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Nuvalent Inc-A 2026年季度报告

2026-05-07 美股财报 李强
报告封面

For the quarterly period ended March 31, 2026OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934 For the transition period from _____________ to _____________Commission File Number: 001-40671 (Exact name of registrant as specified in its charter) Delaware(State or other jurisdiction ofincorporation or organization)One Broadway, 14FloorCambridge, MA(Address of principal executive offices)th Registrant’s telephone number, including area code: (857) 357-7000 Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject tosuch filing requirements for the past 90 days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required tosubmit such files). Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company,or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerginggrowth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer☒Non-accelerated filer☐Emerging growth company☐ Smaller reporting company☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying withany new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ As of April 30, 2026, the registrant had 73,562,661 shares of Class A common stock, $0.0001 par value per share, outstanding and 5,435,254shares of Class B common stock, $0.0001 par value per share, outstanding. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA This Quarterly Report on Form 10-Q (Quarterly Report) of Nuvalent, Inc. contains express or implied forward-looking statementswithin the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended(the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), that are based on ourmanagement’s beliefs and assumptions and on information currently available to our management. These statements relate to futureevents or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factorsthat may cause our actual results, performance or achievements to be materially different from any future results, performance orachievements expressed or implied by these forward-looking statements. Forward-looking statements contained in this QuarterlyReport include, among other things, statements about: •the initiation, timing, progress, results, and costs of our zidesamtinib (NVL-520), neladalkib (NVL-655), NVL-330 anddiscovery programs and our current and future preclinical studies and clinical trials, including statements regarding the timing ofinitiation and completion of studies or trials and related preparatory work, alignment with the U.S. Food and DrugAdministration (FDA) regarding the design of trials, and when the results of the studies or trials will become available; •the ability of our preclinical studies and clinical trials to demonstrate safety and efficacy of our product candidates, and otherpositive results;•the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of our product candidates;•the timing, scope and likelihood of regulatory filings and approvals, including timing of Investigational New Drug applications,New Drug Applications (NDAs), and final FDA approval of our current product candidates or any future product candidates;•the timing, scope or likelihood of foreign regulatory filings and approvals;•our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop productcandidates, including by applying learnings from one program to other programs and from one indication to other indications;•our estimates of the number of patients that we will enroll and our ability to initiate, recruit, and enroll patients in, conduct andsuccessfully complete our clinical trials at the pace that we project;•our ability to scale-up our manufacturing and processing approaches to appropriately address our anticipated commercial needs,which will require significant resources;•our ability