NUV-868

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-1511, the company’s first drug-drug conjugate (DDC) to enter the clinic, for the treatment of various advanced solid tumors Strong balance sheet with cash, cash equivalents, and marketable securities of $597.0 million as of March 31, 2024 NEW YORK--(BUSINESS WIRE)-- Nuvation Bio Inc. (NYSE: NUVB), a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the first quarter ended March 31, 2024, and provided a business update. “The first quarter of 2024 included multiple significant events for Nuvation Bio. We announced and subsequently completed the acquisition of AnHeart Therapeutics, which transformed Nuvation Bio into a late-stage, global company developing multiple clinical programs for some of the most difficult-to-treat cancers. We also treated the first patient in a Phase 1/2 study of NUV-1511, our first DDC to enter the clinic,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “With our robust cash balance and the recent appointment of Colleen Sjogren as our Chief Commercial Officer, along with some new key hires and the integration of new colleagues from AnHeart, we are thoughtfully scaling our organization to execute on our goal of potentially becoming a commercial organization by the end of 2025, while continuing to advance multiple internal programs in various stages of preclinical and clinical development.” Recent Pipeline Updates: Taletrectinib, ROS1 inhibitor: Advanced ROS1-positive non-small cell lung cancer (NSCLC) Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I in China, and TRUST-II, a global study. Updated data from the Phase 2 TRUST-I clinical study (NCT04395677) evaluating taletrectinib in patients in China with advanced ROS1-positive NSCLC will be reported in an oral presentation (abstract #8520) at the 2024 ASCO Annual Meeting on Saturday, June 1, 2024, at 4:30-6:30 p.m. CT/5:30-7:30 p.m. ET. Safusidenib, mIDH1 inhibitor: Grades 2 and 3 IDH1-mutant glioma Safusidenib is being evaluated in a global Phase 2 study for the treatment of patients with grades 2 and 3 IDH1-mutant glioma. NUV-868, BD2-selective BET inhibitor: Advanced solid tumors NUV-868 is being evaluated in a Phase 1b dose escalation study in combination with olaparib for the treatment of patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer, and other solid tumors, and in combination with enzalutamide for the treatment of patients with mCRPC. NUV-1511, DDC: Advanced solid tumors NUV-1511, the Company’s first clinical-stage DDC, is being evaluated in a Phase 1/2 study for the treatment of patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved U.S. Food and Drug Administration (FDA) labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, mCRPC, advanced pancreatic cancer, and platinum-resistant ovarian cancer (PROC). Corporate Updates: Announced entry into a definitive agreement to acquire AnHeart Therapeutics in March 2024 and completed the acquisition in April 2024. Appointed Colleen Sjogren as Chief Commercial Officer. Ms. Sjogren will lead Nuvation Bio’s commercial strategy and operations, including marketing, sales, and market access. First Quarter 2024 Financial Results As of March 31, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of $597.0 million. For the three months ended March 31, 2024, research and development expenses were $12.8 million, compared to $18.8 million for the three months ended March 31, 2023. The decrease was primarily due to a $6.7 million decrease in third-party research services and drug manufacturing costs as a result of completing the Phase 1 monotherapy study of NUV-868, offset by a $0.7 million increase in personnel-related costs driven by stock-based compensation and other benefits. For the three months ended March 31, 2024, general and administrative expenses were $7.3 million, compared to $7.7 million for the three months ended March 31, 2023. The decrease was due to a $0.5 million decrease in professional fees, $0.4 million decrease in insurance, and a $0.2 million decrease in personnel-related costs, offset by a $0.4 million increase in legal fees, a $0.2 million increase in occupancy expense, and a $0.1 million increase in miscellaneous expense. For the three months ended March 31, 2024, Nuvation Bio reported a net loss of $14.8 million, or $(0.07) per share. This compares to a net loss of $21.7 million, or $(0.10) per share, for the comparable period in 2023. About Nuvation Bio Nuvation Bio is a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s portfolio of development candidates includes taletrectinib (ROS1), safusidenib (mIDH1), NUV-868 (BET), and NUV-1511 (DDC). Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, and Shanghai. For more information, please visit and . Forward Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, the expected timing of becoming a commercial organization, the potential therapeutic benefit of Nuvation Bio’s product candidates, the potential of the DDC platform, the advancement of our preclinical and clinical programs, and the strength of Nuvation Bio’s balance sheet. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on May 14, 2024 under the heading “Risk Factors,” and other documents that Nuvation Bio has filed or will the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release. NUVATION BIO INC. and Subsidiaries Condensed Balance Sheets Unaudited (In thousands, except share and per share data) March 31, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $ 34,510 $ 42,649 Prepaid expenses and other current assets 6,796 1,519 Marketable securities 562,466 568,564 Interest receivable on marketable securities 4,283 3,702 Total current assets 608,055 616,434 Property and equipment, net 686 717 Lease security deposit 141 141 Operating lease right-of-use assets 3,168 3,605 Other non-current assets 1,075 587 Total assets $ 613,125 $ 621,484 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 2,436 $ 2,209 Current operating lease liabilities 2,023 1,972 Accrued expenses 11,303 9,793 Total current liabilities 15,762 13,974 Warrant liability 1,812 353 Non-current operating lease liabilities 1,509 2,035 Total liabilities 19,083 16,362 Stockholders' equity Class A and Class B common stock and additional paid in capital, $0.0001 par value per share; 1,060,000,000 (Class A 1,000,000,000, Class B 60,000,000) shares authorized as of March 31, 2024 and December 31, 2023, 219,083,219 (Class A 218,083,219, Class B 1,000,000) and 219,046,219 (Class A 218,046,219, Class B 1,000,000) shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively 952,807 947,745 Accumulated deficit (357,596 ) (342,804 ) Accumulated other comprehensive (loss) income (1,169 ) 181 Total stockholders' equity 594,042 605,122 Total liabilities and stockholders' equity $ 613,125 $ 621,484 NUVATION BIO INC. and Subsidiaries Condensed Statements of Operations and Comprehensive Loss (In thousands, except per share data) For The Three Months Ended March 31, 2024 2023 Operating expenses: Research and development $ 12,842 $ 18,787 General and administrative 7,357 7,734 Total operating expenses 20,199 26,521 Loss from operations (20,199 ) (26,521 ) Other income (expense): Interest income 7,130 4,979 Investment advisory fees (265 ) (230 ) Change in fair value of warrant liability (1,459 ) 142 Net gain (loss) on marketable securities 1 (96 ) Total other income (expense), net 5,407 4,795 Loss before income taxes (14,792 ) (21,726 ) Provision for income taxes — — Net loss $ (14,792 ) $ (21,726 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.07 ) $ (0.10 ) Weighted average common shares outstanding, basic and diluted 219,048 218,741 Comprehensive loss: Net loss $ (14,792 ) $ (21,726 ) Other comprehensive loss, net of taxes: Change in unrealized (loss) gain on available-for-sale securities, net (1,350 ) 2,588 Comprehensive loss $ (16,142 ) $ (19,138 )

3月26日，Nuvation Bio和葆元医药宣布，两家公司已达成最终协议，Nuvation Bio以全股票交易方式收购葆元医药。Nuvation Bio是一家生物制药公司，旨在通过开发差异化和新颖的治疗候选药物以满足肿瘤治疗中亟需的要求。葆元医药是一家致力于为癌症患者开发新型精准疗法的全球性临床阶段生物制药公司。 根据葆元医药新闻稿，收购交割后，在完全稀释的基础上，葆元医药的前股东将持有Nuvation Bio约33%的股份，而Nuvation Bio的现有股东将持有Nuvation Bio约67%的股份。收购预计将于2024年第二季度完成。 根据新闻稿，本次收购将使Nuvation Bio成为一家拥有多个后期阶段临床开发项目的全球性肿瘤医药公司。相关产品管线更新进展如下： 他雷替尼（新一代ROS1抑制剂）正在两项关键2期研究中评估其对ROS1阳性非小细胞肺癌（NSCLC）患者的治疗效果，即中国的TRUST-I和全球关键研究TRUST-II。Nuvation Bio将继续推进这两项研究。 他雷替尼已获得美国FDA和中国NMPA授予的突破性疗法认定，用于治疗晚期或转移性ROS1阳性NSCLC。 NMPA已接受他雷替尼的新药上市申请并将其纳入优先审评，用于治疗既往接受或未接受过ROS1 TKI治疗的局部晚期或转移性ROS1阳性NSCLC成人患者。 Nuvation Bio将继续开发safusidenib，一种新型、选择性、强效的口服mIDH1抑制剂，正在进行一项全球2期研究，用于治疗2级和3级别IDH1突变神经胶质瘤患者。 Nuvation Bio将继续推进其内部研发产品管线的所有临床研究，包括NUV-868的1b期研究和最近启动的NUV-1511的1/2期研究。 Nuvation Bio创始人、总裁兼首席执行官David Hung医学博士表示：“这项交易对我们公司来说是一个重要的里程碑，反映了Nuvation Bio为最难治疗癌症的患者开发疗法的持续努力。葆元的主要资产他雷替尼在完成两项关键研究后将成为我们的主要资产，它是一种差异化的新一代ROS1抑制剂，具有成为同类最佳的潜力，可以克服现有疗法的重大局限性。葆元团队为开发这项资产所完成的工作给我们留下了深刻的印象，我们准备在葆元迄今为止取得进展上再接再厉。” 葆元医药联合创始人兼首席执行官王钧源博士说道，葆元医药致力于精诚服务患者，过去五年来公司不懈努力，推进下一代精准肿瘤药物管线研发。很高兴能够作为Nuvation Bio的一部分继续他们的使命。期待与Nuvation Bio团队合作，为亟需新疗法的癌症患者带来更好的选择。 参考资料：[1]Nuvation Bio 将以全股票交易收购葆元医药. Retrieved Mar 26, 2024. From https://mp.weixin.qq.com/s/iICvfinHkRgYzQegGPEdxw 内容来源于网络，如有侵权，请联系删除。