Presented preliminary Phase 1 clinical data
from ALKOVE-1 trial of NVL-655, initiated Phase 2 portion of
ARROS-1 trial of NVL-520, and continued advancement of NVL-330
toward clinical development
Appointed industry veteran Perrin Wilson Ph.D.
as Senior Vice President of Business Development and
Strategy
Net proceeds from $300
million public offering, along with cash, cash equivalents,
and marketable securities as of September
30, 2023, expected to extend operating runway into
2027
CAMBRIDGE, Mass., Nov. 14,
2023 /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 and reported third quarter 2023 financial
results.
"This has been another incredible year of execution for
Nuvalent. With our recent presentation at ANE, we have now
delivered preliminary proof-of-concept data for both of our novel
parallel lead programs in ROS1 and ALK-positive cancers, and our
third development candidate, NVL-330, is advancing toward clinical
development," said James Porter,
Ph.D., Chief Executive Officer at Nuvalent. "This level of
achievement in just over five years since first program inception
is only made possible by the tireless dedication of our team to our
goal of delivering potential new therapies to patients as quickly
as possible."
Dr. Porter continued, "As we turn our focus towards execution on
our global development plans to support potential NDA submission
and continued portfolio expansion, we are committed to maintaining
the high standard and sense of urgency we have established to date.
We continue to grow our team in support of this next phase of
development and are thrilled to welcome Dr. Perrin Wilson, who brings deep expertise in both
business development and commercial strategy."
"We are encouraged by the positive reception to our progress and
continued support from both new and longstanding stockholders,
leading to a successful $300 million
public offering," added Alexandra
Balcom, Chief Financial Officer at Nuvalent. "With a strong
portfolio, proven team, and meaningful cash runway extension
expected into 2027, we believe we are well positioned to evaluate
opportunities to further accelerate and expand the potential reach
of our programs, and to deliver on our mid- and long-term
goals."
Recent Pipeline Highlights and Key Anticipated
Milestones
- Reported Preliminary Phase 1 Clinical Data from ALKOVE-1
Trial that Support Best-In-Class Potential of NVL-655 for Patients
with ALK-Positive NSCLC: Nuvalent recently reported preliminary
dose-escalation data from the Phase 1 portion of its ongoing
ALKOVE-1 Phase 1/2 clinical trial in patients with advanced
ALK-positive non-small cell lung cancer (NSCLC) at the 35th
AACR-NCI-EORTC Symposium in Boston,
Massachusetts. Preliminary activity was demonstrated in
heavily pre-treated patients with ALK-positive NSCLC, including in
subgroups of patients who had likely exhausted all available
therapies including lorlatinib, had a history of brain metastases,
or had single or compound ALK resistance mutations. Additionally,
NVL-655 demonstrated a favorable preliminary safety profile
consistent with its ALK-selective, TRK sparing design.
The ALKOVE-1 clinical trial is continuing to enroll patients in the
Phase 1 portion of the trial and is focused on further
characterizing the safety, pharmacokinetics, and pharmacodynamic
profiles, determining the recommended Phase 2 dose (RP2D), and if
applicable, the maximum tolerated dose of NVL-655. Upon RP2D
selection, the trial is designed to transition directly into the
Phase 2 portion, which will 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 intended to support potential
registration in patients with ALK-positive NSCLC who are both
lorlatinib-naïve and lorlatinib-treated.
In addition to the planned Phase 2 cohorts, Nuvalent intends to use
these preliminary data in patients with heavily pre-treated
ALK-positive NSCLC to guide discussions with physicians that will
inform development strategies in TKI-naïve ALK-positive NSCLC.
- Initiated the Phase 2 Portion of the ARROS-1 Trial of
NVL-520 with Registrational Intent for Patients with Advanced
ROS1-positive NSCLC: Nuvalent announced the initiation of the
Phase 2 portion of ARROS-1 trial following alignment with the US
Food and Drug Administration (FDA) on a RP2D of 100 mg daily. The
Phase 2 portion of the trial includes potential registrational
cohorts for patients with TKI-naïve and TKI-pretreated
ROS1-positive NSCLC. The company expects to share updated data from
the ARROS-1 trial at a medical meeting in 2024.
- Advancing NVL-330 through IND-enabling Studies: Nuvalent
is continuing to advance NVL-330, its novel HER2-selective
inhibitor in development for the treatment of HER2 exon 20
insertion-positive cancers, through IND-enabling studies.
Recent Leadership Appointments
- Strengthened Leadership Team with Appointment of
Perrin Wilson, Ph.D., as
Senior Vice President of Business Development &
Strategy: Dr. Wilson brings over 15 years of experience
across business development and commercial functions, including
leading deals from research stage to company acquisitions and
integrations, championing brand strategy and product launches.
Before joining Nuvalent, Dr. Wilson held positions of increasing
responsibility at Forma Therapeutics/Novo Nordisk, including Head
of Forma Business Development and Integration Management Office,
Vice President Business Development and Senior Director Global
Marketing, Sickle Cell Disease Strategy. During her time at Forma,
Dr. Wilson led the Novo Nordisk acquisition and the out-licensing
of Forma's oncology portfolio to three different partners, and was
responsible for developing the global brand plan for Forma's lead
molecule and supporting ex-US and lifecycle management strategy.
Prior to Forma, Dr. Wilson spent seven years at Takeda in various
business development and commercial roles leading several
transactions to strengthen Takeda's oncology pipeline, including
the acquisition of ARIAD, and leading the global strategy and
pre-launch preparations for Takeda's myelodysplastic syndromes
program. Dr. Wilson received her B.Sc. degree in biology from
Lafayette College and a Ph.D. in
biomedical sciences from The Rockefeller
University.
Financing Highlight
Completed Successful Public Offering of
Common Stock Raising $300 Million in
Gross Proceeds: On October 19,
2023, Nuvalent closed an underwritten public offering of
5,357,143 shares of Class A common stock at a price to the public
of $56.00 per share. The gross
proceeds from the offering were approximately $300 million, resulting in net proceeds of
approximately $282 million after
deducting underwriting discounts, commissions and other offering
expenses.
Upcoming Events
- Stifel 2023 Healthcare Conference: Management will be
participating in a fireside chat on Wednesday, November 15, 2023, at 12:00 pm ET in New
York, NY.
- Piper Sandler 35th
Annual Healthcare Conference: Management will be participating
in a fireside chat on Wednesday, November
29, 2023, at 1:00 pm ET in
New York, NY.
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.
Third Quarter 2023 Financial Results
- Cash Position & Operating Runway: Cash, cash
equivalents and marketable securities were $413.3 million as of September 30, 2023. The company's cash, cash
equivalents and marketable securities as of September 30, 2023, in combination with the net
proceeds from the public offering of approximately $282 million, are expected to extend the
company's operating runway into 2027.
- R&D Expenses: Research and development (R&D)
expenses were $29.6 million for the third quarter of
2023.
- G&A Expenses: General and administrative (G&A)
expenses were $9.2 million for the third quarter of 2023.
- Net Loss: Net loss for the third quarter of 2023
was $33.6 million, or $0.59 per
share.
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, a program in HER2 Exon 20
insertion-positive cancers, 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; the expected timing of data
announcements; 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 for
the ARROS-1 trial its 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 trial; 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 the
ARROS-1 Phase 2 trial 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 NVL-520; the
occurrence of adverse safety events; 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 June 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.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
SELECTED STATEMENTS
OF OPERATIONS DATA
|
|
(In thousands,
except share and per share data)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
29,611
|
|
|
$
|
14,625
|
|
|
$
|
77,658
|
|
|
$
|
40,876
|
|
General and
administrative
|
|
|
9,172
|
|
|
|
5,763
|
|
|
|
25,397
|
|
|
|
15,933
|
|
Total operating
expenses
|
|
|
38,783
|
|
|
|
20,388
|
|
|
|
103,055
|
|
|
|
56,809
|
|
Loss from
operations
|
|
|
(38,783)
|
|
|
|
(20,388)
|
|
|
|
(103,055)
|
|
|
|
(56,809)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income and
other income
(expense)
|
|
|
5,138
|
|
|
|
672
|
|
|
|
15,128
|
|
|
|
1,078
|
|
Total other income,
net
|
|
|
5,138
|
|
|
|
672
|
|
|
|
15,128
|
|
|
|
1,078
|
|
Net loss
|
|
$
|
(33,645)
|
|
|
$
|
(19,716)
|
|
|
$
|
(87,927)
|
|
|
$
|
(55,731)
|
|
Net loss per share
attributable to
common
stockholders, basic and diluted
|
|
$
|
(0.59)
|
|
|
$
|
(0.41)
|
|
|
$
|
(1.55)
|
|
|
$
|
(1.15)
|
|
Weighted average
shares of common stock
outstanding, basic and diluted
|
|
|
57,091,394
|
|
|
|
48,410,514
|
|
|
|
56,888,839
|
|
|
|
48,338,580
|
|
SELECTED BALANCE
SHEET DATA
|
|
(In
thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2023
|
|
|
2022
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
413,258
|
|
|
$
|
472,163
|
|
Working
capital
|
|
$
|
390,670
|
|
|
$
|
458,510
|
|
Total assets
|
|
$
|
425,080
|
|
|
$
|
482,459
|
|
Total
liabilities
|
|
$
|
29,103
|
|
|
$
|
19,481
|
|
Total stockholders'
equity
|
|
$
|
395,977
|
|
|
$
|
462,978
|
|
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SOURCE Nuvalent, Inc.