Aimmune Therapeutics Announces Third Quarter 2016 Financial Results And Provides Corporate Update

Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing CODIT™ ( Characterized Oral Desensitization Immuno Therapy) treatments for life-threatening food allergies, today announced financial results for the third quarter of 2016. For the quarter and nine months ended September 30, 2016, net loss was $22.1 million and $55.7 million, respectively, compared to a net loss of $9.0 million and $19.8 million for the comparable periods in 2015. As of September 30, 2016, Aimmune had $159.3 million in cash, cash equivalents and investments compared to $199.8 million at December 31, 2015. Aimmune also recently announced a $145.0 million equity investment by Nestlé Health Science, which it expects to close in the fourth quarter.

"These are exciting times at Aimmune with the recently announced equity investment by Nestlé Health Science, completion of North American enrollment in the Phase 3 PALISADE trial of AR101, and progress on plans for RAMSES, a real-world experience trial of AR101," said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. "Our research and development expenses were significantly higher this quarter as a result of exceeding our enrollment target in PALISADE in North America and a lower patient dropout rate than initially projected. We expect to complete European enrollment in PALISADE by year-end, keeping us on track for top-line data in the fourth quarter of 2017. In addition, we look forward to initiating RAMSES in early 2017 and beginning our collaboration with Nestlé Health Science. Their investment will put us in a strong cash position of approximately $300 million and enable important additional pipeline advancement activities beyond AR101 for peanut allergy. We look forward to sharing additional details on our development plans and progress in the coming months."

Corporate Highlights

Equity Investment by Nestlé Health Science . In November, Aimmune announced that Nestlé Health Science will make a $145.0 million equity investment in Aimmune. Aimmune and Nestlé Health Science also entered into a strategic collaboration agreement designed to enable the successful development and commercialization of innovative food allergy therapies. Aimmune will retain all current and future pipeline assets developed with the CODIT approach, including AR101. Nestlé Health Science will receive 7,552,084 newly issued shares of Aimmune's common stock, corresponding to a 15 percent stake, after the completion of the transaction. Assuming the closing of the transaction, Aimmune will have approximately 49.9 million shares of common stock outstanding. The collaboration does not include any development milestones, product marketing rights or royalties.

Addition to the Aimmune Board of Directors. In connection with the Nestlé Health Science equity investment and collaboration, Aimmune announced that Nestlé Health Science Chief Executive Officer Greg Behar will join the Aimmune Board of Directors.

Independent Study Published Demonstrating Oral Immunotherapy Induces Sustained Unresponsiveness in Very Young Children. In August, Aimmune announced that the results of an independent academic clinical trial called DEVIL (Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance) were published in the Journal of Allergy and Clinical Immunology, demonstrating the ability of low-dose oral immunotherapy to induce sustained unresponsiveness in peanut-allergic children under three years of age. While the current focus of the AR101 development program is induction and maintenance of desensitization through continued treatment, the DEVIL findings suggest that early intervention with oral immunotherapy in newly diagnosed children under three years of age can lead to a very high rate of disease modification. Aimmune intends to build on the DEVIL observations by expanding its research with AR101 into younger children.

AR101 Development Highlights

Completed North American Enrollment in Phase 3 PALISADE TRIAL of AR101. In September, Aimmune announced completion of North American enrollment in PALISADE. The company exceeded its target of 350 patients randomized in the U.S. and Canada ahead of schedule and expects final enrollment to be between 425 and 450 patients in North America. PALISADE enrollment in Europe is ongoing and is expected to complete by the end of 2016. Accordingly, the company continues to expect that top-line data from PALISADE will be available in the fourth quarter of 2017, followed by regulatory submissions for marketing approval of AR101 in both the U.S. and Europe in 2018.

Announced Plans for RAMSES Real-World Experience Trial of AR101. In September, Aimmune announced plans to begin enrolling patients in the RAMSES ( Real-World AR101 Market- Supporting Experience Study) trial in early 2017. RAMSES is a 2:1 randomized, double-blind, placebo-controlled trial, which will not require an oral food challenge for entry. Instead, patients will be selected based on stringent entry criteria, including a well-documented medical history of IgE-mediated reactions to peanut (including anaphylaxis), skin reactivity, and analyses of peanut-specific immunological markers. The study will monitor treatment-emergent adverse events during the initial six-month dosing period and thereafter. Aimmune expects that the absence of an entry food challenge may further improve the tolerability profile of AR101 in early stages of dosing by removing exposure to high levels of peanut allergen that may otherwise prime the immune system prior to treatment.

AR101 Phase 2 Data Presentations

Today, Aimmune reported further insights on peanut-specific biomarkers and immune responses from its Phase 2 studies of AR101 in two oral presentations (Abstracts #O055 and #O056) at The 2016 Annual Scientific Meeting of the American College of Asthma, Allergy & Immunology (ACAAI). Data presented suggest that baseline levels of the biomarker peanut-specific IgE = 100 kUA/L may predict up-dosing completion and treatment response to AR101. According to the published scientific literature, at least 80 to 90 percent of people with peanut allergy have peanut-specific IgE levels below this threshold. The company also reported that peanut-specific biomarkers continue to improve with long-term maintenance therapy on 300 mg of AR101 per day. Specifically, after 22 weeks of up-dosing and 26 weeks of maintenance therapy, peanut-specific IgE levels decreased from 35.8 kUA/L at baseline to 27.8 kUA/L, while peanut-specific IgG4 increased from 0.6 kUA/L to 10.6 kUA/L. The production of IgG4 antibodies and a decrease in both IgE antibody levels and in the ratio of antigen-specific IgE to IgG4 are immuno-regulatory changes that have been associated with successful immunotherapy in previously published studies.

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