Olaparib

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 )

The Bristol Myers setback follows another similar one by AstraZeneca's Imfinzi. Another attempt at improving upon AstraZeneca’s Imfinzi in stage 3, unresectable non-small cell lung cancer (NSCLC) has gone up in flames. The latest failure comes from a phase 3 trial conducted by Bristol Myers Squibb. The company’s Opdivo, used with concurrent chemoradiotherapy, followed by Opdivo plus BMS’ Yervoy, failed to beat Imfinzi maintenance in unresectable stage 3 NSCLC, BMS said Friday. The Imfinzi regimen features chemoradiation alone followed by Imfinzi during the maintenance phase of treatment. Approved by the FDA in early 2018, unresectable stage 3 NSCLC has been Imfinzi’s main indication, and it’s where the AZ PD-L1 inhibitor is the standard of care for patients whose cancer has not progressed after chemoradiation. BMS tried to challenge AZ’s dominance by launching the phase 3 CheckMate-73L trial in 2019. The company figured that because chemoradiotherapy increases PD-L1 expression, concurrent immune checkpoint inhibition may improve outcomes. But, now, the study found the Opdivo-Yervoy-concurrent-chemoradiation regimen couldn’t extend the time before tumor progression or death versus the Imfinzi maintenance approach. The adverse events observed were generally consistent with the known profiles of each component in the combination, BMS said. The CheckMate-73L study features another arm testing Opdivo monotherapy during the maintenance phase. But because its primary endpoint measures progression-free survival for the Opdivo-Yervoy arm, the entire study is now considered negative. The study’s many secondary endpoints include overall survival for either experimental arm against Imfinzi and for the two Opdivo arms against each other. The BMS setback follows another similar one by Imfinzi itself. Because the current Imfinzi regimen is given only to patients who have not progressed after initial chemoradiotherapy, AZ had tried to expand the drug’s patient base by giving Imfinzi and chemoradiation concurrently. However, that regimen recently failed to beat Imfinzi maintenance in the phase 3 PACIFIC-2 trial. Besides those regimens, China’s CStone Pharmaceuticals in 2022 reported positive phase 3 results from the GEMSTONE-301 trial for its China-approved PD-L1 inhibitor Cejemly (sugemalimab) when used after chemoradiotherapy in unresectable stage 3 NSCLC. However, that study was conducted solely in China, and the drug was pitted against placebo, not Imfinzi, so the results are not considered meaningful for the U.S. market. Now, market watchers are turning their attention to Merck & Co.’s PD-1 king Keytruda. The phase 3 KEYLYNK-012 trial is testing concurrent use of chemoradiation and Keytruda, followed by Keytruda with or without AZ and Merck’s PARP inhibitor Lynparza, versus Imfinzi maintenance in unresectable stage 3 NSCLC. However, the regimen doesn’t look very promising after a pair of phase 3 flops for the PD-1/PARP combo in metastatic NSCLC. There’s also Roche’s PD-L1 inhibitor Tecentriq. The Swiss pharma is running the phase 3 SKYSCRAPER-03 trial pairing Tecentriq with the company’s closely watched TIGIT inhibitor tiragolumab in the maintenance setting following concurrent platinum-based chemoradiation. The trial finished enrollment about a year ago and bears a primary completion date this October, according to Roche. AZ isn’t giving up its expansion efforts, either. The PACIFIC-9 trial is evaluating Imfinzi together with either the company’s anti-CD73 antibody oleclumab or Innate Pharma-partnered anti-NKG2A antibody monalizumab as a maintenance therapy. A readout from that phase 3 study could be two years away.