Xenon Pharmaceuticals (XENE) investor relations material

Pipeline milestones

• Azetukalner’s X-TOLE2 results supported an NDA filing in September; the application is under review as preparations begin for commercialization.

• XEN1701, a NaV1.7 inhibitor, and XEN1120, a Kv7 modulator, met phase I target product profile expectations; both are planned for phase II acute-pain proof-of-concept studies in 2027.

Psychiatry program

• X-NOVA2, the first phase III MDD study, is planned to unblind in December, with efficacy and safety data intended to guide the program; phase III safety observations resemble the epilepsy profile.

• X-NOVA2 has ~360 randomized participants and an estimated 90% power to detect a 2.5-point HAMD-17 separation; the primary endpoint is HAMD-17 at six weeks, with SHAPS also assessed.

• If results support further MDD development, management plans to consult FDA on the path forward; X-NOVA3 enrollment was paused, and X-NOVA2 enrollment was completed at a smaller sample size than originally designed.

• Phase II X-NOVA showed separation from placebo on MADRS, HAMD-17 and SHAPS, with a dose response; management said higher-dose epilepsy studies show more adverse events, including rare psychiatric events, while psychosis cases resolve without long-term sequelae.

Epilepsy launch plans

• Launch preparations include payer research on pricing and access, demand forecasting, general-neurology targeting, and expansion of market access, commercial operations, sales and marketing teams.

• Management expects a standard NDA review and likely DEA scheduling, with market entry expected around January 2028; the launch curve is expected to build gradually as prescribing expands beyond epileptologists.

• Management cited annualized gross prices of ~$15,400 for cenobamate and ~$18,000 for BRIVIACT, and said azetukalner could be priced above both; the intended treatment position is an early add-on after generic agents.

• Four starting doses of 10, 15, 20 or 25 mg are expected on label; management highlighted therapeutic-dose initiation and no need to adjust other anti-seizure medicines as potential advantages for general neurologists.