CAMBRIDGE, Mass., June 18, 2025 /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 appointment of Christy Oliger to its Board of Directors."Christy's proven success in delivering new therapies to patients living with cancer strengthens our Board as we evolve from a development-stage company toward potential commercialization," said James Porter, Ph.D., C ...

Summary of Nuvalent (NUVL) FY Conference Call - May 27, 2025 Company Overview - **Company**: Nuvalent (NUVL) - **Industry**: Oncology, specifically focusing on targeted therapies for ROS1 and ALK non-small cell lung cancer Key Points and Arguments ROS1 Program 1. **Upcoming Data Release**: Nuvalent is preparing to release pivotal data for TKI pretreated ROS1 patients in the first half of 2025, with plans for a standalone press release and full data at a future medical meeting [4][20] 2. **Zidosanthanib Profile**: The drug aims to address limitations of existing therapies like crizotinib, particularly in brain penetrance and ROS1 resistance mutations, offering a selective treatment option for ROS1 patients [5][35] 3. **Patient Enrollment**: As of December 2024, 430 patients were enrolled in the study, with 330 in the phase two cohorts, indicating strong interest from investigators and patients [6][7] 4. **Data Strategy**: The initial dataset will focus on previously treated ROS1 patients, with plans to follow up with data from TKI naive patients [9][12] 5. **Safety and Efficacy**: The company emphasizes the importance of a well-tolerated safety profile to keep patients on therapy longer, which is a significant differentiator from existing treatments [12][15] Market Opportunity 6. **Commercial Potential**: The market for ROS1 lung cancer treatments is significant, with crizotinib generating approximately $400 million in sales, but Nuvalent believes it can outperform crizotinib due to its limitations [33][35] 7. **Competitive Landscape**: Nuvalent acknowledges the challenges faced by other drugs in the ROS1 space but believes zidosanthanib's differentiated profile will allow it to capture market share [36][37] ALK Program 8. **Regulatory Strategy**: Nuvalent is developing a program for ALK non-small cell lung cancer, aiming to create a drug that can work in the third-line setting where current options are limited [41][45] 9. **Clinical Development**: The ALK program is designed to address both second and third-line treatment needs, with a focus on achieving better durability and response rates than existing therapies like lorlatinib [52][53] 10. **Study Design**: The company plans to conduct a randomized study comparing its ALK drug to the standard of care, alectinib, to establish its efficacy [53][60] HER2 Program 11. **Emerging HER2 Program**: Nuvalent is also developing NVL-330 for HER2 exon 20 lung cancer, focusing on creating a drug with high brain penetrance to address unmet needs in this area [62][66] 12. **Current Status**: The HER2 program is in the dose escalation phase, with no specific timeline for data release yet provided [67] Additional Important Insights - **Regulatory Engagement**: Nuvalent is committed to maintaining open dialogue with regulators to expedite the approval process for its drugs [30][31] - **Market Perception**: There is a growing recognition of the potential in the ROS1 market, with Nuvalent emphasizing the importance of addressing patient needs to create commercial opportunities [32][33] - **Pricing Strategy**: While it is too early to comment on pricing, Nuvalent will consider precedents in the market when determining the price for zidosanthanib [40] This summary encapsulates the key discussions and insights from the Nuvalent conference call, highlighting the company's strategic focus on developing innovative therapies for ROS1 and ALK non-small cell lung cancer, as well as its emerging HER2 program.

(Mark One) Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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) Delaw ...

Clinical Trials and Data - Topline pivotal data for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population expected in the first half of 2025, supporting NDA submission by mid-year 2025[2] - Initiation of ALKAZAR Phase 3 trial for neladalkib planned for the first half of 2025, with pivotal data anticipated by year-end 2025[2][4] - Enrollment ongoing in HEROEX-1 Phase 1a/1b trial for NVL-330, a novel HER2-selective inhibitor[8] - New preclinical data for neladalkib presented at AACR Annual Meeting, demonstrating suppression of resistance in mutagenesis screens[10] Financial Performance - Cash, cash equivalents, and marketable securities totaled $1.1 billion as of March 31, 2025, expected to fund operations into 2028[17] - R&D expenses for Q1 2025 were $74.4 million, while G&A expenses were $20.4 million[17] - Net loss for Q1 2025 was $84.6 million, with a net loss per share of $1.18[17][22] - Total operating expenses for Q1 2025 were $94.8 million, compared to $52.6 million in Q1 2024[22] - Total assets as of March 31, 2025, were $1.1 billion, with total liabilities of $94.7 million[24] Leadership Changes - Leadership team strengthened with promotions of Ruth Adams, Joshua Horan, and Jessie Lin to Senior Vice President roles[4][11]

Topline pivotal data expected for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population in the first half of 2025 in support of anticipated first NDA submission by mid-year 2025 Initiation of ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC planned for first half of 2025Pivotal data for neladalkib in TKI pre-treated ALK-positive NSCLC population anticipated by year-end 2025Strengthened leadership team with key internal promotionsCAMBRIDGE, Mass., May 8, 2 ...

CAMBRIDGE, Mass., April 29, 2025 /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 publication of a manuscript in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research, which supports the rational molecular design of zidesamtinib, its novel and selective ROS1 inhibitor. Zidesamtinib is currently being evaluated in the ...

CAMBRIDGE, Mass., April 23, 2025 /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 two "Trial in Progress" poster presentations for its novel ALK-selective inhibitor, neladalkib, and novel HER2-selective inhibitor, NVL-330, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting from May 30 – June 5, 2025, in Chicago. Posters will be archive ...

CAMBRIDGE, Mass., April 1, 2025 /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 Stifel 2025 Virtual Targeted Oncology Forum on Tuesday, April 8, 2025, at 2:30 p.m. ET. A live webcast will be available in the Inve ...

CAMBRIDGE, Mass., March 25, 2025 /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 upcoming poster presentations further characterizing the preclinical profiles of its novel ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib, at the American Association for Cancer Research (AACR) Annual Meeting 2025 from April 25-30, 2025, ...

CAMBRIDGE, Mass., Feb. 28, 2025 /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 fireside chats during the following March investor conferences: TD Cowen 45th Annual Health Care Conference on Wednesday, March 5, 2025 at 9:50 a.m. ET in Bos ...