On May 9, 2022 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, 2022, and provided a business update (Press release, Nuvation Bio, MAY 9, 2022, View Source [SID1234613965]).

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"We are encouraged by the important progress we have made so far this year across our pipeline of novel oncology therapeutic candidates for difficult-to-treat cancers. In the first quarter, we dosed the first patient in our Phase 1 study of NUV-868 in patients with advanced solid tumors and continued to advance our NUV-422 program across multiple tumor types, well positioning us to execute on multiple milestones later this year," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We believe that our NUV-422, NUV-868, and DDC development programs are our most unique and differentiated programs with the highest potential to meaningfully change the lives of cancer patients. To further focus on these programs, efficiently allocate our robust cash balance and strategically manage our pipeline, we have decided to deprioritize our early stage NUV-569 and A2A programs."

Recent Business Highlights

NUV-422, CDK 2/4/6i: GBM, aBC, mCRPC

On track for multiple milestones across tumor types in 2022. Nuvation Bio expects to share data from the Phase 1 dose escalation study of NUV-422 later this year. As supported by these data and following selection of a recommended Phase 2 dose, the Company plans to initiate Phase 2 monotherapy dose expansion cohorts in glioblastoma multiforme (GBM), advanced breast cancer (aBC), and metastatic castration-resistant prostate cancer (mCRPC) to evaluate the safety and efficacy of NUV-422. In addition, the Company is planning to initiate Phase 1b combination studies of NUV-422 plus fulvestrant in aBC and NUV-422 plus enzalutamide in mCRPC to evaluate safety and tolerability and to determine a recommended Phase 2 combination dose. The Company plans to initiate the Phase 2 monotherapy and Phase 1b combination studies before the end of the year.
NUV-868, BD2-Selective BETi: Advanced solid tumors

Dosed the first patient in the Phase 1 study of NUV-868. In January 2022, the U.S. Food and Drug Administration (FDA) cleared Nuvation Bio’s Investigational New Drug (IND) application for NUV-868 for the treatment of advanced solid tumors, including ovarian cancer, pancreatic cancer, mCRPC, and triple negative breast cancer (TNBC). The recently initiated Phase 1 study is designed to determine the safety and dose of NUV-868 to be used as a monotherapy and in combination with olaparib or enzalutamide for the Phase 2 and 2b portions of the study.
Drug-Drug Conjugate (DDC) Program: Solid tumors

Nuvation Bio is on track to select its first clinical candidate for the DDC program by the end of 2022.
First Quarter 2022 Financial Results

As of March 31, 2022, Nuvation Bio had cash, cash equivalents and marketable securities of $737.7 million.

For the three months ended March 31, 2022, research and development expenses were $20.7 million, compared to $15.9 million for the three months ended March 31, 2021. The increase was primarily due to a $5.4 million increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial, as well as a $3.1 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation, partially offset by $3.7 million related to the issuance of common stock as consideration for the purchase of in-process research and development in the prior year that did not recur in 2022.

For the three months ended March 31, 2022, general and administrative expenses were $7.5 million, compared to $4.6 million for the three months ended March 31, 2021. The increase was primarily due to a $1.9 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation, a $0.5 million increase in insurance, a $0.4 million increase in legal fees, a $0.3 million increase in professional fees, and a $0.1 million increase in other miscellaneous expenses, partially offset by a $0.4 million decrease in taxes.

For the three months ended March 31, 2022, Nuvation Bio reported a net loss of $21.3 million, or $(0.10) per share. This compares to a net loss of $20.4 million, or $(0.12) per share, for the comparable period in 2021.