Preliminary dose-escalation data anticipated
in second half of 2023 from ongoing ALKOVE-1 Phase 1/2 clinical
trial of NVL-655 for patients with advanced ALK-positive NSCLC and
other solid tumors
Strong financial position with expected
operating runway into the second half of 2025
CAMBRIDGE, Mass., May 11, 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 announced plans to share preliminary data from the
dose-escalation portion of its ongoing ALKOVE-1 Phase 1/2 clinical
trial for NVL-655, a novel ALK-selective inhibitor, in the second
half of 2023, and reported first quarter 2023 financial
results.
ALKOVE-1 is a Phase 1/2, multicenter, open-label,
dose-escalation and expansion trial evaluating NVL-655 in patients
with advanced ALK-positive non-small cell lung cancer (NSCLC) and
other solid tumors. The Phase 1 dose-escalation portion of the
study is enrolling patients with previously treated ALK-positive
solid tumors and will evaluate the overall safety and tolerability
of NVL-655. Additional objectives include determination of the
recommended Phase 2 dose (RP2D), characterization of the
pharmacokinetic profile, and evaluation of preliminary anti-tumor
activity. Preclinical data, including those presented
recently at the American Association for Cancer Research
(AACR) Annual Meeting 2023, demonstrated that NVL-655 had broad
preclinical activity across diverse ALK oncoproteins, single and
compound resistance mutations, and tumor types while maintaining
strong selectivity for ALK over TRKB and CNS penetrance.
"2023 is a year of focused, data-driven execution towards our
goal of delivering a pipeline of novel kinase inhibitors to
patients as efficiently as possible," said James Porter, Ph.D., Chief Executive Officer at
Nuvalent. "We plan to report preliminary data from our ALKOVE-1
trial of NVL-655 for patients with advanced ALK-positive NSCLC and
other solid tumors in the second half of the year. We continue to
enroll patients in the Phase 1 portion of the ARROS-1 trial of
NVL-520 for advanced ROS1-positive NSCLC and other solid tumors in
support of RP2D selection, and to advance NVL-330, our novel
HER2-selective inhibitor for patients with HER2 exon 20
insertion-positive cancers, through IND-enabling studies. With a
solid cash position and an expert team, we are well-positioned to
deliver on both our near- and long-term goals."
First Quarter 2023 Financial Results
- Cash Position & Operating Runway: Cash, cash
equivalents and marketable securities were $450.5
million as of March 31, 2023. Nuvalent believes the
existing cash, cash equivalents and marketable securities are
expected to be sufficient to fund its current operating plan into
the second half of 2025.
- R&D Expenses: Research and development (R&D)
expenses were $22.1 million for the first quarter of
2023.
- G&A Expenses: General and administrative
(G&A) expenses were $8.1 million for the first quarter of
2023.
- Net Loss: Net loss for the first quarter of 2023
was $25.2 million, or $0.44 per
share.
About NVL-655
NVL-655 is a novel brain-penetrant
ALK-selective inhibitor created 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
the solvent front G1202R mutation or compound mutations G1202R /
L1196M ("GRLM"), G1202R / G1269A ("GRGA"), or G1202R/L1198F
("GRLF"). NVL-655 has been optimized for CNS penetrance to improve
treatment options for patients with brain metastases. NVL-655 has
been observed in preclinical studies to selectively inhibit
wild-type ALK and its resistance variants over the structurally
related tropomyosin receptor kinase (TRK) family to potentially
avoid TRK-related CNS adverse events seen with dual TRK/ALK
inhibitors and drive more durable responses for patients. NVL-655
is currently being investigated in the ALKOVE-1 study
(NCT05384626), a first-in-human Phase 1/2 clinical trial for
patients with advanced ALK-positive NSCLC and other solid
tumors.
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), a program in
HER2 Exon 20 insertion-positive cancers, and multiple
discovery-stage research programs. We routinely post information
that may be important to investors on our website
at 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 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 studies; the potential
of Nuvalent's pipeline programs, including NVL-520, NVL-655 and
NVL-330; 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 studies 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 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 COVID-19 or other 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 studies; 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 Annual Report
on Form 10-K for the year ended December 31, 2022, 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
March 31,
|
|
|
|
|
2023
|
|
|
2022
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
$
|
22,125
|
|
|
$
|
12,693
|
|
General and
administrative
|
|
|
|
8,085
|
|
|
|
4,995
|
|
Total operating
expenses
|
|
|
|
30,210
|
|
|
|
17,688
|
|
Loss from
operations
|
|
|
|
(30,210)
|
|
|
|
(17,688)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest income and
other income, net
|
|
|
|
5,018
|
|
|
|
139
|
|
Total other income,
net
|
|
|
|
5,018
|
|
|
|
139
|
|
Net loss
|
|
|
$
|
(25,192)
|
|
|
$
|
(17,549)
|
|
Net loss per share
attributable to
common
stockholders, basic and diluted
|
|
|
$
|
(0.44)
|
|
|
$
|
(0.36)
|
|
Weighted average
shares of common stock
outstanding, basic and diluted
|
|
|
|
56,703,873
|
|
|
|
48,284,778
|
|
SELECTED BALANCE
SHEET DATA
|
|
(In
thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
|
December
31,
|
|
|
|
2023
|
|
|
2022
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
450,462
|
|
|
$
|
472,163
|
|
Working
capital
|
|
$
|
439,272
|
|
|
$
|
458,510
|
|
Total assets
|
|
$
|
460,989
|
|
|
$
|
482,459
|
|
Total
liabilities
|
|
$
|
17,021
|
|
|
$
|
19,481
|
|
Total
stockholders' equity
|
|
$
|
443,968
|
|
|
$
|
462,978
|
|
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SOURCE Nuvalent, Inc.