UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | | Trading | | | --- | --- | --- | | Title of each class | Symbol(s) | Name of each exchange on which registered | | Class A Common Stock, $0.0001 par value ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Nuvation Bio Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 85-0862255 ( State or other jurisdiction of incorporation or organization) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39351 NUVATION BIO INC. (Exact name of Registrant as specified in its Charter) Delaware 85-0862255 (State or other jurisdiction of in ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39351 Nuvation Bio Inc. (Exact Name of Registrant as Specified in its Charter) ( State or other jurisdiction of incorporation ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39351 Nuvation Bio Inc. (Exact Name of Registrant as Specified in its Charter) ( State or other jurisdiction of incorporation or o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 Registrant's telephone number, including area code: (332) 208-6102 Securities registered pursuant to Section 12(b) of the Act: OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39 ...

Financial Performance - The company has incurred significant net losses of $41.7 million and $86.8 million in 2020 and 2021, respectively, with an accumulated deficit of $162.8 million as of December 31, 2021[290]. - The company has not generated any product revenue since inception and anticipates continuing to incur significant operating losses for the foreseeable future[290]. - As of December 31, 2021, the company had $765.4 million in cash and investments, which is expected to fund operations for at least the next 12 months[295]. - The company has federal and state net operating loss carryforwards of $42.7 million and $76.2 million, respectively, which may be limited under certain tax regulations[302]. Product Development and Regulatory Approval - The company is focused on the development of its lead product candidate NUV-422 for various cancer indications, including high-grade gliomas and advanced breast cancer[306]. - The company has not completed any clinical trials or obtained regulatory approvals, which are critical for future commercialization efforts[289]. - The company expects to incur significant costs associated with launching and commercializing its product candidates if they receive regulatory approval[292]. - The company may require additional capital to complete its planned clinical development programs, which could divert management from day-to-day activities[298]. - The company faces risks related to the timing and costs of drug discovery and regulatory review, which could impact its ability to generate revenue[297]. - The company may experience ownership changes that could limit its ability to use net operating loss carryforwards, potentially increasing future tax liabilities[305]. - The company is focused on developing product candidates based on its proprietary Drug-Drug Conjugate (DDC) platform, which is currently in preclinical development and has not yet completed any clinical trials[310]. - The biotechnology industry is characterized by rapidly advancing technologies, and the company's future success depends on maintaining a competitive position with its DDC platform[311]. - The company faces significant uncertainty regarding the time and cost of product candidate development due to the novel nature of its DDC technology[312]. - Clinical trials are expensive and time-consuming, with high risks of failure at any stage, impacting the company's ability to obtain regulatory approvals[317]. - The company may encounter substantial delays in preclinical studies or clinical trials, which could result in additional costs and impair its ability to achieve regulatory milestones[326]. - The ongoing COVID-19 pandemic may disrupt supply chains and affect the company's research and clinical trial activities, leading to increased development costs[328]. - Delays in patient enrollment for clinical trials could adversely affect the timing and outcome of trials, impacting the development of product candidates[335]. Market Competition and Commercialization - Company currently has no products approved for commercial sale and lacks sales, marketing, manufacturing, or distribution capabilities[347]. - Company faces substantial competition from major pharmaceutical and biotechnology companies, which may result in others commercializing products before it does[350]. - The Orphan Drug designation for NUV-422 may not guarantee market exclusivity, as other therapies can be approved for the same condition[345]. - The ability to achieve market acceptance for NUV-422 and other product candidates will depend on factors such as pricing, coverage, and reimbursement from third-party payors[356]. - Third-party payors may challenge prices and deny coverage for the company's product candidates, limiting commercialization potential[357]. - The process of obtaining and maintaining reimbursement status for products is time-consuming and costly, with significant variability among third-party payors in the U.S.[361]. - Increasing efforts by governmental and third-party payors to cap healthcare costs may limit coverage and reimbursement for newly approved products, leading to pricing pressures and high barriers for new product entry[362]. - Regulatory approvals for product candidates will be subject to ongoing oversight and extensive requirements, which may result in significant expenses and limit commercialization capabilities[363]. - Changes in government regulations could delay or prevent regulatory approval, impacting the ability to achieve or sustain profitability[364]. - Factors affecting the ability to generate revenues include demand for products, pricing strategies, and obtaining coverage and reimbursement approvals[365]. Operational Risks and Compliance - The company lacks sales and marketing capabilities and may need to develop these functions or outsource them, which could be costly and time-consuming[367]. - Reliance on third-party contract research organizations (CROs) for drug discovery and clinical trials poses risks if these parties fail to perform satisfactorily[372]. - The company does not have its own manufacturing capabilities and relies on third-party contract manufacturing organizations (CMOs), which may face production shortages or other supply interruptions[378]. - Regulatory actions against third-party manufacturers could impact the supply chain and result in significant costs or delays[380]. - The company faces risks related to the inability to consistently meet product specifications and quality requirements, which could hinder manufacturing and commercialization efforts[381]. - The company may face regulatory risks if contract suppliers or manufacturers fail to meet FDA requirements, potentially impacting product development and market approval[383]. - Significant scale-up of manufacturing for product candidates may require additional processes and technologies, which could be costly and subject to regulatory review[384]. - The company may need substantial additional capital for future development and commercialization of product candidates, potentially requiring collaboration agreements with other companies[385]. - Competition for collaboration opportunities is significant, with established companies having advantages in resources and experience[386]. - The company may face challenges in negotiating timely collaboration agreements, which could delay or reduce the development of product candidates[388]. - Legislative changes, such as the Affordable Care Act, may increase costs and difficulties in obtaining marketing approval for product candidates[390]. - Future healthcare reforms may exert downward pressure on product pricing and reimbursement, adversely affecting future revenues[395]. - Compliance with healthcare laws and regulations is critical, as non-compliance could result in substantial penalties[396]. - The company’s operations may be impacted by various federal and state healthcare laws, including anti-kickback statutes and false claims laws[397]. - The company may face substantial costs to ensure compliance with applicable healthcare laws and regulations, which could include civil, criminal, and administrative penalties[399]. Intellectual Property and Data Protection - The patent prosecution process is uncertain and may not result in sufficient patent protection, impacting the company's competitive position[405]. - The company may face challenges in maintaining and enforcing patent rights, which could limit its ability to compete effectively in the market[409]. - Adverse determinations in patent challenges could reduce the scope of patent rights, allowing competitors to commercialize similar technologies without payment[410]. - Compliance with U.S. and foreign data protection laws may require onerous obligations in contracts and restrict data collection and usage[404]. - The company must navigate complex state and federal laws regarding healthcare practices, which may complicate compliance efforts[401]. - Significant penalties could arise from violations of healthcare laws, including exclusion from government-funded healthcare programs[399]. - The company may face challenges in obtaining exclusive licenses for co-owned patents, which could allow competitors to market similar products[411]. - Reliance on third parties for product development increases the risk of trade secret exposure, potentially harming the company's competitive position[413]. - The company may incur significant costs and time in enforcing its patents, with the risk of patents being found invalid or unenforceable[415]. - Patent litigation in the U.S. often involves counterclaims of invalidity, which could jeopardize the company's patent protection[416]. - The company may struggle to protect its intellectual property rights globally due to high costs and varying legal protections in different jurisdictions[420]. - Compulsory licensing laws in several countries could compel the company to grant licenses to third parties, diminishing the value of its patents[423]. - Failure to identify relevant third-party patents could adversely affect the company's ability to develop and market its product candidates[424]. - The company may face significant challenges in obtaining licenses from third parties on commercially reasonable terms, impacting its ability to commercialize products[426]. - Patent terms may not provide adequate protection against competition, as patents generally expire 20 years from the earliest filing date[429]. - The company may be eligible for a patent term extension of up to five years under the Hatch-Waxman Amendments for approved products, but there are no guarantees for such extensions[430]. - Changes in patent law could weaken the company's ability to obtain and enforce patents, increasing uncertainty regarding future patent protection[432]. - Recent patent reform legislation may raise uncertainties and costs related to patent application prosecution and enforcement[433]. - Compliance with procedural and fee requirements is crucial for maintaining patent protection; failure to comply could result in loss of patent rights[434]. - The company faces potential legal proceedings alleging infringement of third-party intellectual property rights, which could negatively impact business success[435]. - There is a risk of claims from third parties asserting ownership of the company's intellectual property, which may require litigation to resolve[439]. - Intellectual property litigation could lead to significant expenses and distract management from core responsibilities[442]. - The company relies on trade secrets for competitive advantage, but protecting these secrets is challenging and breaches could harm its position[443]. - Trademark registrations are pending, and failure to secure these could hinder the company's ability to build brand recognition[444]. - The company is highly dependent on its trademarks and trade names for brand recognition, which may be challenged or infringed upon, potentially harming its competitive position[447]. Human Resources and Growth - As of December 31, 2021, the company had 64 employees and anticipates growth in personnel and operations, particularly in research and clinical development[461]. - The company faces intense competition for hiring qualified personnel, which could limit its ability to pursue growth strategies and impact its business operations[460]. - The company may encounter difficulties in managing growth as it expands its development and regulatory capabilities, potentially disrupting operations[461]. Cybersecurity and Operational Disruptions - The company faces risks related to unauthorized disclosure of sensitive data, which could result in negative publicity and legal liability[469]. - There is a significant risk of cyber incidents, which may increase in frequency and sophistication, potentially disrupting operations and affecting data integrity[470]. - The ongoing COVID-19 pandemic has significantly disrupted the company's operations, affecting clinical trials and supply chains, which could delay business plans and impact financial results[451]. - The company relies on a worldwide supply chain for clinical trials and commercialization, which could be disrupted by health epidemics or government restrictions[452]. - Misconduct by employees or third parties could lead to regulatory sanctions and harm the company's reputation, impacting its business operations[463].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39351 Nuvation Bio Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 85-0862255 | | --- | --- | | ( St ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-39351 Nuvation Bio Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 85-0862255 | | --- | --- | | ( State or other jurisdiction of | (I.R.S. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39351 Nuvation Bio Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 85-0862255 ( State or other jurisdiction ...