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.

• Anticipates first U.S. commercial launch in 2026 and expects cash runway into 2029.

• Team exceeds 200 FTEs, with hybrid operations and Nasdaq listing.

• Leadership and board have significant experience in drug discovery, development, and prior FDA approvals.

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 planned for TKI pre-treated patients in 1H 2026; ALKAZAR Phase 3 trial ongoing for TKI-naïve patients.

• NVL-330 for HER2-altered NSCLC in Phase 1, with ongoing enrollment in the HEROex-1 trial.

• Additional discovery research programs are active, 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.

• In TKI-naïve ROS1+ NSCLC, preliminary ORR was 89% with 96% DOR at 6 and 12 months.

• Neladalkib demonstrated 31% ORR in heavily pre-treated ALK+ NSCLC, 68% ORR in ALK G1202R mutation, and 46% ORR in lorlatinib-naïve patients; safety profile generally well tolerated with most common TEAEs being transaminase elevations.

• Both lead assets show strong intracranial activity and are designed to avoid TRK-related neurotoxicities.