Nuvalent (NUVL) investor relations material

Company overview and strategic direction

• Focuses on structure-based drug design targeting validated kinase biology, reducing development risk.

• OnTarget 2026 plan aims for first drug approval in 2026, with key 2025 milestones including pivotal data for ROS1 and ALK programs and NDA submission for TKI pretreated ROS1.

• Building a fully integrated biotech company, with commercial readiness underway and recent financing completed.

• Open to strategic partnerships, especially for ex-US markets, but positioned to commercialize independently.

ALK program highlights and market opportunity

• ALK non-small cell lung cancer market estimated at $2–2.5 billion, with potential to expand by increasing time on therapy.

• NVL-655 targets third-line patients post-lorlatinib, with plans to move into earlier lines and potentially replace alectinib as standard of care.

• Phase 1/2 trial enrolled over 1,000 patients rapidly, showing deep, durable responses in both second- and third-line settings.

• Durability of response is double that of lorlatinib in third-line, with 18-month duration and high response rates in second-line.

• Ongoing phase 3 ALCAZAR trial compares NVL-655 to alectinib, with data expected in the second half of 2029.

Differentiators and patient engagement

• Strong partnerships with patient advocacy groups have driven rapid trial enrollment and fostered commercial enthusiasm.

• NVL-655 designed to avoid neurocognitive side effects seen with lorlatinib, addressing a key patient and physician concern.

• Safety profile notable for clean CNS effects; liver enzyme elevations are manageable and common in this drug class.