Nuvation Bio Inc. filed SEC Form 8-K: Regulation FD Disclosure
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| Item 7.01 | Regulation FD Disclosure. |
Nuvation Bio Inc. (the “Company”) posted to its website an updated corporate presentation that will be shared with investors and others from time to time. A copy of the corporate presentation is attached hereto as Exhibit 99.1.
The information in this Item 7.01 and in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 8.01 | Other Events. |
On November 26, 2025, the Company announced its decision to discontinue development of NUV-1511, the first compound in its first-of-its-kind drug-drug conjugate (DDC) program. While NUV-1511 was well tolerated and did demonstrate promising signals in some patients, the Company has made this decision due to lack of sufficiently consistent efficacy across cohorts. The Company thanks the patients and trial investigators who have participated in clinical studies of NUV-1511. Importantly, the Company is not terminating the DDC platform. Instead, the Company will be using information learned from the NUV-1511 program to evaluate new DDC candidates that may have more consistently robust activity. Resources budgeted for NUV-1511, which included a projected $100-150 million in R&D and CMC-related costs through 2029, will be transferred to other pipeline molecules and to the development of next-generation DDC candidates, incorporating key learnings from NUV-1511.
Notably, the Company recently announced first patient in part 2 of G203, a global randomized study of safusidenib, a novel, selective, potent, oral mIDH1 inhibitor, in high-risk grade 3 or grade 4 IDH1-mutant glioma. The Company will also continue to invest in the commercial launch of IBTROZI (taletrectinib) and development of the program, including enrollment of the TRUST-IV study evaluating the medicine in the adjuvant setting of early-stage ROS1+ NSCLC.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit Number |
Description | |
| 99.1 | Corporate Presentation of Nuvation Bio Inc. (November 26, 2025) | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NUVATION BIO INC. | ||||||
| Date: November 26, 2025 | By: | /s/ Philippe Sauvage | ||||
| Name: | Philippe Sauvage | |||||
| Title: | Chief Financial Officer | |||||