Invion Ltd. · ASX:IVX
Invion — Shareholder Meeting (November 2015)
33 slides from Invion's shareholder meeting presentation, Nov 18, 2015
Slide 1: Invion Limited AGM: Chair's Address & CEO Presentation
ASX ANNOUNCEMENT INVION LIMITED AGM: CHAIR’S ADDRESS & CEO PRESENTATION Brisbane, Australia and Delaware, United States, 18 November 2015: Invion Limited (ASX: IVX) is pleased to provide the Chair’s Address and CEO presentation to the 2015 Annual General Meeting of Shareholders being held today at 2
Slide 2: Chair's address: strategy, share purchase plan and options
ASX ANNOUNCEMENT The overarching goal of activities in 2015 has been to enhance the value of the company’s assets by continuing to mitigate risk along each program’s development pathway, and to realise the potential of those assets. To this end, the corporate and business strategy has been focused o
Slide 3: Chair's address: litigation against former directors
ASX ANNOUNCEMENT Lastly, it is appropriate I note the recent decision of the High Court of Australia in relation to the litigation against former directors of the company. In June 2014, the Supreme Court of Queensland determined that the defendants in the litigation be required to repay the sum of $
Slide 4: Invion Limited (ASX:IVX) CEO Presentation to AGM
CEO Presentation to AGM 18 November | 2015 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 comprehensive or provide all
Slide 5: Assets in development
Assets in development 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 activity • clinically ef
Slide 6: Press coverage: Invion pushes to develop respiratory drug
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Slide 7: Invion successfully completes Phase 2 study of INV102
STOP PRESS: Invion successfully completes Phase 2 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 of cigarettes smoked >
Slide 8: Milestone update: achievements in 2015
Milestone update: achievements in 2015 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, COPD & cystic fibrosis
Slide 9: Pipeline: 4Q 2014
Pipeline: 4Q 2014 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 INV104 (zafirlukast) As
Slide 10: Pipeline: 4Q 2015
Pipeline: 4Q 2015 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 Reporting 2016 Inhaled I
Slide 11: Targeting chronic inflammatory airway disease: INV102 (nadolol)
Targeting chronic inflammatory airway disease INV102 (nadolol)
Slide 12: Treating the airway: background and rationale
Treating the airway: background and rationale > 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 corticosteroid (ICS)
Slide 13: The vicious cycle of chronic inflammatory airway disease
The “vicious cycle” of chronic inflammatory airway disease Inflammation from: - 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 ciliated epithelial cell
Slide 14: 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 Chronic bronchitis Cystic Fibrosis 11
Slide 15: Mucus causes death due to asthma, COPD and cystic fibrosis
Mucus causes death due to asthma, COPD and cystic fibrosis Mucus plug in bronchus Autopsy slide from 8 year old girl with fatal asthma. Mucus is increased AND abnormal. 12
Slide 16: Smoking cessation, COPD and chronic airway disease: market size
Smoking cessation, COPD and chronic airway disease: market size and interconnectedness 13
Slide 17: Oral or inhaled nadolol reverses epithelial changes
Oral or inhaled nadolol reverses epithelial changes and decreases inflammatory cytokines 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
Slide 18: 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 beta-arrestin pathway in b2 airway receptors ligand ligand LABA INV102 Newly discovered pathway ~2000 The canonical cAMP-dependent (R. Lefkowitz) pathway Adenylyl cyclase Beta-arrestin Adeny
Slide 19: INV102: reversing the vicious cycle of airway inflammation
INV102: reversing the vicious cycle of airway inflammation 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 cells DECREASED mucin
Slide 20: INV102: Phase 2 smoking cessation trial design
INV102: Phase 2 smoking cessation trial design 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 Change in FEV1, N=155
Slide 21: Phase 2 data strong confirmation of Invion's strategy
Phase 2 data strong confirmation of Invion’s strategy 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 need for conclusion of
Slide 22: Leveraging the data: upcoming analysis and reporting
Leveraging the data: upcoming analysis and reporting 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) > Correlation of smoking
Slide 23: Forward strategy: progress on 3 routes to new airway therapy
Forward strategy: progress on 3 routes to a new class of airway-specific therapy 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 “short path to market stra
Slide 24: Inhaled nadolol program: progress and clinical development strategy
Inhaled nadolol program: progress and clinical development strategy 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-on to existing therap
Slide 25: INV104 (zafirlukast)
INV104 (zafirlukast) Target: a novel inhaled non-steroidal anti-inflammatory treatment for asthma
Slide 26: Target: an inhaled reformulation of a successful oral asthma therapeutic
Target: an inhaled reformulation of a successful oral therapeutic for asthma Oral Inhaled 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 expanded exercise induc
Slide 27: FDA pre-IND established framework for reformulation of zafirlukast
FDA pre-IND established framework for reformulation of zafirlukast Agreement reached with FDA on: > chemistry manufacturing and controls (GMP) > active pharmaceutical ingredient (API) with drug master file (DMF) > formulation: dry powder inhaler (DPI) approved for development > toxicology and bioana
Slide 28: About Hovione and the XCaps inhaler
About Hovione and the XCaps inhaler > 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, the company focuses o
Slide 29: INV103 (ala-Cpn10): targeting autoimmune disease
Targeting chronic inflammation caused by autoimmune disease INV103 (ala-Cpn10)
Slide 30: INV103 (ala-Cpn10): background and rationale
INV103 (ala-Cpn10): background and rationale > 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 Resolution Associated Molecula
Slide 31: INV103 (ala-Cpn10): phase 2 lupus data
INV103 (ala-Cpn10): phase 2 lupus data > 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 effect on stimulated periph
Slide 32: Milestone update: achievements in 2015
Milestone update: achievements in 2015 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, COPD & cystic fibrosis
Slide 33: Dr Greg Collier, Managing Director and CEO
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: [email protected] W: www.inviongroup.com