Shares plans to initiate Phase 3
combination study evaluating adagrasib with pembrolizumab in first
line non-small cell lung cancer in patients with TPS
≥ 50%
Announces compelling initial clinical data
for MRTX1719 in MTAP-deleted cancers demonstrating favorable safety
profile and early signs of strong clinical activity
David Meek
to depart Company, Charles M. Baum,
M.D., Ph.D., President and Founder, to assume role of interim CEO
during search for permanent CEO
Company will announce financial results for
the second quarter 2023 along with recent corporate updates during
a conference call at 5:30 p.m. ET /
2:30 p.m. PT
SAN
DIEGO, Aug. 8, 2023 /PRNewswire/ -- Mirati
Therapeutics, Inc.® (NASDAQ: MRTX), a commercial
stage biotechnology company, today announced financial results for
the second quarter 2023 along with recent pipeline and corporate
updates.
"We are pleased to share the significant progress made during
the second quarter of 2023, highlighted by an update to the
clinical data and articulation of our path to develop
KRAZATI® in front line non-small cell lung cancer
(NSCLC). Coupled with strong second quarter KRAZATI sales
performance, these data reinforce our belief that KRAZATI is the
best-in-class KRASG12C inhibitor with significant
potential to positively impact the lives of patients living with
cancer," said Charles Baum, M.D,
Ph.D., interim CEO, president and founder, Mirati Therapeutics,
Inc. "Further, we advanced our robust pipeline of targeted oncology
programs, including MRTX1719, our potentially first-in-class MTA
cooperative PRMT5 inhibitor, where we demonstrated a favorable
safety profile, proof of mechanism and compelling early clinical
activity in patients with MTAP-deleted cancers. Looking ahead, we
are confident in the potential of our broad pipeline of innovative,
potentially best-in-class programs including MRTX1133 and our next
generation of KRAS inhibitors, as well as MRTX1719 and MRTX0902,
our SOS1 inhibitor. We continue to demonstrate our proven
expertise in the discovery and development of transformational
treatments for people living with cancer."
Pipeline Updates
Adagrasib (Potent and selective KRASG12C
inhibitor)
- In August, the Company shared updated clinical data in
first-line NSCLC for the combination of adagrasib with
pembrolizumab. The Company announced plans to begin enrolling
patients with TPS ≥ 50% in a Phase 3 clinical study by year-end
2023.
- In August, the Company shared that KRYSTAL 17, a Phase 2
clinical study evaluating adagrasib in combination with
chemo-immunotherapy for patients with TPS < 50% has been
initiated. The Company intends to provide an update on this study
and outline potential registrational development plans in
2024.
- In July, the company announced the European Medicine Agency's
(EMA) Committee for Medicinal Products for Human Use (CHMP) issued
a negative opinion on the Conditional Marketing Authorisation
Application (MAA) for KRAZATI® (adagrasib) for
the treatment of patients with KRASG12C -mutated
advanced NSCLC. The evaluation of the full MAA is not impacted and
will be considered by the CHMP following the data from KRYSTAL-12,
a Phase 3 clinical study of adagrasib versus docetaxel in
second line NSCLC patients. The Company has requested a formal
reexamination of the Conditional MAA. (View Release)
- In June, the Journal of Clinical Oncology published clinical
results from the KRYSTAL-1 study of adagrasib, a potent and
selective KRASG12C inhibitor, demonstrating durable
intracranial activity in patients living with
KRASG12C-mutated NSCLC with untreated central nervous
system metastases. (View Release)
- In June, the Company presented updated clinical data for
adagrasib as a targeted treatment for
KRASG12C-mutated advanced pancreatic ductal
adenocarcinoma (PDAC), biliary tract cancer and other solid tumors
at the American Society of Clinical Oncology (ASCO) Annual Meeting.
Based on these results, the Company plans to discuss a tumor
agnostic Accelerated Approval approach with FDA by year-end 2023.
(View Release)
- The Company is on track to complete a supplemental New Drug
Application (sNDA) for third-line and beyond colorectal cancer in
patients with a KRASG12C mutation by year-end 2023.
- The Company continues to enroll in KRYSTAL-10, a Phase 3
registrational clinical study in second-line colorectal cancer
patients, evaluating the combination of adagrasib plus
cetuximab versus chemotherapy. The Company expects to complete
enrollment by year-end 2023 and plans to share top line results in
2024.
- The Company continues to enroll in KRYSTAL-12, a Phase 3
clinical study of adagrasib versus docetaxel in second line
NSCLC patients. The Company plans to share data from this study in
2024.
MRTX1719 (MTA cooperative PRMT5 inhibitor)
- In August, the Company presented initial clinical data from the
Phase 1 dose escalation clinical study evaluating MRTX1719, an MTA
cooperative PRMT5 inhibitor, in patients with solid tumors
harboring MTAP-gene deletions, demonstrating a favorable safety
profile and early signs of clinical activity. A manuscript
characterizing the Company's preclinical and early clinical
experience with 1719 including case studies from the Phase 1 study
was accepted by Cancer Discovery and will publish online on
August 8, 2023. The Company expects
to initiate a Phase 2 study in the first half of 2024.
MRTX1133 (Potent and selective KRASG12D
inhibitor)
- The Company continues to enroll patients in the Phase 1/2
clinical study with plans to share initial clinical data in the
first half of 2024.
MRTX0902 (Potent SOS1 inhibitor)
- In July, the Company initiated a cohort within the Phase 1/2
trial evaluating the combination of MRTX0902 plus adagrasib
with plans to share initial clinical data in 2024.
Sitravatinib (Potent TAM receptor inhibitor)
- In May, the Company announced that the Phase 3 SAPPHIRE study
evaluating sitravatinib plus nivolumab
(OPDIVO®)1 in second or third line
non-squamous NSCLC study did not meet its primary endpoint of
overall survival at the final analysis. The Company plans to
disclose study data at an upcoming medical meeting. (View
Release)
Recent Corporate Updates
- In August, the Company announced that David Meek departed as CEO. Charles Baum, M.D., Ph.D., will assume the role
of interim CEO while the Company searches for a permanent CEO.
- In June, the Company announced Carol
Gallagher, Pharm.D. was appointed to the Company Board of
Directors as an independent director. (View Release)
Second Quarter Financial Results
- Cash, cash equivalents and short-term investments of
approximately $779.4 million as of
June 30, 2023. Net reduction in cash,
cash equivalents and short-term investments for the second quarter
of 2023 was $122.9 million. The
Company expects 2023 net cash burn to annualize within a range of
$560 million to $580 million.
- Net KRAZATI® product revenue for the three and six months ended
June 30, 2023 was $13.4 million and $19.7
million, respectively. Net product revenue during the three
months ended June 30, 2023 was
comprised of $11.7 million of
commercial sales and $1.7 million of
sales to a third-party commercial customer for its clinical trials.
There was no product revenue for the same periods in 2022.
- License and collaboration revenue for the three and six months
ended June 30, 2023 was $0.3 million and $1.2
million, respectively, related to clinical supply revenue
earned under the agreement with Zai
Lab. License and collaboration revenue for the same periods
in 2022 was $5.4 million and
$6.1 million, respectively, related
to a $5 million milestone payment
from Zai Lab for the initiation of
the first pivotal clinical trial of adagrasib for the first
indication in China, and clinical
supply revenue earned under the agreement with Zai Lab.
- Cost of product revenue for the three and six months ended
June 30, 2023 was $1.3 million and $2.1
million, respectively, of which $1.0
million and $1.6 million,
respectively, related to product manufacturing and distribution
costs, and royalties incurred on net sales of KRAZATI®, and the
remainder represented non-cash amortization expense for our
intangible asset. There was no cost of product revenue for the same
periods in 2022.
- Research and development expenses for three and six months
ended June 30, 2023 were $124.2 million and $250.9
million, respectively, compared to $128.3 million and $259.3
million for the same periods in 2022, respectively. The
decrease was primarily driven by a reduction in clinical
development costs for sitravatinib as enrollment was completed in
the SAPPHIRE Phase 3 clinical study in the second quarter of 2022,
and a decrease in share-based compensation due to a decrease in the
fair value of equity awards granted during the period, partially
offset by increases in costs for earlier stage clinical development
programs such as MRTX1133, and an increase in salaries and other
employee related expense to support portfolio advancement.
- Selling, general and administrative expenses for the three and
six months ended June 30, 2023 were
$75.5 million and $149.0 million, respectively, compared to
$54.2 million and $108.2 million, respectively for the same periods
in 2022. The increases were primarily due to an increase in
headcount-related costs, including share-based compensation and
salaries, and commercial-related costs to support the marketing and
sales of KRAZATI®.
- Net loss for the three months ended June
30, 2023 was $176.9 million,
or $3.04 per share basic and diluted,
compared to a net loss of $176.4
million, or $3.18 per share
basic and diluted for the same period in 2022. Net loss for the six
months ended June 30, 2023 was
$361.5 million, or $6.22 per share basic and diluted, compared to a
net loss of $364.8 million, or
$6.57 per share basic and diluted for
the same period in 2022.
Conference Call Information
There will be a conference call on August
8, 2023 at 5:30 p.m. ET /
2:30 p.m. PT during which company
executives will review financial information for the second quarter
and provide corporate updates.
Investors and the general public are invited to listen to a live
webcast of the call at the "Investors and Media" section on
Mirati.com or by dialing the U.S. toll free +1 773-305-6853 or
international +1 888-394-8218, confirmation code: 6674271.
A replay of the call will be available approximately 2 hours
after the event has ended at the same website.
About Mirati Therapeutics, Inc.®
Mirati Therapeutics, Inc. is a commercial 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. Unified for patients, Mirati's vision is to unlock the
science behind the promise of a life beyond cancer.
For more information about Mirati, visit us
at Mirati.com or follow us on Twitter, LinkedIn, and
Facebook.
Forward Looking Statements
This press release includes forward-looking statements regarding
Mirati's business, financial guidance and the therapeutic and
commercial potential of KRAZATI® (adagrasib),
sitravatinib (TAM receptor inhibitor), MRTX1719
(MTA-cooperative PRMT5 inhibitor), MRTX0902 (SOS1 inhibitor), and
MRTX1133 (selective KRASG12D inhibitor), Mirati's
technologies and Mirati' other products in development. Any
statement describing Mirati's goals, expectations, intentions or
beliefs, financial or other projections, is a forward-looking
statement and should be considered an at-risk statement. Such
statements are subject to certain risks and uncertainties,
including those inherent in the process of discovering, developing
and commercializing medicines that are safe and effective for use
as human therapeutics, and in the endeavor of building a business
around such medicines.
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'
annual report on Form 10-K, and most recent Form 10-Q, which are on
file with the Securities and Exchange Commission and 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: ir@mirati.com
Media Relations: media@mirati.com
1OPDIVO® (nivolumab) and the related logo
are registered trademarks of Bristol-Myers Squibb Company
Mirati Therapeutics,
Inc.
Consolidated Balance
Sheets
(unaudited)
(in
thousands)
|
|
|
June
30,
|
|
December
31,
|
|
2023
|
|
2022
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash, cash equivalents
and short-term investments
|
$
779,434
|
|
$ 1,083,837
|
Accounts receivable,
net
|
10,523
|
|
865
|
Inventory
|
8,644
|
|
3,020
|
Other current
assets
|
20,316
|
|
21,239
|
Total current
assets
|
818,917
|
|
1,108,961
|
Property and
equipment, net
|
16,867
|
|
17,540
|
Intangible asset,
net
|
14,397
|
|
14,914
|
Long-term
investment
|
4,565
|
|
3,465
|
Right-of-use
asset
|
35,431
|
|
36,122
|
Other long-term
assets
|
24,866
|
|
21,645
|
Total
assets
|
$
915,043
|
|
$ 1,202,647
|
|
|
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
Current
liabilities
|
|
|
|
Accounts
payable
|
$
32,507
|
|
$
38,861
|
Accrued
liabilities
|
107,483
|
|
120,587
|
Total current
liabilities
|
139,990
|
|
159,448
|
Lease
liability
|
42,722
|
|
43,661
|
Other
liabilities
|
3,380
|
|
3,022
|
Total
liabilities
|
186,092
|
|
206,131
|
|
|
|
|
Shareholders'
equity
|
728,951
|
|
996,516
|
|
|
|
|
Total liabilities
and shareholders' equity
|
$
915,043
|
|
$ 1,202,647
|
Mirati Therapeutics,
Inc.
Consolidated
Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands,
except per share data)
|
|
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
(unaudited)
|
|
(unaudited)
|
Revenue
|
|
|
|
|
|
|
|
Product revenue,
net
|
$
13,365
|
|
$
—
|
|
$
19,656
|
|
$
—
|
License and
collaboration revenues
|
325
|
|
5,362
|
|
1,201
|
|
6,071
|
Total
revenue
|
13,690
|
|
5,362
|
|
20,857
|
|
6,071
|
Expenses
|
|
|
|
|
|
|
|
Cost of product
revenue
|
1,025
|
|
—
|
|
1,583
|
|
—
|
Cost of product
revenue - intangible asset amortization
|
258
|
|
—
|
|
517
|
|
—
|
Research and
development
|
124,187
|
|
128,339
|
|
250,870
|
|
259,315
|
Selling, general and
administrative
|
75,490
|
|
54,228
|
|
148,980
|
|
108,179
|
Total operating
expenses
|
200,960
|
|
182,567
|
|
401,950
|
|
367,494
|
Loss from
operations
|
(187,270)
|
|
(177,205)
|
|
(381,093)
|
|
(361,423)
|
Other income (expense),
net
|
10,357
|
|
760
|
|
19,594
|
|
(3,408)
|
Net
loss
|
$
(176,913)
|
|
$
(176,445)
|
|
$
(361,499)
|
|
$
(364,831)
|
Unrealized gain (loss)
on available-for-sale investments
|
26
|
|
(909)
|
|
2,069
|
|
(5,711)
|
Foreign currency
translation adjustment
|
(34)
|
|
—
|
|
(65)
|
|
—
|
Comprehensive
loss
|
$
(176,921)
|
|
$
(177,354)
|
|
$
(359,495)
|
|
$
(370,542)
|
Net loss per share,
basic and diluted
|
$
(3.04)
|
|
$
(3.18)
|
|
$
(6.22)
|
|
$
(6.57)
|
Weighted average common
shares outstanding, basic and diluted
|
58,232
|
|
55,552
|
|
58,132
|
|
55,511
|
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SOURCE Mirati Therapeutics, Inc.