Array BioPharma Reports Financial Results for the First Quarter of Fiscal 2011
BOULDER, Colo.--(BUSINESS WIRE)-- Array BioPharma Inc. (NASDAQ:ARRY - News) today reported financial results for the first quarter of fiscal 2011.
Array reported revenue of $18.5 million for the first quarter of fiscal 2011, compared to revenue of $7.9 million for the same period in fiscal 2010. Array spent $13.9 million in proprietary research and development for the quarter to advance its clinical development and discovery programs. This compares to $19.2 million spent on proprietary research and development during the first quarter of fiscal 2010. Array reported a net loss of $10.6 million, or ($0.20) per share, for the first quarter, compared to a net loss of $24.8 million, or ($0.52) per share, for the first quarter in fiscal 2010. Array ended the first quarter of fiscal 2011 with $109 million in cash, cash equivalents and marketable securities.
“Array remains focused on creating value by advancing our key development products both alone, and in concert with our industry-leading partners,” said Robert E. Conway, Chief Executive Officer. “As our pipeline continues to progress and demonstrate patient benefit, we expect an increasing number of value creating events in calendar 2011 and beyond.”
SUMMARY OF KEY DEVELOPMENT PROGRAMS
MEK162 (ARRY-162) (Novartis) – MEK inhibitor for cancer: Array completed patient enrollment in an expansion of a Phase 1 trial of MEK162 in biliary tract cancer patients at ten clinical sites in North America. Array also initiated a second expansion study in patients with KRAS or BRAF mutant colorectal cancer. The expansions are designed to evaluate safety, pharmacokinetics, pharmacodynamics and to obtain preliminary efficacy data. During calendar 2011, Array plans to complete the biliary tract and colorectal cancer expansions and initiate a Phase 2 trial in patients with KRAS mutant colorectal cancer.
Selumetinib (AZD6244) (AstraZeneca) – MEK inhibitor for cancer: AstraZeneca completed enrollment in two 80 patient trials: a Phase 2 trial of selumetinib plus DTIC compared with DTIC in first line melanoma patients with BRAF mutation and a Phase 2 trial of selumetinib plus Taxotere compared with Taxotere in second line non small lung cancer patients with KRAS mutation. In addition, AstraZeneca initiated a Phase 2 trial of selumetinib compared with Temodar® (temozolomide) in patients with metastatic melanoma of the eye. One hundred fifty nine patients are anticipated to enroll in this trial.
AstraZeneca presented Phase 1 clinical trial results at the 2010 ASCO annual meeting in June 2010 with the new selumetinib capsule formulation. This study evaluated two doses of selumetinib in combination with chemotherapies. In a subgroup of 18 patients with melanoma whose tumors were evaluable for mutational status, selumetinib plus chemotherapy had a 56% response rate in patients with BRAF mutations with a median time to progression of 31 weeks, versus 8 weeks in the patients with wild-type BRAF. This is the first disclosed efficacy data with the new formulation of selumetinib, which provides twice the drug exposure at the preferred dose.
ARRY-520 – KSP inhibitor for Multiple Myeloma (MM): Array has completed enrollment and established the maximum tolerated dose in a Phase 1 trial with ARRY-520, a novel KSP inhibitor, in patients with MM. Array plans to provide results of this study at a scientific meeting later this year. In addition, Array initiated a Phase 2 single agent study in patients with MM and is initiating a Phase 1b combination study with Velcade® (bortezomib) in patients with MM.
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. 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 2010 ASCO Breast Cancer Symposium in National Harbor, Maryland. Interim results were presented on 17 patients with HER2 positive metastatic breast cancer treated with ARRY-380 at doses greater than or equal to 200 mg BID. All of these patients had been previously treated with Herceptin® (trastuzumab), and 81 percent were previously treated with Tykerb® (lapatinib). Twenty-nine percent of these patients had a partial response or stable disease for six months or longer. Thirteen of the 17 patients had measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST); of these patients, seven (54 percent) had regressions in target lesions. Of the four patients with no measurable disease, three had regressions of non-target chest wall lesions as documented by photographic evaluation.
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.
Array will hold a conference call on Tuesday, November 9, 2010, 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, November 9, 2010 Time: 9:00 a.m. eastern time Toll-Free: 877-419-6593 877-419-6593 Toll: 719-325-4760 719-325-4760 Pass Code: 2106248
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 (888) 203-1112 or (719) 457-0820 (719) 457-0820 . The access code is 2106248.
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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