NUV-868

NEW YORK--(BUSINESS WIRE)--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 third quarter ended September 30, 2025, and provided a business update. “We are thrilled that 204 new patients have received IBTROZI during our first full quarter as a commercial-stage company,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Our early launch progress underscores our team’s expertise in rare disease and ability to execute, as well as the positive sentiment of the community for the value of our medicine. We are also pleased to share that IBTROZI’s robust durability profile continues to mature and now shows a 50-month median duration of response as of the latest August data cut-off.” Dr. Hung continued, “Our broader pipeline also continues to progress with urgency. After multiple collaborative discussions with the U.S. FDA, we reached alignment on our pivotal study plans for safusidenib and recently dosed our first patient for the maintenance treatment of high-grade IDH1-mutant glioma.” Third Quarter 2025 and Recent Corporate Highlights: IBTROZI (taletrectinib), ROS1 inhibitor: Advanced ROS1+ NSCLC In the third quarter, 204 new patients started treatment with IBTROZI. In September 2025, the Company presented new and updated long-term results from the pivotal Phase 2 TRUST-I and TRUST-II studies of IBTROZI at the IASLC 2025 World Conference on Lung Cancer (WCLC), highlighting durability of responses and favorable safety profile across both trials with additional follow-up time. In September 2025, our partner Nippon Kayaku received approval of IBTROZI from Japan’s Ministry of Health, Labour and Welfare for the treatment of patients with advanced ROS1+ NSCLC. The Company will receive a $25 million milestone payment upon the first establishment of the reimbursement price in Japan, which is expected by year end. The Company will receive a $25 million milestone payment upon the first establishment of the reimbursement price in Japan, which is expected by year end. In September 2025, the Company enrolled the first patient in the TRUST-IV phase 3 study of IBTROZI for the adjuvant treatment of ROS1+ early-stage NSCLC. In October 2025, the Company presented 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 ten patients whose tumors progressed following treatment with entrectinib. IBTROZI demonstrated a confirmed overall response rate of 80% in ten patients whose tumors progressed following treatment with entrectinib. Today, the company is announcing that IBTROZI’s median DOR has matured to 50 months as of an August 2025 data cut-off from the pooled TRUST-I and TRUST-II studies. The Company plans to prepare a supplemental New Drug Application (sNDA) to include the updated data in the IBTROZI label and will provide additional data from the August 2025 data cut-off at a medical conference in 2026. The Company plans to prepare a supplemental New Drug Application (sNDA) to include the updated data in the IBTROZI label and will provide additional data from the August 2025 data cut-off at a medical conference in 2026. Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma In October 2025, the Company enrolled the first patient in the G203 study, a global, randomized study of safusidenib for maintenance treatment of high-grade IDH1-mutant glioma. Following an in-progress protocol amendment aligned on with the U.S. Food and Drug Administration (FDA), the Company plans to enroll 300 patients to support potential approval. Following an in-progress protocol amendment aligned on with the U.S. Food and Drug Administration (FDA), the Company plans to enroll 300 patients to support potential approval. Following discussion with the U.S. FDA, the Company has decided not to pursue a head-to-head randomized study of safusidenib against vorasidenib to support approval in non-enhancing grade 2 IDH1-mutant glioma. The Company plans to evaluate safusidenib in high-risk subgroups of low-grade IDH1-mutant glioma for which vorasidenib is not approved. The Company plans to evaluate safusidenib in high-risk subgroups of low-grade IDH1-mutant glioma for which vorasidenib is not approved. NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors The Company expects to provide an update from the Phase 1/2 dose escalation study of NUV-1511 by year end 2025. Third Quarter 2025 Financial Results As of September 30, 2025, Nuvation Bio had cash, cash equivalents, and marketable securities of $549.0 million. Product Revenue, Net To date, our only source of product revenue has been from the U.S. sales of IBTROZI. We began shipping IBTROZI to our U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $7.7 million for the three months ended September 30, 2025. Collaboration and License Agreements Revenue For the three months ended September 30, 2025, collaboration and license agreements revenue was $5.4 million, compared to $0.7 million for the three months ended September 30, 2024. The increase was due to a $3.8 million increase in research and development service revenue under the collaboration agreements with Nippon Kayaku and Innovent, a $0.6 million increase in products supply, and a $0.3 million increase in royalty revenue. The Company anticipates taletrectinib will be listed on China’s National Reimbursement Drug List in 2026. Operating Expenses For the three months ended September 30, 2025, research and development expenses were $28.8 million, compared to $27.7 million for the three months ended September 30, 2024. The increase was due to a $2.0 million increase in third-party costs related to clinical studies and new TRUST-IV study set up for taletrectinib, offset by a $0.9 million decrease in personnel-related costs because employee compensation and benefit costs directly related to commercial drug production were capitalized into inventory. For the three months ended September 30, 2025, selling, general, and administrative expenses were $37.4 million, compared to $19.6 million for the three months ended September 30, 2024. The increase was due to a $9.5 million increase in personnel-related costs as a result of the increase in headcount, a $6.4 million increase in sales and marketing expenses, a $2.2 million increase in other expenses as a result of systems built for the commercial launch of taletrectinib, and a $0.5 million increase in legal fees offset by a $0.3 million decrease in occupancy expenses, $0.3 million decrease in professional fees, and a $0.2 million decrease in foreign currency impact. For the three months ended September 30, 2025, Nuvation Bio reported a net loss of $55.8 million, or $(0.16) per share. The net loss for the comparable period in 2024 was $41.2 million, or $(0.15) per share. Conference Call and Webcast Nuvation Bio will host a conference call and webcast on Monday, November 3, 2025, at 4:30 pm ET to discuss its financial results and business updates for the third quarter of 2025. 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 +1 833-470-1428 (U.S. toll-free) and enter access code 405112. 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, following Priority Review and Breakthrough Therapy Designations for both first- and second-line or later, 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 2033. Nuvation 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. 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. 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 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; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. 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 regarding IBTROZI’S therapeutic and commercial potential, our expectations for receipt and timing of the $25 million milestone payment from Nippon Kayaku, our plans to prepare an sNDA to include updated data in the IBTROZI label, our plans to share new data and updates from our taletrectinib and NUV-1511 clinical programs, our plans for G203 study protocol amendment and patient enrollment, our expectations that the amended G203 study may support approval of safusidenib for the maintenance treatment of high-grade IDH1-mutant glioma, our plan to evaluate safusidenib for subgroups of low-grade IDH1-mutant glioma, our expectations that taletrectinib will be listed on China’s National Reimbursement Drug List in 2026, and statements regarding the strength of Nuvation Bio’s balance sheet. 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 the challenges associated with conducting drug discovery and commercialization, 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; physician and patient behavior; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on November 3, 2025 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. September 30, December 31, 2025 2024 $ 98,897 $ 35,723 8,323 12,722 5,710 - 8,925 7,271 450,148 466,969 5,527 3,570 577,530 526,255 560 586 11,680 4,622 4,329 2,402 7,462 6,761 $ 601,561 $ 540,626 $ 15,360 $ 6,348 1,871 1,663 6,721 11,117 5,982 - 5,618 6,283 32,579 32,833 68,131 58,244 1,738 2,053 11,130 15,572 2,970 969 144,621 - 47,089 - 275,679 76,838 1,404,799 1,373,958 (1,078,778 ) (910,743 ) (139 ) 573 325,882 463,788 $ 601,561 $ 540,626 Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 $ 7,723 $ - $ 8,961 $ - 5,397 727 12,076 2,162 13,120 727 21,037 2,162 3,349 1,515 8,019 2,862 9,771 (788 ) 13,018 (700 ) 28,846 27,731 80,809 69,820 - - - 425,070 37,359 19,582 111,236 43,095 66,205 47,313 192,045 537,985 (56,434 ) (48,101 ) (179,027 ) (538,685 ) 6,033 6,726 16,134 21,000 (6,534 ) (120 ) (7,009 ) (252 ) (171 ) (237 ) (556 ) (749 ) 612 533 315 209 - (11 ) 2 (17 ) 4 - (30 ) - 698 - 2,136 - 642 6,891 10,992 20,191 (55,792 ) (41,210 ) (168,035 ) (518,494 ) - - - - $ (55,792 ) $ (41,210 ) $ (168,035 ) $ (518,494 ) $ (0.16 ) $ (0.15 ) $ (0.49 ) $ (2.11 ) 342,393 273,565 340,597 245,885 $ (55,792 ) $ (41,210 ) $ (168,035 ) $ (518,494 ) (313 ) (742 ) (495 ) (594 ) 501 3,389 (217 ) 1,794 $ (55,604 ) $ (38,563 ) $ (168,747 ) $ (517,294 )