Xenon Pharmaceuticals Inc.

Thank you for standing by. At this time, I would like to welcome everyone to Xenon Pharmaceutical's second quarter 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. I will now turn the conference over to Chad Fugger. You may begin.

Good afternoon. Thank you for joining us in our call and webcast to discuss Zinon's second quarter 2025 financial and operating results. Joining me are Ian Mortimer, Zinon's president and chief executive officer, Dr. Chris Kenney, Zinon's chief medical officer, and Darren Klein, Zinon's chief commercial officer. After completing their prepared remarks today, we will open the call up for 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 potential results from clinical trials, the potential efficacy, basic profile, future development plans, and current and anticipated indication, 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 clinical development program, including the anticipated filing of INDs and NDAs, the timing and results of those filings, and our interactions with regulators, and our ability to successfully obtain regulatory approvals, anticipated timing of the top-line data readout for our clinical trials at the Zetu calendar, and our expectation that we will have sufficient cash to fund operations in the 2027. Today's press release summarizing Xenon's second quarter financial results and the accompanying quarterly report on Form 10Q will be made available under the investor section of our website at xenon-foreman.com and filed with the SEC and on CEDAR+. Now, I would like to turn the call over to Ian.

Thank you, Chad, and good afternoon, everyone, and thanks for joining our call today. We are excited to share a number of advancements across our pipeline as we have made significant progress over the past quarter. As we reflect on the first half of 2025, we continue to advance against our key strategic priorities. Number one, driving towards phase three data, NDA submission, and commercializing IZETU calendar for the treatment of focal onset seizures in the U.S. Number two, broadening the IZETU calendar opportunity across additional epilepsy and neuropsychiatric indications. And number three, expanding our product portfolio through the advancement of our promising earlier stage ion channel programs. Today, we will cover details and milestones relating to these exciting program advancements and momentum we have going into the second half of 2025. I will begin with a brief review of highlights from this past quarter, starting with our most advanced EzetuCalendar phase three clinical trial, XTOL2. As disclosed in today's press release, we have completed patient recruitment in XTOL2. This is a significant milestone in the development of Azetucalner and keeps us tracking to report top line results early in 2026 in anticipation for our first approval and commercial product as a company. We plan to refine our guidance for the timing of top line results after the last patients are randomized. We remain highly encouraged by the potential of Azetucalner to deliver on the promise of a new anti-seizure medication with a differentiated product profile to what is available today. And this could benefit people living with the debilitating effects of uncontrolled seizures. From the outset, we have prioritized working with high-quality, experienced sites to maximize study success while diligently monitoring key metrics throughout the study. As discussed on previous calls, we are pleased that these metrics align consistently with our successful XTOL study and continue to have confidence in XTOL2 and share the epilepsy community's excitement as we progress towards Phase 3 readout. It's this excitement that drives our scientific leadership and investment in the KV7 landscape. Zetucalner is the only KV7 channel opener and the only ASM in development that is backed by long-term efficacy and safety data from clinical studies of patients living with epilepsy. having demonstrated highly compelling placebo-adjusted efficacy in focal onset seizure patients in our Phase IIb trial, and durable and sustained efficacy over time through our open-label extension study, and approximately 800 patient years of exposure and safety data. There remains a substantial need for new, efficacious, and well-tolerated epilepsy therapies, especially for those patients who continue to experience the debilitating impacts of focal seizures even while taking multiple anti-seizure medications and we believe that azetucalynar's key attributes as seen to date demonstrate its potential to provide an important new option for the epilepsy community we consistently hear positive feedback and excitement within the medical community about azetucalynar's compelling value proposition which includes a novel mechanism rapid onset of effect, robust efficacy, and multiple ease of use attributes, including once daily dosing, no required titration, along with a potential mood benefit. Is that your calendar has the potential to be a best in class anti-seizure medication that offers significant and meaningful benefits in the future treatment of epilepsy. Chris will touch on more detail shortly as to our continued work with investigators and anticipation building in the field. In addition, we believe there is significant potential for azetucaliner beyond epilepsy, with initial focus on depression. Within our phase three MDD program, we have now initiated ExNova3, which is the second of three planned studies of azetucaliner in major depressive disorder. Also during the quarter, we initiated the first of two planned phase three studies in bipolar depression one and two, called the EXCEED study. We continue to execute as planned to expand the clinical development of azetucounter into indications and invest in our neuropsychiatric programs. This is a good time to turn the call over to Chris, who will share more details on our late-stage clinical development programs. I'll then provide an overview of our early-stage pipeline programs, as well as conclude with a summary of key milestones ahead. Chris, over to you.