Xenon Pharmaceuticals Inc. Q1 FY2025 earnings call

• Azetukalner Phase 3 epilepsy program: Nearing end of patient recruitment in X-TOLE2, with top-line results anticipated early 2026. Metrics align with successful Phase 2b X-TOLE study. • Neuropsychiatry: Enrollment ongoing in X-NOVA2 (Phase 3 MDD study), X-NOVA3 and BPD studies on track. Mount Sinai investigator-sponsored study of azetukalner in MDD showed drug activity on MADRS and SHAPS. • Early-stage pipeline: Multiple regulatory filings expected, XEN1120 in Phase 1 for pain, Nav1.7 and Nav1.1 programs progressing with IND enabling work complete for some candidates.

No specific product segment financial performance data provided in the transcript.

• Anticipate having sufficient cash to fund operations into 2027. • X-TOLE2 top-line results for epilepsy anticipated early 2026. • Refinement of enrollment and top-line data guidance for clinical studies as they progress.

No specific detailed risk discussions provided in the transcript beyond forward-looking statement caveats.

Q: From the top-line epilepsy data in early 2026, how quickly could you file assuming positive? And color on key metrics tracking vs Phase 2b.

A: On NDA filings, approximately 6 months from top-line data to filing. Key metrics tracked include patient baseline characteristics, compliance to diary, double-blinded period metrics, and rollover rates into open label extension.

Q: Quantification on patients still needed to recruit for XTOLE-2, screen failure rate vs XTOLE-2.

A: Close to completing recruitment in next few months. Screen failure rates similar to Phase 2b as inclusion/exclusion criteria are similar.

Q: Reasons for XTOLE-2 timeline slippage, implications on competitive dynamics and learnings for commercial setting; impact of Mount Sinai study on Phase 3 MDD plan.

A: Viewed as minor delay, no impact on competitive dynamics. Mount Sinai study's robust data is reassuring, Phase 3 MDD program powered appropriately.

Q: Details on fMRI primary endpoint in Mount Sinai study, neuroimaging expectations vs approved MDD drugs.

A: fMRI primary endpoint was negative, but clinical scales showed efficacy consistent with X-NOVO study.

Q: Enrollment timeline for X-TOLE3 relative to X-TOLE2, design of BPD trial.

A: X-TOLE3 enrollment later than X-TOLE2; BPD trial will include Bipolar 1 and 2 patients, with stratification considerations to be detailed later.

Q: Update on X-TOLE2 enrollment guidance, patient baseline AEDs in Phase 3.

A: Will refine enrollment guidance as study nears end. Track patient baseline demographics including AEDs, consistent with Phase 2 population.

Q: Inclusion of Bipolar 1 and 2 patients in BPD study, dosing in Mount Sinai study.

A: Included both due to similar underlying depression pathophysiology; dosing in Mount Sinai study not affecting results due to QD dosing.

Q: Seizure freedom measure in X-TOLE2 and lead indication selection for XEN1120.

A: Seizure freedom tracked over long-term open label extension. XEN1120 Phase 1 in healthy volunteers to assess PK and AE profile, with plan to move to proof-of-concept in pain.