Nuvation Bio halts NUV-1511, focuses on safusidenib and IBTROZI

Rhea-AI Filing Summary

Nuvation Bio Inc. announced it is discontinuing development of NUV-1511, the first compound from its drug-drug conjugate platform, due to a lack of sufficiently consistent efficacy across patient cohorts, despite being well tolerated and showing promising signals in some patients. The company plans to use knowledge from this program to design new DDC candidates and will reallocate the $100-150 million of projected NUV-1511 R&D and CMC costs through 2029 to other pipeline molecules and next-generation DDC programs. Nuvation Bio highlighted ongoing initiatives, including a global randomized G203 trial of safusidenib in high-risk IDH1-mutant glioma and continued investment in the commercial launch and development of IBTROZI (taletrectinib), such as the TRUST-IV study in early-stage ROS1+ non-small cell lung cancer. The company also furnished an updated corporate presentation to accompany these updates.

Positive

• None.

Negative

• NUV-1511 program discontinued due to lack of sufficiently consistent efficacy across trial cohorts, removing the first clinical asset from Nuvation Bio’s DDC platform.

Insights

Biotech pipeline and R&D strategy analyst

Nuvation drops NUV-1511 for inconsistent efficacy, shifts spend to other programs.

Nuvation Bio is stopping development of NUV-1511, the lead asset in its drug-drug conjugate platform, because efficacy results were not consistently strong across trial cohorts, even though the drug was well tolerated and showed promising signals in some patients. This removes one near-term DDC asset from the pipeline and represents a notable setback for that specific program.

The company states that the DDC platform itself is continuing, using insights from NUV-1511 to design next-generation candidates. It intends to redirect the $100-150 million of NUV-1511-related R&D and CMC spending that had been projected through 2029 toward other pipeline molecules and future DDC compounds, which concentrates resources on programs it views as having stronger prospects.

Alongside this shift, Nuvation emphasizes ongoing efforts such as the G203 global randomized study of safusidenib in high-risk grade 3 or 4 IDH1-mutant glioma and continued investment in IBTROZI (taletrectinib), including the TRUST-IV study in early-stage ROS1+ non-small cell lung cancer. These programs become more central to the company’s development story following the discontinuation of NUV-1511.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

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Accepted by SEC EDGAR 11/26/2025 - 08:34 AM Learn about SEC filing dates

FAQ

What did Nuvation Bio (NUVB) announce about the NUV-1511 program?

Nuvation Bio announced it is discontinuing development of NUV-1511, the first compound in its drug-drug conjugate (DDC) platform, because efficacy results were not sufficiently consistent across patient cohorts, despite tolerability and some promising signals.

Is Nuvation Bio ending its entire DDC platform with the NUV-1511 decision?

No. The company stated it is not terminating the DDC platform. Instead, it will use what it learned from NUV-1511 to evaluate new DDC candidates that may have more consistently robust activity.

How much spending is being reallocated after discontinuing NUV-1511 at Nuvation Bio?

Resources budgeted for NUV-1511, including projected $100-150 million in R&D and CMC-related costs through 2029, will be transferred to other pipeline molecules and next-generation DDC candidates.

What other clinical programs is Nuvation Bio (NUVB) highlighting after ending NUV-1511?

Nuvation Bio highlighted the G203 global randomized study of safusidenib in high-risk grade 3 or 4 IDH1-mutant glioma and its continued investment in the commercial launch of IBTROZI (taletrectinib), including the TRUST-IV study in the adjuvant setting of early-stage ROS1+ non-small cell lung cancer.

What investor materials did Nuvation Bio furnish with this update?

Nuvation Bio posted an updated corporate presentation on its website, which will be shared with investors and others, and furnished it as Exhibit 99.1 to the report.

Why did Nuvation Bio decide to discontinue NUV-1511 despite some promising signals?

The company noted that while NUV-1511 was well tolerated and showed promising signals in some patients, it chose to discontinue the program due to lack of sufficiently consistent efficacy across cohorts.

false 0001811063 0001811063 2025-11-26 2025-11-26 0001811063 us-gaap:CommonStockMember 2025-11-26 2025-11-26 0001811063 nuvb:RedeemableWarrantsEachWholeWarrantExercisableForOneShareOfCommonStockAtAnExercisePriceOf11.50PerShareMember 2025-11-26 2025-11-26

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 26, 2025

Nuvation Bio Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-39351		85-0862255
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

1500 Broadway, Suite 1401 New York, NY		10036
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (332) 208-6102

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations 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		Trading Symbol(s)		Name of each exchange on which registered
Class A Common Stock, $0.0001 par value per share		NUVB		The New York Stock Exchange
Redeemable Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50 per share		NUVB.WS		The New York Stock Exchange

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. ☐

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