Nuvalent, INC. 8-K Filing

Key Financial Figures

• $0.0001 — which registered Class A Common Stock, $0.0001 par value per share NUVL The Nasdaq

Filing Documents

• d23395d8k.htm (8-K) — 73KB
• 0001193125-25-283893.txt ( ) — 191KB
• nuvl-20251117.xsd (EX-101.SCH) — 3KB
• nuvl-20251117_lab.xml (EX-101.LAB) — 18KB
• nuvl-20251117_pre.xml (EX-101.PRE) — 11KB
• d23395d8k_htm.xml (XML) — 4KB

From the Filing

8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 17, 2025 NUVALENT, INC. (Exact name of registrant as specified in its charter) Delaware 001-40671 81-5112298 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) Nuvalent, Inc. One Broadway , 14th Floor , Cambridge , Massachusetts 02142 (Address of principal executive offices, including zip code) (857) 357-7000 (Registrant's telephone number, including area code) Not Applicable (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trade Symbol(s) Name of each exchange on which registered Class A Common Stock, $0.0001 par value per share NUVL The Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 ( 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 ( 240.12b-2 of this chapter). Emerging growth company If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Item8.01 Other Events. On November 17, 2025, Nuvalent, Inc. (the "Company") announced positive topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in tyrosine kinase inhibitor ("TKI") pre-treated patients with advanced ALK-positive non-small cell lung cancer ("NSCLC") from the global ALKOVE-1 Phase 1/2 clinical trial. Additionally, the Company shared the first report of preliminary data from the Phase 2 exploratory cohort for TKI-nave patients with advanced ALK-positive NSCLC from the ALKOVE-1 study. Summary of Topline Pivotal Data Neladalkib is being evaluated in ALKOVE-1, a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive NSCLC and other solid tumors. The recommended Phase 2 dose ("RP2D") for neladalkib of 150 mg once daily ("QD") was determined during the Phase 1 dose-escalation portion of the trial. The global, single-arm, multi-cohort, open-label Phase 2 portion is designed to evaluate neladalkib at the RP2D with registrational intent for TKI pre-treated patients with advanced ALK-positive NSCLC. Global enrollment in ALKOVE-1 remains ongoing for adult and adolescent patients with ALK-positive solid tumors other than NSCLC, and for adolescent patients with ALK-positive NSCLC. In this topline pivotal dataset for the TKI pre-treated ALK-positive NSCLC population, data are pooled across Phase 1 and 2 and reported for the primary objective of objective response rate (ORR, RECIST 1.1) by blinded independent central review ("BICR"). Key secondary objectives include duration of response ("DOR"), intracranial ORR ("IC-ORR"), and safety. As of the data cut-off date of August 29, 2025, 781 patients with ALK-positive solid tumors had received neladalkib at any starting dose across the Phase 1 and Phase 2 portions of the ALKOVE-1 clinical trial. Of these, 656 patients with advanced ALK-positive NSCLC were treated with neladalkib at the RP2D. Efficacy Analysis in TKI Pre-treated Advanced ALK-positive NSCLC The pivotal primary analysis population consisted of 253 TKI pre-treated patients with advanced ALK-positive NSCLC with measurable disease by BICR who received neladalkib at the RP2D by September 30, 2024, with DOR follow-up of at least 6 months available for nearly all responders. The pivotal primary analysis population was distinct from the ALK TKI pre-treated populations that have been reported for the currently available ALK TKIs: Patients received a median of 3 prior lines of therapy (range, 1 – 11) and 51% had received prior chemotherapy. 78% of patients had received 2 or more prior ALK TKIs prior chemotherapy, of which 91% had received prior lorlatinib. No approved therapies have demonstrated activity after lorlatinib. 19% of patients had a secondary ALK G1202R resistance mutation, and 17% had a compound ALK resistance mutation, which are key drivers of disease progression. 40% of patient

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