Well-capitalized with operating runway
anticipated into 2027
CAMBRIDGE, Mass., Feb. 27,
2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq:
NUVL), a clinical-stage biopharmaceutical company focused on
creating precisely targeted therapies for
clinically proven kinase targets in cancer, today highlighted
pipeline progress, reiterated key anticipated milestones and
reported fourth quarter and full year 2023 financial results.
"With our OnTarget 2026 operating plan as a clear guide, the
Nuvalent team continues to prove its ability to execute on its
goals as demonstrated by the recently announced initiation of the
Phase 2 portion of our ALKOVE-1 study for NVL-655 and the receipt
of FDA breakthrough therapy designation for NVL-520 based on
preliminary data from our ARROS-1 study." said Alexandra Balcom, Chief Financial Officer at
Nuvalent. "We now have two global registration-directed studies
underway in support of our target of a first approved product in
2026 and we look forward to providing updates on both of our
parallel lead programs at medical meetings later this year."
"Our ability to deliver on our program goals is interconnected
with our ability to build the team and maintain a strong culture
centered around our core values of Patient Impact, Empowerment, and
Collaboration. In recognition of his leadership and contributions
across these areas, we are proud to announce the promotion of
Matthew Metivier to Senior Vice
President of Human Resources," said James Porter, Ph.D., Chief Executive Officer at
Nuvalent. "Backed by a dedicated and expert team, and a strong
balance sheet, we are well positioned to continue delivering on our
planned 2024 milestones across our portfolio of precisely
targeted therapies for patients with cancer."
Recent Pipeline Progress and Anticipated Milestones
ROS1 Program
- The U.S. Food and Drug Administration (FDA) has granted
breakthrough therapy designation (BTD) to NVL-520 for the treatment
of patients with ROS1-positive metastatic non-small cell lung
cancer (NSCLC) who have been previously treated with 2 or more ROS1
tyrosine kinase inhibitors (TKIs). NVL-520 was previously granted
FDA Orphan Drug Designation for the treatment of ROS1-positive
NSCLC.
- The company expects to share updated data from the ARROS-1
Phase 1/2 trial at a medical meeting in 2024. Enrollment is ongoing
in the global Phase 2 portion of the study.
ALK Program
- Nuvalent recently announced the initiation of the Phase 2
portion of the ALKOVE-1 trial of NVL-655 for patients with advanced
ALK-positive NSCLC and other solid tumors, following alignment with
the FDA on a recommended Phase 2 dose (RP2D) of 150 mg once daily.
The Phase 2 portion of the ALKOVE-1 clinical trial is designed to
evaluate the safety and activity of NVL-655 in several expansion
cohorts of patients defined based on the number and type of prior
anti-cancer therapies they have received. The Phase 2 cohorts are
designed with registrational intent for TKI pre-treated patients
with ALK-positive NSCLC and to enable preliminary evaluation in
patients with ALK-positive NSCLC who are TKI naïve.
- The company expects to share updated data from the ALKOVE-1
trial at a medical meeting and to outline its broader front-line
development strategy for its ALK program in 2024.
HER2 Program
- The company expects to initiate the Phase 1 trial for its HER2
program in 2024.
Recent Leadership Promotions
- Promotion of Matthew Metivier
to Senior Vice President of Human Resources: Mr. Metivier
brings over 20 years of experience in various human resources
leadership roles, specifically within the
biotechnology/pharmaceutical industry, with a focus on building
companies and guiding organizations through the early development
phase to commercial launch. At Nuvalent, Mr. Metivier has built and
led our Human Resources capabilities and facilitated our people and
culture strategy to ensure we optimize our work environment to
attract, retain and develop the talent needed to achieve our
mission. Prior to joining Nuvalent, he held leadership roles of
increasing responsibility in human resources at Gamida Cell, Ltd,
Sage Therapeutics, Inc, and Infinity Pharmaceuticals. Mr. Metivier
holds an MBA from Suffolk University
with a concentration in Organizational Behavior and a B.A. in
Political Science and Business Studies from Providence College.
Upcoming Events
- TD Cowen 44th Annual Health Care
Conference: Management will be participating in a fireside
chat on Wednesday, March 6, 2024, at
1:30 p.m. ET in Boston, MA.
- Leerink Global Biopharma Conference 2024: Management
will be participating in a fireside chat on Tuesday, March 12, 2024, at 8:00 a.m. ET in Miami,
FL.
A live webcast of each fireside chat will be available in the
Investors section of Nuvalent's website at www.nuvalent.com, and
will be archived for 30 days following the conference.
Fourth Quarter and Full Year 2023 Financial Results
- Cash Position: Cash, cash equivalents and
marketable securities were $719.9
million as of December 31,
2023. Nuvalent believes these existing cash, cash
equivalents and marketable securities to be sufficient to fund its
current operating plan into 2027.
- R&D Expenses: Research and development
(R&D) expenses were $35.6 million
for the fourth quarter of 2023 and $113.2
million for the year ended December
31, 2023.
- G&A Expenses: General and administrative
(G&A) expenses were $10.9 million
for the fourth quarter of 2023 and $36.2
million for the year ended December
31, 2023.
- Net Loss: Net loss was $38.3
million for the fourth quarter of 2023 and $126.2 million for the year ended December 31, 2023.
About OnTarget 2026
OnTarget 2026 delineates Nuvalent's 3-year operating plan
towards bringing new, potential best-in-class medicines to patients
with cancer. As part of this plan announced in January 2024, Nuvalent outlined the following
anticipated milestones throughout 2024, leading to the company's
first potential pivotal data in 2025 and first potential approved
product in 2026:
- 2024: Execute on Global Registrational Strategies
- Progress the Phase 2 portion of its ARROS-1 trial of NVL-520 in
patients with advanced ROS1-positive NSCLC with registrational
intent;
- Initiate the Phase 2 portion of its ALKOVE-1 trial of NVL-655
in patients with advanced ALK-positive NSCLC with registrational
intent;
- Launch the front-line development strategy for its ALK
program;
- Present interim data from its ongoing ARROS-1 and ALKOVE-1
clinical trials at medical meetings; and,
- Initiate the Phase 1 trial for its HER2 program.
- 2025: First Pivotal Data
- 2026: First Approved Product
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
investigational candidates for ROS1-positive, ALK-positive, and
HER2-positive non-small cell lung cancer, and multiple
discovery-stage research programs.
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 period over
which Nuvalent estimates its cash, cash equivalents and marketable
securities will be sufficient to fund its future operating expenses
and capital expenditure requirements; Nuvalent's estimate of its
cash, cash equivalents and marketable securities as of December 31, 2023; the expected timing of data
announcements, clinical trial initiations and FDA product
approvals, including the projections in our OnTarget 2026 operating
plan; the preclinical and clinical development programs for
NVL-520, NVL-655 and NVL-330; the potential clinical effect of
NVL-520 and NVL-655; the potential benefits of NVL-330; the design
and enrollment of the ARROS-1 and ALKOVE-1 trials, including their
intended pivotal registration-directed design; the potential of
Nuvalent's pipeline programs, including NVL-520, NVL-655 and
NVL-330; the implications of data readouts and presentations;
timing and content of potential discussions with regulators and
investigators; the design and timing of the planned Phase 2 portion
of the ARROS-1 and ALKOVE-1 trials; Nuvalent's research and
development programs for the treatment of cancer; and risks and
uncertainties associated with drug development. 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 that
Nuvalent may not fully enroll the ARROS-1 or ALKOVE-1 trials or
that enrollment will take longer than expected; unexpected concerns
that may arise from additional data, analysis, or results obtained
during preclinical studies or clinical trials; the risk that
results of earlier clinical trials may not be predictive of the
results of later-stage clinical trials; the risk that data from our
clinical trials may not be sufficient to support registration and
that Nuvalent may be required to conduct one or more additional
studies or trials prior to seeking registration of our product
candidates; risks that Nuvalent may not achieve the goals and
milestones set forth in its OnTarget 2026 operating plan; the
occurrence of adverse safety events; risks that the FDA may not
approve our potential products on the timelines we expect, or at
all; risks of unexpected costs, delays, or other unexpected
hurdles; risks that Nuvalent may not be able to nominate drug
candidates from its discovery programs; the direct or indirect
impact of public health emergencies or global geopolitical
circumstances on the timing and anticipated timing and results of
Nuvalent's clinical trials, strategy, and future operations,
including the ARROS-1 and ALKOVE-1 trials; the timing and outcome
of Nuvalent's planned interactions with regulatory authorities; and
risks related to obtaining, maintaining, and protecting Nuvalent's
intellectual property. These and other risks and uncertainties are
described in greater detail in the section entitled "Risk Factors"
in Nuvalent's Quarterly Report on Form 10-Q for the quarterly
period ended September 30, 2023, as
well as any prior and 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.
SELECTED STATEMENTS
OF OPERATIONS DATA
|
|
(In thousands,
except share and per share data)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
|
Year Ended December
31,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
35,585
|
|
|
$
|
22,855
|
|
|
$
|
113,243
|
|
|
$
|
63,731
|
|
General and
administrative
|
|
|
10,852
|
|
|
|
6,444
|
|
|
|
36,249
|
|
|
|
22,377
|
|
Total operating
expenses
|
|
|
46,437
|
|
|
|
29,299
|
|
|
|
149,492
|
|
|
|
86,108
|
|
Loss from
operations
|
|
|
(46,437)
|
|
|
|
(29,299)
|
|
|
|
(149,492)
|
|
|
|
(86,108)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income and
other income (expense), net
|
|
|
8,145
|
|
|
|
3,176
|
|
|
|
23,273
|
|
|
|
4,254
|
|
Total other income
(expense), net
|
|
|
8,145
|
|
|
|
3,176
|
|
|
|
23,273
|
|
|
|
4,254
|
|
Net loss
|
|
$
|
(38,292)
|
|
|
$
|
(26,123)
|
|
|
$
|
(126,219)
|
|
|
$
|
(81,854)
|
|
Net loss per share
attributable to
common
stockholders, basic and diluted
|
|
$
|
(0.62)
|
|
|
$
|
(0.49)
|
|
|
$
|
(2.17)
|
|
|
$
|
(1.65)
|
|
Weighted average
shares of common stock
outstanding, basic and diluted
|
|
|
62,183,325
|
|
|
|
53,616,336
|
|
|
|
58,223,339
|
|
|
|
49,668,864
|
|
SELECTED BALANCE
SHEET DATA
|
|
(In
thousands)
|
|
(Unaudited)
|
|
|
|
December
31,
|
|
|
|
2023
|
|
|
2022
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
719,905
|
|
|
$
|
472,163
|
|
Working
capital
|
|
$
|
694,665
|
|
|
$
|
458,510
|
|
Total assets
|
|
$
|
732,384
|
|
|
$
|
482,459
|
|
Total
liabilities
|
|
$
|
31,823
|
|
|
$
|
19,481
|
|
Total stockholders'
equity
|
|
$
|
700,561
|
|
|
$
|
462,978
|
|
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SOURCE Nuvalent, Inc.