Xenon Pharmaceuticals Inc.

Good day, thank you for standing by, and welcome to today's Xenon Pharmaceuticals Reports First Quarter Results Call 2022. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during that session, you will need to press star 1 on your telephone keypad. If you require any further assistance, please press star zero. Thank you. I would now like to hand the conference over to your speaker today, Ms. Sherry Olin, Chief Financial Officer of Zenon Pharmaceuticals. The floor is yours.

Thank you. Good afternoon, everyone. Thank you for joining us on our call and webcast to discuss Zenon's first quarter 2022 financial and operating results. Joining me are Ian Mortimer, Xenon's President and Chief Executive Officer, Dr. Chris Kenney, Xenon's Chief Medical Officer, and Dr. Chris Von Segern, 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 our and our collaborators' development plans, anticipated regulatory interactions and submissions, anticipated results and realistic timelines. the potential efficacy, safety profile, addressable market, and commercial potential of our proprietary and partnered 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 at least 2024, 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 statements. Today's press release summarizing Xenon's first 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.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. Thanks for joining our call. Today, I will provide a high-level update on our proprietary pipeline programs, And then I'll turn the call over to Chris Kenney, who will provide additional color around the new developments and next steps within our XCN 1101 program, including the newly initiated XCN 1101 Phase II clinical trial in major depressive disorder, or MDD. Sherry will conclude our call by providing an update on our partner programs and briefly summarizing our financial results and anticipated key milestone events ahead. Chris Von Sageren is also on the call to provide his perspective during the Q&A session. Within our own proprietary pipeline, we continue to support our ongoing XEN496 Phase III EPIC pediatric clinical trial, which is a randomized double-blind placebo-controlled parallel group clinical trial evaluating the efficacy, safety, and tolerability of XEN496 in approximately 40 pediatric patients aged one month to less than six years with KCNQ2-DEE. Based on published physician case studies with azogabine and its KV7 mechanism of action, We believe that XEN496 has the potential to address an important unmet medical need. We continue to receive encouraging feedback from clinicians, caregivers, and patient advocates on our XEN496 program, including most recently at the Pediatric Academic Societies Conference in Denver. There is significant interest in the opportunity to provide a precision medicine which has the potential to positively impact the lives of these young patients. We continue to build momentum with new sites and jurisdictions coming on board, and we expect to complete the XEN496 EPIC Phase III clinical trial in 2023. Turning now to our XEN1101 program, we have made significant progress advancing XEN1101 into a broad clinical development program in both epilepsy and depression. Building on our top-line Phase IIb XTOL results in adult focal epilepsy from last fall, we continue to accrue compelling evidence from various subgroup analyses of the XTOL data and in-term safety and efficacy data from the ongoing XTOL Open Label Extension Study, or OLE. Most recently, at ASCENT 2022, the annual meeting hosted by the American Society for Experimental Neurotherapeutics we presented additional data showing that XEN 1101 has demonstrated substantial efficacy in a difficult-to-treat patient population with even more impressive efficacy in subgroup analyses of patients with less severe disease. Later this year, we expect to be in a position to share additional XEN 1101 XTOL data, both from additional subgroup analyses, including a time course to efficacy analysis, as well as data from the ongoing XTOL OLE. As we analyze additional XCN 1101 data, our confidence continues to grow based on robust, compelling, and consistent data across seizure reduction endpoints and subgroups and in the OLE, indicating that XCN 1101 could play a key role in treating adult patients with focal epilepsy. We are excited to be able to share additional data augmenting the already impressive profile of XCN 1101. In addition to its robust efficacy, the tolerability profile of XCN1101 is consistent with an active CNS drug, and its AE profile is in line with other anti-seizure medications. XCN1101 also presents other differentiating attributes, including its only-in-class potassium channel mechanism and a dosing regimen of one pill once a day with no titration required. Our team is excited to continue to advance this program and has made considerable progress over the last quarter. We have finalized the proposed trial designs for our two Phase III clinical trials, along with completing CRO vendor selection. Our end of Phase II meeting with the U.S. FDA taking place this quarter also marks an important milestone. We look forward to providing an update from this important regulatory interaction after we receive written FDA minutes. In addition, we anticipate providing further details around the potential expansion into another epilepsy-related indication in the coming months. We have also made great progress in our work examining indications outside of epilepsy. We are excited that our Xenon-sponsored Phase 2 clinical trial, which we are calling ExNova, is now underway to assess if ExCN 1101 improves depressive symptoms in patients with MDD and anhedonia. In addition, the investigator-led Phase 2 MDD study with our collaborators at Mount Sinai continues to progress. So in summary, this was an incredibly exciting time at Zenon, with a number of mid- and late-stage clinical trials ongoing and more on the horizon. On behalf of the entire team, we look forward to keeping you posted on our progress. So I'll pause here and ask Chris Kenney to provide some more details on Exnova and other developments within our clinical programs. Chris?