Drug Development and Regulatory Progress - Nuvation Bio submitted a New Drug Application (NDA) for taletrectinib to the U.S. FDA in October for advanced ROS1-positive non-small cell lung cancer (NSCLC), with potential commercialization as early as mid-2025[1][4] - The pivotal Phase 2 TRUST-I and TRUST-II studies showed a confirmed objective response rate of 89% in TKI-naïve patients and a median duration of response of 44 months[2][4] - Taletrectinib is the only ROS1 TKI in development with Breakthrough Therapy Designation from the U.S. FDA for line-agnostic treatment of advanced ROS1+ NSCLC[4] - The company plans to advance safusidenib, a mutant IDH1 inhibitor, and NUV-1511, a drug-drug conjugate, with meaningful clinical progress expected next year[2][5] Financial Performance - Nuvation Bio reported a net loss of $41.2 million, or $(0.15) per share, for Q3 2024, compared to a net loss of $19.6 million, or $(0.09) per share, in the same period of 2023[12] - Revenue for the three months ended September 30, 2023, was $727,000, and for the nine months ended, it was $2,162,000, both showing no revenue compared to the same periods in 2022[19] - Gross deficit for the three months ended September 30, 2023, was $(788,000), and for the nine months ended, it was $(700,000)[19] - Total operating expenses for the three months ended September 30, 2023, were $47,313,000, compared to $26,339,000 for the same period in 2022, reflecting an increase of 79.9%[19] - Research and development expenses for the three months ended September 30, 2023, were $27,731,000, up from $18,561,000 in the same period last year, representing a 49.5% increase[19] - Net loss for the three months ended September 30, 2023, was $(41,210,000), compared to $(19,649,000) for the same period in 2022, indicating a 109.5% increase in losses[19] - Net loss per share attributable to common stockholders for the three months ended September 30, 2023, was $(0.15), compared to $(0.09) for the same period in 2022[19] - Comprehensive loss for the three months ended September 30, 2023, was $(38,563,000), compared to $(18,552,000) for the same period in 2022[19] - Interest income for the three months ended September 30, 2023, was $6,726,000, slightly up from $6,523,000 in the same period last year[19] - The company reported a total other income of $6,891,000 for the three months ended September 30, 2023, compared to $6,690,000 for the same period in 2022[19] Cash and Liabilities - As of September 30, 2024, Nuvation Bio had cash, cash equivalents, and marketable securities totaling $549.1 million[1][9] - Total liabilities as of September 30, 2024, were $68.9 million, significantly higher than $16.4 million at the end of 2023, reflecting increased operational costs[17] Management Changes - The company appointed Philippe Sauvage as Chief Financial Officer in October, bringing over 20 years of experience in finance and operations[7] Expense Trends - General and administrative expenses for Q3 2024 were $19.6 million, compared to $7.8 million in Q3 2023, driven by higher personnel and marketing expenses[11]

Financial Performance - The company incurred a net loss of $861.3 million as of September 30, 2024, with significant losses attributed to research and development and general administrative costs [100]. - Cash used in operating activities for the nine months ended September 30, 2024, was $84.1 million, compared to $52.97 million for the same period in 2023 [115]. - The company reported a net decrease in cash and cash equivalents of $12.6 million for the nine months ended September 30, 2024, compared to a decrease of $76.7 million in 2023 [115]. - Cash used in operating activities was impacted by a net loss of $518.5 million and non-cash charges of $440.1 million for the nine months ended September 30, 2024 [116]. - As of September 30, 2024, the company had $549.1 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $861.3 million [114]. Research and Development - The company reported research and development service revenue of $727,000 for the three months ended September 30, 2024, and $2.162 million for the nine months ended September 30, 2024 [106]. - Research and development expenses increased by $9.2 million for the three months ended September 30, 2024, primarily due to a $6.7 million rise in personnel-related costs following the acquisition of AnHeart [109]. - The company recorded a $425.1 million charge for acquired in-process research and development expenses due to the acquisition of AnHeart on April 9, 2024 [110]. - The company expects to incur substantial expenses for the development and potential commercialization of product candidates and ongoing research and development programs [114]. - Research and development expenses are recognized in the periods incurred, with certain costs deferred and capitalized for future use [128]. Product Development and Regulatory - Taletrectinib, the company's leading product candidate, is under evaluation in two Phase 2 pivotal studies for advanced ROS1-positive non-small cell lung cancer (NSCLC) [97]. - The company submitted a New Drug Application (NDA) for taletrectinib to the U.S. FDA in October 2024, with expectations for acceptance by year-end 2024 [99]. - The company has out-licensed commercial rights to taletrectinib in China and Japan while retaining worldwide development and commercial rights [97]. Administrative Expenses - General and administrative expenses rose by $11.8 million for the three months ended September 30, 2024, driven by increased personnel-related costs and higher sales and marketing expenses [111]. Funding and Cash Flow - The company anticipates substantial additional funding will be necessary to support ongoing operations and growth strategy [100]. - The company expects that existing cash and marketable securities will fund operating expenses and capital expenditures for at least the next 12 months [114]. - Cash provided by investing activities for the nine months ended September 30, 2024, was $70.9 million, primarily from $366.2 million in proceeds from the sale of marketable securities [117]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $1.2 million, compared to $0.5 million in 2023 [118]. Other Financial Information - Other income (expense), net increased by $0.2 million for the three months ended September 30, 2024, primarily due to a $0.2 million increase in interest income from investments attributed to higher treasury yields [112]. - For the nine months ended September 30, 2024, other income (expense), net increased by $3.2 million, mainly driven by a $3.4 million increase in interest income from investments [113]. - The company had cash and investments totaling $549.1 million as of September 30, 2024, with no significant fluctuations in interest income reported [133]. - A 10% change in current exchange rates would not materially affect the company's financial results, as expenses are primarily in U.S. dollars [134]. Stock and Warrant Valuation - Stock-based compensation expense is estimated using the Black-Scholes model, with significant variables including expected term, volatility, and risk-free interest rates [131]. - The fair value of warrants is assessed at issuance and quarterly, with changes recognized as non-cash gains or losses on operations [130]. - The assessment for warrant classification requires professional judgment and is based on specific terms under FASB guidelines [130]. - The company does not anticipate material risks from interest rate fluctuations, as it does not engage in speculative investments or use derivatives [133]. - The company has not issued dividends historically and does not expect to do so in the future, estimating a zero dividend yield [131]. - In-process research and development projects acquired are expensed if they have no alternative future use [129]. - The company uses a simplified method for estimating the expected term of options, averaging the vesting term and the original contractual term [131].

Financial Performance - Nuvation Bio reported a net loss of $462.5 million, or $(1.89) per share, for Q2 2024, compared to a net loss of $20.6 million, or $(0.09) per share, for the same period in 2023[6]. - Revenue for the three months ended June 30, 2024, was $1,435,000, compared to $0 for the same period in 2023[12]. - Gross profit for the three months ended June 30, 2024, was $88,000, indicating a gross margin of approximately 6.1%[12]. - Total operating expenses increased significantly to $470,473,000 for the three months ended June 30, 2024, compared to $26,131,000 for the same period in 2023[12]. - Net loss for the three months ended June 30, 2024, was $462,492,000, compared to a net loss of $20,640,000 for the same period in 2023, representing an increase in loss of approximately 2,237%[12]. Research and Development - Research and development expenses for Q2 2024 were $29.2 million, up from $18.6 million in Q2 2023, primarily due to a $5.9 million increase in personnel-related costs and a $4.7 million increase in third-party research services[5]. - Research and development expenses for the three months ended June 30, 2024, were $29,247,000, up from $18,590,000 for the same period in 2023, reflecting a growth of approximately 57.3%[12]. - Nuvation Bio has decided not to initiate a Phase 2 study of NUV-868 in solid tumor indications after reviewing data from earlier studies[4]. - The global Phase 2 study of safusidenib for diffuse IDH1-mutant glioma is ongoing[3]. Cash and Assets - As of June 30, 2024, Nuvation Bio reported cash, cash equivalents, and marketable securities totaling $577.2 million[5]. - Cash and cash equivalents decreased from $42,649,000 as of December 31, 2023, to $34,285,000 as of June 30, 2024, a decline of about 19.7%[11]. - Total current assets decreased from $616,434,000 as of December 31, 2023, to $587,172,000 as of June 30, 2024, a decline of approximately 4.3%[11]. - Class A convertible preferred stock outstanding as of June 30, 2024, was valued at $274,938,000, with 851,202 shares issued[11]. - Weighted average common shares outstanding for the three months ended June 30, 2024, were 244,738,000, compared to 218,848,000 for the same period in 2023, an increase of approximately 11.8%[12]. Liabilities - Total liabilities increased from $16,362,000 as of December 31, 2023, to $62,665,000 as of June 30, 2024, an increase of approximately 283%[11]. Regulatory and Product Development - Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of ROS1-positive non-small cell lung cancer (NSCLC)[3]. - The company plans to present pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies at the ESMO Congress 2024 to support its planned New Drug Application (NDA) in the U.S.[2]. - Nuvation Bio aims to potentially commercialize taletrectinib in the U.S. in 2025, pending regulatory approval[2]. - The company recorded a $425.1 million charge for acquired in-process research and development expenses due to the acquisition of AnHeart Therapeutics[5].

SAN FRANCISCO and SUZHOU, China, June 2, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that results from the pivotal Phase 2 TRUST-I study conducted in China evaluating taletrectinib, next-generation ROS1 tyrosine kinase inhibitor (TKI), were publishe ...

SAN FRANCISCO, U.S. and SUZHOU, China, June 1, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that results from the pivotal Phase 2 TRUST- I study conducted in China evaluating taletrectinib, next-generation ROS1 tyrosine kinase inhibitor (TKI), were p ...

Financial Performance - As of March 31, 2024, the company reported an accumulated deficit of $361.2 million since its inception in 2018[109]. - For the three months ended March 31, 2024, total operating expenses decreased to $20.2 million from $26.5 million in the same period of 2023, a reduction of $6.3 million[118]. - The net loss for the three months ended March 31, 2024, was $14.8 million, compared to a net loss of $21.7 million for the same period in 2023, reflecting an improvement of $6.9 million[118]. - Cash used in operating activities for the three months ended March 31, 2024, was $15.7 million, down from $19.3 million in the same period of 2023[128][129]. - Other income increased by $0.6 million for the three months ended March 31, 2024, primarily due to an increase in interest income from investments[121]. Research and Development - Research and development expenses decreased by $6.0 million to $12.8 million for the three months ended March 31, 2024, primarily due to a reduction in third-party costs[119]. - The company expects to incur substantial expenses in the foreseeable future for the development and potential commercialization of its product candidates[125]. - The FDA cleared an Investigational New Drug application for NUV-1511 in January 2024, marking a significant advancement in the company's development pipeline[107]. Cash and Investments - The company had $597.0 million in cash, cash equivalents, and marketable securities as of March 31, 2024, which is expected to fund operations for at least the next 12 months[122][124]. - As of March 31, 2024, the company had cash and investments totaling $597.0 million, including cash, money market funds, government securities, and corporate bonds[148]. - In 2024, cash provided by investing activities was $7.5 million, with $128.5 million spent on marketable securities and $136.0 million received from their sale[131]. - In 2023, cash used in investing activities was $52.0 million, with $237.0 million spent on marketable securities and $185.0 million received from their sale[131]. - Cash provided by financing activities in 2024 was $21 thousand, compared to $0.3 million in 2023[132]. Risk Management - The company does not anticipate material risks from changes in interest rates, as fluctuations in interest income have not been significant[149]. - A 10% change in current exchange rates would not materially affect the company's financial results, as expenses are generally denominated in U.S. dollars[150]. Accounting Policies - The company expenses all research and development costs in the periods incurred, with capitalized amounts expensed as related goods are delivered[135]. - The fair value of stock-based awards is estimated using the Black-Scholes option-pricing model, influenced by stock price and other variables[140]. - The company evaluates critical accounting policies and estimates based on historical experience and reasonable assumptions, which may differ from actual results[133]. - The company has not issued any dividends and does not expect to do so in the future, estimating the dividend yield to be zero[146]. Corporate Developments - The company completed the acquisition of AnHeart Therapeutics Ltd. in April 2024, enhancing its pipeline with taletrectinib, a next-generation ROS1 inhibitor[106][107].

Exhibit 99.1 Nuvation Bio Reports First Quarter 2024 Financial Results and Provides Business Update Acquisition of AnHeart Therapeutics transformed Nuvation Bio into a late-stage, global oncology company with potential to become a commercial organization by the end of 2025 Updated data from the pivotal Phase 2 TRUST-I clinical study of taletrectinib, a ROS1 inhibitor, to be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting First patient treated in a Phase 1/2 study of NUV-151 ...

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, 2023 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 ...

Exhibit 99.1 Nuvation Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Determined maximum tolerated dose (MTD) in Phase 1 monotherapy study of NUV-868; Phase 1b studies of NUV-868 in combination with olaparib or enzalutamide remain ongoing Received U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) application for NUV-1511, the first clinical candidate from our novel drug-drug conjugate (DDC) platform Strong balance sheet with cash ...

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, 2023 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. Delaware 85-0862255 ( State or other jurisdiction of incorporation or organization) 1500 Broadway, Su ...