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Array BioPharma Reports Financial Results for the Second Quarter of Fiscal 2009
Array reported revenue of
Array reported revenue of
SUMMARY OF RECENT PROGRESS
“Over the past month, we put in place multiple measures to conserve
capital and focus our resources on advancing eight promising clinical
programs in cancer, inflammation and diabetes through clinical proof of
Initiating clinical development of a novel glucokinase activator for Type II diabetes
During the first quarter of calendar 2009, Array plans to initiate Phase 1 clinical development with ARRY-403, a novel glucokinase activator. At a recent scientific meeting, Array reported that ARRY-403 demonstrates potent, highly glucose-blood-level dependent control of both fasting and non-fasting glucose concentrations.
Advancing programs for the treatment of chronic inflammatory disease and pain
Array initiated a worldwide, 170-patient, 12-week Phase 2 clinical trial with ARRY-797, a p38 inhibitor, in patients with ankylosing spondylitis and continued a dose escalation trial with ARRY-797 to test tolerability of up to 1200 mg daily in a sub-chronic setting for 7 days. Array is also on track with recruitment of a 28-day Phase 1b trial of ARRY-797 in patients with stable rheumatoid arthritis taking methotrexate. Array announced the achievement of both the primary and secondary endpoints from a 250-patient Phase 2 acute inflammatory dental pain study evaluating the analgesic efficacy of ARRY-797 at the 2008 ACR/ARHP Annual Scientific Meeting.
Array’s MEK inhibitor for inflammation, ARRY-162, continued a worldwide, 200-patient, 12-week Phase 2 trial with ARRY-162 added to methotrexate in patients with rheumatoid arthritis. Over 100 patients have been enrolled to date and complete enrollment is expected in the first quarter of calendar 2009.
Array initiated dosing ARRY-300, a targeted small molecule MEK inhibitor, in a Phase 1 clinical trial. The Phase 1 clinical trial is a randomized, single-blind, placebo-controlled, single-ascending dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of ARRY-300 in healthy volunteers.
Progressing four novel clinical candidates for cancer
Array is in the process of initiating sites in a Phase 1b/2 trial of ARRY-520, a novel KSP inhibitor, in patients with multiple myeloma. Array is continuing a Phase 1 trial of ARRY-520 in patients with solid tumors and a Phase 1b/2 trial of ARRY-520 in patients with acute myelogenous leukemia (AML).
Array is planning a Phase 1b trial of ARRY-614, our p38/Tie-2 inhibitor, in patients with myelodysplastic syndromes (MDS) to determine the safety, maximum tolerated dose, pharmacokinetics and preliminary estimates of efficacy of the compound in this patient population. This study is expected to begin during the second quarter 2009. Array recently completed a Phase 1 clinical trial with ARRY-614 in a single and multiple dose escalation study in healthy volunteers for safety, tolerability, exposure and inhibition of mechanism related biomarkers.
Array continued a Phase 1b expansion trial for ARRY-543, our ErbB-2/EGFR inhibitor. Half of the patients in this trial have trastuzumab-resistant ErbB2-positive metastatic breast cancer and half of the patients have other ErbB-family-driven cancers. Results from this trial are anticipated in the first half of 2009. Array is also continuing a Phase 1b trial of ARRY-543 in combination with Xeloda® (capecitabine) in patients with solid tumors. Array anticipates initiating two additional Phase 1b trials, in combination with Taxotere® (docetaxel) and Gemzar® (gemcitabine), respectively, in the first half of calendar 2009.
Recruitment in a Phase 1 safety trial of ARRY-380, a selective, oral ErbB-2 inhibitor, remains on track. This trial is expected to be complete in 2009.
Unveiling three discovery programs
At the JP Morgan Healthcare conference, Array disclosed three discovery candidates:
Secured a milestone payment on one of Array’s many partnered programs
Array received a
CONFERENCE CALL DETAILS
Array will hold a conference call on
Conference Call Information
|Tuesday, February 3, 2009|
|9:00 a.m. eastern time|
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 2036041.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements about our future plans for advancing certain of our
proprietary drug programs, the potential to earn future milestone
payments, license fees or royalty revenue, and the plans of our
collaborators to further develop drugs we have out-licensed or on which
we are collaborating. These statements involve significant risks and
uncertainties, including those discussed in our annual report filed on
form 10-K for the year ended
Array BioPharma Inc.
|Three Months Ended||Six Months Ended|
|License and milestone revenue||2,648||2,784||4,158||3,756|
|Cost of revenue||5,063||5,240||10,183||10,553|
Research and development for proprietary
|General and administrative||4,480||4,830||8,974||9,207|
|Total operating expenses||33,252||30,618||67,375||57,927|
|Loss from operations||(25,563||)||(22,200||)||(53,939||)||(42,916||)|
|Impairment of marketable securities||(10,452||)||-||(14,362||)||-|
|Basic and diluted net loss per share||$||(0.79||)||$||(0.43||)||$||(1.50||)||$||(0.84||)|
|Number of shares used to compute per share data||47,605||47,174||47,589||47,142|
Summary Balance Sheet Data
|December 31,||June 30,|
|Cash, cash equivalents and marketable securities||$||99,954||$||125,531|
|Property, plant and equipment, gross||83,018||81,966|
Stockholders' (deficit) equity
Array BioPharma Inc.
Tricia Haugeto, 303-386-1193