BOULDER, Colo., May 3, 2016 /PRNewswire/ -- Array BioPharma
Inc. (NASDAQ: ARRY), a biopharmaceutical company focused on the
discovery, development and commercialization of targeted small
molecule cancer therapies, today reported results for its fiscal
year third quarter ending March 31,
2016 and provided an update on the progress of its key
clinical development programs.
"We have a number of near-term value-drivers, highlighted by our
planned NDA submission for binimetinib based on results from our
Phase 3 trial in NRAS-mutant melanoma patients (NEMO)," said Ron
Squarer, Array's Chief Executive Officer. "At ASCO, we
will present full results from the NEMO trial, as well as provide
an update on our Phase 2 study of encorafenib plus cetuximab in
BRAF-mutant colorectal cancer patients. Later this summer, we plan
to share top-line results from COLUMBUS, our Phase 3 trial of
binimetinib and encorafenib in BRAF melanoma patients. We
also expect results from SELECT-1, a study of selumetinib in second
line KRAS-mutant non-small cell lung cancer patients. Given
our estimated cash runway, a series of strong partnerships and
continued Novartis funding of ongoing binimetinib and encorafenib
trials, we are well positioned to execute on our long-term
strategy."
KEY PIPELINE UPDATES
Binimetinib (MEK162) and encorafenib (LGX818)
Novartis Agreement
Novartis continues to conduct and/or
substantially fund all ongoing trials with binimetinib and
encorafenib through their completion, including the NEMO and
COLUMBUS trials. Reimbursement revenue from Novartis was
approximately $74 million for the
previous 9 months, of which $64
million was recorded over the past two quarters.
NEMO: Global Phase 3 trial of binimetinib versus dacarbazine
in NRAS-mutant melanoma patients
Based on the results of the
NEMO trial, Array plans to submit an NDA during the first half of
2016. Results from NEMO will be presented at the 2016
American Society of Clinical Oncology conference (ASCO), and will
include progression free survival (PFS), overall survival (OS),
objective response rate (ORR), safety and pre-specified sub-group
analyses, including outcomes in patients who received prior
treatment with immunotherapy.
Activating NRAS mutations are present in approximately 20% of
patients with metastatic melanoma, and has been a poor prognostic
indicator for these patients. Treatment options for this population
remain limited beyond immunotherapy (PD-1, CTLA4), therefore
binimetinib could represent an important additional therapy for
these patients.
COLUMBUS: Global Phase 3 trial of binimetinib plus
encorafenib versus vemurafenib in BRAF-mutant melanoma
patients
As part of Array's standard data cleaning protocol,
it was recently learned that additional PFS events need to be
observed prior to database lock and final analysis, a process
previously expected to be complete by the end of June. Array
now projects COLUMBUS top-line results availability during the
third quarter of 2016.
Activating BRAF mutations are present in approximately 50% of
patients with metastatic melanoma. In two separate Phase 1/2
trials in this patient population, binimetinib plus encorafenib
demonstrated encouraging clinical activity and an attractive
tolerability profile, including low incidence of pyrexia, and
little to no incidence of rash or photosensitivity. Patients
treated in two Phase 3 trials of dabrafenib plus trametinib
(COMBI-d and COMBI-v) experienced greater than 50% incidence of
pyrexia (fever), while in a large, randomized trial of vemurafenib
and cobimetinib (coBRIM) nearly 50% of patients experienced
photosensitivity reactions. Of the patients who experienced
pyrexia on COMBI-d and COMBI-v, one-third to one-half reported
three or more events, and at least half required dose modifications
including interruptions, reductions, or discontinuation as a result
of their pyrexia. Of the patients who experienced
photosensitivity on coBRIM, the median duration of photosensitivity
was three months, duration was as long as 14 months for some
patients. Only 63% of patients with photosensitivity
reactions experienced resolution while on study.
BRAF-Mutant Colorectal Cancer
Array's updated results,
including PFS and OS, from its Phase 2 combination trial with
encorafenib in patients with BRAF-mutant colorectal cancer (BRAF
CRC) will be presented at ASCO 2016. Based on the strength of
existing Phase 2 combination data, Array plans to initiate a Phase
3 global registration trial in this patient population later this
year.
Colorectal cancer is the third most common cancer among men and
women in the United States, with
approximately 134,000 new cases and nearly 50,000 deaths from the
disease projected in 2016. BRAF mutations occur in up to 20%
percent of patients with colorectal cancer and represents a poor
prognosis for these patients. Historical published PFS and OS
results after first line range from 1.8 to 2.5 months and 4.7 to
5.9 months, respectively. In addition, historical published
response rates from various studies for EGFR-based therapy in this
population range from 6% to 8%. Array's data shared at the 2015
European Society of Medical Oncology's World Congress of
Gastrointestinal Cancer (ESMO GI) compare favorably both to
currently available therapies for BRAF CRC patients, and to other
recently published investigational approaches in this population.
The combination of encorafenib and cetuximab has demonstrated a
well-tolerated safety profile with most treatment related adverse
events being grade 1 or 2 and few grade 3 or 4 adverse
events.
ARRY-797 (ARRY-371797)
Phase 2 trial
on-going in patients with LMNA A/C-related dilated cardiomyopathy
(DCM)
Array is conducting a 12-patient Phase 2 study to
evaluate the effectiveness and safety of ARRY-797 in patients with
LMNA A/C-related DCM, a serious, genetic cardiovascular disease.
Results will be presented at the European Society of Cardiology on
August 30, 2016. By age 45,
approximately 70% of patients with LMNA A/C-related DCM will have
died, suffered a major cardiac event, or will have undergone a
heart transplant. Data on the primary endpoint of mean change in
six-minute walk test (6MWT) at 12 weeks relative to baseline
exceeds benchmarks set by a number of drugs for rare diseases
recently approved on the basis of the 6MWT as a primary endpoint.
Secondary endpoints in the ARRY-797 trial, including changes in
N-Terminal pro-Brain-derived Natriuretic Peptide (NT-proBNP, a
serum biomarker of heart failure severity), and patient reported
outcomes, are directionally consistent with the primary endpoint.
Data for patients followed through 48 weeks suggest a durable
effect. Taken together, the data to date suggest a path forward for
this program, and Array has met with regulators to discuss the
design of a study that could be the basis for marketing
approval.
Selumetinib (partnered with AstraZeneca)
Registration trials advancing in NSCLC (SELECT-1), thyroid
cancer (ASTRA) and neurofibromatosis type 1
AstraZeneca
continues to advance selumetinib in three registration trials:
SELECT-1 in patients with KRAS-mutant non-small cell lung cancer
(NSCLC), a registration trial in patients with neurofibromatosis
type 1 and ASTRA in patients with differentiated thyroid cancer.
AstraZeneca expects top-line results from SELECT-1 in the second
half of 2016 and projects a regulatory filing of selumetinib in
NSCLC in the first half of 2017.
SELECT-1 is a 500-patient randomized, double-blind,
placebo-controlled study that was designed to evaluate the safety
and efficacy of selumetinib plus docetaxel as a second line therapy
in locally advanced or metastatic KRAS-mutant NSCLC. KRAS mutations
are amongst the most common mutations in NSCLC, present in
approximately a quarter of these patients. The study is designed to
evaluate PFS as the primary endpoint and a key secondary endpoint
is OS. AstraZeneca's decision to progress selumetinib to Phase 3 in
NSCLC followed the results from a randomized Phase 2 study
evaluating the combination of selumetinib with docetaxel against
docetaxel alone in KRAS-mutation positive NSCLC. This study
demonstrated response rates of 37.2% vs 0% (p<0.0001), and a
statistically significant improvement in PFS of 5.3 vs 2.1 months
(HR 0.58, p<0.014).
ARRY-954 / Select Tropomyosin Receptor Kinase A (TrkA)
inhibitor for pain and inflammation
Asia-Focused
Strategic Collaboration with Asahi Kasei Pharma Corporation; Array
retains the right for all compounds for all indications outside of
Asia
In March 2016, Array announced a strategic
collaboration with Asahi Kasei Pharma Corporation to develop and
commercialize select preclinical TrkA inhibitors, including
Array-invented ARRY-954, for pain, inflammation and other
non-cancer indications. Under the terms of the agreement, Array
retains the right for all compounds for all indications outside of
Asia. Within Asia, Array retains the right to cancer
indications for all compounds, excluding those compounds being
developed by Asahi Kasei Pharma, including ARRY-954. Asahi Kasei
Pharma will have exclusive rights to develop and commercialize
products in Japan, Korea,
Taiwan and China for pain, inflammation and other
non-cancer indications. Array received an upfront payment of
$12 million, is entitled to receive
up to $64 million if certain
development and commercialization milestones are achieved, and is
eligible for up to double-digit royalties. Activation of the TrkA
pathway by Nerve Growth Factor (NGF) has been implicated in the
pathogenesis of many difficult to treat human pain conditions such
as osteoarthritis pain, chronic low back pain, diabetic peripheral
neuropathy, cancer pain and interstitial cystitis.
FINANCIAL HIGHLIGHTS
Cash, cash equivalents, marketable securities were approximately
$118 million and accounts receivable
was approximately $63 million at the
end of the quarter. Accounts receivable primarily consist of
receivables expected to be paid by Novartis within three months and
the $12.0 million up-front fee from
Asahi Kasei Pharma, which was received in April 2016. In March
2015, binimetinib and encorafenib became wholly-owned assets
of Array, which prompted changes to the classification of revenue
and expenses for the programs. The new expense classifications were
included in the fourth quarter of fiscal 2015 financial results.
Beginning in the first quarter of fiscal 2016, Array reports
revenue from Novartis reimbursements under its agreements with
Novartis for binimetinib and encorfenib as a separate line item
called "reimbursement revenue." The net earnings (or loss) per
share described below are diluted net earnings (or loss) per
share.
Third Quarter of Fiscal 2016 Compared to Second Quarter of
Fiscal 2016 (Sequential Quarters Comparison)
Revenue
for the third quarter of fiscal 2016 was $43.0 million, compared to $35.4 million for the prior sequential quarter.
The $7.6 million increase in revenue
was primarily due to higher reimbursement revenue from Novartis.
Cost of partnered programs for the third quarter of fiscal
2016 was $5.8 million, compared to
$5.7 million for the prior quarter.
Research and development expense was $48.8 million, compared to $41.4 million in the prior quarter. The increase
in research and development expense is primarily related to the
ongoing transition of binimetinib and encorafenib trials from
Novartis to Array. Net loss for the third quarter was
$22.7 million, or ($0.16) per share, and was $24.2 million, or ($0.17) per share in the prior quarter.
Third Quarter of Fiscal 2016 Compared to Third Quarter of
Fiscal 2015 (Prior Year Comparison)
Compared to the same
quarter of fiscal 2015, revenue for the third quarter of
fiscal 2016 increased by $36.4
million, primarily due to $36.9
million in reimbursement revenue from Novartis. Cost of
partnered programs decreased by $6.3
million compared to the third quarter of fiscal 2015
primarily due to binimetinib development costs being presented as
research and development expense instead of cost of partnered
programs upon becoming wholly-owned programs. Research and
development expense increased by $37.0
million compared to the third quarter of fiscal 2015 due to
the categorization of binimetinib costs, as well as new spending on
encorafenib. Net loss for the third quarter of fiscal
2016 was $22.7 million, or
($0.16) per share, and was net income
of $58.3 million, or $0.37 net income per share, for the same quarter
in fiscal 2015.
Nine Months of Fiscal 2016 Compared to Nine Months of Fiscal
2015 (Prior Year Comparison)
For the nine months ended
March 31, 2016, revenue was
$94.7 million, compared to
$39.6 million for the same period in
fiscal 2015. Net loss for the nine months ended March 31, 2016, was $67.8
million, or ($0.47) per share,
compared to a net income of $22.1
million, or $0.16 per share,
in the comparable prior year period. The third quarter of fiscal
2015 included a one-time $80.0
million net gain on the binimetinib and encorafenib
agreements. Cash outflows for the nine months ended
March 31, 2016 was $62 million.
CONFERENCE CALL INFORMATION
Array will hold a
conference call on Tuesday, May 3,
2016 at 9:00 a.m. Eastern Time
to discuss these results. Ron Squarer, Chief Executive Officer,
will lead the call.
Date:
|
Tuesday, May 3,
2016
|
Time:
|
9:00 a.m. Eastern
Time
|
Toll-Free:
|
(844)
464-3927
|
Toll:
|
(765)
507-2598
|
Pass
Code:
|
86078064
|
Webcast, including
Replay and Conference Call Slides:
|
http://edge.media-server.com/m/p/stxvbem8
|
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. Five registration studies are
currently advancing related to three cancer drugs. These programs
include binimetinib (MEK162), encorafenib (LGX818) and selumetinib
(AstraZeneca). 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 timing
of the completion or initiation of further development of our
wholly-owned and our partnered programs, including the timing of
regulatory filings, expectations that events will occur that will
result in greater value for Array, 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
plans to build a late-stage development company. 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 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 May 3, 2016. 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.
Array BioPharma
Inc.
|
Condensed
Statements of Operations
|
(Unaudited)
|
(in thousands, except
per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
Nine Months Ended
March 31,
|
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
Reimbursement
revenue
|
|
$
|
36,941
|
|
$
|
1,340
|
|
$
|
73,912
|
|
$
|
1,340
|
|
Collaboration
revenue
|
|
5,249
|
|
5,162
|
|
18,800
|
|
17,882
|
|
License and milestone
revenue
|
|
857
|
|
99
|
|
1,962
|
|
20,367
|
|
Total
revenue
|
|
43,047
|
|
6,601
|
|
94,674
|
|
39,589
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
Cost of partnered
programs
|
|
5,847
|
|
12,140
|
|
17,722
|
|
37,415
|
|
Research and
development for proprietary programs
|
|
48,802
|
|
11,817
|
|
111,151
|
|
35,824
|
|
General and
administrative
|
|
8,406
|
|
8,187
|
|
25,702
|
|
23,064
|
|
Total
operating expenses
|
|
63,055
|
|
32,144
|
|
154,575
|
|
96,303
|
|
Gain on the
Binimetinib and Encorafenib Agreements, net
|
|
-
|
|
80,010
|
|
-
|
|
80,010
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(20,008)
|
|
54,467
|
|
(59,901)
|
|
23,296
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
|
Realized gain from
marketable securities, net
|
|
-
|
|
6,402
|
|
-
|
|
6,402
|
|
Interest
income
|
|
76
|
|
15
|
|
167
|
|
36
|
|
Interest
expense
|
|
(2,743)
|
|
(2,577)
|
|
(8,092)
|
|
(7,631)
|
|
Total
other expense, net
|
|
(2,667)
|
|
3,840
|
|
(7,925)
|
|
(1,193)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
|
$
|
(22,675)
|
|
$
|
58,307
|
|
$
|
(67,826)
|
|
$
|
22,103
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
- basic
|
|
$
|
(0.16)
|
|
$
|
0.42
|
|
$
|
(0.47)
|
|
$
|
0.16
|
Net loss per share
- diluted
|
|
$
|
(0.16)
|
|
$
|
0.37
|
|
$
|
(0.47)
|
|
$
|
0.16
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
143,338
|
|
139,769
|
|
142,792
|
|
135,113
|
Weighted average
shares outstanding - diluted
|
|
143,338
|
|
166,265
|
|
142,792
|
|
138,573
|
Summary Balance
Sheet Data
|
(in
thousands)
|
|
|
March
31,
|
|
June
30,
|
|
|
2016
|
|
2015
|
|
|
|
|
|
Cash, cash
equivalents, marketable securities and accounts
receivable
|
|
$
|
181,317
|
|
$
|
185,129
|
Property, plant and
equipment, gross
|
|
$
|
60,428
|
|
$
|
58,438
|
Working
capital
|
|
$
|
128,045
|
|
$
|
148,623
|
Total
assets
|
|
$
|
196,184
|
|
$
|
198,207
|
Long-term debt,
net
|
|
$
|
111,999
|
|
$
|
107,280
|
Total stockholders'
equity (deficit)
|
|
$
|
(14,803)
|
|
$
|
42,653
|
CONTACT:
|
Tricia
Haugeto
|
|
(303)
386-1193
|
|
thaugeto@arraybiopharma.com
|
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SOURCE Array BioPharma Inc.