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ArQule, Inc. (ARQL - Snapshot Report) recently reported a loss of 9 cents per share in the fourth quarter of 2012, narrower than the Zacks Consensus Estimate of 13 cents per share. The company had reported earnings per share of 7 cents in the year-ago quarter.

Revenues of $5.1 million in the fourth quarter of 2012 were down 68.8% from a year ago but in line with the Zacks Consensus Estimate.

Research and development expenses were $7.2 million, down 25.1% from the year-ago quarter. General and administrative expenses were $3.3 million, down 6.4% from the year-ago quarter.

We note that ArQule and partner Daiichi Sankyo announced disappointing phase II results on oncology candidate, tivantinib (ARQ 197) in Feb 2013.

The study evaluated ArQule’s lead pipeline candidate, tivantinib, in combination with Pfizer’s (PFE - Analyst Report) Camptosar (irinotecan) and  Bristol-Myers Squibb/Eli Lilly’s (BMY - Analyst Report)/(LLY - Analyst Report) Erbiutx (cetuximab) in patients with refractory or relapsed colorectal cancer (CRC).

For the full year, revenues came in at $36.4 million, down 23 % from 2011 and below the Zacks Consensus of $37 million. Loss per share came in at 18 cents, narrower than the Zacks Consensus Estimate of a loss of 23 cents per share and 20 cents reported in 2011.


ArQule will continue to focus on tivantinib, which has now entered into phase III with the initiation of the METIV-HCC (MET-high patients with Tivantinib in HCC) trial in second-line HCC (hepatocellular carcinoma or liver cancer).

METIV-HCC trial, initiated in early 2013, is a controlled study of previously treated patients with MET-high inoperable HCC who will receive tivantinib as a single agent or placebo.

ArQule expects revenues between $12 and $15 million in 2013. The Zacks Consensus Estimate for revenues in 2013 was $18 million.

ArQule anticipates net loss between $28 million and $31 million in 2013. Loss per share is estimated between 45 cents and 50 cents. The Zacks Consensus Estimate was 48 cents.

ArQule currently carries a Zacks Rank #3 (Hold).

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