SAN DIEGO, March 9, 2017 /PRNewswire/ -- Mirati
Therapeutics, Inc. (NASDAQ: MRTX) ("the Company," "we," "our,"
"us," or "Mirati") today reported financial results for the fourth
quarter and year ended December 31,
2016 and provided an update on its product development
programs.
"We have made significant progress which positions us to report
key data from all of our programs in 2017," said Charles M. Baum, M.D., Ph.D., President and CEO
of Mirati. "Earlier this year, we presented glesatinib data
demonstrating clinical responses in non-small cell lung cancer
patients with MET driver alterations. In addition, preliminary data
from our Phase 1b trial of sitravatinib has shown clinical benefit
in patients with RET mutations. We plan to provide updates
for both glesatinib and sitravatinib in the second half of this
year.
We are excited about our immuno-oncology programs which combine
sitravatinib or mocetinostat with checkpoint inhibitors.
There is strong scientific rationale that sitravatinib or
mocetinostat can significantly enhance the efficacy of checkpoint
inhibitors. Following our successful public offering in January, we
are well positioned to achieve the 2017 milestones in each of our
programs with funding into late
2018."
Single Agent Programs
Glesatinib (MGCD265)
The Company is enrolling patients
in its registration-enabling Phase 2 non-small cell lung cancer
(NSCLC) AMETHYST clinical trial, which is evaluating single agent
glesatinib for the treatment of NSCLC patients with MET driver
alterations. In January 2017, the
Company reported early data that demonstrated promising activity in
these molecularly selected patients. In NSCLC patients with
MET Exon 14 deletion mutations treated with glesatinib, across both
the Phase 1b and Phase 2 trials, tumor reduction was observed in 11
of 13 patients, with confirmed and unconfirmed partial responses in
6 of 13 evaluable patients. Glesatinib also demonstrated clinical
benefit in NSCLC patients with MET gene amplification, including
tumor reduction in six of eight patients as well as two unconfirmed
partial responses out of eight evaluable patients. The Company
expects to provide an update on efficacy data from the AMETHYST
trial in the second half of 2017.
Sitravatinib (MGCD516)
The Company is enrolling
patients in its Phase 1b expansion clinical trial, which is
evaluating single agent sitravatinib for the treatment of NSCLC
patients with RET, CHR4q12 and CBL genetic alterations. In
January 2017, the Company reported
that six NSCLC patients with RET fusion mutations had been enrolled
and all four evaluable patients showed tumor reductions with one
confirmed and one unconfirmed response. The Company expects
to provide an update on efficacy data in the third quarter of
2017.
Immuno-oncology Combination
Programs
Sitravatinib plus nivolumab
Sitravatinib is a potent
inhibitor of the TAM (Tyro, Axl, Mer) and split (KDR, KIT) tyrosine
kinase families which have been shown in preclinical studies to
enhance anti-tumor immunity and the effects of checkpoint
inhibitors. In November 2016, the
Company initiated enrollment in a multicenter Phase 2 NSCLC
clinical trial evaluating sitravatinib in combination with
nivolumab, a PD-1 checkpoint inhibitor approved for the treatment
of patients with NSCLC. The trial is enrolling patients who have
relapsed after treatment with a checkpoint inhibitor. The
Company expects to provide initial results from this combination
trial in the second half of 2017.
Mocetinostat (MGCD103) plus durvalumab
The Company is
collaborating with MedImmune/Astra Zeneca on a Phase 1b/2 clinical
trial combining mocetinostat, an orally administered
spectrum-selective Class 1 HDAC inhibitor, and durvalumab,
MedImmune's monoclonal antibody inhibiting PD-L1. Preclinical
data have shown that mocetinostat significantly enhances the
efficacy of the checkpoint inhibitor through its effects on the
tumor microenvironment. The combination trial is exploring the
potential of mocetinostat to enhance the effectiveness of
durvalumab in NSCLC patients and the Company expects to provide an
update in mid 2017.
Preclinical Programs
The Company's lead preclinical programs to develop inhibitors of
LSD1 and KRAS are expected to have meaningful milestones in 2017.
The Company's LSD1 inhibitor is highly-potent and potentially
best-in-class with potential for rapid clinical proof-of-concept in
small cell lung cancer and/or acute myeloid leukemia. An
investigational new drug (IND) submission is planned for this
compound in the fourth quarter of 2017. The Company has
identified a mutant-selective KRAS inhibitor which is advancing to
the candidate selection phase. Prototype inhibitors have
demonstrated marked tumor regression in KRAS mutant tumor models
and the Company anticipates selecting an IND candidate in the
second half of 2017.
Financing
In January 2017, the Company
strengthened its balance sheet by completing a public offering of
common stock and pre-funded common stock warrants generating net
proceeds of $66.8 million. Following
this offering, the Company expects that its available cash, cash
equivalents and short-term investments are sufficient to fund
operations into late 2018.
Fourth Quarter and Full Year Financial Results
Cash, cash equivalents, and short-term investments were
$56.7 million on December 31,
2016, as compared to $122.3 million
on December 31, 2015.
Research and development expenses for the fourth quarter of 2016
were $16.0 million, compared to
$14.9 million for the same period in
2015. Research and development expenses for the year ended
December 31, 2016 were $68.5
million, compared to $49.0
million for the same period in 2015. The increases in
research and development expenses for both periods primarily
reflect costs to advance the clinical development of the Company's
glesatinib and sitravatinib oncology development programs, an
increase in salaries and related expense, which is due to an
increase in research and development employees during 2016 compared
to the same period of 2015, and an increase in early discovery
expenses.
General and administrative expenses for the fourth quarter of
2016 were $3.9 million, compared to
$3.6 million for the same period in
2015. General and administrative expenses for the year ended
December 31, 2016 were $15.3
million, compared to $15.8
million for the same period in 2015. The comparable level of
expenses for both periods reflect a consistent level of general and
administrative activities during both periods.
Other income, net, was $0.1
million for both the fourth quarter of 2016 and 2015. Other
income, net, for the year ended December 31,
2016 was $0.6 million compared
to $0.2 million for the same period
in 2015.
Net loss for the fourth quarter of 2016 was $19.7 million, or $0.99 per share basic and diluted, compared to
net loss of $18.4 million, or
$0.96 per share basic and diluted for
the same period in 2015. Net loss for the year ended
December 31, 2016 was $83.1
million, or $4.20 per share
basic and diluted, compared to net loss of $64.5 million, or $3.82 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.
Our clinical pipeline consists of three product candidates:
glesatinib, sitravatinib and mocetinostat. Both glesatinib and
sitravatinib are orally bioavailable, spectrum-selective kinase
inhibitors with distinct target profiles that are in development
for the treatment of patients with NSCLC and other solid tumors.
Glesatinib targets the MET receptor tyrosine kinase family and is
in Phase 2 clinical development. Sitravatinib targets RET
rearrangements, CHR4q12 amplifications (encompassing KDR, PDGFRA
and KIT), and CBL and AXL mutations, and is in Phase 1b clinical
development as a single agent. Sitravatinib is also being evaluated
in a Phase 2 combination with nivolumab, a PD-1 inhibitor, for the
treatment of patients with NSCLC. Sitravatinib is a potent
inhibitor of the TAM (Tyro, Axl, Mer) and split (KDR, KIT) tyrosine
kinase families, which regulate multiple stages in the cancer
immunity cycle and are thought to enhance anti-tumor immunity by
improving the efficacy of immune checkpoint (PD-1/PD-L1)
inhibitors. Our third product candidate is mocetinostat, an orally
bioavailable, spectrum-selective Class 1 histone deacetylase
inhibitor. Mocetinostat is in Phase 1b/2 clinical development in
combination with durvalumab, MedImmune's PD-L1 immune checkpoint
inhibitor, for the treatment of patients with NSCLC. More
information 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
Condensed Balance Sheets
(in
thousands)
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
2016
|
|
2015
|
|
|
|
|
|
Assets
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
|
$
56,734
|
|
$
122,327
|
Other current
assets
|
|
2,821
|
|
3,075
|
Total current
assets
|
|
59,555
|
|
125,402
|
|
|
|
|
|
Property and
equipment, net
|
|
629
|
|
614
|
Other
assets
|
|
3,260
|
|
2,001
|
|
|
|
|
|
Total
assets
|
|
$
63,444
|
|
$
128,017
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
15,002
|
|
$
9,798
|
Total current
liabilities
|
|
15,002
|
|
9,798
|
Other
liabilities
|
|
133
|
|
43
|
Total
liabilities
|
|
15,135
|
|
9,841
|
|
|
|
|
|
Stockholders'
equity
|
|
48,309
|
|
118,176
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
63,444
|
|
$
128,017
|
|
|
|
|
|
Mirati
Therapeutics, Inc.
Consolidated
Statements of Operations and Comprehensive Loss
(in thousands
except per share data)
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
(unaudited)
|
|
|
Expenses
|
|
|
|
|
|
|
|
Research and
development
|
$
15,952
|
|
$
14,913
|
|
$
68,487
|
|
$
48,959
|
General and
administrative
|
3,901
|
|
3,575
|
|
15,292
|
|
15,755
|
Total operating
expenses
|
19,853
|
|
18,488
|
|
83,779
|
|
64,714
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(19,853)
|
|
(18,488)
|
|
(83,779)
|
|
(64,714)
|
|
|
|
|
|
|
|
|
Other income,
net
|
131
|
|
71
|
|
661
|
|
170
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
(19,722)
|
|
$
(18,417)
|
|
$
(83,118)
|
|
$
(64,544)
|
Unrealized gain
(loss) on
available-for-sale investments
|
(51)
|
|
35
|
|
(25)
|
|
37
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
$
(19,773)
|
|
$
(18,382)
|
|
$
(83,143)
|
|
$
(64,507)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per
share
|
$
(0.99)
|
|
$
(0.96)
|
|
$
(4.20)
|
|
$
(3.82)
|
|
|
|
|
|
|
|
|
Weighted average
number of
shares used in computing net
loss per share, basic and diluted
|
19,929
|
|
19,271
|
|
19,787
|
|
16,902
|
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SOURCE Mirati Therapeutics, Inc.