Targeted Therapeutics for Inflammatory Disease

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1 Targeted Therapeutics for Inflammatory Disease

2 Forward Looking Statements / Safe Harbor This presentation and the accompanying oral commentary contain forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation and the accompanying oral commentary, including statements regarding our future financial condition, business strategy and plans and objectives of management for future operations, are forward looking statements. In some cases, you can identify forward-looking statements by terminology such as believe, will, may, estimate, continue, anticipate, intend, should, plan, might, approximately, expect, predict, could, potentially or the negative of these terms or other similar expressions. Forward looking statements appear in a number of places throughout this presentation and the accompanying oral commentary and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for AQX-1125 and our future product candidates, our intellectual property position, the degree of clinical utility of AQX-1125 and our future product candidates, particularly in specific patient populations, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In evaluating these statements, you should specifically consider various factors, including the risks outlined under the caption Risk Factors set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2014, which we filed with the Securities and Exchange Commission ( SEC ) on May 13, 2014 and other reports and filings we will make with the SEC from time to time. Forward-looking statements represent our management s beliefs and assumptions only as of the date of this presentation. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. 2

3 Corporate Highlights Small molecules against novel target (SHIP1) with broad anti-inflammatory potential AQX-1125: large, underserved markets - in Phase 2 trials for COPD exacerbations and BPS/IC Positive results from two PoC clinical trials Large, diverse library of next generation compounds Decisive near-term milestones - top-line Phase 2 clinical data expected in Q & Q

4 Experienced Management David Main, President & CEO INEX Pharmaceuticals, QLT Stephen Shrewsbury, CMO Sarepta, MAP, Chiron, Glaxo Kamran Alam, CFO Angiotech, AnorMED, PwC Lloyd Mackenzie, VP Technical Ops QLT, Inflazyme 4

5 Successful $53M IPO - (NASDAQ:AQXP) ~$55M cash on hand as at March 31 st, 2014 Analyst coverage: Backed by Large Pharma Investment: 5

6 SHIP1 is an Attractive Drug Target SHIP1 is nature s way of regulating PI3K in immune cells PI3K All cells PI-4,5-P 2 PIP 3 SHIP1 Immune cells PI-3,4-P 2 PTEN All cells SHIP1 Activators Cancer Cell growth and survival Inflammation Cell activation and function SHIP1 activators have the potential to become the next generation of anti-inflammatory drugs 6

7 Development Strategy / Opportunities Mucosal Inflammaon Unmet Need Lung/Airway COPD Exacerbations (Moderate-Severe) Urinary Tract BPS/IC Short Duraon Trials Acute Endpoints Exacerbaons, Flares, Pain Expand into Chronic Endpoints Chronic Rhinosinusitis Asthma: Glomerulonephritis Gastrointestinal Steroid unresponsive, Moderate-severe Eosinophilic Esophagitis Non-CF Bronchiectasis Crohn's Disease Churg-Strauss Syndrome Ulcerative Colitis Idiopathic Pulmonary Fibrosis Current Phase 2 trials supported by preclinical and clinical PoC 7

8 AQX-1125 Clinical Program 8

9 Clinical Development in Large, Underserved Markets Research/Preclinical Phase 1 Phase 2 AQX-1125 SHIP1 Activator Completed Ongoing SAD / MAD / FE Chronic Obstructive Pulmonary Disease (COPD) PoC Asthma PoC Chronic Obstructive Pulmonary Disease Exacerbations (COPD) Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) Next Gen SHIP1 Activator Future Other Respiratory, Urology, Gastrointestinal Inflammation Oncology Phase 2-ready Differentiated oral once daily product for multiple indications 9

10 COPD PoC: Inhibition of Sputum Neutrophils AQX-1125 met primary endpoint in healthy volunteers CI ( ) CI ( ) Robust inhibition of inflammation in COPD model 10

11 COPD PoC: Comparative LPS Challenge Data Drug Class % Neutrophil Inhibition AQX-1125 SHIP1 activator 62% Ph p38 MAP kinase Inhibitor 50% Roflumilast (Daxas, Daliresp) PDE4 inhibitor 39% Prednisolone / Fluticasone Corticosteroids No effect AQX-1125 compares favorably to other anti-inflammatory drugs for COPD 11

12 AQX-1125 Overview Desirable properties for oral once daily dosing Positive Phase 1 & Phase 2a PoC clinical trials > 100 subjects dosed Novel mechanism of action with broad antiinflammatory properties and strong translation from preclinical to clinical Patent coverage in major markets until 2028 Aquinox currently holds worldwide rights 12

13 COPD Exacerbations ~600 million affected globally Despite numerous therapies, majority of moderate to severe patients still suffer exacerbations High unmet need for effective oral anti-inflammatories that reduce exacerbations and slow/prevent disease progression AQX-1125 s anti-inflammatory and anti-fibrotic properties and its tolerability may provide clear competitive differentiation 13

14 Targeting Unstable Patients with Frequent Exacerbations AQX Unstable Bronchodilators Stable Hurst et al, AJRCCM, 2009, 79:

15 FLAGSHIP Trial: Summary Objective: Evaluate AQX-1125 in COPD patients post exacerbation ~400 moderate to severe COPD patients from EU and AUS / NZ Endpoints: Primary: Sized to detect effect of AQX-1125 (200 mg capsule q.d.) vs. placebo on recurrent COPD exacerbations over 12 weeks (reduction of AAC for EXACT*) utilizing ediaries Secondary: CAT, PFT, safety, PK, healthcare utilization (rescue meds / hospitalization) Key Milestone Dates: First Paent Q Top- line data Q Full data 2015 at Scienfic Meeng *EXACT= EXAcerbaons of Chronic obstrucve pulmonary disease Tool 15

16 EXACT-PRO Developed by Specialists in Outcome Measurement & Pharma Consortium AZ, Almirall, Bayer, BI, Forest, GSK, Merck, Novartis, Ortho-McNeil, Pfizer, Sepracor FDA guidance received January 2014 Designed to standardize the method for evaluating the frequency, severity, and duration of acute exacerbations of COPD Patient reported outcome (PRO) daily questionnaire utilizing ediaries Developed with considerable regulatory consultation (FDA and EMA) EXACT together with PFTs offer more robust evaluation of diseasemodifying drugs in unstable COPD patients 16

17 BPS/IC ~14 million affected in the US Disease driven by chronic inflammation and pain following damage to bladder lining Common treatment approach: direct instillation for short-term relief of symptoms After oral dosing, AQX-1125 reaches bladder systemically and by clearance through urine AQX-1125 s distribution and anti-inflammatory properties make it compelling for BPS/IC investigation 17

18 LEADERSHIP Trial: Summary Objective: Evaluate AQX-1125 in subjects with BPS/IC pain Endpoints: ~70 moderate to severe patients from Canadian and US sites IND Accepted by FDA in May, 2014 Primary: Sized to detect effect of AQX-1125 (200 mg capsule once daily) vs. placebo on reduction of mean pain score (11 point NRS*) at 6 weeks vs. baseline utilizing ediaries Secondary: urinary symptoms, safety, PK, QOL Key Milestone Dates: First Paent Q Top- line data Q Full data 2015 at Scienfic Meeng *NRS= Numerical Rang Scale 18

19 Key Milestones COPD Exacerbations First patient: Q Top-line Data: Q Scientific Meeting: 2015 BPS/IC First patient: Q Top-line Data: Q Scientific Meeting: 2015 Additional AQX-1125 Trials: 1 st Phase 2 Trial Initiated: Q nd Phase 2 Trial Initiated: Q Next Generation Compounds: Lead Selection: Q Near-term data, expanded market opportunities and pipeline advancement 19

20 Targeted Therapeutics for Inflammatory Disease Corporate Presentation

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