Nuvalent Highlights Pipeline and Business Achievements, Reiterates Key Anticipated Milestones, and Reports Second Quarter 2025 Financial Results

Core Insights - Nuvalent, Inc. has initiated a rolling NDA submission for zidesamtinib targeting TKI pre-treated patients with advanced ROS1-positive NSCLC, aiming for completion in Q3 2025 [1][5] - The company has also started the ALKAZAR Phase 3 trial for neladalkib in TKI-naïve advanced ALK-positive NSCLC, with pivotal data expected by year-end 2025 [1][4] - Financial results for Q2 2025 show a net loss of $99.7 million, with R&D expenses at $80.9 million and G&A expenses at $23.7 million [10][15] Pipeline Achievements - The NDA submission for zidesamtinib is based on positive data from the ARROS-1 Phase 1/2 trial, which included 104 patients as of June 16, 2025 [5] - The ALKAZAR trial will randomize patients 1:1 to receive either neladalkib or alectinib, reflecting input from physician-scientists and regulatory agencies [4] - Preliminary data for neladalkib in ALK-positive solid tumors will be presented at the ESMO Congress 2025 [1][9] Business Updates - Jason Waters has been promoted to Senior Vice President, Commercial, to enhance the company's commercial strategy [2][10] - The company has a strong cash position of $1.0 billion as of June 30, 2025, expected to fund operations into 2028 [10][15] - Christy Oliger has been appointed to the board of directors, bringing over 30 years of experience in the pharmaceutical industry [10]