NVL-655 IND cleared by FDA, supporting planned initiation of
ALKOVE-1 Phase 1/2 clinical trial in patients with ALK-positive
NSCLC and other solid tumors in second quarter of 2022
Enrollment ongoing in ARROS-1 trial of NVL-520 for advanced
ROS1-positive NSCLC and other solid tumors
Discovery pipeline continues to advance toward two
development candidate nominations in 2022
CAMBRIDGE, Mass., March 29,
2022 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a
clinical-stage biopharmaceutical company focused on creating
precisely targeted therapies for clinically proven kinase
targets in cancer, today reported pipeline and business progress
and fourth quarter and full year 2021 financial results.
As part of today's update, Nuvalent is announcing that its
Investigational New Drug (IND) application for NVL-655 for the
treatment of ALK-positive NSCLC and other solid tumors was cleared
by the U.S. Food and Drug Administration (FDA). NVL-655 is a novel
ALK-selective inhibitor designed with the aim to address the
clinical challenges of emergent treatment resistance, central
nervous system (CNS)-related adverse events, and brain metastases
that may limit the use of currently available ALK inhibitors.
Nuvalent plans to initiate the ALKOVE-1 Phase 1/2 study of NVL-655
for patients with advanced ALK-positive non-small cell lung cancer
(NSCLC) and other solid tumors in the second quarter of 2022.
"The Nuvalent team has continued to demonstrate the ability to
discover novel molecules with preclinical profiles suggesting
best-in-class potential and to progress them efficiently into
clinical development. With the clearance of our IND for NVL-655,
Nuvalent is on track to have two parallel lead compounds in
clinical trials by mid-year," said James
Porter, Ph.D., Chief Executive Officer at Nuvalent. "We
believe we are well positioned with two clinical-stage, novel
product candidates in areas of significant medical need, and
sustainable internal discovery efforts with the goal of delivering
multiple additional product candidates. I am incredibly proud of
all that this team has accomplished and their continued dedication
to advancing new potential therapeutic options for patients in
need."
Recent Pipeline Highlights
- Enrollment Ongoing in ARROS-1 Trial of NVL-520 for Patients
with Advanced ROS1-positive NSCLC: Nuvalent is actively
enrolling patients in the Phase 1 portion of its ARROS-1 clinical
trial, a Phase 1/2 study evaluating NVL-520 in patients with
advanced ROS1-positive NSCLC and other solid tumors. NVL-520,
Nuvalent's lead product candidate, is a novel ROS1-selective
inhibitor designed with the aim to address the clinical challenges
of emergent treatment resistance, CNS adverse events, and brain
metastases that may limit the use of currently available ROS1
kinase inhibitors.
- Discovery Pipeline Advancing toward Selection of Next
Development Candidates: Nuvalent continues to advance its early
pipeline efforts with multiple discovery-stage research programs.
The company expects to nominate product candidates in 2022 for its
discovery programs directed toward ALK IXDN compound resistance
mutations and HER2 exon 20 insertions.
Recent Business Highlights
- Strengthened Board of Directors with Appointment of
Emily Drabant Conley, Ph.D.: In
February 2022, Nuvalent appointed
Emily Drabant Conley, Ph.D., Chief
Executive Officer of Federation Bio, to its Board of Directors. Dr.
Conley's work has contributed to industry-shaping advances in
genomics that empower patients and clinicians with actionable
health data. Prior to Federation Bio, she spent over a decade at
23andMe where, as Vice President of Business Development, she was
instrumental in powering the company's growth from 30 employees
into a household name.
Fourth Quarter and Full Year 2021 Financial Results
- Cash Position: Cash, cash equivalents and marketable
securities were $288.1 million as of
December 31, 2021. Nuvalent expects
that its existing cash, cash equivalents and marketable securities
will be sufficient to fund its planned operations into 2024.
- R&D Expenses: Research and development
(R&D) expenses were $13.2 million
for the quarter ended December 31,
2021, and $35.6 million for
the year ended December 31,
2021.
- G&A Expenses: General and administrative
(G&A) expenses were $4.2 million
for the quarter ended December 31,
2021, and $10.3 million for
the year ended December 31,
2021.
- Net Loss: Net loss was $17.3 million for the
quarter ended December 31, 2021, and
$46.3 million for the year ended
December 31, 2021.
SELECTED
STATEMENTS OF OPERATIONS DATA
|
|
(In thousands,
except share and per share data)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
|
Year Ended
December 31,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
13,194
|
|
|
$
|
4,699
|
|
|
$
|
35,559
|
|
|
$
|
15,403
|
|
General and
administrative
|
|
|
4,184
|
|
|
|
515
|
|
|
|
10,258
|
|
|
|
1,502
|
|
Total operating
expenses
|
|
|
17,378
|
|
|
|
5,214
|
|
|
|
45,817
|
|
|
|
16,905
|
|
Loss from
operations
|
|
|
(17,378)
|
|
|
|
(5,214)
|
|
|
|
(45,817)
|
|
|
|
(16,905)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of
preferred stock
tranche
rights
|
|
|
—
|
|
|
|
(1,363)
|
|
|
|
(635)
|
|
|
|
2,384
|
|
Other income (expense),
net
|
|
|
89
|
|
|
|
(3)
|
|
|
|
114
|
|
|
|
(35)
|
|
Total other income
(expense), net
|
|
|
89
|
|
|
|
(1,366)
|
|
|
|
(521)
|
|
|
|
2,349
|
|
Net loss
|
|
$
|
(17,289)
|
|
|
$
|
(6,580)
|
|
|
$
|
(46,338)
|
|
|
$
|
(14,556)
|
|
Net loss per share
attributable to
common
stockholders, basic and diluted
|
|
$
|
(0.36)
|
|
|
$
|
(2.14)
|
|
|
$
|
(2.13)
|
|
|
$
|
(5.08)
|
|
Weighted average shares
of common stock
outstanding, basic and diluted
|
|
|
48,268,256
|
|
|
|
3,070,672
|
|
|
|
21,783,754
|
|
|
|
2,867,221
|
|
SELECTED BALANCE
SHEET DATA
|
|
(In
thousands)
|
|
(Unaudited)
|
|
|
|
December
31,
|
|
|
|
2021
|
|
|
2020
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
288,111
|
|
|
$
|
10,332
|
|
Working
capital
|
|
$
|
281,841
|
|
|
$
|
6,266
|
|
Total assets
|
|
$
|
293,824
|
|
|
$
|
10,646
|
|
Total
liabilities
|
|
$
|
8,787
|
|
|
$
|
6,615
|
|
Total stockholders'
equity (deficit)
|
|
$
|
285,037
|
|
|
$
|
(31,323)
|
|
About Nuvalent
Nuvalent, Inc. (Nasdaq: NUVL) is a
clinical-stage biopharmaceutical company focused on creating
precisely targeted therapies for patients with cancer, designed to
overcome the limitations of existing therapies for clinically
proven kinase targets. Leveraging deep expertise in chemistry and
structure-based drug design, we develop innovative small molecules
that have the potential to overcome resistance, minimize adverse
events, address brain metastases, and drive more durable responses.
Nuvalent is advancing a robust pipeline with parallel lead programs
in ROS1-positive and ALK-positive non-small cell lung cancer
(NSCLC), along with multiple discovery-stage research programs. We
routinely post information that may be important to investors on
our website at http://www.nuvalent.com. Follow us on Twitter
(@nuvalent) and LinkedIn.
Forward-Looking Statements
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
without limitation, implied and express statements regarding
Nuvalent's strategy, business plans, and focus; the clinical
development programs for NVL-520, NVL-655, ALK IXDN compound
resistance mutations and HER2 exon 20 insertions and the timing
thereof; the potential clinical effect of NVL-520 and NVL-655; the
design and enrollment of the ARROS-1 study and the timing thereof;
the design and initiation of the ALKOVE-1 Phase 1/2 study and the
timing thereof; the potential of Nuvalent's pipeline programs,
including NVL-520 and NVL-655; Nuvalent's research and development
programs for the treatment of cancer; risks and uncertainties
associated with drug development; capital allocation; and
Nuvalent's future financial and operating results and its
expectations related thereto. The words "may," "might," "will,"
"could," "would," "should," "expect," "plan," "anticipate," "aim,"
"goal," "intend," "believe," "expect," "estimate," "seek,"
"predict," "future," "project," "potential," "continue," "target"
or the negative of these terms and similar words or expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Drug
development and commercialization involve a high degree of risk,
and only a small number of research and development programs result
in commercialization of a product. You should not place undue
reliance on these statements or the scientific data presented.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs and are subject to
a number of risks, uncertainties, and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, risks associated
with: risks that Nuvalent may not fully enroll the ARROS-1 study or
it will take longer than expected; unexpected concerns that may
arise from additional data, analysis, or results obtained during
clinical trials; the occurrence of adverse safety events; risks of
unexpected costs, delays, or other unexpected hurdles; the impact
of COVID-19 on countries or regions in which Nuvalent has
operations or does business, as well as on the timing and
anticipated timing and results of its clinical trials, strategy,
and future operations, including the global ARROS-1 study and the
planned initiation of the ALKOVE-1 Phase 1/2 study; the timing and
outcome of Nuvalent's planned interactions with regulatory
authorities; and obtaining, maintaining, and protecting its
intellectual property. These and other risks and uncertainties are
described in greater detail in the section entitled "Risk Factors"
in the Company's Quarterly Report on Form 10-Q for the quarter
ended September 30, 2021, as well as
any subsequent filings with the Securities and Exchange Commission.
In addition, any forward-looking statements represent Nuvalent's
views only as of today and should not be relied upon as
representing its views as of any subsequent date. Nuvalent
explicitly disclaims any obligation to update any forward-looking
statements.
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SOURCE Nuvalent, Inc.