Xenon Q2: Phase 3 study recruitment complete, topline data in 2026, new CCO appointed.

• Xenon completes recruitment for Phase 3 X-TOLE2 FOS study • Topline data expected in early 2026 • Phase 3 studies underway for X-NOVA3 in MDD and X-CEED in BPD • Phase 1 healthy volunteer study initiated for Nav1.7 pain candidate • Darren Cline appointed as Chief Commercial Officer • Conference call scheduled for 4:30 pm ET today

Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company, reported its second quarter 2025 financial results and provided a business update. The company highlighted significant milestones in its clinical development programs and appointed a new Chief Commercial Officer (CCO).

Key Highlights

- Phase 3 X-TOLE2 FOS Study: Xenon completed patient recruitment for its Phase 3 X-TOLE2 study in focal onset seizures (FOS). Topline data is anticipated in early 2026, which could pave the way for the company's first potential approval and commercial product.
- Phase 3 Neuropsychiatric Studies: The company is currently conducting Phase 3 studies for azetukalner in major depressive disorder (MDD) and bipolar depression (BPD). The X-NOVA3 study in MDD and the X-CEED study in BPD have been initiated.
- Early-Stage Pipeline: Xenon has initiated a Phase 1 healthy volunteer study for its lead Nav1.7 development candidate for pain. Additionally, the company is working on Nav1.1 lead candidate to address the underlying cause and symptoms of Dravet Syndrome.
- Leadership Appointment: Darren Cline was appointed as Chief Commercial Officer to lead the transition of Xenon to a commercial-stage company with the anticipated launch of azetukalner across three potential indications.

Financial Results

- Cash and Cash Equivalents: As of June 30, 2025, Xenon had $624.8 million in cash and cash equivalents, compared to $754.4 million at the end of 2024.
- Research and Development Expenses: The company spent $75.0 million on R&D in the second quarter, up from $49.7 million in the same period in 2024, primarily due to ongoing azetukalner Phase 3 clinical trials and increased personnel-related costs.
- General and Administrative Expenses: General and administrative expenses were $19.2 million, compared to $19.4 million in the same period in 2024.
- Net Loss: Xenon reported a net loss of $84.7 million for the second quarter, compared to $57.9 million in the same period in 2024. The increase in net loss was primarily attributable to higher R&D expenses, increased personnel-related costs, and lower interest income.

Conference Call

Xenon will host a conference call and webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss its second quarter 2025 results. A listen-only webcast can be accessed on the Investors section of the Xenon website, with a replay available following the event.

References

[1] https://www.globenewswire.com/news-release/2025/08/11/3131213/33485/en/Xenon-Reports-Second-Quarter-2025-Financial-Results-Business-Update.html