Nuvalent (NUVL) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Platform strategy and innovation

• Focuses on precision oncology, leveraging deep expertise in chemistry and structure-based drug design to address clinically proven kinase targets.

• Collaborates closely with physicians to identify patient needs and limitations of existing therapies, guiding drug discovery.

• Emphasizes solving resistance mutations and minimizing off-target toxicities to improve patient outcomes.

• Utilizes learnings from literature and prior kinase inhibitor development to anticipate and address emerging resistance.

• Maintains a robust discovery pipeline, with ongoing research in various oncology indications beyond disclosed lead programs.

Lead programs and clinical progress

• Three lead programs target ROS1, ALK, and HER2 in non-small cell lung cancer, all discovered during the company's stealth phase.

• Both ROS1 and ALK programs have received FDA breakthrough therapy designation, reflecting significant unmet medical need and promising early data.

• ALK inhibitor NVL-655 demonstrated activity in heavily pretreated patients, including those with resistance mutations and CNS disease, with favorable safety profile.

• ROS1 program zidesamtinib showed efficacy in advanced patients, including those with CNS involvement and resistance mutations, and avoided CNS toxicities.

• HER2 program NVL-330, focused on Exon 20 insertions in lung cancer, is designed for broad mutation coverage and brain penetrance; phase I study recently initiated.

Data updates and regulatory milestones

• Upcoming ESMO update will provide additional follow-up on durability and enrollment status for both ALK and ROS1 programs.

• Phase II pivotal studies are ongoing for both ALK and ROS1, with pivotal data expected from at least one program next year and first approval targeted for 2026.

• Phase III strategy for ALK will be disclosed this year, with design informed by prior randomized studies and evolving standards of care.

• Breakthrough therapy designation enables enhanced regulatory dialogue, expediting development and potential market entry.