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ArQule Reports First Quarter 2019 Financial Results

May 1, 2019 Off By BusinessWire

Conference call scheduled today at 9:00 a.m. ET

BURLINGTON, Mass.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24ARQL&src=ctag" target="_blank"gt;$ARQLlt;/agt; lt;a href="https://twitter.com/hashtag/arql?src=hash" target="_blank"gt;#arqllt;/agt;–ArQule,
Inc. (Nasdaq: ARQL) today announced its financial results for the first
quarter, 2019.

For the quarter ended March 31, 2019, the Company reported a net loss of
$10,267,000, or $0.09 per share, compared with net loss of $6,532,000,
or $0.07 per share, for the quarter ended March 31, 2018.

As of March 31, 2019, the Company had a total of approximately
$92,223,000 in cash, cash equivalents, and marketable securities.

Key Highlights from Q1, 2019

ARQ 531, our potent and reversible dual inhibitor of both wild-type
and C481S-mutant BTK. Reported in March that the first evaluable
CLL patient with a C481S mutation enrolled in cohort 7 (65 mg QD) of
our phase 1 trial achieved a partial response that has since been
confirmed with a subsequent scan. This is in addition to a previously
reported follicular lymphoma patient who had also achieved a partial
response and continues on therapy. Cohort 7 has been cleared for
safety and we have begun enrolling patients in cohort 8 (75 mg QD). No
additional DLTs have been observed at any dose. We plan to present
detailed, updated data from this ongoing trial at the European
Hematological Association meeting in June

Miransertib, our potent and selective first-generation AKT
inhibitor. Concluded interactions with the FDA and defined the
registrational trial designs for both Proteus syndrome and
PIK3CA-Related Overgrowth Spectrum (PROS). We have finalized the
protocol and received the first conditional IRB approvals
ARQ 751, our highly potent and selective next-generation AKT
inhibitor. Signal generation work in genetically-defined solid
tumors continues, and we plan to present the final data set at a major
conference by year end
Derazantinib, our FGFR inhibitor, partnered with Basilea and
Sinovant, in a registrational trial for intrahepatic
cholangiocarcinoma. Substantially completed the timely recruitment
and transfer of clinical and other responsibilities to Sinovant and
Basilea

Paolo Pucci, Chief Executive Officer of ArQule, commented, “We have made
tremendous progress across our pipeline in Q1, and we are particularly
pleased with the safety and dose dependent clinical activity profile
that is emerging with ARQ 531.”

“We are busy collecting data for our ARQ 531 presentation at EHA, and we
are confident that we will demonstrate meaningful incremental clinical
activity in addition to the two PRs already announced”, commented Dr.
Brian Schwartz, Chief Medical Officer of ArQule. “We are also pleased by
the rapid review of the initial IRBs for our registrational trial with
miransertib in Proteus syndrome and PROS.”

Revenues and Expenses

Revenues for the first quarter, 2019, were $1,345,000 compared with
revenues of $4,138,000 for the first quarter, 2018.

Research and development expenses in the first quarter, 2019 were
$7,448,000 compared with $5,812,000 for the first quarter, 2018.

General and administrative expenses in the first quarter, 2019 were
$4,300,000 compared with $2,351,000 for the first quarter, 2018.

2019 Financial Guidance

Our 2019 financial guidance has not changed. For 2019, ArQule expects
revenue to range between $3 and $5 million. Net loss is expected to
range between $40 and $43 million, and net loss per share to range
between $(0.37) and $(0.39) for the year. ArQule expects to end 2019
with between $60 and $63 million in cash and marketable securities.

Conference Call and Webcast

ArQule will hold its first quarter financial results call today, May 1,
2019 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 four 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 pipeline includes:
ARQ 531, an orally bioavailable, potent and reversible dual inhibitor of
both wild type and C481S-mutant BTK, in phase 1 for patients with B-cell
malignancies refractory to other therapeutic options; miransertib (ARQ
092), a potent and selective inhibitor of the AKT serine/threonine
kinase, planned to initiate registrational trial cohorts in Proteus
syndrome and PROS in 2019, and in phase 1b in combination with the
hormonal therapy, anastrozole, in patients with advanced endometrial
cancer; ARQ 751, a next generation highly potent and selective AKT
inhibitor, in phase 1 for patients with AKT1 and PI3K mutations; and
derazantinib, a multi-kinase inhibitor designed to preferentially
inhibit the fibroblast growth factor receptor (FGFR) family, in a
registrational trial for iCCA in collaboration with Basilea and
Sinovant. ArQule’s current discovery efforts are focused on the
identification and development of novel kinase inhibitors, leveraging
the Company’s proprietary library of compounds.

Forward-Looking Statements

This press release contains forward-looking statements, including
without limitation under the headings “Key Highlights from Q1, 2019,”
and quotes of management in connection with the Company’s clinical
trials and planned clinical trials, as well as under “2019 Financial
Guidance” with respect to projected financial results. 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 from those set forth in this press release. For
example, while initial results from the development of ARQ 531,
miransertib, ARQ 751 and derazantinib have been promising, such results
are not necessarily indicative of results that will be obtained from
ongoing or subsequent trials and the results achieved in ongoing or
later stage trials may not be sufficient to meet applicable regulatory
standards or to justify further development. 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. 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 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. Regulatory authorities may disagree with
the Company’s or its collaborators’ view of data or require additional
data or information or additional studies. In addition, the planned
timing of completion of clinical trials is subject to the ability of the
Company and, in certain cases, its collaborators 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. In addition, the
Company uses or expects to use companion diagnostics in biomarker-guided
clinical trials with its product candidates. The Company or its
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. Furthermore, the Company may not have
the financial or human resources to successfully pursue drug discovery
in the future. With respect to partnered programs, even if certain
compounds show initial promise our collaborators may decide not to
continue to develop them. Our collaborators in the development of
derazantinib have certain rights to unilaterally terminate their
agreement with ArQule. If either were to do so, the Company
might not be able to complete development and commercialization of
derazantinib on its own in the affected territory. 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
disclaims any obligation to update the information contained in this
press release as new information becomes available.

ArQule, Inc.
Condensed Statement of Operations and Comprehensive Loss
(In Thousands, Except Per Share Amounts)
(Unaudited)

	Quarter Ended March 31,
	2019			2018

Research and development revenue	$	1,345		$	4,138

Costs and expenses:
Research and development	7,448			5,812
General and administrative	4,300			2,351
Total costs and expenses	11,748			8,163

Loss from operations	(10,403		)	(4,025		)

Interest income	566			159
Interest expense	(430		)	(396		)
Other expense (1)	—			(2,270		)
Net loss	(10,267		)	(6,532		)

Unrealized gain (loss) on marketable securities	117			(25		)

Comprehensive loss	$	(10,150	)	$	(6,557	)


Basic and diluted net loss per share	$	(0.09	)	$	(0.07	)

Weighted average shares used in calculating:
Basic and diluted loss per share	109,020			87,112

(1) Non-cash expense associated with the change in fair value of our
preferred stock warrant liability which was converted to common stock
and common stock warrants in May 2018. Accordingly, at March 31, 2019,
the warrant liability was zero.

Balance sheet data (in thousands):	March 31, 2019		December 31, 2018

Cash, equivalents and marketable securities- short term	$	92,223	$	99,558
Marketable securities- long term	—		—
	$	92,223	$	99,558

Total assets	$	98,473	$	106,676
Stockholders’ equity	$	71,086	$	78,968