Array BioPharma Reports Financial Results for the Second Quarter of Fiscal 2011
BOULDER, Colo.--(BUSINESS WIRE)-- Array BioPharma Inc. (NASDAQ:ARRY - News) today reported financial results for the second quarter of fiscal 2011.
Array reported revenue of $16.5 million for the second quarter of fiscal 2011, compared to revenue of $9.6 million for the same period in fiscal 2010. The Company spent $14.5 million in proprietary research and development for the quarter to advance its fully owned clinical development and discovery programs. This compares to $19.1 million spent on proprietary research and development during the second quarter of fiscal 2010. Array reported a net loss of $12.4 million, or ($0.23) per share, for the second quarter, compared to a net loss of $21.8 million, or ($0.44) per share, for the second quarter in fiscal 2010. Cash used in operating activities was $11.0 million during the quarter. Array ended the second quarter of fiscal 2011 with $98.9 million in cash, cash equivalents and marketable securities.
The Company reported revenue of $35.0 million for the six-month period ended December 31, 2010, compared to revenue of $17.5 million for the same period in fiscal 2010. Net loss for the six months ended December 31, 2010, was $23.1 million, or ($0.42) per share, compared to a net loss of $46.6 million, or ($0.96) per share, reported in the same six-month period in fiscal 2010.
“With the completion of two Phase 2 trials expected for our MEK inhibitor, selumetinib, by our partner AstraZeneca, along with the potential for AstraZeneca’s initiation of Phase 3 trials for selumetinib, calendar 2011 looks to be a significant year for Array,” said Robert E. Conway, Chief Executive Officer. “Given the advancement of our proprietary and partnered programs anticipated for the year along with our solid cash position and reduced burn rate, we believe we are positioned to deliver value from Array’s research and development engine to partners and shareholders.”
SUMMARY OF KEY DEVELOPMENT PROGRAMS
Selumetinib (AZD6244) (AstraZeneca) – MEK inhibitor for cancer:
AstraZeneca completed enrollment in two Phase 2 trials with selumetinib, which are the first two randomized Phase 2 combination trials with a MEK inhibitor:
•Selumetinib plus DTIC compared with DTIC in first line melanoma patients with BRAF- mutation. The trial completed enrollment of 91 patients in March 2010 with the primary end-point of overall survival. •Selumetinib plus Taxotere compared with Taxotere in second line non small lung cancer patients with KRAS-mutation. The trial completed enrollment of approximately 80 patients in July 2010 with the primary end-point of overall survival.
In addition, AstraZeneca has multiple on-going Phase 2 combination trials:
•Selumetinib compared with Temodar® (temozolomide) in patients with metastatic melanoma of the eye. Approximately 160 patients are anticipated to enroll in this trial. •Selumetinib with Tarceva® (erlotinib) in patients with KRAS wild type NSCLC (selumetinib plus Tarceva vs. Tarceva) and in patients with KRAS mutant NSCLC (selumetinib plus Tarceva vs. selumetinib). Approximately 100 patients are anticipated to enroll in this trial. •Selumetinib with Camptosar® (irinotecan) in patients with KRAS or BRAF mutant 2nd line colorectal cancer. Approximately 60 patients are anticipated to enroll in this trial. •Selumetinib with Nexavar® (sorafenib) in patients with advanced hepatocellular carcinoma. Approximately 100 patients are anticipated to enroll in this trial.
In total, AstraZeneca has 40 on-going or completed Phase 1 or 2 clinical trials with selumetinib.
MEK162 (ARRY-162) (Novartis) – MEK inhibitor for cancer:
Pursuant to an agreement signed in April 2010, Array and Novartis are engaged in the joint development of MEK162 in oncology indications. Array has completed or is enrolling patients with solid tumors in an ongoing multi-arm Phase 1 MEK162 dose escalation and expansion trial. Pending the results of these multiple arms, we intend to conduct additional trials with MEK162 in combination with other agents, as well as in single agent trials. The current status of this study is:
•The dose escalation trial completed enrollment of 19 patients in January 2010. •The first expansion arm in patients with biliary tract cancer completed enrollment of 28 patients in September 2010. •Approximately 25 patients with KRAS-mutant colorectal cancer and 15 patients with BRAF-mutant colorectal cancer are anticipated to enroll in additional expansion arms of this trial.
ARRY-520 – KSP inhibitor for Multiple Myeloma (MM): Array presented data on a Phase 1 trial with ARRY-520, a novel KSP inhibitor, in patients with MM at the December 2010 Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida.
This Phase 1, open-label, multicenter, dose-escalation study was designed to evaluate the safety, pharmacokinetics and pharmacodynamics of ARRY-520. The study enrolled patients with relapsed or refractory MM with at least two prior lines of therapy (including both a bortezomib and an IMiD-based regimen) with a median of five prior therapies. ARRY-520 has shown promising preliminary clinical activity. Of 30 evaluable patients, confirmed partial responses have been observed in two patients, one of whom had eight prior lines of treatment and has continued on study for more than 18 months. In addition, confirmed minimal responses have been reported in two patients. As of December 4, 2011 [clearly should be "2010"], twelve patients remained on study, including all responders, and eight patients had been treated for longer than six months.
Array has two other on-going clinical trials of ARRY-520:
•Phase 2 trial in patients with relapsed or refractory multiple myeloma. •Phase 1b combination study with ARRY-520 and Velcade® (bortezomib) in patients with relapsed or refractory multiple myeloma.
AMG 151 / ARRY-403 (Amgen) – Glucokinase activator for type 2 diabetes: Array completed a Phase 1 multiple ascending dose clinical trial in patients with type 2 diabetes with AMG 151 / ARRY-403, a small-molecule glucokinase activator that Array partnered with Amgen Inc. in December 2009. Amgen is responsible for all future development under the collaboration agreement. Array also continued a research program, which is being funded by Amgen to identify and advance second-generation glucokinase activators.
OTHER RECENT EVENTS
ARRY-380 – HER2 oral, selective inhibitor for cancer: Array announced positive interim results of its novel, oral HER2 (ErbB2) inhibitor, ARRY-380, in a Phase 1 trial in patients with advanced cancer at the December 2010 San Antonio Breast Cancer Symposium.
Interim results were presented on 19 patients with HER2 positive cancer treated with ARRY-380 at doses greater than or equal to 200 mg (twice daily). All of the HER2 positive metastatic breast cancer patients had been previously treated with Herceptin® (trastuzumab), and 81 percent were previously treated with Tykerb® (lapatinib). Thirty two percent of the 19 patients had a partial response or stable disease for six months or longer. Fifteen of the 19 patients had measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST); of these patients, seven had regressions in target lesions. Of the four patients with no measurable disease, three had regressions of non-target chest wall lesions.
ARRY-380 was well-tolerated; the predominant treatment-related adverse events have been Grade 1. Because ARRY-380 is selective for HER2 and does not inhibit EGFR, there was, as expected, a low incidence and severity of diarrhea, rash and fatigue. Additionally, there were no Grade 4 events or adverse cardiac events reported. The maximum tolerated dose of ARRY-380 established in this Phase 1 trial is 600 mg (twice daily). An expansion cohort in patients with HER2 positive metastatic breast cancer is ongoing to confirm safety and explore efficacy and pharmacodynamic markers.
ARRY-382 (Celgene) cFMS inhibitor for cancer: In December 2010, Array announced that it received a $10 million clinical research milestone payment in its collaboration with Celgene Corporation (NASDAQ:CELG - News), entered into in September 2007. Array anticipates initiating a Phase 1 dose escalation trial in cancer patients with ARRY-382 during the first quarter of calendar 2011. Array is responsible for the continued development of ARRY-382 through Phase 1, and Celgene has an option to obtain exclusive rights to ARRY-382. If Celgene exercises this option, Celgene would be responsible for additional development and commercialization of this drug, and Array would be entitled to receive additional milestones as well as royalties on sales of the drug.
Array will hold a conference call on Tuesday, February 1, 2011, at 9:00 a.m. eastern time to discuss these results. Robert E. Conway, Chief Executive Officer, and Michael Carruthers, Chief Financial Officer, will lead the call.
Conference Call Information
Date: Tuesday, February 1, 2011 Time: 9:00 a.m. eastern time Toll-Free: 800-482-9816 Toll: 719-325-2114 Pass Code: 4527581
A replay of the call will be available as a webcast on www.arraybiopharma.com and by phone for one week by dialing toll-free (888) 203-1112 or (719) 457-0820. The access code is 4527581.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small-molecule drugs to treat patients afflicted with cancer and inflammatory diseases. Our proprietary drug development pipeline includes clinical candidates that are designed to regulate therapeutically important target proteins and are aimed at significant unmet medical needs. For more information on Array, please go to www.arraybiopharma.com.
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