SAN DIEGO, Aug. 4, 2016 /PRNewswire/ -- Mirati
Therapeutics, Inc. (NASDAQ: MRTX) (the Company or Mirati) today
reported financial results for the second quarter ended
June 30, 2016 and provided an update
on its product development programs.
"We reported progress across our pipeline during the second
quarter, including clinical responses in patients treated with
glesatinib and sitravatinib. We have since treated a number
of patients with the new spray-dried dispersion formulation of
glesatinib and have observed improved tolerability compared to the
original formulation," said Charles M.
Baum, M.D., Ph.D., President and CEO of Mirati.
"Confirming responses to this formulation is our highest
priority. We are encouraged by enrollment rates in this
clinical trial as well as our other trials, and will provide
efficacy updates for all of our programs as they progress."
Current
Programs
Glesatinib (MGCD265)
The Phase 2 clinical trial in
non-small cell lung cancer (NSCLC) patients
with MET genetic alterations is currently
enrolling patients on the new spray-dried dispersion (SDD)
formulation of glesatinib. Enrollment rates in the trial
continue to increase, due in part to the Company's diagnostic
partnerships. These have significantly increased the ability to
identify and enroll patients and have further confirmed that
approximately seven percent of NSCLC patients express the mutations
of interest. To date, the SDD formulation is demonstrating
improved tolerability. An 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.
Mocetinostat (MGCD103)
The Phase 2
clinical trial for mocetinostat in combination with durvalumab,
MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor,
was initiated in June 2016 and 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.
Second Quarter and First Half 2016 Financial Results
Cash, cash equivalents, and short-term investments were
$91.3 million at June 30, 2016, compared to $122.3 million at December
31, 2015.
Research and development expenses for the second quarter of 2016
were $18.4 million, compared to
$11.3 million for the same period in
2015. Research and development expenses for the six months ended
June 30, 2016 were $36.4 million compared to $19.5 million for the same period in 2015.
The increase in research and development expenses for both the
three and six months ended June 30,
2016 primarily relates to an increase in expenses associated
with ongoing clinical trials, primarily for glesatinib, as well as
an increase in other research and development expenses, which
reflects both higher compensation costs due to an increase in
research and development employees during the three and six months
ended June 30, 2016 compared to the
same period of 2015, as well as a one-time license fee of
$2.5 million related to an early
stage discovery project.
General and administrative expenses for the second quarter of
2016 were $3.8 million, compared to
$4.2 million for the same period in
2015. General and administrative expenses for the six months ended
June 30, 2016 were $7.9 million compared to $8.0 million for the same period of 2015.
The decrease in general and administrative expense for second
quarter primarily reflects a decrease in employee-related expense,
which was primarily due to a reversal of non-cash stock-based
compensation expense associated with unvested stock options granted
to our former Chief Operations Officer, partially offset by a
non-recurring severance charge associated with his
resignation.
Net loss for the second quarter of 2016 was $22.0 million, or $1.11 per share, compared to net loss of
$15.5 million, or $0.95 per share, for the same period in 2015. Net
loss for the six months ended June 30,
2016 was $44.0 million, or
$2.24 per share, compared to
$27.4 million, or $1.74 per share, for the same period of
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-PD1 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 the RET rearrangements, CHR4q12
amplifications, and CBL mutations. Our third product candidate is
mocetinostat, an orally bio-available, Class 1 selective histone
deacetylase 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 is available at www.mirati.com.
Forward Looking Statements
Certain statements
contained in this news release, other than statements of fact that
are independently verifiable at the date hereof, contain
"forward-looking" statements, within the meaning of the Private
Securities Litigation Reform Act of 1995, that involve significant
risks and uncertainties. For more detailed disclosures and
discussions regarding such forward looking statements, please refer
to Mirati's filings with the U.S. Securities and Exchange
Commission ("SEC"), including without limitation Mirati's filings
on Forms 10-K, 10-Q, and 8-K. Forward looking statements are based
on the current expectations of management and upon what management
believes to be reasonable assumptions based on information
currently available to it. Such statements can usually be
identified by the use of words such as "may," "would," "believe,"
"intend," "plan," "anticipate," "estimate," "expect," and other
similar terminology, or by statements that certain actions, events
or results "may" or "would" be taken, occur or be achieved. Such
statements include, but are 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
involve significant risks and uncertainties and are neither a
prediction nor a guarantee that future events or circumstances will
occur. Such risks 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 described in Mirati's filings with the SEC. We are
including this cautionary note to make applicable, and to take
advantage of, the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995 for forward-looking statements. The
information in this news release is given as of the date above and
Mirati expressly disclaims any obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, unless required by law.
Mirati
Therapeutics, Inc.
Consolidated
Balance Sheets
(in
thousands)
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2016
|
|
2015
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash,
cash equivalents and short-term
investments
|
|
$
91,313
|
|
$
122,327
|
Other
current assets
|
|
1,726
|
|
3,075
|
Total current
assets
|
|
93,039
|
|
125,402
|
|
|
|
|
|
Property
and equipment, net
|
|
558
|
|
614
|
Other
assets
|
|
2,396
|
|
2,001
|
Total
assets
|
|
$
95,993
|
|
$
128,017
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
$
13,790
|
|
$
9,798
|
Total current
liabilities
|
|
13,790
|
|
9,798
|
Other
liability
|
|
24
|
|
43
|
Total
liabilities
|
|
13,814
|
|
9,841
|
|
|
|
|
|
Stockholders'
equity
|
|
82,179
|
|
118,176
|
Total liabilities
and stockholders' equity
|
|
$
95,993
|
|
$
128,017
|
|
|
|
|
|
Mirati
Therapeutics, Inc.
Consolidated
Statements of Operations and Comprehensive Loss
(in thousands
except per share data, unaudited)
|
|
|
|
|
|
|
|
Three months
ended
|
|
Six months
ended
|
|
|
June
30,
|
|
June
30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Expenses
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
18,441
|
|
$
11,276
|
|
$
36,429
|
|
$
19,483
|
General and
administrative
|
|
3,786
|
|
4,240
|
|
7,916
|
|
8,019
|
Total operating
expenses
|
|
22,227
|
|
15,516
|
|
44,345
|
|
27,502
|
Loss from
operations
|
|
(22,227)
|
|
(15,516)
|
|
(44,345)
|
|
(27,502)
|
|
|
|
|
|
|
|
|
|
Other income,
net
|
|
166
|
|
70
|
|
370
|
|
116
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
(22,061)
|
|
$
(15,446)
|
|
$
(43,975)
|
|
$
(27,386)
|
|
|
|
|
|
|
|
|
|
Unrealized gain
(loss) on available-for-sale investments
|
|
33
|
|
(9)
|
|
60
|
|
(4)
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
$
(22,028)
|
|
$
(15,455)
|
|
$
(43,915)
|
|
$
(27,390)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
(1.11)
|
|
$
(0.95)
|
|
$
(2.24)
|
|
$
(1.74)
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares used in computing net loss per share, basic and
diluted
|
|
19,912,938
|
|
16,235,261
|
|
19,646,889
|
|
15,727,891
|
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SOURCE Mirati Therapeutics, Inc.