Aimmune Therapeutics Announces Financial Results for the Third Quarter 2015

BRISBANE, Calif.–(BUSINESS WIRE)–Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company
developing desensitization treatments for food allergies, today
announced financial results for the third quarter and nine months ended
September 30, 2015.

“As we near the end of 2015, I am very pleased with the progress we have
made, both as a growing company and with our lead asset AR101 for the
treatment of peanut allergy, which is moving into Phase 3 imminently,
with clinical sites opening next month. We recently cleared a final
hurdle to this pivotal registration trial by completing the efficacy
portion of our ARC002 study, the follow-on to our ARC001 Phase 2 study,”
said Stephen Dilly, M.B.B.S., Ph.D., Chief Executive Officer of Aimmune.

“We are looking forward to launching the PALISADE Phase 3 pivotal trial,
and we are very grateful for the thoughtful guidance we’ve received from
regulatory authorities on both sides of the Atlantic in designing this
registration trial for children, adolescents and adults. We remain
laser-focused on excellent execution, the hallmark of our leadership
team of drug development experts who have filed more than 30 previous
BLAs, NDAs and MAAs among us.”

“PALISADE is expected to enroll 500 peanut-allergic patients ages 4-55
years in over 60 centers in North America and Europe,” added Robert
Elfont, M.D., Ph.D., Chief Medical Officer of Aimmune. “We believe the
similarity of PALISADE to our ARC001 Phase 2 trial, which delivered
positive efficacy and safety data, derisks the clinical design of this
registration trial, as does the experience of more than a thousand
patients who have been desensitized to peanut protein via oral
immunotherapy (OIT) in academic and specialist centers.

“More than 5 million people in the United States and Europe have peanut
allergy, which is usually a lifelong condition. AR101 is aimed at
treating patients in age groups representing more than 90 percent of the
peanut allergic population,” continued Dr. Elfont. “We are acutely aware
of the need to protect people of all ages from accidental exposure so
that they can move safely into new environments — the children starting
school, the teens becoming more independent and increasingly operating
outside parental supervision, and the adults who want to participate
more freely in the many aspects of daily life where peanuts may be
present.”

Recent Progress

  • Aimmune has received approval from the European Medicines Agency (EMA)
    for the company’s pediatric investigation plan, or PIP, for AR101 for
    the treatment of peanut allergy. In Europe, an approved PIP is a
    required component of the EMA regulatory approval process. A Marketing
    Authorisation Application (MAA) can be accepted only if the sponsor
    has an approved PIP and has completed the relevant studies outlined in
    that plan.
  • Aimmune expects the $168 million in net proceeds from its initial
    public offering (IPO) in August 2015 to enable the company to advance
    AR101 through the PALISADE Phase 3 trial to obtain pivotal data to
    support regulatory filings in the United States and the European Union.

Upcoming Milestones

  • Aimmune plans to initiate enrollment in the PALISADE (PEANUT ALLERGY
    ORAL IMMUNOTHERAPY STUDY OF AR101 FOR DESENSITIZATION
    IN CHILDREN AND ADULTS) Phase 3 pivotal trial for AR101 at the
    beginning of 2016 to support regulatory submissions in the United
    States and the European Union. PALISADE is an international,
    randomized, double-blind, placebo-controlled trial that is expected to
    enroll approximately 500 peanut-allergic children, adolescents and
    adults ages 4-55 years. AR101 has received the FDA’s Breakthrough
    Therapy Designation for the desensitization of peanut-allergic
    patients 4-17 years of age.
  • Aimmune plans to release results from its ARC002 Phase 2 trial for
    AR101 at the American Academy of Allergy, Asthma, and Immunology
    (AAAAI) meeting in March 2016. The ARC002 trial is the open-label,
    follow-on study to the ARC001 Phase 2 trial. It was designed to
    provide long-term safety and tolerability data for AR101 and to
    replicate the efficacy results from the ARC001 trial in placebo
    patients crossing over to receive AR101 for 22 weeks of updosing.
    ARC002 was also designed to measure ongoing desensitization using
    AR101 as a low-dose daily maintenance therapy. A double-blind,
    placebo-controlled food challenge (DBPCFC) was administered after 22
    weeks of updosing and then again after 12 weeks of a low daily dose of
    300 mg of AR101 maintenance therapy. Desensitization was assessed by
    passing the primary endpoint of 443 mg of cumulative peanut protein,
    as well as at two higher challenge levels, 1,043 mg and 2,043 mg. As
    previously reported, in the ARC001 trial, 100 percent (23/23) of
    patients completing the trial and 79 percent (23/29) of patients in
    the intent-to-treat analysis tolerated exposure to cumulative doses of
    at least 443 mg of peanut protein in a DBPCFC after an average of 22
    weeks of treatment.
  • Aimmune plans to initiate two Phase 2 studies of characterized oral
    desensitization immunotherapy (CODIT™) product candidates in 2016.

Third Quarter 2015 Financial Results

For the third quarter and nine months ended September 30, 2015, net loss
was $9.0 million and $19.8 million, respectively. This compares to net
loss of $3.1 million and $7.5 million for the comparable periods in 2014.

On a per share basis, net loss for the third quarter and nine months
ended September 30, 2015, was $0.36 and $1.73, respectively. This
compares to net loss per share of $1.07 and $2.56 for the comparable
periods in 2014. The weighted average shares outstanding for the third
quarter and nine months ended September 30, 2015, were 25.1 million and
11.4 million shares, respectively, compared to 2.9 million shares for
both comparable periods in 2014. On August 5, 2015, Aimmune completed
its IPO, and Series A and Series B preferred stock were converted to
common stock. At September 30, 2015, Aimmune had 42.2 million shares of
common stock outstanding.

Research and development expenses were $3.9 million for the third
quarter of 2015 and $9.1 million for the nine months ended September 30,
2015, compared to $2.5 million and $5.5 million, respectively, for the
comparable periods in 2014. This increase was primarily due to increased
clinical trial and contract manufacturing costs for the AR101
development program.

General and administrative expenses were $5.2 million for the third
quarter of 2015 and $10.8 million for the nine months ended September
30, 2015, compared to $0.7 million and $2.0 million, respectively, for
the comparable periods in 2014. This increase was primarily due to
additional personnel to support the company’s growth and consulting
services incurred for market research and commercial strategy.

Cash, cash equivalents and investments totaled $219.4 million at
September 30, 2015, compared to $2.3 million at December 31, 2014. Total
cash at September 30, 2015, reflected the $168 million in net proceeds
from Aimmune’s IPO in August 2015.

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 formulation of naturally occurring peanut proteins and
pharmaceutical-grade inactive ingredients. Aimmune tests AR101 for three
key allergenic proteins (Ara h1, h2 and h6), which are representative of
the full range of peanut allergens. This process ensures the consistency
of AR101 and enables 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 plans to initiate enrollment in a
Phase 3 study of its lead product, AR101, a complex mixture of natural
peanut proteins and pharmaceutical-grade ingredients for the treatment
of peanut allergy, one of the most common food allergies, at the
beginning of 2016. 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: the timing and size of Aimmune’s planned Phase
3 trial; Aimmune’s plans regarding additional clinical trials and
release of data; Aimmune’s expectations regarding the potential benefits
of AR101; and Aimmune’s expectations regarding potential applications of
the CODIT™ system. 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; 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 the prospectus relating to
the initial public offering dated August 5, 2015, and the Quarterly
Report on Form 10-Q for the third quarter of 2015 filed on or about the
date of this release. 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.

 
AIMMUNE THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET
(In thousands)
       
September 30, December 31,
2015

2014 (1)

(unaudited)    
Assets
Cash and cash equivalents $ 112,661 $ 2,269
Short-term investments 103,946
Prepaid expenses   1,180   106  
Total current assets 217,787 2,375
Long-term investments 2,784
Property and equipment, net 1,829 87
Restricted cash 100 40
Other assets   314   29  
Total assets $ 222,814 $ 2,531  
 
Liabilities and Stockholders’ Equity
Current liabilities $ 3,100 $ 1,804
Other liabilities   826   56  
Stockholders’ equity   218,888   671  
Total liabilities and stockholders’ equity $ 222,814 $ 2,531  
 
(1) Derived from the audited financial statements,
included in the company’s registration statement on Form S-1 dated
August 5, 2015.
 
 
AIMMUNE THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)
           

Three Months Ended
September 30,

Nine Months Ended
September 30,

2015 2014 2015 2014
Operating Expenses
Research and development(1) $ 3,850 $ 2,469 $ 9,050 $ 5,470
General and administrative(1)   5,174   660   10,792   2,028
Total operating expenses   9,024   3,129   19,842   7,498
Loss from operations (9,024 ) (3,129 ) (19,842 ) (7,498 )
Other income (expense), net
Interest income   33   0   34   12
Net loss and comprehensive loss $ (8,991 ) $ (3,129 ) $ (19,808 ) $ (7,486 )
Other comprehensive loss, net of tax:
Unrealized losses on investments   (2 )     (2 )  
Other comprehensive loss   (2 )     (2 )  
Comprehensive loss $ (8,993 ) $ (3,129 ) $ (19,810 ) $ (7,486 )
 
Net loss per common share, basic and diluted $ (0.36 ) $ (1.07 ) $ (1.73 ) $ (2.56 )
Shares used in computing net loss per share, basic and diluted(2) 25,149,428 2,926,665 11,446,922 2,926,665
                 
(1) Includes employee stock-based compensation charges of:
 

Three Months Ended
September 30,

Nine Months Ended
September 30,

2015 2014 2015 2014
Research and development $ 300 $ 5 $ 396 $ 14
General and administrative   1,462   12   2,355   34
$ 1,762 $ 17 $ 2,751 $ 48
 
(2) At September 30, 2015, Aimmune had 42,249,431 shares
of common stock outstanding.
 

Contacts

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