[8-K] Nuvation Bio Inc. Reports Material Event

Rhea-AI Filing Summary

Nuvation Bio Inc. released an updated corporate presentation and highlighted newly published positive Phase 2 data for its IDH1 inhibitor safusidenib in Japanese patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant gliomas. In an open-label study of 27 patients, safusidenib achieved an objective response rate of 44.4%, and median duration of response was not yet estimable because no progression had occurred. As of the data cut-off on March 10, 2023, median progression-free survival had not been reached, with 87.9% of patients progression free at 24 months and median follow-up of 28 months, suggesting durable disease control.

Adverse events were mostly mild to moderate; grade 3 or higher treatment-related events occurred in 18.5% of patients, with no grade 5 events and 11.1% discontinuations. A Good Clinical Practice noncompliance issue in adverse event collection was addressed through re-investigation and re-collection of safety data. Nuvation Bio is advancing the G203 global randomized study of safusidenib as maintenance therapy in high-grade and high-risk grade 2 IDH1-mutant gliomas, with a protocol amendment to finalize it as a global Phase 3 trial. The primary endpoint is progression-free survival by blinded central review, which the U.S. Food and Drug Administration has agreed could support full approval.

Positive

• Encouraging Phase 2 efficacy: Safusidenib achieved an objective response rate of 44.4% in 27 patients with grade 2 IDH1-mutant gliomas, with median progression-free survival not yet reached at a 28-month median follow-up and 87.9% progression-free at 24 months.
• Manageable safety profile: Most adverse events were mild to moderate; grade 3 or higher treatment-related events occurred in 18.5% of patients, with no grade 5 events and 11.1% discontinuations.
• Clear late-stage pathway: The G203 trial is being finalized as a global Phase 3 maintenance study in high-grade and high-risk grade 2 IDH1-mutant gliomas, with progression-free survival by blinded central review as the primary endpoint.
• Regulatory alignment: The U.S. Food and Drug Administration agreed that progression-free survival assessed by Blinded Independent Central Review using Response Assessment in Neuro-Oncology 2.0 could support full approval for safusidenib in this setting.

Negative

• None.

Insights

Biotech clinical and regulatory analyst

Positive Phase 2 glioma data and FDA-aligned Phase 3 design support safusidenib’s late-stage development.

The disclosure centers on safusidenib, an oral mutant IDH1 inhibitor, showing encouraging activity in grade 2 IDH1-mutant gliomas. In 27 Japanese patients without prior chemo- or radiotherapy, the study reported an objective response rate of 44.4%. Median progression-free survival was not reached at a median follow-up of 28 months, and 87.9% of patients remained progression free at 24 months, which indicates prolonged disease control in this cohort.

Safety was manageable, with grade 3 or higher treatment-related adverse events in 18.5% of patients, no grade 5 events, and 11.1% discontinuations. The text notes a Good Clinical Practice noncompliance issue in adverse event collection that required re-investigation and re-collection, and states that this related only to safety reporting, which is important context for interpreting the safety profile.

The company is moving the G203 global randomized study into a definitive Phase 3 design for maintenance treatment of high-grade and high-risk grade 2 IDH1-mutant gliomas. The primary endpoint is progression-free survival by Blinded Independent Central Review using Response Assessment in Neuro-Oncology 2.0, and the U.S. Food and Drug Administration has agreed this endpoint could support full approval in this setting. This regulatory alignment, combined with the Phase 2 efficacy and durability signals, represents a constructive step for safusidenib’s development program.

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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

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 8, 2025, positive results from a Phase 2 study of safusidenib in Japanese patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant gliomas were published in the online journal of Neuro-Oncology. Safusidenib is a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1 being developed by the Company.

As reported in the new publication, the open-label, multicenter, single-arm study evaluated 27 patients with IDH1-mutant grade 2 gliomas who had no prior anticancer therapy except for resection or biopsy. The study met its primary endpoint, demonstrating an objective response rate (ORR) of 44.4%; median duration of response could not be estimated because no progression events had occurred. As of the data cut-off date (March 10, 2023), median progression-free survival (PFS) was not yet reached with a median follow-up time of 28 months, demonstrating the long-term potential of safusidenib to delay disease progression. At 24 months, 87.9% of patients were progression free.

Adverse events were mostly mild to moderate and manageable. Grade 3 or greater treatment-related adverse events occurred in five (18.5%) patients. No grade 5 events were reported. Three (11.1%) patients had treatment-emergent adverse events that led to study treatment discontinuation, two of which were considered related to safusidenib by study investigators and were resolved with dose interruption and/or appropriate medical management.

A Good Clinical Practice (GCP) noncompliance issue regarding the collection of adverse events was identified during the study. Therefore, all safety data presented in this manuscript was based on a subsequent re-investigation and re-collection of adverse events performed in strict accordance with the study protocol to ensure data integrity. The GCP noncompliance issue related only to safety reporting.

As previously announced on October 23, 2025, the Company is progressing the G203 study, a global, randomized study of safusidenib for the maintenance treatment of high-grade IDH1-mutant gliomas, with a protocol amendment on track to increase the sample size and include patients with grade 2 high-risk IDH1-mutant glioma, which will finalize the study as a global Phase 3 study to support potential regulatory approvals. The primary endpoint is PFS as assessed by Blinded Independent Central Review per Response Assessment in Neuro-Oncology 2.0, which the U.S. Food and Drug Administration agreed could support full approval in this setting. Secondary endpoints include overall survival, PFS as assessed by the investigator, ORR and duration of response.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Description
99.1		Corporate Presentation of Nuvation Bio Inc. (November 17, 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 17, 2025				By:		/s/ Philippe Sauvage
				Name:		Philippe Sauvage
				Title:		Chief Financial Officer

FAQ

What did Nuvation Bio (NUVB) report about safusidenib’s Phase 2 results?

Nuvation Bio reported positive Phase 2 data for safusidenib in Japanese patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant gliomas. In 27 patients, the open-label study achieved an objective response rate of 44.4%. Median progression-free survival was not reached at a median follow-up of 28 months, and 87.9% of patients were progression free at 24 months as of the March 10, 2023 data cut-off.

What is safusidenib and what type of cancer is NUVB targeting?

Safusidenib is described as a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1. Nuvation Bio is developing it for patients with IDH1-mutant gliomas, including grade 2 disease and high-grade IDH1-mutant gliomas, with a focus on maintenance treatment settings in the G203 randomized study.

How safe was safusidenib in the Phase 2 Japanese glioma study reported by NUVB?

The safety profile was characterized as mostly mild to moderate and manageable. Grade 3 or greater treatment-related adverse events occurred in 18.5% of patients, no grade 5 events were reported, and 11.1% of patients discontinued study treatment due to treatment-emergent adverse events. A Good Clinical Practice noncompliance issue in adverse event collection led to a re-investigation and re-collection of safety data.

What is the G203 study that Nuvation Bio is running for safusidenib?

The G203 study is a global, randomized trial of safusidenib as maintenance treatment for high-grade IDH1-mutant gliomas. A protocol amendment is on track to increase the sample size and include patients with grade 2 high-risk IDH1-mutant glioma, finalizing the trial as a global Phase 3 study intended to support potential regulatory approvals.

Which endpoints will support safusidenib’s potential approval in NUVB’s G203 Phase 3 trial?

The primary endpoint in G203 is progression-free survival assessed by Blinded Independent Central Review using Response Assessment in Neuro-Oncology 2.0. Secondary endpoints include overall survival, progression-free survival assessed by investigators, objective response rate, and duration of response. The U.S. Food and Drug Administration agreed that the centrally assessed progression-free survival endpoint could support full approval in this setting.

What other information did Nuvation Bio share with investors in this update?

Nuvation Bio noted that it posted an updated corporate presentation on its website, which will be shared with investors and others from time to time. The presentation is provided as an exhibit and accompanies the clinical update on safusidenib’s Phase 2 results and the advancement of the G203 Phase 3 development program.