Xenon Pharmaceuticals Inc.

Good day, ladies and gentlemen, and welcome to the Q2 2021 Xenon Pharmaceuticals, Inc. Earnings Conference Call. At this time, all participants are in the listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. O.D. rates. Thank you. Please go ahead.

Thank you. Good afternoon. Thanks for joining us on our call and webcast to discuss our second quarter 2021 financial and operating results. Joining me on today's call are Ian Mortimer, Xenon's President and Chief Executive Officer, Simon Pinstone, Executive Chair of Xenon's Board, Sherry Ollen, Xenon's Chief Financial Officer, and Chris Von Seggern, Xenon's Chief Commercial Officer. Please be advised that during this call, we will make a number of statements that are forward-looking, including statements regarding the anticipated impact and timing of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, the timing of and results from clinical trials and preclinical development activities of our proprietary and partnered product candidates, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our proprietary and partnered product candidates, the anticipated timing of IND or IND equivalent submissions, and the initiation of future clinical trials for our proprietary products and those related to our other partnered candidates, the efficacy of our clinical trial designs, our ability to successfully develop our proprietary development program, the timing and results of our and our collaborators' interactions with regulators, the timing and anticipated enrollment in our clinical trials, the potential receipt of milestone payments and royalties from our collaborators, our expectation of having sufficient cash to fund operations into 2023, and the timing of potential publication or presentation of future clinical data. Four of the 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 Zenon's second quarter 2021 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 non-FEDAR. Now, I would like to turn the call over to Ian.

Jody, and good afternoon, everyone, and thanks for joining us today. We continue to make strong progress across our portfolio of proprietary and partnered neurology-focused therapeutic programs. Importantly, we remain on track to report top-line data from our XCN 1101 Phase IIb XTOL study in late September to mid-October. In anticipation of this important milestone, we will focus the majority of our attention on XCN 1101 today. I will, however, begin with a brief overview of the rest of our proprietary and partner programs. I'll then ask Simon to provide an update on our XCN 1101 XTOL clinical trial, and then I'll provide some commentary on the study design and statistical assumptions. And Chris will provide an overview of the work we've done on the commercial assessment of XEN 1101 and where XEN 1101 could fit into the treatment of adult focal epilepsy. Sherry will provide a financial update, and then we'll open the call up for your questions. So I'll start with an update on our non-XEN 1101 programs and partnered assets. Briefly, in our XEN 496 program, site initiation as well as patient identification and enrollment continue in our Phase III randomized double-blind placebo-control parallel group multicenter clinical trial called the EPIC study to evaluate the efficacy, safety, and tolerability of XCN496 in approximately 40 pediatric patients aged one month to less than six years with KCNQ2 developmental and epileptic encephalopathy. Based on its KV7 mechanism of action, as well as published physician case studies, we believe that XEN496 has the potential to address an important unmet medical need for these young patients. And we look forward to keeping you updated on the progress of the EPIC study. Patient enrollment also continues in the investigator-led phase two proof of concept study examining the potential clinical efficacy, safety, and tolerability of XEN007. as a treatment in pediatric patients diagnosed with treatment-resistant absence seizures. This study has enrolled different conditions with absence seizures, including Javan syndrome, childhood absence epilepsy, or CAE, and juvenile absence epilepsy, or JAE. Based on the initial data and promising signs of drug activity in three patients with CAE, which we presented at AES at the end of last year, the goal is to focus future enrollment on childhood and juvenile absence seizures. The lead investigator has also expanded the study to include an additional Canadian site which is currently screening patients and is also evaluating the addition of other sites. Additional results from a larger cohort are anticipated by the end of this year, which will help inform our decision regarding the future development of XEN007. In addition to the clinical progress, we have also recently received both orphan drug designation and rare pediatric designation for CAE, and these are important milestones for this program. Moving to our partnered programs, where we also expect important milestone events in 2021, Neurocrine Biosciences is anticipating the advancement of MBI 921352 into Phase II clinical development with two efficacy studies expected to initiate this year, one in adult focal seizures and second in patients older than 12 years of age with SCN8A developmental and epileptic encephalopathy. In addition, Flexion Therapeutics is expecting top-line results from its Phase 1B FX301 clinical trial in bunionectomy later this year. We look forward to keeping you updated on our collaborators' progress. So now let's turn our attention to XCN1101, which is a novel next-gen KV7 modulator being developed for the treatment of epilepsy and potentially other neurological disorders, where we're looking forward to our top-line data from our Phase IIb EXTOL clinical trial, expected in late September to mid-October. We are encouraged by the compelling product profile that is emerging for XEN1101. Last month, we hosted a webinar with two leading key opinion leaders in the epilepsy space to discuss the focal epilepsy landscape, the XTOL clinical trial, and the important attributes of XCN 1101 and its potential in the treatment of adult focal epilepsy. We also disclosed in our quarter today an update on our strategy to continue to expand the intellectual property protection of XCN 1101. We have recently received allowance of a U.S. patent application with claims directed to four distinct crystalline forms of XCN 1101. And any patent issued from this allowed application is expected to expire in 2040. In addition, we have a number of pending patent applications, which we believe will continue to provide added protection to XCN 1101. So overall, we're very pleased with the progress we've made on our XCN 1101 intellectual property portfolio. So at this point, I'd like to turn the call over to Simon, and he'll provide an overview of our clinical experience to date and the trial design of our Phase IIb EXTL study and what we can expect in our top-line data press release. Simon?