BOULDER, Colo., Aug. 9, 2017 /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 fourth
quarter and full year of fiscal 2017 and provided an update on the
progress of its key clinical development programs and new
partnerships.
"With the NDAs filed for binimetinib and encorafenib, we look
forward to working with the FDA and EMA as they review our
applications," said Ron Squarer, Chief Executive Officer.
"The robust PFS benefit together with the attractive tolerability
profile demonstrated in COLUMBUS suggest the combination represents
a potentially important addition to the MEK/BRAF treatment
landscape for patients with BRAF-mutant melanoma."
COLUMBUS PHASE 3 TRIAL: NDAs filed with U.S. Food and Drug
Administration (FDA) and MAAs filed with the European Medicines
Agency (EMA) for binimetinib and encorafenib; COLUMBUS Part 2 data
to be presented at 2017 ESMO Congress
On July 5, 2017, Array announced that it submitted
two NDAs to the FDA to support use of the combination of
binimetinib 45 mg twice daily and encorafenib 450 mg once daily
(COMBO450) for the treatment of patients with BRAF-mutant
advanced, unresectable or metastatic melanoma. The submissions are
supported by data from the pivotal Phase 3 COLUMBUS study. In
addition, Array's European partner, Pierre
Fabre, filed the MAAs for binimetininb and encorafenib with
the EMA in July 2017.
Part 1 of the COLUMBUS study showed that patients who received
COMBO450 had a significantly longer progression free survival (PFS)
compared to patients receiving vemurafenib. COMBO450
demonstrated a PFS of 14.9 months compared with 7.3 months observed
with vemurafenib [hazard ratio (HR) 0.54, (95% CI 0.41-0.71,
P<0.001)]. Part 2 of COLUMBUS was designed specifically to
assess the contribution of binimetinib to the combination of
binimetinib and encorafenib by reducing the dose of encorafenib to
300mg in the combination arm to allow for a comparison of equal
doses across arms. In COLUMBUS Part 2, the primary analysis
compared PFS in patients treated with binimetinib 45mg twice daily
plus encorafenib 300mg daily (COMBO300) to patients treated with
encorafenib 300mg daily as a single agent. In May 2017, Array announced top-line results that
showed the mPFS for patients treated with COMBO300 was 12.9 months
compared to 9.2 months for patients treated with single agent
encorafenib, with HR of 0.77 [95% CI 0.61-0.97, p=0.029]. COMBO300
was generally well-tolerated and reported dose intensity and
adverse events (AEs) were consistent with COMBO450 results in
COLUMBUS Part 1.
A presentation of COLUMBUS Part 2 results entitled "Results of
COLUMBUS Part 2: A Phase 3 Trial of Encorafenib (ENCO) Plus
Binimetinib (BINI) Versus ENCO in BRAF-Mutant Melanoma,"
will take place at the 2017 European Society for Medical Oncology
Congress (ESMO 2017) in Madrid,
Spain on September 9 at
2:45 pm Central European Summer Time
(CEST) (8:45 am EDT). The
presentation will include progression free survival, objective
response rate (ORR), dose intensity, safety and
tolerability.
BEACON CRC PHASE 3 TRIAL: Safety lead-in data to be presented
at 2017 ESMO and Array's investor reception on September 9, 2017; Randomized portion of trial
enrolling patients
Array is advancing BEACON CRC, a global
Phase 3 trial of encorafenib and Erbitux® (cetuximab), with or
without binimetinib, versus standard of care in patients with
BRAF-mutant colorectal cancer (CRC) who have previously
received first- or second-line systemic therapy. In May 2017, Array announced that based on an
attractive safety profile and with early encouraging clinical
activity observed in the 30-patient safety lead-in, the randomized
portion of the trial was initiated.
A presentation of data from the safety lead-in entitled "BEACON
CRC: Safety Lead-In (SLI) for the Combination of Binimetinib
(BINI), Encorafenib (ENCO), and Cetuximab (CTX) in Patients (Pts)
with BRAFV600E Metastatic Colorectal Cancer
(mCRC)," will take place at ESMO 2017 on September 9 from 1:15 – 2:15 pm CEST (7:15 – 8:15
am EDT). The presentation will include details on the
safety and tolerability profile of the triplet therapy, encorafenib
+ binimetinib + cetuximab, as well as preliminary measures of
efficacy including ORR and available durability results.
ESMO INVESTOR RECEPTION AND WEBCAST: Array will
host an investor reception during ESMO 2017 where key opinion
leaders in the colorectal cancer field, including Dr. Scott Kopetz, M.D.
Anderson and Dr. Axel
Grothey, Mayo Clinic will give presentations covering the
BRAF-mutant colorectal cancer landscape and data from
Array's BEACON CRC safety lead-in. The presentations will be
webcast, for those who wish to participate remotely. Details
of the webcast will be posted prior to the event on
www.arraybiopharma.com.
Date:
|
Saturday, September
9, 2017
|
Time:
|
4:00-6:00 PM CEST
(10:00 am – 12-noon EDT)
|
Location:
|
Neuvo Boston Hotel,
Madrid, Spain
|
RSVP:
|
https://www.eiseverywhere.com/arrayesmo2017
|
BEACON CRC was initiated based on results from a Phase 2 study
which included the combination of encorafenib and cetuximab in 50
patients with advanced BRAF-mutant CRC, and presented at the
2016 ASCO annual meeting. In this arm, median Overall Survival for
these patients exceeded one year, which is more than double several
separate historical standard of care published benchmarks for this
population. [11-16] The objective response rate (ORR) was 22
percent; historical published benchmarks in this patient population
using standard of care regimens range between 4 percent to 8
percent. [14-17]
Worldwide, colorectal cancer is the third most common type of
cancer in men and the second most common in women, with
approximately 1.4 million new diagnoses in 2012. Of these, nearly
750,000 were diagnosed in men, and 614,000 in women. Globally in
2012, approximately 694,000 deaths were attributed to colorectal
cancer. In the U.S. alone, an estimated 135,430 patients will be
diagnosed with cancer of the colon or rectum in 2017, and
approximately 50,000 are estimated to die of their disease.
[5] In the United States, BRAF mutations are estimated to
occur in 10 to 15 percent of patients with colorectal cancer and
represent a poor prognosis for these patients.[6-9] Based on
Array's historical experience, only a small portion of metastatic
BRAF-mutant CRC patients exhibit high levels of
microsatellite instability-high (MSI-H).
ONO PHARMACEUTICAL COLLABORATION: New license,
development and commercialization partnership for binimetinib and
encorafenib initiated in Japan and
South Korea
Array entered
into a license, development and commercialization partnership with
Ono Pharmaceutical for binimetinib and encorafenib. As a result of
this agreement, Ono received rights to develop and commercialize
binimetinib and encorafenib in Japan and South
Korea.
Under the terms of the agreement, Array received an upfront
payment of $31.2 million (¥3.5
billion) and retains exclusive commercialization rights for
binimetinib and encorafenib in the United
States, Canada and
Israel. Array is entitled to receive up to an additional
$156 million (¥17.3 billion) if
certain development and commercial milestones are achieved. A
portion of these milestones is related to the Phase 3 BEACON CRC
trial. In addition, Array will be eligible for robust,
tiered, double-digit royalties based on product sales in
Japan and South Korea. Ono
obtained the right to conduct clinical trials of binimetinib and
encorafenib in Japan and
South Korea, as well as
participate in all future global development of binimetinib and
encorafenib by contributing 12% of those future costs.
NEW CLINICAL COLLABORATIONS WITH MERCK AND BRISTOL-MYERS SQUIBB ANNOUNCED IN MSS
CRC: Clinical trials with binimetinib and anti-PD-1 therapy
expected to begin in the second half of 2017
Array entered
into clinical research collaborations with Merck and Bristol-Myers
Squibb to study binimetinib plus anti-PD-1 therapy in patients with
microsatellite stable metastatic CRC (MSS CRC). The trial
with Merck will investigate the safety, tolerability and efficacy
of binimetinib with Merck's KEYTRUDA® (pembrolizumab).
The trial with Bristol-Myers Squibb will investigate the safety,
tolerability and efficacy of binimetinib in combination with
Bristol-Myers Squibb's Opdivo® (nivolumab) and Opdivo +
Yervoy® (ipilimumab) regimen. Array entered into these
collaborations based on the growing body of preclinical and
clinical evidence that the immune activity of an anti-PD-1 therapy
can be enhanced when combined with a MEK inhibitor, such as
binimetinib.
The Phase 1/2 studies are expected to establish recommended dose
regimens and explore the preliminary anti-tumor activity of the
combinations. Results from these studies, which are
anticipated to begin in the second half of 2017, will be used to
determine optimal approaches to further clinical development of
these combinations. Under the Merck agreement, Merck will act as
the sponsor of this clinical trial, and Array will supply Merck
with binimetinib for use in the trial. Under the
Bristol-Myers Squibb agreement, Array and Bristol-Myers Squibb will
jointly support the study with Array acting as the sponsor. The
majority of colorectal cancers exhibit microsatellite stability
(MSS). [10]
OTHER CLINICAL UPDATES: ARRY-382 and ARRY-797
programs
Array is advancing a Phase 1/2 dose escalation
immuno-oncology trial of ARRY-382 in combination with pembrolizumab
(Keytruda®), a PD-1 antibody, in patients with advanced solid
tumors, including melanoma and non-small cell lung cancer. ARRY-382
is a wholly-owned, highly selective and potent, small molecule
inhibitor of CSF-1R kinase activity.
Array plans to initiate a Phase 3 trial of ARRY-797, an oral,
selective p38 MAPK inhibitor, in patients with LMNA A/C-related
dilated cardiomyopathy later this year as it evaluates options
regarding the asset, including advancing it internally, partnering
the program for further development and commercialization or
creating a separate company. LMNA A/C-related dilated
cardiomyopathy is a rare, degenerative cardiovascular disease
caused by mutations in the LMNA gene and characterized by poor
prognosis.
OTHER BUSINESS DEVELOPMENT UPDATES
Selumetinib /
MEK inhibitor (partnered with AstraZeneca)
In 2003,
AstraZeneca acquired exclusive worldwide rights to selumetinib for
oncology indications from Array. Under its agreement with
AstraZeneca, Array has earned $26.5
million in up-front and milestone payments to date and has
the potential to earn additional selumetinib milestone payments of
approximately $30 million as well as
royalties on product sales. On July 28,
2017, AstraZeneca and Merck announced an agreement to share
the development and commercialization costs for selumetinib
monotherapy and non-PD-L1/PD-1 combination therapy opportunities.
Merck will fund all development and commercialization costs of
Keytruda in combination with selumetinib. AstraZeneca will fund all
development and commercialization costs of Imfinzi in combination
with selumetinib. Under their agreement, gross profits from
selumetinib product sales generated through monotherapy or
combination therapies will be shared equally. AstraZeneca will book
all product sales of selumetinib and gross profits due to Merck
under the collaboration will be recorded by AstraZeneca under cost
of sales. Based on this, Array remains eligible to receive
from AstraZeneca milestones and royalties on all future selumetinib
sales, and now expects to receive a portion of certain
consideration paid by Merck to AstraZeneca. Array has
informed AstraZeneca that it is disputing the small consideration
that AstraZeneca intends to pay Array related to both upfront and
potential future milestones under AstraZeneca's agreement with
Merck. Furthermore, prior to the announcement of the
AstraZeneca / Merck agreement, Array informed AstraZeneca of its
position that the Neurofibromatosis type 1 (NF1) development
program is outside the permitted field of its license.
NEW PRECLINICAL LICENSE AND COLLABORATION AGREEMENT WITH
AMGEN IN INFLAMMATION: Array to Advance Program for
Autoimmune Disorders; Amgen Responsible for Clinical Development
and Worldwide Commercialization
Array initiated a
collaboration agreement with Amgen for the discovery and
development of novel drugs for autoimmune disorders. The
undisclosed target and lead inhibitors were discovered using
Array's proprietary Kinase-Directed Phenotypic Screening Platform
that leverages Array's deep expertise in chemistry and early lead
development. Under the terms of the agreement, Amgen and
Array will collaborate on preclinical development with Array
leading the medicinal chemistry work. Amgen is responsible for
clinical development and commercialization. In exchange for
exclusive rights to Array's preclinical program, Amgen will make
upfront and milestone payments, as well as pay royalties on sales
of resulting therapies.
FINANCIAL HIGHLIGHTS
Novartis continues to
substantially fund all ongoing trials with binimetinib and
encorafenib that were active or planned as of the close of the
Novartis Agreements in 2015, including the COLUMBUS Phase 3 trial.
Reimbursement revenue from Novartis was approximately $107 million for the previous 12 months, of which
$22 million was recorded in the
quarter ending June 30, 2017.
Fourth Quarter of Fiscal 2017 Compared to Third Quarter of
Fiscal 2017 (Sequential Quarters Comparison)
- Revenue for the fourth quarter of fiscal 2017 was
$33.8 million, compared to
$33.3 million for the prior quarter.
Array achieved a $3 million milestone
from Roche for advancement of ipatasertib, an AKT inhibitor, into a
Phase 3 trial and a $1 million
milestone from Loxo Oncology for advancement of LOXO-292, a RET
inhibitor, into a Phase 1 trial.
- Cost of partnered programs for the fourth quarter of
fiscal 2017 was $10.1 million,
compared to $7.4 million for the
prior quarter. The increase was primarily due to higher costs
incurred for the BEACON CRC trial as it continues to advance.
- Research and development expense was $39.1 million, compared to $46.1 million in the prior quarter. The decrease
was primarily due to reduced expenses associated with the Novartis
transitioned studies.
- Loss from Operations for the quarter was $26.3 million, which includes $3 million of stock-based compensation and
$0.6 million of depreciation
expense. This compares to a loss from operations of
$31.9 million in the previous
quarter, which included $2.9 million
of stock-based compensation and $0.5
million of depreciation expense.
- Net loss for the fourth quarter was $29.6 million, or ($0.17) per share, compared to $35.3 million, or ($0.21) per share, in the prior quarter.
The decrease in net loss was primarily due to lower research and
development expenses.
- Cash, Cash Equivalents and Marketable Securities as of
June 30, 2017 were $235.1 million.
Fourth Quarter of Fiscal 2017 Compared to Fourth Quarter
of Fiscal 2016 (Prior Year Comparison)
- Revenue for the fourth quarter of fiscal 2017 decreased
$9.4 million compared to the same
quarter of fiscal 2016. The decrease was primarily due to decreased
reimbursement revenue for the Novartis transitioned studies.
- Cost of partnered programs increased $4.6 million compared to the fourth quarter of
fiscal 2016. The increase was primarily due to higher costs
incurred for the BEACON CRC trial.
- Research and development expense decreased $10.4 million, compared to the fourth quarter of
fiscal 2016. The decrease was due to expenses associated with the
Novartis transitioned studies.
- Net loss for the fourth quarter of fiscal 2017 was
$29.6 million, or ($0.17) per share, compared to $25.0 million, or ($0.17) per share, for the same quarter in fiscal
2016.
Full Year of Fiscal 2017 Compared to Full Year of Fiscal
2016 (Prior Year Comparison)
- Revenue was $150.9 million
for the fiscal year ended June 30,
2017, compared to $137.9
million in fiscal 2016. This increase was primarily
driven by higher milestone revenue earned in 2017 from Loxo, Roche
and Genetech.
- Net loss for the fiscal year ended June 30, 2017, was $116.8
million, or ($0.72) per share,
compared to a net loss of $92.8
million, or ($0.65) per share,
in fiscal 2016. The increased loss was due to the higher
spend on proprietary programs partially offset by higher milestone
revenue.
- Net cash used in operating activities for the fiscal
year ended June 30, 2017 was
$39 million, compared to $70 million in fiscal 2016. The lower cash
used in 2017 was driven by receipt of a $31.2M upfront from our partner Ono.
CONFERENCE CALL INFORMATION
Array will hold a
conference call on Wednesday, August 9,
2017 at 9:00 a.m. Eastern Time
to discuss these results and provide an update on the progress of
its key clinical development programs. Ron Squarer, Chief Executive
Officer, will lead the call.
Date:
|
Wednesday, August 9,
2017
|
Time:
|
9:00 a.m. Eastern
Time
|
Toll-Free:
|
(844)
464-3927
|
Toll:
|
(765)
507-2598
|
Pass
Code:
|
44703107
|
Webcast, including Replay and Conference Call Slides:
http://edge.media-server.com/m/p/af6yqtav
COLUMBUS Results
As presented at the 2016 Society for Melanoma Research Annual
Congress, results from Part 1 of the COLUMBUS study showed that
COMBO450 significantly extend PFS in patients with advanced
BRAF-mutant melanoma, with a PFS of 14.9 months compared
with 7.3 months observed with vemurafenib [hazard ratio (HR) 0.54,
(95% CI 0.41-0.71, P<0.001)]. As part of the trial design, the
primary analysis was based on a Blinded Independent Central Review
(BICR) of patient scans, while results by local review at the
investigative site were also analyzed. The table below outlines the
median PFS (mPFS) results, as determined by both assessments, for
COMBO450 versus vemurafenib, COMBO450 versus encorafenib, and
encorafenib versus vemurafenib:
|
|
mPFS
BICR
|
|
mPFS Local
Review
|
COMBO450 vs.
Vemurafenib
|
|
COMBO450
|
Vemurafenib
|
|
COMBO450
|
Vemurafenib
|
|
14.9
months
|
7.3 months
|
|
14.8
months
|
7.3 months
|
|
HR (95% CI): 0.54
(0.41-0.71); P<0.001
|
|
HR (95% CI): 0.49
(0.37-0.64); P<0.001
|
|
COMBO450 vs.
Encorafenib
|
|
COMBO450
|
Encorafenib
|
|
COMBO450
|
Encorafenib
|
|
14.9
months
|
9.6 months
|
|
14.8
months
|
9.2 months
|
|
HR (95% CI): 0.75
(0.56-1.00); P=0.051
|
|
HR (95% CI): 0.68
(0.52-0.90); P=0.006
|
|
Encorafenib vs.
Vemurafenib
|
|
Encorafenib
|
Vemurafenib
|
|
Encorafenib
|
Vemurafenib
|
|
9.6 months
|
7.3 months
|
|
9.2 months
|
7.3 months
|
|
HR (95% CI): 0.68
(0.52-0.90); P=0.007
|
|
HR (95% CI): 0.70
(0.54-0.91); P=0.008
|
In this study, COMBO450 was generally well-tolerated, with a
median duration of treatment of 51 weeks and median relative dose
intensity for encorafenib and binimetinib of 100% and 99.6%,
respectively. Grade 3/4 adverse events (AEs) that occurred in more
than 5% of patients receiving COMBO450 were increased
gamma-glutamyltransferase (GGT) (9%), increased blood creatine
phosphokinase (CK) (7%) and hypertension (6%). The incidence of
selected any grade of AEs of special interest, defined based on
toxicities commonly associated with commercially available
MEK+BRAF-inhibitor treatments for patients receiving COMBO450
included: rash (23%), pyrexia (18%), retinal pigment epithelial
detachment (13%) and photosensitivity (5%). Full safety
results of COLUMBUS Part 1 were presented at the 2016 Society for
Melanoma Research Annual Congress.
COLUMBUS Part 2 was designed specifically to assess the
contribution of binimetinib to the combination of binimetinib and
encorafenib by reducing the dose of encorafenib to 300mg in the
combination arm to allow for a comparison of equal doses across
arms. In COLUMBUS Part 2, the primary analysis compared PFS in
patients treated with binimetinib 45mg twice daily plus encorafenib
300mg daily (COMBO300) to patients treated with encorafenib 300mg
daily as a single agent. Top-line results showed the mPFS for
patients treated with COMBO300 was 12.9 months compared to 9.2
months for patients treated with single agent encorafenib, with HR
of 0.77 [95% CI 0.61-0.97, p=0.029]. COMBO300 was generally
well-tolerated and reported dose intensity and AEs were consistent
with COMBO450 results in COLUMBUS Part 1. Further results from
COLUMBUS Part 2 will be presented at ESMO 2017.
Binimetinib and encorafenib are investigational medicines and
are not currently approved in any country.
Metastatic melanoma is the most serious and life-threatening
type of skin cancer and is associated with low survival rates[1-2].
There are about 200,000 new cases of melanoma diagnosed worldwide
each year, approximately half of which have BRAF mutations, a key
target in the treatment of metastatic melanoma[1, 3, 4].
About the Phase 3 COLUMBUS Study
The COLUMBUS trial,
(NCT01909453), is a two-part, international, randomized, open label
Phase 3 study evaluating the efficacy and safety of the combination
of binimetinib plus encorafenib to vemurafenib and encorafenib
monotherapy in 921 patients with locally advanced, unresectable or
metastatic melanoma with BRAF V600 mutation. Prior
immunotherapy treatment was allowed. Over 200 sites across
North America, Europe, South
America, Africa,
Asia and Australia participated in the study. Patients
were randomized into two parts:
- In Part 1, 577 patients were randomized 1:1:1 to receive 45mg
binimetinib plus 450mg encorafenib (COMBO450), 300mg encorafenib
alone, or 960mg vemurafenib alone. The dose of encorafenib in the
combination arm is 50% higher than the single agent maximum
tolerated dose of 300mg. A higher dose of encorafenib was
possible due to improved tolerability when combined with
binimetinib. The primary endpoint for the COLUMBUS trial was
a PFS comparison of COMBO450 versus vemurafenib. PFS is determined
based on tumor assessment (RECIST version 1.1 criteria) by a
Blinded Independent Central Review (BICR). Secondary endpoints
include a comparison of the PFS of encorafenib monotherapy to that
of COMBO450 and a comparison of overall survival (OS) for COMBO450
to that of vemurafenib alone.
- In Part 2, 344 patients were randomized 3:1 to receive 45mg
binimetinib plus 300mg encorafenib or 300mg encorafenib alone. Part
2 is designed to provide additional data to help evaluate the
contribution of binimetinib to the combination of binimetinib and
encorafenib. As the comparison of COMBO450 to encorafenib in Part 1
did not achieve statistical significance, analyses of other
endpoints including the statistical analysis conducted in Part 2 is
descriptive.
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. Eight registration studies
are currently advancing related to seven Array-owned or partnered
drugs: binimetinib (MEK162), encorafenib (LGX818), selumetinib
(partnered with AstraZeneca), danoprevir (partnered with Roche),
ipatasertib (partnered with Genentech), larotrectinib (partnered
with Loxo Oncology) and tucatinib (partnered with Cascadian
Therapeutics).
References
[1] Melanoma Skin Cancer. American Cancer
Society. Available at:
https://www.cancer.org/cancer/melanoma-skin-cancer.html (link is
external). Accessed June 2017.[2] A Snapshot of Melanoma. National
Cancer Institute. Available at:
https://seer.cancer.gov/statfacts/html/melan.html (link is
external). Accessed June 2017.
[3] Globocan 2012: Estimated Cancer Incidence, Mortality and
Prevalence Worldwide in 2012.
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx (link is
external). Accessed June 2017.
[4] Klein O, et al. (2013) BRAF inhibitor activity in V600R
metastatic melanoma. Eur J Cancer. 49(5):1073-1079.
[5] Cancer Facts & Figures 2017. American Cancer Society.
Available at:
https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2017.html
(link is external). Accessed July
2017.
[6] Saridaki Z, et al. (2013) BRAFV600E Mutation Analysis in
Patients with Metastatic Colorectal Cancer (mCRC) in Daily Clinical
Practice: Correlations with Clinical Characteristics, and Its
Impact on Patients' Outcome. PLoS ONE 8(12): e84604.
doi:10.1371/journal.pone.0084604
[7] Sorbye H, et al. (2015) High BRAF Mutation Frequency and Marked
Survival Differences in Subgroups According to KRAS/BRAF Mutation
Status and Tumor Tissue Availability in a Prospective
Population-Based Metastatic Colorectal Cancer Cohort. PLoS ONE
10(6): e0131046. doi:10.1371/journal.pone.0131046
[8] Loupakis F, et al. (2009) KRAS codon 61, 146 and BRAF mutations
predict resistance to cetuximab plus irinotecan in KRAS codon 12
and 13 wild-type metastatic colorectal cancer. British Journal of
Cancer 101(4), 715 – 721
[9] Vecchione, et al. (2016) A Vulnerability of a Subset of Colon
Cancers with Potential Clinical Utility. Cell 165, 317–330
[10] Boland, C. Richard, et al. (2010) Microsatellite Instability
in Colorectal Cancer. Gastroenterology, 138(6): 2073–2087.e3.
doi:10.1053/j.gastro.2009.12.064
[11] Ulivi et al., J Transl Med. 2012
[12] Saridaki et al., PLoS One. 2013
[13] Loupakis et
al., Br J Cancer. 2009
[14] De Roock et al., Lancet
Oncol, 2010
[15] Peeters et al., ASCO 2014
[16] Kopetz et al., ASCO 2017
[17] Seymour et al., Lancet Oncol, 2013 (supplementary
appendix)
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 for binimetinib/encorafenib, 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,
our future capital requirements 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 relating to the regulatory approval process for our
drug candidates, which may not result in approval for our drug
candidates, cause delays in development or require that we expend
more resources to obtain approval than expected; 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 August 9, 2017. 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.
-more-
Array BioPharma
Inc.
|
Condensed
Statements of Operations
|
(Unaudited)
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Twelve Months
Ended
|
|
|
|
|
|
|
June
30,
|
|
June
30,
|
|
|
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
Reimbursement revenue
- Novartis
|
|
|
$
21,843
|
|
$
33,418
|
|
$ 107,197
|
|
$107,330
|
|
Collaboration
revenue
|
|
|
5,962
|
|
7,873
|
|
23,811
|
|
26,673
|
|
License and milestone
revenue
|
|
|
5,973
|
|
1,914
|
|
19,844
|
|
3,876
|
|
|
Total
revenue
|
|
|
33,778
|
|
43,205
|
|
150,852
|
|
137,879
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
Cost of partnered
programs
|
|
|
10,092
|
|
5,444
|
|
35,395
|
|
23,166
|
|
Research and
development for proprietary programs
|
|
|
39,098
|
|
49,504
|
|
178,199
|
|
160,655
|
|
General and
administrative
|
|
|
10,926
|
|
10,565
|
|
39,336
|
|
36,267
|
|
|
Total operating
expenses
|
|
|
60,116
|
|
65,513
|
|
252,930
|
|
220,088
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(26,338)
|
|
(22,308)
|
|
(102,078)
|
|
(82,209)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
|
|
Impairment loss
related to cost method investment
|
|
|
—
|
|
—
|
|
(1,500)
|
|
—
|
|
Realized gain on
investments and other
|
|
|
112
|
|
|
|
897
|
|
—
|
|
Change in fair value
of notes payable
|
|
|
(500)
|
|
|
|
(2,600)
|
|
—
|
|
Interest
income
|
|
|
286
|
|
76
|
|
796
|
|
243
|
|
Interest
expense
|
|
|
(3,152)
|
|
(2,782)
|
|
(12,333)
|
|
(10,874)
|
|
|
Total other expense,
net
|
|
|
(3,254)
|
|
(2,706)
|
|
(14,740)
|
|
(10,631)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
$
(29,592)
|
|
$
(25,014)
|
|
$(116,818)
|
|
$ (92,840)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
- basic
|
|
|
$
(0.17)
|
|
$
(0.17)
|
|
$
(0.72)
|
|
$
(0.65)
|
Net loss per share
- diluted
|
|
|
$
(0.17)
|
|
$
(0.17)
|
|
$
(0.72)
|
|
$
(0.65)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
|
170,779
|
|
143,475
|
|
163,207
|
|
142,964
|
Weighted average
shares outstanding - diluted
|
|
|
170,779
|
|
143,475
|
|
163,207
|
|
142,964
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary Balance
Sheet Data
|
|
|
|
|
(Unaudited)
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
June 30,
2017
|
|
June 30,
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
|
$
235,055
|
|
$
110,538
|
|
|
|
|
|
|
|
Working
capital
|
|
|
$
188,026
|
|
$
102,867
|
|
|
|
|
|
|
|
Total
assets
|
|
|
$
279,145
|
|
$
168,900
|
|
|
|
|
|
|
|
Long-term debt,
net
|
|
|
$
121,305
|
|
$
113,655
|
|
|
|
|
|
|
|
Total stockholders'
equity (deficit)
|
|
|
$
11,727
|
|
$
(37,932)
|
|
|
|
|
CONTACT:
|
Tricia
Haugeto
|
|
(303)
386-1193
|
|
thaugeto@arraybiopharma.com
|
View original content with
multimedia:http://www.prnewswire.com/news-releases/array-biopharma-reports-financial-results-for-the-fourth-quarter-and-full-year-of-fiscal-2017-300501735.html
SOURCE Array BioPharma