Targeting first approved product in 2026
towards realizing mission of bringing new, potential best-in-class
treatments to patients with cancer
Well-capitalized to support OnTarget 2026
initiatives with operating runway anticipated into 2027
Company to present at 42nd Annual
J.P. Morgan Healthcare Conference on Tuesday, January 9th at 7:30 a.m. PT
CAMBRIDGE, Mass., Jan. 8, 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 announced its
"OnTarget 2026" operating plan to guide efforts towards having its
first potential approved product in 2026.
"Over the last three years, Nuvalent has evolved from an
emerging preclinical-stage start-up to an established biotech
leader in advanced clinical development. In this period, we have
disclosed three novel programs, demonstrated preliminary
proof-of-concept for our two lead clinical programs, and launched
our first registration-directed study," said James Porter, Ph.D., Chief Executive Officer at
Nuvalent. "These accomplishments demonstrate a track record of
successful execution and resolute focus on our founding goal: to
translate our expertise in chemistry and structure-based drug
design into potential best-in-class treatments for patients with
cancer."
Dr. Porter continued, "2024
marks the beginning of the 'next 3 years' culminating in our
first potential FDA approval expected in 2026, a critical milestone
towards fulfilling our commitment to patients. Throughout this
year, our priority is on execution of the global registrational
strategies for our ROS1 and ALK programs that underpin our ultimate
goal of moving up the treatment paradigm, including the potential
launch of our first-line ALK strategy. We expect pivotal data from
at least one of our parallel-lead programs in 2025 in support of
potential New Drug Application submissions in 2026. By 2026, we
also anticipate further advancing our HER2 program and our pipeline
of discovery programs."
"OnTarget 2026' outlines a clear set of mission-driven
priorities that also deliver multiple transformative catalysts for
our stakeholders over the short, intermediate, and long term," said
Alexandra Balcom, Chief Financial
Officer at Nuvalent. "Backed by strong product candidates,
scientific rigor, and a bolstered balance sheet, we believe we are
well positioned to continue achieving our goals as a growing team
aligned around a firm commitment to patient impact."
OnTarget 2026: The Path to Patient Impact
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, Nuvalent expects to achieve 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;
- Initiate the Phase 1 trial for its HER2 program; and,
- Present interim data from its ongoing ARROS-1 and ALKOVE-1
clinical trials at medical meetings.
- 2025: First Pivotal Data
- 2026: First Approved Product
2023 Year-End Cash and Guidance
Nuvalent ended 2023 with approximately $719.9 million in cash, cash equivalents and
marketable securities (unaudited), which, based on its current
operating plans, is expected to fund its operations into
2027. This amount is a preliminary, unaudited estimate only
as of today, could change following completion of year-end closing
procedures, and does not present all information necessary for an
understanding of our financial position as of December 31, 2023.
Presentation at 42nd Annual J.P. Morgan Healthcare
Conference
Dr. Porter will present at the 42nd Annual J.P.
Morgan Healthcare Conference in San
Francisco on Tuesday, January 9,
2024 at 7:30 a.m. PT in
San Francisco. A live webcast 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.
About NVL-520
NVL-520 is a brain-penetrant ROS1-selective inhibitor created
with the aim to overcome limitations observed with currently
available ROS1 inhibitors. NVL-520 is designed to remain active in
tumors that have developed resistance to currently available ROS1
inhibitors, including tumors with treatment-emergent ROS1 mutations
such as G2032R. In addition, NVL-520 is designed for brain
penetrance to potentially improve treatment options for patients
with brain metastases, and to avoid inhibition of the structurally
related tropomyosin receptor kinase (TRK) family. Together, these
characteristics have the potential to avoid TRK-related CNS adverse
events seen with dual TRK/ROS1 inhibitors and to drive deep,
durable responses for patients across all lines of therapy. NVL-520
has received orphan drug designation for ROS1+ non-small cell lung
cancer (NSCLC) and is currently being investigated in the ARROS-1
trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for
patients with advanced NSCLC and other solid tumors.
About NVL-655
NVL-655 is a novel brain-penetrant ALK-selective inhibitor
created with the aim to overcome limitations observed with
currently available ALK inhibitors. NVL-655 is designed to remain
active in tumors that have developed resistance to first-, second-,
and third-generation ALK inhibitors, including tumors with both
single or compound treatment-emergent ALK mutations such as those
involving G1202R. In addition, NVL-655 is designed for CNS
penetrance to improve treatment options for patients with brain
metastases, and to avoid inhibition of the structurally related
tropomyosin receptor kinase (TRK) family. Together, these
characteristics have the potential to avoid TRK-related CNS adverse
events seen with dual TRK/ALK inhibitors and to drive deep, durable
responses for patients across all lines of therapy. NVL-655 has
received orphan drug designation for ALK+ non-small cell lung
cancer (NSCLC) and is currently being investigated in the ALKOVE-1
clinical trial (NCT05384626), a first-in-human Phase 1/2 clinical
trial for patients with advanced ALK-positive NSCLC and other solid
tumors.
About NVL-330
NVL-330 is a novel, brain-penetrant, and HER2-selective tyrosine
kinase inhibitor designed to address the combined medical need of
treating HER2-mutant tumors, including those with HER2 exon 20
insertion mutations, avoiding treatment related adverse events due
to off-target inhibition of wild-type EGFR, and treating brain
metastases.
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 and FDA product
approvals; 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; 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;
risks related to obtaining, maintaining, and protecting Nuvalent's
intellectual property; and the risk that Nuvalent's estimate of its
cash, cash equivalents and marketable securities as of December 31, 2023 may differ from the final
amount determined upon completion of its year-end closing
procedures. 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/nuvalent-announces-ontarget-2026-operating-plan-and-key-anticipated-milestones-302028095.html
SOURCE Nuvalent, Inc.