Xenon Pharmaceuticals — Q3 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $110.4 million for the quarter ended September 30, 2026, compared to a net loss of $90.9 million for the same period in 2025.
• Research and development expenses were $95.6 million for the quarter, an increase from $77.1 million in the prior year period.
• General and administrative expenses were $24.4 million for the quarter, up from $19.3 million in the prior year period.
• Other income was $11.5 million for the quarter, compared to $6.1 million in the prior year period, driven by higher interest income.
• Cash, cash equivalents, and marketable securities totaled $1,153.5 million as of September 30, 2026, compared to $586.0 million as of December 31, 2025.
• Revenue was $0 for the quarter ended September 30, 2026, compared to $0 for the same period in 2025.
• For the nine months ended September 30, 2026, revenue was $0, compared to $7.5 million in the prior year period.
• Net loss for the nine months ended September 30, 2026, was $323.5 million, compared to $240.6 million in the prior year period.
• Basic and diluted net loss per share was $1.11 for the quarter ended September 30, 2026, compared to $1.15 in the prior year period.

Guidance and Future Outlook:

• Anticipates cash runway sufficient to fund operations into 2029 based on current operating plans.
• Plans to initiate Phase 3b/4 X-FIRST study for azetukalner as a first add-on antiseizure medication in Q1 2027.
• Expects to initiate Phase 2 proof-of-concept studies for pain programs XEN1701 and XEN1120 in H1 2027.
• Anticipates topline data readout for Phase 3 X-NOVA2 study in MDD in December 2026.
• Expects enrollment completion for X-TOLE3 study outside of Japan in 2026.
• Expects data from Phase 1b study of NBI-921355 in collaboration with Neurocrine Biosciences in 2027.

Business Segments and Product Lines:

• Submitted New Drug Application (NDA) for azetukalner in focal seizures to the FDA in September 2026.
• Completed enrollment in Phase 3 X-NOVA2 study for major depressive disorder (MDD) with approximately 360 patients.
• Initiated a voluntary pause on new patient enrollment in ongoing Phase 3 clinical studies of azetukalner in MDD and bipolar depression (BPD); currently enrolled patients remain active.
• Presented positive Phase 1 data for XEN1701 (NaV1.7) and XEN1120 (KV7) pain programs at the IASP World Congress on Pain, achieving target profiles and demonstrating tolerability.
• X-TOLE3 study for azetukalner in focal seizures continues to enroll to support non-U.S. regulatory submissions.
• X-ACKT study for azetukalner in primary generalized tonic-clonic seizures (PGTCS) continues to enroll.
• IND-enabling studies are ongoing for an oral small molecule NaV1.1 program targeting Dravet syndrome.
• Phase 1 SAD/MAD study is ongoing for XEN1720, a second NaV1.7 candidate.

Market and Competitive Landscape:

• Azetukalner is described as the most advanced, clinically validated potassium channel modulator in late-stage clinical development.
• Company highlights strong efficacy and consistent safety for azetukalner across more than 1,500 patient-years of data.
• Management notes positive scientific exchange with epileptologists and neurologists regarding azetukalner's product profile.
• XEN1701 and XEN1120 target novel, non-opioid pain therapeutics using ion channel biology expertise.

Risks and Challenges:

• Forward-looking statements include risks that clinical studies may not demonstrate safety and efficacy.
• Risks include potential failure of product candidates, failure to receive regulatory approvals, or delays making candidates commercially viable.
• Assumptions regarding planned expenditures and cash sufficiency may be incorrect.
• Regulatory agencies may delay study initiation or impose additional requirements.
• Market, industry, and regulatory conditions may impact clinical study enrollment.
• Competition and geopolitical events may adversely affect the business.

Management Commentary and Tone:

• Ian Mortimer, President and CEO, expressed significant progress with the azetukalner NDA submission and strong confidence in the product profile.
• Management noted excitement regarding the growing value of the earlier-stage pipeline, specifically the pain programs.
• Tone indicates confidence in the ability to achieve milestones and progress clinical studies.

Other Key Points:

• As of September 30, 2026, there were 98,275,278 common shares and 1,507,885 pre-funded warrants outstanding.
• Xenon will attend four investor conferences in Q4 2026, including the Guggenheim, Stifel, Jefferies, and Evercore Healthcare Conferences.
• Total assets increased to $1,199.9 million as of September 30, 2026, from $633.2 million as of December 31, 2025.
• Shareholders' equity increased to $1,146.4 million as of September 30, 2026, from $581.8 million as of December 31, 2025.
• The company presented six abstracts at the 16th European Epilepsy Congress, including an encore oral presentation of X-TOLE2 data.