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 ...

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 ...