Array BioPharma Reports Financial Results For The Second Quarter Of Fiscal 2012

Array BioPharma Inc. (NASDAQ: ARRY) today reported financial results for the second quarter of fiscal 2012.

Array reported revenue of $23.2 million for the second quarter of fiscal 2012, compared to revenue of $16.5 million for the same period in fiscal 2011. The net loss was significantly reduced to $3.8 million, or ($0.06) per share, for the second quarter, compared to a net loss of $12.4 million, or ($0.23) per share, for the second quarter in fiscal 2011. The net loss improved due to increased revenue recognized from up-front and milestone payments during the current quarter. Array spent $13.2 million on research and development for the quarter to advance its proprietary pipeline, compared to $14.5 million spent for the same period last year. Array ended the second quarter of fiscal 2012 with $61 million in cash, cash equivalents and marketable securities.

The company reported revenue of $45.4 million for the six-month period ended December 31, 2011, compared to revenue of $35.0 million for the same period in fiscal 2011. Net loss for the six months ended December 31, 2011, was $7.4 million, or ($0.13) per share, compared to a net loss of $23.1 million, or ($0.42) per share, reported in the same six-month period in fiscal 2011.

“Array expects to have multiple readouts on data in calendar 2012 and we look forward to sharing results throughout the year,” said Kyle Lefkoff, Executive Chairman, Array BioPharma. “We have a solid team in place driving our programs forward and significant management bench strength to successfully operate while we search for a new Chief Executive Officer.”

There are currently nine Array-invented drugs in Phase 2 clinical development, seven of which are partner-funded. Over the next 12 months, the company expects results to be reported from seven clinical trials.

• Phase 2 final combination results for selumetinib plus docetaxel in patients with non-small cell lung cancer (top-line results were reported in September 2011)
• Phase 2 combination data for selumetinib plus DTIC in patients with melanoma
• Phase 2 data for MEK162 in patients with melanoma
• Phase 2 top-line data for ARRY-797 in patients with osteoarthritis pain
• Phase 2 combination data for ARRY-520 plus dexamethasone in patients with multiple myeloma (MM)
• Phase 1b combination data for ARRY-520 plus Velcade® (bortezomib) in patients with MM
• Phase 1 dose escalation data (interim) for the new formulation of ARRY-614 in patients with myelodysplastic syndromes

SUMMARY OF RECENT AND EXPECTED KEY EVENTS

Proprietary Development Programs

ARRY-614 – Dual p38/Tie2 inhibitor for Myelodysplastic Syndromes (MDS): Array presented positive clinical data for ARRY-614 at the December 2011 Annual Meeting of the American Society of Hematology (ASH). ARRY-614 demonstrated activity as measured by hematologic improvement (increased neutrophils, platelets and/or red blood cells) in patients with MDS and was generally well tolerated.

In a Phase 1 dose-escalation/expansion trial of 44 evaluable patients, ARRY-614 demonstrated activity as a single agent in patients with Low or Intermediate-1 risk MDS, as measured by the International Prognostic Scoring System (IPSS), and for whom treatments with approved therapies have failed, including hypomethylating agents and lenalidomide. As shown below, there was a 38% response rate for hematologic improvement in patients receiving the highest dose of 1200 mg daily (n=16). At this dose, ARRY-614 demonstrated multilineage hematologic improvement in 67% of the responders, improving more than one cytopenia (neutropenia, thrombocytopenia and/or anemia). Hematologic improvement was demonstrated in 30% of all patients and generally increased with increasing total daily dose.

N=44 evaluable patients		Total Daily Dose in mg
		400 (n=15)		600 (n=10)		900 (n=3)		1200 (n=16)
Response Hematologic Improvement		20%		30%		33%		38%

Hematologic improvement with ARRY-614 was durable, with multiple patients remaining on therapy for over nine months. Clinically significant hematologic toxicity was minimal. Observed changes in pharmacodynamic markers included p38-dependent normalization of plasma erythropoietin, as well as decreases in phospho-p38 and disease-related apoptosis in the bone marrow.

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