Preliminary Phase 1 clinical data from ARROS-1
Study presented at the 2022 EORTC-NCI-AACR Symposium supports
best-in-class potential of NVL-520 for patients with ROS1-positive
NSCLC
Enrollment progressing in ALKOVE-1 Phase 1/2
trial with parallel-lead candidate, NVL-655, for ALK-positive
NSCLC
NVL-330 demonstrates potency and selectivity
for HER2 Exon 20 insertion mutations, and brain penetration in
preclinical studies
$264.5 million
upsized public offering along with cash, cash equivalents, and
marketable securities as of September 30,
2022 expected to extend operating runway into second half of
2025
CAMBRIDGE, Mass., Nov. 10,
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 recent business and pipeline
progress and third quarter 2022 financial results.
"This has been a transformational year for Nuvalent, exemplified
by the totality of the data presented at EORTC-NCI-AACR (ENA) which
showcased the rapid and meaningful progress our team has made
towards our mission of delivering a portfolio of precisely
targeted therapies for patients with cancer," said James Porter, Ph.D., Chief Executive Officer at
Nuvalent. "Importantly, we reported preliminary data from the Phase
1 portion of our ARROS-1 study for NVL-520 in heavily pre-treated
patients with ROS1-positive non-small cell lung cancer (NSCLC),
representing the first clinical proof-of-concept data from our
portfolio. We believe these data support the planned investigation
of NVL-520 in the treatment-naïve setting as part of the next phase
of our study and continue to support the best-in-class potential of
NVL-520 for the treatment of patients with ROS1-positive NSCLC. We
look forward to engaging with regulators to discuss the recommended
Phase 2 dose and beginning the Phase 2 portion of the ARROS-1
trial."
Dr. Porter continued, "Furthermore, the learnings from our work
on NVL-520 and the ARROS-1 trial have directly informed our
parallel lead program, NVL-655, and the design of the ALKOVE-1
trial for patients with ALK-positive NSCLC, as well as our
earlier-stage pipeline including our third development candidate,
NVL-330. Data supporting the differentiated preclinical profiles of
NVL-655 and NVL-330 were presented at ENA. Enrollment in the Phase
1 portion of the ALKOVE-1 study continues, and we look forward to
updating on each of these programs in the future."
"In just a few years from the company's creation, we have
brought forward three potential best-in-class molecules and
delivered clinical proof-of-concept data from our first program,
which is a testament to the strength of our team and our ability to
execute," added Alexandra Balcom,
Chief Financial Officer at Nuvalent. "This execution enabled us to
complete an upsized public offering of our common stock that
meaningfully extends our expected operating runway and fuels the
continued advancement of our clinical-stage pipeline with NVL-520
and NVL-655, as well as our early research and development
pipeline, led by NVL-330. With a founding scientific thesis that we
have started to see play out in the clinic, this is an energizing
time for Nuvalent and we are excited to carry this momentum
forward."
Pipeline Progress
- Preliminary Dose-Escalation Data from Ongoing ARROS-1 Trial
Demonstrates Proof-of-Concept for NVL-520's Potential Best-in-Class
Clinical Profile: Initial data from the Phase 1 dose-escalation
portion of Nuvalent's ongoing ARROS-1 Phase 1/2 clinical trial of
NVL-520, its novel, brain-penetrant, ROS1-selective inhibitor, as a
potential treatment for patients with advanced ROS1-positive NSCLC
and other solid tumors were presented during the "New Drugs on the
Horizon" plenary session at ENA 2022. Data presented showed that a
favorable preliminary safety profile was observed with NVL-520
treatment with no dose-limiting toxicities, treatment-related
serious adverse events, treatment-related dizziness, or adverse
events leading to treatment reductions or discontinuations.
Additionally, treatment with NVL-520 resulted in encouraging
preliminary signs of activity observed across all dose levels in
heavily pre-treated patients with ROS1-positive NSCLC, including in
subgroups of patients with G2032R resistance mutation or with brain
metastases.
The ARROS-1 clinical trial is continuing to enroll patients in the
Phase 1 portion of the study and is focused on further
characterizing the safety profile of NVL-520, its pharmacokinetic
profile, and determining the recommended Phase 2 dose.
- New Data in Patient-Derived Models Continues to Support
Best-in-Class Preclinical Profile of Parallel Lead Candidate,
NVL-655: A poster presented at ENA 2022 included new
preclinical data on NVL-655, Nuvalent's brain penetrant,
ALK-selective inhibitor, in additional patient derived models
harboring single and compound ALK resistance mutations. Notably,
NVL-655 induced regression in an in vivo model derived from a
patient with ALK fusion-positive NSCLC harboring G1202R/L1196M
compound mutation after disease progression on sequential
crizotinib, alectinib and lorlatinib treatment. Among all
inhibitors tested, NVL-655 showed the broadest preclinical activity
across ALK fusion partners and resistance mutations while
maintaining a wide selectivity window over TRKB.
Clinical investigation of NVL-655 is ongoing and enrollment is
progressing in the Phase 1 portion of the ALKOVE-1 Phase 1/2 study
of NVL-655 for patients with advanced ALK-positive NSCLC and other
solid tumors. The Phase 1 portion of the ALKOVE-1 trial is focused
on characterizing the safety profile of NVL-655, its
pharmacokinetic profile, and determining the recommended Phase 2
dose.
- Preclinical Profile of NVL-330 Demonstrates Achievement of
Target Characteristics of Potency and Selectivity for HER2 Exon 20
Insertion Mutations, and Brain Penetration: Nuvalent presented
preclinical data characterizing its third development candidate,
NVL-330, a novel, brain-penetrant HER2-selective tyrosine kinase
inhibitor targeting HER2 exon 20 insertion mutations (HER2ex20)
during a poster session at ENA 2022. Preclinical data demonstrated
that NVL-330 potently inhibited HER2ex20 in cell-based assays and
was highly selective for HER2ex20 as opposed to the structurally
related wild-type EGFR and other off-target kinases – a critical
aspect of NVL-330's design given that off-target inhibition of EGFR
results in dose-limiting side effects including skin rash and
gastrointestinal toxicity. In addition, given its demonstrated
preclinical brain penetrance and intracranial activity, NVL-330 has
the potential to treat or prevent brain metastasis as a potential
best-in-class molecule.
Financing Highlight
- Completed Upsized Public Offering of Common Stock Raising
$264.5 Million in Gross Proceeds:
On November 3, 2022, Nuvalent closed
an upsized underwritten public offering of 7,895,522 shares of
Class A common stock at a price to the public of $33.50 per share. The gross proceeds from the
offering were approximately $264.5
million, before deducting underwriting discounts,
commissions and other offering expenses, which when combined with
the company's existing cash, cash equivalents and marketable
securities as of September 30, 2022,
is expected to extend the company's operating runway into the
second half of 2025.
Upcoming Events
- Evercore ISI HealthCONx Conference 2022: Management will
be participating in a fireside chat during the Evercore ISI
HealthCONx Conference 2022 on Wednesday,
November 30, 2022, at 8:50 a.m.
ET.
- The Piper Sandler 34th Annual Healthcare
Conference: Management will be participating in a fireside chat
during The Piper Sandler 34th Annual Healthcare
Conference on Thursday, December 1,
2022, at 9:00 a.m. ET.
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 2022 Financial Results
- Cash Position: Cash, cash equivalents and marketable
securities were $240.1 million as of September 30,
2022. The company's cash, cash equivalents and marketable
securities as of September 30, 2022,
in combination with the proceeds from the follow-on offering, are
expected to be sufficient to fund the company's current operating
plan into the second half of 2025.
- R&D Expenses: Research and development
(R&D) expenses were $14.6 million for the third quarter of
2022.
- G&A Expenses: General and administrative
(G&A) expenses were $5.8 million for the third quarter of
2022.
- Net Loss: Net loss for the third quarter of 2022
was $19.7 million, or $0.41 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 (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 and the proceeds from its follow-on public offering will
be sufficient to fund its future operating expenses and capital
expenditure requirements; 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 ALK IXDN and other 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
Quarterly Report on Form 10-Q for the quarterly period
ended June 30, 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
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
14,625
|
|
|
$
|
9,055
|
|
|
$
|
40,876
|
|
|
$
|
22,365
|
|
General and
administrative
|
|
|
5,763
|
|
|
|
3,372
|
|
|
|
15,933
|
|
|
|
6,074
|
|
Total operating
expenses
|
|
|
20,388
|
|
|
|
12,427
|
|
|
|
56,809
|
|
|
|
28,439
|
|
Loss from
operations
|
|
|
(20,388)
|
|
|
|
(12,427)
|
|
|
|
(56,809)
|
|
|
|
(28,439)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of preferred stock
tranche
rights
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(635)
|
|
Other income,
net
|
|
|
672
|
|
|
|
1
|
|
|
|
1,078
|
|
|
|
25
|
|
Total other income
(expense), net
|
|
|
672
|
|
|
|
1
|
|
|
|
1,078
|
|
|
|
(610)
|
|
Net loss
|
|
$
|
(19,716)
|
|
|
$
|
(12,426)
|
|
|
$
|
(55,731)
|
|
|
$
|
(29,049)
|
|
Net loss per share
attributable to
common
stockholders, basic and diluted
|
|
$
|
(0.41)
|
|
|
$
|
(0.39)
|
|
|
$
|
(1.15)
|
|
|
$
|
(2.26)
|
|
Weighted average
shares of common
stock
outstanding, basic and diluted
|
|
|
48,410,514
|
|
|
|
32,066,089
|
|
|
|
48,338,580
|
|
|
|
12,858,574
|
|
SELECTED BALANCE
SHEET DATA
|
|
(In
thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
|
December
31,
|
|
|
|
2022
|
|
|
2021
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
240,064
|
|
|
$
|
288,111
|
|
Working
capital
|
|
$
|
232,270
|
|
|
$
|
281,841
|
|
Total assets
|
|
$
|
249,558
|
|
|
$
|
293,824
|
|
Total
liabilities
|
|
$
|
12,975
|
|
|
$
|
8,787
|
|
Total stockholders'
equity
|
|
$
|
236,583
|
|
|
$
|
285,037
|
|
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SOURCE Nuvalent, Inc.