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Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2012

Stocks in this article: ARRY

In this trial, ARRY-797 was considered overall to be well-tolerated at the selected dose of 400 mg twice-daily. The most common adverse events observed in patients treated with ARRY-797 were dizziness, diarrhea and nausea, which were mainly mild in severity. ARRY-797 treatment was associated with sporadic, transient increases in creatine kinase and aspartate aminotransferase. Mild prolongations of the QTc interval and sustained decreases in systolic and diastolic blood pressure were also observed. Given the scope of a development program in pain, Array will seek an appropriate partner to maximize the value of this drug.

ARRY-614 – Dual p38/Tie2 inhibitor for Myelodysplastic Syndromes (MDS): Array advanced ARRY-614 in a Phase 1 clinical trial in patients with MDS using an optimized formulation of the drug with improved plasma exposure and lower inter-subject variability. Array intends to meet with the FDA to discuss the development plan to support registration.

ARRY-520 – KSP inhibitor for Multiple Myeloma (MM): Array advanced ARRY-520 in three clinical trials:

1. Phase 2 trial in combination with dexamethasone in patients with MM refractory to Revlimid, Velcade and dexamethasone therapy

2. Phase 1b trial in combination with Velcade plus dexamethasone in patients with relapsed or refractory MM

3. Phase 1b investigator-sponsored trial in combination with Kyprolis® (carfilzomib) in patients with relapsed or refractory MM who are refractory or intolerant to Velcade therapy

Positive results in any one of these trials could define a path to late stage development.

ARRY-502 – CRTh2 antagonist for asthma: Array continued a Phase 2a trial with ARRY-502, a CRTh2 antagonist, in patients with persistent asthma. Array expects top-line results from this trial during the second quarter of calendar 2013 and intends to seek a partner for further development of ARRY-502 in this large- market disease indication.

Selumetinib (AZD6244) (AstraZeneca) – MEK inhibitor for cancer: Results for selumetinib in patients with KRAS mutation-positive NSCLC were presented in June 2012 at the American Society of Clinical Oncology (ASCO) annual meeting. This double-blind, randomized Phase 2 study showed statistically significant improvement in progression-free survival, objective response rate, and alive and progression-free at six months as well as longer median overall survival of 9.4 versus 5.2 months in favor of selumetinib in combination with docetaxel versus docetaxel alone. In addition, AstraZeneca initiated a bioequivalence trial comparing the current Phase 2 and planned Phase 3 capsule formulations. And Array expects results to be reported this year for the Phase 2 trial with selumetinib in combination with dacarbazine versus dacarbazine alone as first-line treatment in patients with BRAF-mutant melanoma.

MEK162 (Novartis) – MEK inhibitor for cancer: Novartis and Array are currently conducting eleven clinical trials, including two Phase 2 trials, three Phase 1b trials in combination with different PI3 kinase inhibitors, two Phase 1b trials in combination with different RAF inhibitors and one Phase 1b trial in combination with paclitaxel. Promising data on MEK162 in an ongoing Phase 2 trial of patients with BRAF and NRAS mutated advanced melanoma were presented at the ASCO annual meeting. In this trial, MEK162 showed clinical activity and good tolerability in patients with BRAF or NRAS melanoma. This is the first targeted therapy to show activity in patients with NRAS mutated melanoma.

OTHER DEVELOPMENTS

  • In July, Array received an $8.5 million milestone in its collaboration on AMG 151 with Amgen Inc. The milestone was achieved after Amgen reached a pre-defined patient enrollment level in a Phase 2a clinical trial in patients with Type 2 diabetes.
  • At the 2012 ASCO annual meeting, Genentech, a member of the Roche Group, presented results from a Phase 1b dose escalation trial showing that GDC-0068, an AKT inhibitor invented by Array scientists, was well-tolerated, when combined with Taxotere or mFOLFOX6, up to the single-agent maximum tolerated dose. Both combinations show evidence of clinical benefit, including in patients with PI3K/Akt pathway alterations and with prior taxanes or platinum agent treatment.
  • In April, Genentech initiated a Phase 1 trial with GDC-0575, a Chk-1 inhibitor Array licensed to Genentech, to evaluate multiple ascending-doses alone and in combination with Gemzar® (gemcitabine).

CONFERENCE CALL INFORMATION

Array will hold a conference call on Tuesday, August 14, 2012, at 9:00 a.m. eastern time to discuss these results. Ron Squarer, Chief Executive Officer, and Michael Carruthers, Chief Financial Officer, will lead the call.

Date:

      Tuesday, August 14, 2012

Time:

9:00 a.m. eastern time

Toll-Free:

800-561-2718

Toll:

617-614-3525

Pass Code:

62242246

Webcast & Conference Call Slides: http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-irhome

A replay of the call will be available as a webcast on www.arraybiopharma.com

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 and inflammatory diseases. Array is evolving into a late-stage development company, with two wholly-owned programs, ARRY-614 and ARRY-520, and three partnered programs, selumetinib partnered with AstraZeneca, MEK162 partnered with Novartis, and danoprevir, partnered with InterMune / Roche, having potential Phase 3 decisions by the end of calendar year 2013. 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 the timing of the announcement of the results of clinical trials for our proprietary and our partnered programs, the timing of the completion or initiation of further development of our wholly-owned and our partnered programs, our potential to earn future milestone and royalty payments under our collaboration agreements, expectations that events will occur that will result in greater value for the Company, the potential for the results of ongoing preclinical and clinical trials to support regulatory approval or the marketing success of a drug candidate, our ability to partner our proprietary drug candidates for up-front fees, milestone and/or royalty payments, our future plans to progress and develop our proprietary programs and the plans of our collaborators to progress and develop programs we have licensed to them, and our plans to build a late-stage development company. These statements involve significant risks and uncertainties, including those discussed in our most recent annual report filed on Form 10-K, in our quarterly reports filed on Form 10-Q, 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 and development efforts and to create effective, commercially viable drugs; 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 BioPharma Inc. to meet objectives tied to milestones and royalties; our ability to effectively and timely conduct clinical trials in light of increasing costs and difficulties in locating appropriate trial sites and in enrolling patients who meet the criteria for certain clinical trials; risks associated with our dependence on third-party service providers to successfully conduct clinical trials within and outside the United States; our ability to achieve and maintain profitability and maintain sufficient cash resources; 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; and our ability to attract and retain experienced scientists and management. We are providing this information as of August 13, 2012. 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
(Unaudited)
(in thousands, except per share amounts)
               

Three Months Ended June 30,

Twelve Months Ended June 30,

2012 2011   2012 2011
 
Revenue
License and milestone revenue $ 17,622 $ 15,595 $ 71,249 $ 53,426
Collaboration revenue   3,042     3,451     13,886     18,475  
Total revenue 20,664 19,046 85,135 71,901
 
Operating expenses
Cost of revenue 6,259 7,635 24,261 28,916
Research and development for proprietary
programs 14,877 19,279 56,719 63,498
General and administrative   4,473     4,292     15,202     16,261  
Total operating expenses   25,609     31,206     96,182     108,675  
 
Gain (Loss) from operations (4,945 ) (12,160 ) (11,047 ) (36,774 )
 
Other income (expense)
Realized gains (losses) on auction rate securities, net - - - 1,891
Interest income 15 16 32 406
Interest expense   (3,095 )   (9,608 )   (12,566 )   (21,847 )
Total other expense, net   (3,080 )   (9,592 )   (12,534 )   (19,550 )
 
Net loss $ (8,025 ) $ (21,752 ) $ (23,581 ) $ (56,324 )
 
Weighted average shares outstanding -
basic and diluted   90,897     56,991     70,619     55,447  
 
Net loss per share - basic and diluted $ (0.09 ) $ (0.38 ) $ (0.33 ) $ (1.02 )
 
 
Summary Balance Sheet Data
(in thousands)
          June 30,     June 30,
2012 2011
 
Cash, cash equivalents and marketable securities

 

$ 89,650 $ 64,708
Property, plant and equipment, gross

 

$ 86,287 $ 85,968
Working capital

 

$ 17,171 $ 754
Total assets

 

$ 108,073 $ 89,374
Long-term debt, net

 

$ 92,256 $ 91,540
Stockholders' equity

 

$ (85,806 ) $ (130,858 )




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