BOULDER, Colo.--(BUSINESS WIRE)--Jan. 30, 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
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Phase 2 data for MEK162 in patients with melanoma
-
Phase 2 top-line data for ARRY-797 in patients with osteoarthritis pain
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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.
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N=44 evaluable patients
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Total Daily Dose in mg
|
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400 (n=15)
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600 (n=10)
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900 (n=3)
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1200 (n=16)
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Response
Hematologic Improvement
|
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20%
|
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30%
|
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33%
|
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38%
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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.
ARRY-614’s dual p38/Tie2 inhibition is a unique mechanism of action for
the treatment of MDS. p38 and Tie2 are overactivated in the bone marrow
of patients with MDS. ARRY-614 enables the repopulation of red blood
cells, platelets and neutrophils and is believed to restore bone marrow
function by blocking myelosuppression. A new formulation of ARRY-614
with improved exposure and lower inter-subject variability is currently
being investigated in a Phase 1 clinical trial in patients with MDS. In
the first half of 2012, we intend to meet with the FDA to discuss the
primary endpoints for a registration trial.
ARRY-520 – KSP inhibitor for Multiple Myeloma (MM): Array
presented Phase 1 and Phase 2 clinical data for ARRY-520 at the December
2011 ASH meeting. These data indicate that ARRY-520 has shown
preliminary clinical activity in heavily pre-treated patients with MM
and was generally well tolerated.
In the Phase 2 trial, ARRY-520 demonstrated promising activity in
patients with relapsed or refractory MM who had received both a
proteasome inhibitor and an IMiD-based regimen. Objective responses were
observed in six patients (19%), with four confirmed partial responses
and one unconfirmed partial response. Importantly, ARRY-520 demonstrated
an 18% response rate (minimal response or better) in patients with MM
refractory to both lenalidomide and bortezomib (i.e., dual-refractory
MM).
ARRY-520 is a potent, selective KSP inhibitor. The mechanism of action
of ARRY-520 is distinct from other drugs in myeloma. ARRY-520-induced
apoptosis requires loss of the survival protein MCL-1. Myeloma and other
hematologic cancers depend on MCL-1 as a key survival protein. ARRY-520
has demonstrated durable single-agent activity in patients with
dual-refractory MM, a population with significant unmet need. In
preclinical studies of MM, ARRY-520 is highly active; regressions have
been observed in bortezomib- and lenalidomide-resistant models, and
synergy has been observed when combined with bortezomib or lenalidomide.
Combinations of ARRY-520 with other active agents may provide greater
patient benefit and offer extensive development opportunities in earlier
lines of therapy.
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ARRY-520 is currently undergoing evaluation in three clinical
trials.
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1.
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Phase 2 trial in combination with dexamethasone in patients with MM
refractory to lenalidomide, bortezomib and dexamethasone therapy
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2.
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Phase 1b trial in combination with bortezomib plus dexamethasone in
patients with relapsed and refractory MM
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3.
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Phase 1b investigator-sponsored trial in combination with
carfilzomib in patients with relapsed or refractory MM
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Array expects positive results in any one of the above trials will
define a path to late stage development.
ARRY-797 – p38 inhibitor for pain: Array continued a
randomized, double-blind 28-day Phase 2 trial comparing ARRY-797 with
oxycodone and placebo in approximately 150 patients with moderate to
severe pain from osteoarthritis of the knee despite continuing NSAID
use. This growing patient population has limited therapeutic options
other than joint replacement or chronic opioids. Enrollment is ongoing;
Array anticipates reporting top-line results during the first half of
calendar 2012. These results will define a path for further development
in chronic and/or acute pain.
ARRY-502 – CRTh2 antagonist for asthma: Array completed a
randomized, double-blind, 14-day multiple ascending dose Phase 1 trial
with ARRY-502 in healthy subjects. ARRY-502 was well tolerated at all
doses evaluated, and all observed treatment-related adverse events were
mild. Proportional increases in ARRY-502 exposure were seen with
increasing dose and overall low inter-subject variability. ARRY-502
provided robust and sustained pharmacodynamic activity. Array plans to
initiate a Phase 2 trial in persistent asthma during the first half of
2012. Array expects top-line results from this trial during the first
quarter of calendar 2013 and intends to seek a partner for further
development of ARRY-502 in this large market disease.
Select Partnered Programs
Selumetinib (AZD6244) (AstraZeneca) – MEK inhibitor for cancer: There
are currently 19 Phase 2 trials ongoing with selumetinib, including a
Phase 2 trial with selumetinib in combination with dacarbazine versus
dacarbazine alone as first-line treatment in patients with BRAF-mutant
melanoma. This trial, sponsored by AstraZeneca, completed enrollment of
91 patients in March 2010 and has the primary endpoint of overall
survival. Array anticipates top-line results for this trial will be
reported in the first half of 2012.
In addition, over the next five months, further data and analyses will
be presented at for the randomized Phase 2 trial comparing selumetinib
in combination with docetaxel versus docetaxel alone in the second-line
treatment of patients prospectively selected with KRAS-mutant, locally
advanced or metastatic, non-small cell lung cancer. Array
previously announced positive top-line results from this trial including
statistically significant improvement in progression-free survival,
objective response rate, and alive and progression-free at six months as
well as numerical improvement in overall survival.
MEK162 (ARRY-162) (Novartis) – MEK inhibitor for cancer: MEK162
was recently identified by Novartis as reaching clinical proof of
concept. The following trials are advancing: a Phase 2 open-label trial
with MEK162 in patients with advanced melanoma and three Phase 1b
combination trials with other targeted agents in selected patients with
advanced solid tumors.
Array also presented Phase 1 data on MEK162 in 28 patients with biliary
tract cancer at the ASCO Gastrointestinal Cancers Symposium in January
2012. MEK162 was well tolerated and showed signs of clinical efficacy in
this patient population, including a complete response and a partial
response. Stable disease was observed in 12 patients.
AMG 151 (ARRY-403) (Amgen) – Glucokinase activator for Type 2
diabetes: Amgen continued a 28-day Phase 2a 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 to end of treatment.
Array Analyst and Investor Day: Array hosted an Analyst and
Investor Day on December 16, 2011 in New York City. The meeting featured
a group of distinguished independent experts who shared their
perspectives on the general landscape of cancer treatments in
development and Array’s drug candidates: Jeffrey Infante, M.D.,
Director, Drug Development Program, Sarah Cannon Research Institute;
Robert Orlowski, M.D., Ph.D., Professor, Department of Lymphoma/Myeloma,
University of Texas MD Anderson Cancer Center; and Guillermo
Garcia-Manero, M.D., Professor of Medicine and Chief, Section of
Myelodysplastic Syndrome, University of Texas MD Anderson Cancer Center.
A webcast of the meeting is available on our website: http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-EventDetails&EventId=4241464.
Robert E. Conway Resigned from Array and Kyle Lefkoff Appointed
Executive Chairman: On January 16, 2012, Array announced that Robert
E. Conway resigned as Chief Executive Officer and Director for personal
reasons. The Board appointed Kyle Lefkoff, Chairman of the Board, to
serve as Executive Chairman. In this capacity, Mr. Lefkoff will lead the
effort to identify a new Chief Executive Officer.
Array will hold a conference call on Tuesday, January 31, 2012, at 9:00
a.m. Eastern time to discuss these results. Michael Carruthers, Chief
Financial Officer, and Kevin Koch, President and Chief Science Officer
will lead the call.
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 has four core proprietary clinical programs: ARRY-614 for
myelodysplastic syndromes, ARRY-520 for multiple myeloma, ARRY-797 for
pain and ARRY-502 for asthma. In addition, Array has 10 partner-funded
clinical programs including two MEK inhibitors in Phase 2: selumetinib
with AstraZeneca and MEK162 with Novartis. 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
time of the completion or initiation of further development of 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 ability to attract and hire a Chief Executive Officer with the
experience we are seeking. 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 January 30, 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.
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Array BioPharma Inc.
|
|
Condensed Statements of Operations
|
|
(Unaudited)
|
|
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Six Months Ended
December 31,
|
|
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
License and milestone revenue
|
|
$
|
19,195
|
|
|
$
|
11,131
|
|
|
$
|
37,657
|
|
|
$
|
23,924
|
|
|
Collaboration revenue
|
|
|
4,033
|
|
|
|
5,370
|
|
|
|
7,701
|
|
|
|
11,090
|
|
|
Total revenue
|
|
|
23,228
|
|
|
|
16,501
|
|
|
|
45,358
|
|
|
|
35,014
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
Cost of revenue
|
|
|
6,266
|
|
|
|
7,382
|
|
|
|
12,711
|
|
|
|
14,663
|
|
|
Research and development for proprietary
|
|
|
|
|
|
|
|
|
|
programs
|
|
|
13,150
|
|
|
|
14,482
|
|
|
|
25,748
|
|
|
|
28,337
|
|
|
General and administrative
|
|
|
3,782
|
|
|
|
3,905
|
|
|
|
7,502
|
|
|
|
8,173
|
|
|
Total operating expenses
|
|
|
23,198
|
|
|
|
25,769
|
|
|
|
45,961
|
|
|
|
51,173
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (Loss) from operations
|
|
|
30
|
|
|
|
(9,268
|
)
|
|
|
(603
|
)
|
|
|
(16,159
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
|
|
|
|
|
|
|
Realized gains (losses) on auction rate securities, net
|
|
|
-
|
|
|
|
865
|
|
|
|
-
|
|
|
|
798
|
|
|
Interest income
|
|
|
3
|
|
|
|
136
|
|
|
|
9
|
|
|
|
356
|
|
|
Interest expense
|
|
|
(3,836
|
)
|
|
|
(4,175
|
)
|
|
|
(6,792
|
)
|
|
|
(8,067
|
)
|
|
Total other expense, net
|
|
|
(3,833
|
)
|
|
|
(3,174
|
)
|
|
|
(6,783
|
)
|
|
|
(6,913
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,803
|
)
|
|
$
|
(12,442
|
)
|
|
$
|
(7,386
|
)
|
|
$
|
(23,072
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding -
|
|
|
|
|
|
|
|
|
|
basic and diluted
|
|
|
60,004
|
|
|
|
55,285
|
|
|
|
58,515
|
|
|
|
54,350
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted
|
|
$
|
(0.06
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
(0.13
|
)
|
|
$
|
(0.42
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary Balance Sheet Data
|
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
June 30,
|
|
|
|
2011
|
|
2011
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$
|
61,277
|
|
|
$
|
64,708
|
|
|
Property, plant and equipment, gross
|
|
$
|
86,651
|
|
|
$
|
85,968
|
|
|
Working capital
|
|
$
|
(15,133
|
)
|
|
$
|
754
|
|
|
Total assets
|
|
$
|
82,152
|
|
|
$
|
89,374
|
|
|
Long-term debt, net
|
|
$
|
90,036
|
|
|
$
|
91,390
|
|
|
Stockholders' deficit
|
|
$
|
(127,193
|
)
|
|
$
|
(130,858
|
)
|
Source: Array BioPharma Inc.
Array BioPharma Inc.
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com
