Xenon Pharmaceuticals Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Q4 2022 Zenon Pharmaceuticals, Inc. Earnings Conference call. I would now like to turn the call over to Sherry Olin, CFO. Please go ahead.

Good afternoon. Thank you for joining us on our call and webcast to discuss Zenon's fourth quarter and full year 2022 financial and operating results. Joining me are Ian Mortimer, Zenon'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 progress across our pipeline. Chris Kenney will provide an overview of our XEN 1101 Phase 3 Epilepsy Program, as well as a brief summary of additional supporting XTOL data we released in December, and I will summarize our 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 about our commercialization strategies. 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 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 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 statement. Today's press release summarizing Zenon's fourth quarter and full year 2022 financial results and the accompanying annual report on Form 10-K 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, Sherri. Good afternoon, everyone, and thanks for joining us on our call today. As I reflect on our progress in 2022, I'm extremely proud of reaching a number of key milestone events for Xenon and building significant momentum in our XEN-1101 program. In particular, we had a successful end of phase two meeting with FDA and gained alignment on our XEN-1101 phase three program, as well as the key regulatory elements required for an NDA submission. This was followed by another critical milestone in Q4 with the initiation of our first XEN-1101 phase three epilepsy trial. Furthermore, throughout 2022, we presented additional XCN 1101 clinical data from XTOL and from the XTOL Open Label Extension, supporting our continued confidence in what we believe is a compelling profile for XCN 1101, including a novel mechanism of action and what we believe would be the only potassium channel modulator available on the market if approved. Efficacy data generated in our Phase 2b XTOL trial, which demonstrated statistically significant reduction in all seizure reduction endpoints at all doses tested. QD dosing requiring no titration supporting early onset and statistically significant efficacy at week one. And even greater seizure reduction in the open label extension with greater periods of seizure freedom. Overall, we believe our XEN 1101 efficacy data to date compares favorably to medicines currently available for focal onset epilepsy patients. Our market research strongly suggests that prescribing physicians are seeking new, differentiated therapeutic options that approve upon the existing anti-seizure medications, and we remain committed to improving the lives of patients with epilepsy. We entered 2023 in an enviable and clear leadership position in the KV field. with XCN 1101 in a broad phase three program supported by our clinical development and existing cash resources required to execute on our ambitious plan. This year, we are sharply focused on advancing XCN 1101 in our Phase III XTOL II and XTOL III clinical trials and focal onset seizures, while in parallel evaluating the efficacy of XCN 1101 in primary generalized tonic-clonic seizures, or PGTCS, in our Phase III exact clinical trial, as well as generating important data from our Phase II X-NOVA study in major depressive disorder. Later in the call today, Chris Kenny will outline some of the highlights of the data we presented at AES 2022 in December that continue to support our belief in XCN 1101's highly promising product profile. We have recently received some questions about the slower than anticipated patient enrollment and other headwinds faced by company sponsors of other clinical trials, including studies ongoing in focal onset epilepsy. Although we acknowledge that the current environment for clinical development can still be challenging, we remain confident in our ability to execute on our XCN 1101 Phase 3 program. This high level of confidence is based on our experience with our XTOL Phase 2b study, which was similar in size to our Phase 3 FOS studies, along with our continued relationships with key investigators, many of whom already have familiarity and experience with XCN 1101. Given that we are still in the initial stages of our Phase 3 trials, we have not yet given specific guidance on enrollment or timing of top-line data. However, in terms of site initiation and patient screening, we are tracking as expected and consistent with our development plan. Turning briefly to our ongoing Phase 2 Ex Nova clinical trial, you will recall that this study is examining XCN1101 in major depressive disorder. in parallel with an investigator-led Phase II MDD study being conducted by our collaborators at Mount Sinai. Our decision to examine XCN1101 in MDD was based on encouraging published clinical results via evaluated izogabine at a 300 milligram TID dose as a treatment for MDD and anhedonia, as well as promising preclinical data with XCN1101. It is also important to note that depression is a common comorbidity within the epilepsy patient population. We are anticipating top line results from our ex nova study in the third quarter of this year, and this will help guide our future plans for XCN 1101 and MDD. While I am proud of the great progress made by our team in 2022, we are determined to continue to build upon the momentum generated in our XCN 1101 program And we look forward to additional clinical inflection points in 2023. I'll now ask Chris to provide some more detailed comments on our XEN 1101 Phase III Epilepsy Program and additional supportive data that we have generated. Chris, over to you.