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Jun 30, 2022
Xenon Pharmaceuticals Q2 2022 Earnings Report
Xenon Pharmaceuticals' financial position strengthened and clinical programs progressed.
Key Takeaways
Xenon Pharmaceuticals reported a net loss of $31.2 million for the second quarter of 2022, with revenue of $0.5 million. The company's cash and cash equivalents and marketable securities totaled $788.2 million, expected to fund operations into 2026. Key clinical programs, including XEN1101 for epilepsy and major depressive disorder, are advancing, with Phase 3 trials planned or underway.
Xenon remains on track to initiate the XEN1101 Phase 3 program within second half of this year
Cash runway extended into 2026 following successful completion of equity offering in June
FDA aligned on key elements of the Phase 3 program to support a New Drug Application (NDA) submission for XEN1101
Phase 2 ‘X-NOVA’ study is underway examining XEN1101 in major depressive disorder
Xenon Pharmaceuticals
Xenon Pharmaceuticals
Forward Guidance
Xenon anticipates having sufficient cash to fund operations into 2026, excluding any revenue generated from existing partnerships or potential new partnering arrangements. The company plans to initiate two identical Phase 3 clinical trials called X-TOLE2 and X-TOLE3, which are designed closely after the Phase 2b X-TOLE clinical trial.
Positive Outlook
- Sufficient cash to fund operations into 2026
- Advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy
- Plans to submit an NDA upon completion of the first XEN1101 Phase 3 clinical trial (X-TOLE2), if successful
- Alignment was obtained with the FDA at the EOP2 meeting on key elements of a single Phase 3 clinical trial to pursue an additional epilepsy indication of primary generalized tonic clonic seizures (PGTCS)
- XEN496, a Kv7 potassium channel opener, is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE).
Challenges Ahead
- Clinical trials may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates
- Promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials
- Our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect
- Any of our or our collaborators’ product candidates, including XEN1101 may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable
- Regulatory agencies may impose additional requirements or delay the initiation of clinical trials