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5/9/2024
Thank you for standing by. My name is Liz and I'll be your conference operator today. At this time, I'd like to welcome everyone to the first quarter 2024 Zen and Pharmaceuticals Incorporated Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker remarks, there will be a question and answer session. If you'd 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, please press star one again. Thank you. I'd now like to turn the call over to Chad Bejerre, BP Investor Relations. Please go ahead.
Thank you, operator, and good afternoon. Thank you for joining us on our call and webcast to discuss Xenon's first quarter 2024 financial and operating results. Joining me today are Ian Mortimer, Xenon's President and Chief Executive Officer, Dr. Chris Kenney, Xenon's Chief Medical Officer, Dr. Chris Von Segern, Xenon's Chief Commercial Officer, and Sherry Olin, Xenon's Chief Financial Officer. Ian will begin with a summary of our recent progress. Chris Kenney will provide an overview of our ongoing clinical stage programs, including our plans in Major Depressive Disorder, or MDD. Chris Von Segern will summarize key findings from recently completed market research. And Sherry Olin will close with a summary of our financial results and anticipated milestone event before opening the call up to your questions. 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, and current and anticipated indication, addressable market, regulatory success, and commercial potential of our and our partners' product candidates, the efficacy of our clinical trial design, our ability to successfully develop and achieve milestones in our clinical development programs, the timing and results of our interactions with regulators, our ability to successfully develop and obtain regulatory approvals, anticipated enrollment in our clinical trials and the timing thereof, and our expectation that we will have sufficient CAS to fund operations in the 2027. Today's press release summarizing Xenon's first quarter 2024 financial results and the accompanying quarterly report on Form 10Q will be made available under the investor section of our website at xenon-pharma.com and filed with the SEC and on CEDAR+. Now, I would like to turn the call over to Ian.
Ian? Thank you, Chad, and good afternoon, everyone, and thanks for joining us on our call today. Before I provide an update on our pipeline, I'm excited to announce that we have received approvals from the United States Adopted Names, or USAN Council, and the World Health Organization International Non-Proprietary Names, or INN, expert committee for the use of ezetucalner as the non-proprietary or generic name for XEN1101. Notably, the calner suffix refers to the molecule's novel KV7 mechanism of action. If ultimately approved for use in patients, ezetucalner would become the first medicine with a calner suffix to be launched commercially. This is an important milestone for Xenon and represents another step forward as we advance ezetucalner towards commercialization. Moving now to our pipeline, this past quarter we continued to make strong progress. Our team remains focused on three key areas. Number one, the continued execution of our AZETU calendar phase three epilepsy program. Number two, the expansion of AZETU calendar beyond epilepsy with our MDD program. And three, the continued advancement of our discovery portfolio. First, in our epilepsy program, patient enrollment continues to progress in our XTOL2 and XTOL3 clinical trials in focal onset seizures, or FOS. and our exact clinical trial in primary generalized tonic-clonic seizures, or PGTCS. We continue to anticipate the patient enrollment for the first of these trials, XTOL2, will complete in late 2024 to early 2025. Second, we made important advancements in our IZETU calendar MDD program over this past quarter, including reaching alignment with the FDA through end-to-phase two interactions on key components of our phase three program which we look forward to initiating in the second half of this year. We are also continuing to evaluate additional opportunities for Zetucalner, focusing specifically on other potential neuropsychiatric indications, where a scientific rationale exists, as well as a commercial fit with epilepsy and MDD. Later in the call, Chris Kenney will provide additional details on next steps in our MDD program. And third, we are continuing to progress our early stage discovery efforts as a reminder is that you calendar is the most clinically validated and advanced therapeutic and development across multiple indications. And we see the mechanism is having broad potential applicability. The breadth and depth of potential therapeutic indications for the mechanism provides a compelling strategic rationale for the development of additional KV7 product candidates that are chemically diverse from azetucaliner and could provide additional development opportunities. For that reason, we are excited to continue to leverage our ion channel expertise with the goal of progressing multiple KV7 molecules forward into clinical development in order to extend the reach of this promising and differentiated mechanism to more patients in need. Beyond our robust potassium channel development efforts, we continue to evaluate and advance development candidates targeting sodium channels, including NAV1.1 and NAV1.7, which may have utility in treating seizure disorders and pain, respectively. We expect multiple candidates to move through GLP toxicology studies and into clinical development over the next few years. During the first quarter, we also continued our outreach efforts to key opinion leaders and leading physicians. At the recent annual meeting of the American Academy of Neurology, or AAN, we hosted two oral presentations related to our X-Toll Epilepsy Program. And we engage with neurologists and epileptologists who continue to express significant excitement about Zetucalner's unique and compelling profile in both epilepsy and MDD. We look forward to continuing to showcase Zetucalner at upcoming medical conferences throughout the remainder of this year. And Chris will note some of the near-term conferences where Xenon will have a presence. So we're off to a great start to the year, and I'm proud of the continued progress across Xenon's pipeline, including both clinical and preclinical efforts. So now I'll turn the call over to Chris Kenney, who will provide some additional details on the progress within our ZETU calendar clinical programs. Chris, over to you.
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