Xenon Pharmaceuticals Inc.

Well, thank you for standing by and welcome to Xenon Pharmaceuticals Incorporated third quarter 2023 earnings conference call. I would now like to turn the call over to Sherry Olin, our CFO. We now begin the conference.

Thank you. Good afternoon, everyone. Thank you for joining us on our call and webcast to discuss Xenon's third quarter 2023 financial and operating results. Joining me are Ian Mortimer, Xenon's President and Chief Executive Officer, Dr. Chris Kenney, Xenon's Chief Medical Officer, and Dr. Chris Von Segern, Xenon's Chief Commercial Officer. Ian will open today's call with a summary of our progress. Chris Kenney will provide an overview of our ongoing XTN 1101 clinical programs, and Chris Von Segern will summarize key findings from our market research around the potential of 1101 in major depressive disorder, or MDD, treatment landscape. I will summarize our financial results, progress within our partnered programs, and anticipated company milestone events before opening the call to your questions. Please be advised that during this call, we will make a number of statements that are forward-looking, including statements regarding the timing of and potential results from our and our collaborators' clinical trials, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our and our partners' product candidates, the efficacy of our clinical trial designs, our ability to successfully develop and achieve milestones in our XTN 1101 and other development programs, the timing and results of our interactions with regulators, our ability to successfully develop and obtain regulatory approval of XTN 1101 and our other product candidates, anticipated enrollment in our clinical trials and the timing thereof, and our expectation that we will have sufficient cash to fund operations into 2026. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected on today's call. We undertake no obligation to publicly update any forward-looking statements. Today's press release summarizing Xenon's third quarter financial results. And the accompanying report on Form 10-Q will be made available under the investor section of our website at www.zenon-pharma.com and filed with the SEC and on CDAR. Now I'd like to turn the call over to Ian.

Thanks, Sherry, and good afternoon, everyone, and thanks for joining our call today. I'm excited to share with you the progress that we have made this past quarter across our neurology pipeline. To begin, we remain confident in our ability to execute on our ambitious XCN 1101 Phase III program, and this includes our XTOL II and XTOL III clinical trials in patients with focal onset seizures, or FOS, and our exact clinical trial in patients with primary generalized tonic-clonic seizures, or PGTCS. We believe our experience with our Phase IIb XTOL study which was similar in design to our ongoing XTOL-2 and XTOL-3 trials, provides us with a solid foundation of operational experience and strong existing relationships with leading clinical investigators in the epilepsy space. As a reminder, we aligned with FDA on key elements of our Phase III program, including plans to submit an NDA upon the successful completion of XTOL-2, our first XEN-1101 Phase III clinical trial. along with the existing data package from our Phase 2b XTOL clinical trial and additional safety data from other clinical trials to meet regulatory requirements. In XTOL, we screened patients over a period of 26 months, from the first quarter of 2019 through the first quarter of 2021. And in XTOL 2, we initiated our first clinical site late last year, with our first patient being randomized in Q1 of this year. And we expect patient enrollment to complete in the second half of 2024. So this would be in line or faster than XTOL based on our current assumptions and expectations. And as a reminder, XTOL 2 will recruit more patients than XTOL. So overall, we are pleased with the progress our team has made so far this year. In addition to ongoing execution in our phase three epilepsy program, we also continue to showcase XCN 1101 and connect with leading epileptologists and neurologists, including at the 35th International Epilepsy Congress, or IEC, that took place in Dublin in early September. We presented data from the ongoing open-label extension study from our Phase IIb EXTOL trial, showing the long-term efficacy of Exxon 1101 as demonstrated by patients experiencing continued seizure reduction during the OLE and extended periods of seizure freedom and this is translating into overall improvements in patients' quality of life. Chris Kenney will provide some more details around the significance of these findings later in the call today. We are also pleased to report that the peer-reviewed results from our Phase IIb EXTOL study of ExCN 1101 in adults with focal epilepsy were recently published in the prestigious JAMA Neurology Journal. Turning now to our program in major depressive disorder, We remain on track to see top line results from our XCN 1101 Phase II Ex Nova study in late November to mid-December. Given the high unmet need in MDD and the fact that depression is the most common comorbidity in epilepsy, we are keenly interested in these data. In September, we hosted a well-received webinar with leading MDD clinicians, Dr. James Murrow and Dr. Sanjay Mathew. who provided their commentary on the mechanistic rationale supporting potassium channel modulation as a potential treatment for MDD. Before turning the call over to Chris Kenney, I would also like to remind everyone that we have planned for a significant presence at the annual American Epilepsy Society meeting, or AES, next month with multiple posters and presentations alongside our booth and scientific exhibits. And so for those of you who are planning to attend, we look forward to connecting with you in Orlando next month. So I'll now pass the call over to Chris. Chris?