ArQule Reports Second Quarter 2012 Financial Results

ArQule, Inc. (NASDAQ: ARQL) today announced its financial results for the second quarter of 2012.

For the quarter ended June 30, 2012, the Company reported a net loss of $885,000 or $0.01 per share, compared with a net loss of $10,804,000 or $0.20 per share, for the second quarter of 2011. For the six-month period ended June 30, 2012, the Company reported a net loss of $5,145,000 or $0.09 per share, compared to a net loss of $12,270,000 or $0.24 per share, for the six-month period ended June 30, 2011.

At June 30, 2012, the Company had a total of approximately $147,068,000 in cash, equivalents and marketable securities.

Operational Update

• Completion of patient recruitment in the randomized, double-blind Phase 3 MARQUEE pivotal trial of tivantinib in second-line patients with non-squamous, non-small cell lung cancer (NSCLC);
• Presentation of randomized Phase 2 data at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) highlighting significant clinical benefits observed in second-line hepatocellular carcinoma (HCC) patients with MET-high tumors treated with tivantinib as a single agent;
• Presentations of Phase 1 data at the 2012 Annual Meeting of ASCO highlighting evidence of the clinical benefit and safety of tivantinib in combination with sorafenib in cohorts of patients with HCC, renal cell carcinoma and melanoma.

“The timely completion of patient recruitment in the MARQUEE trial marks an important milestone in the development of tivantinib in non-squamous cell non-small cell lung cancer, a disease with a high unmet need for additional effective treatment options,” said Paolo Pucci, chief executive officer of ArQule. “Approximately 1,000 patients from more than 200 clinical sites worldwide are participating in this trial, which is being conducted under a Special Protocol Assessment in the U.S.

“Findings presented recently at ASCO represent the first randomized data reported in HCC with an investigational MET inhibitor as single-agent therapy in second-line treatment,” said Mr. Pucci. “Based on the positive clinical results in previously treated HCC patients with MET-high tumors, planning is underway for a Phase 3 trial in this population.”

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