Updated Phase 1 data from ALKOVE-1 and ARROS-1 clinical trials to be presented at the ESMO Congress 2024 Durable activity of NVL-655 and zidesamtinib in heavily pre-treated patient populations supports ongoing Phase 2 investigation in earlier lines of treatment Company plans to host a conference call on September 14, 2024 at 8:30 a.m. ET/2:30 p.m. CEST following oral presentations at ESMO CAMBRIDGE, Mass., Sept. 9, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical compan ...

CAMBRIDGE, Mass., Aug. 29, 2024 /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 that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in a fireside chat during the Morgan Stanley 22nd Annual Global Healthcare Conference on Thursday, September 5, 2024, at 1:05 p.m. ET in NYC. A live webcast will ...

CAMBRIDGE, Mass., July 22, 2024 /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 the initiation of HEROEX-1, its Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC). About NVL-330 Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical c ...

Details for the presentations are as follows: Title: Phase 1/2 ARROS-1 study of zidesamtinib (NVL-520) in ROS1 fusion-positive solid tumors Presentation Number: 1256MO Session Category: Mini oral session Session Title: NSCLC metastatic Presentation Date and Time: Saturday September 14, 2024, 10:30 – 10:35 CEST Location: Santander Auditorium – Hall 5 Presenter: Benjamin Besse, M.D., Ph.D. (Institut Gustav Roussy, Villejuif, France) Title: Profiling of Zidesamtinib and Other ROS1 Inhibitors in an Intracranial ...

Core Insights - Nuvalent, Inc. has promoted Henry Pelish, Ph.D., to Chief Scientific Officer, reflecting his significant contributions to the company and its mission in cancer therapy development [1][7] - Dr. Pelish has been with Nuvalent since 2018, overseeing the development of key investigational drugs and has over 15 years of experience in cancer biology and chemistry [2][7] - The company focuses on creating targeted therapies for cancer, specifically for clinically proven kinase targets, and aims to address limitations of existing treatments [7] Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company that develops precisely targeted therapies for cancer [1][7] - The company leverages expertise in chemistry and structure-based drug design to create innovative small molecules that can overcome resistance and minimize adverse events [7] - Nuvalent is advancing a robust pipeline, including investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, along with multiple discovery-stage research programs [7]

Core Viewpoint - Nuvalent's NVL-655 has received FDA's Breakthrough Therapy Designation for treating locally advanced or metastatic ALK+ non-small cell lung cancer (NSCLC), indicating its potential to be a significant therapy for patients who have developed resistance to existing treatments [1][6]. Company Background - Nuvalent is a clinical-stage biopharmaceutical company focused on developing targeted kinase therapies for oncology, particularly NSCLC [26]. - The company has a pipeline that includes kinase agents for ROS1-positive, ALK-positive, and HER2-altered NSCLC, along with undisclosed discovery-stage candidates [3]. Pipeline Overview - NVL-655 is designed as a brain-penetrant ALK selective TKI, aiming to overcome tumor resistance to ALK inhibitor therapy and reduce CNS adverse events [4][17]. - The drug has shown a 71% objective response rate in lorlatinib-native populations, indicating its potential effectiveness [7]. - The ALKOVE-1 Phase II trial is currently ongoing, with expectations for updated trial data to be presented at a medical conference later this year [21]. Market Potential - The U.S. NSCLC market is projected to grow from approximately $11.4 billion in 2023 to $76.3 billion by 2030, with the ALK+ NSCLC patient population expected to represent 2%-7% of all NSCLC patients [10]. - NVL-655 could potentially generate annual sales of $1.6 billion to $2.12 billion by capturing 30%-40% of the ALK+ NSCLC market [11]. Financial Outlook - Analysts estimate that NVL-655 could achieve peak sales of around $2.6 billion, contributing to a valuation of Nuvalent between $10.4 billion and $13 billion, translating to a share price of approximately $161 to $201 [12]. - The company had about $691.8 million in cash and equivalents at the end of Q1, which is expected to sustain operations into 2027 [17]. Competitive Landscape - NVL-655 aims to differentiate itself from existing therapies by potentially offering a better safety profile and effectiveness in patients with CNS metastases, a common issue in ALK+ NSCLC [20][24]. - The drug's ability to target both the original and mutated forms of the ALK gene positions it favorably against current treatments [26].

Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for cancer, specifically targeting clinically proven kinase targets [3] - The company leverages expertise in chemistry and structure-based drug design to develop innovative small molecules aimed at overcoming resistance and minimizing adverse events [3] - Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, along with multiple discovery-stage research programs [3] Upcoming Events - James Porter, Ph.D., CEO, and Alexandra Balcom, CFO, will participate in a fireside chat at the 2024 Jefferies Global Healthcare Conference on June 5, 2024, at 4:30 p.m. ET in NYC [1] - A live webcast of the event will be available on the company's website and archived for 30 days following the presentation [2]

Core Insights - Nuvalent, Inc. has received FDA breakthrough therapy designation for NVL-655, aimed at treating patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs) [1][4][5] Group 1: Drug Development and Clinical Trials - NVL-655 is a novel brain-penetrant ALK-selective TKI designed to address treatment resistance, brain metastases, and off-target CNS adverse events associated with existing therapies [3][6] - The breakthrough therapy designation is based on preliminary safety and activity data from the Phase 1 portion of the Phase 1/2 ALKOVE-1 clinical trial, which is currently ongoing [5][6] - The company plans to provide updates from the ALKOVE-1 trial at a medical meeting in the second half of 2024 [4][5] Group 2: Market Context and Patient Needs - ALK rearrangements occur in approximately 5% of metastatic NSCLCs, with up to 40% of these patients presenting with brain metastases at diagnosis [2] - About 50% of patients develop resistance mutations after treatment with existing first- or second-generation ALK TKIs, highlighting the need for new treatment options [2][4] - There is currently no clear standard of care for patients who have been treated with two or more ALK TKIs, indicating a significant unmet medical need [2][4] Group 3: Company Overview - Nuvalent, Inc. focuses on creating targeted therapies for cancer, leveraging expertise in chemistry and structure-based drug design to develop innovative small molecules [7] - The company is advancing a robust pipeline that includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered NSCLC, along with multiple discovery-stage research programs [7]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission File Number: 001-40671 NUVALENT, INC. (Exact Name of Registrant as Specified in its Charter) Delawar ...

Exhibit 99.1 Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2024 Financial Results Updates from the ongoing Phase 1/2 ARROS-1 and ALKOVE-1 clinical trials expected at a medical meeting in the second half of 2024 Strong financial position with operating runway anticipated into 2027 Recent Pipeline Progress and Anticipated Milestones ROS1 Program ALK Program HER2 Program • Nuvalent presented new preclinical data at the American Association for Cancer Re ...