Zanzalintinib

Exelixis CEO Michael Morrissey, Ph.D., said he\'s carefully evaluating whether the company would expand outside the U.S.\n Exelixis may only have one drug on the market right now, but with phase 3 results for a potential new blockbuster on the horizon and a growing pipeline, the Cabometyx maker is aiming big. Specifically, the drugmaker intends to become a top 5 solid tumor company by U.S. sales.“It’s all about building franchises,” Exelixis CEO Michael Morrissey, Ph.D., said in an interview with Fierce on the sidelines of the J.P. Morgan Healthcare Conference in San Francisco. “It’s all about having the mindset that you’re not going to do one compound for one indication, because the economy of scale doesn’t work,” he added.Since its first FDA approval more than 13 years ago in medullary thyroid cancer, cabozantinib—sold as Cabometyx and Cometriq—has been Exelixis’ sole approved drug, driving $2.1 billion in U.S. revenues in 2025, according to a preliminary calculation the company unveiled at JPM. Cabozantinib alone has put the California company at No. 10 on the U.S. solid tumor rankings by sales.Morrissey described cabozantinib as a “franchise molecule,” having recently added its sixth and seventh indications in pancreatic and extra-pancreatic neuroendocrine tumors (NETs), respectively.Now, Exelixis hopes to repeat the success with zanzalintinib, which the company considers “the foundation of future oncology franchises” with the potential to reach $5 billion in peak annual sales. The company has just filed the next-generation TKI with the FDA for use alongside Roche’s Tecentriq in previously treated metastatic colorectal cancer (mCRC). Several other phase 3 programs are either underway or being planned for earlier stages of disease and in other tumor types. Zanzalintinib’s first phase 3 readout was not exactly the most exciting outcome that doctors were hoping for. The phase 3 Stellar-303 study linked zanzalintinib to a 20% reduction in the risk of death compared with Bayer’s Stivarga in patients with previously treated mCRC, meeting one of its dual primary endpoints. Patients’ median overall survival was improved by 1.5 months to 10.9 months with the investigational therapy. That limited magnitude of improvement, combined with an increase in grade 3 or higher adverse events, raised a question around whether the combo could be the new standard of care.The answer to that question is partly dependent on the final analysis of the trial’s other primary endpoint, OS in a subgroup of patients without liver metastases, which Exelixis expects to read out mid-2026.Despite the modest showing in the study, Morrissey noted that doctors have wanted to use an immunotherapy-based regimen for late-line colorectal cancer, and that Stellar-303 offers them their first hope after multiple prior pivotal trial failures within the PD-1/L1 class.As for the non-liver metastases population, Morrissey noted that data were getting close to statistical significance at the last analysis. He acknowledged that showing an OS improvement in the subgroup is important “from a marketing point of view” when educating doctors about zanzalintinib’s overall profile, but added that “it’s not a must-have.”In any case, the bigger fight is not in late-line mCRC. Instead, earlier treatment settings and expansions into other tumor types will be key to zanzalintinib’s success.“We’re moving up,” Morrissey said, referring to the company’s efforts earlier in the treatment sequence.Exelixis recently reached a collaboration with diagnostic company Natera, which will provide a ctDNA assay to identify patients with resected stage 2/3 CRC who have completed definitive therapy but still have molecular residual disease (MRD) to enroll in the phase 3 Stellar-316 trial. This is a high-risk population who likely will progress to metastatic disease within about six months to nine months after surgery and adjuvant chemotherapy, Morrissey noted.Using its ctDNA assay to detect MRD, Natera recently helped Roche turn a previous failure in a broad group of muscle-invasive bladder cancer patients into a phase 3 win in a selective MRD-positive trial population.Partnering with Natera could also save Exelixis some effort when selecting trial sites.“They’ve been screening patients for years,” Morrissey said. “So they know the institutions that use it well, they know the investigators that use it a lot, and they know what patients are already MRD-positive. So it’s the ideal setup to be able to lock and load.”CRC is only piece of the zanzalintinib puzzle. Another major opportunity for the TKI lies in kidney disease, for which Exelixis has formed a clinical development partnership with Merck & Co. In December, Litespark-033, the first Merck-sponsored pivotal trial under the collaboration, kicked off to evaluate zanzalintinib and Merck’s Welireg. A second phase 3 is being planned.In another major milestone expected this year, the phase 3 Stellar-304 study pitting zanzalintinib and Bristol Myers Squibb’s Opdivo against Pfizer’s Sutent in previously untreated patients with advanced non-clear cell renal cell carcinoma is expected to read out mid-2026. Collaborating with the competitionExelixis already knows how to work with Big Pharma through Cabometyx, which Morrissey said highlights the idea of collaborating with the competition. Opdivo was once Cabometyx’s biggest competition in kidney cancer until the CheckMate-9ER trial showed the power of combining the two agents. Results from that trial helped drive a 2.5-fold increase in Cabometyx’s revenue in the ensuing five years, Morrissey said.Exelixis’ franchise-in-a-molecule plan for zanzalintinib includes other tumor types, although Morrissey is letting data determine the biggest indication.“Our job is to do the right selection and the right prioritization and then execute at the highest level, and then the data will tell us where to go,” he said.Even with blockbuster sales pegged to their names, the two TKIs might not be enough to get Exelixis into the “top 5” spot, especially considering that cabozantinib is expected to face generics at the beginning of 2031.“We probably need more,” Morrissey said.The CEO, for now, also wouldn’t pick a potential third pillar of the company following zanzalintinib. Exelixis’ earlier-stage pipeline includes antibody-drug conjugates targeting DLL3, 5T4 and tissue factor; a PD-L1xNKG2A bispecific; and molecular glue and degraders targeting KRAS.On the commercial side, Exelixis has been building out its gastrointestinal cancer sales force following Cabometyx’s NET approvals in March 2025. The hope is that the same sales force can cover zanzalintinib in CRC, too, although Morrissey recognized that the timing of the back-to-back launches may be tight.“Those are good problems to have if you have to scale the organization, because you’re so successful clinically,” Morrissey said.But seemingly running counter to a potential business expansion and its lofty corporate aspirations, Exelixis recently launched a reorganization that includes winding down a site in Pennsylvania and 130 layoffs. Morrissey described the overhaul as the final move in his push to implement a back-to-office policy after the pandemic. RELATED: UPDATED: Exelixis to lay off 130 employees, shut down Pennsylvania site in post-pandemic downsizing “It concentrates all of our critical mass and all of our brain power in Alameda, [California],” Morrissey said.While the satellite operation outside of Philadelphia and its big remote workforce “worked okay,” it “wasn’t nearly as effective” as people working together in the same office, the CEO observed.Exelixis first unveiled the goal to become a “top 5 solid tumor oncology company” during an R&D event in December. During his interview with Fierce, Morrissey put a “U.S.” parameter around that goal because the company has so far relied on partners to handle ex-U.S. markets, including Ipsen in Europe and Takeda in Japan. As the company grows, will it look to build a global footprint?“We’re looking at that very carefully right now,” Morrissey said. “We’re really analyzing all the options that we have relative to ex-U.S. We have deep expertise, and our commercial organization in the U.S. competes with Big Pharma every single day very effectively. So, we’re obviously going to really retrench in the U.S., and then look carefully at how we operationalize the rest of the world.”

– STELLAR-316 will use Natera’s Signatera™ assay to identify MRD-positive patients for trial enrollment and to monitor response to therapy – – STELLAR-316 将使用 Natera 的 Signatera™ 检测方法来识别 MRD 阳性的患者以进行试验入组，并监测治疗反应 –ALAMEDA, Calif. 阿拉米达，加利福尼亚州& &AUSTIN, Texas 德克萨斯州奥斯汀--(BUSINESS WIRE)--Jan. 7, 2026-- --（商业资讯）--2026年1月7日-- Exelixis, Inc. Exelixis公司(Nasdaq: EXEL) and (Nasdaq: EXEL) 和Natera 纳特拉(Nasdaq: NTRA), a global leader in cell-free DNA and precision medicine, today announced their collaboration on the planned (Nasdaq: NTRA)，无细胞DNA和精准医学的全球领导者，今天宣布了他们就计划中的合作Exelixis 埃克塞利西斯-sponsored STELLAR-316 trial. This randomized phase 3 pivotal trial will evaluate zanzalintinib, Exelixis’ novel oral kinase inhibitor, with and without an immune checkpoint inhibitor, in patients with resected stage II/III colorectal cancer (CRC). 赞助的STELLAR-316试验。这项随机的三期关键试验将评估Exelixis的新型口服激酶抑制剂赞扎林替尼，联合或不联合免疫检查点抑制剂，在切除的II/III期结直肠癌（CRC）患者中的疗效。This press release features multimedia. View the full release here: 本新闻稿包含多媒体。请点击此处查看完整发布：https://www.businesswire.com/news/home/20260107329077/en/ https://www.businesswire.com/news/home/20260107329077/en/Using Natera’s Signatera™ test following completion of definitive therapy*, patients with CRC who test positive for molecular residual disease (MRD) and have no radiographic evidence of disease will be eligible for enrollment in the STELLAR-316 trial. Working with patients and their providers, this trial will be fully enrolled with patients who are receiving commercial Signatera testing as part of their routine standard of care.. 在完成确定性治疗后，使用Natera的Signatera™检测，那些分子残留病（MRD）呈阳性且无影像学疾病证据的结直肠癌（CRC）患者将有资格入组STELLAR-316试验。通过与患者及其医疗服务提供者合作，该试验将完全招募那些作为常规护理标准的一部分而接受商业Signatera检测的患者。The primary endpoint of STELLAR-316 is disease-free survival. Signatera will also be used for longitudinal monitoring of circulating tumor DNA clearance, one of the secondary endpoints of the trial. STELLAR-316 的主要终点是无病生存期。Signatera 还将用于纵向监测循环肿瘤 DNA 清除情况，这是该试验的次要终点之一。Exelixis 埃克塞利西斯expects to initiate STELLAR-316 in mid-2026. 预计将在2026年年中启动STELLAR-316。CRC is the third most common cancer and the second leading cause of cancer-related deaths in the CRC 是第三大常见癌症，也是癌症相关死亡的第二大原因。U.S. 美国1 1Of the approximately 89,000 stage II/III colorectal cancer cases projected for 2035, 在预计2035年发生的约89,000例II/III期结直肠癌病例中，2 2about 20% of these patients are expected to remain MRD-positive following definitive therapy. 大约20%的患者在确定性治疗后预计仍为MRD阳性。3 3Patients with stage II/III CRC who are MRD-positive have been shown to experience worse outcomes in multiple clinical studies 在多项临床研究中，显示II/III期结直肠癌患者如果微小残留病（MRD）呈阳性，其预后较差 3,4,5 3,4,5and there are no established or approved therapies for this specific patient population in the 并且对于这一特定患者群体，没有已建立或批准的疗法在U.S. 美国“Patients with colorectal cancer who are MRD-positive following definitive therapy face a high risk of recurrence, underscoring the urgent need for new treatment options that can help prevent clinical metastatic progression,” said “在接受确定性治疗后MRD阳性的结直肠癌患者面临很高的复发风险，这凸显了对能够帮助防止临床转移进展的新治疗方案的迫切需求，”Dana T. Aftab 达纳·T·阿夫塔卜, Ph.D., Executive Vice President, ，博士，执行副总裁，Research and Development 研究与开发, ，Exelixis 埃克塞利西斯. “STELLAR-316 is our second pivotal trial of zanzalintinib in patients with CRC and represents our continued commitment to addressing unmet needs in this patient population by conducting rigorous trials with the potential to improve standards of care. We are excited to collaborate with Natera on STELLAR-316, which, if successful, could make zanzalintinib the first MRD-guided treatment for these patients.”. “STELLAR-316 是我们在结直肠癌患者中进行的第二项关键性赞扎林替尼试验，代表了我们通过开展具有提高护理标准潜力的严格试验来满足这一患者群体未满足需求的持续承诺。我们很高兴与 Natera 在 STELLAR-316 上合作，如果成功，这可能使赞扎林替尼成为这些患者的首个微小残留病灶（MRD）指导治疗。”“Exelixis and Natera’s collaboration on STELLAR-316 underscores both companies’ commitment to advancing new approaches to treat CRC,” said “Exelixis和Natera在STELLAR-316上的合作强调了两家公司致力于推进治疗结直肠癌的新方法，”John Simmons 约翰·西蒙斯, Ph.D., Global Vice President, Biopharma, Natera. “Leveraging Signatera to inform trial enrollment will help to identify high-risk patients earlier, enabling intervention when disease burden is lower – and importantly, with the potential to improve clinical outcomes.” 博士，Natera全球副总裁，生物制药部。“利用Signatera指导试验入组将有助于更早识别高风险患者，在疾病负担较低时进行干预——重要的是，有可能改善临床结果。”*Colon: adjuvant chemotherapy, rectal: total neoadjuvant therapy *结肠：辅助化疗，直肠：全程新辅助治疗About Zanzalintinib 关于赞扎林替尼Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. Zanzalintinib 是一种新型的口服激酶抑制剂，可抑制 TAM 激酶（TYRO3、AXL、MER）、MET 和 VEGF 受体的活性。这些激酶在肿瘤发生过程中发挥重要作用，包括肿瘤细胞增殖、转移、血管生成、耐药性以及逃避免疫抗肿瘤免疫。With zanzalintinib, . 使用赞扎林替尼，。Exelixis 埃克塞利西斯sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer and neuroendocrine tumors.. 该公司在开发其旗舰药物卡博替尼的过程中积累了丰富的经验，希望在此基础上改进关键特性，包括药代动力学半衰期。 Zanzalintinib目前正在被开发用于治疗晚期实体瘤，包括结直肠癌、肾癌和神经内分泌肿瘤。Exelixis 埃克塞利西斯recently confirmed it has submitted a New Drug Application to the 最近确认已提交新药申请至U.S. Food & Drug Administration 美国食品药品监督管理局for zanzalintinib for the treatment of patients with previously treated metastatic colorectal cancer, when used in combination with atezolizumab (Tecentriq 用于治疗先前接受过治疗的转移性结直肠癌患者时，与阿特珠单抗（Tecentriq）联合使用的赞扎利替尼® ®). The regulatory filing was based on positive results from the phase 3 STELLAR-303 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 population at the final analysis. ）。该监管文件基于 3 期 STELLAR-303 关键试验的积极结果，该试验达到了其双重主要终点之一，最终分析显示，在意向治疗人群中，zanzalintinib 与 atezolizumab 的联合疗法相较于 regorafenib 在降低死亡风险方面具有统计学上的显著优势。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. Data pertaining to the other dual primary endpoint, . 在预先指定的各亚组中，包括地理区域、RAS状态、肝脏受累情况以及之前的抗VEGF治疗，均一致观察到联合治疗带来的总生存期（OS）益处。关于另一个双重主要终点的数据，。OS in 操作系统在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.. 截至数据截止时，未出现肝转移的患者（非肝转移或NLM）数据尚不成熟。预先设定的中期分析显示，总生存期（OS）有倾向于支持联合治疗的趋势。基于当前的事件发生率，试验将继续进行至计划中的最终分析，预计将在2026年年中完成。Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials. Zanzalintinib 是一种研究性药物，尚未获准用于任何用途，并且正在进行临床试验。About CRC 关于CRCCRC is the third most common cancer and the second leading cause of cancer-related deaths in the CRC 是第三大常见癌症，也是癌症相关死亡的第二大原因。U.S. 美国1 1Approximately 154,000 new cases will be diagnosed in the 大约会有154,000个新病例被诊断出U.S. 美国with around 53,000 expected deaths from the disease in 2025. 预计到 2025 年，约有 53,000 人死于该疾病。1 1CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent. CRC 最常在 65-74 岁的人群中被诊断出来，男性以及非西班牙裔的美洲印第安人/阿拉斯加原住民后裔中更为常见。6 6Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is just 16.2%. 将近四分之一的结直肠癌病例在转移阶段被诊断出来，此时的五年生存率仅为16.2%。6 6The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy. 肝脏是结直肠癌转移最常见的部位。肝转移显著影响生存率，仅接受姑息性化疗的患者中位五年生存率低于14%。7 7About 关于Exelixis 埃克塞利西斯Exelixis 埃克塞利西斯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. 是一家全球领先的肿瘤学公司，在癌症治疗的最前沿创新下一代药物和治疗方案。凭借卓越的药物发现与开发能力，我们正在快速拓展产品组合，通过临床差异化的的小分子和生物治疗管线，针对日益扩展的肿瘤类型及适应症进行研发。This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX. 这一全面的方法利用了我们科学和合作伙伴关系数十年的坚实投资，以推动我们的研究项目，并扩大我们旗舰商业产品CABOMETYX的影响力。® ®(cabozantinib). （卡博替尼）。Exelixis 埃克塞利西斯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 是由一种大胆的科学追求所驱动，致力于创造能够为更多患者带来未来希望的变革性治疗方案。如需了解有关公司及其帮助癌症患者更强劲康复、更长寿生活的使命，请访问www.exelixis.com www.exelixis.com, follow ，跟随@ExelixisInc @ExelixisIncon X (Twitter), like 在X（Twitter）上，像Exelixis, Inc. Exelixis公司on Facebook and follow 在 Facebook 上关注并跟随Exelixis 埃克塞利西斯on LinkedIn. 在领英上。About Natera 关于NateraNatera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera™ 是无细胞 DNA 和精准医学领域的全球领导者，致力于肿瘤学、女性健康和器官健康。我们的目标是将个性化基因检测和诊断作为标准护理的一部分，以保护健康，并为更早、更有针对性的干预提供信息，从而帮助人们过上更长寿、更健康的生活。Natera’s tests are supported by more than 325 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in . Natera的检测方法得到了325多篇同行评审出版物的支持，证明了其卓越的性能。Natera在ISO 13485认证和CAP认可的实验室运营，这些实验室是根据《临床实验室改进修正案》（CLIA）认证的。Austin, Texas 德克萨斯州奥斯汀市, and ，以及San Carlos, California 加利福尼亚州圣卡洛斯, and through ，以及通过Foresight Diagnostics 前瞻性诊断, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in ，其子公司，运营一家获得ISO 27001认证和CAP认可的CLIA认证实验室，在Boulder, Colorado 科罗拉多州博尔德市. For more information, visit 欲了解更多信息，请访问www.natera.com www.natera.com. 。Exelixis Forward-Looking Statements Exelixis前瞻性声明This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ clinical development plans for zanzalintinib, including in collaboration with Natera for the phase 3 pivotal trial STELLAR-316; Exelixis’s belief in the therapeutic potential of zanzalintinib, including the potential to be the first MRD-guided treatment for patients with CRC; Exelixis’ commitment to addressing unmet needs in patients with CRC by conducting rigorous trials with the potential to improve standards of care; and Exelixis’ scientific pursuit to create transformational treatments that give more patients hope for the future. 本新闻稿包含前瞻性声明，包括但不限于：Exelixis关于赞扎林替尼的临床开发计划，包括与Natera合作进行的3期关键试验STELLAR-316；Exelixis对赞扎林替尼治疗潜力的信心，包括其可能成为首个针对结直肠癌（CRC）患者的微小残留病灶（MRD）引导治疗；Exelixis通过开展严谨的试验来满足CRC患者未满足的需求，并致力于提高护理标准；以及Exelixis科学追求创造变革性疗法，为更多患者带来未来的希望。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. 任何涉及对未来事件或情况的预期、预测或其他描述的陈述均为前瞻性陈述，这些陈述基于Exelixis当前的计划、假设、信念、预期、估计和预测。前瞻性陈述涉及风险和不确定性。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 potential failure of zanzalintinib to demonstrate safety and/or efficacy in clinical trials; complexities and the unpredictability of the regulatory review and approval processes in the . 实际结果和事件发生的时间可能与前瞻性声明中预期的情况大相径庭，原因是这些风险和不确定性，其中包括但不限于：zanzalintinib可能无法在临床试验中证明其安全性和/或有效性；监管审查和批准过程的复杂性及不可预测性。U.S. 美国and elsewhere; Exelixis’ and Natera’s continuing compliance with applicable legal and regulatory requirements; the costs of conducting clinical trials; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of zanzalintinib; Exelixis’ and Natera’s ability to protect its intellectual property rights; market competition; changes in economic and business conditions; and other factors affecting . 和其他地方；Exelixis和Natera持续遵守适用的法律和监管要求；进行临床试验的成本；Exelixis依赖第三方供应商开发、制造和供应zanzalintinib；Exelixis和Natera保护其知识产权的能力；市场竞争；经济和商业环境的变化；以及其他影响因素。Exelixis 埃克塞利西斯and its development programs 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’ future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to . Exelixis最近的年度报告Form 10-K以及随后的季度报告Form 10-Q中，在“风险因素”标题下不时详细说明的其开发计划，以及Exelixis未来向证券交易委员会提交的文件。本新闻稿中的所有前瞻性声明均基于可获得的信息。Exelixis 埃克塞利西斯as of the date of this press release, and 截至本新闻稿发布之日，且Exelixis 埃克塞利西斯undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law. 不承担更新或修改本文包含的任何前瞻性陈述的义务，除非法律要求。 Natera Forward-Looking Statements 纳特拉前瞻性声明All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. 本新闻稿中包含的所有非历史事实的声明均为前瞻性声明，并不代表Natera的计划、估计或预期将会实现。这些前瞻性声明代表了Natera在本新闻稿发布当日的预期，Natera不承担更新前瞻性声明的义务。These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. 这些前瞻性陈述受到已知和未知的风险和不确定性的影响，可能导致实际结果出现重大差异，包括关于临床或其他研究结果是否支持我们产品提供的使用、此类研究结果的影响、我们对测试的可靠性、准确性和性能的期望，或我们的测试和产品对患者、供应商和支付方的益处。Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the . Natera最近在表格10-K和10-Q的“风险因素”中详细讨论了更多的风险和不确定性，以及Natera向美国证券交易委员会提交的其他文件。SEC 证券交易委员会from time to time. These documents are available at 不时地。这些文件可以在www.natera.com/investors www.natera.com/investorsand 和www.sec.gov www.sec.gov. 。Exelixis 埃克塞利西斯, the ，这个Exelixis 埃克塞利西斯logo and CABOMETYX are registered 商标和CABOMETYX已注册U.S. 美国trademarks. 商标。TECENTRIQ is a registered TECENTRIQ 是一个注册商标U.S. 美国trademark of 商标Genentech 基因泰克, a member of the Roche Group. ，罗氏集团的成员。1 1Key Statistics for Colorectal Cancer. ACS website. Available at: 结直肠癌的关键统计数据。ACS网站。可访问： https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html. Accessed . 已访问January 2026 2026年1月. 。2 2Decision 决策Resource Group 资源组. Diagnosed stage II/III CRC incident cases in 2035. 2035年诊断为II/III期CRC的新发病例。3 3Shah PK et al. Circulating tumor DNA for Detection of Molecular Residual Disease (MRD) in Patients with Shah PK 等。循环肿瘤 DNA 用于检测患者的分子残留病灶 (MRD) Stage II 第二阶段/III Colorectal Cancer (CRC): Final Analysis of the BESPOKE CRC Sub cohort, presented at the 2025 ASCO GI. /III 结直肠癌 (CRC): BESPOKE CRC 子队列的最终分析，于2025年ASCO GI上发表。4 4Cohen SA 科恩 SA, et al. Real-world monitoring of ctDNA reliably predicts cancer recurrence and treatment efficacy in patients. Ann Surg. Published online `, 等。ctDNA 的真实世界监测可可靠预测患者的癌症复发和治疗效果。《外科年鉴》在线发表。`August 7, 2025 2025年8月7日. doi:10.1097/SLA.0000000000006887. . doi:10.1097/SLA.0000000000006887.5 5Nakamura, Y., Watanabe, J., Akazawa, N. et al., ctDNA-based molecular residual disease and survival in resectable colorectal cancer. Nat Med (2024). 中村悠也、渡边淳、赤泽直树等，基于ctDNA的分子残留病灶与可切除结直肠癌的生存率。《自然医学》（2024）。6 6Cancer Stat Facts: Colorectal Cancer. SEER website. Available at: 癌症统计资料：结直肠癌。SEER网站。可访问：https://seer.cancer.gov/statfacts/html/colorect.html https://seer.cancer.gov/statfacts/html/colorect.html. Accessed . 已访问January 2026 2026年1月. 。7 7Ros J, Salva F, Dopazo C, et al. Liver transplantation in metastatic colorectal cancer: are we ready for it? 罗斯 J，萨尔瓦 F，多帕佐 C，等。肝移植治疗结直肠癌转移：我们准备好了吗？Br 溴J Cancer 癌症期刊. 。May 2023 2023年5月;128(10):1797-1806. ;128(10):1797-1806.View source version on 查看源版本 businesswire.com 业务连线网站 : ：https://www.businesswire.com/news/home/20260107329077/en/ https://www.businesswire.com/news/home/20260107329077/en/Exelixis Investor Contact: Exelixis投资者联系人：Andrew Peters 安德鲁·彼得斯SVP, Strategy and Investor Relations 高级副总裁，战略与投资者关系Exelixis, Inc. Exelixis公司650-837-7248 650-837-7248apeters@exelixis.com apeters@exelixis.comNatera Investor Contact: Natera 投资者联系人：Mike Brophy 迈克·布罗菲Chief Financial Officer 首席财务官Natera, Inc. 纳特拉公司investor@natera.com 投资者@纳特拉.comExelixis Media Contact: Exelixis 媒体联系人：Hal Mackins 哈尔·麦金斯For 为了Exelixis, Inc. Exelixis公司415-994-0040 415-994-0040hal@torchcommunications.com hal@torchcommunications.comNatera Media Contact: Natera媒体联系人：Lesley Bogdanow 莱斯利·博格丹诺夫Vice President, Corporate Communications 副总裁，企业传播部Natera, Inc. 纳特拉公司pr@natera.com pr@natera.comSource: 源：Exelixis, Inc. Exelixis公司