On May 4, 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 first quarter ended March 31, 2023, and provided a business update (Press release, Nuvation Bio, MAY 4, 2023, View Source [SID1234631072]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We saw strong clinical execution in the first quarter as we continued to enroll patients in the Phase 1 monotherapy and Phase 1b combination studies of NUV-868," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We look forward to submitting an IND for our first DDC clinical candidate by the end of this year, demonstrating our ongoing effort to tackle some of the greatest unmet needs in oncology."
Recent Business Updates
NUV-868, BD2-Selective BETi: Advanced solid tumors
Dosing underway in both regimens of the Phase 1b combination study. The Company continues to enroll 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 in combination with enzalutamide in patients with mCRPC.
Dosing underway in the Phase 1 monotherapy study. The Company continues to enroll the Phase 1 monotherapy study in advanced solid tumors.
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.
First Quarter 2023 Financial Results
As of March 31, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $646.6 million. For the three months ended March 31, 2023, research and development expenses were $18.8 million, compared to $20.7 million for the three months ended March 31, 2022. The decrease was primarily due to a $1.3 million decrease in personnel-related costs driven by a headcount reduction as well as a $0.6 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 March 31, 2023, general and administrative expenses were $7.7 million, compared to $7.5 million for the three months ended March 31, 2022. The increase was primarily due to a $1.1 million increase in personnel-related costs driven by stock-based compensation and other benefits offset by a $0.3 million decrease in insurance, a $0.3 million decrease in legal fees and a $0.3 million decrease in other professional fees.
For the three months ended March 31, 2023, Nuvation Bio reported a net loss of $21.7 million, or $(0.10) per share. This compares to a net loss of $21.3 million, or $(0.10) per share, for the comparable period in 2022.