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Array BioPharma Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2009
Array reported revenue of
Array reported revenue of
“We are pleased to report positive results from our Phase 1 clinical trial of ARRY-403 in patients with Type 2 diabetes,” said Robert E. Conway, Chief Executive Officer. “There are 24 million Type 2 diabetic patients in the U.S. with the incidence of the disease accelerating at an alarming rate. Many of these patients are unable to control their glucose levels with existing therapy and need better approaches to manage their disease. ARRY-403 provides a unique mechanism of action for controlling diabetes with the potential to address this critical unmet medical need. We have initiated an aggressive development program, while also seeking a partner to maximize ARRY-403’s benefit to patients.”
SUMMARY OF RECENT PROGRESS
Clinical trial completed in Type 2 diabetic patients:
ARRY-403 – GK activator for Type 2 diabetes: Array announced positive top-line data from a Phase 1 clinical trial in patients with Type 2 diabetes with its novel small molecule glucokinase activator (GKA), ARRY-403. The drug met its primary and secondary endpoints of safety, pharmacokinetics and glucose control. Additional data is available from Array BioPharma’s website at www.arraybiopharma.com
Six clinical programs advanced for the treatment of cancer:
ARRY-162 – MEK inhibitor for cancer: Array filed an investigational new drug application with the
ARRY-520 – KSP inhibitor for AML & 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, respectively.
ARRY-614 - p38/Tie-2 Inhibitor for MDS: In
ARRY-543 - ErbB family inhibitor for solid tumors: Array completed enrollment in a Phase 1b trial with ARRY-543 in patients with ErbB2+ metastatic breast cancer and other ErbB-expressing tumors. Array continued a Phase 1 dose-escalation study with tablet formulation in patients with solid tumors and a Phase 1b trial in combination with Xeloda® (capecitabine) in patients with solid tumors. Array initiated dosing patients in two additional Phase 1b trials, in combination with Taxotere® (docetaxel) and Gemzar® (gemcitabine).
ARRY-380 - ErbB2 selective inhibitor for cancer: Patient recruitment in a Phase 1 trial with ARRY-380, an oral, selective ErbB2 (Her2) inhibitor, remains on track to complete enrollment this year. The trial is designed to evaluate the safety and pharmacokinetics of ARRY-380 in patients with advanced cancer and to establish the maximum tolerated dose.
ARRY-300 – MEK inhibitor: Array completed enrollment in a Phase 1 trial with ARRY-300, a targeted small molecule MEK inhibitor. The Phase 1 trial was a randomized, single-blind, placebo-controlled, single-ascending dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of ARRY-300 in healthy volunteers. ARRY-300 will be a back-up for ARRY-162.
Two clinical program updates for the treatment of chronic
inflammatory disease and pain:
ARRY-162 - MEK inhibitor for RA: Array completed a 12 week Phase 2, randomized, double-blind, placebo controlled global proof-of-concept trial with ARRY 162 in patients with active RA who were receiving stable doses of methotrexate for ≥ 6 weeks. Top-line results are expected to be available in
ARRY-797 - p38 inhibitor for AS: Array announced top-line results from its Phase 1, seven-day, dose escalation trial up to 1,200 mg daily of ARRY-797 in healthy volunteers. In addition, the top-line results were announced in a second study, where ARRY-797 was evaluated in a 28-day Phase 1b trial in stable RA patients taking methotrexate. A preliminary analysis of both trials indicates that ARRY-797 was well-tolerated with a pharmacokinetic profile consistent with earlier studies. In the 28-day, three-arm RA study with a total of 28 patients, ARRY-797 showed inhibition of CRP levels (marker of inflammation) only during the first three weeks of dosing and a beneficial reduction in NTx levels (marker of bone remodeling) throughout the study. In addition, ARRY-797 showed a trend to improve the patients’ assessment of pain (VAS score) over the course of the study.
Array continues to conduct a full analysis of safety, pharmacokinetics and efficacy data from both studies and anticipates that complete results from the studies will be presented at a medical conference in 2010. Based on these preliminary results, Array has discontinued the enrollment of new patients in its clinical trial of ARRY-797 in ankylosing spondylitis. Array is evaluating alternative development paths in sub-chronic pain and supportive care indications.
Array’s Information Technology Platform recognized by CIO magazine: IDG's CIO magazine announced Array as a recipient of the 2009 CIO 100. The 22nd annual award program recognizes organizations around the world that exemplify the highest level of operational and strategic excellence in information technology.
Array received additional capital: Array received
Array will hold a conference call on
Conference Call Information
|Tuesday, August 11, 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 6778402.
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.|
|Condensed Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended June 30,||Year Ended June 30,|
|Collaboration revenue||$ 3,801||$ 4,645||$ 17,228||$ 21,513|
|License and milestone revenue||1,706||1,441||7,754||7,295|
|Cost of revenue||4,157||5,086||19,855||21,364|
Research and development for proprietary
|General and administrative||4,587||2,647||18,020||15,591|
|Total operating expenses||30,057||36,083||127,435||127,302|
|Loss from operations||(24,550||)||(29,997||)||(102,453||)||(98,494||)|
|Other income (expense)|
|Impairment of marketable securities||-||(1,872||)||(17,742||)||(1,872||)|
|Total other income||(2,440||)||(2,440||)||(25,650||)||2,206|
|Loss before income tax benefit||(26,990||)||(32,437||)||(128,103||)||(96,288||)|
|Income tax benefit||288||-||288||-|
|Net loss||$ (26,702||)||$ (32,437||)||$ (127,815||)||$ (96,288||)|
|Weighted average shares outstanding -|
|basic and diluted||48,119||47,529||47,839||47,309|
|Net loss per share - basic and diluted||$ (0.55||)||$ (0.68||)||$ (2.67||)||$ (2.04||)|
|Summary Balance Sheet Data|
|June 30,||June 30,|
|Cash, cash equivalents and marketable securities||$ 57,488||$ 125,531|
|Property, plant and equipment, gross||$ 83,683||$ 80,878|
|Working capital||$ (5,378||)||$ 66,346|
|Total assets||$ 95,055||$ 163,077|
|Long-term debt, net||$ 68,170||$ 35,355|
|Stockholders' equity||$ (73,701||)||$ 38,027|
Array BioPharma Inc.
Tricia Haugeto, 303-386-1193