About ArQule
ArQule, Inc. (NASDAQ: ARQL)
http://www.arqule.com
FOCUS
ArQule, Inc. is a clinical-stage biotechnology company that is researching and developing innovative cancer therapeutics targeting critical biological processes implicated in a wide range of cancers. The Company’s assets include tivantinib (ARQ 197) a lead product in Phase 3 clinical testing and in a series of Phase 1 and 2 trials that will provide clinical data over the next 12 to 24 months. The Company also has a pipeline of early clinical-stage and pre-clinical product candidates, as well as a highly differentiated discovery engine marked by flexibility and efficiency.
LEAD PRODUCT
Tivantinib is a first-in-class, small molecule inhibitor of the c-Met receptor tyrosine kinase ("c-Met"). C-Met and its signaling pathway is an area of great interest in cancer biology as research has shown that c-Met plays a key role in cancerous cell proliferation, metastasis, new blood vessel formation and resistance to various drug therapies.
Tivantinib is being explored broadly as single agent therapy and in combination with approved anti-cancer drugs to treat a variety of cancers. The tivantinib clinical trial program currently includes non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer and gastric cancer, as well as earlier stage, signal generation studies in multiple tumor types.
PARTNERSHIPS
ArQule has licensed commercial rights to tivantinib for cancer to Daiichi Sankyo Co., Ltd. in the U.S., Europe, South America and the rest of the world, excluding Japan and certain other Asian countries, where commercial rights are licensed to Kyowa Hakko Kirin Co., Ltd. These partnerships help the Company to manage its balance sheet through non-dilutive funding and cost-sharing, while establishing a foundation for forward integration through retention of co-commercialization rights in the U.S.
PIPELINE
ArQule’s proprietary pipeline contains multiple therapeutic products with diverse biological targets and mechanisms of action. It includes: ARQ 736, a pan-RAF kinase inhibitor in Phase 1 clinical testing; ARQ 621, an inhibitor of the Eg5 kinesin motor protein in Phase 1 clinical testing; and a series of pre-clinical stage inhibitors of fibroblast growth factor receptor.
DISCOVERY TECHNOLOGY
Drug discovery at ArQule is based on an innovative and efficient drug discovery engine utilizing proprietary structure-based drug design technology known as the ArQule Kinase Inhibitor Platform (AKIP™). This platform targets the inactive forms of kinases that have pivotal roles in cancer and other diseases. AKIP integrates in silico drug design, parallel robotic chemistry and novel assay development expertise to create non-ATP competitive inhibitors that interact with these kinases in novel binding modes. Therapeutic candidates identified through AKIP are then further optimized with the appropriate degree of selectivity intended to impart greater efficacy and fewer side effects.
MANAGEMENT
ArQule’s management includes individuals with expertise in the biotechnology and pharmaceutical industries including discovery research, clinical development, regulatory review, product launch, commercialization, business development and financing.
Paolo Pucci
Chief Executive Officer
Peter S. Lawrence
President and Chief Operating Officer
Brian Schwartz, M.D.
Chief Medical Officer
Thomas C.K. Chan, Ph.D.
Chief Scientific Officer
Business Development Contact
Manish Tandon, Ph.D., MBA
Director, Business Development and Alliance Management
Investor Contact
William B. Boni
Vice President, Investor Relations and Corporate Communications
FINANCIAL INFORMATION (December 31, 2010)
►Net cash and marketable securities at 12/31/10: $83 million
►Net loss guidance for 2011: $35-40 million
►Net cash and marketable securities guidance for 12/31/11: $85-90 million
ANALYSTS
ArQule, Inc. - Analyst Coverage
HEADQUARTERS
19 Presidential Way
Woburn, MA 01801
781-994-0300