ArQule Announces Third Quarter Fiscal 2012 Results

ArQule, Inc. (NASDAQ: ARQL) today reported its results of operations for the fiscal quarter and nine months ended September 30, 2012.

The Company reported a net loss of $431,000 or $0.01 per share for the quarter ended September 30, 2012, compared to a net loss of $2,260,000 or $0.04 per share for the quarter ended September 30, 2011. For the nine-month period ended September 30, 2012, the Company reported a net loss of $5,576,000 or $0.09 per share, compared to a net loss of $14,530,000 or $0.28 per share for the same period in 2011.

At September 30, 2012, the Company had a total of $140,158,000 in cash, equivalents and marketable securities.

Recent Operational Developments

Tivantinib (ARQ 197)

• Agreement with the U.S. FDA on a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial of tivantinib as single agent therapy in patients with hepatocellular carcinoma (HCC);
• Recommendation by the Data Monitoring Committee (DMC) of the MARQUEE trial of tivantinib and erlotinib to stop the study early for futility following a planned interim analysis;
• Discontinuation of the ATTENTION trial of tivantinib and erlotinib in Asia.

Earlier-stage pipeline

• Advancement of ARQ 087, an inhibitor of fibroblast growth factor receptor (FGFR), toward clinical testing.

“Recent developments in the tivantinib non-small cell lung cancer clinical development program have re-focused our near-term efforts on the commencement of a Phase 3 trial with tivantinib as single agent therapy in second-line HCC,” said Paolo Pucci, chief executive officer of ArQule. “We will be conducting this trial under the recently announced SPA, and our determination to pursue this trial in a timely fashion is fueled by the recognition of the high unmet need among patients suffering from this disease.

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