Nuvalent (NUVL) Corporate 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.

• Cash runway expected into 2029, supporting ongoing clinical and commercial expansion.

• Team of over 200 FTEs, Nasdaq-listed, with hybrid operations based in Cambridge, MA.

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

Pipeline and clinical development

• Zidesamtinib (NVL-520) for ROS1+ NSCLC: NDA accepted for TKI pre-treated patients, PDUFA date September 18, 2026; strong efficacy and safety data in pivotal ARROS-1 trial.

• Neladalkib (NVL-655) for ALK+ NSCLC: NDA submitted for TKI pre-treated patients; ALKAZAR Phase 3 trial ongoing for TKI-naïve patients.

• NVL-330 for HER2-altered NSCLC: Phase 1 trial ongoing, designed for brain penetrance and HER2 selectivity.

• Additional discovery programs and new candidate disclosure planned by year-end 2026.

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; 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.

• Both agents designed to avoid TRK-related neurotoxicities, with safety profiles supporting long-term use.