Two clinical-stage programs ongoing for
potential best-in-class ROS1 and ALK-selective inhibitors
On-track for selection of two additional
development candidates in 2022
Ended the first quarter of 2022 with
$272.7 million in cash, cash
equivalents, and marketable securities to support planned
operations into 2024
CAMBRIDGE, Mass., May 12, 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 pipeline and business progress
and first quarter 2022 financial results.
"At Nuvalent, we're building a fully integrated biotech company
with the goal to design, develop, and deliver a portfolio of
best-in-class therapies for patients with cancer. We view 2022 as a
critical year of execution and we have already made meaningful
progress across our pipeline. Enrollment is progressing well in the
ongoing Phase 1 portion of our ARROS-1 Phase 1/2 trial of NVL-520
for advanced ROS1-positive NSCLC and other solid tumors, and
following the recently announced clearance of the IND for NVL-655,
we are on track for planned initiation of our ALKOVE-1 Phase 1/2
study for advanced ALK-positive NSCLC and other solid tumors in the
second quarter of 2022," said James
Porter, Ph.D., Chief Executive Officer at Nuvalent. "By
year-end, our team has the potential to have delivered four novel
development candidates since company formation, with two clinical
trials underway. With an exceptional team and strong foundation in
place, I am confident in our ability to bring precisely
targeted therapies that can enable deeper and more durable
responses to patients with cancer."
Upcoming Pipeline
Milestones
- ALKOVE-1 Trial of NVL-655 for Patients with ALK-positive
Non-Small Cell Lung Cancer (NSCLC) Expected to Begin in Second
Quarter of 2022: Nuvalent has received confirmation from the
U.S. Food and Drug Administration (FDA) that its Investigational
New Drug (IND) application for NVL-655 has been cleared. The
company is on track to initiate the ALKOVE-1 Phase 1/2 study of
NVL-655 for patients with advanced ALK-positive NSCLC and other
solid tumors, anticipated in the second quarter of 2022. NVL-655 is
a novel ALK-selective inhibitor designed to address the clinical
challenges of emergent treatment resistance, CNS adverse events,
and brain metastases that may limit the use of currently available
ALK kinase inhibitors.
- Selection of Two Additional Development Candidates from
Discovery Pipeline Targeted in 2022: Nuvalent continues to
advance its pipeline expansion efforts with multiple
discovery-stage research programs. The company expects to select
development candidates for its programs directed toward ALK IXDN
compound resistance mutations and HER2 Exon 20 insertions in
2022.
Recent Business
Highlights
- Appointed Anna Protopapas as Chair of Board of
Directors: Nuvalent appointed Anna Protopapas, President and
Chief Executive Officer of Mersana Therapeutics, as Chair of its
Board of Directors in March 2022. Ms.
Protopapas joined Mersana in March
2015 and has a substantial track record of executive
leadership and business growth in the field of oncology. Her broad
industry experience ranges from global development to commercial
expertise with a focus on building companies from start-ups to
leaders in their categories.
- Presented Expanded Preclinical Profiles of NVL-520 and
NVL-655 at AACR 2022: Nuvalent presented new preclinical data
supporting the potential for broad clinical utility of NVL-520 and
NVL-655 across an expanded set of ROS1 and ALK fusion partners,
resistance mutations, and tumor types beyond NSCLC.
Upcoming Investor Conference
Presentations
- 2022 H.C. Wainwright Hybrid Global Investment
Conference: Dr. Porter will conduct an in-person corporate
presentation during the 2022 H.C. Wainwright Hybrid Global
Investment Conference on Wednesday May 25,
2022 at 4:00 p.m. ET. The
conference is being held May 23-26,
2022, with in-person presentations and meetings in
Miami, FL. A live webcast will be
available in the Investors section of the company's website at
www.nuvalent.com and will be archived for 30 days following the
presentation.
First Quarter 2022 Financial
Results
- Cash Position: Cash, cash equivalents and marketable
securities were $272.7 million as of
March 31, 2022. Nuvalent continues to
expect the existing cash, cash equivalents, and marketable
securities to be sufficient to fund its planned operations into
2024.
- R&D Expenses: Research and development
(R&D) expenses were $12.7 million for the first quarter of
2022.
- G&A Expenses: General and administrative
(G&A) expenses were $5.0 million for the first quarter of
2022.
- Net Loss: Net loss for the first quarter of 2022
was $17.5 million, or $0.36 per share.
SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS
DATA
|
|
(In thousands, except share and per share
data)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2022
|
|
|
2021
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
12,693
|
|
|
$
|
5,484
|
|
General and administrative
|
|
|
4,995
|
|
|
|
678
|
|
Total operating
expenses
|
|
|
17,688
|
|
|
|
6,162
|
|
Loss from
operations
|
|
|
(17,688)
|
|
|
|
(6,162)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Change in fair value of preferred stock tranche
rights
|
|
|
—
|
|
|
|
(635)
|
|
Other income (expense), net
|
|
|
139
|
|
|
|
12
|
|
Total other income (expense),
net
|
|
|
139
|
|
|
|
(623)
|
|
Net loss
|
|
$
|
(17,549)
|
|
|
$
|
(6,785)
|
|
Net loss per share
attributable to
common
stockholders, basic and diluted
|
|
$
|
(0.36)
|
|
|
$
|
(2.20)
|
|
Weighted average shares
of common stock
outstanding, basic and diluted
|
|
|
48,284,778
|
|
|
|
3,085,009
|
|
SELECTED CONSOLIDATED BALANCE SHEET
DATA
|
|
(In thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
272,734
|
|
|
$
|
68,526
|
|
Working
capital
|
|
$
|
266,349
|
|
|
$
|
281,841
|
|
Total assets
|
|
$
|
277,039
|
|
|
$
|
293,824
|
|
Total
liabilities
|
|
$
|
8,124
|
|
|
$
|
8,787
|
|
Total stockholders'
equity
|
|
$
|
268,915
|
|
|
$
|
285,037
|
|
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), along with
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 clinical development programs for NVL-520, NVL-655,
ALK IXDN compound resistance mutations and HER2 Exon 20 insertions
and the timing thereof; the potential clinical effect of NVL-520
and NVL-655; the design and enrollment of the ARROS-1 study and the
timing thereof; the design and initiation of the ALKOVE-1 Phase 1/2
study and the timing thereof; the potential of Nuvalent's pipeline
programs, including NVL-520 and NVL-655; Nuvalent's research and
development programs for the treatment of cancer; risks and
uncertainties associated with drug development; and capital
allocation. 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 study or it will take
longer than expected; unexpected concerns that may arise from
additional data, analysis, or results obtained during 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 HER2
Exon 20 and ALK IXDN 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 global ARROS-1 study
and the planned initiation of the ALKOVE-1 Phase 1/2 study; 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, 2021, as well as any 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.
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SOURCE Nuvalent, Inc.