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ArQule Reports Second Quarter 2013 Financial Results

ArQule, Inc. (NASDAQ: ARQL) today announced its financial results for the second quarter of 2013.

For the quarter ended June 30, 2013, the Company reported a net loss of $6,786,000 or $0.11 per share, compared with a net loss of $885,000 or $0.01 per share for the second quarter of 2012. For the six-month period ended June 30, 2013, the Company reported a net loss of $12,561,000 or $0.20 per share, compared with a net loss of $5,145,000 or $0.09 per share, for the six-month period ended June 30, 2012.

At June 30, 2013, the Company had a total of approximately $111,114,000 in cash, equivalents and marketable securities.

Operational Update

  • Data from the Company’s Phase 2 trial in colorectal cancer (CRC) presented at the 2013 ASCO Annual Meeting included trends in improved progression free survival (PFS), overall response rate (ORR) and overall survival (OS) in patients who received tivantinib in combination with irinotecan and cetuximab.
  • Enrollment in the Phase 3 METIV-HCC trial in hepatocellular carcinoma (HCC) is proceeding as planned following the initiation of this trial in January, 2013 toward the goal of recruiting approximately 300 patients at 120 clinical sites.
  • A recent exploratory analysis of the MET IHC (immunohistochemistry) sub-group from the MARQUEE trial in non-squamous non-small cell lung cancer (NSCLC) demonstrated that the MET high tivantinib group showed a substantial improvement in OS relative to control, a benefit not seen in the intent-to-treat (ITT) population; complete data from this trial are planned for presentation at the European Cancer Congress in the fall of 2013.
  • A focused workforce reduction of approximately 25 positions effective immediately has resulted in total personnel at the Company numbering approximately 67; as a result, current cash, cash equivalents and marketable securities will be sufficient to fund the Company’s working capital and capital requirements into 2016, with no impact on current financial guidance for 2013. This action is intended to align human and financial resources with the Company’s primary focus on clinical-stage development, while retaining its core discovery capabilities.

“Data from a randomized, placebo-controlled, double-blind, Phase 2 clinical trial with tivantinib in combination with cetuximab and irinotecan in patients with relapsed or refractory KRAS wild-type metastatic CRC were presented at the 2013 ASCO Annual Meeting,” said Paolo Pucci, chief executive officer of ArQule. “These data analyses identified signals of clinical benefit in trends toward improved PFS, ORR and OS.

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