Financial Performance - Cash, cash equivalents, and marketable securities were $943.1 million as of September 30, 2025, sufficient to fund operations into 2028[13]. - Research and development expenses for Q3 2025 were $83.8 million, compared to $60.6 million in Q3 2024, reflecting a 38.2% increase[13]. - General and administrative expenses for Q3 2025 were $28.9 million, up from $15.8 million in Q3 2024, representing an 83.5% increase[13]. - The net loss for Q3 2025 was $122.4 million, compared to a net loss of $84.3 million in Q3 2024, indicating a 45% increase in losses[13]. - Total stockholders' equity as of September 30, 2025, was $845.4 million, down from $1,069.8 million at the end of 2024[19]. Clinical Development - The company completed its rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC[4]. - The company is on track to report topline pivotal data for neladalkib in TKI pre-treated advanced ALK-positive NSCLC by year-end 2025[3]. - The company is progressing with the ALKAZAR Phase 3 trial for TKI-naïve patients with advanced ALK-positive NSCLC[8]. - Preliminary clinical data for neladalkib showed encouraging activity in advanced ALK-positive solid tumors beyond NSCLC[3]. - The company presented new preclinical data for NVL-330, indicating a favorable profile for HER2-altered NSCLC[8].
Nuvalent(NUVL) - 2025 Q3 - Quarterly Results