Xenon Pharmaceuticals Inc.

Good afternoon. My name is Jeannie and I will be your conference operator today. I would like to welcome you to the Q4 2023 Xenon Pharmaceuticals Inc. Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remark will be a question and answer session. If you would like to ask a question during that time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the conference over to Sherry Olin, Chief Financial Officer. You may begin your conference.

Good afternoon. Thank you for joining us on our call and webcast to discuss Zenon's fourth quarter and full year 2023 financial and operating results. Joining me today are Ian Mortimer, Zenon's President and Chief Executive Officer, Dr. Chris Kenney, Zenon's Chief Medical Officer, and Dr. Chris Von Segern, Zenon's Chief Commercial Officer. Ian will begin with a summary of our recent progress in areas of focus for 2024. Chris Kenney will provide an overview of our ongoing XCN 1101 clinical programs, including our plans in major depressive disorder, or MDD, and Chris Von Sageren will comment on key findings from our market research on the potential of XCN 1101 in the MDD treatment landscape. I will close with a summary of our financial results and anticipated milestone events, before opening the call up 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 XCN 1101 and other development programs, the timing and results of our interactions with regulators, our ability to successfully develop and obtain regulatory approval of XCN 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 2027. 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 Xenon's fourth quarter and full year 2023 financial results and the accompanying annual report on Form 10-K will be made available under the investor section of our website at www.xenon-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 us on our call today. We are proud of the significant progress made across our pipeline in 2023. including advancement of XEN-1101 in our broad Phase III epilepsy program, as well as strong execution in our Phase II ExNova clinical trial, which culminated in the release of top-line data in late November that demonstrated XEN-1101 to have clinically meaningful drug activity in patients with major depressive disorder, or MDD. In addition, we've made considerable progress in the maturity of our discovery portfolio, which I will expand upon in a moment. Our team has made excellent progress since the release of ExNova, which includes completing a capital raise in December to fully fund a broad Phase III program in MDD and setting a date for an end-to-Phase II meeting with the FDA in April. We have also taken meaningful steps towards designing our Phase III program and are committed to initiating the first of three planned Phase III clinical trials in the second half of this year. XCN 1101 is the most clinically validated and advanced KV7 therapeutic in development, across multiple indications, and we believe the mechanism may have broad applicability. This is reflected in our comprehensive strategy to pursue multiple indications with XCN 1101, while also advancing additional novel KV7 drug candidates. Our extensive know-how, developed over almost two decades in ion channel drug discovery, as well as our experience with potassium channels, positions us to maintain a leadership position in the KV7 space. And we plan to continue exploring the pipeline in a mechanism potential of XCN 1101 and earlier stage drug candidates. We've made strong progress in our KV7 preclinical program in 2023, including the identification of several promising product candidates. And we expect more than one candidate will be in IND enabling studies this year, and if successful, could enter first in human studies next year. Looking beyond our robust research and development efforts in the KV7 space, we are also advancing development candidates targeting sodium channels, including NAV1.1 and NAV1.7, which may have utility in treating seizure disorders and pain, respectively. We are uniquely positioned in developing molecules targeting NAV1.7, given the previous pioneering genetics research conducted by xenon scientists that suggests that this particular sodium channel is a key target for the development of novel analgesics. We have made considerable advancements in this program in 2023 and anticipate that multiple NAV 1.7 candidates could also enter IND-enabling studies over the next few years. The benefit of this program is the opportunity to generate important early de-risking human proof-of-concept data. So, the considerable progress made in 2023 puts us in a strong position as we enter this year where we have three key areas of focus. One, the continued execution on our Phase III epilepsy program with a specific focus on XTOL-2, as this is on the critical path to an NDA filing and potential approval for XCN 1101. Second, the expansion of XCN 1101 beyond epilepsy with our now planned Phase III program in MDD, while we continue to evaluate other clinical indications given XCN 1101's compelling profile. And third, the continued maturity of our discovery portfolio, with multiple molecules expected to move into human clinical development over the next few years. So in summary, with a strong balance sheet to support our robust clinical and preclinical plans, we are looking forward to advancing and growing our broad pipeline with the goal of improving outcomes for patients in areas of high unmet medical need. I'll now turn the call over to Chris Kenney, who will provide some more details on the progress within our XCN 1101 clinical program in both epilepsy and depression. Chris Von Segern will then provide an important summary of recently completed market research providing feedback from physicians in the depression space to underscore the promise we believe XCN 1101 has for broad therapeutic utility. So, Chris, over to you.