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 MilestonesTivantinib (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.
- 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.
- 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.
- 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.