Market Overview

Aimmune Therapeutics Announces Second Quarter 2018 Financial Results

Share:

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 Ended
June 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 Ended
June 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
 

View Comments and Join the Discussion!