Array BioPharma reports net loss of $0.13 per share for first quarter of fiscal 2014

Array BioPharma Inc. (NASDAQ: ARRY) today reported results for the first quarter of its fiscal year ending June 30, 2014.

Revenue for the first quarter of fiscal 2014 was $14.2 million, compared to $15.8 million for the same period in fiscal 2013.  The cost of partnered programs increased to $10.7 million, compared to $6.5 million for the same period last year, largely due to increased co-development costs with Novartis related to the start of three MEK162 Phase 3 studies.  Research and development expense declined to $11.7 million, compared to $13.5 million in the same prior year period due to the completion of the Phase 2 asthma study with ARRY-502.  Net loss for the first quarter was $15.7 million, or $(0.13) per share, compared to a net loss of $11.8 million, or ($0.13) per share, for the same period in fiscal 2013.  Array ended the quarter with $124 million in cash, cash equivalents and marketable securities.

Ron Squarer, Chief Executive Officer of Array, noted, "Array is taking an important step today by announcing plans to initiate a Phase 3 trial in 2014 with our wholly-owned multiple myeloma asset, ARRY-520.  In addition, we are excited that five registration trials are already enrolling patients with our partnered MEK inhibitors, selumetinib and MEK162, with another pivotal trial expected to start by year-end."

KEY PIPELINE UPDATES

Wholly-Owned Pipeline Products

ARRY-520 – Expect to initiate Phase 3 trial in multiple myeloma (MM) in mid-2014
ARRY-520 is a highly selective, targeted KSP inhibitor with a mechanism of action distinct from currently available drugs to treat MM.  Even with recent advances with IMiDs and proteasome inhibitors, the vast majority of patients progress on these therapies leaving an unmet need for novel agents which provide benefit in combination with, and after these therapies have failed.  ARRY-520 has demonstrated activity as a monotherapy in heavily pre-treated patients as well as in combination with both Kyprolis® (carfilzomib) and Velcade® (bortezomib).  Across multiple studies, ARRY-520 has been well tolerated with no peripheral neuropathy and limited non-hematologic toxicity.  Adverse events are generally limited to transient, non-cumulative and predominantly asymptomatic hematologic effects.   

Based on the strength of data from ongoing or completed clinical trials, and recent positive discussions with the Food and Drug Administration (FDA), Array expects to initiate a global Phase 3 study of ARRY-520 in patients with relapsed and refractory multiple myeloma (RRMM), of which there are more than 70,000 patients in developed countries.   The trial will evaluate ARRY-520 in several hundred patients with RRMM, comparing Kyprolis plus ARRY-520 to Kyprolis alone, with Progression Free Survival (PFS) as the primary endpoint.  Key secondary endpoints include Overall Survival (OS) and safety and efficacy differences between patients with low- and high-levels of alpha-1-acid glycoprotein (AAG), a potential patient selection marker.  The trial design may include an interim analysis of Objective Response Rate (ORR), which if positive, could support an accelerated regulatory filing.  

Array plans to conduct two clinical studies in addition to the Phase 3 trial.  The first is a randomized Phase 2 trial comparing Kyprolis plus ARRY-520 versus Kyprolis alone in 75 RRMM patients with PFS as the primary endpoint.  This trial, which is expected to begin next month, is designed to provide near-term confirmation of the combinability observed in the ongoing MD Anderson ARRY-520 plus Kyprolis trial.  Positive results will support future regulatory submissions and also help validate the use of AAG. In addition, published results from this trial should support Phase 3 enrollment.  Array is planning to initiate the Phase 3 trial prior to completing this study. 

The second study will evaluate ARRY-520 as a single agent in a robust global Phase 2 trial in patients with RRMM including both low- and high-AAG patients.  Trial initiation is planned for mid-2014.  The primary endpoint will be ORR in patients with low levels of AAG.  This trial is also designed to support future regulatory submissions, will include important safety and pharmacology data, and will also validate the use of AAG. 

Four abstracts on ARRY-520 have been submitted for presentation at the 2013 American Society of Hematology (ASH) Annual Meeting in December 2013. These include data from the following studies:  ARRY-520 plus dexamethasone, ARRY-520 plus Kyprolis, ARRY-520 plus Velcade and preclinical data regarding ARRY-520 plus Pomalyst.  ASH is the world's largest professional society concerned with the causes and treatments of blood disorders.

ARRY-614 – Patient enrollment complete in myelodysplastic syndromes (MDS) clinical trial
ARRY-614 is being studied in Low/Intermediate-1 MDS, a population of more than 100,000 patients in developed countries.  In a previous study of ARRY-614, multi-lineage activity was observed with the most promising effects seen in patients with thrombocytopenia, with several platelet transfusion-dependent patients becoming tranfusion-independent.  Array is evaluating a new formulation of ARRY-614 in an ongoing dose-escalation clinical trial. The maximum tolerated dose has been established and expansion cohorts have been fully enrolled and are ongoing.  Pharmacokinetic and pharmacodynamics assays performed as part of the trial have demonstrated improved bioavailability and target coverage relative to the previously-evaluated formulation. In addition, the study is evaluating safety and the preliminary efficacy of ARRY-614 based on Hematologic Improvement (increases in red blood cells, neutrophils and/or platelets), the reduction or independence from red blood cell and/or platelet transfusions, the durability of these responses, and OS.  Mature response data from this trial is expected early next year.  With these results, Array plans to discuss development plans with regulatory authorities.  

An abstract providing updated data on the current ARRY-614 study has been submitted for presentation at the 2013 ASH Annual Meeting.

Partnered Pipeline Products

MEK162 (co-developing with Novartis) – Phase 3 trial initiated in BRAF-mutant melanoma
Novartis initiated a Phase 3 trial with MEK162 and the Novartis BRAF inhibitor, LGX818, in BRAF-mutant melanoma based on the safety and efficacy data reported in their trial presented at the 2013 American Society for Clinical Oncology (ASCO) Annual Meeting.  The trial, called COLUMBUS, is a 900-patient randomized, open label, multi-center, parallel group, three-arm study comparing the efficacy and safety of LGX818 plus MEK162 and LGX818 monotherapy, as compared to vemurafenib in patients with locally advanced unresectable or metastatic melanoma with BRAF mutation.

There are now three Phase 3 trials enrolling with MEK162 in advanced cancer patients:  NRAS-mutant melanoma, low-grade serous ovarian cancer and BRAF-mutant melanoma.  NRAS-mutant melanoma represents the first indication for MEK162, and the projected regulatory filing from the NRAS-mutant melanoma study is estimated to be in 2015.     

Selumetinib (partnered with AstraZeneca) – SELECT-1 Phase 3 trial initiated in non-small cell lung cancer (NSCLC)
AstraZeneca initiated a Phase 3 clinical trial of selumetinib as second-line therapy in patients with KRAS-mutant advanced or metastatic NSCLC based on the strength of Phase 2 data presented at the 2012 ASCO Annual Meeting.  Array earned a milestone payment for the start of this study in October 2013.

SELECT-1 is a randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of selumetinib in combination with docetaxel with PFS as the primary endpoint.  Secondary endpoints include ORR and OS. SELECT-1, which will enroll approximately 630 patients, will be the largest prospective study ever conducted in this patient population, a genetic sub-type of lung cancer associated with poor prognosis and limited treatment options.  KRAS mutations drive approximately 20 percent of human cancers and have been found in 20 to 30 percent of NSCLC tumors.

AstraZeneca is also conducting two additional registration trials.  A pivotal study assessing the efficacy and tolerability of selumetinib combined with radioactive iodine as adjuvant therapy in patients with differentiated thyroid cancer with high risk of recurrence started in August 2013, and a pivotal study assessing the efficacy and tolerability in combination with dacarbazine in patients with metastatic uveal melanoma is planned to start in late 2013.    

ARRY-380 (ONT-380) (collaboration with Oncothyreon) – Trial initiated in patients with HER2+ breast cancer with brain metastases
ARRY-380 is an orally active, reversible and selective small-molecule HER2 inhibitor. A trial of ARRY-380 in combination with Herceptin® (trastuzumab) was initiated in patients with brain metastases from HER2+ breast cancer.  The trial is being conducted under the sponsorship of the Dana-Farber Cancer Institute, Boston, Massachusetts.  Oncothyreon plans to start additional studies this year.