Corporate Presentation April 2016 Forward-Looking Statements This - PowerPoint PPT Presentation

Corporate Presentation April 2016

Forward-Looking Statements This presentation contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, clinical development plans, anticipated milestones, product candidate benefits, potential market size, product adoption, market positioning, competitive strengths, product development, and other clinical, business and financial matters. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially. Risks and uncertainties include, but are not limited to, our limited operating history, our need for additional financing to achieve our goals, our dependence on our lead product AR101, the need for additional clinical testing of AR101, uncertainties relating to the regulatory process, uncertainties relating to the timing and operation of clinical trials, potential safety issues, possible lack of market acceptance of our product candidates, the intense competition in the biopharmaceutical industry, our dependence on exclusive third-party suppliers and manufacturers, and limitations on intellectual property protection. A further list and description of these risks, uncertainties and other factors can be found in our report on Form 10-K for the year ended December 31, 2015. Copies of this filing are available online at www.sec.gov or www.aimmune.com. Any forward-looking statements made in this presentation speak only as of the date of the presentation. We do not undertake to update any forward-looking statements as a result of new information or future events or developments. 2

Aimmune Investment Highlights (Nasdaq: AIMT) Public Company Initially Focused on Peanut Allergy  Peanut allergy is a serious chronic disease affecting all age groups  Over 5M peanut-allergic patients in U.S. and Europe, 50% react to less than half a peanut Lead Program AR101 is First Application of CODIT ™ System  FDA Breakthrough Therapy and Fast Track Designations  Robust clinical data in peanut allergy desensitization  Technology is applicable to other food allergies Potential Near-Term Commercialization: Global Phase 3 Underway  Pivotal Phase 3 across ~60 sites in 11 countries (U.S., Canada, EU); patients ages 4-55  Targeting pivotal data in 2017 and BLA filing in 2018  IP protection and full global rights to all programs Capital and Experience to Deliver  Seasoned team: Leaders with >30 approved NDAs, BLAs and MAAs  Funded through pivotal data with ~$200M in cash and investments (12/31/15) 3

Why Is This Important? Peanut protein can be difficult to spot One accident can be fatal 4

Peanut Allergy Population Is Large And Growing Prevalence of peanut allergy in U.S. and EU5 Peanut Allergy is… Millions of patients (age 1-55)  Prevalent: >5 million patients in the 7.5 U.S. and EU5 6.8 – Number of peanut allergic children in the U.S. tripled 6.1 between 1997-2008, continues 5.3 3.8 to grow 3.4  Chronic: Only 20% lifetime chance 3.0 U.S. 2.6 of resolution  Dangerous: ~100 deaths and 100,000 ER visit per year  Burdensome: More Quality of Life 3.7 3.4 3.1 EU5 2.8 impact than Type 1 Diabetes  Not Treated: Zero approved treatments* 2015E 2020F 2025F 2030F Source: FARE, Gupta (2013), Avery (2003), Cummings (2010), Sicherer (2010), Venter C (2010), Hourihane JO (2007), Nicolaou (2010), World Bank, Euromonitor, Aimmune internal analysis 5 * Available options are limited to food avoidance, use of antihistamines and rescue therapy (epinephrine injections)

The Diagnosis of Peanut Allergy Encompasses a Wide Range of Sensitivity About 50% of Patients are Sensitive …Often by Only Trace Amounts to Half a Peanut or Less… Found in Everyday Foods Triggering % of Food Amount Patients Equivalent Cumulative % Responses 50% of Patients ≤5 mg ~1% 5-50 mg ~35% ~100 mg Peanut Protein 51-100 mg ~10% 1/3 Source: VITAL 2.0 study*  A Useful Treatment Should Protect the Most At-Risk Patients  Patients with Low Thresholds are at Greatest Risk from Accidental Exposure Sources: Deschildre (2015) MIRABEL study, Allen (2013) VITAL 2.0 study * Allergen reference doses for precautionary labeling. Graphic retrieved from Zurzolo (2013) 6

Oral Immunotherapy (OIT) A Promising Approach to Treat Peanut Allergy Published History of Safe, Effective Use for 100+ Years in >1,000 Patients  Desensitization with orally administered peanut protein – Start with very low dose unlikely to trigger acute reaction  Gradually increase protein dose over time (6 months – 2 years) to target dose – Long term maintenance at daily target dose  Achieves near 100% desensitization in patients who complete therapy – Protection is a multiple of daily maintenance dose  Favorable tolerability profile – No persistent side effects; infrequent and transient eosinophilic esophagitis (EoE) High Demand but No Approved Product  Only ~40 U.S. centers have OIT programs based on pharmacy compounded ‘home-brew’  Two-year wait at some centers, families moving for treatment  74% of surveyed allergists* would adopt an FDA-approved peanut OIT product *Greenhawt MJ, Vickery BP J Allery Clin Immunol Pract (2015) 7

A Collective Call to Action for an FDA-Approved Oral Immunotherapy (OIT) Product  Aimmune grew out of a 2011 meeting with patient advocates, FDA, NIH, academic leaders, and industry representatives  All stakeholders called for rigorous pharmaceutical development of an OIT product OIT Recognized as a Promising Approach to Deliver Reliable Protection Against Accidental Exposure for Food Allergy Patients 8

Proprietary CODIT ™ Platform Refines OIT; Aims to Transform Treatment of Food Allergies CODIT ™ Makes  Standardized, regulated, biologic drug product ‘AR101’ Peanut OIT a  Convenient supply & packaging enables Practical use at scale Reality  Optimized protocol to minimize adverse AR101 reactions while maintaining efficacy and reliable protection  Quality GMP manufacturing QC/QA focused on scale and stability testing  Tailored commercial offering compatible with and reinforcing current allergy practice  Support services for patients and physicians to aid long-term compliance 9

How CODIT™ Works Food Allergy Desensitization Development of allergy Allergic response to food Ag Ag Ag Ag Ag Ag Ag Gut dendritic cell Gut mast cell B cell T Reg cell Basophil + Decreased Th0 cell Th2 cell IgE levels Th2 cell plus IL-4, 5, 6, 19, 13, etc. Free + IgG4 Ag + Eosinophil Ag Ag Basophil B cell IgG4-producing Eosinophil Increased plasma cell IgG4 levels Mast cell Desensitization degranulation induces T Reg and Food allergen binds to IgE, IgG4 production, Free IgE triggering massive mast cell which inhibits IgE Mast-cell degranulation and Th2-mediated response to Mast-cell bound IgE bound IgG4 inflammatory cascade allergen challenge 10

AR101 Phase 2 Trials: Up-Dosing and Maintenance Phase 2 (ARC001 and ARC002): Phase 2b (ARC002): ~22 weeks up-dosing ~12 weeks maintenance 300 mg Exit DBPCFC Additional Endpoint: at ~22 Weeks ~8 Tolerate 2,043 mg* 10-Step CODIT ™ 6 mg Up-Dosing to 300 mg Day 1 Primary Endpoint: ~1.5 Tolerate 443 mg* Additional Endpoint: Entry DBPCFC ~4 Tolerate 1,043 mg* at Screening Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) Key inclusion criterion: ~0.2 Tolerate ≤ 43 mg* * Reflects cumulative dose in the DBPCFC; Tolerate = dose is tolerated with no dose-limiting symptoms 11

ARC002 Phase 2b Results Intention-to-Treat (ITT) Completers n=47 n=40 100% 100% % of Subjects Tolerating % of Subjects Tolerating 80% 80% 60% 60% 100% 90% 85% 40% 79% 40% 60% 51% 20% 20% 0% 0% Cumulative 2,043 mg 1,043 mg 443 mg 2,043 mg 1,043 mg 443 mg Dose: AR101 Efficacy Improves with 12 Weeks Maintenance Therapy Plus ~22 Weeks Up-Dosing Bird A, et al. AAAAI 2016 12

AR101 Prevented and Blunted Reactions to Clinically Relevant Amounts of Peanut Protein Food Challenge Symptom Severity at 6 Months Maximal Symptom Severity None Mild Moderate Severe n=26 n=25 n=23 n=17 n=12 n=6 Placebo 100% Reactions Requiring Epinephrine 50% Placebo : 11 patients (3 required 2 injections) 0 Cumulative Dose: 3 mg 13 mg 43 mg 143 mg 443 mg 1,043 mg n=44 n=44 n=44 n=44 n=44 n=42 AR101 100% Reactions Requiring Epinephrine AR101: 2 patients 50% (0 required 2 injections) 0 Cumulative Dose: 3 mg 13 mg 43 mg 143 mg 443 mg 1,043 mg Real World: 13 Burks W, et al. EAACI 2015; Bird A, et al. AAAAI 2016

AR101 Drove >2,000mg Increase in Median Tolerated Dose in Phase 2 Food Challenge Results (Maximum Tolerated Dose) at 9 Months Group Median Tolerated Dose Placebo AR101 in Food Challenge n=26 n=40 Baseline sensitivity (week 0) 28 mg 13 mg Week 22 (after up-dosing) 43 mg 1,043 mg Week 36 (after maintenance) n/a 2,043 mg Increase in Median Tolerated Dose on 2,030 mg AR101 Phase 2 Efficacy Supports Phase 3 Primary Endpoint of Tolerating 1,043 mg 14