Nuvation Bio Reports Strong Q4 Results Amid Regulatory Progress

SAN FRANCISCO, March 6, 2025—Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company focused on oncology, announced significant advancements in its fourth quarter and full year 2024 financial results today. The U.S. Food and Drug Administration (FDA) has granted Priority Review for taletrectinib, a drug targeting advanced ROS1-positive non-small cell lung cancer. The Prescription Drug User Fee Act (PDUFA) goal date for this medication is set for June 23, 2025.

In a pivotal year, Nuvation Bio reported its financial standing remains robust with $502.7 million in cash and marketable securities as of December 31, 2024. This figure was further enhanced by securing up to $250 million in non-dilutive financing from Sagard Healthcare Partners in March 2025.

In Q4 2024, the company experienced a net loss of $49.4 million, equivalent to $(0.15) per share, compared to a loss of $13.8 million during the same period in 2023. This increase in net loss was largely attributed to elevated research and development (R&D) expenses, which soared to $29.3 million from $15.4 million year-over-year.

“Nuvation Bio had a transformative year in 2024, marked by significant milestones. We moved closer to commercialization with taletrectinib and launched an Expanded Access Program to address urgent patient needs,” said David Hung, M.D., Founder, President, and CEO. “With the close of our recent financing, we are well-positioned to continue working toward improving the lives of people battling cancer.”

The increase in R&D costs is primarily due to the acquisition of AnHeart Therapeutics and the associated increases in personnel-related and clinical trial expenses. Additionally, selling, general and administrative (SG&A) expenses rose to $26.1 million from $5.5 million year-over-year, underlining the costs related to business scaling and integration.

Nuvation Bio’s therapeutic candidate, taletrectinib, has also gained momentum abroad, receiving approval in China and undergoing review in Japan. This reflects a broader strategic move to diversify its market reach and enhance the therapeutic options available for patients with advanced ROS1+ non-small cell lung cancer.

The receipt of the FDA Priority Review designation underscores the agency’s recognition of the unmet medical need within this specific patient population. With the potential U.S. launch expected in mid-2025, Nuvation Bio aims to position itself as a leader in this area of oncology.

Analysts view the recent financing strategy as a pivotal move that allows Nuvation Bio to preserve shareholder equity while providing substantial capital for further development and commercialization efforts. The company’s clear regulatory strategy indicates a comprehensive approach to drug development that strategically diversifies regulatory risk across various markets.

As Nuvation Bio continues to develop its pipeline, which includes safusidenib for glioma treatment and NUV-1511, a drug-drug conjugate for advanced solid tumors, the firm remains focused on addressing significant unmet medical needs in the oncology landscape.

To summarize, Nuvation Bio’s latest report not only highlights financial results but also emphasizes pivotal regulatory developments that could reshape the treatment landscape for advanced ROS1-positive non-small cell lung cancer patients.