ArQule Announces Third Quarter Fiscal 2012 Results

“The MARQUEE trial, fully enrolled early this year, will be stopped for futility at the interim analysis following the recommendation of the DMC, which was focused on the primary endpoint of overall survival in the intent-to-treat population,” said Mr. Pucci. “Data will continue to be compiled to a mature cut-off point, and patients who were on study drug treatment at the time of the DMC recommendation will have the opportunity to remain on treatment at their physician’s discretion. Following final database compilation and analyses, complete trial results will be presented in a scientific forum.

“With respect to the ATTENTION trial, Kyowa is discontinuing that study as announced earlier this week based on a recommendation by the trial’s Safety Review Committee,” said Mr. Pucci. “Complete data from the trial are expected in the second half of 2013.

“Our financial position continues to be strong,” said Mr. Pucci, “and we expect to conclude this year with between $127 million and $130 million in cash, equivalents and marketable securities.”

Revenues and Expenses

The Company reported total revenues of $10,944,000 for the quarter ended September 30, 2012, compared to revenues of $11,954,000 for the quarter ended September 30, 2011. Revenues for the nine months ended September 30, 2012 were $31,271,000, compared to revenues of $30,806,000 for the nine months ended September 30, 2011.

The $1.0 million revenue decrease in the three month period is due to revenue decreases of $4.6 million from the $10 million milestone payment received from Kyowa Hakko in the third quarter of 2011 and $3.0 million from the Company’s Daiichi Sankyo AKIP™ agreement, partially offset by an increase of $0.6 million from the Company’s Daiichi Sankyo ARQ 092 agreement, and lower contra-revenue of $6.0 million associated with the Daiichi Sankyo tivantinib agreement.

The $0.5 million revenue increase in the nine month period is due to lower contra-revenue of $11.3 million associated with the Company’s Daiichi Sankyo tivantinib agreement, and revenue increases of $1.2 million from the Daiichi Sankyo AKIP™ agreement and $2.2 million from the Daiichi Sankyo ARQ 092 agreement. These revenue increases were partially offset by a $10.2 million decrease in revenue recognized on the $25 million MARQUEE milestone payment received from Daiichi Sankyo in the first quarter of 2011 and a $4.0 million decrease in revenue recognized on the $10 million milestone payment received from Kyowa Hakko in the third quarter of 2011.

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