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8/6/2026
Ladies and gentlemen, thank you for standing by. My name is Angela and I will be your conference operator today. At this time, I would like to welcome everyone to the second quarter 2026 Xenon Pharmaceuticals Inc. earnings conference call. I'd like to remind everyone that this call is being recorded and that 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 in your telephone keypad to raise your hand and enter the queue. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Miss Colleen Alabiso, Senior Vice President of Corporate Affairs at Zenon Pharmaceuticals Inc. You may begin.
Good afternoon. Thank you for joining us on our call and webcast to discuss Phenom's second quarter 2026 financial and operating results. Joining me today are Ian Mortimer, President and Chief Executive Officer, Dr. Chris Kenney, Chief Medical Officer, Darren Cline, Chief Commercial Officer, and Tucker Kelly, Chief Financial Officer. After completing our prepared remarks today, we will open the call up for 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 in current and anticipated indications, addressable market, regulatory success, and commercial potential of our and our partners' product candidates. The strength of our clinical trial design, our ability to successfully develop and achieve milestones in our clinical development programs, including the anticipated filing of INDs or equivalents and NDAs, the timing and results of those filings and our interactions with regulators, our ability to successfully obtain regulatory approvals, Anticipated timing of top-line data readouts for our clinical trials of Azetje Kellner and other candidates, and our expectation that we will have sufficient cash to fund operations into 2029. Today's press release summarizing Xenon's second quarter financial results and the quarterly report on Form 10-Q will be made available under the Investor section of our website at xenon-pharma.com. and filed with the SEC and CDAR+. I'll now turn the call over to Ian.
Thanks, Colleen, and good afternoon to everyone joining us today. We're excited to recap another productive quarter for Xenon as we work toward our goal of becoming a fully integrated neuroscience company delivering life-changing medicines to patients. In the second quarter, we remain focused on three key areas. First, Preparing our new drug application for azetucalner, or AZK, for focal seizures, as well as sharing our exciting Phase 3 XTOL2 results with healthcare providers and preparing our go-to-market strategy. Second, advancing five additional Phase 3 studies of AZK in epilepsy and neuropsychiatry indications, which may help significantly expand the addressable patient population. And third, advancing and expanding our pain programs, including the Phase 1 studies of XEN1120 targeting KV7 and XEN1701 targeting NAV1.7, as well as initiating clinical development of an additional NAV1.7 molecule, XEN1720, demonstrating our belief in and the importance of this target. I'll provide a bit more detail of our recent achievements before passing the call over to Chris, Darren, and Tucker. First, we are making great progress towards submitting our NDA for AZK and preparing for launch. I'm happy to share that we've completed a successful pre-NDA meeting with the Food and Drug Administration, and we're on track for a submission later this quarter. We have continued to share our XTOL2 data with HCPs, including at two important meetings for the epilepsy community, first at the American Academy of Neurology meeting in April, where many of you will recall that the XTOL2 results were featured as a late-breaking science abstract and podium presentation. Then in June, we had another opportunity to present the top-line XTOL2 results at the Epilepsy Foundation Pipeline Conference. This is attended by HCPs, researchers, industry, and patient advocates. Beyond these congresses, our MSLs have been out in the community responding to HCP requests to learn more about our data. Overall, we continue to hear very positive feedback and excitement for both the XTOL2 results, including the best placebo-adjusted efficacy and FOS to our knowledge, and AZK's differentiated profile, including a novel mechanism of action, rapid onset of effect, once-daily dosing with no titration, and no need for dose adjustments with other ASMs. We feel increasingly confident in AZK's potential to become a preferred add-on therapy for the significant number of patients who do not achieve seizure freedom with initial treatment. Darren will share a bit more on the excitement from the epilepsy community later in the call, as well as the progress we continue to make on preparing for the launch of AZK. We also continue to focus on expanding the opportunity for a ZetuCalendar, including through the XTOL3 study in FLS to support potential regulatory submissions outside the U.S., As well as the exact study in primary generalized tonic-clonic seizures to support regulatory submissions for an additional epilepsy indication. Through our ongoing Phase III Ex Nova II, Ex Nova III, and Exceed studies, we continue to advance our work to broaden IZETU-Calendar's opportunity to neuropsychiatry. There is strong rationale for KV7 openers in major depressive disorder and bipolar depression, and ACK could deliver a novel mechanism where innovative treatments are urgently needed. especially treatments that may also impact anhedonia and that could offer differentiated tolerability profiles as well as rapid onset of action. We continue to expect our first phase three MDD study results in the first half of 2027, and we will narrow that guidance as we get closer to the top line readout. Additionally, we're excited about the progress of our early clinical pipeline for pain. We are nearing completion of our phase one studies for both Ramos, XCN 1701, and XCN 1120. And data generated to date supports the initiation of phase two proof of concept studies in acute pain for both programs. We have also recently advanced a second NAV 1.7 candidate for pain into a phase one clinical trial. So this will give us multiple shots on goal for this important pain target. Success in any one of these three novel non-opioid pain programs would meaningful increase value for Xenon and our opportunity to impact the lives of millions who live with chronic or acute pain. And in line with our continued commitment to epilepsy, we also continue to invest in multiple high quality candidates targeting various ion channels. This includes our preclinical NAV 1.1 program for Dravet syndrome, where we are in IND enabling studies with the intent of putting the best candidate into the clinic, It also includes our partner program with Neurocrin, MBI 921355, an investigational selective inhibitor of NAV1.2 and NAV1.6 in development for the potential treatment of certain types of epilepsy, which continues to advance through a Phase 1B study with data expected in 2027. So with that, now I'll turn over the call to Chris, who will provide additional clinical and regulatory updates. Chris?
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