NEW YORK, NY / ACCESSWIRE / June 20, 2016 / Rising Tide Equity Research, LLC announced today the release of its Initial Equity Report on ArQule, Inc (NASDAQ: ARQL), a biopharmaceutical company engaged in the research and development of innovative 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 patients. Their clinical development targets biological pathways implicated in a wide range of cancers and certain non-oncology indications. ArQule's discovery and development efforts are guided by an understanding of the role of biomarkers, which are indicators of a particular biological condition or process and may predict the clinical benefit of their compounds in defined patient populations. The Company's proprietary clinical-stage pipeline consists of four drug candidates, all of which are in targeted patient populations making ArQule a leader among companies their size in precision medicine.

ArQule has a long history of kinase drug discovery and development, having discovered and introduced eight kinase inhibitors into human clinical trials with a ninth about to enter the clinic. Their drug discovery efforts have been informed by their historical expertise in chemistry, their work in rational drug design, and insight into kinase binding and regulation. They have applied this knowledge to produce clinical compounds for a number of kinase targets and to build an extensive library of proprietary compounds with the potential to target multiple kinases in oncology and other therapeutic areas, such as rare diseases. They expect to bring further pre-clinical programs forward either directly or through collaborators and to evaluate new targets beyond kinases.

Clinical Development Activities:

ArQule's prioritized clinical stage pipeline consists of four drug candidates, all of which are in targeted, biomarker-defined patient populations, making ArQule a potential early leader in precision medicine. ArQule's proprietary pipeline includes:

- ARQ 197, ArQule's lead product, is in Phase 3 clinical development. It is an oral, selective inhibitor of the c-MET receptor tyrosine kinase, for second-line treatment of hepatocellular carcinoma. This program has been partnered with Daiichi Sankyo in the West and Kyowa Hakko Kirin in Asia.

- ARQ 092, designed to inhibit the AKT serine/threonine kinase is in Phase 1 clinical trials for multiple oncology indications as well as ultra-rare Proteus syndrome. This program has been partnered with the National Institutes of Health (NIH).

- ARQ 087, a multi kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family, is in Phase 2 trials for intrahepatic cholangiocarcinoma and in Phase 1b trials for multiple oncology indications.

- ARQ 761, a ?-lapachone analog being evaluated as a promoter of NQO1-mediated programmed cancer cell necrosis, is in Phase 1/2 for multiple oncology indications. This program has been partnered with the University of Texas Southwestern Medical Center.

Catalysts and Upcoming Milestones:

Of these programs, three have been awarded Orphan Drug Designation by the FDA in addition to a Special Protocol Assessment for their Phase 3 trials. The Phase 3 trials in hepatocellular carcinoma have been partnered and fully funded by Daiichi Sankyo and Kyowa Hakko Kirin. These trials are nearing completion and top-line data is anticipated in the fourth quarter of 2017. The company recently announced positive data from its Phase 1 Proteus Syndrome program and based on these results, the National Institute of Health (NIH) has chosen to continue the program and increase patient inclusion criteria. Data from these additional patients is anticipated in the third quarter of 2017. Phase 1b data in lymphoma, endometrial tumors, and solid tumors is also anticipated by years end. Near term, ArQule will be presenting preliminary clinical data from its intrahepatic cholangiocarcinoma (iCCA) program at the European Society for Medical Oncology, Gastrointestinal Cancer Conference being held June 29th - July 2nd, 2016. Initial data from this study will be presented and top-line data is anticipated in the third quarter.

Conclusion:

In the coming weeks and months, ArQule will provide updates on five of their clinical programs, including top-line results from two, Phase 3 studies. They are currently investigating four clinical compounds in ten different clinical trials. To support their clinical development activities, they have been able to create partnerships and collaborations with well-known pharmaceutical companies such as Daiichi Sankyo, Beryllium, The National Institute of Health, and the National Cancer Institute, among others. The breadth of their clinical development and support of these institutions provide scientific validation for their clinical approach. The company recently completed an equity offering providing them with adequate financial resources to fund clinical development into 2018. In this equity offering, many large financial institutions either increased or initiated new positions creating a solid foundation of institutional investors. With a market cap of $123 million, five significant catalysts in the near term, over 70% institutional ownership, a broad range of clinical development activities, and multiple partnerships, ArQule is positioned for growth in the coming months.

The complete Rising Tide Equity Report, including important disclosures, is available to download at no cost on the Rising Tide Equity Research website, https://www.risingtideequity.com/equity-research/

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SOURCE: Rising Tide Equity Research