ArQule, Inc. (NASDAQ: ARQL) today announced its financial results for the second quarter of 2011.
“The primary objective is to evaluate progression-free survival in these previously treated patients, based on the clinical benefit observed in this sub-group within our randomized Phase 2 trial.”
For the quarter ended June 30, 2011, the Company reported a net loss of $10,804,000 or $0.20 per share, compared with a net loss of $8,227,000 or $0.18 per share, for the second quarter of 2010. For the six-month period ended June 30, 2011, the Company reported a net loss of $12,270,000 or $0.24 per share, compared to a net loss of $17,979,000 or $0.40 per share, for the six-month period ended June 30, 2010.
At June 30, 2011, the Company had a total of approximately $127,248,000 in cash, equivalents and marketable securities.
Operational Update
- Substantial completion of patient recruitment in the Phase 2 trial with tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor tyrosine kinase, in hepatocellular carcinoma (HCC);
- Initiation of recruitment in a randomized, open-label Phase 2 combination trial of tivantinib and erlotinib in NSCLC patients with KRAS mutations;
- Planned initiation by Kyowa Hakko Kirin, ArQule's partner in the Asian territory, of a Phase 3 trial of tivantinib in non-squamous NSCLC patients with wild-type EGFR in Japan and other Asian countries;
- Presentations of data at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO) and the 14th World Conference on Lung Cancer highlighting the potential benefit and tolerability of tivantinib in combination with sorafenib and gemcitabine.
"Enrollment in our single agent, randomized Phase 2 trial in HCC is substantially completed," said Paolo Pucci, chief executive officer of ArQule. "Availability of data from this trial will depend upon the rate of events observed in the 240 milligram twice daily cohort of patients, and we anticipate having these data toward the end of 2011.
"We have initiated patient recruitment in a Phase 2 trial comparing tivantinib and erlotinib against chemotherapy in NSCLC patients with KRAS mutations," said Mr. Pucci. "The primary objective is to evaluate progression-free survival in these previously treated patients, based on the clinical benefit observed in this sub-group within our randomized Phase 2 trial.
"We expect that Kyowa Hakko Kirin will independently initiate the recruitment of a Phase 3 trial in Asia of tivantinib and erlotinib in non-squamous NSCLC patients with wild type EGFR in the near future," said Mr. Pucci. "The worldwide registration program for tivantinib in NSCLC also includes the ongoing pivotal Phase 3 trial of tivantinib and erlotinib in non-squamous NSCLC conducted by Daiichi Sankyo Co., Ltd. in collaboration with ArQule at more than 200 sites and in more than 20 countries outside of Asia."
Revenues and Expenses
The Company reported total revenues of $5,447,000 for the quarter ended June 30, 2011, compared to revenues of $7,106,000 for the second quarter of 2010. Revenues for the six months ended June 30, 2011 were $18,852,000, compared to revenues of $13,431,000 for the six months ended June 30, 2010.
The revenue decrease in the 2011 three-month period is primarily due to an increase in contra-revenue associated with expenses for our tivantinib collaboration with Daiichi Sankyo, partially offset by revenue recognized from the AKIP™ discovery collaboration with Daiichi Sankyo. The revenue increase in the 2011 six-month period is primarily due to revenue recognized from a milestone payment from Daiichi Sankyo received in the first quarter, partially offset by increased contra-revenue.
Total costs and expenses for the quarter ended June 30, 2011 were $16,388,000, compared to $15,844,000 for the second quarter of 2010. Total costs and expenses for the six months ended June 30, 2011 were $31,324,000, compared to $31,617,000 for the same period in 2010.
Research and development costs for the three and six-month periods ended June 30, 2011 were $12,836,000 and $24,229,000, respectively, compared with $12,318,000 and $24,762,000 for the 2010 three and six-month periods.
General and administrative costs for the three and six-month periods ended June 30, 2011 were $3,552,000 and $7,095,000 respectively, compared with $3,526,000 and $6,855,000 for the 2010 three and six-month periods.
Confirmed Financial Guidance
As previously stated, for 2011 ArQule expects net use of cash to range between $40 and $45 million. Revenues are expected to range between $27 and $32 million. Net loss is expected to range between $35 and $40 million, and net loss per share to range between $(0.66) and $(0.75). ArQule expects to end 2011 with between $85 and $90 million in cash and marketable securities.