Nuvalent (NUVL) investor relations material

Company overview and strategic approach

• Focuses on structure-based drug design and kinase inhibitors for targeted therapies in oncology.

• Collaborates closely with physicians to address unmet needs and improve patient outcomes.

• Emphasizes innovative chemistry to overcome limitations of existing therapies.

• Well-capitalized to support upcoming milestones and pipeline expansion.

Key program milestones and regulatory progress

• OnTarget 2026 plan aims for first potential approval, with FDA NDA accepted for TKI-pretreated ROS1; PDUFA date set for September 18.

• Commercial launch readiness for ROS1 is underway, with plans to submit TKI-naive data in the second half of the year.

• ALK program completed pre-NDA meeting and is on track for NDA submission for previously treated patients.

• Phase III ALKAZAR study enrolling TKI-naive ALK patients; HER2-altered NSCLC program progressing in phase I.

• New development candidate expected to be announced by year-end.

Clinical data and differentiation

• Zidesamtinib for ROS1 shows high response rates, durable responses, and strong intracranial activity, outperforming existing drugs.

• TKI-naive ROS1 cohort shows 89% response rate and 96% one-year durability; 67% intracranial CR rate.

• Neladalkib for ALK demonstrates double the durability of lorlatinib in resistant patients and alectinib-like durability beyond alectinib.

• Both programs address off-target toxicity issues seen in current therapies, aiming for better tolerability and broader patient benefit.