Xenon Pharmaceuticals Inc.

Good day, and thank you for standing by. Welcome to the Q3 2022 Zenon Pharmaceuticals, Inc. Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sherry Allens, Chief Financial Officer. Please go ahead.

Thank you, and good afternoon, everyone. Thank you for joining us on our call and webcast to discuss Zenon's third quarter 2022 financial and operating results. Joining me are Ian Mortimer, Zenon's President and Chief Executive Officer, Dr. Chris Kenney, Zenon's Chief Medical Officer, and Dr. Chris von Segern, Xenon's Chief Commercial Officer. Ian will open today's call with a summary of progress across our pipeline. Chris Kenny will provide additional detail around our recently launched XEN 1101 Phase 3 program, and I will summarize this quarter's financial results, progress within our partnered programs, and our anticipated company milestone events. Chris von Segern will be available during our Q&A session to address questions around our commercialization strategies. Please be advised that during this call, we will make a number of statements that are forward-looking, including statements regarding our and our collaborators' development plans, anticipated regulatory interactions and submissions, anticipated results and related timelines, the potential efficacy, safety profile, addressable market, and commercial potential of our proprietary and partnered product candidates, the efficacy of our trial designs, and anticipated enrollment, the potential receipt of milestone payments and royalties from our collaborators, our expectation of having sufficient cash to fund operations into 2026, and the timing of potential release of future clinical data. 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 statement. Today's press release summarizing Zenon's third quarter 2022 financial results and the accompanying quarterly report on Form 10Q 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 would like to turn the call over to Ian.

Thanks, Sherry. Good afternoon, everyone. Thanks for joining the call. I'm truly excited to open today's call with confirmation that we have launched our XCN 1101 phase 3 program, thereby continuing to build upon our leadership position in the KB field and driving our mission to provide new therapies for patients with epilepsy. The Xenon team is focused on executing on our ambitious development plans for XCN 1101. including our two Phase III clinical trials in focal onset seizures called XTOL-2 and XTOL-3, and a Phase III clinical trial in primary generalized tonic-clonic seizures called EXACT. These comprehensive Phase III plans build upon the foundation of the compelling data generated with XTN-1101 to date, including statistically significant reduction in every seizure reduction endpoint at all doses tested in XTOL, and even greater seizure reduction data in the open label extension with greater periods of seizure freedom. The adverse event profile of XCN1101 is consistent with other ASMs that are active in the CNS. These positive data, along with feedback from KOLs and primary research findings, support our firm belief that XCN1101 could play a significant role in treating epilepsy. In addition, XCN1101's differentiated profile includes a number of desirable attributes, such as an only-in-class potassium channel mechanism and a dosing regimen of once a day with no titration, while providing meaningful and statistically significant seizure reduction after only one week of dosing. Ultimately, our goal is to deliver a differentiated therapeutic option for the unmet needs within a broad population of epilepsy patients, and our progress over the past quarter has been significant. Turning now to our ongoing Phase II Ex Nova clinical trial, this study is examining ExCN 1101 in major depressive disorder, or MDD, in parallel with an investigator-led Phase II MDD study being conducted by our collaborators at Mount Sinai. Our decision to examine ExCN 1101 in MDD was based in part on promising clinical results with azogabine, dose 300 milligrams TID, as a treatment for MDD and anhedonia. as well as encouraging preclinical data with both Izogavine and XCN1101. It is also important to note that depression is the most common comorbidity within the epilepsy patient population. We have further refined our guidance with the expectation that we will receive top line results from the Ex Nova study in the third quarter of 2023, as we've made good progress on site initiation and patient enrollment to date. In addition to the clinical development activities supporting our robust XCN 1101 program, we continue to advance our ongoing XCN 496 Phase III EPIC pediatric clinical trial evaluating XCN 496 in patients with KCNQ2 developmental and epileptic encephalopathy, or KCNQ2DEE. These are patients who are one month to less than six years old in the study. As with other clinical trials examining orphan or ultra-rare indications, it's often a challenge to identify, screen, and enroll eligible patients. And while there is significant interest from parents, caregivers, and physicians to provide a precision medicine to this important unmet medical need, this is also a young and fragile patient population, which sometimes makes travel to clinical sites difficult. Taking into account these challenges around EPIC's enrollment rate to date, we've adjusted our expectations around the completion date of the study to 2024. Based on what we know about the KV7 mechanism of action and further supported by physician case studies with azogabine, we believe XCN496 has the potential to positively impact the lives of these young patients. Before turning the call over to Chris, I want to reiterate the immense amount of progress made across our pipeline in 2022, and I'm looking forward to additional clinical inflection points in 2023. I'll now ask Chris to provide some more detailed comments on our XCN1101 program, and multiple Phase III clinical trials. Chris?