SAN DIEGO, Feb. 25, 2021 /PRNewswire/ -- Mirati
Therapeutics, Inc. (NASDAQ: MRTX), a late-stage targeted
oncology company, today reported financial results for the fourth
quarter and full year of 2020, which reflect the company's progress
across its clinical and discovery pipeline and strength as it
expands its operational structure and capabilities in preparation
for potential commercialization in the
United States.
"Our commitment to patients with cancer has enabled us to
advance our two clinical programs, adagrasib and sitravatinib, as
well as our preclinical pipeline. These preclinical programs
include MRTX1133, a potentially first-in-class KRAS G12D selective
inhibitor and a first-in-class synthetic lethal PRMT5 inhibitor,"
said Charles M. Baum, M.D., Ph.D.,
president and chief executive officer, Mirati Therapeutics, Inc.
"We have added significant new talent and capabilities across the
organization which combined with our financial resources will allow
us to accelerate and expand development across our pipeline."
Corporate Updates:
- Announced a strategic research and development collaboration
with MD Anderson Cancer Center to expand the clinical and
preclinical evaluation of Mirati's two investigational small
molecule, potent and selective KRAS inhibitors, adagrasib, a G12C
inhibitor, and MRTX1133, a G12D inhibitor, each as monotherapy and
in combination with other agents. (View Release)
- Entered into McKesson's MYLUNG consortium
("Molecularly Informed Lung Cancer Treatment
in a Community Cancer Network: A Pragmatic
Consortium"), a collaborative research endeavor to deepen
understanding of molecular testing barriers, improve care for
patients with lung cancer, and expand the opportunity for patients
to participate in clinical trials. (View Release)
- Ended the fourth quarter with approximately $1.4 billion in cash, cash equivalents, and
short-term investments.
Adagrasib:
- Initiated KRYSTAL-7 (849-007), a Phase 2 clinical trial of
adagrasib in combination with pembrolizumab
(KEYTRUDA®)1 in 1st line non-small
cell lung cancer (NSCLC).
- Initiated an additional Phase 2 cohort of the KRYSTAL-1
(849-001) in patients with KRAS G12C and the STK11 co-mutation in
1st line NSCLC.
- Initiated KRYSTAL-12 (849-012), a Phase 3 clinical trial of
monotherapy adagrasib versus docetaxel in 2nd line
NSCLC.
- Plan to initiate by Q2 2021 KRYSTAL-10 (849-010), a Phase 3
clinical trial of adagrasib in combination with cetuximab
(ERBITUX®)2 in 2nd line colorectal
cancer.
1KEYTRUDA® is
a registered trademark of Merck
2ERBITUX® is a
registered trademark of Eli Lilly and Company in the U.S.
and Merck KGaA outside the U.S.
Preclinical Updates:
- Advanced a first-in-class PRMT5 inhibitor, leveraging a
synthetic lethal strategy in MTAP-deleted cancers. This agent
specifically inhibits the PRMT5 enzyme in the presence of
methylthioadenosine (MTA), a nucleoside cofactor, which is uniquely
elevated in cancers exhibiting the most commonly observed gene
deletion event (MTAP/CDKN2A) across human cancers. Because PRMT5 is
critical to the survival of normal human cells, the ability to
specifically target the PRMT5/MTA complex in MTAP-deleted cancer
cells while sparing normal human cells is expected to offer a wide
therapeutic index compared with conventional first generation PRMT5
or MAT2A inhibitors.
Financial Results for the Fourth Quarter 2020
- License and collaboration revenues for the three months ended
December 31, 2020, were $1.7 million, and relate to the manufacturing
supply services agreement with BeiGene. License and collaboration
revenues for the twelve months ended December 31, 2020 were $13.4 million, of which $11.4 million related to a license agreement with
ORIC Pharmaceuticals, Inc. and $2.0
million related to the manufacturing supply services
agreement with BeiGene. License and collaboration revenues for the
three and twelve months ended December 31,
2019 were $0.5 million and
$3.3 million, respectively, and
relate to the manufacturing supply services agreement with
BeiGene.
- Research and development expenses for the fourth quarter of
2020 were $82.7 million, compared to
$62.9 million for the same period in
2019. Research and development expenses for the year ended
December 31, 2020 were $299.3 million, compared to $182.9 million for the same period in 2019. The
increase in research and development expenses is due to an increase
in expense associated with the development of adagrasib, MRTX1133,
and other preclinical and early discovery activities, 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 expenses of
$12.2 million during the fourth
quarter of 2020, compared to $10.6
million for the same period in 2019, and $48.0 million during the year ended December 31, 2020, compared to $31.0 million for the same period in 2019.
- General and administrative expenses for the fourth quarter of
2020 were $25.3 million, compared to
$12.2 million for the same period in
2019. General and administrative expenses for the year ended
December 31, 2020 were $83.4 million, compared to $42.6 million for the same period in 2019. The
increase is due primarily to an increase in share-based
compensation expense and an increase in employee-related expenses
and professional service expense. The Company recognized general
and administrative-related share-based compensation expenses of
$9.6 million during the fourth
quarter of 2020, compared to $6.1
million for the same period in 2019, and $37.8 million during the year ended December 31, 2020, compared to $24.5 million for the same period in 2019.
- Net loss for the fourth quarter of 2020 was $101.1 million, or $2.08 per share basic and diluted, compared to
net loss of $72.4 million, or
$1.83 per share basic and diluted for
the same period in 2019. Net loss for the year ended December 31, 2020 was $357.9 million, or $7.96 per share basic and diluted, compared to
net loss of $213.3 million, or
$5.69 per share basic and diluted for
the same period in 2019.
- Cash, cash equivalents, and short-term investments were
$1.4 billion at December 31, 2020.
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose
mission is to discover, design and deliver breakthrough therapies
to transform the lives of patients with cancer and their loved
ones. The company is relentlessly focused
on bringing forward therapies that address areas of high
unmet need, including lung cancer, and advancing a pipeline of
novel therapeutics targeting the genetic and immunological drivers
of cancer. Mirati is using its scientific expertise to
develop novel solutions in two registration-enabling
programs: adagrasib (MRTX849), an investigational small
molecule, potent and selective KRAS G12C inhibitor, as monotherapy
and in combination with other agents, and sitravatinib, an
investigational spectrum-selective inhibitor of receptor tyrosine
kinases in combination with checkpoint inhibitor therapies.
Mirati is also advancing its differentiated preclinical portfolio,
including MRTX1133, an investigational KRAS G12D inhibitor, and
other oncology discovery programs. Unified for patients, Mirati's
vision is to unlock the science behind the promise of a life beyond
cancer.
For more information about Mirati Therapeutics, visit us
at Mirati.com or follow us
on LinkedIn.
Forward Looking Statements
This press release contains
forward-looking statements regarding the business of Mirati
Therapeutics, Inc. ("Mirati"). Any statement describing Mirati's
goals, expectations, financial or other projections, intentions or
beliefs, development plans and the commercial potential of Mirati's
drug development pipeline, including without limitation adagrasib
(MRTX849), sitravatinib and MRTX1133, is a forward-looking
statement and should be considered an at-risk statement. Such
statements are subject to risks and uncertainties, particularly
those challenges inherent in the process of discovering, developing
and commercialization of new drug products that are safe and
effective for use as human therapeutics, and in the endeavor of
building a business around such drugs.
Mirati's forward-looking statements also involve assumptions
that, if they never materialize or prove correct, could cause its
results to differ materially from those expressed or implied by
such forward-looking statements. Although Mirati's forward-looking
statements reflect the good faith judgment of its management, these
statements are based only on facts and factors currently known by
Mirati. As a result, you are cautioned not to rely on these
forward-looking statements. These and other risks concerning
Mirati's programs are described in additional detail in Mirati's
quarterly reports on Form 10-Q and annual reports on Form 10-K,
which are on file with the U.S. Securities and Exchange Commission
(the "SEC") available at the SEC's Internet site
(www.sec.gov).These forward-looking statements are made as of the
date of this press release, and Mirati assumes no obligation to
update the forward-looking statements, or to update the reasons why
actual results could differ from those projected in the
forward-looking statements, except as required by law.
Mirati Contacts:
Investor Relations
Temre
Johnson
(858) 332-3562
ir@mirati.com
Media Relations
Priyanka
Shah
(908) 447-6134
media@mirati.com
Mirati
Therapeutics, Inc.
Consolidated
Balance Sheets
(in
thousands)
|
|
|
December 31,
2020
|
|
December 31,
2019
|
|
|
|
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash, cash equivalents
and short-term investments
|
$
|
1,390,106
|
|
|
$
|
415,050
|
|
Other current
assets
|
13,537
|
|
|
9,357
|
|
Total current
assets
|
1,403,643
|
|
|
424,407
|
|
Property and
equipment, net
|
7,809
|
|
|
1,776
|
|
Long-term
investment
|
15,629
|
|
|
—
|
|
Right-of-use
asset
|
39,890
|
|
|
582
|
|
Other long-term
assets
|
9,157
|
|
|
5,435
|
|
Total
assets
|
$
|
1,476,128
|
|
|
$
|
432,200
|
|
|
|
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
Current
liabilities
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
71,472
|
|
|
$
|
48,082
|
|
Deferred revenue and
other current liabilities
|
—
|
|
|
824
|
|
Total current
liabilities
|
71,472
|
|
|
48,906
|
|
Lease
liability
|
41,905
|
|
|
—
|
|
Other
liabilities
|
1,962
|
|
|
999
|
|
Total
liabilities
|
115,339
|
|
|
49,905
|
|
|
|
|
|
Shareholders'
equity
|
1,360,789
|
|
|
382,295
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
$
|
1,476,128
|
|
|
$
|
432,200
|
|
Mirati
Therapeutics, Inc.
Consolidated
Statements of Operations and Comprehensive Loss
(in
thousands)
|
|
|
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
(unaudited)
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
License and
collaboration
revenues
|
|
$
|
1,707
|
|
|
$
|
526
|
|
|
$
|
13,398
|
|
|
$
|
3,335
|
|
Total
Revenue
|
|
1,707
|
|
|
526
|
|
|
13,398
|
|
|
3,335
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
Research and
development
|
|
82,705
|
|
|
62,941
|
|
|
299,349
|
|
|
182,866
|
|
General and
administrative
|
|
25,338
|
|
|
12,231
|
|
|
83,412
|
|
|
42,573
|
|
Total operating
expenses
|
|
108,043
|
|
|
75,172
|
|
|
382,761
|
|
|
225,439
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(106,336)
|
|
|
(74,646)
|
|
|
(369,363)
|
|
|
(222,104)
|
|
|
|
|
|
|
|
|
|
|
Other income,
net
|
|
5,249
|
|
|
2,270
|
|
|
11,426
|
|
|
8,848
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(101,087)
|
|
|
$
|
(72,376)
|
|
|
$
|
(357,937)
|
|
|
$
|
(213,256)
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss)
gain on
available-for-sale investments
|
|
(699)
|
|
|
—
|
|
|
(130)
|
|
|
410
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
$
|
(101,786)
|
|
|
$
|
(72,376)
|
|
|
$
|
(358,067)
|
|
|
$
|
(212,846)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
(2.08)
|
|
|
$
|
(1.83)
|
|
|
$
|
(7.96)
|
|
|
$
|
(5.69)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of
shares used in computing net
loss per share, basic and
diluted
|
|
48,588
|
|
|
39,451
|
|
|
44,988
|
|
|
37,468
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Mirati Therapeutics, Inc.