For the three months ended March 31, 2025, selling, general, and administrative expenses were
$35.4 million, compared to $7.4 million for the three months ended March 31, 2024. The increase was due to a $10.7 million increase in personnel-related costs as a result of the acquisition of AnHeart, $12.2 million increase
in sales and marketing expenses, $1.4 million increase in professional fees, $0.5 million increase in occupancy expenses, $1.1 million increase in legal fees, $0.2 million increase in foreign currency impact and $2.0 million
increase in other expenses as a result of the integration of AnHeart offset by $0.1 million decrease in taxes.
For the three months ended
March 31, 2025, Nuvation Bio reported a net loss of $53.2 million, or $(0.16) per share. This compares to a net loss of $14.8 million, or $(0.07) per share, for the comparable period in 2024.
Conference Call and Webcast
Nuvation Bio will host a
conference call on Wednesday, May 7, 2025, at 4:30 p.m. ET, during which company executives will provide an overview of its programs, summarize the commercial strategy for taletrectinib, and review financial results for the first quarter of
2025.
Investors and the general public are invited to listen to the live webcast and can register on the Nuvation Bio website at
https://investors.nuvationbio.com. Those unable to register can access the live conference call by dialing +1 833-470-1428 (U.S. toll-free) and entering access
code 341248.
A replay of the webcast will be available on the Company’s website shortly after the conference call concludes.
About Taletrectinib
Taletrectinib is an oral, potent,
central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two
Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.
Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S.
FDA has accepted and granted Priority Review to Nuvation Bio’s NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib
Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+
NSCLC and other NSCLC indications. In January 2025, China’s NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.
About Nuvation Bio
Nuvation Bio is a global oncology
company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients’ lives. Our diverse pipeline includes taletrectinib, 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.