only Activity Date Announcement of the Placement and Entitlement Offer 20 March 2015 Mailing of the Entitlement Offer details 23 March 2015 Ex-date 24 March 2015 Record Date for Entitlement Offer (7.00pm (Sydney time)) 26 March 2015 Information Booklet and Entitlement & Ac
Slide 9: Pro forma Balance Sheet
Pro forma Balance Sheet 31-Dec-14 Placement Entitlement 31-Dec-14 Historical Offer Pro forma For personal use only Notes to the Pro Forma Balance Sheet: Historical Pro Forma Adjustments $ $ $ $ The Pro Forma Historical Financial Current Assets Information has been derived from the Cash and cash equi
Slide 10: Company overview and key milestones
For personal use only Company overview and key milestones Invion: targeting inflammation
Slide 11: Invion: targeting inflammation
Invion: targeting inflammation For personal use only > Global life sciences group in pharmaceutical drug development > Expertise and assets target chronic inflammation in two key areas of human health: > inflammatory airways disease (respiratory disease) > inflammation caused by autoimmune disease >
Slide 12: Invion's assets
Invion’s assets For personal use only Respiratory > INV102 (nadolol): a beta blocker (beta adrenergic biased ligand) currently used to treat high blood pressure, coronary chest pain (angina) and migraine, is being repurposed to treat chronic inflammatory airway diseases (e.g. asthma and COPD). > INV
Slide 13: Pipeline
Pipeline For personal use only Formulation ………….. ………….. ………….. Research Phase I Phase II development and clinical feasibility Oral INV102 (nadolol) Asthma NIH funded Smoking cessation Inhaled INV102 (nadolol) Asthma COPD Cystic Fibrosis Inhaled INV104 (zafirlukast) Asthma INV103 (ala-Cpn10) Lupus (
Slide 14: Recent INV102 (nadolol) milestones and clinical data
Recent INV102 (nadolol) milestones and clinical data For personal use only > Phase II smoking cessation trial blind-broken interim data released Jan 15. Clinically relevant changes in four biomarkers of inflammation demonstrated: > IL-8, a powerful chemoattractant for inflammatory cells, was stable
Slide 15: Targeting chronic inflammatory airway disease
For personal use only Targeting chronic inflammatory airway disease INV102 (nadolol) INV104 (zafirlukast)
Slide 16: Spectrum of airway disease and opportunities
Spectrum of airway disease and opportunities For personal use only Global market size: $34B $2.4B $1.2B Exercise Mild Moderate Severe Chronic Smoker’s Cystic Induced Asthma Asthma Asthma Bronchitis Cough Fibrosis Asthma INV104 (zafirlukast) INV102 (nadolol) Monotherapy + combinations Monotherapy + c
Slide 17: The critical role of the epithelium in severe airway disease
The critical role of the epithelium in severe airway disease Normal respiratory epithelium Severe asthma For personal use only Chronic bronchitis Cystic fibrosis 17
Slide 18: INV102 reverses epithelial changes in pre-clinical studies
INV102 reverses epithelial changes in pre-clinical studies For personal use only Control lung tissue Lung tissue of ‘asthmatic’ mice: epithelial Lung tissue of ‘asthmatic’ mice treated cells have been converted to mucus- with INV102 (nadolol) for 28 days: producing goblet cells. No effect of restore
Slide 19: INV102 reverses epithelial changes via inhibition of the beta-arrestin pathway
INV102 reverses epithelial changes via inhibition of the beta-arrestin pathway For personal use only > INV102 development is based on the science of Richard A. Bond PhD, Professor of Pharmacology, U Houston. In collaboration with nobel-prize winning Robert Lefkowitz, Dr Bond undertook studies on the
Slide 20: Respiratory therapeutics: oral program
For personal use only Respiratory therapeutics: oral program INV102 (nadolol)
Slide 21: Oral INV102: emerging phase II clinical data
Oral INV102: emerging phase II clinical data Phase II asthma trial (NIMA): interim analysis For personal use only > Randomised, placebo-controlled, 60 patient clinical trial in patients with mild asthma > High % of patients (> 90%) tolerated titration to maximum possible dose without severe adverse
Slide 22: Respiratory therapeutics: inhaled program
For personal use only Respiratory therapeutics: inhaled program INV102 (nadolol) in asthma, COPD & cystic fibrosis INV104 (zafirlukast) in asthma
Slide 23: Inhaled INV102: program status
Inhaled INV102: program status For personal use only > Collaboration with 3M Drug Delivery systems > Target outcome: proprietary formulation and device using 3M’s proprietary pressurised metered dose inhalation (pMDI) technology > Collaboration encompasses manufacture for toxicology and phase I stud
Slide 24: Inhaled INV104: program status
Inhaled INV104: program status For personal use only > First inhaled non-steroidal anti-inflammatory drug for asthma > Ongoing collaboration to develop proprietary formulation and device > Largely risk mitigated development based on chemistry, inhaled toxicology and inhaled proof of concept studies
Slide 25: Targeting chronic inflammation caused by autoimmune disease
For personal use only Targeting chronic inflammation caused by autoimmune disease INV103 (ala-Cpn10)
Slide 26: INV103 phase II lupus trial: interim blinded data
INV103 phase II lupus trial: interim blinded data For personal use only > Double-blind, randomised, placebo-controlled clinical trial in lupus patients. Up to 40 subjects in up to 5 cohorts (8 patients per cohort), increasing dose and increasing disease severity. Doses 10mg, 30mg, 100mg, 300mg > Dat
Slide 27: Invion: key milestones next 6-8 months
Invion: key milestones next 6-8 months For personal use only 1H 2015 Blind-broken interim data from phase II smoking cessation trial Completion of enrolment of INV102 oral (nadolol) in smoking cessation > Pre-IND status for inhaled INV102 (nadolol) as a potential therapy for asthma, COPD & cysti
Slide 28: Key risks for investors
Key risks for investors Funding risk – the development of the respiratory franchise which includes progress to phase III clinical For personal use only > trials for oral INV102 (nadolol) in smoking cessation; plus the development of two inhaled drugs (INV102 & INV104) are the primary drivers of cash
Slide 29: Key risks for investors
Key risks for investors Toxicology – in parallel with clinical trials, Invion will continue to test its product candidates in animal For personal use only > species under controlled conditions governed by Good Laboratory Practices (GLP) and its equivalent regulations under the International Committe
Slide 30: Corporate snapshot
Corporate snapshot For personal use only Sector Life Sciences (Biotechnology) Principal activities Clinical-stage pharmaceutical drug development Pipeline 3 drug assets, multiple clinical and pre-clinical programs Operations Australia & USA ASX code IVX Share price (11-Mar-15) $0.039 (3.9 cents) Sha
Slide 31: Disclaimer
For personal use only Disclaimer • The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Invion Limited ACN 094 730 4
Slide 32: Contact
For personal use only Dr Greg Collier Managing Director and CEO Invion Limited GPO Box 1557 Brisbane, QLD, 4001 Australia P: +61 7 3295 0500 E: greg.collier@inviongroup.com W: www.inviongroup.com Investor Presentation March | 2015