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ARQL reports 1st quarter earnings



Wed, May 6, 2015, 9:49AM EDT - US Markets close in 6 hrs and 11 mins


ArQule Reports First Quarter 2015 Financial Results
Conference call scheduled today at 9:00 a.m. eastern time
Business Wire ArQule, Inc.
2 hours ago
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WOBURN, Mass.--(BUSINESS WIRE)--

ArQule, Inc. (ARQL) today announced its financial results for the first quarter of 2015.

For the quarter ended March 31, 2015, the Company reported a net loss of $4,551,000 or $0.07 per share, compared to a net loss of $7,141,000 or $0.11 per share, for the first quarter of 2014.

At March 31, 2015, the Company had a total of $53,581,000 in cash, equivalents and marketable securities.

Operational Update

Enrollment in the pivotal Phase 3 METIV-HCC trial in hepatocellular carcinoma (HCC) with tivantinib is continuing on schedule toward the goal of completing patient accrual by year end;
Presentations of ARQ 087 at the Annual Meeting of the American Association for Cancer Research (AACR) provide further rationale for the ongoing development of this compound in Phase 2 cholangiocarcinoma and beyond;
The protocol for ARQ 092 Phase 1 trial in Proteus syndrome has been approved by the Institutional Review Board (IRB), and a regulatory submission to begin a clinical trial has been made by our partners at the National Institutes of Health (NIH);
A research and development collaboration has been established with Beryllium Development Corp. to pursue small molecule inhibitors of PD1 and PDL-1 using ArQule’s proprietary library.
“Clinical centers are actively enrolling patients in the Phase 3 METIV-HCC trial with tivantinib, which is focused on HCC patients who are MET-high,” said Paolo Pucci, chief executive officer of ArQule. “We believe this is the only trial in this setting that targets a biomarker-defined patient population. The METIV-HCC trial is being conducted with our partner, Daiichi Sankyo Co., Ltd., while a second Phase 3 trial in HCC with tivantinib is being conducted in Japan by Kyowa Hakko Kirin, our partner in Asian territories.

“Two studies with ARQ 087, our proprietary FGFR inhibitor, were presented at AACR on April 21, 2015,” said Mr. Pucci. “Data from the first study demonstrate the correlation of circulating FGF levels with clinical benefit in patients, including tumor responses seen to date in intrahepatic cholangiocarcinoma (iCCA) following single agent treatment with this compound. Data from the second presentation underscore the potential broad therapeutic application of ARQ 087 in combination with chemotherapies.

“Our recent agreement with Beryllium has the potential to identify and unlock the therapeutic potential of small molecule compounds by combining ArQule’s chemistry and drug development expertise with Beryllium’s discovery platforms,” said Mr. Pucci. “The initial therapeutic targets will be PD-1 and PDL-1, based on the recognition that immuno-oncology represents a promising area of research with potential applications across a number of cancers.”

Revenues and Expenses

The Company reported research and development revenue of $2,785,000 for the quarter ended March 31, 2015, compared with $2,676,000 for the quarter ended March 31, 2014. Revenue in the three months ended March 31, 2015 is comprised of revenue from the Daiichi Sankyo tivantinib development agreement and the Kyowa Hakko Kirin exclusive license agreement for tivantinib. The revenue increase in the quarter ended March 31, 2015 is primarily due to lower contra-revenue from our Daiichi Sankyo tivantinib program.

Total costs and expenses for the quarter ended March 31, 2015 were $7,600,000 compared to $9,981,000 for the first quarter of 2014. Research and development costs for the quarter ended March 31, 2015 were $4,413,000 compared to $6,731,000 for the first quarter of 2014. These decreases were primarily due to lower labor related costs of $0.9 million from the August 2014 restructuring, outsourced clinical and product development costs of $0.8 million, lab expenses of $0.3 million, and other cost decreases of $0.3 million. At March 31, 2015 we had 23 employees dedicated to our research and development program compared to 43 at March 31, 2014.

General and administrative expenses for the first quarter of 2015 were $3,187,000 compared to $3,250,000 for the first quarter of fiscal 2014. This decrease was principally due to lower stock-based compensation expense.

Conference Call and Webcast

Conference call details

Date: May 6, 2015
Time: 9:00 a.m. Eastern Time
Conference Call Numbers
Domestic: 877-868-1831
International: 914-495-8595
Web cast:
http://www.arqule.com
A replay of the conference call will be available beginning two hours after the completion of the call until the end of May 8, 2015 and can be accessed by dialing toll-free 855-859-2056 or 800-585-8367, and outside the U.S. 404-537-3406. The confirmation code for replayed calls is 27606827.


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