Aimmune Therapeutics Announces Fourth Quarter and Full Year 2015 Financial Results and Provides Corporate Update

─ Company Began 2016 with Approximately $200 Million in Cash and
Investments and Its Phase 3 PALISADE Trial Underway for Peanut Allergic
Patients ─

─ Late-Breaker Presentation on New AR101 Phase 2 Data This Sunday at
AAAAI ─

─ Conference Call and Webcast Today at 5 p.m. Eastern Time / 2 p.m.
Pacific Time ─

BRISBANE, Calif.–(BUSINESS WIRE)–Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company
developing CODIT™ (characterized oral desensitization immunotherapy)
treatments for life-threatening food allergies, today announced
financial results for the fourth quarter and full year 2015 and provided
a corporate update. The company recently initiated a pivotal Phase 3
trial, PALISADE, of its lead product candidate, AR101 for the treatment
of peanut allergy.

“The year 2015 was a transformational one for Aimmune highlighted by
achieving positive Phase 2 results and receiving Fast Track and
Breakthrough Therapy Designations for AR101, completing a successful
initial public offering, and commencing the pivotal Phase 3 PALISADE
trial,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “With PALISADE
underway and a strong financial position, we are beginning 2016 with
great momentum and a sharp focus on execution. We look forward to
sharing additional Phase 2 results on AR101 this Sunday, which we
believe demonstrate that long-term desensitization to peanut allergens
can be achieved with a favorable safety and tolerability profile.

“With our Phase 3 trial, we hope to replicate the positive Phase 2
results on a much larger scale. We look forward to sharing our progress
in the year ahead and are extremely excited about the potential of AR101
to become the first FDA- and EMA-approved oral immunotherapy, capable of
providing reliable protection to accidental exposure for the millions of
peanut-allergic children, adolescents, and adults in the United States
and Europe.”

AR101 Highlights

Late-Breaker Presentation on AR101 at AAAAI Meeting Sunday, March 6,
2016.
As previously announced, Dr. J. Andrew Bird will present data
on the efficacy and safety of AR101 for the treatment of peanut allergy
from the ARC002 Phase 2 follow-on trial at the American Academy of
Allergy, Asthma, and Immunology (AAAAI) meeting on Sunday, March 6,
2016, at 2:30 p.m. Pacific Time (Abstract #L60). Patients who completed
ARC001, the initial Phase 2 trial, were eligible to participate in
ARC002, an open-label study designed to evaluate the long-term safety,
efficacy and tolerability of AR101. All abstracts for the 2016 AAAAI
Annual Meeting are available at www.jacionline.org.

Pivotal Phase 3 PALISADE Trial Underway. In January 2016, Aimmune
enrolled the first patient in the pivotal Phase 3 PALISADE (PEANUT
ALLERGY ORAL IMMUNOTHERAPY STUDY OF AR101
FOR DESENSITIZATION IN CHILDREN AND ADULTS) trial. PALISADE is an
international, randomized, double-blind, placebo-controlled trial of
AR101, which is expected to enroll approximately 500 peanut-allergic
children, adolescents and adults ages 4-55 years. PALISADE’s primary
endpoint is the proportion of patients who are able to tolerate at least
1,043 mg cumulative of peanut protein (equivalent to approximately 3 to
4 peanuts) at 12 months after initiation of therapy.

Regulatory Progress. In June 2015, Aimmune received Breakthrough
Therapy Designation for AR101 from the U.S. Food and Drug Administration
(FDA), and in October 2015, Aimmune 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.

Anticipated Milestones

Pivotal Phase 3 PALISADE Trial of AR101: (1) complete enrollment
in the second half of 2016; (2) complete up-dosing of patients in first
half of 2017; and (3) complete trial in the second half of 2017.

Additional Clinical Trials: Aimmune is planning to conduct
additional clinical trials of AR101 including ARC004, an open-label
rollover trial from PALISADE, expected to begin in the fourth quarter of
2016 and ARC005, a pediatric study that will include children ages one
to three, expected to begin in the second half of 2017.

Additional Product Candidates: Aimmune is developing new product
candidates leveraging its proprietary CODIT™ approach. The company
expects to file an investigational new drug application for egg allergy
in late 2016, followed by a third product candidate in 2017.

Fourth Quarter and Full Year 2015 Financial
Results

For the fourth quarter and year ended December 31, 2015, net loss was
$16.0 million and $35.8 million, respectively. This compares to net loss
of $3.6 million and $11.1 million for the comparable periods in 2014.

On a per share basis, net loss for the fourth quarter and year ended
December 31, 2015, was $0.39 and $1.88, respectively. This compares to
net loss per share of $1.24 and $3.80 for the comparable periods in
2014. The weighted average shares outstanding for the fourth quarter and
year ended December 31, 2015, were 41.6 million and 19.0 million shares,
respectively, compared to 2.9 million and 2.9 million shares for the
comparable periods in 2014. On August 5, 2015, Aimmune completed its
initial public offering (IPO), at which time its Series A and Series B
preferred stock was converted to common stock. At December 31, 2015,
Aimmune had 42.2 million shares of common stock outstanding.

Research and development expenses were $10.8 million for the fourth
quarter of 2015 and $19.8 million for the year ended December 31, 2015,
compared to $2.7 million and $8.2 million, respectively, for the
comparable periods in 2014. This increase was primarily due to increased
clinical trial and contract manufacturing costs and additional personnel
related costs to support the pivotal Phase 3 trial of AR101.

General and administrative expenses were $5.4 million for the fourth
quarter of 2015 and $16.2 million for the year ended December 31, 2015,
compared to $0.9 million and $3.0 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 $199.8 million at
December 31, 2015, compared to $2.3 million at December 31, 2014. Total
cash, cash equivalents and investments at December 31, 2015, reflected
the net proceeds from Aimmune’s IPO in August 2015 and Series B issuance
prior to the IPO.

Conference Call and Webcast

Aimmune management will discuss the Company’s financial results for the
fourth quarter and full year of 2015 and provide a general business
update during a conference call beginning at 5:00 p.m. Eastern Time/2:00
p.m. Pacific Time today, March 3, 2016. To listen to a live webcast of
the conference call, visit the Events page under Investor Relations at www.aimmune.com.
Alternatively, participants may dial 1-877-497-1438 (U.S.) or
1-262-558-6296 (international) and provide the conference call passcode
60127471 to join by phone.

An archived replay of the webcast will be available on the Events page
under Investor Relations at www.aimmune.com
for 30 days. An audio-only phone replay will be available until 11:59
p.m. EST on March 7, 2016. Access numbers for the phone replay are
1-855-859-2056 (U.S.) and 1-404-537-3406 (international); the passcode
is 60127471.

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 low daily maintenance dose of AR101 in order to maintain the
desensitization.

The FDA has granted AR101 both Fast Track Designation and Breakthrough
Therapy Designation for the desensitization of peanut-allergic patients
4-17 years of age.

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., is a clinical-stage biopharmaceutical
company developing treatments for peanut allergy and other
life-threatening food allergies. The company’s 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
initiated the Phase 3 PALISADE trial 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, in early 2016. AR101 has received the FDA’s Breakthrough
Therapy Designation for the desensitization of peanut-allergic patients
4-17 years of age. 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 trial,
including its expected size and the timing of enrollment and completion
of the trial; Aimmune’s expectations regarding the additional clinical
trials for AR101, including timing of initiation and release of data;
Aimmune’s expectations regarding the potential benefits of AR101;
Aimmune’s expectations regarding the timing of filing INDs for its egg
allergy and other development program; 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 its Annual Report on Form 10-K for the year ended
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 SHEETS
(In thousands)
                     

December 31,

2015

(unaudited)

December 31,

2014 (1)

Assets
Cash and cash equivalents

$

76,677

$

2,269

Short-term investments 115,158
Prepaid expenses and other current assets   5,622   106
Total current assets 197,457 2,375
Long-term investments 7,992
Property and equipment, net 2,702 87
Restricted cash 40
Prepaid expenses and other assets   4,210   29
Total assets

$

212,361

$

2,531

 
Liabilities and Stockholders’ Equity
Current liabilities

$

5,098

$

1,804

Other liabilities 1,012 56
Stockholders’ equity   206,251   671
Total liabilities and stockholders’ equity

$

212,361

$

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 STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
                               
Three Months Ended

December 31,

Twelve Months Ended

December 31,

2015 2014 2015 2014
Operating Expenses
Research and development (1) $ 10,766 $ 2,712 $ 19,816 $ 8,181
General and administrative (1)   5,389   923   16,181   2,951
Total operating expenses   16,155   3,635   35,997   11,132
Loss from operations (16,155 ) (3,635 ) (35,997 ) (11,132 )
Interest income, net   147     181   12
Net loss $ (16,008 ) $ (3,635 ) $ (35,816 ) $ (11,120 )
 
Net loss per common share, basic and diluted $ (0.39 ) $ (1.24 ) $ (1.88 ) $ (3.80 )
Shares used in computing net loss per basic and diluted share (2) 41,576,095 2,935,518 19,041,124 2,928,896
 

(1) Includes employee stock-based compensation expense
of:

 

 
 
Three Months Ended

December 31,

Twelve Months Ended

December 31,

2015 2014 2015 2014
Research and development $ 2,126 $ 9 $ 2,522 $ 23
General and administrative   1,280   20 $ 3,635 $ 54
Total stock-based compensation expense $ 3,406 $ 29 $ 6,157 $ 77
 
(2) At December 31, 2015, Aimmune had 42,238,900 shares
of common stock outstanding.

Contacts

Investors
Aimmune Therapeutics, Inc.
Laura Hansen, Ph.D.,
650-396-3814
lhansen@aimmune.com
or
Media
Edelman
Amanda
Breeding, 415-229-7649
amanda.breeding@edelman.com

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