Xenon Announces Q2 2024 Financials and Business Update

Xenon Pharmaceuticals Inc., a neuroscience-focused biopharmaceutical company, has provided a corporate update and reported financial results for the second quarter ending June 30, 2024. Specializing in therapeutics for neurological and psychiatric disorders, Xenon is making significant strides in its research and development programs.

Xenon's President and Chief Executive Officer, Ian Mortimer, highlighted the company's progress. He expressed pride in having the only Kv7 potassium channel opener, azetukalner, in development with Phase 2b efficacy and long-term safety data for epilepsy patients. This drug could potentially revolutionize epilepsy treatment, addressing the ongoing challenge many patients face in controlling seizures despite current medications. Xenon's epilepsy program is advancing, with X-TOLE2 topline data expected in the second half of 2025, supporting an anticipated NDA submission.

Xenon continues to build on its Kv7 leadership with a diverse portfolio of chemistries and is advancing Nav1.7 candidates for early human proof-of-concept in pain management. Mortimer believes these advancements position Xenon with one of the most exciting CNS portfolios today.

Azetukalner (XEN1101) is being developed for epilepsy, including focal onset seizures (FOS) and primary generalized tonic-clonic seizures (PGTCS), as well as major depressive disorder (MDD). The Phase 3 FOS studies are progressing, with topline data from X-TOLE2 anticipated in the latter half of 2025. These studies are multicenter, randomized, double-blind, placebo-controlled trials assessing azetukalner's efficacy, safety, and tolerability in patients with FOS. Additionally, the Phase 3 X-ACKT trial is enrolling patients for another epilepsy indication, PGTCS. This trial aims to evaluate azetukalner's efficacy and safety as an adjunctive treatment.

The X-TOLE Phase 2b open-label extension (OLE) has been extended to seven years, amassing over 600 patient-years of exposure data. Eligible patients from the Phase 3 epilepsy studies may enter an OLE study for up to three years. Xenon also presented Phase 2 X-NOVA data at the American Society of Clinical Psychopharmacology (ASCP) meeting in May. This study evaluated azetukalner in patients with MDD. The first of three planned Phase 3 clinical trials for MDD is set to begin in the second half of 2024.

Xenon plans to present three epilepsy-related posters at the 15th European Epilepsy Congress in Rome and a poster on MDD at the Psych Congress in Boston. The company continues to support the Phase 2 proof-of-concept study of azetukalner in MDD led by the Icahn School of Medicine at Mount Sinai, expecting patient enrollment to complete this quarter.

In early-stage pipeline developments, Xenon is advancing multiple therapeutic candidates targeting Kv7, Nav1.7, and Nav1.1 across various indications, with the goal of filing multiple INDs in 2025. The company has nominated several Kv7 candidates, with a lead candidate in IND-enabling studies. Kv7 may be beneficial in treating seizures, pain, and neuropsychiatric disorders like MDD. A lead Nav1.7 candidate is expected to enter IND-enabling studies soon, targeting pain management without the limitations of opioids. Additionally, a lead Nav1.1 candidate may address the underlying cause and symptoms of Dravet Syndrome based on promising pre-clinical data.

Xenon's collaboration with Neurocrine Biosciences includes a Phase 2 clinical trial evaluating NBI-921352 (formerly XEN901) for orphan pediatric epilepsy (SCN8A-DEE). Another Nav1.2/1.6 inhibitor candidate is in IND-enabling studies, aiming for human clinical trials in 2025.

Financially, Xenon reported cash and cash equivalents of $850.6 million as of June 30, 2024, compared to $930.9 million at the end of 2023. This funding is expected to support operations into 2027. Research and development expenses increased to $49.7 million for the quarter, up from $44.0 million in the same period of 2023, primarily due to pre-clinical and discovery programs and increased personnel costs. General and administrative expenses also rose to $19.4 million, driven by higher personnel-related costs and consulting fees. Net loss for the quarter was $57.9 million, compared to $47.5 million in the previous year.

Xenon Pharmaceuticals continues to advance its robust pipeline, driven by innovative research and strong financial backing. With several key milestones on the horizon, the company is well-positioned to make significant contributions to the treatment of neurological and psychiatric disorders.

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