Company plans to host a conference call on October 13, 2023

公司计划于2023年10月13日召开电话会议

CAMBRIDGE, Mass., Sept. 18, 2023 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced it will present preliminary dose-escalation data from its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 at the 35th AACR-NCI-EORTC (ANE) Symposium taking place October 11-15, 2023, in Boston, Massachusetts..

马萨诸塞州剑桥市，2023年9月18日/PRNewswire/-Nuvalent，Inc.（纳斯达克股票代码：NUVL），一家临床阶段的生物制药公司，致力于为临床证实的癌症激酶靶标创建精确靶向的疗法，今天宣布，它将在2023年10月11日至15日在波士顿举行的第35届AACR-NCI-EORTC（ANE）研讨会上展示正在进行的NVL-655 ALKOVE-1 1/2期临床试验的初步剂量递增数据，马萨诸塞州。。

The presentation marks the first disclosure of data characterizing the safety and clinical activity of NVL-655 from the Phase 1 dose-escalation portion of the ongoing ALKOVE-1 Phase 1/2 clinical trial evaluating NVL-655 in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. NVL-655 has been designed with the aim to address challenges that limit clinical use of existing ALK tyrosine kinase inhibitors (TKIs), including treatment emergent resistance mutations, lack of brain penetrance, and off-target CNS adverse events.

该报告标志着NVL-655安全性和临床活性数据的首次公开，该数据来自正在进行的评估NVL-655的ALKOVE-1期1/2期临床试验的1期剂量递增部分，用于晚期ALK阳性非小细胞肺癌（NSCLC）和其他实体瘤。NVL-655的设计旨在应对限制现有ALK酪氨酸激酶抑制剂（TKIs）临床应用的挑战，包括治疗紧急耐药突变，缺乏脑外显率和脱靶CNS不良事件。

The ALKOVE-1 clinical trial is continuing to enroll patients in the Phase 1 portion of the trial..

ALKOVE-1临床试验正在试验的第一阶段继续招募患者。。

Nuvalent plans to host a conference call and webcast on October 13, 2023. Details for the conference call will be provided at a future date and available on the Nuvalent website at www.nuvalent.com.

Nuvalent计划于2023年10月13日举办电话会议和网络广播。电话会议的详细信息将在未来的日期提供，并可在Nuvalent网站www.Nuvalent.com上查阅。

Details for the presentation are as follows:

演示文稿的详细信息如下：

Title: Safety and preliminary activity of the selective ALK inhibitor NVL-655 in patients with ALK fusion-positive solid tumorsAbstract Number: 35177Poster Number: B154Session: Poster Session BSession Date and Time: Friday, October 13, 12:30 pm-4:00 pmPresenting Author: Jessica J Lin, Massachusetts General Hospital (MGH), Boston, MA.

题目：选择性ALK抑制剂NVL-655在ALK融合阳性实体瘤患者中的安全性和初步活性摘要编号：35177海报编号：B154会议：海报会议b会议日期和时间：星期五，10月13日，12:30 pm-4:00 pmPresenting作者：Jessica J Lin，马萨诸塞州总医院（MGH），马萨诸塞州波士顿。

About NVL-655

关于NVL-655

NVL-655 is a novel brain-penetrant ALK-selective inhibitor created to overcome limitations observed with currently available ALK inhibitors. NVL-655 is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R / L1196M ('GRLM'), G1202R / G1269A ('GRGA'), or G1202R/L1198F ('GRLF').

NVL-655是一种新型的脑渗透性ALK选择性抑制剂，旨在克服目前可用的ALK抑制剂所观察到的局限性。NVL-655被设计为在对第一代，第二代和第三代ALK抑制剂产生抗性的肿瘤中保持活性，包括具有溶剂前沿G1202R突变或化合物突变G1202R/L1196M（'GRLM'）的肿瘤，G1202R/G1269A（'GRGA'）或G1202R/L1198F（'GRLF'）。

NVL-655 has been optimized for CNS penetrance to improve treatment options for patients with brain metastases. NVL-655 has been observed in preclinical studies to selectively inhibit wild-type ALK and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and drive more durable responses for patients.

NVL-655已针对CNS渗透率进行了优化，以改善脑转移患者的治疗选择。NVL-655已在临床前研究中观察到选择性抑制野生型ALK及其对结构相关的原肌球蛋白受体激酶（TRK）家族的抗性变体，以潜在地避免用双重TRK/ALK抑制剂观察到的TRK相关CNS不良事件并为患者提供更持久的反应。

NVL-655 is currently being investigated in the ALKOVE-1 clinical trial (NCT05384626), a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors..

NVL-655目前正在ALKOVE-1临床试验（NCT05384626）中进行研究，这是一项针对晚期ALK阳性非小细胞肺癌（NSCLC）和其他实体瘤患者的首次人体1/2期临床试验。。

About Nuvalent

关于Nuvalent

Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses.

Nuvalent，Inc.（纳斯达克股票代码：NUVL）是一家临床阶段的生物制药公司，致力于为癌症患者创造精确的靶向治疗，旨在克服现有治疗方法对临床证实的激酶靶点的局限性。利用化学和基于结构的药物设计方面的深入专业知识，我们开发出具有克服耐药性，减少不良事件，解决脑转移并推动更持久反应的创新小分子。

Nuvalent is advancing a robust pipeline with parallel lead programs in ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC), a program in HER2 Exon 20 Insertion positive cancers, and multiple discovery-stage research programs. We routinely post information that may be important to investors on our website at www.nuvalent.com. Follow us on Twitter (@nuvalent) and LinkedIn..

Nuvalent正在推进一个强大的管道，在ROS1阳性和ALK阳性非小细胞肺癌（NSCLC），HER2外显子20插入阳性癌症计划和多个发现阶段研究计划中并行领导计划。我们经常在我们的网站www.nuvalent.com上发布对投资者可能重要的信息。在Twitter（@nuvalent）和LinkedIn上关注我们。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; the expected timing of data announcements; the preclinical and clinical development programs for NVL-655; the potential clinical effect of NVL-655; the design and enrollment of the ALKOVE-1 clinical trial; the potential of NVL-655; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development.

本新闻稿包含经修订的1995年“私人证券诉讼改革法”含义范围内的前瞻性声明，包括但不限于关于Nuvalent战略，业务计划和重点的默示和明示的声明；数据公告的预期时间；NVL-655的临床前和临床开发计划；NVL-655的潜在临床效果；ALKOVE-1临床试验的设计和注册；NVL-655的潜力；Nuvalent的癌症治疗研究和开发计划；以及与药物开发相关的风险和不确定性。

The words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'aim,' 'goal,' 'intend,' 'believe,' 'expect,' 'estimate,' 'seek,' 'predict,' 'future,' 'project,' 'potential,' 'continue,' 'target' or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“可能”，“可能”，“将会”，“可能”，“将会”，“应该”，“期望”，“计划”，“预期”，“目标”，“目标”，“意图”，“相信”，“期望”，“估计”，“寻求”，“预测”，“未来”，“项目”，“潜在”，“继续”，“目标”或这些术语和类似词语或表达的否定词旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented..

药物开发和商业化涉及高度风险，并且只有少数研究和开发计划导致产品商业化。您不应过分依赖这些陈述或所提供的科学数据。。

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: risks that Nuvalent may not fully enroll the ALKOVE-1 clinical trial or that enrollment will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies or clinical trials, including ALKOVE-1; the occurrence of adverse safety events; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations, including the ALKOVE-1 clinical trial; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property.

本新闻稿中的任何前瞻性声明均基于管理层当前的期望和信念，并受到许多风险，不确定性和重要因素的影响，这些风险，不确定性和重要因素可能导致实际事件或结果与任何前瞻性声明所表达或暗示的实质性差异本新闻稿中包含的声明，包括，但不限于：Nuvalent可能无法完全注册ALKOVE-1临床试验或注册时间将超出预期的风险；在临床前研究或临床试验（包括ALKOVE-1）期间获得的额外数据，分析或结果可能引起意想不到的担忧；不良安全事件的发生；意外成本，延误或其他意外障碍的风险；Nuvalent可能无法从其发现计划中提名候选药物的风险；突发公共卫生事件或全球地缘政治情况对Nuvalent临床试验，策略和未来运作（包括ALKOVE-1临床试验）的时间安排和预期时间以及结果的直接或间接影响；Nuvalent计划与监管机构互动的时间和结果；以及与获取，维护和保护Nuvalent知识产权有关的风险。

These and other risks and uncertainties are described in greater detail in the section entitled 'Risk Factors' in the Company's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, as well as any prior and subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date.

这些和其他风险和不确定性在2023年6月30日结束的季度期间公司季度报告表格10-Q中的“风险因素”部分以及之前和之后向证券提交的任何文件中有更详细的描述。和交易所。此外，任何前瞻性陈述仅代表截至今天的Nuvalent观点，不应依赖于截至任何后续日期的观点。

Nuvalent explicitly disclaims any obligation to update an.

Nuvalent明确拒绝任何更新an的义务。

SOURCE Nuvalent, Inc.

来源Nuvalent，Inc。