This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
8/9/2023
and Chris Kenney will provide an overview of our ongoing Exeon 1101 clinical program. I will summarize our financial results, progress within our partner 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 Exxon 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 expectations 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 statements. Today's press release summarizing Zenon's second quarter financial results and the accompanying annual 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. Thanks for joining us on our call today. We are excited about the continued progress across all aspects of our business during the past quarter. To begin, I'm pleased to announce that patient enrollment is now complete in our XEN 1101 Phase 2 Ex Nova Study in Major Depressive Disorder, or MDD, and we expect the last patients to be randomized in the very near term. Based on the completion of screening, we estimate that more than 160 patients will be randomized. And just as a reminder, the original trial design was to randomize 150 patients, or 50 patients per arm, of 10 milligrams of XCN1101, 20 milligrams of XCN1101, or placebo. Additionally, we have now further narrowed our Q4 guidance and look forward to announcing ExNova top-line data in late November to mid-December. In advance of these results, we intend to host a webinar with key opinion leaders to review the MDD landscape, including findings from our own market research. We'll also discuss the mechanistic rationale supporting KV modulation as a treatment for MDD and review the key elements of our Ex Nova clinical trial. We are targeting mid-September for this webinar, and we'll issue a webcast advisory notice confirming our speakers and additional access details to ensure that you can all virtually attend and participate. We also continue to advance our broad XCN 1101 Phase III epilepsy program and strengthen our leadership position in the KV field, with XCN 1101 representing the only potassium channel opener in late-stage clinical development, with important de-risking clinical data generated from our XTOL Phase IIb clinical trial. All Phase III epilepsy clinical trials are actively recruiting patients, including XTOL II and XTOL III in patients with focal onset seizures, or FOS, and exact in patients with primary generalized tonic-clonic seizures, or PG-TCS. As noted on our last call, we continue to maintain a high degree of confidence in our ability to execute on our XCN 1101 Phase III epilepsy clinical development plans. We have the advantage of being able to draw upon our experience with our XTOL Phase IIb study, which was similar in size and design to both XTOL II and XTOL III. and the established strong relationships with key investigators who are already familiar with XCN 1101. We expect to provide guidance later this year regarding our estimated timing of study completions. In addition to our ongoing Phase III epilepsy program in adults, we also continue to execute on our strategy for the pediatric development plan for XCN 1101, based in part on feedback from FDA. Our team is conducting ongoing work on a pediatric formulation of XCN1101 for younger patients. In addition, the FDA's PK extrapolation rule for focal onset seizures allows us to move into cohorts with progressively younger patients with focal onset seizures with XCN1101 in an open-label setting over time. Finally, also driven by feedback from FDA, we're in the process of expanding the exact Phase III clinical trial to include patients as young as 12 years of age. Before I pass the call to Chris Kenney, I'd like to extend a warm welcome to Dr. Jillian Cannon and Mr. Justin Gover, the two newest appointments to our board of directors that were announced yesterday. Briefly, Jillian brings a vast knowledge of commercializing novel medicines and leading successful neuroscience franchises at large pharmaceutical companies. She's been involved in the commercial efforts of some of the most important epilepsy and depression drugs over the past decades. And many of you will be familiar with Justin as the founding CEO of GW Pharma. Justin and his team led the development and commercial launch of Epidiolex and the eventual sale of GW to Jazz Pharmaceuticals in 2021 for $7.2 billion. Justin has a deep understanding of what it takes to build companies like Xenon, and he's passionate about the epilepsy space. We are looking forward to leveraging the experience of both Jillian and Justin as we continue our efforts on the late-stage clinical development of Exxon 1101 prepare for commercialization, and progress towards achieving our strategic objective of building a leading, fully integrated neurology company. I'd now like to turn the call over to Chris Kenney, who will give additional details on the progress made across our clinical programs and provide a look ahead at some of the upcoming medical meetings where the Xenon team will have a strong presence. Chris will also discuss the significance of the additional XCN 1101 XTOL open label data that is focused on quality of life measures, which is to be presented at the upcoming International Epilepsy Congress in September. So, Chris, over to you.
Thanks a lot, Ian. Building upon Ian's comments, beginning first with our Ex Nova program in MDD, I'm looking forward to co-hosting a webinar in mid-September alongside key opinion leaders in the major depressive disorder space. We intend to focus our discussion on the potential for the KV7 mechanism to treat MDD and outline the importance of the rationale and trial design of our phase two Ex Nova study. Importantly, these top line data will help guide our future plans for XCN 1101 in MDD. You will recall that our initial decision to examine XCN 1101 in MDD was based on encouraging published clinical results with izogabine as well as promising preclinical data with XEN 1101. We were further interested in gathering additional data given that depression is a common comorbidity within the epilepsy patient population. With patient enrollment now complete, the last few patients are expected to be randomized in the very near term, which will then be followed by a six-week treatment period, a four-week follow-up visit, and then database lock and data analysis. Given these steps, we're looking forward to a top-line data readout for ExNova in late November to mid-December of this year. Turning to our Phase III epilepsy programs, as a brief reminder of the ongoing clinical trials within our robust Phase III program, our XTOL2 and XTOL3 clinical trials are running in parallel, with each study targeting enrollment of approximately 360 subjects with focal onset seizures. who will be randomized one-to-one-to-one for once-daily dosing of either 15 or 25 milligrams of Exxon 1101 or placebo. The primary efficacy endpoint is the median percent change, or MPC, in monthly seizure frequency from an eight-week baseline to the 12-week double-blind period with Exxon 1101 compared to placebo. Our phase three exact clinical trial is expected to enroll approximately 160 subjects with primary generalized tonic-clonic seizures. Subjects will be randomized one-to-one for once daily dosing of either 25 milligrams of XCN 1101 or placebo. The primary efficacy endpoint is the MPC and monthly PGTCS frequency from an eight-week baseline through the 12-week double-blind period of XCN 1101 compared to placebo. Of note, We believe we have a strong development rationale for PGTCS based on the KV7 mechanism and the photosensitivity proof-of-concept model of generalized epilepsy. Favorable data in multiple preclinical epilepsy models and the Phase IIb XTOL clinical data that looked at seizure subtypes, including those focal seizures that progressed to bilateral generalized seizures. Our unique parallel development approach in both focal onset seizures and primary generalized tonic-clonic seizures allows us to set the foundation for potentially broader use of Exxon 1101 in two of the most common forms of epilepsy should it be approved. As Ian mentioned, our team is excited to showcase Exxon 1101 at medical conferences later this year, including our presence at the upcoming 35th International Epilepsy Congress in Dublin, in September, where we have the opportunity to highlight new quality of life data from the ongoing XTOL Open Label Extension Study. We're excited to present these new data that focus on the QALY31 subscales of seizure worry, social functioning, and medication effects. Our analysis of these quality of life domains is important and can potentially provide us with insights around how drug tolerability, better seizure control, and improved seizure freedom rates positively affect patients' quality of life. Looking a bit further ahead at AES 2023 in Orlando this year, we expect to provide longer-term OLE data from XTOL, supporting the long-term use of Exxon 1101, as well as important seizure freedom data. We're excited to continue to raise the profile of Exxon 1101 with physicians and the medical community and look forward to keeping you updated on our progress. I will now turn the call over to Sherry, who will give us a brief update on our partnered program with Nurocrin before summarizing our first quarter financial results and upcoming milestones. Sherry?
You're reading a preview of the XENE Q2 2023 earnings call.
Free account.
