A Phase 2B company treating Secondary Progressive Multiple Sclerosis. Annual General Meeting - August 2014
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1 A Phase 2B company treating Secondary Progressive Multiple Sclerosis Annual General Meeting - August 2014
2 Forward Looking Statements This Presentation (and any financial information that may be provided by Innate Immunotherapeutics Limited - the Company ) may contain forward looking statements that involve risks and uncertainties. Such statements include statements regarding the Company s belief or current expectation and are necessarily based on the Company s current understanding of the markets and industries in which it operates. That understanding could change or could prove to be inconsistent with actual developments. The Company s actual results could differ materially from the results discussed in this Presentation, including those anticipated in or implied by any forward looking statements. 2
3 12 Month Highlights Migration to Australia Successful IPO raising $10 million Debt $4.6 million converted to equity Listed December 23 rd Key Phase 2B trial sites selected ASX:IIL Ethics approve clinical trial protocol Patient dosing about to commence 3
4 Financial Position Key Statistics ASX Code IIL Share price $0.20 Shares on issue 172,479,822 Market Cap $34.5 million Options outstanding 19,698,758 Loyalty rights 33,031,926 Cash on hand (30 June) $6.7 million Significant Shareholders Christopher Collins & family 18.8% Australian Ethical 10.1% Probe International (Dr Gelder - founding scientist) 3.3% Picton Cove Pty Ltd 3.2% Watkins Family A/C (Estate Dr Watkins co-founder) 2.2% Fast Forward (US MS Society ) 2.0% 4
5 Secondary progressive multiple sclerosis trial Double blinded, placebo controlled 12 month trial in 90 patients with SPMS across multiple Australian sites Ethics Committee approves lead site WANRI Site initiation confirmed August 26 th Patient dosing expected within 2 weeks Ethics approvals expected for sites in Melbourne and Brisbane in September 5
6 Phase 2B trial major trial objectives 1. Efficacy by clinical assessments including: hand & arm strength and function stamina and walking speed visual disturbance and cognitive impairment 2. Efficacy by patient reporting of: body pain and fatigue other MS related symptoms MIS MRI imaging of brain size and myelin quantity 4. Safety and tolerability of treatment 6
7 Compassionate Use Programme 18 patients with SPMS in NZ are receiving ongoing MIS416 treatment on compassionate grounds Compassionate use is not a clinical trial, not placebo controlled Average time on treatment 24 months (average 52 doses) No apparent dose intolerance or cumulative toxicity Majority of patients self-report sustained significant improvements: reductions in pain and fatigue improvements in bladder control Improvements in social functioning 7
8 Commercial Strategy Significant unmet annual market of US$3 billion or more Target Partners - Pharma active in MS market include: Partner MS programme post phase 2B Pharma with drugs for early-stage MS actively seeking treatments for SPMS Demonstrate application of IIL technology in other important diseases/applications Other Pharma expressing interest in SPMS: 8
9 12 month Outlook Upcoming Milestones Q3, 2014 Phase 2B lead sites initiated and patient enrolment commences Compassionate use extended in Auckland ECTRIMS conference presentation of animal mechanism of action data Q4, 2014 Phase 2B enrolment update Q1, 2015 Commence regular compassionate use updates Q2, 2015 Potential Pharma partner meetings Q3, 2015 Phase 2B major progress announcement 9
10 Why we are confident MIS416 certainly appears beneficial to my MS patients, although it remains to be seen if it is curative. Christchurch based General Practitioner (2013) However, I would certainly recommend MIS416 as I have seen significant improvement in the motor skills and general wellbeing of my current MS patients. 10
11 Please contact Simon Wilkinson, CEO or or simon@innateimmuno.com
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