Array BioPharma Inc. (NASDAQ: ARRY) today reported financial results for the fourth quarter and full year of fiscal 2009.
Array reported revenue of $5.5 million for the fourth quarter of fiscal 2009, compared to revenue of $6.1 million for the same period in fiscal 2008. Array invested $21.3 million in proprietary research and development for the quarter to advance its seven wholly-owned drugs in clinical development and select discovery programs. This compares to $28.4 million invested in research and development during the fourth quarter of fiscal 2008. Array reported a net loss of $26.7 million, or ($0.55) per share, for the fourth quarter, compared to a net loss of $32.4 million, or ($0.68) per share, for the fourth quarter in fiscal 2008. Array ended the fourth quarter of fiscal 2009 with $57.5 million in cash, cash equivalents and marketable securities. In addition, Array received $40.0 million in capital from Deerfield Private Design Fund, L.P. and Deerfield Private Design International, L.P. (collectively the “Deerfield Funds”) on August 5, 2009 under a loan facility agreement dated May 15, 2009.
Array reported revenue of $25.0 million for the fiscal year ended June 30, 2009, compared to revenue of $28.8 million for fiscal 2008. Net loss for the fiscal year ended June 30, 2009, was $127.8 million, or ($2.67) per share, compared to a net loss of $96.3 million, or ($2.04) per share, reported in fiscal 2008. Array invested $89.6 million in proprietary research and development for the year, compared to $90.3 million for fiscal 2008.
“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 FDA and is now able to proceed with a Phase 1 clinical trial in cancer patients with its most advanced wholly-owned MEK inhibitor, ARRY-162. Recent publications have shown that the MEK pathway acts as a central axis in the proliferation of different tumors including melanoma, non-small cell lung, colorectal and pancreatic cancers. The Phase 1 dose escalation study is designed to evaluate safety, pharmacokinetics and pharmacodynamics of ARRY-162 following daily oral administration to patients with advanced solid tumors.
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 March 2009, Array reported data from a Phase 1 clinical trial with ARRY-614 in a single and multiple dose-escalation study in healthy subjects. This study showed that ARRY-614 was well tolerated and exhibited dose-dependent increases in exposure and strong evidence of pharmacodynamic activity. Based on this data and strong biological support for testing a p38 inhibitor in myelodysplastic syndromes (MDS), Array is dosing patients with 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 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.