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IBTROZI launch lifts Nuvation Bio (NUVB) 2025 revenue while losses narrow

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Rhea-AI Filing Summary

Nuvation Bio Inc. reported fourth-quarter and full-year 2025 results, highlighting the first commercial contributions from IBTROZI and stronger collaboration revenue. Net product revenue from U.S. sales of IBTROZI reached $15.7 million in Q4 and $24.7 million for 2025.

Total revenue rose to $41.9 million in Q4 and $62.9 million for 2025, driven by a $25 million milestone from Nippon Kayaku and higher license, service, supply and royalty revenue. The company ended 2025 with $529.2 million in cash, cash equivalents and marketable securities and reported a narrower full-year net loss of $204.6 million, or $(0.60) per share, compared with a $567.9 million loss in 2024.

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Insights

Nuvation Bio shows first IBTROZI sales, higher revenue, but still substantial losses and new debt.

Nuvation Bio is transitioning into a commercial-stage company. 2025 revenue climbed to $62.9 million from $7.9 million, led by IBTROZI product sales of $24.7 million and collaboration revenue including a $25 million milestone tied to Japanese reimbursement.

Operating expenses rose sharply with commercialization. Research and development reached $115.1 million, and selling, general and administrative costs more than doubled to $151.6 million, reflecting headcount growth, stock-based compensation after FDA approval, and higher sales and marketing and legal spend.

The full-year net loss narrowed to $204.6 million from $567.9 million, largely because 2024 included a one-time $425.1 million in-process R&D charge from the AnHeart acquisition. The balance sheet shows $529.2 million in cash and marketable securities but also new liabilities from a revenue interest financing and long-term borrowings totaling over $200 million at year-end 2025.

false 0001811063 0001811063 2026-03-02 2026-03-02
 
 

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): March 2, 2026

 

 

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)
  (I.R.S. Employer
Identification No.)

1500 Broadway, Suite 1401

New York, NY 10036

(Address of principal executive offices)

(332) 208-6102

(Registrant’s telephone number, including area code)

 

 

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 Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class registered

 

Trading
Symbol(s)

 

Name of each exchange

on which

Class A Common Stock, $0.0001 par value per share   NUVB   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 2.02. RESULTS OF OPERATIONS AND FINANCIAL CONDITION

On March 2, 2026, Nuvation Bio Inc. issued a press release announcing its financial results for the quarter ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

The information contained in this Form 8-K, including in the accompanying Exhibit 99.1, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS

(d) Exhibits.

 

Exhibit Number

  

Description

99.1    Press Release of Nuvation Bio Inc. dated March 2, 2026.
104    Cover Page Interactive Data File (embedded within XBRL document)

 

2


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.

 

Dated: March 2, 2026   NUVATION BIO INC.
    By:  

/s/ Philippe Sauvage

      Name: Philippe Sauvage
      Title:  Chief Financial Officer

 

3

Exhibit 99.1

 

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Nuvation Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Successfully started 216 patients on IBTROZI® (taletrectinib) in the fourth quarter of 2025, for a total of 432 new patient starts since launch in the second half of June 2025

Entered into exclusive licensing and collaboration agreement with Eisai on January 11, 2026, for taletrectinib in Europe and additional countries outside U.S., China and Japan

Published positive Phase 2 study results for safusidenib demonstrating durable responses for the treatment of grade 2 IDH1-mutant glioma

Strong balance sheet with cash, cash equivalents, and marketable securities of $529.2 million as of December 31, 2025

Company to host a conference call today at 4:30 pm ET

NEW YORK—March 2, 2026— Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

“We ended our transformational 2025 with a strong fourth quarter that underscored IBTROZI’s rapid adoption, and we believe our medicine is becoming the new standard of care for people living with advanced ROS1+ NSCLC across treatment lines. In 2026, we look forward to further building upon our successful U.S. launch, and partnering closely with Eisai to bring IBTROZI to more patients around the globe,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We are also excited and eager to progress our promising pipeline, with safusidenib now being studied in the pivotal Phase 3 SIGMA trial across those living with high-risk and high-grade IDH1-mutant glioma where significant needs exist for these patients. Lastly, we continue to evaluate additional internal preclinical candidates and external business development opportunities in hopes of furthering our mission to tackle some of the toughest challenges in cancer treatment.”

Fourth Quarter 2025 and Recent Corporate Highlights:

IBTROZI® (taletrectinib), ROS1 inhibitor: Advanced ROS1+ NSCLC

 

   

In the fourth quarter of 2025, 216 new patients started treatment on IBTROZI for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), reflecting the high rate of adoption and confidence in IBTROZI among healthcare professionals and patients.

 

   

With 432 new patients started since launch in the second half of June 2025, the treatment adoption rate is approximately six times greater than that of prior recent ROS1 tyrosine kinase inhibitor (TKI) launches based on IQVIA data.

 

   

On January 11, 2026, the Company entered an exclusive license and collaboration agreement with Eisai Co., Ltd. to develop, register and commercialize taletrectinib for the treatment of ROS1+ NSCLC in Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam, and India.


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In the fourth quarter of 2025, the Company received a $25 million milestone payment from Nippon Kayaku as a result of establishing the reimbursement price in Japan.

 

   

In October 2025, the Company presented clinical data from the pivotal TRUST-II study evaluating IBTROZI in patients previously treated with entrectinib, a brain-penetrant ROS1 therapy at the European Society of Medical Oncology (ESMO) Congress 2025.

 

   

IBTROZI demonstrated a confirmed overall response rate of 80% in 10 patients whose tumors progressed following treatment with entrectinib.

Safusidenib, mIDH1 inhibitor: IDH1-mutant glioma

 

   

In December 2025, the Company announced the publication of positive results from a Phase 2 study of safusidenib in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant gliomas. The findings were first published online on November 8, 2025, in Neuro-Oncology.

 

   

Safusidenib demonstrated durable responses, with an ORR of 44% and 88% of patients were progression-free at 24 months.

 

   

The findings supported favorable interactions with the U.S. Food and Drug Administration (FDA) and the now finalized protocol amendment making the SIGMA study (G203) a Phase 3, pivotal trial evaluating safusidenib maintenance treatment in high-risk and high-grade IDH1-mutant gliomas. The study now also includes an additional exploratory cohort in grade 3 oligodendroglioma.

 

   

In October 2025, the Company enrolled the first patient in the global SIGMA study (G203).

Fourth Quarter and Full Year 2025 Financial Results

As of December 31, 2025, Nuvation Bio had cash, cash equivalents, and marketable securities of $529.2 million.

Product Revenue, Net

To date, our only source of product revenue has been from the U.S. sales of IBTROZI. We began distributing IBTROZI to our U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $15.7 million and $24.7 million for the three and twelve months ended December 31, 2025, respectively.

Collaboration and License Agreements Revenue

For the three months ended December 31, 2025, collaboration and license agreements revenue was $26.2 million, compared to $5.7 million for the three months ended December 31, 2024. The increase is primarily due to a $25 million milestone payment from Nippon Kayaku as a result of establishment of the reimbursement price for IBTROZI in Japan in Q4, offset by a $4.5 million decrease in research and development service revenue under the collaboration agreement with Innovent. Taletrectinib was included in China’s National Reimbursement Drug List effective January 1, 2026.

For the twelve months ended December 31, 2025, collaboration and license agreements revenue was $38.2 million, compared to $7.9 million for 2024. The increase is primarily due to a $19.1 million increase in license revenue and a $6.3 million increase in research and development service revenue as a result of milestone payment from Nippon Kayaku for the establishment of the reimbursement price in Japan in December 2025, a $3.6 million increase in product supply revenue, and a $1.3 million increase in royalty revenue.


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Research and Development Expenses

For the three months ended December 31, 2025, research and development expenses were $34.3 million, compared to $29.3 million for the three months ended December 31, 2024. The increase was due to an $11.4 million increase in third-party costs related to clinical studies, offset by a $2.4 million decrease in personnel-related costs because employee compensation and benefit costs directly related to commercial drug production were capitalized into inventory, as well as a $4.0 million decrease in regulatory milestone payments to Daiichi.

For the twelve months ended December 31, 2025, research and development expenses were $115.1 million, compared to $99.1 million for the twelve months ended December 31, 2024. The increase was primarily due to a $7.8 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation primarily related to one-time charge for the vesting of performance-based awards upon receiving U.S. FDA approval of IBTROZI, a $12.1 million increase in third-party costs related to clinical studies, and a $0.1 million increase in amortization of assembled workforce, offset by a $4.0 million decrease in regulatory milestone payments to Daiichi.

Acquired In-process Research and Development Expenses

On April 9, 2024, as a result of the acquisition of AnHeart Therapeutics Ltd., we recorded a $425.1 million charge representing an acquired in-process research and development asset with no alternative future use in acquired in-process research and development expenses.

Selling, General and Administrative Expenses

For the three months ended December 31, 2025, selling, general, and administrative expenses were $40.3 million, compared to $26.1 million for the three months ended December 31, 2024. The increase was due to a $7.3 million increase in personnel-related costs as a result of the increase in headcount, a $5.9 million increase in sales and marketing expenses, a $2.1 million increase in legal fees, offset by a $0.4 million decrease in professional fees, and a $0.7 million decrease in foreign currency impact.

For the twelve months ended December 31, 2025, selling, general, and administrative expenses were $151.6 million, compared to $69.2 million for the twelve months ended December 31, 2024. The increase was due to a $39.4 million increase in personnel-related costs as a result of the increase in headcount and stock-based compensation primarily related to one-time charge for the vesting of performance-based awards upon receiving U.S. FDA approval of IBTROZI, a $41.0 million increase in sales and marketing expenses, a $3.1 million increase in legal fees, a $0.1 million increase in professional fees and a $0.3 million increase in other expenses, offset by a $1.5 million decrease in foreign currency impact.

Net loss

For the three months ended December 31, 2025, Nuvation Bio reported a net loss of $36.6 million, or $(0.11) per share. The net loss for the comparable period in 2024 was $49.4 million, or $(0.15) per share.

For the twelve months ended December 31, 2025, Nuvation Bio reported a net loss of $204.6 million, or $(0.60) per share. The net loss for the comparable period in 2024 was $567.9 million, or $(2.11) per share.

Conference Call and Webcast

Nuvation Bio will host a conference call and webcast today, March 2, 2026, at 4:30 pm ET to discuss its financial results for the fourth quarter and full year of 2025 and provide business updates.


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Investors and the general public are invited to listen to the live webcast and may register on the Investor Relations section of the Nuvation Bio website. To access the live conference call, participants can dial +1 833-470-1428 (U.S. toll-free) and enter access code 833155. An archived recording will be available on Nuvation Bio’s website for 90 days following the event.

About ROS1+ NSCLC

Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI

IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more at IBTROZI.com.

About the TRUST Clinical Program

The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 138 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

Indication

IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI® (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.


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Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.


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ADVERSE REACTIONS

Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

 

   

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.

 

   

Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.

OTHER CONSIDERATIONS

 

   

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.

 

   

Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.

 

   

Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.

 

   

Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.

 

   

Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.

Please see accompanying full Prescribing Information.

About IDH1-Mutant Glioma

Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,400 people are diagnosed with IDH1-mutant gliomas each year. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high grade tumors.

About Safusidenib

Safusidenib is a novel, oral, potent, brain-penetrant, targeted inhibitor of mutant IDH1. In Phase 1 and 2 clinical studies, safusidenib was well-tolerated and demonstrated anti-tumor activity and high blood-brain barrier penetration.

About Nuvation Bio

Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients’ lives. Our diverse pipeline includes taletrectinib (IBTROZI ®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program.


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Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc).

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements about IBTROZI and safusidenib’s therapeutic and commercial potential, IBTROZI becoming the new standard of care in advanced ROS1+ NSCLC across treatment lines, bringing IBTROZI to more patients worldwide, the need for new therapeutic options in IDH1-mutant gliomas, and our evaluation of additional preclinical candidates and external business development opportunities. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to whether Nuvation Bio is successful in commercializing IBTROZI; the challenges associated with conducting drug discovery and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; whether Nuvation Bio meets its post-marketing requirements and commitments for IBTROZI; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-K filed with the SEC on March 2, 2026 under the heading “Risk Factors,” and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

Media and Investor Contacts

Nuvation Bio Investor Contact

JR DeVita

ir@nuvationbio.com

Nuvation Bio Media Contact

Kaitlyn Nealy

media@nuvationbio.com


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NUVATION BIO INC. and Subsidiaries

Consolidated Balance Sheets

(In thousands, except share and per share data)

 

     December 31,  
     2025     2024  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 164,086     $ 35,723  

Accounts receivable, net of allowance for credit loss of $nil and nil, respectively

     16,076       12,722  

Inventory

     11,411       —   

Prepaid expenses and other current assets

     11,536       7,271  

Marketable securities

     365,125       466,969  

Interest receivable on marketable securities

     3,285       3,570  
  

 

 

   

 

 

 

Total current assets

     571,519       526,255  

Property and equipment, net of accumulated depreciation of $1,184 and $874, respectively

     564       586  

Intangible assets, net of accumulated amortization of $1,856 and $448, respectively

     11,214       4,622  

Operating lease right-of-use assets

     3,918       2,402  

Other non-current assets

     7,607       6,761  
  

 

 

   

 

 

 

Total assets

   $ 594,822     $ 540,626  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

   $ 9,479     $ 6,348  

Current operating lease liabilities

     1,880       1,663  

Contract liabilities, current portion

     7,515       11,117  

Liability related to revenue interest financing agreement, current portion

     9,585       —   

Short-term borrowings

     5,724       6,283  

Warrant liability

     2,865       —   

Accrued expenses

     45,183       32,833  
  

 

 

   

 

 

 

Total current liabilities

     82,231       58,244  

Warrant liability

     —        2,053  

Contract liabilities, net of current portion

     11,305       15,572  

Non-current operating lease liabilities

     2,543       969  

Non-current liability related to revenue interest financing agreement, net of deferred financing costs of $4,241 and $0, respectively

     145,819       —   

Long-term borrowings, net of deferred financing costs of $3,042 and $0, respectively

     47,208       —   
  

 

 

   

 

 

 

Total liabilities

     289,106       76,838  
  

 

 

   

 

 

 

Stockholders’ equity

    

Class A and Class B common stock and additional paid in capital, $0.0001 par value per share; 1,060,000,000 (Class A 1,000,000,000, Class B 60,000,000) shares authorized as of December 31, 2025 and December 31, 2024, 346,503,675 (Class A 345,503,675, Class B 1,000,000) and 337,837,872 (Class A 336,837,872, Class B 1,000,000) shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively

     1,421,273       1,373,958  

Accumulated deficit

     (1,115,370     (910,743

Accumulated other comprehensive income

     (187     573  
  

 

 

   

 

 

 

Total stockholders’ equity

     305,716       463,788  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 594,822     $ 540,626  
  

 

 

   

 

 

 


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NUVATION BIO INC. and Subsidiaries

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except per share data)

 

     Three Months Ended December 31,     Years Ended December 31,  
     2025     2024     2025     2024  

Revenues:

        

Product revenue, net

   $ 15,702     $ —      $ 24,663     $ —   

Collaboration and license agreements revenue

     26,163       5,711       38,239       7,873  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     41,865       5,711       62,902       7,873  
  

 

 

   

 

 

   

 

 

   

 

 

 

Costs and expenses:

        

Cost of sales

     349       —        856       —   

Cost of collaboration and license agreements revenue

     930       4,216       8,442       7,078  

Research and development

     34,297       29,299       115,106       99,119  

Acquired in-process research and development

     —        —        —        425,070  

Selling, general and administrative

     40,326       26,138       151,562       69,233  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and expenses

     75,902       59,653       275,966       600,500  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (34,037     (53,942     (213,064     (592,627
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense):

        

Interest income

     5,296       6,062       21,430       27,062  

Interest expense

     (6,673     (89     (13,682     (341

Investment advisory fees

     (166     (227     (722     (976

Change in fair value of warrant liability

     (1,127     (1,145     (812     (936

Realized gain (loss) on marketable securities

     3       (12     5       (12

Net loss on disposal of fixed assets

     (3     —        (33     —   

Other income (expense)

     115       (92     2,251       (109
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     (2,555     4,497       8,437       24,688  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (36,592     (49,445     (204,627     (567,939

Provision for income taxes

     —        —        —        —   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (36,592   $ (49,445   $ (204,627   $ (567,939
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders

        

Net loss per share attributable to common stockholders, basic and diluted

   $ (0.11   $ (0.15   $ (0.60   $ (2.11
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     344,339       336,934       341,541       268,772  
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss:

        

Net loss

   $ (36,592   $ (49,445   $ (204,627   $ (567,939

Other comprehensive loss, net of taxes:

        

Currency translation adjustment

     (1,006     1,131       (1,501     537  

Change in unrealized gain (loss) on available-for-sale securities

     958       (1,939     741       (145
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (36,640   $ (50,253   $ (205,387   $ (567,547
  

 

 

   

 

 

   

 

 

   

 

 

 

FAQ

How much revenue did Nuvation Bio (NUVB) generate in 2025?

Nuvation Bio generated total revenue of $62.9 million in 2025, up from $7.9 million in 2024. This included $24.7 million in IBTROZI product revenue and $38.2 million from collaboration and license agreements across milestones, services, supply, and royalties.

What were Nuvation Bio’s (NUVB) 2025 net loss and earnings per share?

Nuvation Bio reported a 2025 net loss of $204.6 million, compared with $567.9 million in 2024. Net loss per share was $(0.60) in 2025 versus $(2.11) in 2024, reflecting reduced one-time charges and higher revenue from IBTROZI and collaborations.

How did IBTROZI contribute to Nuvation Bio (NUVB) revenue in 2025?

IBTROZI generated $15.7 million in net product revenue in Q4 2025 and $24.7 million for the full year. Nuvation Bio began U.S. distribution in June 2025, making IBTROZI its only product revenue source as it ramps commercialization in ROS1+ non-small cell lung cancer.

What was Nuvation Bio’s (NUVB) cash position at December 31, 2025?

As of December 31, 2025, Nuvation Bio held $529.2 million in cash, cash equivalents, and marketable securities. Total assets were $594.8 million, providing funding for commercialization and clinical programs despite ongoing net losses and new financing-related liabilities on the balance sheet.

How did Nuvation Bio’s research and development spending change in 2025?

Research and development expenses rose to $115.1 million in 2025 from $99.1 million in 2024. The increase was driven by higher third-party clinical study costs and salaries and benefits, including stock-based compensation linked to FDA approval of IBTROZI, partly offset by lower regulatory milestone payments.

Why did Nuvation Bio’s selling, general and administrative expenses increase in 2025?

Selling, general and administrative expenses increased to $151.6 million in 2025 from $69.2 million in 2024. The rise reflected higher personnel costs from added headcount and performance-based stock compensation, a $41.0 million increase in sales and marketing, and greater legal and other expenses.

What key collaboration milestone affected Nuvation Bio’s 2025 revenue?

A major driver of 2025 collaboration revenue was a $25 million milestone payment from Nippon Kayaku. This payment was triggered by establishment of the reimbursement price for IBTROZI in Japan in Q4 2025, contributing to higher quarterly and full-year collaboration and license agreements revenue.

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Biotechnology
Pharmaceutical Preparations
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