This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration. Need a new registration confirmation email? Click here
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.
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.