ArQule Added to the NASDAQ Biotechnology Index

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BURLINGTON, Mass.–(BUSINESS WIRE)–Dec 19, 2018–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 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. 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

View source version on businesswire.com:https://www.businesswire.com/news/home/20181219005156/en/

CONTACT: 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

KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS ONCOLOGY PHARMACEUTICAL FDA

SOURCE: ArQule, Inc.

Copyright Business Wire 2018.

PUB: 12/19/2018 07:00 AM/DISC: 12/19/2018 07:01 AM

http://www.businesswire.com/news/home/20181219005156/en



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