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Dec 31, 2022
Xenon Pharmaceuticals Q4 2022 Earnings Report
Xenon Pharmaceuticals reported financial results for Q4 2022, highlighting the advancement of the XEN1101 Phase 3 epilepsy program and anticipated clinical milestones.
Key Takeaways
Xenon Pharmaceuticals reported no revenue for the fourth quarter of 2022. Research and development expenses were $34.8 million, and general and administrative expenses were $8.5 million, resulting in a net loss of $37.4 million. Cash and cash equivalents and marketable securities were $720.8 million as of December 31, 2022.
XEN1101 Phase 3 epilepsy program continued to advance in focal onset seizures and primary generalized tonic clonic seizures.
Topline data from XEN1101 Phase 2 X-NOVA clinical trial in major depressive disorder expected in third quarter.
Cash and cash equivalents and marketable securities were $720.8 million as of December 31, 2022.
Based on current operating plans, Xenon anticipates having sufficient cash to fund operations into 2026.
Xenon Pharmaceuticals
Xenon Pharmaceuticals
Forward Guidance
Xenon anticipates topline results from the XEN1101 Phase 2 X-NOVA study in major depressive disorder in the third quarter and data from Neurocrine's Phase 2 study in adult patients with focal onset seizures in the second half of the year. They also expect to complete the EPIK study in 2024.
Positive Outlook
- Advancement of XEN1101 Phase 3 epilepsy program.
- Anticipated topline data from XEN1101 Phase 2 X-NOVA clinical trial in major depressive disorder in Q3.
- Data read-out from Neurocrine's Phase 2 study in adult patients with focal onset seizures expected in H2.
- Sufficient cash to fund operations into 2026.
- Ongoing X-TOLE Phase 2b OLE continues to generate important long-term data for XEN1101.
Challenges Ahead
- Clinical trials may not demonstrate safety and efficacy of product candidates.
- Assumptions regarding planned expenditures and sufficiency of cash to fund operations may be incorrect.
- Product candidates may fail in development or not receive regulatory approvals.
- Regulatory agencies may impose additional requirements or delay clinical trials.
- The impact of the ongoing COVID-19 pandemic on research and clinical development plans and timelines and results of operations.