Conference call scheduled today at 9:00 a.m.
ET
ArQule, Inc. (NASDAQ: ARQL) today announced its financial
results for the fourth quarter and full year of 2016.
For the quarter ended December 31, 2016, the Company reported a
net loss of $6,820,000 or $0.10 per share, compared with net loss
of $2,852,000 or $0.05 per share, for the quarter ended December
31, 2015. The Company reported a net loss of $22,718,000 or $0.33
per share, for the year ended December 31, 2016, compared with a
net loss of $13,774,000 or $0.22 per share, for the year ended
December 31, 2015.
At December 31, 2016, the Company had a total of approximately
$31,126,000 in cash and marketable securities.
Key Highlights
- ARQ 087, our proprietary FGFR
inhibitor, is planned to advance to a pivotal phase 3 biomarker
driven trial in second-line intrahepatic cholangiocarcinoma (iCCA)
patients with FGFR2 fusions. A phase 1/2 trial including 29
second-line iCCA patients harboring FGFR2 fusions has completed
enrollment and generated compelling clinical evidence to support a
pivotal trial. Preliminary data from this phase 1/2 iCCA trial
demonstrate a 24% response rate. Of 25 evaluable patients, six have
achieved partial responses and a median time on therapy of
approximately 26 weeks has been observed. To date, the disease
control rate for the overall trial is 76%.
- ARQ 092, our lead proprietary AKT
inhibitor, is planned to advance to a company-sponsored phase 1/2
trial in PROS (PIK3CA Rare Overgrowth Spectrum), including Proteus
syndrome. A phase 1/2 trial evaluating patients with PROS,
including more advanced and younger patients, has received
regulatory approval in the U.S. and EU.
- ARQ 531, our proprietary reversible
BTK inhibitor, is on track to begin its first clinical trial.
Preclinical toxicology testing has completed and the company plans
to file an Investigational New Drug (IND) application with FDA in
Q1’17, and to subsequently begin its first clinical trial.
- Tivantinib phase 3 METIV-HCC trial
did not meet its primary endpoint of increased overall survival in
hepatocellular carcinoma (HCC). METIV-HCC is a
biomarker-selected, double-blind, placebo-controlled, randomized
phase 3 study evaluating tivantinib (2:1) versus best supportive
care in patients with MET-overexpressing, inoperable HCC intolerant
to or previously-treated with systemic therapy. Full results from
the trial will be presented at an upcoming scientific forum. The
phase 3 JET-HCC trial conducted by Kyowa Hakko Kirin is expected to
provide final results in late Q1 or early Q2’17.
- Company announced it raised
approximately $15 million from a debt offering. Net proceeds
from the offering will be used to advance ArQule’s proprietary
pipeline and for general business purposes, including working
capital.
2017 Goals
ARQ 087 – FGFR Inhibitor
- Initiate phase 3 trial for second-line
iCCA patients with FGFR2 fusions in Q3’17
- Apply for Breakthrough Therapy
Designation in the U.S.
- Present data on phase 1/2 trial in iCCA
at a scientific congress
ARQ 092 – AKT Inhibitor
- Initiate company-sponsored phase 1/2
trial in PROS, including Proteus syndrome, in Q2’17
- Continue to pursue Pediatric Rare
Disease Voucher Designation from the FDA
- Continue to support the NIH phase 1
trial in Proteus syndrome
ARQ 531 – BTK Inhibitor
- File an IND application in Q1’17
- Initiate phase 1 trial by Q3’17
ARQ 751 – Next-Generation AKT Inhibitor
- Evaluate initial data from phase 1
trial and define next steps
“We are focused on advancing our proprietary pipeline to
meaningful inflection points,” said Paolo Pucci, Chief Executive
Officer of ArQule. “We are looking forward to beginning our first
phase 3 trial with a proprietary asset, ARQ 087, in iCCA, and
initiating company-sponsored clinical trials in PROS with ARQ 092
and in oncology with ARQ 531 this year.”
“We are pleased with the results, including response rate and
durability, that ARQ 087 has demonstrated in the phase 1/2 iCCA
trial,” said Dr. Brian Schwartz, M.D., Head of Research and
Development and Chief Medical Officer at ArQule. “After meetings
with regulatory agencies, we are planning to progress to a pivotal
phase 3 response rate driven trial of approximately 100 iCCA
patients with FGFR2 fusions at sites across the U.S. and E.U. iCCA
is an orphan disease with few treatment options.”
Revenues and Expenses
Revenues for the quarter ended December 31, 2016, were
$1,187,000, compared with revenues of $2,797,000 for the quarter
ended December 31, 2015. Revenues for the year ended December 31,
2016 were $4,709,000 compared with revenues of $11,239,000 for the
year ended December 31, 2015. Research and development revenue in
2016 and 2015 includes revenue from the Daiichi Sankyo tivantinib
development agreement and the Kyowa Hakko Kirin exclusive license
agreement.
Research and development expenses in the fourth quarter of 2016
were $6,242,000, compared with $3,641,000 for the fourth quarter
2015. Fiscal 2016 research and development expenses were
$20,042,000, compared with $15,561,000 for fiscal 2015.
Research and development expense increased $2.6 million in the
fourth quarter of 2016 compared to the fourth quarter of 2015
primarily due to higher outsourced clinical and product development
costs. Research and development expense increased $4.5 million in
2016 primarily due to higher outsourced clinical and product
development costs of $5.3 million, partially offset by lower labor
costs of $0.5 million and facility costs of $0.4 million.
General and administrative expenses in the fourth quarter of
2016 were $1,808,000, compared with $2,028,000 for the fourth
quarter of 2015. General and administrative expenses for fiscal
2016 were $7,563,000, compared to $9,830,000 for fiscal 2015.
General and administrative expense decreased by $0.2 million in
the fourth quarter of 2016 compared to the fourth quarter of 2015
due to lower labor costs. General and administrative expense in
2016 decreased by $2.3 million primarily due to lower facility
costs of $1.6 million and labor related costs of $0.6 million.
2017 Financial Guidance
For 2017, ArQule expects net use of cash to range between $25
and $27 million. Net loss is expected to range between $30 and $32
million, and net loss per share to range between $(0.42) and
$(0.45) for the year. ArQule expects to end 2017 with between $18
and $20 million in cash and marketable securities.
Conference Call and
Webcast
ArQule will hold its fourth quarter and full year financial
results call today, March 7, 2017 at 9:00 a.m. ET. The live webcast
can be accessed in the “Investors and Media” section of our
website, www.arqule.com, under “Events and 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
“Investors and Media” section of our website, www.arqule.com, under
“Events and 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 phase 1
for multiple oncology indications as well as ultra-rare Proteus
syndrome, in partnership with the National Institutes of Health
(NIH); 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, through toxicology testing and plan to
file an Investigational New Drug Application in the first quarter
of 2017. ArQule’s most advanced product, in phase 3 clinical
development, is tivantinib (ARQ 197), an oral, selective inhibitor
of the c-MET receptor tyrosine kinase, for second-line treatment of
MET-overexpressing hepatocellular carcinoma in partnership with
Daiichi Sankyo in the West and Kyowa Hakko Kirin in Asia. 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,
including without limitation under the heading “Goals,” in
connection with the Company’s clinical trials and planned clinical
trials with tivantinib (ARQ 197), ARQ 092, ARQ 087, ARQ 751, and
ARQ 531 as well as under “2017 Financial Guidance” with respect to
projected financial results and its 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,
the pivotal phase 3 METIV-HCC with tivantinib did not meet its
primary endpoint of overall survival. Moreover, ARQ 087, ARQ 092,
ARQ 761, 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 or 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 its partners’ view of the data
or require additional data or information or additional studies. In
addition, the planned timing of completion of clinical trials for
tivantinib is subject to the ability of the Company as well as
Kyowa Hakko Kirin, a licensee of tivantinib, and for ARQ 092 the
National Institutes of Health, our collaborator responsible for the
phase 1 trial in Proteus syndrome, to enroll patients, enter into
agreements with clinical trial sites and investigators, and
overcome technical hurdles and other issues related to the conduct
of the trials for which each of them is responsible. There is a
risk that these issues may not be successfully resolved. In
addition, we and our partner are utilizing a companion diagnostic
to identify MET-high patients in the JET-HCC trial, and we are
utilizing or expect to utilize diagnostic tools in our
biomarker-guided clinical trials with ARQ 087, 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, or
clinical validation. Any delay or failure by our collaborators or
ourselves 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. Positive pre-clinical data may not
be supported in later stages of development. Furthermore, ArQule
may not have the financial or human resources to successfully
pursue drug discovery in the future. Moreover, with respect to
partnered programs, even if certain compounds show initial promise,
Kyowa Hakko Kirin or the NIH may decide not to continue to develop
them. In addition, Daiichi Sankyo and Kyowa Hakko Kirin have
certain rights to unilaterally terminate their agreements with
ArQule. If either company were to do so, the Company might not be
able to complete development and commercialization of the
applicable licensed products on its own. 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)
Quarter EndedDecember
31,
Year Ended December 31,
2016 2015 2016 2015
Research and development revenue $ 1,187 $ 2,797 $ 4,709 $
11,239 Costs and expenses: Research and development 6,242
3,641 20,042 15,561 General and administrative 1,808 2,028 7,563
9,830 Total costs and expenses 8,050
5,669 27,605 25,391 Loss from operations (6,863 ) (2,872 )
(22,896 ) (14,152 ) Interest income 43 20 178 101
Other income - - - 277 Net loss (6,820 ) (2,852 ) (22,718 ) (13,774
) Unrealized gain (loss) on marketable securities (20) 2 (1)
13
Comprehensive loss $ (6,840 ) $ (2,850 ) $ (22,719 ) $ (13,761 )
Basic and diluted net loss per share: Net loss per share $
(0.10 ) $ (0.05 ) $ (0.33 ) $ (0.22 ) Weighted average basic
and diluted common shares outstanding 71,106 62,861 69,714 62,808
Balance sheet data (in
thousands): (Unaudited) December 31,
2016
December 31,2015 Cash, equivalents and
marketable securities- short term $ 31,126 $ 38,772 Marketable
securities- long term - - $ 31,126 $ 38,772 Total assets $
32,380 $ 40,004 Stockholders’ equity $ 23,680 $ 29,179
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170307005137/en/
ArQule, Inc.Dawn Schottlandt, 781-994-0300Sr. Director, Investor
Relations/ Corp. Communicationswww.arqule.com
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