Invion Ltd. · ASX:IVX
Invion — Investor Presentation (November 2015)
31 slides from Invion's investor presentation, Nov 10, 2015
Slide 1: Investor Presentation November 2015
Investor Presentation November | 2015 For personal use only Invion Limited (ASX:IVX) Clinical-stage life sciences company targeting chronic inflammation Disclaimer The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensiv
Slide 2: Assets in development
Assets in development For personal use only Respiratory 1. INV102 (nadolol): beta blocker being targeted to treat chronic inflammatory airway diseases (e.g. asthma and COPD). Oral INV102 is also being studied as an aid to smoking cessation. > Phase 2 completed: • proof of concept in biased ligand ac
Slide 3: Press coverage: Invion pushes to develop respiratory drug
jes poceest ‘ye Principal stars Wed 200 pROBANS woe OX DEMAND Featured Topics _ Commer News Home Latest NEWS Home = Quotes&Charts Portfolio —“ Find Stock Broker Markets pry ith Aust credit close Aust dollar report Aust markets World commodities poorans ess WI a eyes Succ! sn oKing arg Invion pushes
Slide 4: STOP PRESS: Invion completes Phase 2 study of INV102
STOP PRESS: Invion successfully completes Phase 2 For personal use only study of INV102 (nadolol) to aid smoking cessation Data announced 5 October 2015: > Completed Phase 2 trial data demonstrates INV102 treated smokers were more likely to stop smoking completely or dramatically reduce the number o
Slide 5: Milestone update: achievements in 2015
Milestone update: achievements in 2015 For personal use only 3 drug assets in 3 phase 2 clinical trials across 4 development programs Blind-broken interim data from phase 2 smoking cessation trial of INV102 (nadolol) Pre-IND status for inhaled INV102 (nadolol) as a potential therapy for asthma,
Slide 6: Pipeline: 4Q 2014
Pipeline: 4Q 2014 For personal use only Research Formulation Toxicology Phase 1 Phase 2 EOP2 Phase 3 ………….. ………….. ………….. ………….. ………….. ………….. development and clinical feasibility Oral INV102 (nadolol) Smoking cessation Asthma NIH funded Inhaled INV102 (nadolol) Asthma COPD Cystic Fibrosis Inhaled I
Slide 7: Pipeline: 4Q 2015
Pipeline: 4Q 2015 For personal use only Research Formulation Toxicology Phase 1 Phase 2 EOP2 Phase 3 Next milestone ………….. ………….. ………….. ………….. ………….. ………….. development and clinical feasibility Oral INV102 (nadolol) EOP2 Meeting Smoking cessation P3 planning Enrolment complete, Asthma NIH funded Re
Slide 8: Targeting chronic inflammatory airway disease: INV102 (nadolol)
For personal use only Targeting chronic inflammatory airway disease INV102 (nadolol)
Slide 9: 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 10: 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 11: 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 11
Slide 12: Mucus causes death due to asthma, COPD and cystic fibrosis
Mucus causes death due to asthma, COPD and cystic fibrosis For personal use only Mucus plug in bronchus Autopsy slide from 8 year old girl with fatal asthma. Mucus is increased AND abnormal. 12
Slide 13: Smoking cessation, COPD and chronic airway disease: market size
Smoking cessation, COPD and chronic airway disease: market size and interconnectedness For personal use only 13
Slide 14: Oral or inhaled nadolol reverses epithelial changes
Oral or inhaled nadolol reverses epithelial changes and decreases inflammatory cytokines 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 gobl
Slide 15: Mechanism of action of INV102 is unique among drugs
Mechanism of action of INV102 is unique among drugs: INV102 reverses epithelial changes via inhibition of the For personal use only beta-arrestin pathway in b2 airway receptors ligand ligand LABA INV102 Newly discovered pathway ~2000 The canonical cAMP-dependent (R. Lefkowitz) pathway Adenylyl cycla
Slide 16: INV102: reversing the vicious cycle of airway inflammation
INV102: reversing the vicious cycle of airway inflammation For personal use only INV102 (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 epithelial COPD, asthma and CF
Slide 17: INV102: Phase 2 smoking cessation trial design
INV102: Phase 2 smoking cessation trial design For personal use only INCLUSION ORAL DOSING WASHOUT ENDPOINTS 11-15wks 2wks Randomised Primary (IWRS) Nadolol Treatment (n=78) % Decrease in # of Controlled 3-7wks titration & cigarettes per day Clinical Trial 8wks maintenance during last 14 days Safety
Slide 18: Phase 2 data strong confirmation of Invion's strategy
Phase 2 data strong confirmation of Invion’s strategy For personal use only Invion hypothesis Demonstrated in Phase 2 trial Proprietary titration scheme safe and enables subjects Trial subjects treated with INV102 were more likely to achieve abstinence at the to reach efficacious doses of drug - no
Slide 19: Leveraging the data: upcoming analysis and reporting
Leveraging the data: upcoming analysis and reporting For personal use only Data reported Ongoing analysis 5 October 2015 4Q 2015 > Report on effects of nadolol vs placebo > Correlation of smoking cessation/ on key biomarkers reduction data with baseline biomarkers > ERK1/2 (beta arrestin pathway) >
Slide 20: Forward strategy: routes to a new class of airway-specific therapy
Forward strategy: progress on 3 routes to a new class of airway-specific therapy For personal use only Phase 2 data validates Invion approach for directly treating the airway epithelium even in the face of ongoing insult, such as cigarette smoking 1. Oral INV102 in smoking cessation is Invion’s “sho
Slide 21: Inhaled nadolol program: progress and clinical development strategy
Inhaled nadolol program: progress and clinical development strategy Clinical benefits For personal use only 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 22: INV104 (zafirlukast)
For personal use only INV104 (zafirlukast) Target: a novel inhaled non-steroidal anti-inflammatory treatment for asthma
Slide 23: Target: an inhaled reformulation of a successful oral therapeutic for asthma
Target: an inhaled reformulation of a successful oral therapeutic for asthma 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 ? Potential for e
Slide 24: FDA pre-IND established 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 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: INV103 (ala-Cpn10): targeting chronic inflammation caused by autoimmune disease
For personal use only Targeting chronic inflammation caused by autoimmune disease INV103 (ala-Cpn10)
Slide 27: 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 28: INV103 (ala-Cpn10): phase 2 lupus data
INV103 (ala-Cpn10): phase 2 lupus data For personal use only > Three sets of data were reviewed from subjects who received twice-weekly doses of 10, 30 or 100mg of ala-Cpn10, or placebo > INV103 (ala-Cpn10) well tolerated at 3 and 10 times previous highest dose > 10mg iv twice weekly showed no effec
Slide 29: Milestone update: achievements in 2015
Milestone update: achievements in 2015 For personal use only 3 drug assets in 3 phase 2 clinical trials across 4 development programs Blind-broken interim data from phase 2 smoking cessation trial of INV102 (nadolol) Pre-IND status for inhaled INV102 (nadolol) as a potential therapy for asthma,
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 (2-Nov-15) $0.012 Shares on issue
Slide 31: 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