Xenon Pharmaceuticals Inc.

and welcome to the Xenon Pharmaceuticals reports second quarter results 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. If you would like to withdraw your question, again, press the star one. Thank you. Sherry Ahlen, Chief Financial Officer, you may begin your conference.

Thank you. Good afternoon, everyone. Thank you for joining us on our call and webcast to discuss Zenon's second 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, Zenon'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 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 partner product candidates, the efficacy of our clinical 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 Xenon's second quarter 2022 financial results and the accompanying quarterly report on Form 10-Q 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, Sherry. Good afternoon, everyone, and thanks for joining our call. I'll start today's call with a high-level summary of our recent progress. I'll then turn the call over to Chris Kenney, who will provide additional color around our XEN 1101 and the Phase 2 meeting with the FDA and our next steps within our Phase 3 program, including our expansion into the additional epilepsy indication of primary generalized tonic-clonic seizures, or PGTCS. Chris will also provide his perspective on the additional XTOL data, which we recently released. Chris Von Sagan will then share some market research insights shaping our clinical plans in PGTCS, and the commercial opportunity for developing XEN 1101 within this indication, where there remains a significant unmet medical need. Sherry will conclude our call by briefly summarizing our partner programs, financial results, and events ahead. We look forward to taking your questions during the Q&A session at the end of the call. I am pleased to report several important achievements within our XEN 1101 program this past quarter, along with continued progress across the rest of our pipeline. Within XCN 1101, the clinical data generated to date, along with feedback from KOLs and primary market research findings, support our belief that XCN 1101 could play a particularly important role in treating epilepsy. With a differentiated profile and desirable attributes, such as an only-in-class potassium channel mechanism, and a dosing regimen of one pill once a day with no titration, providing meaningful seizure reduction after only one week of dosing. In addition to its robust efficacy in focal onset seizures, the XCN1101-AE profile is in line with other anti-seizure medications. Following a positive end of Phase II meeting with the FDA, we're excited to advance our XCN1101 Phase III program, starting with the initiation of XTOL-2 in the second half of this year. Additionally, we have strong scientific rationale supporting the use of XCN1101 to address primary generalized tonic-clonic seizures and we're looking forward to initiating our Phase 3 exact clinical trial in PGTCS. Ultimately, our goal is to deliver a new, differentiated therapeutic option for a broad population of epilepsy patients. Our team recently completed additional analyses of efficacy data from our Phase 2 BXTOL trial, and these further support our Phase 3 development plans for XEN1101. including a time course to efficacy analysis demonstrating that all doses of XCN1101 rapidly reduced the frequency of focal onset seizures within one week compared to placebo. Chris Kenney will provide some more details on these data, as well as our first cut of open-label extension efficacy data from EXTEL and our Phase III plan. In addition, our Phase II ex-nova study is underway examining XCN1101 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 XCN1101 in MDD was based in part on promising clinical results with izogabine, dose 300 milligrams TID, as a treatment for MDD and anhedonia, as well as encouraging preclinical data with XCN1101. It is also important to note that depression is one of the most common comorbidities within the epilepsy patient population. Popline results from the Ex Nova study are anticipated in 2023. Turning to another program within our proprietary pipeline, we continue to support our ongoing XCN496 Phase III EPIC pediatric clinical trial evaluating XCN496 in patients aged one month to less than six years with KCNQ2-DEE. There is significant interest from caregivers and physicians to provide a precision medicine to address this important unmet medical need, which has the potential to positively impact the lives of these young patients. Our clinical development plans are supported by published physician case studies with azogabing and XEN496's KV7 mechanism of action. We expect completion of EPIC in 2023. So overall, we continue to make meaningful progress across the pipeline, and we're excited to move XTN 1101 into a broad phase three program in the near term. So I'll pause here and ask Chris Kenney to provide some more detailed comments on our end of phase two meeting with FDA, our phase three clinical trial designs, as well as some additional supporting data from XTOL and the XTOL OLE, which continues to support our high level of confidence and conviction in our XTN 1101 program. Chris, over to you.