Xenon Pharmaceuticals reports Q1 EPS (62c), consensus (66c)

Reports cash and cash equivalents and marketable securities were $885.4 M as of March 31 compared to $930.9M as of December 31, 2023. Based on current operating plans, including the completion of the azetukalner Phase 3 epilepsy studies and fully supporting late-stage clinical development of azetukalner in MDD, Xenon anticipates having sufficient cash to fund operations into 2027. As of March 31 there were 75,459,681 common shares and 2,173,081 pre-funded warrants outstanding. Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “I am excited to announce that we have received approval for the use of ‘azetukalner’ as the nonproprietary, or generic, name for XEN1101, recognizing its novel Kv7 mechanism of action. This is an important milestone for Xenon, representing another step forward as we advance azetukalner towards commercialization.” Mortimer continued, “We have made significant advancements in our azetukalner MDD program over this past quarter, including reaching alignment with the FDA on key features of our Phase 3 program. Supported by the data generated from our Phase 2 proof-of-concept X-NOVA clinical trial demonstrating clinically meaningful drug activity in depression, we believe azetukalner has the potential to offer a differentiated and competitive profile in MDD based on its unique mechanism of action and a potential benefit on anhedonia, a key co-morbidity of depression. We look forward to initiating our Phase 3 program in the second half of this year, with the goal of potentially providing a new therapeutic option to address the unmet medical need that remains in major depressive disorder.” Mr. Mortimer added, “We recently hosted two oral presentations at the American Academy of Neurology annual meeting where we were met with neurologists and epileptologists who continue to express significant excitement about the unique mechanism of azetukalner and the compelling clinical data we have generated to date in both epilepsy and MDD. We look forward to continuing to showcase azetukalner at medical conferences throughout the remainder of this year.”