SAN DIEGO, Nov. 3, 2016 /PRNewswire/ -- Mirati
Therapeutics, Inc. (NASDAQ: MRTX) ("the Company" or "Mirati") today
reported financial results for the third quarter ended September 30, 2016 and provided an update on its
product development programs.
"We are pleased by the continued progress in all three of our
clinical development programs during the third quarter and are
encouraged by enrollment rates, particularly in our Phase 2 trial
for glesatinib," said Charles M.
Baum, M.D., Ph.D., President and CEO of Mirati. "We
are focused on establishing the response rate in these patients,
and will provide an efficacy update as we collect data on a
meaningful number of patients."
Current
Programs
Glesatinib (MGCD265)
Patient enrollment continues in
the glesatinib Phase 2 clinical trial in non-small cell lung cancer
(NSCLC) patients with MET genetic
alterations. Enrollment rates in the trial continue to
increase, due in part to the Company's diagnostic partnerships,
which have enabled accelerated patient identification and
enrollment. Patients in the Phase 2 clinical trial are
demonstrating improved tolerability. An interim update will be
provided once data is collected on at least 15 patients.
Sitravatinib (MGCD516)
The Phase 1b clinical trial of
sitravatinib continues to enroll patients with RET, CHR4q12 and CBL
genetic alterations in NSCLC and other solid tumors. Patient
enrollment is on track, and updates will be provided on the status
of this clinical trial as we receive more data.
We are also initiating a Phase 2 clinical trial to assess the
potential for glesatinib or sitravatinib, each in combination with
Nivolumab, to enhance the clinical efficacy of Nivolumab in
patients with NSCLC.
Mocetinostat (MGCD103)
The Phase 2 clinical trial for
mocetinostat in combination with durvalumab, MedImmune's
investigational anti-PD-L1 immune checkpoint inhibitor, is
progressing as planned. The clinical trial is exploring the
potential of mocetinostat to enhance the effectiveness of
checkpoint inhibitors in NSCLC and other solid tumors.
Third Quarter and Nine Month 2016 Financial Results
Cash, cash equivalents, and short-term investments were
$73.0 million on September 30,
2016, as compared to $122.3 million
on December 31, 2015.
Research and development expenses for the third quarter of 2016
were $16.1 million, compared to
$14.6 million for the same period in
2015. Research and development expenses for the nine months ended
September 30, 2016 were $52.5
million, compared to $34.0
million for the same period in 2015. The increase in
research and development expenses for both the three and nine
months ended September 30, 2016 compared to the same periods
of 2015 relates to an increase in expenses associated with ongoing
clinical trials for both glesatinib and sitravatinib, as well as an
increase in other research and development expenses, which reflects
higher compensation expense due to an increase in research and
development employees during the three and nine months ended
September 30, 2016. A one-time license fee of
$2.5 million related to an early
stage discovery project also contributed to the increase in
expenses for the nine months ended September
30, 2016 compared to the same period in 2015.
General and administrative expenses for the third quarter of
2016 were $3.5 million, compared to
$4.2 million for the same period in
2015. General and administrative expenses for the nine months ended
September 30, 2016 were $11.4
million, compared to $12.2
million for the same period in 2015. The decrease in general
and administrative expenses for the three and nine months ended
September 30, 2016 compared to the
same periods of 2015 is largely the result of a decrease in
non-cash stock-based compensation expense.
Net loss for the third quarter of 2016 was $19.4 million, or $0.97 per share basic and diluted, compared to
net loss of $18.7 million, or
$1.11 per share basic and diluted for
the same period in 2015. Net loss for the nine months ended
September 30, 2016 was $63.4
million, or $3.21 per share
basic and diluted, compared to net loss of $46.1 million, or $2.86 per share basic and diluted for the same
period in 2015.
About Mirati Therapeutics
Mirati Therapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on developing a pipeline of targeted oncology
products intended to treat specific genetic and epigenetic drivers
of cancer in selected subsets of cancer patients with unmet
needs. In addition, our product candidates will be evaluated
in combination with checkpoint inhibitors (anti-PD-1 and PD-L1) to
determine whether they will enhance the efficacy of those agents in
patients with non-small cell lung cancer ("NSCLC") and other solid
tumors. Our clinical pipeline consists of three product
candidates: glesatinib, sitravatinib and mocetinostat. Both
glesatinib and sitravatinib are orally bio-available,
spectrum-selective kinase inhibitors with distinct target profiles
that are in development for the treatment of patients with NSCLC
and other solid tumors. Glesatinib is in Phase 2 clinical
development, and targets the MET and Axl receptor tyrosine kinase
families. Sitravatinib is in Phase 1b clinical development
and targets genetic alterations in RET rearrangements, CHR4q12
amplifications, and CBL mutations. Our third product candidate is
mocetinostat, an orally bio-available, Class 1 selective histone
deacetylase ("HDAC") inhibitor. Mocetinostat is in Phase 2
clinical development in combination with durvalumab, MedImmune's
anti-PD-L1 immune checkpoint inhibitor, for the treatment of
patients with NSCLC. More information about these programs is
available at www.mirati.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this press release regarding the business
of the Company that are not historical facts may be considered
"forward-looking statements," including, but not limited to,
statements regarding Mirati's development plans and timelines,
potential regulatory actions, expected use of cash resources, the
timing and results of clinical trials, and the potential benefits
of and markets for Mirati's product candidates.
Forward-looking statements are typically, but not always,
identified by the use of words such as "may," "would," "believe,"
"intend," "plan," "anticipate," "estimate," "expect," and other
similar terminology. Forward-looking statements are based on
current expectations of management and upon what management
believes to be reasonable assumptions based on information
currently available to it, and are subject to risks and
uncertainties. Such risks and uncertainties may cause actual
results to differ materially from the expectations set forth in the
forward-looking statements. Such risks and uncertainties
include, but are not limited to, potential delays in development
timelines or negative clinical trial results, reliance on third
parties for development efforts, changes in the competitive
landscape, changes in the standard of care, as well as other risks
detailed in Mirati's recent filings on Forms 10-K and 10-Q with the
United States Securities and Exchange Commission. Mirati undertakes
no obligation to update any forward-looking statements to reflect
new information, events or circumstances, or to reflect the
occurrence of unanticipated events.
Mirati
Therapeutics, Inc.
|
Consolidated
Balance Sheets
|
(in
thousands)
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2016
|
|
2015
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
|
$
72,982
|
|
$
122,327
|
Other current
assets
|
|
2,504
|
|
3,075
|
Total current
assets
|
|
75,486
|
|
125,402
|
|
|
|
|
|
Property and
equipment, net
|
|
537
|
|
614
|
Other
assets
|
|
3,135
|
|
2,001
|
|
|
|
|
|
Total
assets
|
|
$
79,158
|
|
$
128,017
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
13,661
|
|
$
9,798
|
Total current
liabilities
|
|
13,661
|
|
9,798
|
Other
liabilities
|
|
13
|
|
43
|
Total
liabilities
|
|
13,674
|
|
9,841
|
|
|
|
|
|
Stockholders'
equity
|
|
65,484
|
|
118,176
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
79,158
|
|
$
128,017
|
|
|
|
|
|
Mirati
Therapeutics, Inc.
|
Consolidated
Statements of Operations and Comprehensive Loss
|
(in thousands
except per share data, unaudited)
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Expenses
|
|
|
|
|
|
|
|
Research and
development
|
$
16,106
|
|
$
14,563
|
|
$
52,535
|
|
$
34,046
|
General and
administrative
|
3,475
|
|
4,161
|
|
11,391
|
|
12,180
|
Total operating
expenses
|
19,581
|
|
18,724
|
|
63,926
|
|
46,226
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(19,581)
|
|
(18,724)
|
|
(63,926)
|
|
(46,226)
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
160
|
|
(17)
|
|
530
|
|
99
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
(19,421)
|
|
$
(18,741)
|
|
$
(63,396)
|
|
$
(46,127)
|
Unrealized gain on
available-for-sale investments
|
(34)
|
|
6
|
|
26
|
|
2
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
$
(19,455)
|
|
$
(18,735)
|
|
$
(63,370)
|
|
$
(46,125)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.97)
|
|
$
(1.11)
|
|
$
(3.21)
|
|
$
(2.86)
|
|
|
|
|
|
|
|
|
Weighted average
number of shares used in computing net loss per share, basic and
diluted
|
19,924
|
|
16,842
|
|
19,740
|
|
16,103
|
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SOURCE Mirati Therapeutics, Inc.