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Aimmune Therapeutics Announces COO Transition

— COO Howard Raff to Retire from Leadership Position to Focus on
Future Pipeline Development

— Aimmune Builds Clinical Team with Key Allergist / Immunologist Hires —

BRISBANE, Calif.--(BUSINESS WIRE)--Oct. 9, 2015-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing desensitization treatments for food allergies, today announced that Aimmune’s Chief Operating Officer, Howard Raff, Ph.D., who joined the company as its second employee upon its 2011 founding as Allergen Research Corporation, will retire from his position on October 31, 2015. Dr. Raff will become a consultant for Aimmune, working on developing future product opportunities for food allergens.

Aimmune expects to announce a new Chief Operating Officer, with substantial commercial experience, in the coming weeks.

“Many of Aimmune’s accomplishments to date, especially around our drug development and regulatory pathway, are direct results of Howie’s rolling up his sleeves and making them happen,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “I have had the pleasure of working with Howie for more than a decade, and I am delighted for him to take this opportunity, after getting us to a Phase 3-ready state, to move from day-to-day functions to a visionary role and explore other potential applications of our expertise to help food allergy patients. Everyone at Aimmune is grateful for Howie’s contributions and appreciates the robust operations team he has assembled. I know that he is looking forward to working closely with our new COO to transition effectively when that individual comes on board.”

Aimmune has also enhanced the capabilities of its clinical team with the additions of Brian Vickery, M.D., and Sean Bennett, M.D., Ph.D., as Senior Medical Directors in the United States and Andrea Vereda, M.D., Ph.D., as Medical Affairs Director for Europe. Dr. Vickery, who is board-certified in allergy and immunology and completed a fellowship in allergy and clinical immunology at Yale University, will also be an Adjunct Professor of Pediatrics at the University of North Carolina at Chapel Hill. As an Assistant Professor of Pediatrics at UNC and at Duke University, Dr. Vickery worked closely with Dr. Wesley Burks, a leading expert on food allergy. Dr. Bennett, a pediatrician who earned his M.D. and Ph.D. in microbiology and immunology from the University of Colorado, joined Aimmune from Gilead Sciences, where he focused on pediatric development programs. Dr. Vereda, an allergist who earned her M.D. and Ph.D. at the Universidad Autónoma de Madrid and received additional training and conducted research in allergy at Mt. Sinai Hospital in New York City, has also collaborated with the World Allergy Organization on global projects.

“Brian, Sean and Andrea all bring key understanding and experience to our clinical team, and each contributes a unique perspective as we prepare to launch our Phase 3 clinical trial for AR101,” said Aimmune’s Chief Medical Officer, Robert Elfont, M.D., Ph.D. “In addition to seeing and treating food allergy patients, Brian has worked extensively with academic clinical trials, including as the lead investigator for the ongoing DEVIL (Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance) study. Sean is the ideal biotech complement, with deep experience leading global cross-functional teams for several compounds through the various phases of clinical development. And Andrea has performed important research and investigated issues with leading allergists around the world. Our team is excited to apply our collective expertise to advance the development of much-needed treatments for food allergy sufferers.”

About AR101 and CODIT™

Aimmune Therapeutics is developing AR101 as a potential desensitization therapy for patients with peanut allergy to provide them with protection from peanut allergens at a level believed to substantially exceed the amount typically encountered in an accidental exposure. AR101 is a complex mixture of naturally occurring proteins and pharmaceutical-grade inactive ingredients designed to enable the convenient dosing of consistent amounts of peanut protein with well-defined concentrations of peanut allergens. Patients ingest AR101 mixed into small amounts of palatable, age-appropriate food.

AR101 is part of Aimmune’s approach to treating food allergies using its characterized oral desensitization immunotherapy, or CODIT™, system. The CODIT system leverages extensive independent scientific research on oral immunotherapy, or OIT, demonstrating that food allergy patients can be desensitized to food allergens by being administered well-defined, gradually increasing doses of the allergen over a period of months. Aimmune’s CODIT system is designed to precisely control the amounts of the allergens administered in a systematic dosing regimen, beginning with very low doses of the allergens. Once a patient attains desensitization to a clinically meaningful level, the patient continues to take a daily maintenance dose of the CODIT system product in order to maintain the desensitization.

About Food Allergies

Food allergies are a significant and growing health problem in the United States, Europe and throughout the developed world. It is estimated that more than 30 million people in the United States and Europe have a food allergy, and more than five million people in the United States and Europe have peanut allergy, including more than two million children. The prevalence of peanut allergy in children in the United States is estimated to have increased at a constant annual growth rate of approximately 10 percent between 1997 and 2008, and experts believe it has continued to rise since 2008. For people living with food allergies, certain foods can cause severe allergic reactions, including potentially life-threatening anaphylaxis. There are no approved medical therapies to cure food allergies or prevent their effects. Currently, food-allergic patients manage their condition by strict allergen avoidance and carrying epinephrine auto-injectors for use in case of accidental exposure. Thus, in addition to the unmet medical need, food allergies can impose a significant quality of life burden. For more information, please see www.foodallergy.org and www.niaid.nih.gov/topics/foodallergy.

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., founded in 2011 as Allergen Research Corporation (ARC), is a clinical-stage biopharmaceutical company developing treatments for peanut allergy and other food allergies. Aimmune Therapeutics’ characterized oral desensitization immunotherapy (CODIT™) system, an approach to oral immunotherapy (OIT), uses rigorously characterized product candidates with gradual, controlled up-dosing protocols to obtain clinically meaningful desensitization to food allergens. Aimmune Therapeutics recently completed a Phase 2 study of its lead product, AR101, a complex mixture of naturally occurring proteins and pharmaceutical-grade ingredients for the treatment of peanut allergy, one of the most common food allergies. For more information, please see www.aimmune.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune’s clinical development plans and anticipated executive hiring. Risks that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will incur losses for the foreseeable future and will need additional funds to finance its operations; the accuracy of the company's estimates regarding its ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; reliance on third parties for the manufacture of the Company's product candidates; regulatory developments in the United States and foreign countries; and the Company’s ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune's most recent filings with the Securities and Exchange Commission, including the prospectus relating to the initial public offering dated August 5, 2015, and the Quarterly Report on Form 10-Q for the second quarter of 2015 dated August 31, 2015. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

This press release concerns a product that is under clinical investigation and which has not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). It is currently limited to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated.

Source: Aimmune Therapeutics, Inc.

Media:
Edelman
Amanda Breeding, 415-229-7649
amanda.breeding@edelman.com
or
Investors:
Aimmune Therapeutics, Inc.
Amy Figueroa, 650-352-1039
investorrelations@aimmune.com