On November 2, 2023 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported its financial results for the third quarter ended September 30, 2023, and provided a business update (Press release, Nuvation Bio, NOV 2, 2023, View Source [SID1234636834]).
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"We remain focused on strong clinical execution of our NUV-868 program for advanced solid tumors," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We look forward to expanding our clinical pipeline with an IND submission for our first DDC clinical candidate expected before the end of the year, building upon our unwavering commitment to bringing transformative cancer therapies to patients who need them most."
Recent Business Updates
NUV-868, BD2-Selective BETi: Advanced solid tumors
Dosing underway in the Phase 1 monotherapy study and both regimens of the Phase 1b combination study. Nuvation Bio continues to treat patients in the Phase 1 monotherapy study of NUV-868 in advanced solid tumors, the Phase 1b study of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and the Phase 1b study of NUV-868 in combination with enzalutamide in patients with mCRPC.
Drug-Drug Conjugate Platform: Solid tumors
Nominated first clinical candidate. Nuvation Bio remains on track to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023.
Third Quarter 2023 Financial Results
As of September 30, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $619.3 million. For the three months ended September 30, 2023, research and development expenses were $18.6 million, compared to $21.3 million for the three months ended September 30, 2022. The decrease was primarily due to a $0.7 million decrease in personnel-related costs driven by a headcount reduction as well as a $2.0 million decrease in third-party costs related to research services and manufacturing primarily due to the termination of the NUV-422 program.
For the three months ended September 30, 2023, general and administrative expenses were $7.8 million, compared to $8.1 million for the three months ended September 30, 2022. The decrease was primarily due to a $0.6 million decrease in insurance and a $0.1 million decrease in recruiting and computer expenses offset by a $0.4 million increase in personnel-related costs driven by stock-based compensation and other benefits.
For the three months ended September 30, 2023, Nuvation Bio reported a net loss of $19.6 million, or $(0.09) per share. This compares to a net loss of $27.2 million, or $(0.12) per share, for the comparable period in 2022.