— Company Began 2017 with Approximately $283
Million in Cash and Investments, Sufficient to Support Current
Development Plans through Regulatory Submissions —
— Conference Call and Webcast Today at 8:00
a.m. ET —
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 2016 and provided a corporate
update.
“We began 2017 with great momentum, having achieved significant
clinical and corporate milestones last year, particularly in the
fourth quarter,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D.
“In November 2016, we completed global enrollment of our ongoing
Phase 3 PALISADE trial, which lays a strong foundation for our
AR101 Phase 3 development program in peanut allergy. That same
month, we also announced a strategic investment of $145 million by
Nestlé Health Science while retaining full global rights to AR101
and our pipeline. As a result, we began 2017 in a strong financial
position with approximately $283 million in cash and investments.
Our resources and efforts in 2017 will continue to be focused
largely on execution of our Phase 3 program for AR101. We continue
to expect to have top-line data from PALISADE available around
year-end 2017 and submit regulatory filings in the U.S. and Europe
in late 2018. Our current capital resources fund us through these
events.”
Corporate Highlights
Investment by Nestlé Health Science Kicks Off Two-Year
Strategic Collaboration. In November 2016, Aimmune announced
that Nestlé Health Science purchased $145 million of the company’s
common stock in a private placement and that the two companies
entered into a two-year strategic collaboration designed to enable
the successful development and commercialization of innovative food
allergy therapies. The strategic collaboration enables both parties
to discuss areas of interest, including Aimmune’s current and
future development programs, through a newly established pipeline
forum. Aimmune maintains worldwide commercial rights to all of its
product candidates, including AR101.
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 joined the Aimmune Board of Directors.
Commercial Manufacturing Facility on Track for Completion by
End of 2017. Aimmune has completed construction of a commercial
manufacturing facility for AR101 in a leased building at the site
of one of its current contract manufacturers. Equipment
installation and operating systems qualification are ongoing in
this new facility. Aimmune anticipates that this manufacturing
facility will be operational by the end of 2017.
AR101 Phase 3 Program
Highlights
Enrollment in PALISADE Complete; Top-Line Results Anticipated
Around the End of 2017. In November 2016, Aimmune announced
completion of enrollment of PALISADE, an international, randomized
3:1, double-blind, placebo-controlled Phase 3 trial of the efficacy
and safety of AR101 in patients with peanut allergy. A total of 554
patients ages 4–49 years were enrolled, 90 percent of whom were
between the ages of 4 and 17. Based on recent feedback from the
U.S. Food and Drug Administration, the primary efficacy analysis
will now be conducted in the 4–17 age group, which aligns with the
AR101 Breakthrough Therapy Designation population in Phase 2. The
primary endpoint of PALISADE is the proportion of patients ages
4–17 who tolerate a single dose of 600 mg of peanut protein, which
is equivalent to a cumulative amount of 1,043 mg of peanut protein,
in the exit double-blind, placebo-controlled food challenge
(DBPCFC) after approximately one year on study. Current
expectations are that the up-dosing portion of the study will be
completed by mid-year 2017. From that point, once all patients are
treated for six months on the maintenance dose of 300 mg of AR101
per day, topline results should become available around year-end
2017.
RAMSES (Real-world AR101 Market-Supporting Experience Study)
Planned to Start in the Second Quarter of 2017. In September
2016, Aimmune announced plans to initiate RAMSES, a randomized 2:1,
double-blind, placebo-controlled trial, to gain experience with
AR101 in a real-world setting where the DBPCFC is not required for
diagnosis of peanut allergy. Instead of requiring a DBPCFC for
entry into RAMSES, 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.
RAMSES 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. 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. Aimmune expects RAMSES to enroll approximately 440
patients ages 4–17 at multiple sites in the United States and
Canada, beginning in the second quarter of 2017.
ARTEMIS (AR101 Trial in Europe Measuring oral Immunotherapy
Success) Planned to Start in the Middle of 2017. In November
2016, Aimmune announced plans to initiate ARTEMIS, a randomized
3:1, double-blind, placebo-controlled trial, in peanut-allergic
children and adolescents ages 4–17 in Europe. ARTEMIS will explore
protection at an endpoint of tolerating a single dose of 1,000 mg
of peanut protein, which is equivalent to a cumulative amount of
2,043 mg of peanut protein, after nine months of treatment.
Patients will undergo approximately six months of up-dosing and
then three months of maintenance therapy at 300 mg of AR101 per
day, followed by an exit DBPCFC. ARTEMIS builds on the observation
that a high proportion of patients in the ARC002 Phase 2 trial of
AR101 tolerated a cumulative amount of 2,043 mg of peanut protein
at the nine-month endpoint. ARTEMIS is designed to confirm that
finding in a double-blind, placebo-controlled setting. Aimmune
expects ARTEMIS to enroll approximately 160 patients at multiple
sites in Europe beginning in mid-2017.
ARC004 Continues to Enroll Eligible Patients Who Have
Completed PALISADE. Patients who have completed PALISADE are
provided the opportunity to roll over into the ARC004 trial.
Patients who were in the AR101 treatment arm of PALISADE will
continue to receive AR101 in ARC004. Patients who were in the
placebo arm of PALISADE will undergo up-dosing with AR101 in ARC004
and then continue to maintenance therapy at the target dose of 300
mg of AR101 per day. The first ARC004 patient was enrolled into the
study in December 2016. ARC004 is designed to test dose forgiveness
and the durability of AR101 treatment response in a multi-arm
structure to inform the potential for reduced frequency of dosing
during the maintenance phase of AR101 therapy.
Fourth Quarter and Full Year Financial
Results
Cash, cash equivalents, and investments totaled $282.5 million
at December 31, 2016, compared to $199.8 million at December 31,
2015. The increase reflects the $145.0 million equity investment by
Nestlé Health Science in November 2016, partially offset by cash
used in operations.
For the quarter and year ended December 31, 2016, net loss was
$25.0 million and $80.8 million, respectively, compared to a net
loss of $16.0 million and $35.8 million for the comparable periods
in 2015.
On a per share basis, net loss for the quarter and year ended
December 31, 2016, was $0.55 and $1.89, respectively, compared to
net loss per share of $0.39 and $1.88 for the comparable periods in
2015. The weighted average shares outstanding for the quarter and
year ended December 31, 2016, were 45.5 million and 42.8 million
shares, respectively, compared to 41.6 million and 19.0 million
shares for the comparable periods in 2015. In November 2016,
Aimmune agreed to sell 7.6 million newly issued shares of common
stock to Nestlé Health Science. At December 31, 2016, Aimmune had
50.2 million shares of common stock outstanding.
Research and development expenses for the quarter and year ended
December 31, 2016, were $17.0 million and $54.6 million,
respectively, compared to $10.8 million and $19.8 million for the
comparable periods in 2015. The increases in both periods were
primarily due to increased clinical trial and contract
manufacturing costs and additional personnel-related costs,
including stock-based compensation expense, to support the PALISADE
trial.
General and administrative expenses for the quarter and year
ended December 31, 2016, were $8.3 million and $26.9 million,
respectively, compared to $5.4 million and $16.2 million for the
comparable periods in 2015. The increases in both periods were
primarily due to additional personnel-related costs, including
stock-based compensation expense, to support the company’s
growth.
2017 Financial Guidance
Aimmune provided the following financial guidance for 2017:
Research and development expenses(1) $95
million – $105 million General and administrative expenses(1) $35
million – $40 million Capital expenditures Approximately $5 million
(1)Includes stock-based
compensation expenses of: Research and development $5 million – $7
million General and administrative $7 million – $8 million
Conference Call Today at 8 a.m. Eastern
Time / 5 a.m. Pacific Time
Aimmune management will host a conference call to discuss its
financial results and provide a general business update today at 8
a.m. Eastern Time / 5 a.m. Pacific Time. The conference call will
be accessible via the company’s website at www.aimmune.com on the
Events page under Investor Relations. Please connect to the
company’s website at least 15 minutes prior to the start of the
conference call to ensure adequate time for any software download
that may be required to listen to the webcast. Alternatively,
please call 1-877-497-1438 (U.S.) or 1-262-558-6296 (international)
and provide the conference ID # 84650109 to join by phone. An
archived copy of the webcast will be available on the company’s
website for at least 30 days after the conference call.
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 2017 financial guidance; Aimmune’s expectations for its
Phase 3 PALISADE trial of AR101, including the expected timing of
topline data; Aimmune’s expectations regarding the potential
benefits of AR101; Aimmune’s expectations regarding the sufficiency
of its capital resources; Aimmune’s expectations for the RAMSES and
ARTEMIS trials, including the timing and enrollment of these
trials, and the ARC004 trial; 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 for its commercial manufacturing facility, including
the timing of completion of the facility; 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
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 2016 to be filed on March 15, 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
31,2016(unaudited)
December 31,2015
(1)
Assets Cash and cash equivalents $ 124,010 $ 76,677
Short-term investments 124,921 115,158 Prepaid expenses and other
current assets 2,749 5,622 Total current assets
251,680 197,457 Long-term investments 33,602 7,992 Property and
equipment, net 10,391 2,702 Prepaid expenses and other assets
3,116 4,210 Total assets $ 298,789 $ 212,361
Liabilities and Stockholders’ Equity Current liabilities $
11,450 $ 5,098 Other liabilities 1,367 1,012 Stockholders’ equity
285,972 206,251 Total liabilities and stockholders’
equity $ 298,789 $ 212,361 (1)Derived from the audited
financial statements, included in the Company's Annual Report on
Form 10-K for the year ended December 31, 2015.
AIMMUNE THERAPEUTICS, INC. CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (In thousands, except per share
amounts) (Unaudited)
Three Months EndedDecember
31,
Twelve Months EndedDecember
31,
2016 2015 2016 2015 Operating Expenses
Research and development(1) $ 16,958 $ 10,766 $ 54,642 $ 19,816
General and administrative(1) 8,343 5,389
26,885 16,181 Total operating expenses 25,301
16,155 81,527 35,997 Loss from operations (25,301 )
(16,155 ) (81,527 ) (35,997 ) Interest income, net 225
147 703 181 Net loss $ (25,076 ) $ (16,008 ) $
(80,824 ) $ (35,816 ) Net loss per common share, basic and
diluted $ (0.55 ) $ (0.39 ) $ (1.89 ) $ (1.88 ) Shares used in
computing net loss per basic and diluted share(2) 45,491 41,576
42,751 19,041
(1)Includes employee stock-based
compensation expense of:
Three Months EndedDecember
31,
Twelve Months EndedDecember
31,
2016 2015 2016 2015 Research and
development $ 1,128 $ 2,126 $ 4,838 $ 2,522 General and
administrative 2,420 1,280 7,803 3,635
Total stock-based compensation expense $ 3,548 $ 3,406 $ 12,641 $
6,157 (2)At December 31, 2016, Aimmune had 50,196,883 shares
of common stock outstanding.
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version on businesswire.com: http://www.businesswire.com/news/home/20170315005378/en/
Aimmune Therapeutics, Inc.InvestorsLaura Hansen, Ph.D.,
650-396-3814lhansen@aimmune.comMediaStephanie Yao,
650-351-6479syao@aimmune.com
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