[Detailed results behind the recently reported top-line Phase 2 selumetinib combo NSCLC data is to be reported in calendar 2012 so, at a minimum, we're at least two months away from this detailed data. CC is tomorrow and I'll post any tidbits above and beyond what's in this PR, including whether or not ARRY gives any inkling as to whether they believe AZN will proceed into Phase 3 trials with selumetinib. Given their tone in the PR, notwithstanding the risk of ARRY just talking book, I assume ARRY expects AZN to take selumetinib into Phase 3 trials.]
Array BioPharma Reports Financial Results for the First Quarter of Fiscal 2012
BOULDER, Colo.--(BUSINESS WIRE)-- Array BioPharma Inc. (NASDAQ:ARRY - News) today reported financial results for the first quarter of fiscal 2012.
Array reported revenue of $22.1 million for the first quarter of fiscal 2012, compared to revenue of $18.5 million for the same period in fiscal 2011. During the first quarter of fiscal 2012, Array earned $2.5 million in revenue for achieving a milestone from its collaboration with Genentech. Array reported a significantly reduced net loss of $3.6 million, or ($0.06) per share, for the first quarter, compared to a net loss of $10.6 million, or ($0.20) per share, for the first quarter in fiscal 2011. Array spent $12.6 million in proprietary research and development for the quarter to advance its proprietary pipeline, compared to $13.9 million spent for the same period last year. Cash flow from operations was $13.6 million for the first quarter of fiscal 2012. Array ended the first quarter of fiscal 2012 with $78 million in cash, cash equivalents and marketable securities.
There are currently eight Array-invented drugs in Phase 2 clinical development, six of which are partner-funded. During fiscal 2012, the company expects results to be reported on six clinical trials, the first of which was announced in September 2011: Top-line results of selumetinib in combination with docetaxel versus docetaxel alone in patients with second-line KRAS-mutant non-small cell lung cancer (NSCLC). Complete results from this Phase 2 trial are expected to be released in calendar 2012. Additional data releases planned during fiscal 2012 include:
• Phase 2 combination data on selumetinib in patients with melanoma • Phase 2 data on ARRY-520 in patients with multiple myeloma (MM) • Phase 2 data on ARRY-797 in patients with osteoarthritis (OA) pain • Phase 1 data on ARRY-614 in patients with myelodysplastic syndromes (MDS) • Phase 1 data on ARRY-502 in healthy volunteers
“The recently announced top-line Phase 2 results for selumetinib in KRAS mutant NSCLC, we believe, are the most promising results to date in this patient population,” said Robert E. Conway, Chief Executive Officer. “Selumetinib in combination with docetaxel showed statistical significance in the key secondary end-points of progression free survival, objective response rate, and alive and progression free at six months, as well as a numerical increase in the primary endpoint of overall survival versus docetaxel alone, demonstrating the therapeutic potential of this drug. There is a significant opportunity to help the more than 160,000 patients with KRAS mutant NSCLC who currently have a poor prognosis with limited treatment options.”
SUMMARY OF RECENT AND EXPECTED KEY EVENTS Top-line Results Announced for Selumetinib and ARRY-502
Selumetinib (AZD6244) (AstraZeneca) – MEK inhibitor for cancer: Array announced results from a randomized Phase 2 placebo-controlled study conducted by AstraZeneca comparing the efficacy of selumetinib in combination with docetaxel versus docetaxel alone in the second-line treatment of 87 patients prospectively selected with KRAS-mutant, locally advanced or metastatic NSCLC. This was the first completed randomized combination trial with a MEK inhibitor. Selumetinib was licensed from Array to AstraZeneca. The study’s primary endpoint of overall survival demonstrated a numerically greater increase in survival in favor of selumetinib in combination with docetaxel versus docetaxel alone, but did not reach statistical significance.
The key secondary endpoints of progression-free survival, objective response rate, and alive and progression-free at six months were all demonstrated with statistical significance, showing improvement in favor of selumetinib in combination with docetaxel versus docetaxel alone. Further data and analyses will be presented by the study’s academic investigators at a forthcoming scientific conference.
AstraZeneca is also completing a Phase 2 trial with selumetinib in combination with dacarbazine versus dacarbazine alone as first-line treatment of patients with melanoma whose tumors harbor BRAF mutations. This trial completed enrollment of 91 patients in March 2010 with the primary endpoint of overall survival.
ARRY-502 – CRTh2 antagonist for asthma: Array completed a 14-day Phase 1, randomized, double-blind, multiple ascending dose trial with ARRY-502 in healthy volunteers. Preliminary results indicated that ARRY-502 was well tolerated at all doses evaluated with all treatment-related adverse events being mild. There were proportional increases in ARRY-502 exposure with increasing dose. ARRY-502 provided robust and sustained pharmacodynamic activity. Phase 1 clinical data, along with other assessments, indicate the potential for once a day dosing of ARRY-502 in asthma. Array plans to initiate a Phase 2 trial in persistent asthma during the first half of 2012.
Proprietary Development Programs ARRY-520 – KSP inhibitor for Multiple Myeloma (MM): Array will present Phase 1 data and top-line results of a Phase 2 trial with ARRY-520 in patients with relapsed or refractory MM at the American Society of Hematology (ASH) annual meeting in December 2011. Array is expanding this study with a combination of ARRY-520 and dexamethasone in patients with MM refractory to both Velcade® (bortezomib) and Revlimid® (lenalidomide) (dual-refractory MM). Array continues to enroll a Phase 1b combination study with ARRY-520 and Velcade in patients with relapsed or refractory MM. By year-end, M.D. Anderson Cancer Center plans to initiate an investigator-sponsored Phase 1b study with ARRY-520 and carfilzomib in patients with relapsed or refractory MM in collaboration with Array and Onyx Therapeutics, Inc.
ARRY-614: A dual p38/Tie2 inhibitor for Myelodysplastic Syndromes (MDS): Array will present top-line results at the 2011 ASH Annual Meeting from a Phase 1 dose escalation/expansion trial with ARRY-614 in patients with Low/Intermediate-1 risk MDS. Array has tested a new formulation with enhanced drug exposure and lower variability which has the potential to be the commercial formulation and will be used in future studies expected to start this quarter.
ARRY-797 – p38 inhibitor for Pain: Array continued a 28-day Phase 2, randomized, double-blind study comparing ARRY-797 with OxyContin® and placebo in approximately 150 patients with moderate to severe pain from osteoarthritis of the knee despite continuing NSAID use. Array anticipates reporting top-line results during the first half of calendar 2012.
Select Partnered Programs and New Partnering Agreements AMG 151 (ARRY-403) (Amgen) – Glucokinase Activator for Type 2 diabetes: In October 2011, Amgen initiated a Phase 2a, 28-day trial of AMG 151 in combination with metformin in approximately 224 patients with Type 2 diabetes. The primary endpoint is change in fasting plasma glucose levels from baseline from day one to end of treatment.
MEK162 (ARRY-162) (Novartis) – MEK inhibitor for cancer: Novartis is continuing a Phase 2 open-label trial with MEK162 in patients with metastatic malignant cutaneous melanoma and three Phase 1b combination trials in selected patients with advanced solid tumors.
ARRY-575 (Genentech) – Chk-1 inhibitor for cancer: Array and Genentech, a member of the Roche Group, announced an oncology agreement for the development of each company’s small-molecule Checkpoint kinase 1 (Chk-1) program. The programs include Genentech’s compound GDC-0425 (RG7602), currently in Phase 1, and Array’s compound ARRY-575, which is being prepared for an investigational new drug application to initiate a Phase 1 trial in cancer patients. Under the terms of the agreement, Genentech is responsible for all clinical development and commercialization activities. Array received an upfront payment of $28 million in September 2011 and is eligible to receive clinical and commercial milestone payments up to $685 million and up to double-digit royalties on sales of any resulting drugs.
ARRY-543 (ASLAN Pharmaceuticals) - HER2 / EGFR inhibitor for gastric cancer: ASLAN Pharmaceuticals Pte Ltd and Array entered into a license agreement in July 2011 to develop Array's HER2 / EGFR inhibitor, ARRY-543, currently entering Phase 2 development for solid tumors. Under the agreement, ASLAN will fund and globally develop ARRY-543 through proof of concept, initially targeting patients with gastric cancer through a development program conducted in Asia. Upon achievement of proof of concept, ASLAN will identify a global partner for Phase 3 development and commercialization. Array and ASLAN will share the proceeds of such partnering transaction.
Strengthening Leadership Hired Karsten Witt, M.D.: Array hired Karsten Witt, M.D., as Vice President of Clinical Sciences. Dr. Witt has been involved in filing six investigational new drug applications and five new drug applications across the U.S., Europe and Japan, including the registration of Tarceva® (erlotinib). Prior to joining Array, Dr. Witt served as Sr. Vice President Pharmaceutical Operations at OSI Pharmaceuticals, where he was intimately involved in the development of small-molecule targeted oncology therapies, including the EGFR inhibitor Tarceva®.
Array Analyst Day on December 16, 2011
Array will hold an Analyst Day meeting in New York City on Friday, December 16, 2011, at 8:30 am eastern time. Further details will be announced in the near future.
Array will hold a conference call on Tuesday, November 1, 2011, 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.
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. 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. For more information on Array, please go to www.arraybiopharma.com.
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