Market Overview

Aimmune Therapeutics Announces Fourth Quarter and Full Year 2017 Financial Results

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  • Company began 2018 with approximately $182 Million in cash and
    investments
  • Pro-forma year-end 2017 cash and investments of approximately $372
    Million, including net proceeds from the recently completed public
    offering
  • Announced over-enrollment in the ARTEMIS Phase 3 trial
  • Additional AR101 clinical data readouts expected throughout 2018
  • Planned BLA Submission on Track for Year-End 2018

Aimmune Therapeutics, Inc. (NASDAQ:AIMT), a biopharmaceutical company
developing treatments for life-threatening food allergies, today
announced financial results for the fourth quarter and full year 2017.

"The progress we made in 2017 has set up 2018 as a potentially
transformational year for Aimmune," said Stephen Dilly, MBBS, Ph.D. "We
kicked off this year with positive Phase 3 PALISADE results, which form
the core clinical element for our regulatory submissions for approval of
AR101 to treat peanut allergy in the U.S. and Europe. We are extremely
pleased with the continued high level of enthusiasm from patients and
investigators in our trials, which have exceeded enrollment targets. In
parallel, we are advancing manufacturing and pre-commercial activities
in anticipation of a potential commercial launch. With proceeds from our
recently completed public offering, we are well financed to deliver on
our goals for AR101 and to drive our pipeline of CODIT™ products forward
for additional life-threatening food allergies."

Recent AR101 Program Highlights

Announced Positive Topline Results of Phase 3 PALISADE trial. In
February 2018, Aimmune announced that the Phase 3 PALISADE trial met its
primary endpoint, as 67% of AR101 patients ages 4–17 tolerated at least
a 600-mg dose of peanut protein in the exit double-blind
placebo-controlled food challenge (DBPCFC) compared to 4% of placebo
patients (p<0.00001). The lower-bound of the 95% confidence interval of
the difference between treatment arms at the primary endpoint was 53%,
greatly exceeding the pre-specified threshold of 15% (p<0.00001).
Serious adverse events related to study drug were reported in 1.1% of
AR101 patients ages 4–17. Three suspected cases of eosinophilic
esophagitis were observed with only one case confirmed following biopsy.

Over-Enrolled Phase 3 RAMSES Real-World Trial. In January 2018,
Aimmune announced over-enrollment of RAMSES, which does not require a
DBPCFC, and which will monitor treatment-emergent adverse events during
a six-month up-dosing period. Patients will then be followed in an
open-label manner for at least six months on the maintenance dose of 300
mg of AR101 per day. A total of 506 peanut-allergic patients ages 4-17
have been randomized to treatment with AR101 or placebo.

Over-Enrolled Phase 3 ARTEMIS Trial in Europe. In February 2018,
Aimmune completed enrollment of ARTEMIS in Europe. ARTEMIS is designed
to explore protection at an endpoint of tolerating a single dose of
1,000 mg of peanut protein in a DBPCFC after nine months of treatment. A
total of 175 patients ages 4-17 have been randomized to treatment with
AR101 or placebo.

Completed Enrollment in PALISADE Follow-On Trial ARC004. In
January 2018, Aimmune completed enrollment in ARC004,
which is designed to test the potential for reduced frequency of dosing
during the maintenance phase of AR101 therapy. A total of 358 patients
ages 4-17 years (92% of those who completed PALISADE) chose to
participate in ARC004.

4Q 2017 and Recent Corporate Highlights

Formed Clinical Collaboration with Regeneron and Sanofi. In
October 2017, Aimmune announced a partnership with Regeneron and Sanofi
to explore desensitization with AR101 with adjunctive dupilumab in
peanut-allergic patients in a Phase 2 clinical trial, which is expected
to begin in 2018.

Broadened and Extended Supply Agreement with Golden Peanut and Tree
Nuts
. In January 2018, Aimmune announced the expansion and extension
of its exclusive supply agreement with Golden Peanut and Tree Nuts, the
leading handler, processor, and exporter of peanuts and tree nuts, to
support the anticipated potential commercialization of AR101.

Expanded the Aimmune Scientific Advisory Board. In February 2018,
Aimmune announced that Prof. George du Toit and Dr. Wayne Shreffler,
leading academic experts in allergy and immunology, joined the company's
Scientific Advisory Board.

Upcoming Milestones

Timing     Milestone
2Q 18     Presentation of Phase 3 PALISADE data at the EAACI 37th
Annual Congress
2H 18     RAMSES data available
2H 18     Initiate ARC005 trial of AR101 in infants and toddlers
3Q 18     Data cut from ARC004
YE 18     Initiate Phase 2 trial of AR101 with adjunctive dupilumab
YE 18     Submit Biologics License Application for AR101 to the U.S. Food and
Drug Administration
YE 18     Submit Investigational New Drug Application for AR201 in egg allergy
1H 19     ARTEMIS data available
1H 19     Submit Marketing Authorisation Application for AR101 to the European
Medicines Agency
1H 19     Initiate Phase 2 clinical trial of AR201 in egg allergy
2H 19     Submit Investigational New Drug Application for AR301 in walnut
allergy
2H 19     Initiate Phase 2 clinical trial of AR301 in walnut allergy
2H 19     Potential approval of AR101 in the U.S.
   

Fourth Quarter and Full Year Financial Results

For the quarter and year ended December 31, 2017, net loss was $41.2
million and $131.3 million, respectively, compared to net loss of $25.1
million and $80.8 million for the comparable periods of 2016.

On a per share basis, net loss for the quarter and year ended December
31, 2017, was $0.81 and $2.61, respectively, compared to net loss per
share of $0.55 and $1.89 for the comparable periods of 2016. The
weighted average shares outstanding for each of the quarter and year
ended December 31, 2017, were 50.8 million and 50.4 million shares,
respectively, compared to 45.5 million and 42.8 million shares for the
comparable periods in 2016.

Research and development expenses for the quarter and year ended
December 31, 2017, were $28.7 million and $89.3 million, respectively,
compared to $17.0 million and $54.6 million for the comparable periods
in 2016. The increase was primarily due to the progression of the AR101
program, which include the RAMSES, ARC008, ARTEMIS and ARC011 that
commenced in 2017, and higher contract manufacturing costs to support
clinical development.

General and administrative expenses for the quarter and year ended
December 31, 2017, were $13.0 million and $43.9 million, respectively,
compared to $8.3 million and $26.9 million for the comparable periods in
2016. The increase was primarily due to additional employee-related
costs, including stock-based compensation expense, and external
professional services as Aimmune continues to build the infrastructure
to support the development and potential commercialization of AR101.

Cash, cash equivalents, and investments totaled $182.4 million at
December 31, 2017, compared to $282.5 million at December 31, 2016. The
decrease primarily reflects cash used in operations. In the first
quarter of 2018, the Company completed the sale and issuance of an
aggregate of 6,325,000 shares of Common Stock, which includes the
exercise in full of the underwriters' option to purchase an additional
825,000 shares of common stock, the Company received net proceeds from
the Offering of approximately $190.0 million.

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 regarding the potential
benefits of AR101; Aimmune's expectations for the RAMSES, ARTEMIS and
ARC004 trials, including the expected timing of data readouts and data
cuts for these trials; Aimmune's expectations on regulatory submissions
for marketing approval of AR101 in the United States and Europe,
including the timing of these submissions; Aimmune's expectations
regarding the potential commercial launch of AR101, including the timing
of a potential approval or AR101; Aimmune's expectations regarding the
timing of initiating additional clinical trials for AR101, including
ARC005 and a trial exploring AR101 with adjunctive dupilumab; Aimmune's
expectations on the timing of submitting an IND and initiating phase 2
clinical trials for AR201 in egg allergy and AR301 in walnut allergy;
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 the results of early clinical
trials may not be predictive of future results; 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, 2017. 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.

 

AIMMUNE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
   

December 31,
2017(1)

December 31,
2016(1)

Assets
Cash and cash equivalents $ 73,487 $ 124,010
Short-term investments 108,943 124,921
Prepaid expenses and other current assets 6,681 2,749
Total current assets 189,111 251,680
Long-term investments 33,602
Property and equipment, net 17,205 10,391
Prepaid expenses and other assets 618 3,116
Total assets $ 206,934 $ 298,789
 
Liabilities and Stockholders' Equity
Current liabilities $ 26,599 $ 11,450
Other liabilities 2,530 1,367
Stockholders' equity 177,805 285,972
Total liabilities and stockholders' equity $ 206,934 $ 298,789
 
(1)Derived from the audited financial statements,
included in the Company's Annual Report on Form 10-K for the year
ended December 31, 2017.
 
 
AIMMUNE THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
       

Quarter Ended
December 31,

Year Ended
December 31,

2017 2016 2017 2016
Operating Expenses
Research and development(1) $ 28,654 $ 16,958 $ 89,325 $ 54,642
General and administrative(1)   12,986   8,343   43,949   26,885
Total operating expenses   41,640   25,301   133,274   81,527
Loss from operations (41,640 ) (25,301 ) (133,274 ) (81,527 )
Interest income, net 530 225 2,005 703
Loss before provision for income taxes (41,110 ) (25,076 ) (131,269 ) (80,824 )
Provision for income taxes   56     56  
Net loss $ (41,166 ) $ (25,076 ) $ (131,325 ) $ (80,824 )
 
Net loss per common share, basic and diluted $ (0.81 ) $ (0.55 ) $ (2.61 ) $ (1.89 )
Shares used in computing net loss per basic and diluted share 50,839 45,491 50,401 42,751
 
(1)Includes employee stock-based compensation expense of:

Quarter Ended
December 31,

Year Ended
December 31,

2017 2016 2017 2016
Research and development $ 1,595 $ 1,128 $ 5,077 $ 4,838
General and administrative   3,253   2,420   11,642   7,803
Total stock-based compensation expense $ 4,848 $ 3,548 $ 16,719 $ 12,641
 

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