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ArQule Added to the NASDAQ Biotechnology Index

Wednesday, December 19th 2018 at 12:00pm UTC

BURLINGTON, Mass.–(BUSINESS WIRE)– ArQule, Inc. (Nasdaq: ARQL) today announced that it has been selected
for inclusion in the NASDAQ Biotechnology Index (Nasdaq: NBI), which
will become effective prior to market open on Monday, December 24, 2018.

The Index is designed to track the performance of a set of securities
listed on The Nasdaq Stock Market® (NASDAQ®) that
are classified as either biotechnology or pharmaceutical according to
the Industry Classification Benchmark (ICB) and that meet certain
eligibility criteria. These requirements include minimum market
capitalization and average daily trading volume. The NBI is re-ranked
annually and forms the basis for a number of Exchange Traded Funds
(ETFs), including the iShares Nasdaq Biotechnology ETF. For more
information about the Nasdaq Biotechnology Index visit https://indexes.nasdaqomx.com/Index/Overview/NBI.

“Inclusion in the NBI reflects ArQule’s clinical progress and heightened
investor awareness throughout 2018,” said Peter Lawrence, President and
Chief Operating Officer at ArQule. “We remain focused on rapidly
advancing our pipeline of precision therapeutics for oncology and rare
diseases and look forward to a number of data inflection points during
2019.”

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 pipeline
includes: ARQ 531, an 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; miransertib (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), and in Phase 1b in
combination with the hormonal therapy, anastrozole, in patients with
advanced endometrial cancer; ARQ 751, a next generation AKT inhibitor,
in Phase 1 for patients with AKT1 and PI3K mutations; derazantinib, a
multi-kinase inhibitor designed to preferentially inhibit the fibroblast
growth factor receptor (FGFR) family, in a registrational trial for
iCCA; and ARQ 761, a ?-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. 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 regarding our clinical programs, including a
statement regarding our focus on their rapid advancement and future data
inflection points. 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 early clinical results does not ensure that later-stage clinical
trials will be successful. For example, our drug candidates may not
demonstrate promising therapeutic effect in man; in addition, they may
not exhibit an adequate safety profile in planned 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 during
clinical trials or in the course of developing, testing or manufacturing
our drug candidates that could lead the Company 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 view of the data
or require additional data or information or additional studies. In
addition, we are utilizing diagnostic tests to identify patients in a
number of trials and expect to utilize diagnostic tests in other
clinical trials. We or our collaborators may need to develop and
register these or other diagnostic tests as companion diagnostics with
the FDA. We or our collaborators may encounter difficulties in
developing and obtaining regulatory 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 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. 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.

www.ArQule.com

Contacts

Corporate Contact:
Marc Schegerin, M.D.
Senior Vice
President
Head of Strategy, Finance and Communication
ir@arqule.com

Media
Contact:

Allison Blum, Ph.D.
LifeSci Public Relations
(646) 627-8383
Allison@lifescipublicrelations.com

Source: ArQule, Inc.


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