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.
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 September 2009.
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 $40.0 million in additional capital from the Deerfield Funds on August 5, 2009 under a loan facility agreement dated May 15, 2009. The outstanding principal under the new loan is due by April 2014 and interest is payable monthly. Principal and interest can be repaid, at Array’s option, at any time with shares of Array common stock.
Array will hold a conference call on Tuesday, August 11, 2009, 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.