Aimmune Therapeutics Announces Fourth Quarter and Full Year 2018 Financial Results and Provides Recent Operational Highlights

  • FDA decision on AR101 BLA filing acceptance expected by end of March
  • Submission of AR101 marketing application in Europe on track for
    mid-2019
  • Initiation of AR201 phase 2 trial in egg allergy on track for
    mid-2019
  • Company began 2019 with approximately $340 million in cash and
    investments and potential access to an additional $130 million
  • Webcast and conference call today at 5:00 p.m. ET

BRISBANE, Calif.–(BUSINESS WIRE)–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 2018.

“Last year was one of exceptional progress for Aimmune on multiple
fronts as we advance AR101 to potentially be the first approved
treatment for peanut allergy,” said Jayson Dallas, M.D., President and
CEO of Aimmune. “In addition, we are on track to apply for European
marketing approval of AR101 and initiate a phase 2 trial of AR201 for
egg allergy, both in the middle of the year. We began 2019 in a strong
financial position to commercialize AR101 and advance our pipeline
programs. Our priority now is ensuring launch preparedness and
continuing to collaborate with the allergy community and regulatory
authorities to bring AR101 to the children, teens, and families affected
by peanut allergy.”

AR101 Highlights

  • Biologics License Application (BLA) for AR101 submitted. On
    December 21, 2018, Aimmune submitted a BLA for AR101 to the U.S. Food
    and Drug Administration (FDA) for the treatment of peanut allergy in
    children and adolescents ages 4-17 years. Following the reopening of
    the U.S. government in January 2019, the FDA initiated review of the
    BLA for AR101. Aimmune expects that the FDA will determine whether the
    BLA is acceptable for filing by the end of March 2019. Aimmune is
    currently engaged in discussions with the FDA regarding the review
    timeline for the BLA for AR101 in consideration of multiple factors,
    including: the agency’s initial determination that AR101 is exempt
    from PDUFA; AR101’s Breakthrough Therapy designation; and the apparent
    lack of precedent for the FDA reviewing a BLA for a PDUFA-exempt
    product candidate that has Breakthrough Therapy designation. If the
    Breakthrough Therapy designation for AR101 does not result in an
    expedited review of the BLA for AR101, the BLA will likely be reviewed
    under a 12-month target review period applicable to PDUFA-exempt
    applications, as measured from the January 2019 start date.
  • POSEIDON trial initiated. In December 2018, Aimmune initiated
    its phase 3 POSEIDON trial to explore the efficacy and safety of AR101
    in young peanut-allergic children, ages 1-3.
  • PALISADE results published in NEJM. In November 2018,
    the New England Journal of Medicine (NEJM) published the
    results of Aimmune’s landmark phase 3 PALISADE trial, the largest and
    most rigorously conducted oral immunotherapy trial for the treatment
    of peanut allergy and the only successful phase 3 trial for the
    treatment of peanut allergy ever conducted.
  • AR101 with adjunctive dupilumab trial initiated. In October
    2018, a phase 2 trial of AR101 with adjunctive dupilumab was initiated
    in peanut-allergic patients. Regeneron is the trial’s sponsor, and
    Aimmune is supplying AR101 clinical trial material.
  • Data presented at AAAAI. Aimmune presented nine
    abstracts at the American Academy of Allergy, Asthma and Immunology
    (AAAAI) 2019 Annual Meeting. Notably, new data show that AR101
    treatment reduced accidental exposures to peanut requiring medication
    and increased the amount of peanut tolerated with additional time on
    the AR101 300 mg daily dose.

AR201 Highlights

  • Phase 2 program on track. Aimmune’s Investigational New Drug
    (IND) application for AR201 has been cleared by the FDA and the
    company expects to begin a phase 2 trial in mid-2019.

Corporate Highlights

  • Strengthened balance sheet. In November 2018, Nestlé Health
    Science made an additional $98 million equity investment in Aimmune.
    In January 2019, Aimmune announced it had entered into a loan
    agreement with KKR, a leading global investment firm, for up to $170
    million to fund AR101 commercialization and pipeline development.
  • Board of Directors expanded. In November 2018, Aimmune
    announced the appointment of Brett Haumann, M.B.B.Ch., M.B.A., to its
    Board of Directors. Dr. Haumann brings extensive biotech and
    pharmaceutical leadership experience, including more than 20 years of
    development and discovery work in allergy and pulmonary medicines.
  • Chief Commercial Officer appointed. In January 2019, Aimmune
    named Andrew Oxtoby, a proven pharmaceutical leader, as the company’s
    first Chief Commercial Officer. Mr. Oxtoby joins Aimmune with deep,
    global experience with successful product launches, commercialization
    and strategic planning. In this role, Mr. Oxtoby’s immediate focus is
    the potential U.S. launch of AR101.
 

Upcoming Milestones

 

1Q 19     Potential acceptance of AR101 BLA for review by the U.S. FDA
1H 19     ARTEMIS data on AR101 available
Mid 19     Initiate phase 2 clinical trial of AR201 in egg allergy
Mid 19     Submit Marketing Authorization Application for AR101 to the European
Medicines Agency
   

Fourth Quarter Financial Results

For the quarter and year ended December 31, 2018, net loss was $57.0
million and $210.8 million, respectively, compared to net loss of $41.2
million and $131.3 million for the comparable periods in 2017.

On a per share basis, net loss for the quarter and year ended December
31, 2018, was $0.95 and $3.67, respectively, compared to net loss per
share of $0.81 and $2.61 for the comparable periods in 2017. The
weighted average shares outstanding for the quarter and year ended
December 31, 2018, was 59.8 million and 57.4 million, respectively,
compared to 50.8 million and 50.4 million shares for the comparable
periods in 2017.

Research and development expenses for the quarter and year ended
December 31, 2018, were $33.0 million and $133.4 million, respectively,
compared to $28.7 million and $89.3 million for the comparable periods
in 2017. The increase was primarily due to higher costs from the
progression of certain AR101 clinical trials and higher contract
manufacturing costs to support clinical development and regulatory
activities.

General and administrative expenses for the quarter and year ended
December 31, 2018, were $25.4 million and $81.9 million, respectively,
compared to $13.0 million and $43.9 million for the comparable periods
in 2017. The increase was primarily due to additional employee-related
costs and external professional services as Aimmune continued 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 $303.9 million on
December 31, 2018, compared to $182.4 million on December 31, 2017. The
increase primarily reflects net cash proceeds of $300.0 million
resulting from the issuance of our common stock, partially off-set by
cash used in operating activities of $169.1 million and cash used for
the purchase of plant and equipment of $9.4 million.

Conference Call

In connection with this announcement, Aimmune Therapeutics will host a
conference call and webcast today at 5:00 p.m. ET. To access the live
call by phone, dial (877) 497-1438 (domestic) or +1 (262) 558-6296
(international) and enter the passcode 4097229. To access a live or
recorded webcast of the call, please visit the Investor Relations
section of the Aimmune Therapeutics website at www.aimmune.com.
The recorded webcast will be available for approximately 30 days
following the call.

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., is a biopharmaceutical company developing
oral 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’s regulatory filing
for marketing approval of AR101 in the United States (submitted 4Q18) is
based on data from the pivotal Phase 3 PALISADE clinical trial of AR101,
which in 4-17 year-old subjects met its primary and key secondary
endpoints, and additional ongoing and completed AR101 clinical trials.
Aimmune expects to file for marketing approval of AR101 in Europe
mid-2019. Aimmune has filed an IND application for its second product,
AR201, for the treatment of egg allergy and intends to start a
randomized Phase 2 clinical trial mid-2019. 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 regarding the potential
commercial launch of AR101, including the timing of a potential
acceptance and applicable review period of the BLA for AR101; Aimmune’s
expectations regarding the planned timing and filing for marketing
approval of AR101 in Europe; Aimmune’s expectations on the timing of
initiating a Phase 2 clinical trial for AR201; Aimmune’s expectations on
the planned timing for the announcement of data from the ARTEMIS
clinical trial for AR101; Aimmune’s expectations regarding the timing
and availability of the full amount of proceeds under its loan agreement
with KKR; Aimmune’s expectations regarding the sufficiency of its cash
resources; 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 satisfaction of
closing conditions for each tranche of its loan agreement; Aimmune’s or
any of its collaborative partners’ ability to initiate and/or complete
clinical trials; the unpredictability of the regulatory process; the
possibility that Aimmune’s or any of its collaborative partners’
clinical trials will not be successful; Aimmune’s dependence on the
success of AR101; Aimmune’s reliance on third parties for the
manufacture of Aimmune’s 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 September 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 AR101, a product candidate that is under
clinical investigation, and AR201, a product candidate that Aimmune
expects will be under clinical investigation in 2019. Neither AR101 nor
AR201 has been approved for marketing by the FDA or the European
Medicines Agency (EMA). AR101 and AR201 are currently limited to
investigational use, and no representation is made as to their safety or
effectiveness for the purposes for which they are being investigated.

 
AIMMUNE THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
       

December
31,
2018
(Unaudited)

December
31,
2017(1)

 

Assets
Cash and cash equivalents $ 107,511 $ 73,487
Short-term investments 196,421 108,943
Prepaid expenses and other current assets   8,687   6,681
Total current assets 312,619 189,111
Property and equipment, net 26,328 17,205
Prepaid expenses and other assets   608   618
Total assets $ 339,555 $ 206,934
 
Liabilities and Stockholders’ Equity
Current liabilities $ 38,012 $ 26,599
Other liabilities 2,596 2,530
Stockholders’ equity   298,947   177,805
Total liabilities and stockholders’ equity $ 339,555 $ 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)
(Unaudited)
         

Quarter Ended
December 31,

Year Ended
December 31,

2018 2017 2018 2017
Operating Expenses
Research and development(1) $ 33,029 $ 28,654 $ 133,420 $ 89,325
General and administrative(1)   25,404   12,986   81,921   43,949
Total operating expenses   58,433   41,640   215,341   133,274
Loss from operations (58,433 ) (41,640 ) (215,341 ) (133,274 )
Interest income, net 1,417 530 4,650 2,005
Loss before provision for income taxes (57,016 ) (41,110 ) (210,691 ) (131,269 )
(Benefit) Provision for income taxes   (18 )   56   61   56
Net loss $ (56,998 ) $ (41,166 ) $ (210,752 ) $ (131,325 )
 
Net loss per share, basic and diluted $ (0.95 ) $ (0.81 ) $ (3.67 ) $ (2.61 )
Shares used in computing net loss per basic and diluted share 59,780 50,839 57,403 50,401
 
(1)Includes employee stock-based compensation expense of:

Quarter Ended
December 31,

Year Ended
December 31,

2018 2017 2018 2017
Research and development $ 2,569 $ 1,595 $ 9,945 $ 5,077
General and administrative   5,500   3,253   22,787   11,642
Total stock-based compensation expense $ 8,069 $ 4,848 $ 32,732 $ 16,719
 

Contacts

Investors:
Laura Hansen, Ph.D.
(650) 396-3814 or
lhansen@aimmune.com

Media:
Alison
Marquiss
(650) 376-5583 or
amarquiss@aimmune.com

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