ArQule, Inc. (NASDAQ: ARQL) today reported its results of operations for the fiscal quarter and nine months ended September 30, 2009.
The Company reported a net loss of $8,088,000 or $0.18 per share, for the quarter ended September 30, 2009, compared to a net loss of $11,281,000, or $0.26 per share, for the quarter ended September 30, 2008. For the nine-month period ended September 30, 2009, the Company reported a net loss of $26,268,000 or $0.60 per share, compared to a net loss of $41,235,000, or $0.94 per share, for the same period in 2008.
At September 30, 2009, the Company had a total of $178,106,000 in cash, equivalents and marketable securities, which includes $47,750,000 drawn down in 2008 under notes payable that are collateralized by the Company’s auction rate securities. Net of these notes, at September 30, 2009, the Company had a total of $130,356,000.
Recent Operational Highlights
ARQ 197:
- Completion of patient enrollment in the Phase 2 non-small cell lung cancer (NSCLC) trial testing the combination therapy of ARQ 197 and erlotinib;
- Initiation of patient enrollment in a Phase 2 trial with ARQ 197 in hepatocellular carcinoma (HCC);
- Designation of ARQ 197 as an orphan medical product for the treatment of soft tissue sarcoma by the European Medicines Evaluation Agency (EMEA);
- Continued patient enrollment as planned in the Phase 2 monotherapy trial with ARQ 197 in Microphthalmia Transcription Factor (MiT)-associated tumors;
- Progress in combination safety trials of ARQ 197 with sorafenib and ARQ 197 with gemcitabine, with potential target indications of HCC and pancreatic cancer, respectively.
Pipeline:
- Continued dose escalation in a Phase 1 trial with ARQ 621;
- Acceptance of an abstract highlighting the discovery of fibroblast growth factor receptor (FGFR) inhibitors for presentation at the 2009 AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics Conference.
“Progress in our clinical development program with ARQ 197 is being made across four indications and three combination regimens,” said Paolo Pucci, chief executive officer of ArQule. “Notably, we have completed patient enrollment in our Phase 2 trial in non-small cell lung cancer ahead of schedule, and we expect to have data from this trial available in the first half of 2010.
“We also expect to complete enrollment in our Phase 2 MiT trial late this year, and we recently initiated enrollment in a Phase 2 trial in hepatocellular carcinoma following the successfully completed evaluation of patients in a safety trial,” said Mr. Pucci. “ARQ 197 combination therapy safety trials with sorafenib and gemcitabine are proceeding as well.
“We recently received notification that the EMEA has designated ARQ 197 as an orphan medical product for the treatment of soft tissue sarcoma,” said Mr. Pucci. “Future interactions with regulatory authorities, combined with the evaluation of clinical data from our MiT trial expected to be available in early 2010, will inform our decisions related to the possible advancement of this program.
“Our Phase 1, dose escalation trial with ARQ 621, an inhibitor of the Eg5 kinesin motor protein, is progressing well,” said Mr. Pucci. “We continue to increase dosing and expect to complete this trial early next year.
“With a presentation at the AACR-EORTC-NCI meeting later this month, we will introduce our newest program,” said Mr. Pucci. “This program is focused on the development of potent, small molecule inhibitors of the fibroblast growth factor receptor (FGFR) based upon the independent application of our proprietary kinase discovery technology. Pending successful pre-clinical development, we expect to file an Investigational New Drug (IND) application with a lead candidate from this program in 2010.
“Our oncology-focused, ArQule Kinase Inhibitor Platform (AKIP™) collaboration with Daiichi Sankyo Co., Ltd. continues to move forward,” said Mr. Pucci. “The range and stages of our clinical and pre-clinical activities position us for a number of potential inflection points beginning in the first half of 2010.”
Revenues and Expenses
The Company reported total revenues of $6,436,000 for the quarter ended September 30, 2009, compared to revenues of $2,664,000 for the quarter ended September 30, 2008. Revenues for the nine months ended September 30, 2009 were $17,912,000, compared to revenues of $8,774,000 for the nine months ended September 30, 2008. Increased revenues for the 2009 periods were primarily due to revenues from the Company’s agreements with Daiichi Sankyo Co., Ltd. for ARQ 197 and the AKIP™ discovery collaboration, both signed in late 2008. Revenues for both years include revenue from the Company’s agreement with Kyowa Hakko Kirin Co., Ltd.