Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial Results
Updates from the ongoing Phase 1/2 ARROS-1 and ALKOVE-1 clinical trials expected at a medical meeting in the second half of 2024
Strong financial position with operating runway anticipated into 2027
"Guided by our
Recent Pipeline Progress and Anticipated Milestones
ROS1 Program
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Nuvalent presented new preclinical data at theAmerican Association for Cancer Research (AACR) Annual Meeting demonstrating that zidesamtinib, its novel ROS1-selective inhibitor, was effective at suppressing on-target ROS1 resistance mutations in preclinical mutagenesis screens. - The company expects to share updated data from the ARROS-1 Phase 1/2 trial at a medical meeting in the second half of 2024. Enrollment is ongoing in the global Phase 2 portion of the study.
ALK Program
- Enrollment is ongoing in the global Phase 2 portion of the ALKOVE-1 trial of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors. The Phase 2 cohorts are designed with registrational intent for TKI pre-treated patients with ALK-positive NSCLC and to enable preliminary evaluation in patients with ALK-positive NSCLC who are TKI naïve.
- The company expects to share updated data from the ALKOVE-1 trial at a medical meeting in the second half of 2024. Additionally, Nuvalent plans to outline its broader front-line development strategy for its ALK program in 2024.
HER2 Program
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Nuvalent presented new preclinical data at AACR supporting the broad activity against HER2 oncogenic alterations, selectivity over wild-type EGFR, and differentiated brain-penetrant profile of its novel HER2-selective inhibitor, NVL-330. - The company expects to initiate the Phase 1 trial for its HER2 program in 2024.
Upcoming Events
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TD Cowen 5th Annual Oncology Innovation Summit: Management will be participating in a virtual fireside chat onMay 29, 2024 at9:30 am ET . A live webcast will be available in the Investors section ofNuvalent's website at www.nuvalent.com, and will be archived for 30 days following the conference.
First Quarter 2024 Financial Results
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Cash Position: Cash, cash equivalents and marketable securities were
$691.8 million as ofMarch 31, 2024 .Nuvalent believes these existing cash, cash equivalents and marketable securities to be sufficient to fund its current operating plan into 2027. -
R&D Expenses: Research and development (R&D) expenses were
$38.6 million for the first quarter of 2024. -
G&A Expenses: General and administrative (G&A) expenses were
$14.0 million for the first quarter of 2024. -
Net Loss: Net loss was
$44.5 million for the first quarter of 2024.
About
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2024: Execute on Global Registrational Strategies
- Progress the Phase 2 portion of its ARROS-1 trial of zidesamtinib 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;
- Present interim data from its ongoing ARROS-1 and ALKOVE-1 clinical trials at medical meetings; and,
- Initiate the Phase 1 trial for its HER2 program.
- 2025: First Pivotal Data
- 2026: First Approved Product
About
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
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
CONSOLIDATED STATEMENTS OF OPERATIONS |
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(In thousands, except share and per share amounts) |
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(Unaudite) |
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Three Months Ended |
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|
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2024 |
|
2023 |
Operating expenses |
|
|
|
|
Research and development |
|
$ 38,634 |
|
$ 22,125 |
General and administrative |
|
13,954 |
|
8,085 |
Total operating expenses |
|
52,588 |
|
30,210 |
Loss from operations |
|
(52,588) |
|
(30,210) |
Other income (expense) |
|
|
|
|
Interest income and other income (expense), net |
|
8,489 |
|
5,018 |
Total other income (expense), net |
|
8,489 |
|
5,018 |
Loss before income taxes |
|
(44,099) |
|
(25,192) |
Income tax provision |
|
383 |
|
— |
Net loss |
|
$ (44,482) |
|
$ (25,192) |
Net loss per share attributable to common stockholders, basic and diluted |
|
$ (0.69) |
|
$ (0.44) |
Weighted average shares of common stock outstanding, basic and diluted |
|
64,150,588 |
|
56,703,873 |
SELECTED BALANCE SHEET DATA |
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(In thousands) |
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(Unaudited) |
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|
|
|
|
|
|
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March 31, |
|
|
|
|
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2024 |
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2023 |
|
Cash, cash equivalents and marketable securities |
|
$ 691,837 |
|
$ 719,905 |
|
Working capital |
|
$ 666,067 |
|
$ 694,665 |
|
Total assets |
|
$ 708,466 |
|
$ 732,384 |
|
Total liabilities |
|
$ 33,427 |
|
$ 31,823 |
|
Total stockholders' equity |
|
$ 675,039 |
|
$ 700,561 |
|
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