Conference call scheduled today at 9:00 a.m.
ET
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 EndedMarch 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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190501005281/en/
Corporate Contact:Kathleen FarrenInvestor Relations
&Executive Assistant to the CFOir@arqule.comMedia
Contact:Cait Williamson, Ph.D.LifeSci Public Relations(646)
751-4366cait@lifescipublicrelations.comwww.ArQule.com
ArQule (NASDAQ:ARQL)
Historical Stock Chart
From Mar 2024 to Apr 2024
ArQule (NASDAQ:ARQL)
Historical Stock Chart
From Apr 2023 to Apr 2024