Array BioPharma Inc. (NASDAQ: ARRY) today reported results for the first quarter of its fiscal year ending June 30, 2013.
Array continues its evolution into a late-stage development company, with five products approaching Phase 3 decisions by the end of calendar year 2013. These include two wholly-owned programs: ARRY-614 and ARRY-520, and three partnered programs: selumetinib (with AstraZeneca), MEK162 (with Novartis) and danoprevir (with InterMune/Roche).
Array reported revenue of $15.8 million for the first quarter of fiscal 2013, compared to revenue of $22.1 million for the same period in fiscal 2012. The decrease in first quarter revenue was expected, as Array recognized the majority of its $28 million upfront payment from a license agreement with Genentech during the previous fiscal year. The Company recorded expenses of $13.5 million on proprietary research and development for the quarter to advance its clinical development and discovery programs, compared to $12.6 million during the same period last year. Net loss for the first quarter was $11.8 million, or ($0.13) per share, compared to $3.6 million, or ($0.06) per share, for the same period last year. Array ended the first quarter of fiscal 2013 with $68 million in cash, cash equivalents, and marketable securities.
Ron Squarer, Chief Executive Officer of Array, noted, "This promises to be an important year for Array as several drugs in our wholly-owned and partnered pipelines move towards commercialization. We are on track to advance ARRY-520 for multiple myeloma and ARRY-614 for myelodysplastic syndromes into late-stage development in the coming year. Success with any of these programs will propel Array towards a self-sustaining biopharmaceutical company."
KEY PROGRAM UPDATES
ARRY-520 – KSP inhibitor for Multiple Myeloma (MM):
During the quarter, ARRY‑520, a potent, selective KSP inhibitor with a mechanism of action distinct from other drugs used to treat multiple myeloma, was advanced in three clinical trials. Positive results in any one of these trials will define a clear path to late stage development:
Phase 2 trial in combination with dexamethasone in patients with MM refractory to Revlimid® (lenalidomide), Velcade® (bortezomib) and dexamethasone therapy.
Phase 1b trial in combination with Velcade plus dexamethasone in patients with relapsed or refractory MM.
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.
Three abstracts on ARRY-520 have been submitted, including a potential patient selection biomarker for presentation, at the 2012 American Society of Hematology (ASH) Annual Meeting in December 2012. ASH is the world's largest professional society concerned with the causes and treatments of blood disorders.
ARRY-614 – Dual p38/Tie2 inhibitor for Myelodysplastic Syndromes (MDS):
During the quarter, 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.
Array also submitted an abstract on ARRY-614 for presentation at the 2012 ASH Annual Meeting.