Nuvation Bio Reports Second Quarter 2026 Financial Results and Provides Business Update
Rhea-AI Summary
Nuvation Bio (NYSE: NUVB) reported second quarter 2026 total revenue of $31.7 million, including $23.2 million in net product revenue from IBTROZI and $8.5 million from collaboration and license agreements. Net loss was $62.8 million, or $(0.18) per basic and diluted share.
IBTROZI net product revenue grew about 25% QoQ, with ~160 new U.S. patient starts and ~85% of them TKI‑naïve. As of June 30, 2026, cash, cash equivalents, and marketable securities totaled $661.0 million, excluding $36.5 million in overallotment proceeds received in July. In July, the company also closed a 0.75% Convertible Senior Notes offering with estimated net proceeds of $279.1 million, supported by capped calls to mitigate dilution.
Nuvation Bio highlighted positive updated Phase 2 data for safusidenib in grade 2 IDH1‑mutant glioma, including a 51.9% ORR and 79.1% 36‑month PFS rate, and announced an expanded global clinical program. Regulatory and guideline milestones for IBTROZI included FDA sNDA acceptance with a January 4, 2027 target action date, MHRA validation of a UK MAA, and inclusion in NCCN CNS cancer guidelines for ROS1+ NSCLC with brain metastases.
Positive
- Q2 2026 total revenue $31.7 million, including $23.2 million IBTROZI net product revenue and $8.5 million collaboration and license revenue
- IBTROZI U.S. net product revenue $23.2 million in Q2 2026, reflecting approximately 25% quarter‑over‑quarter growth
- Safusidenib Phase 2 data: 51.9% ORR and 79.1% 36‑month PFS rate in grade 2 IDH1‑mutant glioma with long median follow-up
- Cash, cash equivalents, and marketable securities $661.0 million at June 30, 2026, before July financing inflows
- Convertible Senior Notes financing approximately $279.1 million net proceeds in July 2026, with capped calls at a $10.4580 share cap
- Collaboration and license revenue increased to $8.5 million from $3.6 million year over year, including $2.1 million royalty revenue from China and Japan
Negative
- Net loss $62.8 million in Q2 2026, compared with a $59.0 million net loss in Q2 2025
- Research and development expenses rose to $30.7 million from $27.4 million year over year, driven by higher clinical trial costs
- Selling, general and administrative expenses increased to $42.6 million from $38.5 million, reflecting higher headcount, legal, professional, and marketing costs
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Achieved
IBTROZI is the most prescribed ROS1 TKI in in both first-line and overall new patient starts in 2026 based on IQVIA claims from first five months of the year
~
Announced positive updated long-term Phase 2 data for safusidenib and significant expansion of clinical program to address broad spectrum of IDH1-mutant glioma
Robust balance sheet with cash, cash equivalents, and marketable securities of
Company to host a conference call today at 8:00 am ET
"IBTROZI is now the most prescribed ROS1 TKI in both first-line and overall new patient starts in 2026, based on IQVIA claims data from the first five months of the year, reflecting the medical community's growing conviction that IBTROZI's durability profile belongs at the front of the treatment sequence. Consistent with this, approximately
Dr. Hung continued, "We are equally excited about the progress of safusidenib, with our updated Phase 2 data showing further deepening and durable responses in IDH1-mutant gliomas. We now plan to evaluate the potential of this investigational medicine across the broad spectrum of patients in hopes of fulfilling our ultimate goal of providing an effective therapy for nearly every patient with this disease. During the second quarter, we also strengthened our balance sheet through our convertible notes offering, providing us with the financial flexibility to continue to invest in growing our portfolio."
Second Quarter 2026 and Recent Highlights:
IBTROZI® (taletrectinib), ROS1 inhibitor: Advanced ROS1+ NSCLC
- In the second quarter of 2026, Nuvation Bio reported
$23.2 million 25% quarter-over-quarter growth that reflects the continued adoption and durability of treatment.- Importantly, about
85% of the approximately 160 new patient starts were TKI-naïve, which is about a30% quarter-over-quarter growth in this treatment setting.
- Importantly, about
- In June 2026, Nuvation Bio announced that the
UK Medicines and Healthcare products Regulatory Agency (MHRA) validated the Marketing Authorisation Application (MAA) submitted by partner Eisai Co., Ltd. for taletrectinib for the treatment of advanced ROS1-positive non-small cell lung cancer (ROS1+ NSCLC). - In May 2026, Nuvation Bio announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for IBTROZI with updated efficacy data in TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January 4, 2027. The submission includes an additional 10 months of data from the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff, demonstrating a median duration of response (mDOR) of 49.7 months and median progression-free survival (mPFS) of 49.6 months in TKI-naïve patients in TRUST-I and mDOR of 19.4 months in TKI-pretreated patients in TRUST-II. In the TRUST-II study, the mDOR had not yet been reached in TKI-naïve patients at the time of the data cutoff and is subject to change as the data mature. Importantly, the safety profile remained consistent with prior reports, and no new signals were identified.
- In May 2026, Nuvation Bio announced new patient-reported outcomes data from the pivotal TRUST-II study of IBTROZI in patients with advanced ROS1+ NSCLC, presented at the 2026 ASCO Annual Meeting. Findings showed that
88% of patients reported improved or stable global health quality-of-life scores at first assessment, cognitive function scores improved or remained stable throughout treatment, and patients experienced rapid relief from burdensome symptoms including cough and shortness of breath. - In May 2026, Nuvation Bio announced the successful completion of process technology transfer and product introduction to Thermo Fisher Scientific for
U.S .-based manufacturing of drug product for IBTROZI, further securing critical drug supply for ROS1+ NSCLC patients and providers. - 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 Cancer Research (AACR) Annual Meeting 2026. Notably, in the pooled TKI-naïve population, IBTROZI demonstrated robust confirmed overall response rates (cORR), mDOR and mPFS in TKI-naïve patients. Updated results from the TRUST-I study were also simultaneously published in the Journal of Clinical Oncology.
- 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.
Safusidenib, mIDH1 inhibitor: IDH1-mutant glioma
- In July 2026, Nuvation Bio announced updated positive long-term follow-up data from the Phase 2 (J201) study of safusidenib in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma. Highlights of the findings, at a median of 38.8 months of follow-up, include the following:
- The centrally assessed ORR, per Response Assessment in Neuro-Oncology (RANO) for low grade gliomas (LGG) criteria, was
51.9% . - Median PFS was not reached, and the 36-month PFS rate was
79.1% . - Responses were durable, with only one patient who had previously responded experiencing subsequent disease progression.
- No new safety signals were identified.
- The centrally assessed ORR, per Response Assessment in Neuro-Oncology (RANO) for low grade gliomas (LGG) criteria, was
- In July 2026, Nuvation Bio also announced a significant expansion of the clinical development program for safusidenib supported by the updated long-term follow-up data from the Phase 2 (J201) study. The company initiated two new studies to evaluate safusidenib across the broader landscape of IDH1-mutant glioma: a pivotal Phase 3 study in patients with grade 2 IDH1-mutant glioma outside the
U.S . (G307; NCT07712757) and a Phase 2 study in patients with IDH1-mutant glioma that has progressed after prior treatment with vorasidenib in theU.S . (G209; NCT07703436). - 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.
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 July 2026, Nuvation Bio successfully completed a public offering of
0.75% Convertible Senior Notes with estimated net proceeds of approximately$279.1 million $10.4580 80.0% premium over the last reported sale price of$5.81
Second Quarter 2026 Financial Results
As of June 30, 2026, Nuvation Bio had cash, cash equivalents, and marketable securities of
Product Revenue, Net
To date, Nuvation Bio's only source of product revenue remains from the
Collaboration and License Agreements Revenue
For the three months ended June 30, 2026, collaboration and license agreements revenue was
Taletrectinib was included in
Research and Development Expenses
For the three months ended June 30, 2026, research and development expenses were
Selling, General and Administrative Expenses
For the three months ended June 30, 2026, selling, general, and administrative expenses were
Net income
For the three months ended June 30, 2026, Nuvation Bio reported a net loss of
Conference Call and Webcast
Nuvation Bio will host a conference call and webcast today, August 6, 2026, at 8:00 am ET to discuss its financial results for the second 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 (
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
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
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
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.
Increased AST or ALT each led to dose interruption in
Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in
Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in
ILD/pneumonitis led to dose interruption in
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
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
Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in
Concurrent myalgia with increased CPK within a 7-day time period occurred in
Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures.
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 (≥
The most frequently reported Grade 3/4 laboratory abnormalities (≥
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
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. These early findings support further investigation of safusidenib in the currently enrolling Phase 3 SIGMA study, as well as in the Phase 3 G307 study outside the
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.
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.
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, Nuvation Bio's belief that IBTROZI is becoming the standard of care in advanced ROS1+ NSCLC, Nuvation Bio's plans to evaluate safusidenib across the broad spectrum of patients with IDH-1mutant glioma, and Nuvation Bio's evaluation of additional preclinical candidates and timelines for further updates. 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-Q filed with the SEC on August 6, 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
NUVATION BIO INC. and Subsidiaries | |||
Consolidated Balance Sheets | |||
(In thousands, except share and per share data) | |||
June 30, | December 31, | ||
2026 | 2025 | ||
(unaudited) | |||
Assets | |||
Current assets: | |||
Cash and cash equivalents | $ 258,604 | $ 164,086 | |
Accounts receivable, net of allowance for credit loss of $nil and nil, respectively | 27,826 | 16,076 | |
Inventory | 19,901 | 11,411 | |
Prepaid expenses and other current assets | 13,861 | 11,536 | |
Marketable securities | 402,352 | 365,125 | |
Interest receivable on marketable securities | 3,888 | 3,285 | |
Total current assets | 726,432 | 571,519 | |
Property and equipment, net of accumulated depreciation of | 715 | 564 | |
Intangible assets, net of accumulated amortization of | 10,292 | 11,214 | |
Operating lease right-of-use assets | 3,240 | 3,918 | |
Other non-current assets | 3,824 | 7,607 | |
Total assets | $ 744,503 | $ 594,822 | |
Liabilities and stockholders' equity | |||
Current liabilities: | |||
Accounts payable | $ 12,089 | $ 9,479 | |
Current operating lease liabilities | 1,715 | 1,880 | |
Contract liabilities, current portion | 8,855 | 7,515 | |
Liability related to revenue interest financing agreement, current portion | 12,999 | 9,585 | |
Short-term borrowings | 5,893 | 5,724 | |
Warrant liability | - | 2,865 | |
Accrued expenses | 45,204 | 45,183 | |
Total current liabilities | 86,755 | 82,231 | |
Contract liabilities, net of current portion | 8,228 | 11,305 | |
Non-current operating lease liabilities | 1,910 | 2,543 | |
Non-current liability related to revenue interest financing agreement, net of deferred financing costs of | 151,122 | 145,819 | |
Long-term borrowings, net of deferred financing costs of | - | 47,208 | |
Convertible debt, net of deferred financing costs of | 242,624 | - | |
Total liabilities | 490,639 | 289,106 | |
Stockholders' equity | |||
Class A and Class B common stock and additional paid in capital, | |||
(Class A 1,000,000,000, Class B 60,000,000) shares authorized as of June 30, 2026 and December 31, 2025, | |||
349,822,479 (Class A 348,822,479, 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 | 1,429,288 | 1,421,273 | |
Accumulated deficit | (1,172,813) | (1,115,370) | |
Accumulated other comprehensive loss | (2,611) | (187) | |
Total stockholders' equity | 253,864 | 305,716 | |
Total liabilities and stockholders' equity | $ 744,503 | $ 594,822 | |
NUVATION BIO INC. and Subsidiaries | |||||||
Consolidated Statements of Operations and Comprehensive Loss | |||||||
(In thousands, except per share data) | |||||||
Three Months Ended June 30, | Six Months Ended March 31, | ||||||
2026 | 2025 | 2026 | 2025 | ||||
Revenues: | |||||||
Product revenue, net | $ 23,192 | $ 1,238 | $ 41,702 | $ 1,238 | |||
Collaboration and license agreements revenue | 8,495 | 3,595 | 73,213 | 6,679 | |||
Total revenues | 31,687 | 4,833 | 114,915 | 7,917 | |||
Costs and expenses: | |||||||
Cost of sales | 911 | 172 | 1,286 | 172 | |||
Cost of collaboration and license agreements revenue | 8,560 | 2,404 | 14,176 | 4,498 | |||
Research and development | 30,661 | 27,362 | 65,708 | 51,963 | |||
Selling, general and administrative | 42,591 | 38,484 | 80,900 | 73,877 | |||
Total costs and expenses | 82,723 | 68,422 | 162,070 | 130,510 | |||
Income (loss) from operations | (51,036) | (63,589) | (47,155) | (122,593) | |||
Other income (expense): | |||||||
Interest income | 4,596 | 4,780 | 9,704 | 10,101 | |||
Interest expense | (6,759) | (421) | (13,467) | (475) | |||
Investment advisory fees | (184) | (182) | (379) | (385) | |||
Loss on debt extinguishment | (9,472) | - | (9,472) | - | |||
Change in fair value of warrant liability | - | 454 | 2,865 | (297) | |||
Realized gain (loss) on marketable securities | 9 | (1) | 17 | 2 | |||
Net gain (loss) on disposal of fixed assets | 1 | (34) | 1 | (34) | |||
Other income (expense) | 5 | (14) | 443 | 1,438 | |||
Total other (expense) income, net | (11,804) | 4,582 | (10,288) | 10,350 | |||
Loss before income taxes | (62,840) | (59,007) | (57,443) | (112,243) | |||
Provision for income taxes | - | - | - | - | |||
Net loss | $ (62,840) | $ (59,007) | $ (57,443) | $ (112,243) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ (0.18) | $ (0.17) | $ (0.17) | $ (0.33) | |||
Weighted average common shares outstanding, basic and diluted | 348,770 | 340,746 | 348,055 | 339,685 | |||
Comprehensive income (loss): | |||||||
Net loss | $ (62,840) | $ (59,007) | $ (57,443) | $ (112,243) | |||
Other comprehensive loss, net of taxes: | |||||||
Currency translation adjustment | (471) | (646) | (739) | (182) | |||
Change in unrealized loss on available-for-sale securities | (463) | (225) | (1,685) | (718) | |||
Comprehensive loss | $ (63,774) | $ (59,878) | $ (59,867) | $ (113,143) | |||
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SOURCE Nuvation Bio, Inc.