BOULDER, Colo., Feb. 2, 2016 /PRNewswire/ -- Array BioPharma
Inc. (NASDAQ: ARRY) today reported results for the second quarter
ending December 31, 2015 of its
fiscal year and provided an update on the progress of its key
clinical development programs.
Ron Squarer, Chief Executive Officer of Array, noted, "We
were excited this quarter to share positive results from the first
global Phase 3 trial of binimetinib in patients in NRAS-mutant
melanoma. We plan to submit these results to regulators
during 2016. In addition, we continue to make important
progress with binimetinib and encorafenib in several other clinical
trials, and expect to announce top-line results from COLUMBUS in
BRAF-mutant melanoma in 2016."
KEY PIPELINE UPDATES
Binimetinib (MEK162) and
encorafenib (LGX818)
- NEMO meets primary endpoint; regulatory filing expected in
1H 2016
- COLUMBUS top-line results expected in 1H 2016; regulatory
filing expected in 2H 2016
- New Phase 3 global registration trial in BRAF-mutant
colorectal cancer expected to start in 2016
Update on Phase 3 trials
In December 2015, Array reported top-line results
from the ongoing Phase 3 NEMO clinical trial of binimetinib in
patients with advanced NRAS-mutant melanoma. The study met
its primary endpoint of improving progression-free survival (PFS)
compared with dacarbazine treatment, with a hazard ratio of 0.62,
[95% CI 0.47-0.80] and a p-value of less than 0.001. The median PFS
on the binimetinib arm was 2.8 months versus 1.5 months on the
dacarbazine arm. In the trial, binimetinib was generally
well-tolerated and the adverse events reported were consistent with
previous results in NRAS melanoma patients.
Array plans to submit binimetinib to regulatory authorities for
marketing approval in NRAS-mutant melanoma during the first half of
2016. Results from the NEMO trial including progression free
survival, overall survival, objective response rate, safety and
prespecified subgroup analyses including outcomes in patients who
received prior treatment with immunotherapy will be presented at a
medical conference in 2016.
In addition, Array expects top-line results from Part 1 of the
COLUMBUS trial in the first half of 2016 and projects a regulatory
filing of binimetinib and encorafenib in 2016. In
October 2015, Part 2 of COLUMBUS
achieved its target patient enrollment. The MILO Phase 3
study in patients with low-grade serous ovarian cancer continues to
enroll patients, and Array estimates enrollment to be complete in
2016 with the availability of top-line data, along with a projected
regulatory filing, in 2017.
Based on the strength of the Phase 2 combination data with
encorafenib in patients with BRAF-mutant colorectal cancer shared
at the 2015 European Society of Medical Oncology's (ESMO) World
Congress of Gastrointestinal Cancer, Array plans to initiate a
Phase 3 global registration trial in that patient population in
2016.
Collaboration with Pierre
Fabre
In November 2015,
Array and Pierre Fabre announced a
collaboration agreement for binimetinib and encorafenib. Under the
terms of the agreement, Array received an upfront payment of
$30 million in January 2016 and retains exclusive
commercialization rights for binimetinib and encorafenib in key
territories, including the United
States and Japan. Pierre
Fabre will have exclusive rights to commercialize both
products in other territories, including Europe, Asia
and Latin America. Array is
entitled to receive up to $425
million if certain development and commercialization
milestones are achieved, and is eligible for robust, tiered
double-digit royalties. Array and Pierre
Fabre have agreed to split future development costs on a
60:40 basis (Array:Pierre Fabre) with initial funding committed for
new clinical trials in colorectal cancer and melanoma. The
agreement was reviewed and approved by the European Commission on
Competition in December 2015. All currently active
binimetinib and encorafenib clinical trials remain substantially
funded through completion by Novartis.
Pierre Fabre Oncology, a business unit of the global
10,000-employee Pierre Fabre
company, is supported by over 1,000 employees with a strong focus
on European markets. In 2014, worldwide annual sales of
Pierre Fabre Oncology products surpassed $200 million on the strength of the Oral
Navelbine, Javlor and Busilvex brands. In addition, Pierre Fabre has a significant commitment and
track record in pharmaceutical R&D, developing products for
patients afflicted with lung, breast and other solid tumors and
hematological cancers.
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. 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 6-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, 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.
Enrollment in this trial is complete. Data for patients followed
through 48 weeks supports the durability of effect. Taken
together, the data to date suggest a path forward for this program.
Results with additional patient follow-up will be presented at an
appropriate medical conference in 2016.
Selumetinib (partnered with AstraZeneca) – Three 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, a
registration trial in patients with neurofibromatosis type 1 and
ASTRA in patients with differentiated thyroid cancer.
AstraZeneca expects to share top-line results from SELECT-1 in
mid-2016.
FINANCIAL HIGHLIGHTS
Cash, cash equivalents,
marketable securities and accounts receivable totaled
$185.4 million at the end of the
quarter. Accounts receivable primarily consist of receivables
expected to be paid by Novartis within three months and the
$30.0 million license fee from
Pierre Fabre, which was received in
January 2016. In March 2015,
binimetinib and encorafenib became wholly-owned assets, 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 and,
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."
Second Quarter of Fiscal 2016 Compared to First Quarter of
Fiscal 2016 (Sequential Quarters Comparison)
Revenue
for the second quarter of fiscal 2016 was $35.4 million, compared to $16.2 million for the prior sequential
quarter. The $19.2 million
increase in revenue was primarily due to higher reimbursement
revenue from Novartis. Cost of partnered programs for
the second quarter of fiscal 2016 was $5.7
million, compared to $6.2
million for the prior quarter. Research and
development expense was $41.4
million, compared to $21.0
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 second quarter was $24.2 million, or ($0.17) per share, and was $21.0 million, or ($0.15) per share in the prior quarter.
Second Quarter of Fiscal 2016 Compared to Second Quarter of
Fiscal 2015 (Prior Year Comparison)
Compared to the same
quarter of fiscal 2015, revenue for the second quarter of
fiscal 2016 increased $8.5 million
primarily due to $27.3 million in
reimbursement revenue from Novartis. Cost of partnered
programs decreased $7.4 million
compared to the second 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 $29.5 million
compared to the second quarter of fiscal 2015 due to the
categorization of binimetinib costs, as well as new spending on
encorafenib. Net loss for the second quarter of fiscal
2016 was $24.2 million, or
($0.17) per share, and was
$8.6 million, or ($0.06) per share, for the same quarter in fiscal
2015.
Six Months of Fiscal 2016 Compared to Six Months of Fiscal
2015 (Prior Year Comparison)
For the six months ended
December 31, 2015, revenue was
$51.6 million, compared to
$33.0 million for the same period in
fiscal 2015. Net loss for the six months ended December 31, 2015, was $45.2 million, or ($0.32) per share, compared to a net loss of
$36.2 million, or ($0.27) per share, in the comparable prior year
period.
CONFERENCE CALL INFORMATION
Array will hold a
conference call on Tuesday, February 2,
2016 at 9:00 a.m. Eastern Time
to discuss these results. Ron Squarer, Chief Executive
Officer, will lead the call.
Date:
|
Tuesday, February 2,
2016
|
Time:
|
9:00 a.m. Eastern
Time
|
Toll-Free:
|
(844)
464-3927
|
Toll:
|
(765)
507-2598
|
Pass
Code:
|
30840239
|
Webcast, including
Replay and Conference Call
Slides: http://edge.media-server.com/m/p/bedxufnc
|
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. Six 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 February 2, 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.
CONTACT:
|
Tricia
Haugeto
|
|
(303)
386-1193
|
|
thaugeto@arraybiopharma.com
|
|
|
|
|
|
|
|
|
Condensed
Statements of Operations
|
(Unaudited)
|
(in thousands,
except per share amount)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Six Months Ended
December 31,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Revenue
|
|
|
|
|
|
|
|
Reimbursement
revenue
|
$ 27,348
|
|
$
-
|
|
$ 36,971
|
|
$
-
|
License and
milestone revenue
|
1,105
|
|
20,099
|
|
1,105
|
|
20,268
|
Collaboration
and other revenue
|
6,977
|
|
6,820
|
|
13,551
|
|
12,720
|
Total
revenue
|
35,430
|
|
26,919
|
|
51,627
|
|
32,988
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
Cost of
partnered programs
|
5,663
|
|
13,098
|
|
11,875
|
|
25,275
|
Research and
development for proprietary drug discovery
|
41,351
|
|
11,817
|
|
62,349
|
|
24,007
|
General and
administrative
|
9,938
|
|
8,078
|
|
17,296
|
|
14,877
|
Total operating
expenses
|
56,952
|
|
32,993
|
|
91,520
|
|
64,159
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(21,522)
|
|
(6,074)
|
|
(39,893)
|
|
(31,171)
|
|
|
|
|
|
|
|
|
Other income
(expenses)
|
|
|
|
|
|
|
|
Interest
income
|
51
|
|
8
|
|
91
|
|
21
|
Interest
expense
|
(2,693)
|
|
(2,545)
|
|
(5,349)
|
|
(5,054)
|
Total other
income (expense)
|
(2,642)
|
|
(2,537)
|
|
(5,258)
|
|
(5,033)
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
$ (24,164)
|
|
$ (8,611)
|
|
$ (45,151)
|
|
$ (36,204)
|
|
|
|
|
|
|
|
|
Net earnings (loss)
per share, basic and diluted
|
$ (0.17)
|
|
$ (0.06)
|
|
$ (0.32)
|
|
$ (0.27)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding, basic and diluted
|
142,833
|
|
133,815
|
|
142,524
|
|
132,820
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary Balance
Sheet Data
|
(in
thousands)
|
|
December
31
|
June
30
|
|
2015
|
|
2015
|
|
(unaudited)
|
|
|
|
|
|
|
Cash and cash
equivalents, marketable securities and accounts
receivable
|
$ 185,371
|
|
$ 185,129
|
Property and
equipment, gross
|
$ 59,216
|
|
$ 58,438
|
Working
capital
|
$ 138,862
|
|
$ 148,623
|
Total
assets
|
$ 199,918
|
|
$ 198,207
|
Long-term debt,
net
|
$ 110,386
|
|
$ 107,280
|
Total
stockholders' equity
|
$ 5,874
|
|
$ 42,653
|
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SOURCE Array BioPharma Inc.