Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones and Reports Fourth Quarter and Full Year 2023 Financial Results
Well-capitalized with operating runway anticipated into 2027
"With our
"Our ability to deliver on our program goals is interconnected with our ability to build the team and maintain a strong culture centered around our core values of Patient Impact, Empowerment, and Collaboration. In recognition of his leadership and contributions across these areas, we are proud to announce the promotion of
Recent Pipeline Progress and Anticipated Milestones
ROS1 Program
- The
U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-520 for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors (TKIs). NVL-520 was previously granted FDA Orphan Drug Designation for the treatment of ROS1-positive NSCLC. - The company expects to share updated data from the ARROS-1 Phase 1/2 trial at a medical meeting in 2024. Enrollment is ongoing in the global Phase 2 portion of the study.
ALK Program
-
Nuvalent recently announced the initiation of the Phase 2 portion of the ALKOVE-1 trial of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors, following alignment with the FDA on a recommended Phase 2 dose (RP2D) of 150 mg once daily. The Phase 2 portion of the ALKOVE-1 clinical trial is designed to 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 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 and to outline its broader front-line development strategy for its ALK program in 2024.
HER2 Program
- The company expects to initiate the Phase 1 trial for its HER2 program in 2024.
Recent Leadership Promotions
-
Promotion of
Matthew Metivier to Senior Vice President of Human Resources:Mr. Metivier brings over 20 years of experience in various human resources leadership roles, specifically within the biotechnology/pharmaceutical industry, with a focus on building companies and guiding organizations through the early development phase to commercial launch. AtNuvalent ,Mr. Metivier has built and led our Human Resources capabilities and facilitated our people and culture strategy to ensure we optimize our work environment to attract, retain and develop the talent needed to achieve our mission. Prior to joiningNuvalent , he held leadership roles of increasing responsibility in human resources at Gamida Cell, Ltd, Sage Therapeutics, Inc, and Infinity Pharmaceuticals.Mr. Metivier holds an MBA fromSuffolk University with a concentration in Organizational Behavior and a B.A. in Political Science and Business Studies fromProvidence College .
Upcoming Events
-
TD Cowen 44th AnnualHealth Care Conference : Management will be participating in a fireside chat onWednesday, March 6, 2024 , at1:30 p.m. ET inBoston, MA. -
Leerink Global Biopharma Conference 2024: Management will be participating in a fireside chat onTuesday, March 12, 2024 , at8:00 a.m. ET inMiami, FL.
A live webcast of each fireside chat will be available in the Investors section of
Fourth Quarter and Full Year 2023 Financial Results
-
Cash Position: Cash, cash equivalents and marketable securities were
$719.9 million as ofDecember 31, 2023 .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
$35.6 million for the fourth quarter of 2023 and$113.2 million for the year endedDecember 31, 2023 . -
G&A Expenses: General and administrative (G&A) expenses were
$10.9 million for the fourth quarter of 2023 and$36.2 million for the year endedDecember 31, 2023 . -
Net Loss: Net loss was
$38.3 million for the fourth quarter of 2023 and$126.2 million for the year endedDecember 31, 2023 .
About
-
2024: Execute on Global Registrational Strategies
- Progress the Phase 2 portion of its ARROS-1 trial of NVL-520 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
SELECTED STATEMENTS OF OPERATIONS DATA |
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(In thousands, except share and per share data) |
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(Unaudited) |
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Three Months Ended |
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Year Ended |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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|
|
|
|
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|
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|
|
|
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Research and development |
|
$ |
35,585 |
|
|
$ |
22,855 |
|
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$ |
113,243 |
|
|
$ |
63,731 |
|
General and administrative |
|
|
10,852 |
|
|
|
6,444 |
|
|
|
36,249 |
|
|
|
22,377 |
|
Total operating expenses |
|
|
46,437 |
|
|
|
29,299 |
|
|
|
149,492 |
|
|
|
86,108 |
|
Loss from operations |
|
|
(46,437) |
|
|
|
(29,299) |
|
|
|
(149,492) |
|
|
|
(86,108) |
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Other income (expense): |
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Interest income and other income (expense), net |
|
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8,145 |
|
|
|
3,176 |
|
|
|
23,273 |
|
|
|
4,254 |
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Total other income (expense), net |
|
|
8,145 |
|
|
|
3,176 |
|
|
|
23,273 |
|
|
|
4,254 |
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Net loss |
|
$ |
(38,292) |
|
|
$ |
(26,123) |
|
|
$ |
(126,219) |
|
|
$ |
(81,854) |
|
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
(0.62) |
|
|
$ |
(0.49) |
|
|
$ |
(2.17) |
|
|
$ |
(1.65) |
|
Weighted average shares of common stock outstanding, basic and diluted |
|
|
62,183,325 |
|
|
|
53,616,336 |
|
|
|
58,223,339 |
|
|
|
49,668,864 |
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SELECTED BALANCE SHEET DATA |
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(In thousands) |
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(Unaudited) |
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2023 |
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2022 |
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Cash, cash equivalents and marketable securities |
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$ |
719,905 |
|
|
$ |
472,163 |
|
Working capital |
|
$ |
694,665 |
|
|
$ |
458,510 |
|
Total assets |
|
$ |
732,384 |
|
|
$ |
482,459 |
|
Total liabilities |
|
$ |
31,823 |
|
|
$ |
19,481 |
|
Total stockholders' equity |
|
$ |
700,561 |
|
|
$ |
462,978 |
|
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