For the three months ended June 30, 2024, general and administrative expenses were $16.1 million,
compared to $7.5 million for the three months ended June 30, 2023. The increase was due to a $3.9 million increase in personnel-related costs as a result of the acquisition of AnHeart, a $1.1 million increase in professional
fees, a $1.2 million increase in marketing expense, a $0.8 million increase in legal fees, a $0.2 million increase in occupancy expense, a $0.2 million increase in foreign currency impact, and a $1.4 million increase in
miscellaneous expense offset by a $0.2 million decrease in insurance expense.
For the three months ended June 30, 2024, Nuvation Bio reported a
net loss of $462.5 million, or $(1.89) per share. This compares to a net loss of $20.6 million, or $(0.09) per share, for the comparable period in 2023.
About Taletrectinib
Taletrectinib is an oral, potent,
central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib is being
evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1-positive NSCLC and Breakthrough Therapy Designations by both the
U.S. FDA and China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced or metastatic ROS1-positive NSCLC. Based on results of the TRUST-I clinical study,
China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously
been treated with ROS1 tyrosine kinase inhibitors.
About Nuvation Bio
Nuvation Bio is a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and
novel product candidates. Nuvation Bio’s portfolio of development candidates includes taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET).
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, and Shanghai. For more information, please visit www.nuvationbio.com and https://www.linkedin.com/company/nuvationbio/.
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, our expectations regarding a U.S. NDA, the expected timing of becoming a commercial organization, the potential therapeutic benefit of Nuvation Bio’s product candidates, the
advancement of our clinical programs, and the strength of Nuvation Bio’s balance sheet. These statements