Slide 1: Invion Limited Corporate Presentation
For personal use only Invion Limited (ASX:IVX) Clinical-stage life sciences company targeting chronic inflammation Corporate Presentation October | 2013
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 > INVION: 3 drug candidates in development > INV102 (nadolol): beta blocker being repurposed to treat asthma, COPD, cystic fibrosis, and smoking cessation failures > INV104 (zafirlukast): inhaled anti-leukotriene that reduces inflammation, constri
Slide 4: Management team with proven track record
Management team with proven track record For personal use only Invion’s management and board have significant experience repurposing drugs for new markets, and guiding drugs through FDA regulatory and approval processes. Greg Collier, PhD., Managing Director and Chief Executive Officer > 20 year car
Slide 5: Targeting respiratory disease
For personal use only Targeting respiratory disease Asthma, COPD, chronic bronchitis, cystic fibrosis
Slide 6: Respiratory diseases: major and growing problem
Respiratory diseases: major and growing problem For personal use only Asthma > Up to 400M people worldwide will suffer from asthma by 2025 > Prevalence increasing with rates of allergy > Exercised induced asthma is a specific diagnosis related to exercise or exposure to cold air > Economic cost $56B
Slide 7: Large market opportunity, significant unmet need
Large market opportunity, significant unmet need For personal use only > Prescription respiratory world market $64B > Asthma and COPD prescription drugs $34B > FDA Black box warning on all Long Acting Respiratory world market Beta Agonists (LABAs) and LABA/Steroid combinations: increased risk of dea
Slide 8: Invion's respiratory strategy
Invion’s respiratory strategy Invion's respiratory portfolio is designed to treat a range of hereditary and acquired For personal use only respiratory disorders, leveraging synergies and efficiencies in the development cycle Chronic inflammatory lung disease – respiratory disease Hereditary Acquired
Slide 9: Respiratory pipeline: clinical development stages
Respiratory pipeline: clinical development stages For personal use only Preclinical Phase I Phase II INV102 (nadolol) Asthma Oral therapy Chronic bronchitis Oral therapy (smoking cessation in patients with pre-existing COPD) COPD Inhaled monotherapy Asthma Inhaled combination therapy Inhaled monothe
Slide 10: INV102 (nadolol)
For personal use only INV102 (nadolol) Targeted to treat causes, symptoms and sequelae of inflammatory lung disease
Slide 11: INV102 (nadolol)
INV102 (nadolol) For personal use only > Generic drug being repurposed for a new target > Suite of patents granted and in prosecution > Aim to develop an inhaled drug for the treatment of respiratory diseases including asthma and COPD > Short term path to commercialisation with oral treatment > Nado
Slide 12: 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 13: Mechanism of action targets multiple pathways
Mechanism of action targets multiple pathways For personal use only Mucous plug > Reduction of goblet cell metaplasia > Reduced mucous hypersecretion > Restoration of ciliated epithelium > Reduced levels of pro-inflammatory cytokines: IL-5, IL-10, IL-13 > 50% reduction in eosinophils Healing INV102
Slide 14: 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 15: Completed two phase II clinical trials: POC
Completed two phase II clinical trials: POC 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), the diagnostic
Slide 16: FDA meeting chair quote on beta blockers and LABAs
For personal use only “There might be a way to bring in beta blockers in low-level use in asthmatics. If that turns out to be right, then LABAs might become obsolete.” Professor Eric Swenson, Acting FDA Meeting Chair on LABA Safety, March 10-11, 2010. Extract from Last chance on LABAs, BioCentury, 2
Slide 17: INV102: phase II trial design – mild asthma
INV102: phase II trial design – mild asthma Trial name INV102 (nadolol) in mild asthma (NIMA) For personal use only Trial design Double-blinded, randomised, placebo-controlled, multi-centre Patients 60 subjects (30 subjects in each of two treatment arms) Timing Commenced Q1 2013 Expected completion
Slide 18: INV102: phase II trial design – chronic bronchitis
INV102: phase II trial design – chronic bronchitis Trial name INV102 (nadolol) in smoking cessation of patients with pre-existing COPD For personal use only Trial design Double-blinded, randomised, placebo-controlled Patients 130 (65 per arm: 54 needed for analysis) Timing Commenced Q3 2013 Initial
Slide 19: INV104 (zafirlukast)
For personal use only INV104 (zafirlukast) Inhaled reformulation of a successful oral therapeutic for asthma
Slide 20: INV104 (zafirlukast)
INV104 (zafirlukast) For personal use only > Leukotriene Receptor Antagonist (LTRA) or anti-leukotriene > Targeted as first inhaled non-steroidal anti-inflammatory treatment for asthma > Established activity by inhalation route with excellent flow and deposition (MDI and DPI) > Large market potentia
Slide 21: Mechanism of action
Mechanism of action For personal use only Zafirlukast is a leukotriene receptor antagonist (LTRA) that blocks the action of the cysteinyl leukotrienes on the CysLT1 receptors to reduce: >inflammation >airway constriction >mucus Genetics and pharmacogenetics of the leukotriene pathway Journal of Alle
Slide 22: Respiratory pipeline: clinical development stages
Respiratory pipeline: clinical development stages For personal use only Preclinical Phase I Phase II INV102 (nadolol) Asthma Oral therapy Chronic bronchitis Oral therapy (smoking cessation in patients with pre-existing COPD) COPD Inhaled monotherapy Asthma Inhaled combination therapy Inhaled monothe
Slide 23: Respiratory: milestones to watch
Respiratory: milestones to watch For personal use only Asthma > INV102: Oral phase II study NIH funded ($4M+ non-dilutive) commenced Q1 2013 > Initial data on airway histology and sputum biomarkers anticipated Q1 2014 > Complete phase II data anticipated 2015 > Target outcomes: improve airway hyper-
Slide 24: Respiratory: milestones to watch
Respiratory: milestones to watch For personal use only Asthma & COPD > INV102: Inhaled formulation and delivery to commence Q1 2014 > Preclinical studies due to complete Q3 2014 > Phase II study to commence Q2 2015 Cystic fibrosis > INV102: Inhaled formulation and delivery to commence Q1 2014 > Prec
Slide 25: Targeting autoimmune disease
For personal use only Targeting autoimmune disease Inflammation caused by an over-active immune system
Slide 26: Autoimmune disease
Autoimmune disease For personal use only > Chronic disabling disorders in which underlying defects in the immune response lead the body to attack its own organs and tissues > More than 80 autoimmune diseases have been identified, most common include: > systemic lupus erythematosus (SLE or Lupus) > m
Slide 27: INV103 (ala-Cpn10)
For personal use only INV103 (ala-Cpn10) Modified natural human protein targeting inflammatory disease
Slide 28: INV103 (ala-Cpn10)
INV103 (ala-Cpn10) For personal use only > Modified natural human protein targeting inflammatory disease > Demonstrated anti-inflammatory and immunoregulatory activity in multiple indications > Activity ideally suited to the treatment of inflammation associated with autoimmune disease > Data to date
Slide 29: 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 30: INV103: phase II clinical strategy
INV103: phase II clinical strategy For personal use only Systemic lupus erythematosus (SLE or lupus) > Lupus is a vascular inflammatory disease > IL-6 is a marker of vascular inflammation > INV103 has a significant effect on IL-6 > Pre-IND meeting with US FDA Q4 2012 > FDA confirmed lupus as importa
Slide 31: Lupus: market size, global pipeline, continued unmet need
Lupus: market size, global pipeline, continued unmet need For personal use only Lupus market size ($millions) 4000 3000 2000 1000 0 2007 2011 2020 Lupus market growth drivers • Major unmet clinical need • FDA approval of Belimumab (Benlysta) in 2011 – first lupus drug approval in 50 years • Will inc
Slide 32: INV103: phase II trial design – lupus
INV103: phase II trial design – lupus Trial name INV103 (ala-Cpn10) in mildly active Systemic Lupus Erythematosus (lupus) For personal use only Trial design Double-blinded, randomized, placebo-controlled, intravenous dosing Patients 32 subjects (8 subjects per dose cohort, 4 cohorts) Timing Commence
Slide 33: INV103: phase II milestones
INV103: phase II milestones For personal use only Lupus > Q4 2013 completion of 1 or 2 cohorts > biochemical evidence of efficacy; safety of increased doses > driver for scale manufacture of INV103 > driver for clinically outcome-based dose-ranging in lupus 33
Slide 34: Summary
For personal use only Summary 3 drug assets with multiple paths to market 3 FDA-regulated phase II clinical trials experienced management team significant valuation drivers: 12-36 months
Slide 35: Milestones to watch
Milestones to watch For personal use only 2013 Q1 Asthma - phase II study in asthma initiated, enrollments and patient dosing underway Q2 Lupus - IND filed with FDA Lupus - commencement of phase II study Q3 Chronic bronchitis (smoking cessation) – commencement of phase II study Licence agr
Slide 36: Corporate snapshot
Corporate snapshot For personal use only Sector Life Sciences (Biotechnology) Principal activities Clinical-stage pharmaceutical drug development Pipeline 3 drug candidates Operations Australia & USA ASX code IVX Share price (24-Oct-13) $0.095 (9.5 cents) Shares on issue ~463M Options on issue ~31M
Slide 37: 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 October | 2013
Slide 38: References
References For personal use only Respiratory Market World Health Organization Report: Global surveillance, prevention and control of chronic respiratory diseases (2007); DataMonitor: R&D Trends: COPD (2012); Respiratory and Inflammation, AstraZeneca Annual Report (2012); Smoking Cessation Drugs: Wor