Nuvalent (NUVL) Corporate presentation summary

Strategic vision and operational highlights

• Focus on developing precisely 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 R&D and commercial buildout; team has grown to ~300 FTEs.

• Hybrid operations with offices in Cambridge, MA, and a Nasdaq listing.

Pipeline and clinical development

• Zidesamtinib (NVL-520) and neladalkib (NVL-655) are lead assets, both advancing through pivotal trials for ROS1+ and ALK+ NSCLC, respectively.

• NDA for zidesamtinib in TKI pre-treated ROS1+ NSCLC accepted, with PDUFA date September 18, 2026; NDA for neladalkib in TKI pre-treated ALK+ NSCLC accepted, PDUFA date November 27, 2026.

• Phase 3 ALKAZAR trial for TKI-naïve ALK+ NSCLC and Phase 1a/1b HEROEX-1 trial for HER2-altered NSCLC ongoing.

Clinical data and efficacy

• Zidesamtinib demonstrated 44% ORR in TKI pre-treated ROS1+ NSCLC, with emerging median DOR of 22 months and strong intracranial activity.

• Neladalkib showed 31% ORR in heavily pre-treated ALK+ NSCLC, 68% ORR in ALK G1202R mutation, and 46% ORR in lorlatinib-naïve patients.

• Both drugs exhibited favorable safety profiles, with low discontinuation and dose reduction rates due to adverse events.