Invion Ltd. · ASX:IVX
Invion — Shareholder Meeting (November 2013)
32 slides from Invion's shareholder meeting presentation, Nov 22, 2013
Slide 1: Chairman's Address & CEO Presentation
ASX ANNOUNCEMENT 22 November 2013 INVION LIMITED AGM CHAIRMAN’S ADDRESS & CEO PRESENTATION For personal use only Invion Limited (ASX: IVX) is pleased to provide the Chairman’s Address and CEO presentation for the 2013 Annual General Meeting of Shareholders being held this morning at 10.00am (AEST) a
Slide 2: About Invion Limited
ASX ANNOUNCEMENT It is appropriate that in this address I acknowledge the legal proceedings commenced in February 2012. As was last reported to you, the company has continued to meet all requirements and obligations to progress the matter expeditiously. There have, however, been a number of interloc
Slide 3: Invion Limited CEO presentation 2013 AGM
For personal use only Invion Limited (ASX:IVX) Clinical-stage life sciences company targeting chronic inflammation CEO presentation 2013 AGM
Slide 4: 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 5: 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 asthma, COPD, cystic fibrosis and smoking cessation failures > INV104 (zafirluka
Slide 6: 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 7: Current pipeline: three phase II underway
Current pipeline: three phase II underway preclinical phase I phase II For personal use only INV103 (ala-Cpn10) Lupus (SLE) PK, safety and IL-6 reduction; for partnering INV102 (nadolol) Asthma NIH funded, US$4m non-dilutive (oral program) Smoking cessation in patients with established COPD (oral pr
Slide 8: Pipeline milestones
18 month pipeline 1H14 2H14 1H15 For personal use only INV103 (ala-Cpn10) Lupus (SLE) completion ph II study IV/SC bridging CMC for phase IIB* * with partner INV102 (nadolol) Asthma initial ph II data (oral) ongoing phase II study, completion 2Q15 Smoking cessation phase II interim and final data EO
Slide 9: Targeting autoimmune disease
For personal use only Targeting autoimmune disease INV103 (ala-Cpn10): modified natural human protein
Slide 10: 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 11: 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 12: 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 13: INV103: milestones
INV103: milestones 1H14 2H14 1H15 For personal use only INV103 (ala-Cpn10) Lupus (SLE) completion ph II study IV/SC bridging CMC for phase IIB* ongoing BD activities joint development * with partner INV102 (nadolol) Asthma initial ph II data (oral) ongoing phase II study, completion 2Q15 Smoking ces
Slide 14: Targeting respiratory disease
For personal use only Targeting respiratory disease Two proprietary and unique respiratory franchises
Slide 15: Respiratory therapeutics: oral program
For personal use only Respiratory therapeutics: oral program INV102 in asthma and COPD (smoking cessation)
Slide 16: 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 17: 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 18: 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 19: 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 diagno
Slide 20: INV102: phase II trial design – smoking cessation
INV102: phase II trial design – smoking cessation 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 d
Slide 21: 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 22: Oral program: milestones
Oral program: milestones 1H14 2H14 1H15 For personal use only INV103 (ala-Cpn10) Lupus (SLE) completion ph II study IV/SC bridging CMC for phase IIB* INV102 (nadolol) Asthma initial ph II data (oral) ongoing phase II study, completion 2Q15 Histopathology and sputum data de-risk inhaled INV102 progra
Slide 23: Respiratory therapeutics: inhaled program
For personal use only Respiratory therapeutics: inhaled program INV102 (nadolol) in COPD & cystic fibrosis INV104 (zafirlukast) in asthma
Slide 24: INV102: inhaled development targets
INV102: inhaled development targets For personal use only > Develop franchise across broad range of respiratory inflammation > realize full value of franchise > INV102 monotherapy > COPD (chronic bronchitis): signs and symptoms followed by reduction of exacerbations > Cystic fibrosis (EU) > INV102 c
Slide 25: Inhaled program: development plan
Inhaled program: development plan 1H14 2H14 1H15 For personal use only INV103 (ala-Cpn10) Lupus (SLE) completion ph II study IV/SC bridging CMC for phase IIB* INV102 (nadolol) Asthma initial ph II data (oral) ongoing phase II study, completion 2Q15 Smoking cessation phase II interim and final data E
Slide 26: 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 27: INV104: inhaled development targets
INV104: inhaled development targets For personal use only > Develop non-steroidal anti-inflammatory therapeutics franchise across broad range of respiratory inflammation targets > INV104 monotherapy > Inhaled zafirlukast for mild to moderate asthma marked by atopy > Inhaled zafirlukast for exercise-
Slide 28: Respiratory franchise: oral & inhaled programs
Respiratory franchise: oral & inhaled programs 1H14 2H14 1H15 For personal use only INV103 (ala-Cpn10) Lupus (SLE) completion ph II study IV/SC bridging CMC for phase IIB* INV102 (nadolol) Asthma initial ph II data (oral) ongoing phase II study, completion 2Q15 Smoking cessation phase II interim and
Slide 29: Invion is developing a robust respiratory franchise
Invion is developing a robust respiratory franchise For personal use only > Two drugs: INV102 (nadolol) and INV104 (zafirlukast) > Multiple opportunities for new patents > Proprietary doses and formulations > Synergies in development expertise and know how > GMP requirements: Chemistry and Manufactu
Slide 30: Summary
For personal use only Summary 3 drug assets with multiple paths to market early partnering opportunity for INV103 (ala-Cpn10) two de-risked novel and proprietary inhaled respiratory franchises 3 FDA-regulated phase II clinical trials experienced management team significant valuation driv
Slide 31: 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 (12-Nov-13) $0.12 (12 cents) Share
Slide 32: 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 CEO presentation 2013 AGM