On March 11, 2021 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 year ended December 31, 2020 and provided a business update (Press release, Nuvation Bio, MAR 11, 2021, View Source [SID1234576560]).
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"Nuvation Bio began a new chapter as a public company following the successful completion of our business combination with Panacea in February. With a strong cash position of approximately $830 million after transaction fees, as well as a recently expanded leadership team and employees dedicated to meaningfully improving the survival and quality of life for people with cancer, we are confident in our ability to advance our deep pipeline," said David Hung, M.D., founder and chief executive officer of Nuvation Bio. "Looking ahead, patient recruitment and dosing is ongoing in our Phase 1/2 study of NUV-422 in high-grade gliomas. As we recently announced, NUV-422has received the FDA’s Orphan Drug Designation for the treatment of malignant gliomas. We are also continuing to progress the rest of our portfolio of novel and mechanistically distinct therapies for solid and hematologic cancers. We expect to submit up to five additional Investigational New Drug applications with the U.S. Food and Drug Administration by 2026."
Recent Business Highlights
Debuted as publicly traded oncology company following the closing of a business combination with Panacea Acquisition Corp. In February 2021, Nuvation Bio announced the closing of its business combination with Panacea Acquisition Corp., a SPAC sponsored by EcoR1 Capital, and the commencement of trading shares of the combined company on the New York Stock Exchange (NYSE) under the ticker symbol "NUVB." Nuvation Bio’s total cash position at closing was approximately $830 million after transaction costs, including approximately $646 million held in Panacea’s trust account and received in concurrent private financings led by EcoR1 Capital, as well as 683 Capital, Ally Bridge Group, Avidity Partners, Deerfield Management Company, Irving Investors, Monashee Investment Management LLC, OrbiMed, Wellington Management and other existing Nuvation Bio shareholders including The Baupost Group, Boxer Capital of the Tavistock Group, Fidelity Management & Research Company, LLC, Omega Funds, Perceptive Advisors, Redmile Group and Surveyor Capital (a Citadel Company).
Initiated a Phase 1/2 study of NUV-422, the first of Nuvation’s six compounds to enter the clinic. In December 2020, Nuvation Bio commenced patient enrollment and dosing in the Phase 1/2 study of its lead investigational compound, NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, in adult patients with recurrent or refractory high-grade gliomas, including glioblastoma multiforme (GBM). The Phase 1 dose escalation part of the study is designed to evaluate safety and tolerability, as well as to determine a recommended Phase 2 dose based on the tolerability profile and pharmacokinetic properties of NUV-422. The Phase 2 dose expansion part of the study is expected to initially focus on patients with high-grade gliomas and is designed to evaluate overall response rate, duration of response and survival. Data from the Phase 1 portion of this study is expected in 2022. The U.S. Food and Drug Administration (FDA) in March granted Orphan Drug Designation to NUV-422 for the treatment of malignant gliomas.
Expanded executive team with key appointments. In January 2021, Nuvation Bio appointed Lisa DeLuca as senior vice president, regulatory affairs. Ms. DeLuca brings more than 25 years of regulatory experience to Nuvation Bio and most recently led the regulatory team at Radius Health. In October 2020, Nuvation Bio appointed Jennifer Fox as chief financial officer to lead corporate strategy, business development, investor relations and corporate communications. Ms. Fox joined Nuvation Bio from Citigroup, where she most recently served as a managing director and co-head of the Healthcare Corporate and Investment Banking Group.
Full Year 2020 Financial Results
The following financial results for the year ended December 31, 2020 represent Nuvation Bio Inc. (now known as Nuvation Bio Operating Company Inc.) as a standalone private company, as its business combination with Panacea Acquisition Corp. closed on February 10, 2021. The financial results of Panacea Acquisition Corp. for the year ended December 31, 2020 will be reported in the Annual Report on Form 10-K to be filed by Nuvation Bio in March 2021. Nuvation Bio’s financial statements for the first quarter of 2021, to be reported in May 2021, and for subsequent periods will reflect the financial results of the combined public company.
Research and development expense for the year ended December 31, 2020 was $32.6 million compared to $25.1 million for the year ended December 31, 2019. General and administrative expense for 2020 was $10.9 million, compared to $7.0 million for 2019.
Net loss for 2020 was $41.7 million compared to $33.6 million for 2019.