Full Press Release Details
Nuvation Bio Reports Third Quarter 2025 Financial Results and Provides Business Update
Successfully started 204 patients on IBTROZITM (taletrectinib) in the third quarter of
Updated data continue to show IBTROZI's unprecedented durability in TKI-na ve, advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), with median Duration of Response (DOR) increased to 50 months as of August 2025
Enrolled first patient in global, randomized study of safusidenib with registrational intent for maintenance treatment of high-grade
Enrolled first patient in TRUST-IV phase 3 study of IBTROZI for the
adjuvant treatment of ROS1+ early-stage NSCLC
Strong balance sheet with cash, cash equivalents, and marketable securities of
$549.0 million as of September 30, 2025
Company to host a conference call today at 4:30 pm ET
NEW YORK-November 3, 2025- 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
Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma
NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors
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,
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.
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.
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.
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.
IBTROZI is indicated for the treatment of
adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).
INFORMATION FOR IBTROZITM (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.
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%).
OTHER CONSIDERATIONS
Please see accompanying full Prescribing Information.
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.
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