Slide 1: Invion Limited Corporate Presentation
For personal use only Invion Limited (ASX:IVX) Clinical-stage life sciences company targeting chronic inflammation Corporate Presentation April | 2014
Slide 2: Disclaimer
For personal use only Disclaimer This presentation has been prepared by Invion Limited (Invion or the Company) solely for its use at presentations to be made by the Company. The information contained in this presentation is an overview and does not contain all information necessary to make investmen
Slide 3: Invion: targeting inflammation
Invion: targeting inflammation For personal use only > 3 drug candidates in development > Developing two new respiratory franchises > INV102 (nadolol): beta blocker being repurposed to treat inflammatory airway diseases including COPD and cystic fibrosis > INV104 (zafirlukast): anti-leukotriene bein
Slide 4: Management team with proven track record
Management team with proven track record Invion’s management and board have significant experience repurposing drugs for new For personal use only markets and guiding drugs through FDA regulatory and approval processes. Greg Collier, PhD., Managing Director and Chief Executive Officer > 20 year care
Slide 5: Recent capital raise and development collaboration
Recent capital raise and development collaboration allow acceleration of clinical development For personal use only > Collaboration with 3M Drug Delivery systems > Inhalation development expertise > Proprietary formulation and device > Works will assess the feasibility of inhaled INV102 (nadolol) an
Slide 6: Targeting respiratory disease
For personal use only Targeting respiratory disease INV102 (nadolol) - beta adrenergic inverse agonist INV104 (zafirlukast) - leukotriene receptor antagonist
Slide 7: 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 Zafirlukast Nadolol Monotherapy + combinations Monotherapy + combinations 7
Slide 8: INV102 (nadolol)
INV102 (nadolol) Nadolol is uniquely an inverse -agonist in the airway For personal use only > > inactivates intracellular inflammatory events that are stimulated spontaneously or by agonists > Hypothesized to utilize the beta-arrestin pathway > Clinical data to date > Two phase II clinical trial
Slide 9: Severe airway diseases share the phenotype
Severe airway diseases share the phenotype For personal use only Severe asthma COPD Cystic fibrosis 9
Slide 10: Preclinical studies demonstrate airway healing
Preclinical studies demonstrate airway healing 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 restored epithelium
Slide 11: Medical, regulatory and commercial precedent
Medical, regulatory and commercial precedent For personal use only Precedent: Chronic Heart Failure (CHF) FROM TO CONTRAINDICATED STANDARD OF CARE Warning against use of After careful titration, beta blocker beta blockers in CHF for > 25 years. Carvedilol reduced mortality in Carvedilol annual sales
Slide 12: INV102: phase II trial design - mild asthma
INV102: phase II trial design - mild asthma For personal use only INCLUSION ORAL DOSING WITHDRAWAL ENDPOINTS 26wks 4wks Randomised Efficacy Controlled Randomize Nadolol Treatment Improved Clinical Trial Titration & Tolerability Placebo airway hyper- (N=30, 1:1 Placebo: Active) responsiveness Safety
Slide 13: INV102: phase II trial design - smoking cessation
INV102: phase II trial design - smoking cessation For personal use only INCLUSION ORAL DOSING WASHOUT ENDPOINTS 11-15wks 2wks Randomised Primary E (IWRS) 50% Decrease in # of O Nadolol Treatment (n=65) dose Controlled cigarettes per day P Clinical Trial 3wks titration & each during last 28 days II 5
Slide 14: INV102 (nadolol): oral program
INV102 (nadolol): oral program Airway inflammation 1H14 2H14 1H15 Next milestone For personal use only (calendar year) INV102 (nadolol) = beta adrenergic inverse agonist Completion Asthma oral program, ongoing phase II study 2Q15 EOP2 Smoking cessation oral program, phase II interim and final data a
Slide 15: Respiratory therapeutics: inhaled program
For personal use only Respiratory therapeutics: inhaled program INV102 (nadolol) in COPD & cystic fibrosis INV104 (zafirlukast) in asthma
Slide 16: INV102 (nadolol): comparison oral vs inhaled
INV102 (nadolol): comparison oral vs inhaled Target Product Profile For personal use only Oral Inhaled > IP protection: titration and method of use (USA) > IP protection based on 3M formulation and device > Once daily dosing including titration to avoid > Once daily dosing with no need for titration
Slide 17: INV102 (nadolol): inhaled program
INV102 (nadolol): inhaled program Airway inflammation 1H14 2H14 1H15 Next milestone For personal use only (calendar year) INV102 (nadolol) = beta adrenergic inverse agonist Completion Asthma oral program, ongoing phase II study 2Q15 EOP2 Smoking cessation oral program, phase II interim and final dat
Slide 18: INV104 (zafirlukast)
INV104 (zafirlukast) For personal use only > Nanomolar potent Leukotriene Receptor Antagonist (LTRA) or anti-leukotriene > Targeted as first inhaled non-steroidal anti-inflammatory treatment for asthma > Large market potential with mitigated risk of a reformulated drug > Accolate® (zafirlukast) > De
Slide 19: INV104 (zafirlukast): comparison oral vs inhaled
INV104 (zafirlukast): comparison oral vs inhaled Target Product Profile For personal use only Oral (Accolate®) Label Inhaled INV104 (zafirlukast) > Astra Zeneca patent for zafirlukast expired > IP protection based on 3M formulation and device > Twice per day dosing with food effect, suicidal > Once
Slide 20: INV104 (zafirlukast): inhaled program
INV104 (zafirlukast): inhaled program Airway inflammation 1H14 2H14 1H15 Next milestone For personal use only (calendar year) INV102 (nadolol) = beta adrenergic inverse agonist Completion Asthma oral program, ongoing phase II study 2Q15 EOP2 Smoking cessation oral program, phase II interim and final
Slide 21: Targeting inflammatory disease
For personal use only Targeting inflammatory disease INV103 (ala-Cpn10): modified natural human protein
Slide 22: INV103: Mechanism of action
INV103: Mechanism of action For personal use only HSP10 References: Resolution-associated molecular patterns (RAMPs) in the acute inflammatory response. Inflammation initiates the over-expression and release of RAMPs, such as Cpn10 (Hsp10). These help limit and resolve the inflammatory responses via
Slide 23: INV103 (ala-Cpn10): background and rationale
INV103 (ala-Cpn10): background and rationale For personal use only > Minimally modified form of naturally occurring protein > Maintains heptameric structure and function > Intracellular function: prevent protein misfolding > Extracellular function: Cpn10 proposed as a founding member of the Resoluti
Slide 24: INV103: completed clinical trials
INV103: completed clinical trials For personal use only Phase Indication Route Total INV103 Doses patients patients 1a Healthy volunteers IV/SC 19 14 1.2, 5.5, 10mg IV 5mg SC 1b Multiple Sclerosis IV 12 9 2.5 or 5mg, 5 doses 2a Multiple Sclerosis IV 50 39 Placebo, 5mg 2 Ulcerative Colitis IV 8 8 5mg
Slide 25: INV103 (ala-Cpn10): autoimmune program
INV103 (ala-Cpn10): autoimmune program Airway inflammation 1H14 2H14 1H15 Next milestone For personal use only (calendar year) INV102 (nadolol) = beta adrenergic inverse agonist Completion Asthma oral program, ongoing phase II study 2Q15 EOP2 Smoking cessation oral program, phase II interim and fina
Slide 26: INV103: phase II trial design - lupus
INV103: phase II trial design - lupus For personal use only INCLUSION 1 month, twice-weekly dosing of INV103 (ala-Cpn10) or placebo Double-blind Complete analysis of safety, pharmacokinetics, biomarkers Cohort 1 Data provided under confidentiality to potential partners Randomised Controlled 10mg i.v
Slide 27: Pipeline: 12-18 month outlook
Pipeline: 12-18 month outlook Airway inflammation For personal use only INV102 (nadolol) = beta adrenergic inverse agonist Completion Asthma oral program, ongoing phase II study phase II trial complete 2Q15 EOP2 Smoking cessation oral program, phase II interim and final data and EOP2 phase III comme
Slide 28: Summary
For personal use only Summary 3 drug assets with multiple paths to market early partnering opportunity for INV103 (ala-Cpn10) 3 FDA-regulated phase II clinical trials two de-risked novel and proprietary inhaled respiratory assets collaboration with global partner on inhaled franchise exp
Slide 29: 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 (3-Apr-14) $0.075 (7.5 cents) Shar
Slide 30: Dr Greg Collier, Managing Director and CEO
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 Corporate Presentation April | 2014