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Eisai deal lifts Nuvation Bio (NYSE: NUVB) to Q1 2026 profit

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(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Nuvation Bio reported a strong first quarter of 2026, moving to net income of $5.4 million after a net loss of $53.2 million a year earlier. Total revenue rose to $83.2 million, driven by initial U.S. sales of IBTROZI and a large increase in collaboration and license revenue.

Net product revenue from U.S. sales of IBTROZI (taletrectinib) reached $18.5 million, while collaboration and license agreements revenue climbed to $64.7 million, largely due to an upfront payment under the Eisai agreement. The company ended March 31, 2026 with $533.7 million in cash, cash equivalents, and marketable securities.

Nuvation Bio highlighted updated clinical data showing durable responses for IBTROZI in ROS1‑positive NSCLC and announced acquisition of Japan rights to safusidenib, supporting its global development. Research and development spending increased to $35.0 million, and selling, general and administrative expenses were $38.3 million as the company invests behind its oncology portfolio.

Positive

  • Total revenue surged to $83.2M in Q1 2026, supported by IBTROZI launch and a step-up in collaboration and license revenue.
  • Company reported net income of $5.4M versus a $53.2M loss a year earlier, marking an early move into profitability while funding pipeline growth.
  • Cash, cash equivalents, and marketable securities totaled $533.7M as of March 31, 2026, giving substantial resources to advance IBTROZI, safusidenib, and the DDC platform.

Negative

  • None.

Insights

Q1 2026 shows a sharp revenue ramp and first reported profit.

Nuvation Bio generated total revenue of $83.2M for Q1 2026, up from $3.1M a year earlier, as IBTROZI launch and partnering income scaled. Net product revenue from IBTROZI reached $18.5M, while collaboration and license revenue was $64.7M, helped by the Eisai upfront payment.

The company turned to net income of $5.4M from a prior $53.2M loss, despite higher R&D at $35.0M and SG&A of $38.3M. A cash, cash equivalents, and marketable securities balance of $533.7M as of March 31, 2026 provides substantial funding for clinical programs.

Nuvation also advanced its pipeline, with updated IBTROZI data in ROS1+ NSCLC and acquisition of Japan rights to safusidenib. Future disclosures in periodic reports and clinical updates will clarify how recurring product sales and milestone timing shape profitability beyond this quarter’s Eisai-related revenue.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Total revenue Q1 2026 $83.2M Three months ended March 31, 2026; vs $3.1M in 2025
IBTROZI net product revenue $18.5M U.S. sales for the three months ended March 31, 2026
Collaboration and license revenue $64.7M Three months ended March 31, 2026; includes Eisai upfront
Net income Q1 2026 $5.4M Three months ended March 31, 2026; vs $53.2M loss in 2025
Cash and investments $533.7M Cash, cash equivalents, and marketable securities as of March 31, 2026
Research and development expense $35.0M Three months ended March 31, 2026; vs $24.6M in 2025
Selling, general and administrative expense $38.3M Three months ended March 31, 2026; vs $35.4M in 2025
ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) medical
"IBTROZI’s durability of response and progression-free survival in TKI-naïve and TKI-pretreated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)"
Breakthrough Therapy designations regulatory
"following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease"
A breakthrough therapy designation is a special status granted by a regulatory agency to a drug or treatment that shows strong early signs of being substantially better than current options for a serious illness; it gives the developer faster and more intensive guidance during testing and review. For investors, the designation can shorten time to market, lower development risk and costs, and increase the odds of a valuable approval — like giving a promising product a fast-pass through the approval process.
revenue interest financing agreement financial
"Liability related to revenue interest financing agreement, current portion"
A revenue interest financing agreement is a deal where a company receives cash now in exchange for giving an investor a fixed percentage of future revenue until a set amount or time is reached. Think of it like selling a small slice of every sale to an investor instead of taking a traditional loan or issuing stock. Investors care because it affects future cash flow and returns—payments rise and fall with sales and don’t dilute ownership like equity.
objective response rate medical
"The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee"
The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.
Phase 3 study medical
"TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults"
A phase 3 study is the large-scale clinical trial that tests whether a new drug or medical treatment actually works and is safe in a broad group of patients, typically after earlier smaller tests. Investors watch these studies like a final dress rehearsal because their successful completion is often required for regulatory approval and market access; positive or negative results can sharply change a company’s future sales prospects and stock value.
IDH1-mutant glioma medical
"About IDH1-Mutant Glioma Gliomas are the most common type of brain cancer in adults worldwide"
A disease in which a brain tumor (glioma) carries a specific change in the IDH1 gene that alters the tumor’s metabolism and behavior. That mutation often defines a distinct group of patients with different prognosis and treatment responses, so it matters to investors because it creates a targeted patient population for drugs, diagnostics and clinical trials—think of it like a unique lock that only certain therapies can open.
Total revenue $83.2M vs $3.1M in Q1 2025
Net income (loss) $5.4M vs $(53.2)M in Q1 2025
Product revenue, net $18.5M vs $0 in Q1 2025
Collaboration and license agreements revenue $64.7M vs $3.1M in Q1 2025
false 0001811063 0001811063 2026-05-04 2026-05-04
 
 

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): May 4, 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 May 4, 2026, Nuvation Bio Inc. issued a press release announcing its financial results for the quarter ended March 31, 2026. 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 May 4, 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: May 4, 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 First Quarter 2026 Financial Results and Provides Business Update

Achieved $18.5 million in first quarter of 2026 net product revenues for IBTROZI® (taletrectinib); majority

of the approximately 200 patients started on IBTROZI in the first quarter of 2026 were TKI-naïve,

highlighting continued momentum in the first-line setting

Presented newly updated clinical data demonstrating IBTROZI’s impressive durability of response and

progression-free survival in TKI-naïve and TKI-pretreated patients with advanced ROS1-positive

(ROS1+) non-small cell lung cancer (NSCLC) at AACR 2026

Announced acquisition of Japan rights to safusidenib from Daiichi Sankyo, enabling global development and

commercialization of promising investigational medicine

Strong balance sheet with cash, cash equivalents, and marketable securities of $533.7 million as of

March 31, 2026

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

NEW YORK—May 4, 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 first quarter ended March 31, 2026, and provided a business update.

“We are pleased with IBTROZI’s ongoing launch trends in the first quarter of 2026, as we continue to deepen its adoption across lines of therapy and make significant progress in becoming the standard of care for people living with advanced ROS1-positive NSCLC. The newly updated long-term follow-up data from our pivotal studies presented at AACR demonstrated an unprecedented durability for IBTROZI of now more than four years in TKI-naïve patients, further supporting healthcare providers and their patients’ confidence in selecting IBTROZI. With our partners, we are well on our way to bringing this important medicine to patients in need around the world,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We are also thrilled to have secured exclusive global development and commercialization rights to safusidenib. We look forward to advancing the pivotal Phase 3 SIGMA study for patients with high-risk IDH1-mutant glioma, where targeted treatment options are incredibly limited. Additionally, we are well on track to provide updates on our drug-drug conjugate platform later this year as we further our mission to tackle some of the toughest challenges in cancer treatment.”

First Quarter 2026 and Recent Corporate Highlights:

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

 

   

In the first quarter of 2026, Nuvation Bio reported $18.5 million in net product revenues for IBTROZI.

 

   

In the first quarter of 2026, more than half of the approximately 200 new patients who started treatment with IBTROZI for advanced ROS1+ NSCLC were TKI-naïve, reflecting a sustained high rate of adoption and confidence in IBTROZI among healthcare professionals and patients. Since launch in late June 2025, over 600 patients have started IBTROZI.

 

   

In April 2026, Nuvation Bio presented updated pooled results from the TRUST-I and TRUST-II studies of IBTROZI in both TKI-naïve and TKI-pretreated patients at the American Association for


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Cancer Research (AACR) Annual Meeting 2026. Notably, in the pooled TKI-naïve population, IBTROZI demonstrated robust confirmed overall response rates (cORR), median duration of response (mDOR) and median progression-free survival (mPFS) in TKI-naïve patients. Updated results from the TRUST-I study were also simultaneously published in the Journal of Clinical Oncology.

 

   

For TKI-naïve patients (n=157): the analysis showed a cORR of 89.8%, a mDOR of 49.7 months, a mPFS of 46.1 months and an intracranial response rate of 76.5% in patients with brain metastases (n=17). Median overall survival (OS) was not yet reached.

 

   

For TKI-pretreated patients (n=113): the analysis showed a cORR of 55.8%, a mDOR of 16.6 months, a mPFS of 9.7 months and an intracranial response rate of 65.6% in patients with brain metastases (n=32). Median OS was 29.8 months. Notably, 98% of TKI-pretreated patients (111/113) enrolled following progressive disease on entrectinib or crizotinib rather than intolerance, a higher bar for efficacy. The remaining two patients were enrolled following intolerance to a prior TKI.

 

   

A pooled safety analysis demonstrated a favorable and generally manageable safety profile for IBTROZI, consistent with its prescribing information and no new safety signals were identified with longer follow-up.

 

   

In April 2026, Nuvation Bio announced that taletrectinib (IBTROZI) has been added to the latest National Comprehensive Cancer Network® Clinical Practice Guidelines (NCCN Guidelines®) in Oncology for Central Nervous System (CNS) cancers. Specifically, the NCCN Guidelines® for CNS Cancers now recommend taletrectinib (IBTROZI) as a systemic therapy option for ROS1+ NSCLC patients with brain metastases.

 

   

In March 2026, Nuvation Bio announced with Eisai Co., Ltd. that the European Medicines Agency (EMA) had validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1+ NSCLC. The filing is being considered for full approval and will follow a standard review timeline.

 

   

On January 11, 2026, Nuvation Bio 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 and certain other territories outside of the U.S., China and Japan.

Safusidenib, mIDH1 inhibitor: IDH1-mutant glioma

 

   

In April 2026, Nuvation Bio announced that it has acquired the Japan rights to safusidenib from Daiichi Sankyo, giving Nuvation Bio full global development and commercialization rights. The agreement also transfers ownership of the global clinical development program to Nuvation Bio, inclusive of clinical trials, past and current data generation, and future publications.

 

   

Nuvation Bio plans to present longer-term data from the Phase 2 study at a future medical meeting. As of February 2026, 12 of the 27 patients in the study remain on treatment with safusidenib with a median follow-up of over 5 years.

 

   

In January 2026, Nuvation Bio announced the finalization of the protocol amendment for the ongoing global Phase 3 SIGMA study for the maintenance treatment of patients with IDH1-mutant astrocytoma who have high-risk features following standard-of-care (G203). At that time, Nuvation Bio also announced that the trial would enroll a non-pivotal single-arm cohort to examine the efficacy and safety of safusidenib in chemotherapy- and radiotherapy-naïve patients with grade 3 IDH1-mutant oligodendroglioma with the primary endpoint of this arm being objective response rate.


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Drug-drug conjugate (DDC) platform: Solid tumors

 

   

Nuvation Bio continues to explore new preclinical candidates for this novel modality and aims to provide further updates by year-end 2026.

Corporate Update:

 

   

In March 2026, Nuvation Bio appointed Stephen Dang, Ph.D., as Chief Legal Officer. Dr. Dang originally joined Nuvation Bio in 2021 and has over 18 years of experience in the biopharmaceutical industry across all stages of the drug product life cycle.

First Quarter 2026 Financial Results

As of March 31, 2026, Nuvation Bio had cash, cash equivalents, and marketable securities of $533.7 million.

Product Revenue, Net

To date, Nuvation Bio’s only source of product revenue remains from the U.S. sales of IBTROZI, which Nuvation Bio began distributing to its U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $18.5 million for the three months ended March 31, 2026.

Collaboration and License Agreements Revenue

For the three months ended March 31, 2026, collaboration and license agreements revenue was $64.7 million, compared to $3.1 million for the three months ended March 31, 2025. The increase is primarily due to a $58.7 million increase in license revenue because of the upfront payment received under the Eisai agreement, a $2.4 million increase in product supply, a $1.5 million increase in royalty revenue, and was offset by a $1.0 million decrease in research and development service revenue.

Taletrectinib was included in China’s National Reimbursement Drug List effective January 1, 2026. Royalty revenue for the quarter from collaboration agreements for China and Japan was $1.7 million.

Research and Development Expenses

For the three months ended March 31, 2026, research and development expenses were $35.0 million, compared to $24.6 million for the three months ended March 31, 2025. The increase was primarily due to a $1.5 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, and $8.9 million increase in third-party costs related to clinical trials.

Selling, General and Administrative Expenses

For the three months ended March 31, 2026, selling, general, and administrative expenses were $38.3 million, compared to $35.4 million for the three months ended March 31, 2025. The increase was due to a $5.7 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, and $0.1 million increase in taxes, offset by a $1.7 million decrease in sales and marketing expenses and $1.2 million decrease in professional fees.


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Net income

For the three months ended March 31, 2026, Nuvation Bio reported a net income of $5.4 million, or $0.02 per share on a basic basis and $0.01 per share on a diluted basis. The net loss for the comparable period in 2025 was $53.2 million, or $(0.16) per share on a basic and diluted basis.

Conference Call and Webcast

Nuvation Bio will host a conference call and webcast today, May 4, 2026, at 4:30 pm ET to discuss its financial results for the first quarter of 2026 and provide business updates.

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 +1 833-461-5787 (U.S. toll-free) and enter access code 266802059. 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 taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. 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 194 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).


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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.

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.


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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.

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 2,500 people are diagnosed with IDH1-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. 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-risk features, including high grade tumors.


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About Safusidenib

Safusidenib is an investigational, oral, brain-penetrant, selective inhibitor of mutant IDH1. It is being studied in patient populations with significant unmet medical need, including settings where there are limited or no approved targeted treatment options. In Phase 1 and Phase 2 clinical studies, safusidenib demonstrated encouraging clinical activity, including delayed disease progression and durable responses across a range of tumor grades and risk groups, with a favorable risk-benefit profile that supports the currently enrolling Phase 3 SIGMA study.

About the SIGMA (G203) Study

SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients. Data is anticipated to be available in 2029.

A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients. Data is anticipated to be available in 2027.

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.

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, Nuvation Bio’s expectations that the MAA filing for taletrectinib will follow a standard review timeline and be considered for full approval, the need for new therapeutic options in IDH1-mutant gliomas, Nuvation Bio’s plans for safusidenib development and future data presentations, and Nuvation Bio’s evaluation of additional preclinical candidates. 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,


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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-Q filed with the SEC on May 4, 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)    March 31,
2026
    December 31,
2025
 
     (unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 125,391     $ 164,086  

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

     22,723       16,076  

Inventory

     15,844       11,411  

Prepaid expenses and other current assets

     15,972       11,536  

Marketable securities

     408,338       365,125  

Interest receivable on marketable securities

     3,261       3,285  
  

 

 

   

 

 

 

Total current assets

     591,529       571,519  

Property and equipment, net of accumulated depreciation of $1,260 and $1,184, respectively

     535       564  

Intangible assets, net of accumulated amortization of $2,315 and $1,856, respectively

     10,755       11,214  

Operating lease right-of-use assets

     3,598       3,918  

Other non-current assets

     3,824       7,607  
  

 

 

   

 

 

 

Total assets

   $ 610,241     $ 594,822  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

   $ 22,435     $ 9,479  

Current operating lease liabilities

     1,838       1,880  

Contract liabilities, current portion

     8,651       7,515  

Liability related to revenue interest financing agreement, current portion

     7,944       9,585  

Short-term borrowings

     5,790       5,724  

Warrant liability

     —        2,865  

Accrued expenses

     32,864       45,183  
  

 

 

   

 

 

 

Total current liabilities

     79,522       82,231  

Contract liabilities, net of current portion

     9,743       11,305  

Non-current operating lease liabilities

     2,199       2,543  

Non-current liability related to revenue interest financing agreement, net of deferred financing costs of $4,030 and $4,241, respectively

     151,886       145,819  

Long-term borrowings, net of deferred financing costs of $2,923 and $3,042, respectively

     47,327       47,208  
  

 

 

   

 

 

 

Total liabilities

     290,677       289,106  
  

 

 

   

 

 

 

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 March 31, 2026 and December 31, 2025, 347,693,331 (Class A 346,693,331, Class B 1,000,000) and 346,503,675 (Class A 345,503,675, Class B 1,000,000) shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

     1,431,214       1,421,273  

Accumulated deficit

     (1,109,973     (1,115,370

Accumulated other comprehensive income

     (1,677     (187
  

 

 

   

 

 

 

Total stockholders’ equity

     319,564       305,716  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 610,241     $ 594,822  
  

 

 

   

 

 

 

 


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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
March 31,
 
     2026     2025  

Revenues:

    

Product revenue, net

   $ 18,510     $ —   

Collaboration and license agreements revenue

     64,718       3,084  
  

 

 

   

 

 

 

Total revenues

     83,228       3,084  
  

 

 

   

 

 

 

Costs and expenses:

    

Cost of sales

     375       —   

Cost of collaboration and license agreements revenue

     5,616       2,094  

Research and development

     35,047       24,601  

Selling, general and administrative

     38,309       35,393  
  

 

 

   

 

 

 

Total costs and expenses

     79,347       62,088  
  

 

 

   

 

 

 

Income (loss) from operations

     3,881       (59,004
  

 

 

   

 

 

 

Other income (expense):

    

Interest income

     5,108       5,321  

Interest expense

     (6,708     (54

Investment advisory fees

     (195     (203

Change in fair value of warrant liability

     2,865       (751

Realized gain (loss) on marketable securities

     8       3  

Other income (expense)

     438       1,452  
  

 

 

   

 

 

 

Total other income, net

     1,516       5,768  
  

 

 

   

 

 

 

Income (loss) before income taxes

     5,397       (53,236

Provision for income taxes

     —        —   
  

 

 

   

 

 

 

Net income (loss)

   $ 5,397     $ (53,236
  

 

 

   

 

 

 

Basic earnings (loss) per share attributable to common stockholders

   $ 0.02     $ (0.16
  

 

 

   

 

 

 

Diluted earnings (loss) per share attributable to common stockholders

   $ 0.01     $ (0.16
  

 

 

   

 

 

 

Basic weighted average common shares outstanding

     347,332       338,612  
  

 

 

   

 

 

 

Diluted weighted average common shares outstanding

     377,521       338,612  
  

 

 

   

 

 

 

Comprehensive income (loss):

    

Net income (loss)

   $ 5,397     $ (53,236

Other comprehensive (loss) income, net of taxes:

    

Currency translation adjustment

     (268     465  

Change in unrealized loss on available-for-sale securities

     (1,222     (493
  

 

 

   

 

 

 

Comprehensive income (loss)

   $ 3,907     $ (53,264
  

 

 

   

 

 

 

FAQ

How much revenue did Nuvation Bio (NUVB) generate in Q1 2026?

Nuvation Bio generated total revenue of $83.2 million for the quarter ended March 31, 2026. This included $18.5 million in net product revenue from IBTROZI and $64.7 million from collaboration and license agreements, reflecting both commercial uptake and partnership income.

Was Nuvation Bio (NUVB) profitable in the first quarter of 2026?

Yes, Nuvation Bio reported net income of $5.4 million in Q1 2026. This compares with a net loss of $53.2 million in the same period of 2025, as higher revenues more than offset increased research and development and selling, general and administrative expenses.

How is IBTROZI performing commercially for Nuvation Bio (NUVB)?

IBTROZI generated $18.5 million in net product revenue from U.S. sales during Q1 2026. Approximately 200 patients started IBTROZI in the quarter, with a majority TKI‑naïve, supporting continued momentum in the first‑line setting for advanced ROS1‑positive NSCLC.

What collaboration and license revenue did Nuvation Bio (NUVB) report?

Collaboration and license agreements revenue totaled $64.7 million in Q1 2026, up from $3.1 million a year earlier. Management attributes the increase mainly to an upfront payment under the Eisai agreement, along with higher product supply and royalty revenue from collaboration partners.

What is Nuvation Bio’s (NUVB) cash position after Q1 2026?

As of March 31, 2026, Nuvation Bio held $533.7 million in cash, cash equivalents, and marketable securities. This strong balance sheet supports ongoing commercialization of IBTROZI, development of safusidenib, and advancement of its drug‑drug conjugate platform and other pipeline programs.

How did Nuvation Bio’s R&D and SG&A expenses change in Q1 2026?

In Q1 2026, research and development expenses were $35.0 million, up from $24.6 million in Q1 2025. Selling, general, and administrative expenses were $38.3 million, compared with $35.4 million a year earlier, reflecting higher headcount and stock‑based compensation.

Filing Exhibits & Attachments

4 documents