A Phase 2 company treating Secondary Progressive Multiple Sclerosis. April 2016

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1 A Phase 2 company treating Secondary Progressive Multiple Sclerosis April 2016

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. Effective Date: 18 April

3 ASX:IIL - Investment thesis IIL s lead drug candidate MIS416 will complete a Phase 2B placebo controlled trial for SPMS in April There is strong evidence of safety and likely efficacy from prior trials and a unique 7 year compassionate use programme. There are no drugs approved for the safe ongoing treatment of SPMS. This unmet medical need equate to a potent market of $4B or more. Many large drug companies are following IIL very closely. IIL expects trial outcomes and a pharma transaction in H2/

4 What is multiple sclerosis? (Source: MedicineNet, Inc) The myelin sheath protecting the nerve fibers inside the CNS is damaged by a likely combination of both neuro generative and autoimmune processes This triggers inflammatory processes that cause further damage In early disease, myelin is fully or partially repaired Over time, scar-like plaque builds up around damaged axons inhibiting repair 4

5 Living with multiple sclerosis MS is a chronic, disabling disease typically diagnosed between ages 20 and 40 and in three times more women than men MS symptoms include upper and lower extremity disabilities, visual disturbances, balance and coordination problems, spasticity, altered sensation, swallowing disorders, fatigue, bladder and bowel problems, sexual dysfunction, and cognitive and emotional disturbances MS significantly impacts an individual s quality of life and is associated with high costs for patients, their families, and society as a whole MS is associated with reduced life expectancy of between 5 and 15 years MS is the second most costly chronic condition after congestive heart failure 5

6 Unmet medical need & significant market opportunity Relapsing Remitting MS Sufferers worldwide 60% Secondary Progressive MS Sufferers worldwide 30% Number of approved disease modifying drugs 13 Number of approved disease modifying drugs 0 Estimated annual market revenues (2015)* US$20.5B Potential annual market revenues US$4B * Source: Leerink Partners Estimates, Company Reports and SEC Filings 6

7 Introducing MIS416 a MYELOID directed immune modulator MIS416 is a highly purified microparticle derived from the naturally occurring bacteria P. acnes MIS416 reliably, safely, and uniquely targets myeloid cells MIS416 targeted myeloid cells: Increase in number switch activity from pathogenic to reparative traffic into the CNS (past the blood brain barrier) The targeted cells have an anti-inflammatory effect inside the CNS and have also been shown to: support myelin repair by clearing myelin debris MIS x 0.5 micron rod shaped microparticle secrete important tropic factors that can directly promote neuronal survival and axon regeneration 7

8 NZ based compassionate use programme Under an ongoing New Zealand based Compassionate Use programme, 27 patient with SPMS have received an average of 72 doses [10-178] over a median treatment period of 17 months [4-89]* Long term ongoing treatment with MIS416 has shown no evidence of haematologic, hepatic, or renal toxicity in treated patients 70% of these patients have self-reported significant improvement in their MS related disabilities and/or health related quality of life MIS416 certainly appears beneficial to MS patients, although it remains to be seen if it is curative. However, I would certainly recommend MIS416 as I have seen significant improvement in the motor skills and general wellbeing of my current MS patients. (Christchurch physician currently treating ten SPMS patients as part of the NZ compassionate use programme) * Compassionate use data as at February

9 Phase 2B trial efficacy trial Double blinded, placebo controlled (2:1) 12 month trial of MIS416 i.v. at 500 mcg in 90 patients Baseline, quarterly, and end of dosing (EoD) clinical assessments including: Hand/arm function & strength, cognition, visual acuity, fatigue, MSFC and EDSS Patient reported outcomes: SF-36, pain (BPI), and fatigue (NFI-MS) Baseline, month 3 & EoD MRI (whole brain atrophy and magnetization transfer ratio) Release of top level analysis in Q3/2017 9

10 Commercial Strategy There are no effective drugs approved to treat SPMS Approval of a drug for SPMS could be reviewed under FDA s Expedited Programs for Serious Conditions Pharma with existing drugs for early stage MS (RRMS) are actively seeking drugs to treat SPMS Biogen s RRMS drug Tecfidera sold US$3b in 2014 following approval part way through 2013 Patents protecting use of MIS416 to treat multiple sclerosis issued in USA and Europe (expiry 2029) Upon completion of Phase 2B (2016) Innate s strategy is to license / sell to large Pharma company Potential Target Partners or Acquirers 10

11 Strong interest for potential partners We have engaged early & regularly with target acquirers to share Phase 1B/2A and compassionate use data and discuss Phase 2B efficacy trial plans and design. Multiple meetings with senior execs at 6 pharmas where IIL is highly complementary to their current MS programs. Multiple meetings with senior execs at 9 pharmas who view SPMS as an entrance into other neuro inflammatory diseases. 27 other pharmas engaged but with fewer resources or less expansion intent. All keenly await trial results 11

12 Recent MS related market transactions What does a partnering deal look like in SPMS? December 2014: Servier paid US$47 million option fee to fund Phase 2B trial of GeNeuro s blocking antibody to supposed MS-associated retrovirus Received option to the non-us territorial rights tied to a $408 million package of milestones N.B. The non-us territory accounts for about ~25% of global MS drug revenues Also option buy an equity stake See announcement: < August 2015: Celgene acquired Phase 3 MS company Receptos for US$7.2 billion cash Deal has ranked Receptos #1 for the most value created by any biotech in the last 10 years. September Receptos co-founder and CSO, Dr Robert Peach joins Innate s board 12

13 Active pre-clinical programmes / collaborations include: Oral formulation of MIS416 for SPMS maintenance therapy Ovarian cancer therapeutic vaccine Dr Kunle Odunsi, Professor of Gynaecology & Obstetrics, Roswell Park Cancer Institute (New York). IND filing expected in 2016 Refractory epilepsy (Various collaborators, University of Queensland) Neuro protection and repair (Various collaborators, St Vincent s Hospital, Sydney & University of Queensland) 13

14 Intellectual Property (MIS416) Use in Multiple Sclerosis (not limited to SPMS) - NZ & AU (granted) expiry June US 12,636,733 (granted) expiry 2029 (US =75% of market by revenue) - EU (granted) expiry 2032 (EU = ~20%% of market by revenue) - PCT NZ/2010/ (pending in other markets) Use in Cancer (inc standalone, co-therapy, cancer vaccine adjuvant) - NZ & AU (granted) expiry April PCT/NZ2009/ (national phases in major markets) priority April 2008 Use in Infection (inc prophylactic, therapeutic, vaccine adjuvant) - NZ & AU (granted) expiry April PCT/NZ2009/ (US granted, pending in other major markets) priority April 08 Use in Radiation Exposure (inc pre and post acute or therapeutic exposure) - NZ (granted) - expiry Sept PCT/NZ2009/ (EU Intention to grant; US & Japan pending) 14

15 Key Statistics as at 15 April 2016 ASX Code IIL Share price ~A$0.20 Shares on issue 196,442,177 Market Cap A$40 million Options outstanding 18.6 million (>95% price $0.30 or higher) Register Significant Shareholders C. Collins (R-NY 27th District) 17.3% Top 20 Australian Ethical 9.8% Total shareholders Caitlin & Cameron Collins 5.2% Total small parcel holders Probe International Inc 2.6% Picton Cove Pty Ltd 2.1% <Watkins Family A/C> 1.9% National MS Society (USA) 1.8% 53.5% 2,

16 Board of Directors Michael A Quinn, BSc BEc MBA, Chairman Andrew Sneddon, BEcon, CA Independent Director CEO of Sydney based Innovation Capital. Currently or past director of ResMed (ASX, NYSE), QRxPhrama (ASX), & CAP-XX Limited (LSE). Former partner of PWC where he led the life sciences practice. Currently chairman of Elastagen Pty Ltd, MIRteq Pty Ltd, CustomWare Pty Ltd, InterAcct Solutions Pte and TGR BioSciences Pty Ltd. Elizabeth Hopkins, 20 years of experience in successfully commercializing science B.Sc. (Hons) Pharmacology, outcomes. Ten years with Pfizer s European headquarters, including Independent Director the last two years as Global Project Manager. Currently deputy chair, Christchurch Polytechnic Institute of Technology (CPIT). Christopher Collins, B.S, M.B.A. 30 years of experience in business management. Collins has helped Director acquire, manage and make profitable 17 companies representing various industries. Collins was elected to the US House of Representatives in Collins holds 19% of IIL. Robert Peach, PhD Co-founder and CSO Receptos (acquired by Celgene Aug '15 Independent Director US$7.2b). 30 years of multidisciplinary research expertise in biochemistry and cell biology within the disease areas of immunology, inflammation, and oncology. Simon Wilkinson CEO since years experience in finance, banking and business Director & Chief Executive Officer management. He began his civilian career in retail banking after serving as an officer in the Royal New Zealand Navy. 16

17 Two former clinical trial patients talk about their experience with MIS416: A former clinical trial patient talks about her MIS416 experience: A new compassionate use patient (4-5 months): Simon Wilkinson, CEO or tel

18 Additional information 18

19 Summary of MIS416-induced MYELOID cellular and soluble pathways that can counteract inflammation Bone marrow-derived monocyte Tolerogenic DC Alternate/non classical/m2 macrophage Cellular IL-10 Arginase TGFb IL-27 PDL-1 IDO stnfr IL-12p70 IL-1b TNFa MHC I/II CD80/86 NO Pro-inflammatory mechanisms sil-1r Anti-inflammatory / tolerance mechanisms Upregulation following MIS416 treatment: in Mouse in Human 19

20 MYELOID cells are an important target in progressive MS Relapsing remitting MS has both autoimmune and peripherally derived inflammatory components whereas progressive forms of MS reflect a clear shift towards innate inflammation being a significant cause of continuing neuro-degeneration Gandhi, Laroni, and Weiner conclude in their 2010 paper that: Until now, there are no specific therapies to target innate immune cells in MS. As the role of innate immune system in MS becomes better defined, it will be possible to design therapy to transform immuno-pathogenic innate immune cells to a more immunoregulatory innate immune cells. Myeloid cells have been identified as a significant potential therapeutic target in SPMS as they have natural anti-inflammatory activities that are critical to innate immune homeostasis as well as stimulating wound healing/tissue repair pathways that are established following injury or infection 20

21 Precedence in the literature: MYELOID cells from the periphery can access the CNS and promote myelin repair Innate immunity: the missing link in neuroprotection and neurodegeneration? Nguyen MD, Julien J-P, Rivest S. Nat Rev Neurosci. 2002;3(3): Trafficking CD11b-positive blood cells deliver therapeutic genes to the brain of amyloid-depositing transgenic mice. Lori Lebson, Kevin Nash, Siddharth Kamath, Donna Herber, Nikisha Carty, Daniel C. Lee, at el Recruitment of beneficial M2 macrophages to injured spinal cord is orchestrated by remote brain choroid plexus. Shechter R, Miller O, Yovel G, Rosenzweig N, London A, Ruckh J, et al.. Immunity. 2013;38(3): Infiltrating blood-derived macrophages are vital cells playing an anti-inflammatory role in recovery from spinal cord injury in mice. Shechter R, London A, Varol C, Raposo C, Cusimano M, Yovel G, et al.. PLoS Med. 2009;6(7):e Clinical and Developmental Immunology. 2013;2013 The Benefits and Detriments of Macrophages/Microglia in Models of Multiple Sclerosis. Rawji KS, Yong VW. Harnessing monocyte-derived macrophages to control central nervous system pathologies: no longer 'if' but 'how'. Shechter R, Schwartz M. The Journal of pathology. 2013;229(2):332-46) 21

22 MIS416 effect on trophic factors associated with CNS repair Vascular Endothelial Factor Erythropoietin Baseline (pre-treatment) 24 hr post dose pre-treatment 24 hr post dose EPO (pg/ml) VEGF (pg/ml) sample number (arbitary) sample number (arbitary) Hepatocyte Growth Factor Insulin Growth Factor (Baseline) pre-treatment 24 hr post dose HGF (pg/ml) 400 IGF-1 (pg/ml) 600 Baseline (pre-treatment) 24 hr post dose A selection of phase 1B and 2A patient plasma samples were analysed to screen for the induction of factors associated with neuroprotection. Data are shown from examples that showed a clear response for a given factor Samples are assigned arbitrary sample numbers sample number (arbitary) sample number (arbitary) 22

23 MIS416 effect on M2 phenotype cells in the CNS of healthy mice Peripheral leucocytes (CD45Hi) are naturally present in the CNS. MIS416 treatment enhances the proportion of monocytic myeloid cells (CD11b+F4/80+) associated with regulatory activities (Gr-1-). 23

24 Phase 1B/2A open label trials (completed Oct 11 & July 12) Phase 1B dose escalation study (n=19) showed weekly dosing from 125 µg to 600 µg for 4 weeks was safe & well tolerated Phase 2A dose confirmation study (n=15 enrolled; n=11 completed) showed weekly dosing at 500 µg for 12 weeks was safe & well tolerated Most common side effects transient self limiting headache, fever, chills, muscle pain and weakness 7 of the 11 subjects responded based on the PerfROs. (The probability of observing 7 responders out of 11 persons, even assuming a spontaneous response rate as high as 30% in the absence of intervention, is 0.022*) 8 of the 11 subjects responded based on the PROs. (The probability of observing 8 responders out of 11 persons, even assuming a spontaneous response rate as high as 30% in the absence of intervention, is 0.004*) All but one person showed a response on at least one PerfRO or PRO Both studies were conducted with financial support from the US National MS Society (US$550k) and the NZ Government (NZ$600k) 24

25 Phase 2B trial expected completion March 2017 Key Objectives Study Design Phase 2B (NCT ) Randomized, double-blind, placebo-controlled study of the efficacy and safety of MIS416 in the treatment of subjects with SPMS Design Eligibility criteria includes EDSS 3.0 to 6.5, relapse free for 2yrs, clinical evidence of progression Sites 5 x Australia and 2 x New Zealand N 90 subjects with SPMS randomized 2:1 to MIS416 or saline placebo Doses Weekly i.v. infusion of MIS416 or saline over 13 cycles of 4 doses per cycle (52 weeks), titrated at 125ug of MIS416 for the first dose, 250ug for the second dose, and 500ug for subsequent doses To determine the efficacy of MIS416, relative to placebo, as assessed by various measures of neuromuscular function To explore the effect of MIS416 on disease activity and neurodegeneration by measuring a wide range of blood markers, imaging markers and patient reported outcomes Study is exploratory by design in preparation for phase 3 No adjustments have been made for multiplicity of outcomes, success will be judged on consistency of outcomes rather than statistical testing Status First patient in October 2014 Project last patient out February 2017 No interim analysis Clinical study report Q

26 Phase 2B trial advisors Clinical: Dr Jeffrey Cohen, Director, Experimental Therapeutics Program, Mellen Center for MS Treatment & Research, Cleveland Clinic Patient Reported Outcomes: Deborah Miller, PhD, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Neuromuscular Assessments: Kristy Rose, PhD, Institute for Neuroscience and Muscle Research, The Children s Hospital at Westmead MRI: Dr Doug Arnold, Neurology Professor, McGill University, Neurological Institute Statistics: Gary Cutter, PhD, Professor of Biostatistics and Head of the Section on Research Methods and Clinical Trials, UAB School of Public Health PerfRO and PRO outcomes will be shared with the Multiple Sclerosis Outcomes Assessment Consortium (MSOAC) 26

27 Phase 2B trial PerfROs and PROs Neuromuscular Function: will be assessed on a three monthly basis and include: MS Function Composite (MSFC), comprising the; timed 25 Foot Walk, 9 Hole Peg Test, and Paced Auditory Serial Addition Test Symbol Digit Modalities Test (SDMT) [potential replacement for PASAT in MSFC] Sloan Low-Contrast Letter Visual Acuity (SLCVA) [possible addition to MSFC] Jebsen Hand Function Test (JHFT) [standardized and objective evaluation of fine and gross motor hand function using simulated activities of daily living] Grip, tip and key pinch strength [as type of pathology weakness is mainly pyramidal tract dysfunction, hand grip might be an easy to perform and very reproducible muscle strength test] 6-Minute Walk Test (6MWT) Disability and Health Status: will be assessed on a three monthly basis and include: Expanded Disability Status Scale Patient Reported Outcomes including: o SF-36 and its components o MS Impact Scale (MSIS-29) o Neurological Fatigue Index for MS (NFI-MS) o Brief Pain Inventory (BPI) Cranial MRI: will be performed at Baseline, 3 months, and End of Study Visit to assess: Whole Brain Atrophy (WBA) Magnetisation Transfer Ratio (MTR) 27

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