INVION LIMITED — AGM Information 2016

Nov 13, 2016

AGM Presentation November | 2016

Invion Limited (ASX:IVX) Respiratory drug technologies targeting chronic airway disease

Respiratory drug assets at partnering stage

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01 Asset 1: Nadolol

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Asset 2: Zafirlukast
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• Beta adrenergic biased ligand targeted to reverse mucous metaplasia in the airway epithelium

• Currently contraindicated, represents major shift in medical and scientific thinking around treatment of chronic airway disease

• Phase 2 Data from 155-patient P2 study in chronic bronchitis (smoking cessation) was reported to American Thoracic Society in May 2016. Good safety demonstrated, treated patients were more likely to stop smoking completely or dramatically reduce the number of cigarettes smoked; significant reduction of MUC5AC

• Leukotriene receptor antagonist (LTRA) that reduces inflammation, constriction of the airways and the build-up of mucus in the lungs

• FDA-approved oral therapy being reformulated as proprietary dry powder formulation through a joint development and licensing agreement with Hovione Scientia Limited

• P2 study of nadolol in mild asthma reports 2H16, interim data shows good safety, no increased need for rescue medication

• Feasibility for inhaled nadolol to treat COPD, asthma and cystic fibrosis is well-progressed with 3M Drug Delivery Systems. Tox and clinical supplies manufactured, toxicological studies have commenced. Inhaled delivery will target airway directly, with less dosage.

Platform development position: summary

Nadolol : capitalise on existing extensive research, strong data package and current medical and consumer sentiment for better, more effective therapies

Zafirlukast: capitalise on existing approved successful oral therapy and medical and consumer sentiment seeking safer therapies with fewer detrimental side effects

• Oral: build on existing current strong research and data package via completion of POC study in asthma, COPD, cystic fibrosis

• FDA approved oral therapy. build on existing package through completion of toxicology studies and P2 clinical trials

• Inhaled: utilise oral data package via completion of toxicology and P2 study in in COPD, asthma and cystic fibrosis

• 24 month target:

• P2 data for inhaled zafirlukast as a therapy for asthma and exercise induced bronchospasm (EIB)

• 24 month target:

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• Proof of concept for oral nadolol as a therapy for treatment of chronic airway disease

• P2 data for inhaled nadolol as a therapy for COPD, asthma and cystic fibrosis

Nadolol Target: treatment of signs and symptoms of chronic airway disease via reduction of mucous production and airway healing

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Nadolol directly targets pathway necessary for mucous metaplasia

External research shows

The necessary and sufficient role of the beta arrestin pathway in the development of mucous metaplasia and the chronic bronchitis phenotype (Bond, Dickey)

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That propranolol an inverse agonist without biased ligand activity was ineffective in treating asthma (Short et al)

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The role of biased ligand activity at the beta 2 receptor, which further separates nadolol from all other beta blockers (Lefkowitz: Nobel Prize in Chemistry 2012)

The unique chemistry of nadolol in blocking this pathway, i.e. that there are no other drugs with beta 2 receptor inverse agonism and biased ligand activity (Bond, Penn)

Invion research has demonstrated

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Nadolol reduces the MUC5AC signal in a clinically relevant and statistically significant way compared with placebo

Inhaled formulation shows no dose limiting adverse effects during 4-5 days of dosing in toxicology studies

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Paradigm
shift
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Nadolol can be formulated in a stable proprietary formulation and device (3M Drug Delivery Systems)

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Titration can mitigate possible dose limiting side effects of oral nadolol in patients with chronic airway diseases at doses up to 100mg, higher than usually prescribed for hypertension

Nadolol can be safely administered to patients with asthma and to cigarette smokers with or without airway obstruction Oral nadolol can be administered chronically without increased requirement for bronchodilator therapy/ rescue therapy Nadolol can improve the likelihood of reducing or quitting smoking in patients whose previous attempts have been sabotaged/ undermined by increased cough and sputum

Two key markers of the beta arrestin pathway – ERK1 and MUC5AC – which are necessary for the activation of mucous metaplasia in the airway, showed the most robust changes in phase 2 clinical trials

Partnering opportunity: near term value inflection

Current asset status

FY 2016 – FY 2018

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By mid calendar year 2019

Oral Nadolol

2 x POC studies in mild asthma (Hanania); Completed P2 in mild asthma (data 2H16)

P2 data in chronic bronchitis (smoking cessation) reported Q3 2015 – significant effect on MUC5AC

P2 (proof of concept) study: reduction of signs and symptoms of chronic airway disease ($1M over 2 years)

Proof of concept data for oral nadolol as a therapy for treatment of chronic airway disease

Inhaled Nadolol

Pre-IND status; toxicology and clinical supplies manufactured (3M Drug Delivery Systems); toxicology studies commenced (Charles River Laboratories)

Completion of toxicology

P2 study: treatment of COPD, asthma and cystic fibrosis

($3.2M over 3 years)

P2 data for inhaled nadolol as a therapy for COPD, asthma and cystic fibrosis

Zafirlukast Target: inhaled non-steroidal anti-inflammatory treatment for asthma with delivery method that reduces/ eliminates systemic side effects

Inhaled reformulation of a successful oral therapeutic for asthma

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By enabling reduced ICS dose “steroid sparing” in steroid-dependent asthma

By addition to low dose ICS treatment rather than doubling ICS

As an alternative as first controller medication in mild persistent and moderate asthma Indicated to reduce inhaled corticosteroid (ICS) dependency in adults and children

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Inhaled formulation indicated as monotherapy for mild persistent asthma and exercise-induced asthma

Leukotriene-receptor antagonist (LTRA) or “anti-leukotriene” that reduces inflammation, constriction of the airways, and the build-up of mucus in the lungs

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Approved worldwide as an oral tablet for asthma (AstraZeneca)

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Well established clinical efficacy & safety profile

Inhaled proof of concept using propellants that are now banned (CFCs)

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Inhaled zafirlukast to address major unmet medical need

Current therapies linked to depression and psychotic episodes in children

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Emerging consumer awareness and activism for better education and more detailed explanation of side effects

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FDA Black box warnings exist

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Inhaled zafirlukast can be delivered at 1/100[th] of oral dose thereby reducing systemic side effects

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Framework for reformulation of zafirlukast

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Toxicology and bioanalytical
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4 weeks’ dosing
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2 species for 28 days:
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• Chemistry manufacturing and controls (GMP)

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exposure
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• active pharmaceutical ingredient (API) with drug master file (DMF)

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1 species for 6 months
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• formulation: dry powder inhaler (DPI) approved for development

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IND submission and
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• Phase 1: single rising dose study for safety (paradoxical

• bronchoconstriction) & PK

• • Phase 1: multiple dose safety study for safety & PK

• • Phase 2: cold air, exercise and allergen [cat and ragweed]; steady state dosing for signs and symptoms of asthma [diary card] and attenuation of response to exercise and/or allergen

Finance position

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• Cash reserves of $0.664 million at the end of September 2016

• Operating cash outflows have been reduced reflecting lower capital-intensive activity following the completion of major R&D program milestones

• Cash outflows during the September quarter were $0.232 million

• The Company is driven to realise value from its assets via a commercial transaction following the successful completion of its major R&D milestones. Activities remain directed towards business development, and the partnering (via sale or out-licence) of one or all of its assets.

Dr Greg Collier

Managing Director and CEO Invion Limited

P: +61 7 3295 0500 E: greg.collier@inviongroup.com W: www.inviongroup.com

DisclaimerThe 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 094 730 417 ( Company ). In preparing this presentation, the Company did not take into account the investment objectives, financial situation and particular needs of any particular investor. Further advice should be obtained from a professional investment adviser before taking any action on any information dealt with in the presentation. Those acting upon any information without advice do so entirely at their own risk. Whilst this presentation is based on information from sources which are considered reliable, no representation or warranty, express or implied, is made or given by or on behalf of the Company, any of its directors, or any other person about the accuracy, completeness or fairness of the information or opinions contained in this presentation. No responsibility or liability is accepted by any of them for that information or those opinions or for any errors, omissions, misstatements (negligent or otherwise) or for any communication written or otherwise, contained or referred to in this presentation. Accordingly, neither the Company nor any of its directors, officers, employees, advisers, associated persons or subsidiaries are liable for any direct, indirect or consequential loss or damage suffered by any person as a result of relying upon any statement in this presentation or any document supplied with this presentation, or by any future communications in connection with those documents and all of those losses and damages are expressly disclaimed. Any opinions expressed reflect the Company’s position at the date of this presentation and are subject to change.