Array BioPharma Reports Financial Results for the Second Quarter of Fiscal 2010
BOULDER, Colo.--(BUSINESS WIRE)--Array BioPharma Inc. (Nasdaq: ARRY - News) today reported financial results for the second quarter of fiscal 2010.
Array reported revenue of $9.6 million for the second quarter of fiscal 2010, compared to revenue of $7.7 million for the same period in fiscal 2009. Array spent $19.1 million for proprietary research and development during the quarter to advance its wholly-owned drugs in clinical development and select discovery programs. This compares to $23.7 million spent for research and development during the second quarter of fiscal 2009. Array reported a net loss of $21.8 million, or ($0.44) per share, for the second quarter, compared to a net loss of $37.8 million, or ($0.79) per share, for the second quarter in fiscal 2009. Array ended the second quarter of fiscal 2010 with $115 million in cash, cash equivalents and marketable securities.
Array reported revenue of $17.5 million for the six-month period ended December 31, 2009, compared to revenue of $13.4 million for the same period in fiscal 2009. Net loss for the six months ended December 31, 2009, was $46.6 million, or ($0.96) per share, compared to a net loss of $71.5 million, or ($1.50) per share, reported in the same six-month period in fiscal 2009.
“We are delighted to partner with Amgen on our type 2 diabetes program, including AMG 151 / ARRY-403, which provided a $60 million up-front payment with additional potential milestones of $666 million and a double-digit royalty,” said Robert E. Conway, Chief Executive Officer. “We continued to implement our partnering strategy with our Amgen deal, which significantly added to our cash balance and reduced our burn. Our partnerships, which include seven Array-invented drugs in clinical trials, provide Array with significant upside of $1.9 billion in potential milestones and royalties that range up to 15 percent. As a result of our partnering efforts, we are revising our guidance for the second half of the fiscal year, increasing our revenue and reducing our loss per share.”
SUMMARY OF RECENT PROGRESS
Array Partners with Amgen in Type 2 Diabetes:
AMG 151 / ARRY-403 – GK activator for type 2 diabetes: Array entered into an agreement with Amgen Inc. for Array’s small-molecule glucokinase activator program, including AMG 151 / ARRY-403, which is currently being tested in a Phase 1 multiple ascending dose clinical trial in patients with type 2 diabetes.
Under the terms of the agreement, Array received an upfront payment of $60 million and additional contingent payments up to $666 million if clinical and commercial milestones are achieved for AMG 151 and at least one back-up compound. Amgen is responsible for future clinical development and commercialization for AMG 151 and any resulting back-up compounds, with Array having an option to co-promote in the United States. Array will receive double digit royalties on sales of AMG 151. In addition, Amgen is providing research funding over the next two-years to identify and advance second-generation glucokinase activators.
Five clinical programs advanced for the treatment of cancer:
ARRY-162 – MEK inhibitor for cancer: Array completed enrolling four cohorts and reached the maximum tolerated dose in a Phase 1 clinical trial in cancer patients with its most advanced wholly-owned MEK inhibitor, ARRY-162. ARRY-162 is now advancing into an expansion phase of the trial in biliary tract cancer patients at ten clinical sites in North America. The Phase 1 dose escalation study is designed to evaluate safety, pharmacokinetics and pharmacodynamics of ARRY-162 in patients with advanced solid tumors.
ARRY-520 – KSP inhibitor for AML and MM: Array continued a Phase 1 trial of ARRY-520, a novel KSP inhibitor, in patients with solid tumors and two Phase 1/2 trials in patients with acute myelogenous leukemia and multiple myeloma.
ARRY-614 - p38/Tie-2 Inhibitor for MDS: Array continued dosing patients with myelodysplastic syndromes (MDS) in a Phase 1 trial with ARRY-614 to determine the safety, maximum tolerated dose, pharmacokinetics and preliminary estimates of efficacy of the compound in this patient population.
ARRY-543 - ErbB family inhibitor for solid tumors: Array completed a Phase 1 dose-escalation study with tablet formulation in patients with solid tumors and continued three Phase 1b trials in combination with Xeloda® (capecitabine), Taxotere® (docetaxel) and Gemzar® (gemcitabine), respectively.
ARRY-380 – HER2 oral, selective inhibitor for cancer: Array continues dose escalation in a Phase 1 trial with ARRY-380. The trial is designed to evaluate the safety, maximum tolerated dose and pharmacokinetics of ARRY-380 in patients with advanced cancer.
Array announced positive interim results of this trial at the 2009 San Antonio Breast Cancer Symposium. These results showed that ARRY-380 at doses greater than or equal to 200 mg BID demonstrated evidence of tumor regression in eight out of ten heavily pre-treated patients with HER2 expressing cancers. Of these eight patients, four had prolonged stable disease for 16 weeks or longer. ARRY-380 has been well-tolerated; the predominant adverse events have been Grade 1 and included nausea, rash and fatigue. In completed cohorts, no Grade 3 or 4 treatment-related adverse events and no cardiac adverse events have been observed.
Array enhances clinical leadership:
Bengt Bergstrom, M.D., joined Array as Vice President of Clinical Development. With over 30 years of experience as an M.D. / Ph.D. and more than 17 years working in the pharmaceutical industry, Dr. Bergstrom will lead Array’s clinical science and drug safety activities. Prior to joining Array, Dr. Bergstrom held various leadership positions within drug development, project management, strategic marketing and business development, and clinical sciences at Hoffmann-La Roche, most recently serving as Clinical Science Leader in oncology drug development. He has experience with Phase 1 through 4 clinical trials and has worked with regulatory agencies around the world. He has worked on six approved New Drug Applications as well as several Investigational New Drug Applications. Dr. Bergstrom studied at the University of Lund in Sweden where he received his M.D. and Ph.D.
Array will hold a conference call on Tuesday, February 2, 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.
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