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ArQule Announces Third Quarter Fiscal 2012 Results
Conference call scheduled today at
The Company reported a net loss of
At
Recent Operational Developments
Tivantinib (ARQ 197)
-
Agreement with the U.S.
FDA on a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial of tivantinib as single agent therapy in patients with hepatocellular carcinoma (HCC); - Recommendation by the Data Monitoring Committee (DMC) of the MARQUEE trial of tivantinib and erlotinib to stop the study early for futility following a planned interim analysis;
-
Discontinuation of the ATTENTION trial of tivantinib and erlotinib in
Asia .
Earlier-stage pipeline
- Advancement of ARQ 087, an inhibitor of fibroblast growth factor receptor (FGFR), toward clinical testing.
"Recent developments in the tivantinib non-small cell lung cancer
clinical development program have re-focused our near-term efforts on
the commencement of a Phase 3 trial with tivantinib as single agent
therapy in second-line HCC," said
"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
"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
"Our financial position continues to be strong," said
Revenues and Expenses
The Company reported total revenues of
The
The
For the quarter ended
Research and development costs for the three and nine-month periods
ended
General and administrative costs for the three and nine-month periods
ended
Financial Guidance
The Company is revising its financial guidance for 2012 based on the
following considerations. As a result of the
For 2012
Investor Conference Call
| Date: |
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| Time: |
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Conference Call Dial-In Numbers
| Domestic: | (877) 868-1831 | |||
| International: | (914) 495-8595 | |||
| Webcast: |
A replay of the conference call will be available beginning approximately two hours after its completion for seven days and can be accessed by dialing toll-free 1-855-859-2056 and 1-404-537-3406 from outside the U.S. For archived calls, the access code is 53861797.
About
This press release contains forward-looking statements regarding the
Company's clinical trials with tivantinib (ARQ 197) and other candidate
compounds in earlier stages of development, as well as forward-looking
statements related to the Company's financial guidance for 2012
(including estimates of net use of cash, revenues, net loss, net loss
per share and cash and marketable securities at the end of 2012) and its
agreements with Daiichi Sankyo Co., Ltd. and Kyowa Hakko Kirin Co., Ltd.
These statements are based on the Company's current beliefs and
expectations, and are subject to risks and uncertainties that could
cause actual results to differ materially. Positive information
about pre-clinical and early stage clinical trial results does not
ensure that later stage or larger scale clinical trials will be
successful. For example, tivantinib, ARQ 092 (an AKT inhibitor), ARQ 621
(an Eg5 inhibitor), ARQ 736 (a RAF kinases inhibitor) and ARQ 087 (an
FGFR inhibitor) may not demonstrate promising therapeutic effects; in
addition, they may not demonstrate appropriate safety profiles in
current or later stage or larger scale clinical trials as a result of
known or as yet unanticipated side effects. The results achieved in
later stage trials may not be sufficient to meet applicable regulatory
standards or to justify further development. Problems or delays may
arise during clinical trials or in the course of developing, testing or
manufacturing these compounds that could lead the Company or its
partners to discontinue development. Even if later stage clinical
trials are successful, unexpected concerns may arise from analysis of
data or from additional data. Obstacles may arise or issues may be
identified in connection with review of clinical data with regulatory
authorities, and regulatory authorities may disagree with the Company's
view of the data or require additional data or information or additional
studies. In addition, the planned timing of initiation and
completion of clinical trials for tivantinib is subject to the ability
of the Company or Daiichi Sankyo, its partner, and Kyowa Hakko Kirin, a
licensee of tivantinib, to enroll patients, enter into agreements with
clinical trial sites and investigators, and overcome other technical
hurdles and issues related to the conduct of the trials for which each
of them is responsible that may not be resolved. Drug development
involves a high degree of risk. Only a small number of research and
development programs result in the commercialization of a product. Positive
pre-clinical data may not be supported in later stages of development.
Furthermore,
|
ArQule, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) |
|||||||||||||
|
Three Months Ended |
Nine Months Ended September 30, |
||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||
| (In Thousands, Except Per Share Data) | |||||||||||||
| Research and development revenue | $ | 10,944 | $ | 11,954 | $ | 31,271 | $ | 30,806 | |||||
| Costs and expenses: | |||||||||||||
| Research and development | 8,146 | 11,108 | 26,720 | 35,337 | |||||||||
| General and administrative | 3,387 | 3,127 | 10,500 | 10,222 | |||||||||
| Total costs and expenses | 11,533 | 14,235 | 37,220 | 45,559 | |||||||||
| Loss from operations | (589 | ) | (2,281 | ) | (5,949 | ) | (14,753 | ) | |||||
| Interest income | 150 | 77 | 294 | 244 | |||||||||
| Interest expense | (7 | ) | (6 | ) | (19 | ) | (18 | ) | |||||
| Other income (expense) | 15 | (50 | ) | 98 | (3 | ) | |||||||
| Net loss | (431 | ) | (2,260 | ) | (5,576 | ) | (14,530 | ) | |||||
| Unrealized gain (loss) on marketable securities | 273 | (144 | ) | 166 | (80 | ) | |||||||
| Comprehensive loss | $ | (158 | ) | $ | (2,404 | ) | $ | (5,410 | ) | $ | (14,610 | ) | |
| Basic and diluted net loss per share: | |||||||||||||
| Net loss per share | $ | (0.01 | ) | $ | (0.04 | ) | $ | (0.09 | ) | $ | (0.28 | ) | |
| Weighted average basic and diluted common shares outstanding | 62,224 | 53,534 |
58,987 |
52,495 | |||||||||
| Balance sheet data (in thousands): |
September 30,
2012 |
December 31, 2011 |
||||
| Cash, equivalents and marketable securities- short term | $ | 82,760 | $ | 68,168 | ||
| Marketable securities- long term | 57,398 | 40,475 | ||||
| $ | 140,158 | $ | 108,643 | |||
| Total assets | $ | 144,675 | $ | 117,051 | ||
| Notes payable | $ | 1,700 | $ | 1,700 | ||
| Stockholders' equity | $ | 85,371 | $ | 29,729 | ||
VP, Investor
Relations/
Corp. Communications
www.ArQule.com
Source:
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