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Array BioPharma Reports Financial Results for the Third Quarter of Fiscal 2009

BOULDER, Colo.--(BUSINESS WIRE)--May. 4, 2009-- Array BioPharma Inc. (NASDAQ:ARRY) today reported financial results for the third quarter ended March 31, 2009.

FINANCIAL RESULTS

Array reported revenue of $6.0 million for the third quarter of fiscal 2009, compared to revenue of $7.7 million for the same period in fiscal 2008. Array invested $20.0 million in research and development for the quarter to advance its eight wholly-owned drugs in clinical development and select discovery programs. This compares to $23.8 million invested in research and development during the third quarter of fiscal 2008. Array reported a net loss of $29.6 million, or ($0.62) per share, for the third quarter, compared to a net loss of $24.4 million, or ($0.51) per share, for the third quarter in fiscal 2008. The third quarter of fiscal 2009 loss included $3.4 million or $0.07 per share loss due to a mark-to-market write-down of auction rate securities. Array ended the third quarter of fiscal 2009 with $72.9 million in cash, cash equivalents and marketable securities.

Array reported revenue of $19.5 million for the nine-month period ended March 31, 2009, compared to revenue of $22.7 million for the same period in fiscal 2008. Net loss for the nine months ended March 31, 2009, was $101.1 million, or ($2.12) per share, compared to a net loss of $63.9 million, or ($1.35) per share, reported in the same nine-month period in fiscal 2008.

SUMMARY OF RECENT PROGRESS

“We had a total of 18 presentations and publications on Array-invented drugs at the 2009 AACR conference last month demonstrating the progress we’ve made advancing our oncology pipeline,” said Robert E. Conway, Chief Executive Officer. “During the quarter, we also initiated dosing on an exciting glucokinase activator, ARRY-403, for Type II diabetes patients. We anticipate having proof of concept or Phase 1 clinical results on all eight of our clinical programs in 2009.”

Clinical trial initiated in Type II diabetic patients:

ARRY-403GK activator for Type II diabetes: Array initiated dosing Type II diabetic patients in a Phase 1 clinical trial with its novel small molecule glucokinase activator (GKA), ARRY-403. In the Phase 1 trial, the compound is being evaluated in a single-dose escalation study to evaluate safety, tolerability, pharmacokinetics and blood glucose control. In preclinical studies, ARRY-403 demonstrated effective control of both fasting and non-fasting blood glucose concentrations, and was shown to be highly dependent on blood glucose concentrations.

Three clinical programs advanced for the treatment of chronic inflammatory disease and pain:

ARRY-797 - p38 inhibitor for AS: Array continued a worldwide, 126-patient, 12-week Phase 2 proof-of-concept clinical trial with ARRY-797, a p38 inhibitor, in patients with ankylosing spondylitis (AS). Array also completed a dose escalation trial with ARRY-797 to test tolerability of up to 1200 mg daily in a sub-chronic setting for seven days and completed enrollment of a 28-day Phase 1b trial of ARRY-797 in patients with stable rheumatoid arthritis (RA) taking methotrexate.

ARRY-162 - MEK inhibitor for RA: Array completed patient enrollment in a worldwide, 200-patient, 12-week Phase 2 proof-of-concept clinical trial with ARRY-162, a MEK inhibitor, added to methotrexate in patients with rheumatoid arthritis.

ARRY-300 – MEK inhibitor: Array completed 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.

Four clinical programs advanced for the treatment of cancer & were presented at the American Association for Cancer Research (AACR) conference:

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 Phase 1/2 trials of ARRY-520 in patients with acute myelogenous leukemia (AML) and in patients with multiple myeloma (MM).

AACR Highlights: Preclinical hematological tumor models were particularly responsive to treatment with ARRY-520, with a 100 percent complete response rate observed in AML, acute promyelocytic leukemia, and MM xenografts. Treatment of MM xenografts with ARRY-520 resulted in significant regression of tumors that had previously progressed after treatment with Velcade® (bortezomib) or Revlimid® (lenalidomide). In addition, ARRY-520 retained activity in a wide range of tumors resistant to other molecules with different mechanisms of action, such as the taxanes. Examination of pharmacodynamic activity in preclinical models reinforced that hematological cancers were among the most sensitive to ARRY-520.

ARRY-614 - p38 / Tie-2 inhibitor for MDS: Array is planning a Phase 1b trial of ARRY-614, a 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 of 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.

AACR Highlights: In preclinical hematological tumor models, ARRY-614 demonstrated activity both as a single agent and in combination with Revlimid® (lenalidomide). Results show that ARRY-614 was well-tolerated and effective in inhibiting cytokines, including IL-6 and TNF, which play a role in the regulation of growth and survival in a number of cancers, particularly hematological cancers. As a single agent, ARRY-614 effectively inhibited angiogenesis in vivo and inhibited tumor growth in preclinical models of MM. Additionally, data show that administering p38 inhibitors in combination with lenalidomide yielded superior inhibition of proinflammatory cytokines and that combining ARRY-614 with standard-of-care agents, lenalidomide and Decadron® (dexamethasone), in MM provided additional anti-tumor effects.

ARRY-543 - ErbB-2 / EGFR inhibitor for solid tumors: Array continued its Phase 1b trial of ARRY-543 in combination with Xeloda® (capecitabine) in patients with solid tumors. Array initiated two additional Phase 1b trials, in combination with Taxotere® (docetaxel) and Gemzar® (gemcitabine).

AACR Highlights: Preliminary results presented on Array’s Phase 1 trial showed that ARRY-543 was generally well-tolerated and demonstrated evidence of tumor regression and prolonged stable disease in EGFR- and ErbB2-expressing cancers. Of the confirmed patients with ErbB2-positive metastatic breast cancer treated with ARRY-543, 63 percent achieved stable disease for 16 weeks or longer. Twenty one patients were evaluated: 12 had available biopsies and eight were confirmed ErbB2-positive. Clinical benefit was demonstrated in five of these eight patients and patients with confirmed co-expression of ErbB2 and EGFR tended to have the best clinical benefit. In patients with other cancers shown to express ErbB family members, three patients, with ovarian cancer, cervical cancer and cholangiocarcinoma, respectively, treated with ARRY-543 also achieved stable disease for 16 weeks or more; the patient with cholangiocarcinoma experienced a tumor marker response that was accompanied by a 25 percent regression of target lesions.

ARRY-380 – ErbB-2 inhibitor for cancer: Patient recruitment in a Phase 1 trial of ARRY-380, an oral, selective ErbB-2 inhibitor, remains on track to complete in 2009. The trial is designed to evaluate the safety, maximum tolerated dose, and pharmacokinetics of ARRY-380 in cancer patients.

CONFERENCE CALL DETAILS

Array will hold a conference call on Tuesday, May 5, 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.

Conference Call Information

Date:

  Tuesday, May 5, 2009

Time:

9:00 a.m. eastern time

Toll-Free:

877-856-1964

Toll:

719-325-4815

Pass Code:

2844590

Web Cast:

www.arraybiopharma.com

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 2844590.

About Array BioPharma

Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer, inflammatory and metabolic diseases. Our proprietary drug development pipeline includes clinical candidates that are designed to regulate therapeutically important target proteins and are aimed at significant unmet medical needs. In addition, leading pharmaceutical and biotechnology companies collaborate with Array to discover and develop drug candidates across a broad range of therapeutic areas. For more information on Array, please go to www.arraybiopharma.com.

Forward-Looking Statement

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 June 30, 2008, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, our ability to continue to fund and successfully progress internal research efforts and to create effective, commercially viable drugs, our ability to achieve and maintain profitability, the extent to which the pharmaceutical and biotechnology industries are willing to in-license drug candidates for their product pipelines and to collaborate with and fund third parties on their drug discovery activities, our ability to out-license our proprietary candidates on favorable terms, risks associated with our dependence on our collaborators for the clinical development and commercialization of our out-licensed drug candidates, the ability of our collaborators and of Array to meet objectives tied to milestones and royalties, and our ability to attract and retain experienced scientists and management. We are providing this information as of May 4, 2009. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.

Array BioPharma Inc.
Condensed Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
       
Three Months Ended Nine Months Ended
March 31, March 31,
  2009     2008     2009     2008  
 
Revenue:
Collaboration revenue $ 4,399 $ 5,613 $

13,427

$ 16,868
License and milestone revenue   1,639     2,098    

6,047

    5,854  
Total revenue 6,038 7,711 19,474 22,722
 
Operating expenses
Cost of revenue 5,515 5,725 15,698 16,278

Research and development for proprietary drug discovery

20,029 23,830 68,248 61,997
General and administrative   4,461     3,737     13,435     12,944  
Total operating expenses   30,005     33,292     97,381     91,219  
 
Loss from operations (23,967 ) (25,581 ) (77,907 ) (68,497 )
 
Impairment of marketable securities (3,381 ) - (17,742 ) -
Interest income 412 1,342 1,823 5,281
Interest expense   (2,674 )   (171 )   (7,289 )   (635 )
Net loss $ (29,610 ) $ (24,410 ) $ (101,115 ) $ (63,851 )
 
Basic and diluted net loss per share $ (0.62 ) $ (0.51 ) $ (2.12 ) $ (1.35 )
Number of shares used to compute per share data   48,068     47,428     47,747     47,236  
 
 
Summary Balance Sheet Data
(in thousands)
 
March 31, June 30,
  2009     2008  
 
Cash, cash equivalents and marketable securities $ 72,932 $ 125,531
Property, plant and equipment, gross $ 83,455 $ 81,966
Working capital $ 31,480 $ 66,346
Total assets $ 108,493 $ 163,077
Long-term debt $ 80,979 $ 35,355
Stockholders' equity (deficit) $ (54,958 ) $ 38,027

Source: Array BioPharma Inc.

Array BioPharma
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com