Nuvation Bio Reports Third Quarter 2024 Financial Results and Provides Business Update

Business Wire11-07

Submitted New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration (FDA) in October for the treatment of patients with advanced ROS1-positive (ROS1+) non-small cell lung ...

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overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNuvation Bio Reports Third Quarter 2024 Financial Results and Provides Business Update\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-07 05:05 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/nuvation-bio-reports-third-quarter-210500887.html><strong>Business Wire</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Submitted New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration (FDA) in October for the treatment of patients with advanced ROS1-positive (ROS1+) non-small cell lung ...</p>\n\n<a href=\"https://finance.yahoo.com/news/nuvation-bio-reports-third-quarter-210500887.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"PFS","symbol_name":"Provident Financial Services Inc","start_time":0,"source_url":"https://finance.yahoo.com/news/nuvation-bio-reports-third-quarter-210500887.html","article_id":"2481957065","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/4W726yst3t1yWZle32XTTQ--~B/aD0yNjg7dz04NjQ7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/business-wire.com/20482876080bad37772409311ab651e8"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2481957065","pubTimestamp":1730927100,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Submitted New Drug Application  for taletrectinib to the U.S. Food and Drug Administration  in October for the treatment of patients with advanced ROS1-positive  non-small cell lung cancer , positioning Company to commercialize taletrectinib, if approved, as early as mid-2025. Presented positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib in patients with advanced ROS1+ NSCLC at the 2024 European Society of Medical Oncology  Congress. Appointed industry veteran Philippe Sauvage as the company’s Chief Financial Officer  in October. Strong balance sheet with cash, cash equivalents, and marketable securities of $549.1 million as of September 30, 2024. NEW YORK, November 06, 2024----Nuvation Bio Inc. , a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today reported financial results for the third quarter ended September 30, 2024, and provided a business update.Taletrectinib is the only ROS1","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"PFS":"Provident Financial Services Inc","NUVB":"Nuvation Bio, Inc.","BK4007":"制药","CFO":"VictoryShares US 500 Enhanced Volatility Wtd ETF","BK4211":"区域性银行","BK4212":"包装食品与肉类","DDC":"日日煮","BK4195":"互助储蓄与抵押信贷金融服务"},"translate_title":"Nuvation Bio报告2024年第三季度财务业绩并提供业务更新","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CFO":1,"DDC":1,"PFS":1,"NUVB":0.9},"content_text":"Submitted New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration (FDA) in October for the treatment of patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), positioning Company to commercialize taletrectinib, if approved, as early as mid-2025\nPresented positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib in patients with advanced ROS1+ NSCLC at the 2024 European Society of Medical Oncology (ESMO) Congress\nAppointed industry veteran Philippe Sauvage as the company’s Chief Financial Officer (CFO) in October\nStrong balance sheet with cash, cash equivalents, and marketable securities of $549.1 million as of September 30, 2024\nNEW YORK, November 06, 2024--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today reported financial results for the third quarter ended September 30, 2024, and provided a business update.\nDavid Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, reflected on the quarter and stated: \"In the third quarter, we continued to execute on our goal of bringing taletrectinib to people living with ROS1-positive NSCLC as quickly as possible, which has been our focus since we closed the acquisition of AnHeart Therapeutics earlier this year. In October, we completed the rolling submission of our NDA for line agnostic full approval of taletrectinib in advanced ROS1-positive NSCLC, which was supported by the pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies that we presented at ESMO. We believe that these data – a confirmed objective response rate of 89% and median duration of response approaching four years in the TKI-naïve setting – are the strongest data seen to date in the ROS1 space and increase taletrectinib’s potential to become a best-in-class treatment option. Additionally, we are excited about the momentum of our overall pipeline, including safusidenib, our mutant IDH1 inhibitor for both low- and high-grade diffuse IDH1-mutant glioma, where we plan to make meaningful clinical progress next year, and NUV-1511, our first drug-drug conjugate, which we continue to dose escalate in the clinic.\"\nRecent Pipeline Updates:\nTaletrectinib, ROS1 inhibitor: Advanced ROS1+ NSCLC\n\nCompleted submission of an NDA for taletrectinib to the U.S. FDA for the treatment of advanced ROS1+ NSCLC (line agnostic) in October, in alignment with feedback from the U.S. FDA as part of a pre-NDA meeting.\n  \nCompany expects the U.S. FDA to accept its NDA submission for full approval as early as year-end 2024, which, if approved, will allow Nuvation Bio to launch taletrectinib in the U.S. as early as mid-2025.\nTaletrectinib is the only ROS1 tyrosine kinase inhibitor (TKI) currently in development that has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs (line agnostic).\n\nPooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies were presented at the 2024 ESMO Congress in September. The pooled analysis supported the Company’s NDA submission for taletrectinib.\nKey highlights from the pooled analysis include:\n  \nConfirmed objective responses in 89% of taletrectinib-treated patients with advanced ROS1+ NSCLC who were tyrosine kinase inhibitor (TKI)-naïve and 56% of those who were TKI-pretreated in the study.\nTaletrectinib demonstrated durable responses and prolonged disease control with long-term follow up; median duration of response (DOR) and median progression-free survival (PFS) in TKI-naïve patients were 44 months and 46 months, respectively.\nTaletrectinib’s safety and tolerability profile appeared favorable, including a low treatment discontinuation rate of 7%.\n\nData from the global, pivotal Phase 2 TRUST-II study were presented at the 2024 World Conference on Lung Cancer in September as part of the press program.\n\nSafusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma\n\nSafusidenib is a potentially best-in-class, novel, oral, brain penetrant inhibitor of mutant IDH1.\nPhase 2 study of safusidenib in patients with diffuse IDH1-mutant glioma remains ongoing.\n\nNUV-1511, drug-drug conjugate (DDC): Advanced solid tumors\n\nNUV-1511, the Company’s first clinical-stage DDC, fuses a targeting agent to a widely used chemotherapy agent.\nPhase 1/2 dose escalation study of NUV-1511 in patients with various advanced solid tumors remains ongoing.\n\nNUV-868, BD2-selective BET inhibitor: Advanced solid tumors\n\nAs previously announced, the Company is evaluating next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients.\n\nCorporate Updates:\n\nAppointed Philippe Sauvage as Chief Financial Officer in October. Mr. Sauvage brings over 20 years of global leadership experience in finance, operations, and commercialization within healthcare and biopharmaceutical organizations.\nAppointed David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, as Chairman of the Board of Directors. Additionally, the Company appointed Robert Bazemore as lead independent director.\n\nThird Quarter 2024 Financial Results\nAs of September 30, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of $549.1 million.\nFor the three months ended September 30, 2024, research and development expenses were $27.7 million, compared to $18.5 million for the three months ended September 30, 2023. The increase was primarily due to a $6.7 million increase in personnel-related costs driven by the acquisition of AnHeart, stock-based compensation and other benefits, $2.4 million increase in third-party costs related to research services and drug manufacturing as a result of clinical trial expense for taletrectinib and $0.1 million increase in amortization of assembled workforce.\nFor the three months ended September 30, 2024, general and administrative expenses were $19.6 million, compared to $7.8 million for the three months ended September 30, 2023. The increase was due to a $5.3 million increase in personnel-related costs as a result of the acquisition of AnHeart, $4.2 million increase in sales and marketing expense, $1.8 million increase in professional fees, $0.7 million increase in legal fees, and $0.4 million increase in occupancy expense offset by $0.4 million increase in foreign currency impact and $0.2 million decrease in insurance expense.\nFor the three months ended September 30, 2024, Nuvation Bio reported a net loss of $41.2 million, or $(0.15) per share. This compares to a net loss of $19.6 million, or $(0.09) per share, for the comparable period in 2023.\nAbout Taletrectinib\nTaletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.\nTaletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1+ NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC. Based on pooled results of the TRUST-I and TRUST-II clinical studies, Nuvation Bio submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with advanced ROS1+ NSCLC (line agnostic, full approval). Based on results of the TRUST-I clinical study, China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs.\nAbout Nuvation Bio\nNuvation Bio is a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio’s portfolio of development candidates includes taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET). 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, Boston, and Shanghai. For more information, please visit www.nuvationbio.com and follow us on LinkedIn.\nForward Looking Statements\nCertain 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, our expectations regarding FDA acceptance, the length of the review period, and full approval of a U.S. NDA for taletrectinib, the timing of FDA approval and commercial launch, our expectations of establishing a commercial organization, taletrectinib’s best-in-class therapeutic potential in advanced ROS1+ NSCLC, the potential therapeutic benefit of Nuvation Bio’s product candidates, the advancement of our 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 November 6, 2024, under the heading \"Risk Factors,\" and other documents that Nuvation Bio has filed or will file with 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.\n\n\n\nNUVATION BIO INC. and Subsidiaries\n\n\n\n\n\n\nConsolidated Balance Sheets\n\n\n\n\n\n\nUnaudited\n\n\n\n\n\n\n(In thousands, except share and per share data)\n\nSeptember 30,\n\nDecember 31,\n\n\n\n\n\n2024\n\n\n\n2023\n\n\n\n\n\n\n\n \n\n\nAssets\n\n\n\n\n\n\nCurrent assets:\n\n\n\n\n\n\nCash and cash equivalents\n\n$\n30,036\n\n\n$\n42,649\n\n\n\nAccounts receivable, net of allowance for credit loss of $nil\n\n\n112\n\n\n\n-\n\n\n\nPrepaid expenses and other current assets\n\n\n11,598\n\n\n\n1,519\n\n\n\nMarketable securities\n\n\n519,099\n\n\n\n568,564\n\n\n\nInterest receivable on marketable securities\n\n\n4,140\n\n\n\n3,702\n\n\n\nTotal current assets\n\n\n564,985\n\n\n\n616,434\n\n\n\nProperty and equipment, net of accumulated depreciation of $839 and $666, respectively\n\n\n719\n\n\n\n717\n\n\n\nIntangible assets, net of accumulated amortization of $291\n\n\n2,779\n\n\n\n-\n\n\n\nOperating lease right-of-use assets\n\n\n2,472\n\n\n\n3,605\n\n\n\nLease security deposit\n\n\n144\n\n\n\n141\n\n\n\nOther non-current assets\n\n\n480\n\n\n\n587\n\n\n\nTotal assets\n\n$\n571,579\n\n\n$\n621,484\n\n\n\n\n\n\n\n \n\n\nLiabilities and stockholders' equity\n\n\n\n\n\n\nCurrent liabilities:\n\n\n\n\n\n\nAccounts payable\n\n$\n12,380\n\n\n$\n2,209\n\n\n\nCurrent operating lease liabilities\n\n\n1,781\n\n\n\n1,972\n\n\n\nContract liabilities, current portion\n\n\n12,942\n\n\n\n-\n\n\n\nShort-term borrowings\n\n\n8,426\n\n\n\n-\n\n\n\nAccrued expenses\n\n\n23,506\n\n\n\n9,793\n\n\n\nTotal current liabilities\n\n\n59,035\n\n\n\n13,974\n\n\n\nWarrant liability\n\n\n908\n\n\n\n353\n\n\n\nContract liabilities, net of current portion\n\n\n7,937\n\n\n\n-\n\n\n\nNon-current operating lease liabilities\n\n\n985\n\n\n\n2,035\n\n\n\nTotal liabilities\n\n\n68,865\n\n\n\n16,362\n\n\n\nStockholders' equity\n\n\n\n\n\n\nClass A and Class B common stock and additional paid in capital, $0.0001 par value per share; 1,060,000,000 (Class A 1,000,000,000, Class B 60,000,000) shares authorized as of September 30, 2024 and December 31, 2023, 336,248,642 (Class A 335,248,642, Class B 1,000,000) and 219,046,219 (Class A 218,046,219, Class B 1,000,000) shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively\n\n\n1,362,631\n\n\n\n947,745\n\n\n\nAccumulated deficit\n\n\n(861,298\n)\n\n\n(342,804\n)\n\n\nAccumulated other comprehensive income\n\n\n1,381\n\n\n\n181\n\n\n\nTotal stockholders' equity\n\n\n502,714\n\n\n\n605,122\n\n\n\nTotal liabilities and stockholders' equity\n\n$\n571,579\n\n\n$\n621,484\n\n\n\n\n\n\n\nNUVATION BIO INC. and Subsidiaries\n\n\n\n\n\n\n\n\n\n\n \n\n\nConsolidated Statements of Operations and Comprehensive Loss\n\n\n(In thousands, except per share data)\n\n\n\n\n\n\n\n\n\n\n\n\nThree Months EndedSeptember 30,\n\nNine Months EndedSeptember 30,\n\n\n\n\n\n2024\n\n\n\n2023\n\n\n\n2024\n\n\n\n2023\n\n\n\n\n\n\n\n\n\n\n\n \n\n\nRevenue\n\n$\n727\n\n\n$\n-\n\n\n$\n2,162\n\n\n$\n-\n\n\n\nCost of revenue\n\n\n1,515\n\n\n\n-\n\n\n\n2,862\n\n\n\n-\n\n\n\nGross deficit\n\n\n(788\n)\n\n\n-\n\n\n\n(700\n)\n\n\n-\n\n\n\nOperating expenses:\n\n\n\n\n\n\n\n\n\n\nResearch and development\n\n\n27,731\n\n\n\n18,561\n\n\n\n69,820\n\n\n\n55,938\n\n\n\nAcquired in-process research and development\n\n\n-\n\n\n\n-\n\n\n\n425,070\n\n\n\n-\n\n\n\nGeneral and administrative\n\n\n19,582\n\n\n\n7,778\n\n\n\n43,095\n\n\n\n23,053\n\n\n\nTotal operating expenses\n\n\n47,313\n\n\n\n26,339\n\n\n\n537,985\n\n\n\n78,991\n\n\n\n\n\n\n\n\n\n\n\n \n\n\nLoss from operations\n\n\n(48,101\n)\n\n\n(26,339\n)\n\n\n(538,685\n)\n\n\n(78,991\n)\n\n\n\n\n\n\n\n\n\n\n \n\n\nOther income (expense):\n\n\n\n\n\n\n\n\n\n\nInterest income\n\n\n6,726\n\n\n\n6,523\n\n\n\n21,000\n\n\n\n17,588\n\n\n\nInterest expense\n\n\n(120\n)\n\n\n-\n\n\n\n(252\n)\n\n\n-\n\n\n\nInvestment advisory fees\n\n\n(237\n)\n\n\n(228\n)\n\n\n(749\n)\n\n\n(689\n)\n\n\nChange in fair value of warrant liability\n\n\n533\n\n\n\n383\n\n\n\n209\n\n\n\n260\n\n\n\nRealized (loss) gain on marketable securities\n\n\n(11\n)\n\n\n12\n\n\n\n(17\n)\n\n\n(183\n)\n\n\nTotal other income (expense), net\n\n\n6,891\n\n\n\n6,690\n\n\n\n20,191\n\n\n\n16,976\n\n\n\n\n\n\n\n\n\n\n\n \n\n\nLoss before income taxes\n\n\n(41,210\n)\n\n\n(19,649\n)\n\n\n(518,494\n)\n\n\n(62,015\n)\n\n\n\n\n\n\n\n\n\n\n \n\n\nProvision for income taxes\n\n\n-\n\n\n\n-\n\n\n\n-\n\n\n\n-\n\n\n\n\n\n\n\n\n\n\n\n \n\n\nNet loss\n\n$\n(41,210\n)\n\n$\n(19,649\n)\n\n$\n(518,494\n)\n\n$\n(62,015\n)\n\n\nNet loss attributable to common stockholders\n\n\n\n\n\n\n\n\n\n\nNet loss per share attributable to common stockholders, basic and diluted\n\n$\n(0.15\n)\n\n$\n(0.09\n)\n\n$\n(2.11\n)\n\n$\n(0.28\n)\n\n\nWeighted average common shares outstanding, basic and diluted\n\n\n273,565\n\n\n\n218,935\n\n\n\n245,885\n\n\n\n218,842\n\n\n\n\n\n\n\n\n\n\n\n \n\n\nComprehensive loss:\n\n\n\n\n\n\n\n\n\n\nNet loss\n\n$\n(41,210\n)\n\n$\n(19,649\n)\n\n$\n(518,494\n)\n\n$\n(62,015\n)\n\n\nOther comprehensive loss, net of taxes:\n\n\n\n\n\n\n\n\n\n\nCurrency translation adjustment\n\n\n(742\n)\n\n\n-\n\n\n\n(594\n)\n\n\n-\n\n\n\nUnrealized gain on available-for-sale securities\n\n\n3,389\n\n\n\n1,097\n\n\n\n1,794\n\n\n\n2,228\n\n\n\n\n\n\n\n\n\n\n\n \n\n\nComprehensive loss\n\n$\n(38,563\n)\n\n$\n(18,552\n)\n\n$\n(517,294\n)\n\n$\n(59,787\n)\n\n\n\nView source version on businesswire.com: https://www.businesswire.com/news/home/20241106502244/en/\nContacts\nNuvation Bio Investor Contact:ir@nuvationbio.com\nNuvation Bio Media Contact: media@nuvationbio.com","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; 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