Zanzalintinib

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Feb. 24, 2026 /PRNewswire/ -- USA News Group News Commentary, The global oncology market is on track to nearly triple in value over the next decade, growing from $279.98 billion in 2026 to an estimated $748.17 billion by 2035[1]. Cancer drug revenues alone are projected to reach $335.2 billion by 2033, driven by a surge in targeted therapies and immunotherapy adoption[2]. Five companies advancing novel approaches in the oncology sector include Oncolytics Biotech (NASDAQ: ONCY), Exelixis (NASDAQ: EXEL), Eli Lilly (NYSE: LLY), Merck (NYSE: MRK), and Gilead Sciences (NASDAQ: GILD). The immunotherapy drugs market is experiencing significant growth as rising cancer prevalence accelerates demand for targeted treatments and combination therapies[3]. The immuno-oncology segment specifically is forecast to expand from $65.22 billion in 2025 to $170.19 billion by 2032, representing a compound annual growth rate of 14.9%[4]. Oncolytics Biotech Inc. (NASDAQ: ONCY) recently announced its decision to focus on registrational programs in anal and colorectal cancer, concluding enrollment in the GOBLET gastrointestinal study after generating sufficient clinical and translational data to chart a clear path toward FDA approval. The promising efficacy signal in GOBLET Cohort 4 has defined a clear registrational path for pelareorep in second-line and later squamous cell anal cancer, a setting where available therapies offer only limited benefit to patients. Oncolytics expects to meet with the FDA in mid-April to align on study design, and believes a clinical trial of well under 100 subjects will be sufficient to secure approval in this rare cancer indication. With sufficient cash on hand to execute near-term milestones, the company expects to avoid immediate material dilution, redirecting capital from the GOBLET cohorts toward its highest-conviction registration programs. "GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently," said Jared Kelly, CEO of Oncolytics Biotech. "Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution." The registration push builds on pelareorep's recent Fast Track Designation from the FDA for second-line KRAS-mutant microsatellite-stable (MSS) metastatic colorectal cancer. Clinical data showed pelareorep combined with standard chemotherapy and Avastin® achieved a 33% response rate versus roughly 10% with chemotherapy and Avastin®, while median overall survival reached 27 months versus 11.2 months with standard treatment. KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat populations, with limited options after first-line treatment fails. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually. The company plans to launch a controlled study with the first clinical site activating in March and interim data expected by year-end 2026. Pelareorep is also delivering strong results in anal cancer, where third-line patients achieved a 29% response rate with the median duration of response lasting around 17 months in a setting with no FDA-approved treatments. In second-line or later patients, the 30% response rate more than doubled the benchmark for the FDA-approved immunotherapy. The company continues strengthening its leadership, having recently appointed John McAdory as EVP of Strategy and Operations and Yujun Wu as Head of Biostatistics. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024. CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments: Exelixis (NASDAQ: EXEL) reported strong results for fiscal year 2025, with U.S. net product revenues from its cabozantinib franchise reaching $2.1 billion. The FDA accepted the company's New Drug Application for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer. "The team is highly motivated to build a second Exelixis oncology franchise with zanzalintinib and is working diligently to advance a first potential indication in metastatic colorectal cancer, following the recent acceptance of our New Drug Application by U.S. regulatory authorities," said Michael M. Morrissey, Ph.D., President and CEO of Exelixis. The company has a target FDA action date of December 2026 for zanzalintinib, which could establish a second major oncology franchise. Eli Lilly (NYSE: LLY) announced positive results from its Phase 3 LIBRETTO-432 trial, showing that Retevmo delivered a highly statistically significant improvement in event-free survival as adjuvant therapy in early-stage RET fusion-positive non-small cell lung cancer. The trial is the first randomized Phase 3 study to evaluate a selective RET kinase inhibitor in this population. "We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient's treatment journey," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. The company plans to present detailed results at an upcoming medical congress and discuss findings with global health authorities. Merck (NYSE: MRK) received FDA approval for KEYTRUDA and its subcutaneous formulation KEYTRUDA QLEX plus paclitaxel for adults with PD-L1-positive platinum-resistant ovarian cancer. KEYTRUDA is the first PD-1 inhibitor approved for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. "For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback, it's when options can become limited, and the reality patients face can change very quickly," said Dr. Bradley Monk, gynecologic oncologist at Florida Cancer Specialists and Research Institute. The KEYNOTE-B96 trial demonstrated a 28% reduction in the risk of disease progression or death and a 24% reduction in the risk of death compared to placebo. Gilead Sciences (NASDAQ: GILD) received an updated label for its Kite subsidiary's Yescarta CAR T-cell therapy, with the FDA removing previous limitations of use in relapsed or refractory primary central nervous system lymphoma. Yescarta is now the only CAR T-cell therapy approved for large B-cell lymphoma with this designation. "This update to the axi-cel prescribing information provides clinicians with important evidence for patients who have historically had very limited treatment options," said Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma at Dana-Farber Cancer Institute. Article Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES: Logo - 21% more press release views with Request a Demo

– Total Revenues of $599 million for the Fourth Quarter of 2025, $2.320 billion for the Fiscal Year 2025 – – Cabozantinib Franchise Achieved $2.123 billion in U.S. Net Product Revenues for the Fiscal Year 2025, including $547 million for the Fourth Quarter of 2025 – – GAAP Diluted EPS of $0.88 for the Fourth Quarter of 2025, $2.78 for the Fiscal Year 2025 – – Conference Call and Webcast Today at 5:00 PM Eastern Time – ALAMEDA, Calif. --(BUSINESS WIRE)--Feb. 10, 2026-- Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the fourth quarter and fiscal year of 2025, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones. “Exelixis delivered strong results in 2025 and is well positioned for a breakout year in 2026,” said Michael M. Morrissey , Ph.D., President and Chief Executive Officer, Exelixis . “The cabozantinib franchise continued to grow with robust demand in renal cell carcinoma and neuroendocrine tumors driving a significant increase in net product revenues in 2025 compared to the prior year. Based on the early success in neuroendocrine tumors and with additional gastrointestinal cancer market opportunities ahead, we’ve expedited the full buildout of our GI sales team to accelerate cabozantinib’s growth and prepare for potential future indications for zanzalintinib. The team is highly motivated to build a second Exelixis oncology franchise with zanzalintinib and is working diligently to advance a first potential indication in metastatic colorectal cancer, following the recent acceptance of our New Drug Application by U.S. regulatory authorities.” Dr. Morrissey continued: “2026 is shaping up to be a milestone-rich year for Exelixis . In addition to the continued growth of the cabozantinib franchise and ongoing regulatory engagement for zanzalintinib, we anticipate key clinical readouts from the STELLAR-303 and -304 pivotal trials, planned trial initiations of STELLAR-316 and STELLAR-201 supporting the next wave of zanzalintinib’s pivotal development, and significant progress across our early-stage pipeline. As we execute on these priorities, we remain focused on advancing high-impact opportunities that have the potential to improve standards of care for patients with cancer, drive sustainable growth and build shareholder value.” Fourth Quarter and Fiscal Year 2025 Financial Results Total revenues for the quarter and year ended December 31, 2025 were $598.7 million and $2,320.1 million , respectively, as compared to $566.8 million and $2,168.7 million for the comparable periods in 2024. Total revenues for the quarter and year ended December 31, 2025 included net product revenues of $546.6 million and $2,122.8 million , respectively, as compared to $515.2 million and $1,809.4 million for the comparable periods in 2024. The increases in net product revenues, for both periods, were primarily due to an increase in sales volume. Collaboration revenues, composed of license revenues and collaboration services revenues, were $52.1 million for the quarter ended December 31, 2025 , as compared to $51.5 million for the comparable period in 2024. The increase in collaboration revenues, for the quarter, was primarily related to higher royalty revenues for the sales of cabozantinib outside the U.S. generated by Exelixis’ collaboration partner Ipsen Pharma SAS (Ipsen), partially offset by lower development cost reimbursements earned. Collaboration revenues were $197.3 million for the year ended December 31, 2025 , as compared to $359.3 million for the comparable period in 2024. The decrease in collaboration revenues, for the year, was primarily related to lower milestone-related revenues recognized and lower development cost reimbursements earned, partially offset by higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partner Ipsen. Research and development expenses for the quarter and year ended December 31, 2025 were $213.2 million and $825.0 million , respectively, as compared to $249.0 million and $910.4 million for the comparable periods in 2024. The decreases in research and development expenses, for both periods, were primarily related to decreases in license and other collaboration costs, clinical trial costs, and manufacturing costs to support our development candidates, partially offset by an increase in consulting and outside services. Selling, general and administrative expenses for the quarter ended December 31, 2025 were $123.0 million , as compared to $134.3 million for the comparable period in 2024. The decrease in selling, general and administrative expenses, for the quarter, was primarily related to decreases in corporate giving, stock-based compensation and personnel expenses. Selling, general and administrative expenses for the year ended December 31, 2025 were $518.7 million , as compared to $492.1 million for the comparable period in 2024. The increase in selling, general and administrative expenses, for the year, was primarily related to increases in marketing activities, stock-based compensation, and personnel expenses, partially offset by a decrease in corporate giving. Provision for income taxes for the quarter and year ended December 31, 2025 was $8.2 million and $158.6 million , respectively, as compared to $44.9 million and $160.4 million for the comparable periods in 2024. GAAP net income for the quarter ended December 31, 2025 was $244.5 million , or $0.92 per share, basic and $0.88 per share, diluted, as compared to GAAP net income of $139.9 million , or $0.49 per share, basic and $0.48 per share, diluted, for the comparable period in 2024. GAAP net income per share for the year ended December 31, 2025 was $782.6 million , or $2.88 per share, basic and $2.78 per share, diluted, as compared to GAAP net income of $521.3 million , or $1.80 per share, basic and $1.76 per share, diluted, for the comparable period in 2024. Non-GAAP net income for the quarter ended December 31, 2025 was $259.5 million , or $0.97 per share, basic and $0.94 per share, diluted, as compared to non-GAAP net income of $160.3 million , or $0.56 per share, basic and $0.55 per share, diluted, for the comparable period in 2024. Non-GAAP net income for the year ended December 31, 2025 was $869.5 million , or $3.20 per share, basic and $3.08 per share, diluted, as compared to non-GAAP net income of $593.6 million , or $2.05 per share, basic and $2.00 per share, diluted, for the comparable period in 2024. Non-GAAP Financial Measures To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation, adjusted for the related income tax effect for all periods presented. Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions. These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release. 2026 Financial Guidance Exelixis is maintaining the previously provided financial guidance for fiscal year 2026. Net product and total revenues guidance do not currently reflect any revenues resulting from a potential U.S. regulatory approval and commercial launch of zanzalintinib for the treatment of patients with previously treated metastatic colorectal cancer (CRC). The U.S. Food and Drug Administration (FDA) is currently reviewing Exelixis' New Drug Application (NDA) for this proposed indication, when used in combination with atezolizumab (Tecentriq®). Cabozantinib Highlights Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $546.6 million during the fourth quarter of 2025, with net product revenues of $544.7 million from CABOMETYX (cabozantinib) and $1.8 million from COMETRIQ (cabozantinib). For the year ended December 31, 2025 , net product revenues generated by the cabozantinib franchise in the U.S. were $2,122.8 million , with net product revenues of $2,113.4 million from CABOMETYX and $9.4 million from COMETRIQ. In 2025, global cabozantinib franchise net product revenues generated by Exelixis and its collaboration partners, Ipsen and Takeda Pharmaceutical Company Limited, were $2.9 billion . Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter and year ended December 31, 2025 , Exelixis earned $52.8 million and $179.2 million , respectively, in royalty revenues. Presentation of Results from Subgroup Analysis of the CABINET Phase 3 Pivotal Trial Evaluating CABOMETYX in Advanced Lung and Thymic Neuroendocrine Tumors (NET) at the 2025 European Society for Medical Oncology Congress (ESMO 2025). In October 2025 , results from a subgroup analysis of the CABINET trial evaluating CABOMETYX versus placebo in patients with previously treated advanced NET originating in the lungs or thymus were presented at ESMO 2025. These subgroup results demonstrated that CABOMETYX significantly reduced the risk of disease progression or death versus placebo in patients with lung or thymic NET. The safety profile of CABOMETYX observed in patients with lung or thymic NET was consistent with its known safety profile; no new safety signals were identified. In March 2025 , the U.S. FDA approved CABOMETYX for two new NET indications, advanced pancreatic and extra-pancreatic NET (pNET and epNET), based on results from the CABINET study. Zanzalintinib Highlights FDA Acceptance of NDA for Zanzalintinib in Combination with Atezolizumab for Previously Treated Metastatic CRC. In February 2026 , Exelixis announced that the FDA accepted its NDA for zanzalintinib as a treatment for patients with previously treated metastatic CRC, when used in combination with atezolizumab. The FDA assigned a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026 . The NDA was based on positive results from the STELLAR-303 phase 3 pivotal trial, which met one of its dual primary endpoints, with the combination of zanzalintinib and atezolizumab demonstrating a statistically significant reduction in the risk of death versus regorafenib in the intention-to-treat (ITT) population at the final analysis. An overall survival (OS) benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy. Collaboration Agreement with Natera for STELLAR-316 Phase 3 Pivotal Trial. In January 2026 , Exelixis announced a collaboration with Natera, a global leader in cell-free DNA and precision medicine, for STELLAR-316, the planned, Exelixis -sponsored phase 3 pivotal trial. STELLAR-316 will evaluate zanzalintinib, with and without an immune checkpoint inhibitor, in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease. The primary endpoint of STELLAR-316 is disease-free survival, with secondary endpoints including circulating tumor DNA clearance. Natera will provide its Signatera™ assay to identify MRD+ patients for trial enrollment. Exelixis expects to initiate STELLAR-316 in mid-2026. Merck’s Initiation of LITESPARK-033 Phase 3 Pivotal Trial of Zanzalintinib in Combination with WELIREG® (belzutifan) in First-line Advanced Renal Cell Carcinoma (RCC). In December 2025 , Merck, known as MSD outside of the United States and Canada , initiated LITESPARK-033, the first of two planned Merck-sponsored pivotal trials of zanzalintinib and belzutifan in RCC under the companies’ clinical development collaboration. LITESPARK-033 is evaluating the combination of zanzalintinib and belzutifan versus cabozantinib in first-line advanced RCC following an immunotherapy administered in the adjuvant setting. Details of the second Merck-sponsored trial will be made available by Merck at a later date. Detailed Results from STELLAR-303 Phase 3 Pivotal Trial Presented at ESMO 2025 and Published in The Lancet . In October 2025 , Exelixis presented detailed results from STELLAR-303 at ESMO 2025; these detailed findings were simultaneously published in The Lancet . As previously announced in June, the study met one of its dual primary endpoints, OS in the ITT population, with the OS benefit of the zanzalintinib and atezolizumab combination consistently observed across pre-specified subgroups. Data pertaining to the other dual primary endpoint, OS in patients without liver metastases (non-liver metastases or NLM), were immature at the data cutoff. A prespecified interim analysis showed a trend in OS favoring the combination. The trial will proceed to the planned final analysis for this endpoint, which is expected in mid-2026, based on current event rates. The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified. Corporate Highlights Stock Repurchase Program (SRP) Update. In the fourth quarter of 2025, Exelixis repurchased $264.5 million of the company’s stock, at an average price of $43.17 per share, and completed the $500 million SRP authorized in February 2025 . Since Exelixis’ Board of Directors authorized the first SRP in March 2023 , Exelixis has repurchased a total of $2.16 billion of the company’s common stock, retiring 76.7 million shares, at an average price of $28.14 per share, as of the end of fiscal year 2025. In October 2025 , Exelixis’ Board of Directors authorized the repurchase of up to an additional $750 million of the company’s common stock before December 31, 2026 . Exelixis began executing stock repurchases under the October 2025 SRP in the fourth quarter of 2025. Stock repurchases under this program may be made from time to time through a variety of methods, which may include open market purchases, in block trades, Rule 10b5-1 trading plans, accelerated share repurchase transactions, exchange transactions or any combination of such methods. The timing and amount of any stock repurchases under the SRP will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. The program does not obligate Exelixis to acquire any amount of its common stock, and the SRP may be modified, suspended or discontinued at any time without prior notice. Announcement of Key Priorities and Anticipated Milestones for 2026. In January 2026 , Exelixis announced its key priorities and anticipated milestones for the year, including: anticipated results from the STELLAR-303 dual primary endpoint, OS in NLM patients, in mid-2026, based on current event rates; anticipated topline results from STELLAR-304, the phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell RCC, in mid-2026, based on current event rates; the planned initiations of STELLAR-316 and of STELLAR-201, a potential label-enabling trial evaluating zanzalintinib in recurrent meningioma, a disease with no currently approved systemic therapies, in mid-2026; and the potential filing of two Investigational New Drug applications—one for XB773, an antibody-drug conjugate, and one for a development candidate from our somatostatin receptor subtype 2 agonist program. The company presented details of its 2026 priorities and milestones at the J.P. Morgan 2026 Healthcare Conference. Presentation of Exelixis’ Strategy to Advance Future Oncology Franchises at the Company’s 2025 R&D Day: Building Next-generation Oncology Franchises. In December 2025 , Exelixis hosted its virtual 2025 R&D Day, themed Building Next-generation Oncology Franchises. During the event, company leadership and expert guests outlined Exelixis’ R&D strategy and multi-franchise approach, highlighted key progress and upcoming milestones for the zanzalintinib development program and provided an overview of the rapidly advancing pipeline. The event underscored Exelixis’ continued commitment to expanding treatment options for patients with cancer while delivering sustainable, long-term value for shareholders. A replay of the event webcast can be accessed here in the Investor & News section of www.exelixis.com. Basis of Presentation Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31 . For convenience, references in this press release as of and for the fiscal periods ended January 2, 2026 and January 3, 2025 , are indicated as being as of and for the periods ended December 31, 2025 and 2024, respectively. Conference Call and Webcast Exelixis management will discuss the company’s financial results for the fourth quarter and fiscal year 2025 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, February 10, 2026 . To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on www.exelixis.com for one year. About Exelixis Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our pipeline of franchise molecules, including our novel oral kinase inhibitor zanzalintinib, and to extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ belief that it is well positioned for a breakout year in 2026; Exelixis’ plans to build a second oncology franchise with zanzalintinib; Exelixis’ expedited buildout of its GI sales team to accelerate cabozantinib’s growth and prepare for potential future indications for zanzalintinib; Exelixis’ clinical development plans for, and beliefs regarding the therapeutic potential of, zanzalintinib; Exelixis’ anticipated timing for pivotal data milestones for the STELLAR-303 and STELLAR-304 trials and plans to initiate additional zanzalintinib pivotal trials in 2026, including STELLAR-316 and STELLAR-201; Exelixis’ focus on advancing high-impact opportunities that have the potential to improve standards of care for patients with cancer while driving sustainable growth and building shareholder value; complexities and the unpredictability of the regulatory review and approval process with respect to Exelixis’ NDA for zanzalintinib for the treatment of patients with previously treated metastatic CRC, when used in combination with atezolizumab, including the risk that the FDA may not approve zanzalintinib as a treatment for metastatic CRC in a timely fashion, if at all; timing and availability of details with respect to a second Merck-sponsored trial; Exelixis’ development plans for, and beliefs regarding the therapeutic potential of, its development candidates, including the potential advancement into clinical development of XB773 and a development candidate from our somatostatin receptor subtype 2 agonist program; Exelixis’ FY 2026 financial guidance; the timing, amount, and completion of any stock repurchase programs; Exelixis’ scientific pursuit to create transformational treatments that give more patients hope for the future; and other statements that are not historical facts. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the degree of market acceptance of CABOMETYX and other Exelixis products in the indications for which they are approved and in the territories where they are approved, and Exelixis’ and its partners’ ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX and other Exelixis products in comparison to competing products; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; Exelixis’ ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for its products or to enter into and maintain agreements with third parties to do so; the availability of data at the referenced times; the potential failure of cabozantinib, zanzalintinib and other Exelixis product candidates, both alone and in combination with other therapies, to demonstrate safety and/or efficacy in clinical testing; uncertainties inherent in the drug discovery and product development process; Exelixis’ dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications, their adherence to their obligations under relevant collaboration agreements and the level of their investment in the resources necessary to complete clinical trials or successfully commercialize partnered compounds in the territories where they are approved; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib, zanzalintinib and other Exelixis product candidates; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of its products and product candidates; Exelixis’ ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of Exelixis’ marketed products; changes in economic and business conditions, including as a result of changing trade policies and tariffs and the related uncertainty thereof; and other factors detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ other future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law. Exelixis , the Exelixis logo, CABOMETYX and COMETRIQ are registered U.S. trademarks of Exelixis, Inc. TECENTRIQ (atezolizumab) is a registered trademark of Genentech , a member of the Roche Group. WELIREG® is a registered trademark of Merck Sharp & Dohme LLC , a subsidiary of Merck & Co., Inc., Rahway, N.J. , USA. View source version on businesswire.com: https://www.businesswire.com/news/home/20260210781065/en/ Chris Senner Chief Financial Officer Exelixis, Inc. 650-837-7240 csenner@exelixis.com Andrew Peters SVP, Strategy and Investor Relations Exelixis, Inc. 650-837-7248 apeters@exelixis.com Source: Exelixis, Inc.