Xenon Pharmaceuticals Inc. Q1 FY2023 Earnings Call

Hello, and thank you for standing by. My name is Gigi, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Q1 2023 Xenon Pharmaceuticals Inc. Earnings Conference Call. I would now like to turn the conference over to Sherry Aulin, Chief Financial Officer. Please go ahead.

Thank you, and good afternoon, everyone. Thank you for joining us on our call and webcast to discuss Xenon's First Quarter 2023 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 Seggern, Xenon's Chief Commercial Officer. Ian will open today's call with a summary of our proprietary pipeline programs. Chris Kenny will provide an overview of our XEN1101 Phase 3 epilepsy program, as well as a brief summary of the recent oral presentation of supporting data from the X-TOLE open-label study that was presented at the American Academy of Neurology's Annual Meeting, or AAN. I will summarize our financial results, progress within our partnered programs and our anticipated company milestone events. Chris Von Seggern will be available during our Q&A session to address questions about 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 anticipated presentation of data 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 XEN1101 and other development programs, the timing and results of our interactions with regulators, our ability to successfully develop and obtain regulatory approval of XEN1101 and our other product candidates, anticipated enrollment in our clinical trials and the timing thereof, and our expectation 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 statement. Today's press release summarizing Xenon's first quarter financial results and the accompanying annual report on Form 10-Q will be made available under the 'Investors' section of our website at www.xenon-pharma.com and filed with the SEC and on SEDAR. Now, I would like to turn the call over to Ian.

Thanks, Sherry. And good afternoon, everyone, and thanks for joining us on our call today. We are excited about the continued progress across our broad XEN1101 Phase 3 epilepsy program, including the recent initiation of X-TOLE3. All planned Phase 3 epilepsy clinical trials are now actively recruiting patients, including X-TOLE2 and X-TOLE3 in patients with focal-onset seizures, or FOS, and X-ACKT, in patients with primary generalized tonic-clonic seizures, or PGTCS. XEN1101 is the only potassium channel modulator in late-stage clinical development, and we continue to build on our leadership position in the Kv field, driving our mission to provide new therapies for patients with epilepsy and other neurological conditions. Based on our experience with our X-TOLE Phase 2b study, which was similar in size to both X-TOLE2 and X-TOLE3 and supported by our continued relationships with key investigators, many of whom already have familiarity and experience with XEN1101, we maintained a high degree of confidence in our ability to execute on our XEN1101 Phase 3 program and we are pleased with our progress to date. In addition to our ongoing Phase 3 epilepsy program in adults, we recently obtained feedback from the FDA that has shaped our strategy for our pediatric development plans for XEN1101. Progress and highlights from our XEN1101 pediatric plans include ongoing work on a pediatric formulation of XEN1101 for younger patients. We also expect to take advantage of the FDA's pharmacokinetic extrapolation rule for focal-onset seizures, which allows us to over time move into cohorts of progressively younger patients with focal-onset seizures, with XEN1101 in an open-label setting. And finally, we're in the process of expanding the X-ACKT Phase 3 clinical trial to include patients as young as 12 years of age, and this was driven by feedback from FDA. We believe XEN1101 has the profile and attributes to support broad development, including moving into younger patients with epilepsy, where there continues to be considerable need for new medicines. After careful consideration, we are prioritizing our XEN1101 pediatric epilepsy development plans and will no longer pursue the clinical development of XEN496. We wish to extend our sincere gratitude to the patients and their families who participated in the EPIK clinical trial. We intend to work with study investigators to offer an option for continued access through a transition period for those patients currently on XEN496. Turning to non-epilepsy indications, our Phase 2 XEN1101 X-NOVA study in Major Depressive Disorder or MDD, continues to make good progress. Our decision to examine XEN1101 in MDD was based on encouraging published clinical results with ezogabine, as well as promising preclinical data with XEN1101. We were further interested in gathering additional data given that depression is a common comorbidity within the epilepsy patient population. X-NOVA, which as a reminder was initiated only 12 months ago, has progressed well, and we expect to screen the last patient next month in June. After the last patient goes through a screening period lasting up to 4 weeks and has been randomized, there is a 6-week treatment period and a 4-week follow-up visit, after which the database can be locked and the data analyzed. Given these steps, we are looking forward to a topline data readout for X-NOVA in the fourth quarter of this year, which is a slight shift in our previous guidance of topline data in the third quarter. These data will help guide our future plans for XEN1101 in MDD. In summary, we remain laser-focused on the continued advancement of our Phase 3 XEN1101 program, including X-TOLE2 and X-TOLE3 clinical trials in focal-onset seizures; and X-ACKT clinical trial in PGTCS; as well as executing on our pediatric development plans. We are also looking forward to the important data from our Phase 2 X-NOVA study in MDD later this year. Lastly, we continue to generate important long-term data from our ongoing X-TOLE open-label extension study that affirms the X-TOLE Phase 2b results, supporting our position that XEN1101 presents a novel compelling product profile with the potential to address some of the currently unmet needs of patients with epilepsy. As Chris and Sherry will highlight in their remarks later in the call, we are excited to be entering a data-rich period for Xenon. Between now and the end of the year, we will present additional XEN1101 X-TOLE open-label data focused on quality-of-life measures at the International Epilepsy Congress in September, and 30-month OLE data at the American Epilepsy Society Annual Meeting in December, as well as the 2 Phase 2 readouts in the first quarter of this year, including data from our XEN1101 X-NOVA study, as well as data from our collaboration with Neurocrine. So I'd now like to turn the call over to Chris Kenney, who can provide additional details on the progress made within our Phase 3 XEN1101 program as well as recent and upcoming data presentations for XEN1101. Chris, over to you.

Okay. Thanks, Ian. I would echo that we believe the clinical data generated to date support a very compelling product profile for XEN1101, and that the efficacy data from the Phase 2b X-TOLE study and the ongoing X-TOLE open-label extension, compare favorably to medicines currently available for focal-onset epilepsy patients. To briefly review the XEN1101 clinical trials within our robust Phase 3 program. As Ian mentioned, we now have initiated X-TOLE3, which is running in parallel to our X-TOLE2 study. Each of these studies will enroll approximately 360 subjects with focal-onset seizures who will be randomized 1:1:1 with once daily dosing of either 15 milligrams or 25 milligrams of XEN1101 or placebo. The primary efficacy endpoint is the median percent change or MPC and monthly seizure frequency from an 8-week baseline through the 12-week double-blind period with XEN1101 compared to placebo. We've also successfully executed on our plans to pursue another epilepsy indication, our Phase 3 X-ACKT clinical trial is expected to enroll approximately 160 subjects with primary generalized tonic-clonic seizures. Subjects will be randomized 1:1 for once daily dosing of either 25 milligrams of XEN1101 or placebo. The primary efficacy endpoint is the MPC and monthly PGTCS frequency from an 8-week baseline through the 12-week double-blind period of XEN1101 compared to placebo. I've noted that this parallel approach in both focal-onset seizures and primary generalized tonic-clonic seizures at this stage of development is unique. Our rationale is based on the Kv mechanism in the photo-sensitive proof-of-concept model of generalized epilepsy, favorable data in multiple preclinical epilepsy models and clinical data, including activity we saw across all focal seizure subtypes in the Phase 2b X-TOLE study. Our hope is that we are setting the groundwork for potentially broader use of XEN1101 in both the most common forms of epilepsy, should it be approved. We recently met with physicians and epileptologists at the Annual Meeting of the American Academy of Neurology, who continue to assert the need for new therapeutic options with differentiated mechanisms of action to improve upon existing anti-seizure medications. At AAN, in addition to a poster outlining our X-ACKT clinical trial design, we were thrilled that the XEN1101 program was selected for an oral presentation at this important neurology-focused meeting. Dr. Jackie French, one of the preeminent leaders in the epilepsy field, presented data from our ongoing open-label extension study with XEN1101. She outlined how these data build upon the strong efficacy data generated in the Phase 2b X-TOLE clinical trial. Importantly, she spoke about the data demonstrating continued seizure reduction and extended periods of seizure freedom experienced by patients in the open-label extension study. Her podium presentation outlined several key takeaways. During the open-label extension, there was a sustained monthly reduction in seizure frequency, specifically 80% to 90% seizure reduction as measured by median percent change from the double-blind period baseline. Also, seizure freedom for greater than or equal to 6-month and greater than or equal to 12-month consecutive durations was achieved in 17.5% and 10.5% of patients, respectively. XEN1101 continues to be generally well-tolerated in the open-label extension with adverse events consistent with prior results in other anti-seizure medications. Dr. French expressed that these data are encouraging for prescribing physicians who continue to seek new differentiated therapeutics that improve upon existing options and may provide further hope for the many patients who experience the debilitating impacts of focal seizures even while taking multiple anti-seizure medications. Looking ahead, our team is excited to continue to showcase XEN1101 at medical conferences later this year, including our presence at the upcoming 35th International Epilepsy Congress in Dublin in September, and at the American Epilepsy Society Meeting in December. At IEC in September, we have multiple podium and poster presentations highlighting our XEN1101 Phase 3 program as well as new quality-of-life data from the ongoing X-TOLE open-label extension. In addition, we are in the process of submitting abstracts to the American Epilepsy Society Meeting, including 30-month open-label extension data from X-TOLE supporting the long-term use of XEN1101, as well as important seizure freedom data. We look forward to keeping you updated on our progress on the XEN1101 Phase 3 epilepsy program, as well as continuing to build a profile of XEN1101 with physicians and the medical community. I'll now turn the call over to Sherry, who will give us a brief update on our partnered program with Neurocrine, before summarizing our first quarter financial results and upcoming milestones. Sherry?

Thanks very much, Chris. So beginning with our partnered programs, our collaborators at Neurocrine are conducting 2 separate Phase 2 clinical trials evaluating NBI-921352. One study is focused on adult patients with focal-onset seizures, and the other study is examining the use of NBI-921352 in pediatric patients with SCN8A-related epilepsy. We're looking forward to the results from Neurocrine's adult focal study, which are anticipated in the fourth quarter of this year. I'll now touch on some highlights from the financial statements and would refer you to our news release and 10-Q report for further details. Cash and cash equivalents and marketable securities were $687.3 million as of March 31, 2023, compared to $720.8 million as of December 31, 2022. Based on current operating plans, including the completion of the planned XEN1101 Phase 3 epilepsy studies, we anticipate having sufficient cash to fund operations into 2026. Before concluding our prepared remarks, I'll briefly summarize some of our goals and milestone events ahead, including, as Ian mentioned, a data-rich period for Xenon between now and the end of the year. We will focus on advancing our XEN1101 Phase 3 program, including our X-TOLE2 and X-TOLE3 clinical trials in focal-onset seizures, and our X-ACKT clinical trial in PGTCS. We are excited to present additional XEN1101 X-TOLE open-label extension clinical data at both IEC in September and AES in December. We anticipate topline results in the fourth quarter from our X-NOVA clinical trial in MDD, and we expect another data readout in the fourth quarter of this year from the adult focal-onset study conducted by our partner, Neurocrine. In closing, we believe that we have established an enviable leadership position in the Kv field, that's supported by our clinical development efforts and financial resources to help us execute on our ambitious plans. As we focus our efforts on our Phase 3 epilepsy program, I'm proud of the team we continue to build at Xenon. We are grateful to our employees across the business who are committed to Xenon's mission to deliver new neurology therapeutics to patients in need. I am excited by our success to date and look forward to reporting our progress through 2023. I'll now ask the operator to open the line for any questions.

Thank you. Our first question comes from the line of Paul Matteis from Stifel.

I had one question on the focal seizure Phase 3 program and one question on MDD. On Phase 3, it sounds like things are going well, but you aren't yet guiding to when you expect these results to be ultimately available. Ian, I was wondering if you could give just a little bit more color on what you're seeing on enrollment dynamics, and when do you think you're going to get to a point where you'll be ready to give us a more affirmative guidance? And then on the MDD study, I wanted to ask if you were willing to disclose anything about the patient population you've enrolled specifically as it relates to baseline severity. And the reason I was asking is I think your cutoff on HAM-D is a little bit lower than some of the other contemporary MDD trials. Historically, that can have some impact on things like placebo effect. And so, again, just a little bit curious on the population.

Thanks, Paul. I'm glad to answer your first question, and then Chris Kenny, we can discuss the baseline MADRS score as a cut-off and where we expect the patient population to be. To address your initial inquiry about our progress in Phase 3 epilepsy and recruitment, as I mentioned earlier, we believe we're on track and making good progress. To provide more detail, we monitor site initiations, patient screenings, and patient randomizations. We have developed a model based on our X-TOLE experience and our collaboration with the CRO, and we evaluate our performance against that model. As previously discussed, we use the X-TOLE study as a reference point, although there were challenges during that study due to COVID and a lack of efficacy data on the molecule at that time. Regarding future guidance, we will likely provide topline data later this year. We have been consistent in wanting a couple of quarters of enrollment before we give guidance, ensuring that we have most sites operational. So, that information will be forthcoming. Chris, I'll hand it over to you to discuss the baseline characteristics related to the MDD study.

Sure. Yes. So in terms of the inclusion criteria, patients have to have a Hamilton-D at screening of at least 20. And the idea is to capture a population of depressed patients who are at least moderate. And then based upon that, we are keeping an eye on all baseline characteristics as more patients are being randomized and the baseline characteristics are largely following what we had expected. And we're hoping to share more details on that potentially, obviously, by the end of the year.

Anything you can say, Chris, on how these baseline characteristics compare to other studies that have completed in depression recently?

Very similar.

One moment for our next question. Our next question comes from the line of Brian Abrahams from RBC Capital Markets.

Congrats on all the progress. 2 from me. I guess, first off, as we get closer to the MDD results, I'm curious your latest views on depression as a primary indication for XEN1101 if the data were positive? Or how far behind would next-generation programs be, that could take advantage of the validation of the pharmacology? And then secondarily, what learnings from EPIK can you use to shape how to optimize the development of XEN1101 in kids?

I can address the first question and then share a few thoughts on EPIK. Chris Kenney, feel free to jump in as we consider the pediatric development for 1101. Brian, regarding Major Depressive Disorder (MDD), the data will be a crucial factor. We have discussed multiple avenues here. One is that we continue to generate data relevant to the epilepsy market, given that depression is the most common comorbidity in epilepsy, so this data could be significant. We're also interested in potentially pursuing primary development in MDD. We're conducting additional work between now and the topline data to address some internal commercial questions, and once we have that data, we will provide updates on the program's next steps. You inquired about next-generation compounds utilizing Kv7 pharmacology. We have substantial preclinical efforts underway, but none of those molecules have yet moved into clinical trials. The first ones are expected to transition sometime next year, so there will be a gap between XEN1101 and any backup molecules moving into development. Regarding the transition from EPIK to 1101, the pediatric plans are quite different. XEN496 was developed for a very rare pediatric epilepsy, specifically looking at KCNQ2-DEE, which involves a distinct population compared to pediatric patients with focal epilepsy and primary generalized tonic-clonic seizures. This might be a good opportunity to discuss pediatric patients with epilepsy further. Chris Kenney, if you would like to add insights on the lessons learned from EPIK for the pediatric development of 1101, that would be great. Additionally, Chris Von Seggern can offer perspective on the market opportunity or the patient population for focal and generalized seizures in pediatric patients.

Sure. I would say the biggest feature that's feeding into the pediatric plans for XEN1101 is more about what we learned in the adult X-TOLE study, I would say, than necessarily in the EPIK study. To the extent so the data from the EPIK study is still blinded. And to the extent that you can assess blinded data, it was largely consistent with what we would expect with ezogabine, so we'll unblind that data in the near future. But I wouldn't say that there is any particular learning from that study per se, that has illuminated the path for the pediatric development of XEN1101. Ian, would you want to add to that?

No. I think, that's really good. And Chris, on pediatric development and the patient population?

Yes, absolutely. Happy to share. So when we think about the current development plan focusing predominantly on the adult population, we have to remember that there are hundreds of thousands of patients who are under the age of 18 in the United States that have epilepsy. So in broad-reaching numbers, we're talking about 500,000 patients under the age of 18. And similar to the adult patient population, we see a bias towards more patients with focal-onset seizures than generalized seizure disorders. However, within this patient population, what mirrors very much the adult patient population is the high unmet medical need for patients who have difficult-to-treat disease. And we see a similar dynamic of a large percentage of those patients progressing on to second or third-line therapeutics. And just like the adult population, branded therapeutics tend to play a role in those more difficult-to-treat patients. And as a result, we see a great opportunity for XEN1101 in the pediatric market. Our market research has suggested that the value attributes associated with XEN1101 are similarly positive in the pediatric patient population is what we've seen in the adult population, with actually a slight bias towards QD drugs as being even more beneficial for this audience where compliance becomes a bit more problematic than what we see with adult patients. So there is a great opportunity for XEN1101 as we continue the development in the pediatric population.

Thanks so much for the really detailed answers. That's super helpful.

One moment for our next question. Our next question comes from the line of Tessa Romero from J.P. Morgan.

So X-TOLE3 is off the ground now, which is really nice to see. How should we think about dynamics between enrollment for X-TOLE2 and X-TOLE3? And can you remind us how much overlap there is in the clinical trial sites there? And any color you'd provide us on, with respect to competitive enrollment dynamics for XEN1101 trials in FOS and PGTCS versus other programs at your clinical trial sites? And then, I have one quick follow-up.

Yes, I'll start and Chris can jump in as well. Just to remind everyone, X-TOLE2 and X-TOLE3 are both focused on focal-onset seizures, but they will not take place at the same clinical sites. X-TOLE2 began first, and we have prioritized it in terms of sites because many have experience with XEN1101. For X-TOLE3, we are using some sites that are part of the X-TOLE program, but there’s no overlap with the X-TOLE2 sites so each clinical site can only conduct one of these protocols. On the other hand, for the X-ACKT study, which focuses on primary generalized tonic-clonic seizures, it can be conducted at either X-TOLE2 or X-TOLE3 sites. This gives us an advantage since it involves the same investigators, contracts, and institutions. If a patient qualifies for focal epilepsy, they can be enrolled in X-TOLE2 or X-TOLE3 as suitable, and if they have primary generalized seizures, they can be part of the X-ACKT study. This setup allows us to gain some advantages. Regarding competitive drugs, we believe we are currently the only drug with strong clinical efficacy data in a late-stage clinical development program. While there are a few other molecules in pre-efficacy stages, we have not seen any concerns regarding competition in terms of patient recruitment. Chris, do you have anything to add? Tess, I know you had a follow-up.

One thing, I would add is just that in speaking with investigators and epileptologists in general, there is a fair amount of enthusiasm about the data we've generated so far. So, I would say that the interest to participate in our trials is pretty strong. And that when you think of all the challenges that come along with completing a Phase 3 study, I don't see competition as a major factor.

Okay. Great. And then 1 quick one. That's helpful. Are you able to provide any further color on the ongoing pediatric formulation work you're doing there? And any kind of sense of how long that might take you to land on the formulation? And I was just thinking, can you kind of leverage the learnings that you had from formulating XEN496?

Yes. I want to reiterate what we included in the press release and prepared remarks. For primary generalized tonic-clonic seizures, as requested by the FDA, we will now go down to patients aged 12 and older, which will be an amendment to the protocol. For patients aged 12 and above, a pediatric-specific formulation is not needed; we can use the same formulation as we do for adults. In focal epilepsy, there is a pharmacokinetic extrapolation rule that allows us to include younger patients in an open-label study over time, gradually including progressively younger patients. Regarding pediatric formulation development, we have relevant experience in this area. Our internal CMC group is actively working on formulation development for our preclinical programs as well as for 1101. This work is already in progress, and we should have a clearer idea by later this year about our progress in pediatric formulation development, which is necessary for treating younger patients. However, there is still quite a bit we can accomplish even before we require that specific pediatric formulation.

One moment for our next question. Our next question comes from the line of Jason Gerberry from Bank of America.

This is Dana on for Jason. Congrats on the progress this quarter. So we just have a couple of questions on the MDD X-NOVA readout. And so beyond demonstrating statistical significance on MADRS and good monotherapy tolerability, what else are you focusing on in this readout? And since safety is a key area of interest, was 1101's AE profile a consideration when picking the 10-milligram and 20-milligram doses and were these chosen based on 1101's monotherapy healthy volunteer data? And then also just curious if you've looked at placebo response rates in patients that have clinically significant anhedonia and if they differ from the general MDD subjects?

Chris, could you address the final point regarding anhedonia? I will discuss the overall data. Chris Von Seggern, I know we've conducted market research examining the epilepsy adverse event profile related to depression, so perhaps we can touch on that as well. Dana, in terms of our plan moving forward with MDD, our approach will consider all the data. As you noted, we need to evaluate both efficacy and adverse events, along with how we see this fitting into our decision-making for the next steps. Regarding dose selection, the X-TOLE data was quite informative, along with the data from healthy volunteers. The X-TOLE data particularly helped us determine the dose selection for MDD. The 20-milligram dose in X-TOLE demonstrated efficacy, and we believe it was well-tolerated. The 10-milligram dose was also intriguing because we observed statistical significance across all seizure reduction endpoints at that dose in X-TOLE, while the adverse event profile was relatively mild. Hence, we wanted to test that dose in our MDD Phase 2 study. Before initiating the study, we adjusted the protocol to include a 10-milligram arm, which is why we implemented 10 milligrams, 20 milligrams, and placebo in our MDD study. Chris Von Seggern, since we've examined the adverse event profile, particularly in epilepsy while consulting some prescribers about depression, could you share some of those details? Then we can address the question on anhedonia.

Yes, absolutely. It's important to highlight, building on Ian's comments, that the data from X-TOLE comes from a very challenging patient population with epilepsy, where patients are often on multiple background therapies. Consequently, the adverse event profile in epilepsy is generally higher compared to what you would find with most MDD products. Keeping this in mind, we brought the existing profile from X-TOLE into market research for both the 20-milligram and 10-milligram dosages to gauge whether clinicians would be receptive to a product that provides compelling efficacy alongside that adverse event profile. The feedback we received was that if we can deliver compelling efficacy, there is a market opportunity for a profile like XEN1101. It's crucial to remember that these are potent CNS-penetrant drugs, which will inevitably come with some adverse events. However, when considering the spectrum of approved MDD products, there is a balance of adverse events to weigh. Notably, the main categories of medications currently used are tied to significant sexual side effects and weight gain from the SSRI and SNRI classes. As physicians seek alternative treatment options for patients in later lines of therapy, they tend to be more tolerant of the adverse event profile, consistent with our findings from X-TOLE. Moreover, there is optimism that, in a monotherapy setting and with a less severe patient population, the adverse event profile may be somewhat different or might exhibit less impact compared to what we observe in the epilepsy cohort. Overall, the evidence suggests a viable opportunity if we can demonstrate compelling efficacy with the profile.

Thanks, Chris. Chris Kenney?

I can only be somewhat vague and speculate with limited information, but the study was quite positive. With a relatively small number of patients, they met almost all the efficacy endpoints they aimed for. This is one of the reasons for our optimism and why we are proceeding. I am unsure about the adherence in that study since it appears they only measured it through pill counting. However, I would speculate that if you're conducting a study with a dosage of three times a day, adherence would likely be as good or even better with a once-a-day drug. Therefore, I think adherence is less of a concern with a once-a-day regimen compared to three times a day, but there is nothing in that publication that quantifies adherence that I can recall.

Laura, does that address your question?

One moment for our next question. Our next question comes from the line of Charles Duncan from Cantor Fitzgerald.

This is Elaine Kim on for Charles Duncan. In the X-TOLE OLE study, what can you tell us about treatment persistence seen thus far? And are you continuing to see similar levels of seizure freedom? Additionally, have there been any safety factors, including changes in body weight?

Great. Chris, do you want to comment on the 18-month data from last September, and we'll be doing an additional 30-month data cut later this year. Yes, we'll provide all this information at the American Epilepsy Society at the end of the year. The data we've reviewed so far indicate that over one calendar year, patients gained about 1 kilo on average, which is fairly modest compared to publications discussing weight gain in antiseizure medications. Regarding seizure freedom, the open-label study is still ongoing. In terms of patient years for the X-TOLE study, we're just past the halfway mark. As patients continue on the drug longer, the seizure freedom numbers can only increase. If a patient experiences one year of seizure freedom, that won't diminish; it can only be added to. So we're optimistic about the direction it's heading. We'll share more details at the end of the year.

One moment for our next question. Our next question comes from the line of Mohit Bansal from Wells Fargo.

I have a couple of questions. One of your peers mentioned facing challenges in enrolling epilepsy trials due to competition for patients, and that certain regions like Ukraine and Russia are no longer available. Are you encountering similar difficulties in starting these centers or enrolling in the trials? My second question is about the uptake of Xcopri. It's quite remarkable how well this drug is performing despite the safety concerns and complications. Our discussion with Quralis suggested they prefer less complicated drugs, yet this one isn't straightforward. Does this make you more confident about the launch, or has the launch surprised you as well?

I'm happy to address your first question, and then Chris Von Seggern can discuss the cenobamate launch and how we view it in relation to the attributes of 1101. Regarding epilepsy clinical development and recruitment, we are progressing as expected and are not encountering the challenges that others might be facing. We have a molecule with excellent attributes and compelling efficacy, which supports our conversations with investigators and sites. Other ongoing epilepsy studies are at an earlier stage of development and have yet to demonstrate proof-of-concept efficacy. So far, our enrollment is tracking as anticipated, and we haven't experienced any recruitment challenges. Chris Von Seggern, could you comment on cenobamate?

Yes. So cenobamate is obviously doing a great job early in their launch and we would agree that they've done very well despite some of the limitations of the products. From our perspective, there is ample room for multiple branded products in this marketplace, and we wish them well along their trajectory in the early days. I think you highlighted though something that's quite important, which is that we hear from our market research that the titration profile and the burden associated with the titration is actually quite cumbersome for physicians and it does both limit the ability for the drug to be used more broadly, and we hear quite clearly that physicians in general are not getting to the top dose effects of Xcopri because of safety or tolerability issues during the titration schedule. I mean, that just creates an opportunity for us, when we think about the positioning of our product to move upstream. Our ease-of-use attributes we commonly hear are much better than the other available products. And that gives us an encouraging view on where XEN1101 will be positioned, really fighting upstream of a product like Xcopri, which today, despite its strong start, is still really used for last-line patients. And we believe that 1101 will play sufficiently upstream in the future.

Helpful.

Thank you. This concludes the Q&A portion of the call. This concludes today's call. Thank you for joining, and you may now disconnect.