Slide 1: Invion Limited Investor Presentation
For personal use only Invion Limited (ASX:IVX) Clinical-stage life sciences company targeting chronic inflammation Investor Presentation August | 2015
Slide 2: 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 3: Assets in development
Assets in development For personal use only Respiratory 1. INV102 (nadolol): is a beta blocker (beta adrenergic biased ligand) currently used to treat high blood pressure, coronary chest pain (angina) and migraine, being repurposed to treat chronic inflammatory airway diseases (e.g. asthma and COPD)
Slide 4: 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 5: Targeting chronic inflammatory airway disease: Oral INV102 (nadolol)
For personal use only Targeting chronic inflammatory airway disease Oral INV102 (nadolol)
Slide 6: Treating the airway: background and rationale
Treating the airway: background and rationale For personal use only > Existing drugs do an excellent job in opening constricted airways: bronchodilators include b-adrenergic and anti-muscarinic drug classes > Existing drugs do an excellent job in decreasing inflammatory cells in the airway: inhaled
Slide 7: The vicious cycle of chronic inflammatory airway disease
The “vicious cycle” of chronic inflammatory airway disease Inflammation from: For personal use only - cigarette smoke Increased - chronic infection (C.F.) IL-8 and - allergen, O3 (asthma) beta- + arrestin pathway activity Increased goblet cell Changes in production/ basal cell loss of populations ci
Slide 8: Nadolol has unique properties that could treat airway disease
Nadolol has unique properties that could treat airway disease For personal use only > In cell experiments, INV102 (nadolol): > Blocks the b-arrestin pathway on airway epithelial cell b2 receptors (Lefkowitz) > In animal experiments, nadolol: > Blocks (prevents) or reduces (treats) the increase in go
Slide 9: Nadolol could reverse the vicious cycle of airway inflammation
Nadolol could reverse the “vicious cycle” of airway inflammation Shown in clinical trial For personal use only Nadolol DECREASED IL-8 and + beta- arrestin pathway activity DECREASED goblet cell Restoration production/ of ciliated loss of epithelial ciliated Mucous metaplasia found in cells epithelia
Slide 10: Oral nadolol program: progress and active clinical trials and results
Oral nadolol program: progress and active clinical trials and results Clinical benefits the only drug targeted to address the unmet medical need of mucous metaplasia in the airway For personal use only targeted as an add-on to existing therapies to make them safer and more effective by reducing
Slide 11: Oral nadolol: upcoming analysis and reporting
Oral nadolol: 155 patient phase II smoking cessation study reporting Q315. Leveraging the data: upcoming analysis and reporting For personal use only Third quarter planned analyses and reporting Fourth Quarter Biomarkers Smoking cessation Combined data > Report on effects of nadolol vs placebo > Rep
Slide 12: Oral nadolol: positive endpoint data leads to
Oral nadolol: 155 patient phase II smoking cessation study reporting Q315. For personal use only Positive endpoint data Leads to Oral nadolol program: Smoking Safety Biomarkers end of Phase II meeting cessation with FDA / Phase III > Safety of > Report on > Report on > titration doses No need for +
Slide 13: Oral nadolol: positive endpoint data leads to
Oral nadolol: 155 patient phase II smoking cessation study reporting Q315. For personal use only Positive endpoint data Leads to Oral nadolol program: Smoking Safety Biomarkers end of Phase II meeting cessation with FDA / Phase III > Safety of > Report on > Report on Inhaled nadolol program: > titra
Slide 14: Nadolol franchise: progressively de-risked
Nadolol franchise: progressively de-risked For personal use only oral nadolol inhaled nadolol Data from current Inhaled nadolol is phase II trials in asthma Safety and targeted to treat COPD, and smoking cessation biomarker data asthma and cystic will support the from oral phase II fibrosis. develop
Slide 15: Respiratory therapeutics: inhaled program
For personal use only Respiratory therapeutics: inhaled program INV102 (nadolol) in asthma, COPD & cystic fibrosis
Slide 16: Inhaled nadolol program: progress and clinical development strategy
Inhaled nadolol program: progress and clinical development strategy For personal use only Clinical benefits once daily dosing directly to the site of injury at 1/100 of the oral dose to mitigate systemic side effects targeted for long term use in COPD, severe asthma and cystic fibrosis as an add
Slide 17: 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 18: Nadolol franchise: market size, relevance and interconnectedness
Nadolol franchise: market size, relevance and interconnectedness Chronic Obstructive Pulmonary Disease (COPD) is an umbrella term used to describe For personal use only chronic lung diseases that cause limitations in lung airflow. 18
Slide 19: INV104 (zafirlukast)
For personal use only INV104 (zafirlukast) Target: a novel inhaled non-steroidal anti-inflammatory treatment for asthma
Slide 20: Inhaled reformulation of a successful oral asthma therapeutic
Target: an inhaled reformulation of a successful oral therapeutic for asthma For personal use only INV104 (zafirlukast): > Leukotriene-receptor antagonist (LTRA) or “anti-leukotriene” that reduces inflammation, constriction of the airways, and the build-up of mucus in the lungs > Approved worldwide
Slide 21: Inhaled zafirlukast: background and rationale
Inhaled zafirlukast an anti-leukotriene: background and rationale For personal use only Defined safety Defined CMC profile Airway & nasal Full toxicology 200mcg demonstrated secretions are rich in package completed 12 hour protection LTC4, D4 and E4 Excellent flow using CFC-based Single and multiple
Slide 22: FDA pre-IND framework for reformulation of zafirlukast
FDA pre-IND established framework for reformulation of zafirlukast Agreement reached with FDA on: For personal use only > chemistry manufacturing and controls (GMP) > active pharmaceutical ingredient (API) with drug master file (DMF) > formulation: dry powder inhaler (DPI) approved for development >
Slide 23: Inhaled Product Rationale
Inhaled Product Rationale Oral Inhaled For personal use only Forms Form Risk of neuropsychiatric/suicide ideation events? Risk of liver toxicity ? Greater efficacy due to higher airway concentrations Potential for once a day dosing ? Singulair Potential for expanded EIB claims ? Prevention Only Rapi
Slide 24: Hovione CMC collaboration mitigates major risk
Hovione CMC collaboration mitigates major risk of inhaled zafirlukast development Formulation & device partner, Hovione For personal use only > Invion will collaborate with Hovione to develop the proprietary novel technology – a dry powder formulation of zafirlukast and the accompanying inhalational
Slide 25: About Hovione and the XCaps inhaler
About Hovione and the XCaps inhaler For personal use only > International company with over 50 years’ experience in the development and compliant manufacture of active pharmaceutical ingredients and drug product intermediates > With four FDA inspected sites in the U.S., China, Ireland, and Portugal,
Slide 26: Expected placement of inhaled zafirlukast in treatment regimes
Expected placement of inhaled zafirlukast in treatment regimes > As many as 334 million people have For personal use only asthma which occurs in people of all ages. Wheeze is the most common symptom and the burden of disability is high. > In 2007 the U.S. spent over $56 billion on asthma care, of wh
Slide 27: Inhaled zafirlukast program: progress and clinical development strategy
Inhaled zafirlukast program: progress and clinical development strategy For personal use only Clinical benefits FDA approved as an oral asthma therapy Proof of concept previously conducted using inhaled drug Non-steroidal Higher local concentrations without systemic exposure (decreased risk
Slide 28: INV103 (ala-Cpn10): chronic inflammation in autoimmune disease
For personal use only Targeting chronic inflammation caused by autoimmune disease INV103 (ala-Cpn10)
Slide 29: 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 30: 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 31: Ala-Cpn10 deliverables
Ala-Cpn10 deliverables For personal use only > Completion of dosing of all 4 cohorts > Safety, pharmacokinetics and anti-drug antibodies > Biomarkers of SLE activity including: > Serum IL-6, TNFa, ICAM-1, MCP-1, VCAM-1, > Urinary protein and MCP-1 > Focus on Peripheral Blood Monocytic Cells (PBMC) s
Slide 32: Pipeline
Pipeline For personal use only Formulation ………….. ………….. ………….. Research Phase I Phase II Next milestone development and clinical feasibility Oral INV102 (nadolol) Completion of enrolment Asthma NIH funded 2H15, Reporting 2016 Smoking cessation Phase II data 3Q15 Inhaled INV102 (nadolol) Pre-IND sta
Slide 33: Program targets: 12-18 months
Program targets: 12-18 months Oral nadolol: For personal use only > > advanced into Phase III as an adjunct to smoking cessation in patients with chronic cough and/or chronic bronchitis > IP based on combination of nadolol safety and efficacy with diagnostics from smoking cessation study > Inhaled n
Slide 34: Board and Management with proven track record
Board and Management with proven track record For personal use only > Chairman of Board of Directors, Mr Brett Heading > Senior partner of law firm McCullough Robertson, 27 years as a company director. Former Chairman, ChemGenex Pharmaceuticals (sold to Cephalon $230M); former Director, Peplin Biote
Slide 35: 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 (5-Aug-15) $0.023 (2.3 cents) Shar
Slide 36: Dr Greg Collier, Managing Director and CEO
For personal use only Dr Greg Collier Managing Director and CEO Invion Limited c/- McCullough Robertson Lawyers, Level 11, 66 Eagle Street Brisbane, QLD, 4000 Australia P: +61 7 3295 0500 E: greg.collier@inviongroup.com W: www.inviongroup.com Investor Presentation August | 2015