This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

ArQule Reports Fiscal 2012 Year End And Fourth Quarter Results

Stocks in this article: ARQL

ArQule, Inc. (NASDAQ: ARQL) today announced its financial results for the year and for the fourth quarter ended December 31, 2012.

The Company reported a net loss of $10,872,000 or $0.18 per share, for the year ended December 31, 2012, compared with a net loss of $10,762,000, or $0.20 per share, for the year ended December 31, 2011. For the quarter ended December 31, 2012, the Company reported a net loss of $5,296,000 or $0.09 per share, compared with net income of $3,768,000, or $0.07 per share, for the quarter ended December 31, 2011.

At December 31, 2012, the Company had a total of approximately $130,599,000 in cash and marketable securities.

Operational Milestones

Tivantinib (ARQ 197)

  • Presentation of data at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) from a randomized, double-blind, controlled Phase 2 trial of tivantinib in second-line hepatocellular carcinoma (HCC) that met the primary endpoint of time to progression, with pronounced improvements observed in median overall survival and progression free survival in MET-high patients;
  • Dosing of the first patient in the pivotal Phase 3 METIV-HCC trial of tivantinib as a single agent in second-line HCC MET-high patients in January 2013;
  • Agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of the METIV-HCC trial;
  • Discontinuation of the Phase 3 MARQUEE trial of tivantinib and erlotinib in non-squamous non-small cell lung cancer (NSCLC), conducted by our partner Daiichi Sankyo Co., Ltd., following an interim analysis, with patients already on treatment and re-consented continuing to receive treatment;
  • Permanent suspension of enrollment in the Phase 3 ATTENTION trial of tivantinib and erlotinib in non-squamous NSCLC in Asia conducted by our partner, Kyowa Hakko Kirin Co., Ltd., with patients already enrolled and re-consented continuing to receive treatment;
  • Announcement of top-line data from the randomized Phase 2 signal generation trial of tivantinib in combination with irinotecan and cetuximab in second-line colorectal cancer (CRC) showing a trend of improvements in progression-free survival and objective response rate;
  • Presentation of Phase 1b data at the ASCO Annual Meeting showing that the combination of tivantinib and sorafenib was well tolerated and that preliminary anti-tumor activity was observed in multiple patient extension cohorts, including HCC.

Pipeline / Discovery

  • Commencement of patient dosing in a Phase 1 clinical trial with ARQ 087, an orally bioavailable, multi-kinase inhibitor with pan-FGFR (fibroblast growth factor receptor) activity.

Plans for 2013

“Tivantinib has re-emerged as a Phase 3 clinical-stage compound with the initiation of the METIV-HCC trial in second-line HCC early this year,” said Paolo Pucci, chief executive officer of ArQule. “In 2013 we look forward to multiple data presentations that will inform our future development plans. The primary objectives with tivantinib this year include:

  • timely progress in patient enrollment in the Phase 3 METIV-HCC trial;
  • completion of patient enrollment in the Phase 2 KRAS-mutation positive NSCLC trial;
  • completion and presentation of data analyses from the MARQUEE trial;
  • data read-out from the ATTENTION trial by Kyowa Hakko Kirin expected in late 2013 or early 2014;
  • presentation of final data from the randomized Phase 2 combination trial with irinotecan and cetuximab in colorectal cancer;
  • support of ongoing clinical trials sponsored by the National Cancer Institute/Cancer Therapy Evaluation Program.

“Progress in other programs will focus on the following activities:

  • enrollment of patients in the Phase 1 trial with ARQ 087;
  • completion of patient enrollment in the Phase 1 trial with ARQ 092;
  • screening of the Company’s proprietary library of compounds as part of a drug discovery effort directed toward defined therapeutic targets.

“At the end of 2012, ArQule had $130.6 million in cash and marketable securities,” said Mr. Pucci. “We expect that these available financial resources will be sufficient to finance our working capital requirements well into 2015.”

1 of 4

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,778.15 +421.28 2.43%
S&P 500 2,061.23 +48.34 2.40%
NASDAQ 4,748.3960 +104.0840 2.24%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs