Nuvalent (NUVL) investor relations material

Company milestones and strategic focus

• Celebrated eight years since founding, emphasizing expertise in chemistry and structure-based drug design.

• Preparing for two product launches in 2024, with PDUFA dates for zidesamtinib in September and neladalkib in November.

• Planning to submit TKI-naive data for FDA review to support line extension into TKI-naive ROS1 in the second half of 2024.

• Continuing enrollment in the phase III ALKAZAR study and progressing a HER2 program in non-small cell lung cancer.

• Intends to disclose a fourth program by year-end.

Clinical data and competitive landscape

• Neladalkib demonstrates broad activity against ALK mutations, excellent CNS penetration, and high selectivity, addressing key limitations of existing therapies.

• ALKOVE-1 study shows neladalkib provides durable responses in patients who have failed prior therapies, with a median duration of response of 17.6 months, double that of lorlatinib in similar settings.

• In second-line settings, neladalkib achieves 2.5x to 3x the durability of lorlatinib, with about 60% of patients still responding at 18 months.

• Early first-line data for neladalkib is promising, but the pivotal ALKAZAR trial will provide definitive comparison to standard of care.

• Physicians and patients are highly engaged, reflected in record enrollment rates for clinical trials.

Market dynamics and physician perspectives

• Lorlatinib, despite strong efficacy, faces adoption barriers due to significant cognitive and mood-related toxicities, especially in community settings.

• Alectinib remains the global standard of care for first-line ALK-positive NSCLC, with lorlatinib adoption limited to academic centers.

• Neladalkib is positioned to address the trade-off between efficacy and tolerability, potentially shifting treatment paradigms.

• Patient advocacy groups and online communities are driving awareness and demand for new therapies.