AIMT Aimmune Therapeutics Inc

Aimmune Therapeutics Appoints Eric Bjerkholt as Chief Financial Officer

Aimmune Therapeutics, Inc. (Nasdaq:AIMT), today announced the appointment of Eric Bjerkholt as Chief Financial Officer.

Mr. Bjerkholt joins Aimmune from Sunesis Pharmaceuticals, Inc., where, over 13 years with the company, his role as CFO expanded to oversee multiple aspects of governance, corporate relations, and other functions. In addition to taking Sunesis through its initial public offering in 2005, he raised more than $400 million for the company in other financings. Prior to Sunesis, Mr. Bjerkholt was CFO at IntraBiotics Pharmaceuticals, Inc., and LifeSpring Nutrition, Inc. He began his healthcare career at J.P. Morgan & Co. as an investment banker in New York and then launched the company’s Western U.S. healthcare practice. Mr. Bjerkholt holds a Cand. Oecon. (master’s) degree in economics from the University of Oslo and an M.B.A. from Harvard Business School. He has served on the boards of directors of several publicly traded companies and is currently a member of the board of directors and chair of the audit committee for Corium International, Inc.

“I am delighted to further strengthen our executive team with the addition of Eric Bjerkholt,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “Eric’s deep understanding and direct experience of multiple facets of corporate finance and other related activities will be key assets in the years ahead.”

“This is a very exciting time to join Aimmune,” said Mr. Bjerkholt. “The lead product, AR101, is very promising, peanut allergy is a significant unmet need, and Aimmune is in a very strong financial position. The company plans to report pivotal Phase 3 data around the end of 2017, file a BLA and MAA in 2018, and make first commercial launches in 2019. Although there is much to be done, Aimmune has a highly experienced management team in place and is well-equipped to meet the challenges ahead. I am enthusiastic to get started at the end of April.”

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age and is currently being evaluated in Phase 3 clinical trials. 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 expectations for its Phase 3 PALISADE trial of AR101, including its expected size and timing of topline data; Aimmune’s expectations regarding the potential benefits of AR101; Aimmune’s expectations regarding the sufficiency of its capital resources; Aimmune’s expectations for the RAMSES and ARTEMIS studies, including the timing of the trials; Aimmune’s expectations on regulatory submissions for marketing approval of AR101 in the United States and Europe, including the timing of these submissions; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; the company’s ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s clinical trials will not be successful; Aimmune’s dependence on the success of AR101; the company’s reliance on third parties for the manufacture of the company’s product candidates; possible 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 its Annual Report on Form 10-K for the year ended December 31, 2016. 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 that 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.

EN
13/04/2017

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 PRESS RELEASE

European Commission Approves Aimmune’s PALFORZIA® as First-Ever Treatm...

VEVEY, Switzerland & LONDON--(BUSINESS WIRE)-- Aimmune Therapeutics, Inc., a Nestlé Health Science Company, today announced that the European Commission (EC) has approved PALFORZIA® [defatted powder of Arachis hypogaea L., semen (peanuts)] for the treatment of peanut allergy. PALFORZIA is indicated in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet and may be continued in patients 18 years of age and older. “Today’s approval is a historic moment for the millions of people living with potentially life-threatening peanut allerg...

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