SAN DIEGO, Nov. 4, 2019 /PRNewswire/ -- Mirati
Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted
oncology company, today reported financial results for the third
quarter ended September 30, 2019.
Recent Corporate Updates:
- Presented early clinical data from the Phase1/2 trial of
MRTX849 on October 28, 2019 at the
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics. At the highest dose (600 mg BID), three of
five (3/5) evaluable patients with non-small cell lung cancer
(NSCLC) and one of two (1/2) evaluable patients with colorectal
cancer (CRC) achieved a partial response (PR); the remaining
patients had stable disease (SD). Across all dose levels, three of
six (3/6) patients with NSCLC and one of four (1/4) patients with
CRC achieved a PR. Two responding patients (1 NSCLC and
1 CRC) achieved confirmed PRs, both
with continuing tumor shrinkage following their first scan. The
other two patients with PRs (both NSCLC) have not had confirmatory
scans. Clinical PK data demonstrated that the dose of 600 mg BID
results in drug levels that meet or exceed those likely to lead to
full inhibition of KRAS G12C signaling. Treatment duration ranged
from 6.7- 38.6 weeks as of the data cut-off, October 11, 2019.
- Published data demonstrating the efficacy of MRTX849 in
preclinical studies on October 28,
2019 simultaneously with the Company's oral presentations at
the AACR-NCI-EORTC International Conference on Molecular Targets
and Cancer Therapeutics, in Cancer Discovery, a journal of
the American Association of Cancer Researchers.
- Announced that the Company would have two presentations of
interim Phase 2 data for sitravatinib in combination with nivolumab
in urothelial carcinoma and oral cavity squamous cell carcinoma at
the Society for Immunotherapy of Cancer (SITC) 34th
Annual Meeting on November 9,
2019.
- Announced on July 9, 2019 that
the Company had entered into a clinical collaboration agreement
with Novartis to evaluate the combination of MRTX849, Mirati's
investigational KRAS G12C inhibitor and TNO155, Novartis'
investigational SHP2 inhibitor, in
patients with advanced solid tumors with KRAS G12C mutations.
"The recent data presented demonstrate that MRTX849 treatment
can result in clinical responses at well tolerated doses. We
believe that MRTX849 clinical combinations, including the
combination of MRTX849 with TNO155 in our collaboration with
Novartis, will significantly increase the eligible patient
population," said Charles M. Baum,
M.D., Ph.D., President and Chief Executive Officer at Mirati. "We
continue to expand and accelerate our KRAS programs and expect to
continue expanding our team, including the addition of commercial
talent so that we are ready to deliver our novel cancer therapies
to the patients most in need."
Financial Results for the Third Quarter 2019
Cash, cash equivalents, and short-term investments were
$454.2 million at September 30, 2019, compared to $222.8 million at December
31, 2018. In January 2019, we
completed a public offering of common stock that provided net cash
proceeds of $107.9 million. In
June 2019, we completed a public
offering of common stock that provided net cash proceeds of
$219.9 million.
License and collaboration revenues relate to the Collaboration
and License Agreement between the Company and BeiGene, Ltd.
("BeiGene"), dated January 7, 2018.
License and collaboration revenues for the three and nine months
ended September 30, 2019 were
$1.0 million and $2.8 million, respectively, compared to none and
$9.5 million for the three and nine
months ended September 30, 2018,
respectively. The 2019 revenues relate to revenues earned in
connection with a manufacturing supply services agreement with
BeiGene and the 2018 revenues relate to the license the Company
granted to BeiGene under the Collaboration and License
Agreement.
Research and development expenses for the third quarter of 2019
were $47.4 million, compared to
$23.6 million for the same period in
2018. Research and development expenses for the nine months ended
September 30, 2019 were $119.9 million, compared to $67.1 million for the same period in 2018. The
increase in research and development expenses is due to an increase
in expense associated with the development of sitravatinib and
MRTX849, as well as an increase in salaries and related expense,
including an increase in share-based compensation expense. The
Company recognized research and development-related share-based
compensation expense of $8.6 million
during the third quarter of 2019, compared to $1.8 million for the same period in 2018, and
$20.4 million during the nine months
ended September 30, 2019, compared to
$5.1 million for the same period in
2018.
General and administrative expenses for the third quarter of
2019 were $10.7 million, compared to
$5.3 million for the same period in
2018. General and administrative expenses for the nine months ended
September 30, 2019 were $30.3 million, compared to $15.3 million for the same period in 2018. The
increase is due primarily to an increase in share-based
compensation expense and, to a lesser extent, an increase in
employee related expense, professional services expense and
facilities and insurance expense. The Company recognized general
and administrative-related share-based compensation expense of
$6.5 million during the third quarter
of 2019, compared to $2.2 million for
the same period in 2018, and $18.4
million during the nine months ended September 30, 2019, compared to $6.5 million for the same period in 2018.
Net loss for the third quarter of 2019 was $54.3 million, or $1.38 per share basic and diluted, compared to
net loss of $27.6 million, or
$0.85 per share basic and diluted for
the same period in 2018. Net loss for the nine months ended
September 30, 2019 was $140.9 million, or $3.83 per share basic and diluted, compared to
net loss of $70.1 million, or
$2.31 per share basic and diluted for
the same period in 2018.
About Sitravatinib
Sitravatinib is an investigational spectrum-selective kinase
inhibitor that potently inhibits receptor tyrosine kinases (RTKs),
including TAM family receptors (TYRO3, Axl, Mer), split family
receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent,
sitravatinib is being evaluated in combination with nivolumab
(OPDIVO®), an anti-PD-1 checkpoint inhibitor, in patients whose
cancers have progressed despite treatment with a checkpoint
inhibitor. Sitravatinib's potent inhibition of TAM and split family
RTKs may overcome resistance to checkpoint inhibitor therapy
through targeted reversal of an immunosuppressive tumor
microenvironment, enhancing antigen-specific T cell response and
expanding dendritic cell-dependent antigen presentation.
Sitravatinib is being evaluated in multiple clinical trials to
treat patients who are refractory to prior immune checkpoint
inhibitor therapy, including the ongoing potentially
registration-enabling Phase 3 trial of sitravatinib in combination
with a checkpoint inhibitor in non-small cell lung cancer (NSCLC).
In addition, sitravatinib combinations with checkpoint inhibitors
are being evaluated in selected checkpoint inhibitor naïve
patients.
About MRTX849
MRTX849 is an investigational, orally-available small molecule
that is designed to potently and selectively inhibit a form of KRAS
which harbors a substitution mutation (G12C). KRAS G12C mutations
are present in approximately 14% of non-small cell lung cancer
adenocarcinoma patients, 4% of colorectal cancer patients, and
subsets of other types of cancer. Tumors characterized by KRAS
G12C mutations are commonly associated with poor prognosis and
resistance to therapy, and patients with these mutations have few
treatment options. MRTX849 is being evaluated in a Phase 1/2 trial
treating patients with molecularly-identified, KRAS G12C-positive
advanced solid tumors.
About Mirati Therapeutics
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology
company dedicated to advancing novel therapeutics that extend the
lives of patients by directly addressing the genetic and
immunological drivers of cancer. Mirati's lead drug candidate,
sitravatinib, is designed to selectively target a spectrum of
tyrosine kinases implicated in both tumor growth and the
suppression of immune responses to tumors. Sitravatinib has
demonstrated durable responses in lung cancer patients whose cancer
has progressed despite treatment with checkpoint inhibitors - an
area of significant unmet medical need. Sitravatinib is being
evaluated in multiple clinical trials to treat patients who are
refractory to prior immune checkpoint inhibitor therapy, including
a potentially registration-enabling Phase 3 trial of sitravatinib
in combination with a checkpoint inhibitor in non-small cell lung
cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel inhibitors of KRAS mutations
including MRTX849, a potent and selective inhibitor of KRAS G12C.
This previously difficult to drug target is present in
approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer
as well as smaller percentages of several other difficult-to-treat
cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial
as a treatment for patients with KRAS G12C-positive tumors. Our
research on G12C has led to breakthroughs in targeting other KRAS
mutations including G12D which drives tumor growth in more patients
than G12C and includes pancreatic, colorectal and other types of
cancer. For more information, visit 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 Mirati Therapeutics, Inc. ("Mirati") that are not historical
facts may be considered "forward-looking statements," including
without limitation statements regarding Mirati's development plans
and timelines, potential regulatory actions, expected use of cash
resources, the timing and results of clinical trials, including
without limitation the MRTX849 and sitravatinib clinical trials
referenced above, 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," "will," "would," "believe," "intend," "plan," "anticipate,"
"estimate," "expect," and other similar terminology indicating
future results. Forward-looking statements are based on current
expectations of management and on what management believes to be
reasonable assumptions based on information currently available to
them, and are subject to risks and uncertainties. Such risks and
uncertainties may cause actual results to differ materially from
those anticipated in the forward-looking statements. Such risks and
uncertainties include without limitation potential delays in
development timelines, negative clinical trial results, reliance on
third parties for manufacturing and 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 U.S. Securities and Exchange Commission. Except
as required by law, 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,
2019
|
|
December 31,
2018
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
|
454,212
|
|
|
$
|
222,790
|
|
Other current
assets
|
10,436
|
|
|
3,870
|
|
Total current
assets
|
464,648
|
|
|
226,660
|
|
Property and
equipment, net
|
536
|
|
|
473
|
|
Other long-term
assets
|
5,514
|
|
|
1,321
|
|
Total
assets
|
$
|
470,698
|
|
|
$
|
228,454
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
34,689
|
|
|
$
|
25,775
|
|
Deferred revenue and
other current liabilities
|
647
|
|
|
371
|
|
Total current
liabilities
|
35,336
|
|
|
26,146
|
|
Deferred revenue and
other liabilities
|
873
|
|
|
732
|
|
Total
liabilities
|
36,209
|
|
|
26,878
|
|
|
|
|
|
Stockholders'
equity
|
434,489
|
|
|
201,576
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
|
470,698
|
|
|
$
|
228,454
|
|
Mirati
Therapeutics, Inc.
|
Consolidated
Statements of Operations and Comprehensive Loss
|
(in thousands,
unaudited)
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
License and
collaboration revenues
|
$
|
988
|
|
|
$
|
—
|
|
|
$
|
2,809
|
|
|
$
|
9,467
|
|
Total
Revenue
|
988
|
|
|
—
|
|
|
2,809
|
|
|
9,467
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
Research and
development
|
$
|
47,362
|
|
|
$
|
23,626
|
|
|
$
|
119,925
|
|
|
$
|
67,114
|
|
General and
administrative
|
10,685
|
|
|
5,313
|
|
|
30,340
|
|
|
15,308
|
|
Total operating
expenses
|
58,047
|
|
|
28,939
|
|
|
150,265
|
|
|
82,422
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(57,059)
|
|
|
(28,939)
|
|
|
(147,456)
|
|
|
(72,955)
|
|
|
|
|
|
|
|
|
|
Other income,
net
|
2,786
|
|
|
1,371
|
|
|
6,576
|
|
|
2,809
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
|
(54,273)
|
|
|
$
|
(27,568)
|
|
|
$
|
(140,880)
|
|
|
$
|
(70,146)
|
|
|
|
|
|
|
|
|
|
Unrealized gain
(loss) on available-for-sale investments
|
103
|
|
|
99
|
|
|
412
|
|
|
(35)
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
$
|
(54,170)
|
|
|
$
|
(27,469)
|
|
|
$
|
(140,468)
|
|
|
$
|
(70,181)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
|
(1.38)
|
|
|
$
|
(0.85)
|
|
|
$
|
(3.83)
|
|
|
$
|
(2.31)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares used in computing net loss per share, basic and
diluted
|
39,197
|
|
|
32,410
|
|
|
36,799
|
|
|
30,350
|
|
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SOURCE Mirati Therapeutics, Inc.