Nuvalent(US:NUVL)2025-05-08 11:36Clinical 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]