Conference call scheduled today at 9:00 a.m.
ET
ArQule, Inc. (Nasdaq: ARQL) today announced its financial
results for the second quarter of 2017.
For the quarter ended June 30, 2017, the Company reported a net
loss of $7,201,000 or $0.10 per share, compared with a net loss of
$5,100,000 or $0.07 per share, for the second quarter of 2016. For
the six-month period ended June 30, 2017, the Company reported a
net loss of $14,777,000 or $0.21 per share, compared with a net
loss of $10,081,000 or $0.15 per share, for the six-month period
ended June 30, 2016.
At June 30, 2017, the Company had a total of approximately
$31,007,000 in cash, equivalents and marketable securities.
Key Highlights
- Derazantinib (ARQ 087), a pan-FGFR
inhibitor, has begun recruiting in a registrational
phase 3 trial for FGFR2 fusion positive second-line intrahepatic
cholangiocarcinoma (iCCA). Enrollment is planned to commence in
the current quarter. In May, compelling data from the phase 1/2
trial in second-line iCCA was presented at the American Society of
Clinical Oncology (ASCO) meeting highlighting a disease control
rate of 83% and an objective response rate of 21%.
- ARQ 531, an orally bioavailable,
potent and reversible BTK inhibitor, has been dosed in a
phase 1a/b trial. The trial is enrolling patients with B-cell
malignancies, including B-cell lymphomas, chronic lymphocytic
leukemia, and Waldenstrom's macroglobulinemia, who are refractory
to other therapeutic options, including ibrutinib. Up to 120
patients can be enrolled in the trial. The company also presented
preclinical data for ARQ 531 in diffuse large B-cell lymphoma at
the Annual Congress of the European Hematology Association which
further strengthens the preclinical package for this molecule.
- ARQ 092, lead AKT inhibitor, has
been dosed in a phase 1/2 company-sponsored trial in Overgrowth
Diseases with genetic alterations of the PI3K/AKT1 pathway,
including PROS (PIK3CA-related Overgrowth Spectrum) and Proteus
syndrome. The trial is designed to enroll six patients in a
dose escalation cohort as part of the phase 1 portion of the trial.
An additional 10 patients will be enrolled in an expansion cohort
as part of the phase 2 portion of the trial. The objective of this
study is to determine a clinically meaningful endpoint to pursue in
a registrational trial.
“We have made significant progress over the past few months by
initiating phase 1 trials for ARQ 092 and ARQ 531 with the aim of
achieving clinical proof of principle, and we are now poised to
initiate a registrational trial with derazantinib,” said Paolo
Pucci, Chief Executive Officer of ArQule. "We achieved all of
our targeted pipeline milestones for the first half of 2017, most
notably moving ARQ 531, our BTK inhibitor, into the clinic. We
believe ARQ 531 was the first reversible BTK inhibitor to be dosed
in patients with B-cell malignancies. With four programs in the
clinic, including derazantinib, ARQ 092, ARQ 751, and ARQ 531, we
are poised to continue to achieve our goals for 2017."
“Our pipeline achieved two important milestones with the dosing
of the first patient in two biomarker driven clinical trials
targeting patients in areas of high unmet need,” said
Dr. Brian Schwartz, M.D., Head of Research and Development and
Chief Medical Officer at ArQule. "In the first of these
clinical trials, ARQ 531 aims to demonstrate its potential to
address a large patient population with B-cell malignancies who
become refractory to current therapies. This is a significant
emerging clinical need, particularly in C481S-mutant patients. In
the second trial, ARQ 092 is now being dosed in Overgrowth Diseases
driven by the PI3K/AKT1 mutation targeting a completely unmet
clinical need in a patient population comprised of multiple orphan
diseases. Both programs have the potential to be transformational
and represent well ArQule’s mission to bring life-changing
therapies to address unmet medical needs."
Revenues and Expenses
Revenues for the quarter ended June 30, 2017, were zero compared
with revenues of $1,072,000 for the quarter ended June 30, 2016.
Revenues in the six-months ended June 30, 2017 were zero compared
with revenues of $2,299,000 in the six-months ended June 30, 2016.
Revenue in the three and six-month periods of 2016 is comprised of
revenue from the Daiichi Sankyo tivantinib development agreement
and the Kyowa Hakko Kirin exclusive license agreement. No further
revenue is anticipated from these agreements.
Research and development expense in the second quarter of 2017
was $4,983,000, compared with $4,337,000 for the second quarter of
2016. Research and development expense increased $0.6 million in
the second quarter of 2017 primarily due to higher outsourced
preclinical, clinical and product development costs.
Research and development expense in the six-months ended June
30, 2017 was $10,177,000 compared with $8,535,000 in the six-months
ended June 30, 2016. The $1.6 million increase in research and
development expense in the six-months ended June 30, 2017 was
primarily due to higher outsourced preclinical, clinical and
product development costs.
General and administrative expense was $1,866,000 in the second
quarter of 2017 compared with $1,887,000 in the second quarter
2016.
General and administrative expense was $3,940,000 in the
six-months ended June 30, 2017 compared with $3,931,000 in the
six-months ended June 30, 2016.
Conference Call and
Webcast
ArQule will hold its second quarter 2017 financial results
call today, August 4, 2017 at 9:00 a.m. ET. The live
webcast can be accessed in the "Investors & Media" section of
our website, www.arqule.com, under "Events &
Presentations." You may also listen to the call by dialing (877)
868-1831 within the U.S. or (914) 495-8595 outside
the U.S. A replay will be available two hours after the
completion of the call and can be accessed in the "Investor and
Media" section of our website, www.arqule.com, under "Events
& Presentations."
About ArQule
ArQule is a biopharmaceutical company engaged in the research
and development of targeted therapeutics to treat cancers and rare
diseases. ArQule’s mission is to discover, develop and
commercialize novel small molecule drugs in areas of high unmet
need that will dramatically extend and improve the lives of our
patients. Our clinical-stage pipeline consists of five drug
candidates, all of which are in targeted, biomarker-defined patient
populations, making ArQule a leader among companies our size in
precision medicine. ArQule’s proprietary pipeline includes: ARQ
087, a multi-kinase inhibitor designed to preferentially inhibit
the fibroblast growth factor receptor (FGFR) family, in phase 2 for
iCCA and in phase 1b for multiple oncology indications; ARQ 092, a
selective inhibitor of the AKT serine/threonine kinase, in a phase
1/2 company sponsored study for Overgrowth Diseases, in a phase 1
study for ultra-rare Proteus syndrome conducted by the National
Institutes of Health (NIH), as well as in multiple oncology
indications; ARQ 751, a next generation AKT inhibitor, in phase 1
for patients with AKT1 and PI3K mutations; and ARQ 761, a
β-lapachone analog being evaluated as a promoter of NQO1-mediated
programmed cancer cell necrosis, in phase 1/2 in multiple oncology
indications in partnership with the University of Texas
Southwestern Medical Center. In addition, we have advanced ARQ 531,
an investigational, orally bioavailable, potent and reversible
inhibitor of both wild type and C481S-mutant BTK, in phase 1 for
patients with B-cell malignancies refractory to other therapeutic
options. ArQule’s current discovery efforts are focused on the
identification and development of novel kinase inhibitors,
leveraging the Company’s proprietary library of compounds. You can
follow us on Twitter and LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements regarding
clinical trials with derazantinib (ARQ 087), ARQ 092, ARQ 751 and
ARQ 531 as well as projected financial results and ability to fund
operations with current cash and marketable securities. These
statements are based on the Company’s current beliefs and
expectations and are subject to risks and uncertainties that could
cause actual results to differ materially. Positive information
about pre-clinical and early stage clinical trial results does not
ensure that later stage or larger scale clinical trials will be
successful. For example, derazantinib, ARQ 092, ARQ 751 and ARQ 531
may not demonstrate promising therapeutic effect; in addition, they
may not demonstrate appropriate safety profiles in current or later
stage or larger scale clinical trials as a result of known or as
yet unanticipated side effects. The results achieved in later stage
trials may not be sufficient to meet applicable regulatory
standards or to justify further development. Problems or delays may
arise prior to the initiation of planned clinical trials, during
clinical trials or in the course of developing, testing or
manufacturing these compounds that could lead the Company and, if
applicable, its partners and collaborators to fail to initiate or
to discontinue development. Even if later stage clinical trials are
successful, unexpected concerns may arise from subsequent analysis
of data or from additional data. Obstacles may arise or issues may
be identified in connection with review of clinical data with
regulatory authorities. Regulatory authorities may disagree with
the Company’s or, as applicable, its partners’ views of the data or
require additional data or information or additional studies. In
addition, the planned timing of completion of the Phase 1 clinical
trial for ARQ 092 in Proteus syndrome is subject to the ability of
the National Institutes of Health, our collaborator responsible for
such trial, to enroll patients, and overcome technical hurdles and
other issues related to the conduct of the trial. There is a risk
that these issues may not be successfully resolved. In addition, we
are utilizing or expect to utilize diagnostic tests in our
biomarker-guided clinical trials with derazantinib, ARQ 092, ARQ
751, and ARQ 531; we or our collaborators may encounter
difficulties in developing and obtaining approval for companion
diagnostics, including issues relating to access to certain
technologies, selectivity/specificity, analytical validation,
reproducibility, concordance or clinical validation. Any delay or
failure by our collaborators or us to develop or obtain regulatory
approval of companion diagnostics could delay or prevent approval
of our product candidates. Drug development involves a high degree
of risk. Only a small number of research and development programs
result in the commercialization of a product. Furthermore, ArQule
may not have the financial or human resources to successfully
pursue drug discovery in the future. Our use of cash is subject to
a number of risks and uncertainties including how successful we
and, as applicable, our collaborators are in executing our clinical
strategy and the results obtained therefrom. For more detailed
information on the risks and uncertainties associated with the
Company’s drug development and other activities, see the Company’s
periodic reports filed with the Securities and Exchange Commission.
The Company does not undertake any obligation to publicly update
any forward-looking statements.
ArQule, Inc.
Condensed Statement of Operations and
Comprehensive Loss
(In Thousands, Except Per Share
Amounts)
(Unaudited)
Three Months EndedJune 30, Six
Months EndedJune 30, 2017 2016 2017
2016 Research and development revenue $ — $
1,072 $ — $ 2,299 Costs and expenses: Research and
development 4,983 4,337 10,177 8,535 General and administrative
1,866 1,887 3,940 3,931 Total
costs and expenses 6,849 6,224 14,117
12,466 Loss from operations (6,849 ) (5,152 ) (14,117
) (10,167 ) Interest income 37 52 59 86 Interest expense
(389 ) — (719 ) —
Net loss (7,201 ) (5,100 )
(14,777 ) (10,081 ) Unrealized gain (loss) on
marketable securities (5 ) — (9 )
29 Comprehensive loss $ (7,206 ) $ (5,100 ) $ (14,786
) $ (10,052 ) Basic and diluted net loss per share: Net loss
per share $ (0.10 ) $ (0.07 ) $ (0.21 ) $ (0.15 )
Weighted average basic and diluted common shares outstanding
71,149 71,062 71,143 68,275
Balance sheet data (in
thousands) (Unaudited):
June 30,2017
December 31,2016 Cash, equivalents and
marketable securities- short term $ 31,007 $ 31,126 Marketable
securities-long term - - $ 31,007 $ 31,126 Total assets $
31,774 $ 32,380 Stockholders’ equity
$
10,086 $ 23,680
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170804005104/en/
ArQuleDawn Schottlandt, 781-994-0300Vice President, Investor
Relations/ Corp. Communicationswww.ArQule.com
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