Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical
company developing treatments for life-threatening food allergies,
today announced financial results for the quarter and six months
ended June 30, 2018. As of June 30, 2018, cash, cash equivalents
and investments totaled $295.9 million.
“Since joining Aimmune in mid-June, I have been enormously
pleased to see a strong team in place and solid progress towards
submitting a Biologics License Application for AR101 in peanut
allergy by the end of this year,” said Jayson Dallas, M.D.,
President and CEO of Aimmune. “Our intention in developing AR101 is
to provide a reliable, robust level of protection with the
convenience of daily oral dosing so that people living with peanut
allergy can have peace of mind and more freedom in their daily
lives. We are laser focused on continuing to move AR101 towards
potential approval and preparing for a potential U.S. commercial
launch in 2019. With an estimated 1.6 million peanut-allergic
children and adolescents in the United States alone, we believe the
market opportunity is very large. We are motivated by the
widespread enthusiasm we hear from allergists and patients who are
eager for an approved biologic oral immunotherapy. It is truly
exciting to lead Aimmune into its next phase of becoming a fully
integrated commercial organization with a pipeline of opportunities
in other significant food allergies. I look forward to sharing our
progress in the months ahead.”
Second Quarter Highlights
AR101: Pivotal-stage biologic for the treatment of peanut
allergy
- Announced new clinical data at the
Congress of the European Academy of Allergy, Asthma, and Immunology
(EAACI) showing efficacy across the intent-to-treat population of
peanut-allergic patients enrolled in the Phase 3 PALISADE trial of
AR101.
- Announced results from an
Aimmune-supported survey of more than 100 U.S. allergists showing
that more than 80 percent preferred the term “tolerated dose” as
the most clinically meaningful relevant term to communicate
desensitization levels to oral immunotherapy patients.
- Announced results from a new
pan-European study showing significant psychosocial burden
associated with peanut allergy, with a daily impact on more than 80
percent of people with peanut allergy and parents or caregivers of
peanut-allergic minors.
Corporate
- Appointed Dr. Jayson Dallas, an
experienced leader with an extensive record of global strategic and
commercial operational accomplishments and successful product
launches, as President and Chief Executive Officer.
Second Quarter Financial Results
For the quarter and six months ended June 30, 2018, net loss was
$52.6 million and $102.1 million, respectively, compared to net
loss of $32.5 million and $58.4 million for the comparable periods
in 2017.
On a per share basis, net loss for the quarter and six months
ended June 30, 2018, was $0.91 and $1.83, respectively, compared to
net loss per share of $0.65 and $1.16 for the comparable periods in
2017. The weighted average shares outstanding for the quarter and
six months ended June 30, 2018 was 57.9 million and 55.8 million,
respectively, compared to 50.2 million shares for the comparable
periods in 2017. In the first quarter of 2018, the Company
completed an underwritten public offering with net proceeds of
$190.4 million through the sale and issuance of an aggregate of
6,325,000 shares of common stock.
Research and development expenses for the quarter and six months
ended June 30, 2018, were $35.3 million and $68.7 million,
respectively, compared to $22.2 million and $39.6 million for the
comparable periods in 2017. The increase was primarily due to
higher costs from the progression of certain AR101 clinical trials,
including RAMSES, ARC008, ARC009, ARTEMIS and ARC011, and higher
contract manufacturing costs to support clinical development and
regulatory activities.
General and administrative expenses for the quarter and six
months ended June 30, 2018, were $18.6 million and $35.2 million,
respectively, compared to $10.8 million and $19.7 million for the
comparable periods in 2017. The increase was primarily due to
additional employee-related costs and external professional
services as Aimmune continues to build its infrastructure to
support the development and potential commercialization of AR101.
Stock-based compensation expense also increased primarily due to
the expansion and extension of our long-term commercial supply
agreement with Golden Peanut Company and modification of certain
executives’ stock options resulting from their planned
separation.
Cash, cash equivalents, and investments totaled $295.9 million
at June 30, 2018, compared to $182.4 million at December 31, 2017.
The increase primarily reflects net cash proceeds of $190.4 million
received as of June 30, 2018, from the sale of common stock,
partially off-set by cash used in operating activities of $76.3
million and cash used for purchase of plant and equipment of $6.2
million.
Anticipated Upcoming Milestones
Timing Anticipated
Milestone 2H 18 Safety and tolerability data
available from real-world utilization study of AR101 (RAMSES) 2H 18
Initiate a study of AR101 in infants and toddlers 1 –
4 years old (ARC005) 2H 18 Data cut from the pivotal
Phase III (PALISADE) rollover study (ARC004) YE 18
Regeneron / Sanofi expected to initiate Phase 2 trial of AR101 with
adjunctive dupilumab YE 18 Submit BLA for AR101 to
the U.S. Food and Drug Administration YE 18 Submit
Investigational New Drug Application for AR201 in egg allergy 1H 19
European clinical study data available (ARTEMIS) 1H
19 Submit MAA 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 and commercial launch of AR101 in
the U.S.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a biopharmaceutical company
developing treatments for life-threatening food allergies. The
company’s Characterized
Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to
provide meaningful levels of protection against allergic reactions
resulting from accidental exposure to food allergens 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. Aimmune plans to submit
regulatory filings for marketing approval of AR101 in the United
States and Europe based on data from the pivotal Phase 3 PALISADE
clinical trial of AR101, which in 4-17 year-old subjects met all
its primary and secondary endpoints, and additional ongoing and
completed AR101 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 on the potential size of the market
opportunity in peanut allergy; 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; Aimmune’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; Aimmune’s reliance on third parties for the
manufacture of its product candidates; possible regulatory
developments in the United States and foreign countries; and
Aimmune’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 Quarterly Report on Form 10-Q
for the quarter ended June 30, 2018. 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)
June 30,
2018
(Unaudited)
December 31,2017
(1)
Assets Cash and cash equivalents $ 142,157 $ 73,487
Short-term investments 147,843 108,943 Prepaid expenses and other
current assets 6,826 6,681 Total current assets
296,826 189,111 Long-term investments 5,901 — Property and
equipment, net 23,265 17,205 Prepaid expenses and other assets
664 618 Total assets $ 326,656 $ 206,934
Liabilities and Stockholders’ Equity Current liabilities $
36,094 $ 26,599 Other liabilities 2,724 2,530 Stockholders’ equity
287,838 177,805 Total liabilities and stockholders’
equity $ 326,656 $ 206,934 (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) Quarter Ended June
30,
Six Months EndedJune 30,
2018 2017 2018 2017 Operating Expenses
Research and development(1) $ 35,254 $ 22,191 $ 68,700 $ 39,608
General and administrative(1) 18,559 10,813
35,232 19,737 Total operating expenses 53,813
33,004 103,932 59,345 Loss from operations (53,813 )
(33,004 ) (103,932 ) (59,345 ) Interest income, net 1,294
507 1,930 978 Loss before provision for income
taxes (52,519 ) (32,497 ) (102,002 ) (58,367 ) Provision for income
taxes 33 — 50 — Net loss $ (52,552 ) $
(32,497 ) $ (102,052 ) $ (58,367 ) Net loss per common
share, basic and diluted $ (0.91 ) $ (0.65 ) $ (1.83 ) $ (1.16 )
Shares used in computing net loss per common share, basic and
diluted 57,903 50,230 55,752 50,150
(1) Includes stock-based compensation
expenses of:
Quarter Ended June 30,
Six Months EndedJune 30,
2018 2017 2018 2017 Research and
development $ 2,923 $ 1,191 $ 4,970 $ 2,177 General and
administrative 5,751 3,008 11,311 5,615
Total stock-based compensation expenses $ 8,674 $ 4,199 $ 16,281 $
7,792
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version on businesswire.com: https://www.businesswire.com/news/home/20180808005574/en/
Aimmune Therapeutics, Inc.Investors:Laura Hansen, Ph.D.,
650-396-3814lhansen@aimmune.comorMedia:Stephanie Yao,
650-351-6479syao@aimmune.com
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