ArQule Reports Fiscal 2012 Year End And Fourth Quarter Results

ArQule, Inc. (NASDAQ: ARQL) today announced its financial results for the year and for the fourth quarter ended December 31, 2012.

The Company reported a net loss of $10,872,000 or $0.18 per share, for the year ended December 31, 2012, compared with a net loss of $10,762,000, or $0.20 per share, for the year ended December 31, 2011. For the quarter ended December 31, 2012, the Company reported a net loss of $5,296,000 or $0.09 per share, compared with net income of $3,768,000, or $0.07 per share, for the quarter ended December 31, 2011.

At December 31, 2012, the Company had a total of approximately $130,599,000 in cash and marketable securities.

Operational Milestones

Tivantinib (ARQ 197)

• Presentation of data at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) from a randomized, double-blind, controlled Phase 2 trial of tivantinib in second-line hepatocellular carcinoma (HCC) that met the primary endpoint of time to progression, with pronounced improvements observed in median overall survival and progression free survival in MET-high patients;
• Dosing of the first patient in the pivotal Phase 3 METIV-HCC trial of tivantinib as a single agent in second-line HCC MET-high patients in January 2013;
• Agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of the METIV-HCC trial;
• Discontinuation of the Phase 3 MARQUEE trial of tivantinib and erlotinib in non-squamous non-small cell lung cancer (NSCLC), conducted by our partner Daiichi Sankyo Co., Ltd., following an interim analysis, with patients already on treatment and re-consented continuing to receive treatment;
• Permanent suspension of enrollment in the Phase 3 ATTENTION trial of tivantinib and erlotinib in non-squamous NSCLC in Asia conducted by our partner, Kyowa Hakko Kirin Co., Ltd., with patients already enrolled and re-consented continuing to receive treatment;
• Announcement of top-line data from the randomized Phase 2 signal generation trial of tivantinib in combination with irinotecan and cetuximab in second-line colorectal cancer (CRC) showing a trend of improvements in progression-free survival and objective response rate;
• Presentation of Phase 1b data at the ASCO Annual Meeting showing that the combination of tivantinib and sorafenib was well tolerated and that preliminary anti-tumor activity was observed in multiple patient extension cohorts, including HCC.

Pipeline / Discovery

• Commencement of patient dosing in a Phase 1 clinical trial with ARQ 087, an orally bioavailable, multi-kinase inhibitor with pan-FGFR (fibroblast growth factor receptor) activity.

Plans for 2013

“Tivantinib has re-emerged as a Phase 3 clinical-stage compound with the initiation of the METIV-HCC trial in second-line HCC early this year,” said Paolo Pucci, chief executive officer of ArQule. “In 2013 we look forward to multiple data presentations that will inform our future development plans. The primary objectives with tivantinib this year include:

• timely progress in patient enrollment in the Phase 3 METIV-HCC trial;
• completion of patient enrollment in the Phase 2 KRAS-mutation positive NSCLC trial;
• completion and presentation of data analyses from the MARQUEE trial;
• data read-out from the ATTENTION trial by Kyowa Hakko Kirin expected in late 2013 or early 2014;
• presentation of final data from the randomized Phase 2 combination trial with irinotecan and cetuximab in colorectal cancer;
• support of ongoing clinical trials sponsored by the National Cancer Institute/Cancer Therapy Evaluation Program.

“Progress in other programs will focus on the following activities:

• enrollment of patients in the Phase 1 trial with ARQ 087;
• completion of patient enrollment in the Phase 1 trial with ARQ 092;
• screening of the Company’s proprietary library of compounds as part of a drug discovery effort directed toward defined therapeutic targets.

“At the end of 2012, ArQule had $130.6 million in cash and marketable securities,” said Mr. Pucci. “We expect that these available financial resources will be sufficient to finance our working capital requirements well into 2015.”

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