Nuvalent (NUVL) Company presentation summary

Strategic vision and operational highlights

• Focus on developing targeted therapies for cancer, with parallel lead programs in ROS1+ and ALK+ NSCLC and a third HER2-altered NSCLC program in Phase 1 investigation.

• Cash runway expected into 2029, supporting ongoing global clinical development and commercial buildout.

• Over 200 employees and hybrid operations based in Cambridge, MA, with Nasdaq listing.

• Goal to become a fully integrated, commercial-stage biotech by year-end 2026, with at least one FDA approval and another under review.

• Over $1.4 billion in cash and equivalents at year-end 2025, supporting growth and expansion plans.

Pipeline and clinical development

• Zidesamtinib (NVL-520) for ROS1+ NSCLC: NDA accepted for TKI pre-treated patients, PDUFA date September 18, 2026; ongoing trials for TKI-naïve and other solid tumors.

• Neladalkib (NVL-655) for ALK+ NSCLC: Phase 2 pivotal data in TKI pre-treated patients, ongoing Phase 3 ALKAZAR trial for TKI-naïve patients, and activity in solid tumors beyond NSCLC.

• NVL-330 for HER2-altered NSCLC: Phase 1 trial ongoing, designed as a brain-penetrant, HER2-selective inhibitor with minimized EGFR-related adverse events.

• Additional discovery research programs are ongoing, with a new development candidate to be disclosed by year-end.

Clinical efficacy and safety highlights

• Zidesamtinib showed 44% ORR in TKI pre-treated ROS1+ NSCLC, with median DOR of 22 months and strong CNS activity; safety profile marked by low discontinuation (2%) and dose reduction (10%) rates.

• Neladalkib demonstrated 31% ORR in heavily pre-treated ALK+ NSCLC, 46% in lorlatinib-naïve, and 86% in TKI-naïve patients; durable intracranial responses and manageable safety profile with most common AEs being transaminase elevations.

• NVL-330 preclinical data show broad HER2 and HER2ex20 activity, high selectivity over EGFR, and promising brain penetrance.