Xenon Pharmaceuticals Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 12, 2025
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Operator

Thank you for standing by. My name is Carly, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q1 twenty twenty five Xenon Pharmaceuticals Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

Operator

Thank you. I would now like to turn the call over to Chad Fougier, Xenon's Vice President of Investor Relations. Please go ahead.

Chad Fugere
Chad Fugere
VP - IR at Xenon Pharmaceuticals

Good afternoon. Thank you for joining us on our call and webcast to discuss Xenon's first quarter twenty twenty five financial and operating results. Joining me are Ian Mortimer, Xenon's President and Chief Executive Officer Doctor. Chris Kenny, Xenon's Chief Medical Officer and Sherry Allen, Xenon's Chief Financial Officer. After completing their prepared remarks today, we will open the call up for your questions.

Chad Fugere
Chad Fugere
VP - IR at Xenon Pharmaceuticals

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 anticipated indications, 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 clinical development programs, including the anticipated filing of INDs and NDAs, the timing and results of those filings and our interactions with regulators, our ability to successfully obtain regulatory approvals, anticipated timing of the top line data readout for our clinical trials of the Zetsu counter, and our expectation that we will have sufficient cash to fund operations into 2027. Today's press release summarizing Xenon's first quarter financial results and the accompanying quarterly report on Form 10 Q will be made available under the Investors section of our website at xenonpharma.com and filed with the SEC and on CDER plus Now, I would like to turn the call over to Ian.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Thanks, Chad. And good afternoon, everyone. And thanks for joining our call today. I'll begin with a brief review of highlights from the past quarter and our progress across our growing neuroscience focused pipeline, including progress on our Phase three studies of a set to calendar and epilepsy are expanding clinical development work in psychiatry, as well as our early stage programs that are entering first in human studies this year. After that, I'll turn the call over to Chris, who will share more details on our clinical development programs, including high level top line results from the completed investigator led MDD study, along with an update on our recent engagement efforts to raise the profile of the EZET2 calendar.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Sherri will close with a summary of our partner program, financial results and anticipated milestones. Starting with our EZET2 calendar Phase three epilepsy program. As you've heard from us consistently delivering data from our EXTOL-two study remains our number one priority at Xenon. We are nearing the end of patient recruitment in EXTOL-two, which we expect will complete within the next few months with top line results anticipated early next year. While acknowledging the slight delay versus our prior guidance, I want to emphasize that we are approaching the conclusion of this study and importantly progressing towards our goal of bringing this important new medicine to patients.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

From the outset to maximize study success, we have prioritized working with high quality experienced sites and monitored key metrics rigorously throughout the study. As we approach the conclusion of this work, we are very pleased that these metrics align consistently with our successful Phase 2b XTOL study. Bottom line, we continue to have high confidence in XTOL two and share the epilepsy community's excitement as we progress towards our Phase three readout. It's this excitement that drives us and our scientific leadership and investment in the KV7 landscape. As a reminder, is that to counter is the only KV7 opener and the only new ASM in development that is backed by long term efficacy and safety data from clinical studies of patients living with epilepsy.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Now having amassed over seven hundred patient years of exposure in focal epilepsy patients. There remains a substantial need for new efficacious and well tolerated epilepsy therapies, especially for those patients who continue to experience the debilitating impacts of focal seizures, even while taking multiple anti seizure medications. And we believe that is that to counter key attributes as seen to date demonstrate its potential to provide an important new option for the epilepsy community. We consistently hear positive feedback about the need for a new medicine to address continuing unmet needs in epilepsy treatment. And there's excitement within the medical community about Ezetucalendar's potential to offer a novel mechanism without titration, early onset of effect, seizure freedom and mood benefit.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Ezetucalendar has the potential to be a best in class anti seizure medication that could offer significant and meaningful benefits in the future treatment of epilepsy. Shifting to broadening the use of azacitaxel beyond epilepsy into neuropsychiatry, enrollment is ongoing in our first Phase three MDD study X NOVA two with our second MDD study X NOVA three and our first Phase three study in bipolar depression, both on track to initiate by mid year. In addition, and as mentioned in today's press release, we now have the final results from the investigator sponsored study of ezetucalner in MDD. Chris will provide some details on these results in a moment. But briefly, the results are consistent with our expectations and our prior ex NOVA study, including clear drug activity on both MADRS and SHAPs based on separation between a set to calendar and placebo at every time point.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

We believe these results reaffirm the already strong scientific rationale to pursue further development in this high unmet need patient population. Moving now to our early stage pipeline, there is significant momentum across our preclinical programs with multiple regulatory filings expected this year to support the initiation of first in human trials across a number of validated ion channel targets. This broadening and building out of our early stage pipeline is a direct result of the successful leveraging of our extensive knowledge and expertise in developing potassium and sodium channel therapeutics. As our diverse pipeline of early stage drug candidates continues to mature, I'm incredibly proud of the considerable progress we are making across multiple programs targeting ion channels that include Kv7, Nav1.7 and Nav1.1. Today, I'll give you an update on each of these promising programs.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Recognizing the potential broad applicability of the KV7 mechanism of EZET2 counter, we have identified multiple chemically diverse KV7 development candidates and believe that this mechanism may have utility in a broad range of therapeutic indications, including seizure disorders, pain and neuropsychiatric disorders such as MDD and BPD. I am pleased to report that a clinical trial application was recently accepted for XEN11020, a KV7 channel opener that we intend to study as a potential treatment for pain and a Phase one study in healthy adult participants is now underway. As a reminder, there is good clinical evidence supporting the development of novel selective KV7 openers optimized for pain. We also have a number of other KV7 molecules and chemistries that will follow XEN110. We also continue to make substantial progress within our NAV 1.7 sodium channel program, where we believe we may have addressed the limitations of first generation drugs targeting NAV 1.7.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

A key part of Xenon's heritage involves our pioneering work that contributed to the strong human genetic validation of NAV1.7 as a pain target. And we believe NAV1.7 could represent a new class of medicines, which address the unmet medical needs for effective alternatives to opioids. We have nominated multiple selective NAV 1.7 development candidates to date and IND enabling work is complete for our lead candidate XEN1101 for which we expect to initiate a Phase one first in human study in the third quarter of this year. Work within our NAV1.1 program also continues to progress. Our preclinical work to date suggests that targeting Nav1.1 could potentially address the underlying cause and symptoms of Dravet syndrome.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Data shows that dosing with an orally available small molecule CNS penetrant and highly selective Nav1.1 potentiator suppressed induced seizures and improved motor function, supporting the potential for improvements in Dravet patient motor function. Further, in these animal models, chronic dosing suppressed spontaneous seizures protected against sudden unexpected death and epilepsy or SUDEP and increased long term potentiation of potential cellular correlate of learning and memory. These preclinical data are incredibly exciting and we anticipate that a lead NAV 1.1 candidate will enter IND enabling studies this year. This summer, we plan to host multiple R and D webinars to showcase various early stage programs that will include deeper dives into mechanism, underlying human genetics, preclinical results and other supporting data, as well as an overview of disease prevalence and unmet medical needs within certain patient populations. This first webinar will take place in June and will focus on our approach to treating pain with drug candidates targeting both NAV1.7 and KV7.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

As Xenon continues to advance promising late and early stage programs, I believe we are entering a catalyst rich period for the company as we near most importantly, the first Phase three top line readout of the Zetu calendar in FOS. This represents a major inflection point for Xenon signaling our evolution from a clinical stage to commercial organization. And I look forward to keeping you updated on our progress as we await results. I'll now turn the call over to Chris, who will provide some additional details around our clinical development programs and importantly, the IST results, as well as our broader outreach to the HCP and patient communities. Chris, over to you.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

All right, Ian, thanks a lot. As a reminder, our Phase three epilepsy program includes our two XTOL studies in focal onset seizures or FOS, that's XTOL-two and XTOL-three and our exact study in primary generalized tonic clonic seizures or PGTCS. As Ian noted, we're nearing the end of patient recruitment in XTOL-two in the next few months. Despite the modest change to our top line guidance, we remain highly confident in the conduct and quality of the XTOL-two study. As Ian mentioned, we continue to see investigator enthusiasm around the ZETU counter and a high rollover rate into the open label extension study consistent with rates observed in EXTOL.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

In addition, as with all our studies, we track a number of key metrics throughout the study as we near the end of EXTOL two. We believe that we are seeing strong consistency on all of these metrics when we compare to our successful Phase 2b XTOL study. We continue to be excited by the prospect of this first Phase three FOS study outcome and we believe the finish line is in sight as we look forward to completing patient recruitment in the next few months. As we're getting closer to top line data, we continue our ongoing educational and scientific outreach efforts to raise the profile of the Z2 counter amongst healthcare providers. Our team recently presented three epilepsy related posters at the American Academy of Neurology or AAM that took place in early April.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Building upon more than seven hundred plus patient years of data, we're excited to share our thirty six month ISERITU calendar data from our ongoing extol open label extension study and FOS that shows sustained monthly reduction in seizure frequency, impressive seizure freedom rates, and a consistent AE safety profile suggesting long term efficacy and tolerability of azetucala. We also presented an exploratory analysis from our XTOL study showing reduced seizure frequency rates across four focal seizure subtypes. These promising data support our conviction that EZET2 calendar may offer hope for people who continue to seek new efficacious and well tolerated therapies to address the debilitating impacts of uncontrolled seizures. AAN also provided another time opportunity for us to connect directly with a broad range of healthcare providers and patient advocacy groups. Discussions at the conference were wide ranging and gave us the opportunity to present the science and the data to date and highlight the mental health burdens associated with epilepsy and engage in meaningful discussions around the under detected and undertreated depressive symptoms associated with epilepsy.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

One of our poster presentations focused on patient reported survey data that we collected which further illustrates the substantial burden of illness for people living with epilepsy. With reduced quality of life, high seizure frequency and fatigue as well as other comorbidities such as anxiety and depression, further underscoring the need for new treatments to help people living with epilepsy. We also highlighted the zetu counter's potential in neuropsychiatric disorders such as MDD and bipolar depression based on scientific rationale and unmet medical needs. Before I dive into an update on our company sponsored clinical programs and neuropsychiatric indications, I wanted to provide additional details and context from the recently completed investigator sponsored study of a Zetu counter in MDD that was led by Doctor. James Murrow at the Icahn School of Medicine Mount Sinai.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

As a reminder, this study was designed as a 60 patient placebo controlled trial with a functional primary endpoint to evaluate the effect of a twenty milligram daily dose of the EZET2 counter on brain measures of reward as measured by the change in activation within the bilateral ventral striatum from baseline to end of treatment at week eight as assessed by functional MRI and also to evaluate secondary endpoints that include an assessment of MADRS and CHAPS through an eight week period. Despite being a small study, the results provide additional evidence supporting the potential of the KV mechanism and is that you call them to have antidepressant and anti hedonic effects, which is a significant unmet need in treating patients with depression. Highlights of the IST results include the following. Compared to Exnova and what we expect in our Phase three program given our entry criteria, the investigator initiated trial enrolled a less impaired population as indicated by lower baseline MADRS and SHAP scores. Both MADRS and SHAPs is that you counter numerically outperform placebo at every time point measured.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

As expected given the small sample size the improvements were not significant. Looking specifically at MADRS compared to subjects in the placebo group, subjects in the Ezetu Kalman group saw both early and larger improvements in MADRS scores. The separation was approximately two points at the first time point measured, week two, confirming early onset of effect and peaked at a greater than four point delta between active and placebo at week six. As a reminder, week six was the end of the study for Exnova and is the end for our Phase II MDD studies. Therefore confirming and actually slightly outperforming our Phase II Exnova data.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

For the IST, the study went out to eight weeks and the separation between active and placebo was less pronounced at week eight compared to week six due to a significant improvement in placebo between week six and eight. When looking at the individual patient data, this effect could potentially be explained by three subjects whose MADRS scores fluctuated considerably between week six and week eight, all in the context of a small sample size. Subjects in the Ezekielen also saw earlier and greater improvements on SHAAPS, measure of anhedonia, which is a core symptom of MDD. Again, we see the same pattern with early separation between Ezekielen and placebo group. And this separation continued throughout the study consistent with the separation seen in our ex NOVA study, including a greater than three point Delta between active and placebo at week six.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

On the safety side is that ducalbin was generally well tolerated with an AE profile generally consistent with prior studies and the known mechanism. In addition, there were no reports of weight gain or sexual dysfunction, which are common adverse events with standard of care agents. The most common adverse events include dizziness, incoordination and confusion. As we look at the totality of the data, most of these AEs were mild or moderate in severity, with only one serious adverse event deemed unrelated to Ezekieliner and a low rate of treatment discontinuations due to adverse events that was comparable to placebo. So in summary, Ezekielenner demonstrated consistent and numerically greater improvements on MADRS and CHAPs at all time points measured.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Importantly, the greater than 4.3 separation between the Ezetucalendar and placebo on MADRS and CHAPS respectively at week six demonstrates meaningful drug activity and reflects the length of the double blind period in our Phase three MDD program. In addition, we believe the benefit risk profile of the zetucalendar is reinforced as there is nothing unexpected or concerning in the adverse event profile seen in this study, given the study design and small numbers. The lead investigator Doctor. James Murrow has submitted an abstract to present these data at the American Society of Clinical Psychopharmacology or ASCP later this month and intends to submit for peer review publication at a later date. Turning to Xenon's efforts to expand the vetracalumab use in neuropsychiatry, I wanted to first highlight that Exnova two, the first of three planned Phase three clinical trials evaluating the zetucalendar in patients with MDD continues to enroll patients after initiating late last year and the next the second study Exonoga three is on track to initiate by the year.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

We continue to engage with physicians who treat patients with MDD to educate them about our ongoing clinical studies and the potentially differentiated profile of the Ezetu Kallinger versus standard of care agents. Of note, physicians are interested in Ezetu Kallinger's novel selected KV7 mechanism of action and its potential benefit on anhedonia, rapidity of onset, as well as its potentially favorable tolerability profile with data to date supporting no notable adverse effects on sexual function or weight gain. We also plan to run two identical clinical studies evaluating the Zetu calendar in a mixed population of bipolar I and bipolar II depression with the first study on track to initiate by mid year after recently receiving IND clearance from FDA. We look forward to providing more details around our BPD registrational program once our first trial is initiated. In summary, as we drive towards a Phase III FOS readout, we believe that AZETU calendar provides the promise of a new anti seizure medication to people living with the burdens of seizures and looking beyond epilepsy could address the needs of people living with neuropsychiatric disorders such as MDD and bipolar depression.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

I'd like to now turn the call over to Sherry who will begin by providing some additional detail around our partner program before summarizing our financial results. Sherri?

Sherry Aulin
Sherry Aulin
CFO at Xenon Pharmaceuticals

Thanks, Chris. Now looking briefly at our financial results, we recognized revenue of $7,500,000 during the first quarter related to a milestone payment in connection with our collaboration with Neurocrine, triggered by the initiation of a Phase one study of NBI-nine hundred twenty one thousand three hundred and fifty five, a selective inhibitor of Nav1.2 and Nav1.6 in development for the potential treatment of certain types of epilepsy. Cash and cash equivalents and marketable securities totaled $691,100,000 as of 03/31/2025, compared to $754,400,000 as of 12/31/2024. Based on current operating plans, including the completion of the AZET2Kelner Phase III epilepsy studies and supporting late stage clinical development of AZET2 KELNER in MDD and BPD, we anticipate having sufficient cash to fund operations into 2027. Given our proven track record of strong fiscal management, Xenon is in the fortunate position of having a strong balance sheet to support multiple registrational programs for AZETU KELNER and the continued maturation of our early stage pipeline.

Sherry Aulin
Sherry Aulin
CFO at Xenon Pharmaceuticals

I would refer you to our news release and 10 Q report filed today for further details around our financial results. We're entering a transformational period for Xenon as we evolve from a clinical to commercial stage company. We believe that positive top line results from our Phase III epilepsy program will enable an NDA submission to the FDA with the goal of advancing AZED2Kelner towards commercialization. In addition, other late stage neuropsychiatric programs will be well underway by year end, with two ex NOVA trials in MDD expected to be recruiting patients and a registrational study in BPD also initiated by midyear. Our deep pipeline also contains multiple promising early stage therapeutic candidates across a number of ion channel targets, supporting our goal to be a fully integrated premier neuroscience focused company.

Sherry Aulin
Sherry Aulin
CFO at Xenon Pharmaceuticals

On behalf of everyone on the Xenon team, we're incredibly excited in Xenon's evolution and remain focused on taking important steps forward to bring us closer to delivering azeti calner to people living with epilepsy. With that, I will pause and open the call for your questions. Operator?

Operator

Your first question comes from Paul Matteis with Stifel.

Paul Matteis
Paul Matteis
Analyst at Stifel Financial

Thanks for taking our question. We were just wondering, from the top line epilepsy data in early twenty twenty six, how quickly could you file assuming that's positive? And then just a second question, you guys talked about tracking some key metrics. Could you provide any color on what those are?

Paul Matteis
Paul Matteis
Analyst at Stifel Financial

And yeah, just like kind of what those metrics are and how they compare to the Phase 2b? Thank you.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Sure. Yeah, happy to address both of those questions. So, on the top line data to NDA filings, we haven't provided specific guidance, but I think many people have heard from us in the past and we'll be able to refine this over time, but it's approximately kind of six months from top line data to filing important to note is that it is the clinical data that's on the critical path. So we know just how broad and NDA filing is, as it relates to the non clinical sections, CMC clinical pharmacology, all of the data, all of that's in really good shape. And we're already writing certain sections of the NDA now and we'll continue to do that through the remainder of this year.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

On the metrics question, so there's a lot of things that we track in all of our clinical studies to really make sure that we believe we have, we're working with the highest quality sites. We're making sure we're getting the right patients in, the conduct is there. But just to give you a bit of an idea in epilepsy, we have a patient screening period, we have a baseline period, then the patients are randomized, they go through a double blind period. And then if they complete the double blind period, they have an ability to roll over into open label extension. So as we think about that, there's lots of things that we can kind of measure along the way.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

So in that kind of screening, I'll give you some examples kind of in that screening and baseline period, we can look at the patient baseline characteristics, the demographics, what their baseline seizure burden is. We can measure even before they get randomized what their compliance is going to be like to a diary. We can also look throughout the double blind to the number of things. And then we can look at rollover rates into the open label extension So there's a number of things that we kind of track along the way just to make sure that we're comfortable in terms of the way the study is being conducted.

Paul Matteis
Paul Matteis
Analyst at Stifel Financial

Great. Thank you guys so much.

Operator

Your next question comes from Tess Romero with JPMorgan.

Tessa Romero
Tessa Romero
Equity Analyst at J.P. Morgan

Hi, Ian and team. Good afternoon, guys, and thanks so much for taking our question. Following up here, can you provide any quantification on how many patients you still need to recruit for EXTOL-two? Any numbers you can put around it for us? And what are you specifically focused on to ensure you meet this guidance?

Tessa Romero
Tessa Romero
Equity Analyst at J.P. Morgan

Or is it really just par for the course here? We noticed on ClinicalTrials.gov that it seems like some additional trial sites have recently been added. And finally, can you talk to what the screen failure rate is coming out to be? And is that similar to what you saw in XDL2? Thanks so much.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Sure, Tess. I'm happy to provide my perspective. Chris, you can add to this as well. Yes, Tess, I think you kind of saw in the press release and with our prepared remarks is we're getting close. So we feel we're in the next couple of months we'll be done.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Difficult to predict exactly, there's always we've talked about in previous calls, kind of these ebbs and flows in a clinical trial like epilepsy, just given the number of clinical sites that we use overall and the number of patients that are screened or randomized from any given site is a reasonably small number that you do see some variability kind of months to months in screenings and randomizations. But I think we feel good that we're getting close to the end. We can see the finish line and we'll get there over the next couple of months. In terms of kind of new sites, yes, I mean, look, the vast majority of the sites for EXTOL-two have been up and running for some time. Obviously in the early parts of a clinical trial, if we look back in a couple of years ago, as the study was getting up and running, those sites come online at different rates for a whole bunch of different reasons.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Some of its jurisdictional based and some of it's just the individual site as we work through contracting and site visits. There's a couple of sites that have come in late. And the only reason there is because for whatever reason, maybe they now have the resources ready to participate in a clinical trial or there was something else that prevented them from starting earlier. But I think it's a very, very small number. So I wouldn't focus too much on that.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

I think what we should all be focused on is that we're getting close to the end here. Chris, anything to add?

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

I think you covered it. Thanks for the question, Tess. I guess the one piece that you asked about was the screen failure rate. So Ian already provided you with a number of metrics that we follow in the Phase three program to to ensure that the quality and the conduct of XTOL-two is heading in the direction that we want and screen failure rate is one of them. And so we haven't seen, I think as you know the inclusion exclusion criteria are really quite similar between the two studies and in fact there's sort of a pretty standard recipe that's used for FOS studies.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

So it's basically a very similar study to the Phase two. So we're seeing, so not surprisingly based upon that we're seeing screen failure rates that are very similar.

Operator

You. Your next question comes from Brian Abrahams with RBC Capital Markets.

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

Hey, good evening. Thanks for taking my questions. Really two from me. I guess, first, do you have any sense as to the reasons behind the slight timeline slippage for EXTOL-two? Are there kind of implications on kind of competitive dynamics there and any learnings that you can apply to patient finding in commercial setting?

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

And then secondly, on the Mount Sinai study, it seems like in a more mild population, I don't think they had a HAM D entry criteria there. There were fairly robust effects as good or even better than what you saw in your study. Any thoughts on how that might impact, I guess, your Phase III plan in terms of your entry criteria or any modifications there or to the powering of your Phase III in MDD, given what you're seeing coming out of Mount Sinai? Thanks.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Thanks, Brian. Chris, I can take the first one just on the timeline and any competitive dynamics and commercial stuff. And then do you want to address just any learnings from the and any read through into the phase three MDD program? So, Brian on your first question. Yeah, look, we view this as a pretty minor delay.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

We'll get there in the next couple of months and we should see data early next year. I think, as I mentioned on the last question, when we kind of take a big step back, we do see some variability just kind of months to months. So I don't think we read too much into this. On the competitive side, we're not seeing a change there. So we're not seeing the competitive dynamics change at the individual site level, given at least in our experience, most clinical sites, and maybe I should say most investigators focus on one FOS study at a time on therapeutic side.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

They're generally not running multiple. Sometimes you'd get a handful of different PIs at an institution, different PIs may focus on different things, but for the most part, the experience and feedback we've had from our clinical investigators is they're focused on kind of one study at a time. And given that, we've been in this phase three program longer than our competitors have in terms of their clinical programs right now. I don't think that's having any impact. I will just comment a little bit on the commercial setting because I think that's a really, I think that's an important question.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

When we look at clinical development and the inclusion exclusion criteria, including the baseline seizure burden that's necessary to do the statistical analysis and the powering in a clinical study, that's a very different population than what we think about in the commercial setting. And all of the work we've done commercially from primary market research to feedback from physicians at AES and all of the medical congresses, is there still this 3050% of patients that are not getting good seizure control and are really looking for new therapies. And as we've said a number of times, if we look at the profile and the attributes of EZET2 CALNER, we get this really warm reception and excitement about is that to calendar coming to market, it'll be the first time we have a novel mechanism in quite some time. If we look at the placebo adjusted efficacy from XTOL, we look at the long term open label data, the no titration, the easy to use attributes and potentially the benefit on mood as well as that we see early onset. And that's kind of a package that I think we haven't really seen in the treatment of epilepsy.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

And I think the commercial excitement continues to be there. And I would actually say the profile of is that to counter coming off of AES in Los Angeles a few months ago, AAN and all of our outreaches, the profile of the molecule just continues to grow in the medical community. But Chris, I'll let you handle the second one in terms of the IST.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Yes, sure. Thanks Ian. So, and thanks Brian for the question. I'm just going to say kind of one, make one overarching comment and then I'll answer your question directly. I'm just, I mean, I'd like to kind of zoom out for a second and just acknowledge that, you know, depression having one study after the other be positive for any drug is challenging.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

And what we're sitting on now is the second study in major depressive disorder using a Z2 counter that suggests that this drug may have activity on depression and anhedonia. Our ex NOVA study, the investigator initiated trial. But then don't forget that there were actually, there was another controlled trial with ezogabine that showed similar results and there was an open label as well. So you actually have four studies that are suggesting two different drugs with the same mechanism of action showing that this mechanism shows promise. So just on a high level, it's really, I think it's just reassuring.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

I mean, we don't know how the Phase three program is going to pan out but it's reassuring. To be more specific about your question, they use different criteria to get patients into their study. Major enrichment criteria that Doctor. Murrow and Doctor. Matthews used was the clinical global impression of change rather than the HAM D or any other depression scale.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

And I should just say this, mean, Ian and Sherry have been very consistent all along. This study is not gaining. We weren't waiting for this data to change anything. And so the punch line is that we have no intention of changing anything in the Phase three program. But I would attribute the really robust data more to the fact that it's two sites, two investigators that the data is very controlled and then things get more complex as you kind of blow out to a Phase three program with 40 or so sites.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

So anyway, I mean it's pretty impressive we got separation of active and placebo of four points at week six. The Phase three program is powered at two to 2.5 points. So I think we're in pretty good shape. And again thanks for the question Brian.

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

Thanks Chris and thanks Ian.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Thank you.

Operator

Your next question comes from Brian Skorney with Baird.

Brian Skorney
Senior Research Analyst at Baird

Hey, good afternoon, guys. Thank you for taking the question. I guess also to follow-up on the ISP study as well. Maybe you could just kind of walk through the details around the fMRI primary endpoint, what the neuroimaging expectations were here originally, what the thought process on making that the primary was and what we've seen versus other active MDD drugs that are approved on similar neuroimaging endpoints. Thanks.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Thanks, Brian. Chris, do want to address the FMRI question?

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Yes, sure. Happy to Ian. Thanks for the question. Mean, these were two academicians, Doctor. Murrow and Doctor.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Matthew who were following up on a study that they had done where the primary endpoint was fMRI with ezogabine and that study had 46 patients, less than 30 per arm. And yet the results for fMRI were somewhat promising, they were non significant in that ezogabine trial but they did appear to be promising. And so what they did is they powered a study larger than that 46 up to 60 and powered the study for fMRI to see if there was a difference and there wasn't. So I would position this as, I mean all along we've been really interested in what the clinical scale showed. But in defense of the approach it really does ask a very interesting mechanistic question about how is it that this mechanism actually improves depression and there was a hypothesis behind it about the reward circuit which I'll spare all of you the details of.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

But ultimately as a clinician and as a company we were really interested in clinical scales and they showed consistency improvements in separation between active and placebo for MADRS and CHAPS on the order of what we saw with Exnovus. So overall yes, the primary endpoint of fMRI was negative and so I don't want to dodge that but the clinical scale showing evidence of efficacy similar to what we're planning on doing in Phase III is I think a pretty good outcome for us.

Brian Skorney
Senior Research Analyst at Baird

Great, thank you.

Operator

Your next question comes from Mark Goodman with Leerink Partners.

Basma Radwan
Equity Research Associate at Leerink Partners

Hi, good afternoon. Thank you for taking our question. This is Basma on for Mark. We have a question about the NAV1.1 in Dravet syndrome. Given the competitive landscape and the multiple ongoing trials in Dravet syndrome, first, we would like to know how would you like to what's your plan to assess the efficacy of this asset?

Basma Radwan
Equity Research Associate at Leerink Partners

And also, since this is a precise approach, are you going to plan to assess behavior and cognition in your trial as well? Thank you. That's it for us.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Thank you for the question. Yeah, as you've seen in our prepared remarks and for those that had the opportunity to attend the American Epilepsy Society meeting last December, I think we're generating some really compelling preclinical data in that really gets to the heart of your question, both on seizure reduction, but the potential for disease modification as well. So, we would agree that there are a number of drugs that are used and have been developed to treat Dravet syndrome, but there's been very few that have gotten really gotten to the underlying genetic cause of the disease. And so we think to our knowledge, we're the only company that's developing an oral small molecule that can potentiate the channel that can have an impact not only in these genetic animals, these animals that actually have a 50% loss of function of Nav1.1 which is the human, it really is the human disease is that we can protect these animals from seizures, spontaneous seizures from SUDEP and then we can have this impact on long term potentiation. So that's the real potential here.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

So it is a little bit early to kind of map out the entire development plan for NAV 1.1. But given our approach, we would want to look at in clinical development both seizure reduction as well as some of those endpoints that you're referring to in terms of disease modification. And we really think that a lot of these pediatric and genetically defined epilepsy, that's where the field needs to go. We need to continue to provide better drugs for these patients both in terms of seizure reduction, but importantly disease modification. And that's really what we hope to address with the NAV 1.1 program.

Basma Radwan
Equity Research Associate at Leerink Partners

Thank you.

Operator

Your next question comes from Myles Minter with William Blair.

Myles Minter
Research Analyst - Healthcare at William Blair

Hi, everyone. Thanks for taking the question. Just on the powering, I think you've said it's XTOL-two ninety nine percent powered at 25, 90 percent at fifteen mg for that three sixty patient target enrollment. And we did some work. I think if you look at Phase II going to Phase III, the placebo doesn't really change in FOS studies, but the drug effect comes down and I think it was about a 7% on that median, seizure frequency.

Myles Minter
Research Analyst - Healthcare at William Blair

So just wondering, given your comments that you powered this study based on what you saw in XTOL, which was better than we expected, you know, do you assume some sort of effect size erosion going into Phase three? If you do, are you going to take this as an opportunity to maybe increase enrollment beyond that three sixty patient number? Just wondering how you think about that. Thanks.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Thanks Miles. Chris, can I pass this one to you in terms of the modeling for the primary endpoint in the external program?

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Yes, actually happy cover this one. So you're correct Myles, the study is powered at greater than 99% for the twenty five milligram. It's actually powered higher than 90% on the fifteen milligram arm. So, and then it's powered for multiple key secondary endpoints as well as we're interested in week one endpoints and patient global impression of change and so forth trying to get them into the label. So we think that we're covered from a powering perspective.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

I do hear what you're saying that conventionally these studies can be over enrolled at times but I would say that the study is powered appropriately right now and that we're, you know, that in general is a fairly good consistency transitioning from Phase two to Phase three in epilepsy. And the Phase two data was robust and so I think we're in good shape from a powering standpoint and enrollment perspective. Do you want to add to that Ian?

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

No, Chris, you covered it. Thank you.

Operator

Your next question comes from Laura Chico with Wedbush.

Dylan Shindler
Biotechnology Equity Research Associate at Wedbush Securities

Hi. Thanks very much for taking the question. This is Dylan on for Laura Chico. So just to clarify, how long do you envision EXTOL-three enrollment taking relative to EXTOL-two? We're just trying to understand the separation of the readout timing.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Thanks, Dylan. Yeah, we haven't given for the other two epilepsy studies or the depression program. We haven't given specific guidance to top line data. So, we go back and just remind everyone when we transition from Phase 2b, our EXTOAL study into Phase three, we focused on EXTOAL II and that was based on that being on the critical path to filing the NDA interaction that we had had at that time. And so XTOL II was up and running first and we also prioritized into XTOL II the majority of sites that we had worked with in XTOL, both from the individual site level as well as a number of the countries that we prioritized.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

And so there is a delay to XTOL three because it did get up and running later. We haven't given specific guidance on that, but it will be later than ExTOL two. I think later this year we'll be in a position to give guidance on ExTOL three.

Dylan Shindler
Biotechnology Equity Research Associate at Wedbush Securities

Thank you.

Operator

Your next question comes from Paul Choi with Goldman Sachs.

Analyst

Hi, this is Daniel on for Paul. We are interested about your trial design for the BPD. Like, do you try to stratify the BPD type one and type two in order to increase the detection for the signal to noise ratio? Thank you.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Thanks for the question. So I'll give a high level comment and then Chris, I think you can address specifically bipolar I and bipolar II in terms of the patient population that we're including in the Phase III program. But we'll provide when the bipolar registration program gets up and running in the next couple of months, we've said mid year the first Phase three will be up and running. We'll give more detailed information on the Phase three design. So standby for kind of the more granular detail on the endpoints and powering assumptions and sample size, but we can address your specific question on bipolar one and bipolar two and including both of those in the Phase three program, Chris?

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Yes, sure. So thanks for the question. So the bipolar, there'll be two studies in bipolar depression. There'll be a mixture both studies will be a mixture of type one and type two as you know, based upon the question that you're asking. So, you know, were specifically asking about stratification.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

So we, as I said in my prepared remarks, we intend to share a lot more information about those studies in the near future. I just suffice it to say that, you know, if you have a primary endpoint and you think that it can be affected by something in the study like a mixture of patients and stratification is a pretty good question to be thinking of. And I think, you know, on a theoretical level there's reason to think that there could be a little bit of a difference in the response between Type one and Type two and there's probably going to be, you know, not a fiftyfifty mixture of one and two, it will be lopsided and so I think you're making a good point about stratification, something that we're definitely seriously considering and we're going to share all that soon.

Operator

Your next question comes from Andrew Tsai with Jefferies.

Andrew Tsai
Andrew Tsai
SVP at Jefferies Financial Group

Hi. Thanks for the updates. My best wishes to Sherry. Believe that's your last earnings call at Xenon. For EXPL2, is the general guidance still to revise the data timing guidance to a specific time point over time such as a specific month or by chance could you plan to press release or announce when you do in fact complete enrollment?

Andrew Tsai
Andrew Tsai
SVP at Jefferies Financial Group

And then secondly, we know back in EXTOL there was a stronger efficacy differential for patients who are on fewer AEDs at baseline. Any color on the enrolled phase three, XTOL2 and three base patient type in terms of the number of prior and concomitant AEDs there on a baseline? Thank you.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Thanks, Andrew. Yes, I can address those. So, yes, as we do with all of our clinical studies, as we get closer to the end, you can expect us narrowing and refining that guidance just so everyone has a really good idea of when the top line data are going to be available. Generally, we've just updated enrollment in our quarters, but as we get closer to top line data, we'll definitely be refining there. In terms of the patient baseline kind of the demographics as your question on fewer AEDs and I would even broaden out, it's more than just fewer AEDs, but I think that's a good one to track.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

And obviously we track all of that. I think what we're I'm not going to give you a specific number right now because the study is still ongoing and so those things can change. But we are getting close to the end of the study. And so as you heard in our prepared remarks and in some of the Q and A already is that we're seeing kind of consistency with the XTOL study. So I think the way that you can interpret those comments is that we believe that the patient population overall in Phase three will be consistent with the Phase two population.

Andrew Tsai
Andrew Tsai
SVP at Jefferies Financial Group

Great. Thanks.

Operator

Your next question comes from Joseph Thorn with TD Cowen.

Joseph Thome
Joseph Thome
Analyst at Cowen

Hi there. Good evening. Thank you for taking my questions. Maybe the first one on the inclusion of the bipolar I patients. Maybe you could just give us a little bit more detail as to why you decided to include both bipolar I and bipolar II patients in the study, especially given the Biohaven data that came out earlier this year.

Joseph Thome
Joseph Thome
Analyst at Cowen

And then maybe just a second question on the Sinai Phase two, obviously it's small, but, I think in that study, the patients were taking two pills of ten milligrams, I guess assuming BID and then obviously your Phase two, it was twenty milligrams once a day. Do you think there is anything in sort of that two tablets versus one tablet that could have led to the greater results here? And are you thinking about changing anything relative to that? Obviously, no, it's small study. But thank you.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Thanks, Joe. Chris, do you want to just comment on BP one and two and just make sure that we're clear that obviously we're not it's not manic patients that were or patients with mania that we're enrolling. So maybe you can just go through a few details there. And also just the clarification on the dosing from the IST.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Yes, sure. So I mean, yeah, what Ian just said is critically important. So you're talking about the same patients between the Biohaven study and ours in the sense that they have bipolar but they're very different because all those are Type one by definition because they have these manic episodes. But we're interested in the portion of the disease where these patients are struggling with most of the time which is depression. So the underlying pathophysiology of the depression is thought to be pretty similar between type one and type two and we sought out, you know, advice from multiple key opinion leaders who spend time in this area of research and got a pretty consistent message that it was worth studying both.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

So we think that the chance of success is good while those patients are, you know, in a depressive state. And yeah, I mean the fact that, you know, mania study was negative from Biohaven, I mean there's been a very limited release of information. So I think it's hard to kind of know what to glean from that. I mean one thing that's reassuring is assuming that placebo and drug behaves similarly it tells us that the mechanism doesn't exacerbate mania which I think is somewhat reassuring as we go forward into bipolar depression. But I think if you take a look at the totality of the data that exists there's a much stronger argument to go forward into bipolar depression than mania and I think I actually said the same thing in the last earnings call which was before those data came out.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Thanks for the question Joseph. Tablets, yeah. So same thing.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Yeah, just on the number of, yeah.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Yeah, the quick answer is don't think that that should make any difference whether they're taking 210s or 120, same formulation. The drug has, you know, a long elimination half life and so it probably makes very little difference whether the drug is being taken, you know, once or twice and whether you're taking it as two ten tablets or one hundred twenty. So I don't think that explains any of the differences. I think, look, I mean again zoom out like there's a consistency of separation between drug and placebo on SHAPs and MADRS in two controlled studies with the Zetu counter and with supporting data from ezogabine. And you're talking about small studies, right?

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Sogabine forty six patients, our study had about fifty five patients per arm and then this study, the investigator initiated trial was about 30 patients per arm. So they're small studies and I think you're going to end up with variability and I would be cautious to kind of over interpret a point here or a point there.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

But Chris, just to I just want to be clear. I know they were taking two ten milligrams, but it was QD dosing. Oh, sorry. Yeah, in the ISC. So Joe, just to be clear, that was just based on drug supply that was available, but it was two tens versus 20, but it was QD not BID.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

And so we wouldn't have expected any differences in any of the results based on a change in dosing.

Joseph Thome
Joseph Thome
Analyst at Cowen

Okay. That's very helpful. Thank you. Your

Operator

next question comes from Jason Gerberry with Bank of America.

Dina Ramadane
Equity Analyst at Bank of America Securities

Hey, good evening. This is Dina on for Jason. Thank you guys for taking our question. First one, apologies if a similar question might have already been asked, but can you just remind us for EXALT two where seizure freedom measure kind of fits into the statistical hierarchy and if you have any assumptions for how seizure freedom rates will kind of shake out relative to the high single digit percentage that we saw in XTOL. And then for ZEN eleven twenty, just how are you guys thinking about lead indication selection and you can maybe speak to what you're hoping to see from the drug's pharmacology profile and in phase one testing.

Dina Ramadane
Equity Analyst at Bank of America Securities

Thank you.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

Thanks, Gina. I'll do Chris. Why don't I do the XC1120 question first, and then maybe I can start on the seizure freedom question and then please provide your perspective as well. So on XEN11020, so yes, really great progress. I'm overall incredibly pleased with the progress that we've been making on our discovery portfolio.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

I mean, you just think about it, we're in the last couple of months Neurocrine filed this CTA for three fifty five, which is a molecule that we synthesized. This is this NAV1.61.2 inhibitor. We have filed a CTA or in first in human for XEN1101.20 and in the next couple of months we'll be in the clinic with a NAV1.7. We finished the GLP in life for that. So three INDs in a pretty short period of time the early stage portfolio.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

So I think it's really exciting times. The first in human for XEN110 to answer your specific question will be a traditional healthy volunteer study where we're going to want to see a number of things. Going to look at obviously the pharmacokinetic profile as well as the adverse event profile at a variety of different dose levels. And then as we think about future development, what we said in our prepared remarks is we'd like to take this molecule into a proof of concept study in pain. We think there's good clinical validation and rationale to go into pain and I think that would really broaden out the applicability for the mechanism and so that's the current plans for XEN110.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

On your question on the epilepsy program in terms of seizure freedom, when we think about seizure freedom, it's all just like kind of some global comments because I think it's important to set context and then Chris can get into his perspective and some of the details is, I wouldn't say there's a standard definition for seizure freedom, but generally when we talk to clinicians is they really think about the patients over a one year period. So have they had any seizures over one year? So obviously that's something that's not tested in the double blind portion of a clinical study because the double blind portion is eight weeks or twelve weeks depending on the study. And so you really are following those patients in open label extension and seeing how they're doing over a longer period of time. And that's what's really important as we look at that kind of 100% reduction in seizure burden.

Ian Mortimer
President and CEO at Xenon Pharmaceuticals

That's why the open label data that we continue to generate and we continue to present at medical congresses. As a reminder, we started with a one year open label extension study for XTOL. We extended it to three and then five and now it's a seven year study. So we have patients that have been on a Zetu calendar for many, many years and we can look at those seizure freedom rates, which we've published, we think are really impressive over time. But Chris, maybe just talk about that one hundred percent of seizure reduction in the double blind period.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Yes, sure. I mean, think that it's worth emphasizing the epileptologists when they think of seizure freedom they're looking over a really long time horizon, not eight weeks or twelve weeks. Specifically the question was about whether seizure freedom is in the statistical hierarchy, it isn't. We're interested in the rapidity to onset that we saw in XTOL and so the week one time point is in the statistical hierarchy but not seizure freedom. Where we're really focusing on the seizure freedom is the data that we're seeing over several years in the XTOL OLE and then obviously eventually in the Phase III open label as well.

Christopher Kenney
Christopher Kenney
Chief Medical Officer at Xenon Pharmaceuticals

Thanks for the question.

Dina Ramadane
Equity Analyst at Bank of America Securities

Thank you.

Operator

I will now turn the call back over to Sherri Ahlin for closing remarks.

Sherry Aulin
Sherry Aulin
CFO at Xenon Pharmaceuticals

Thanks, everyone, for joining us today on our call. I know there were a few of you that we didn't get we didn't manage to get to your questions during the allotted time, so we'll reach out to you directly after this to connect. Operator, we'll now end the call.

Operator

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

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Key Takeaways

  • Xenon is nearing completion of patient recruitment in its Phase III XTOL-2 study for focal epilepsy and still expects a top-line readout in early 2026, maintaining confidence despite a slight delay from prior guidance.
  • Final results from an investigator-sponsored MDD trial of the KV7 opener showed consistent drug activity on MADRS and SHAPS with a >4-point separation at week 6, supporting planned EXNOVA-2/3 Phase III MDD studies and two bipolar depression trials by mid-year.
  • Early-stage programs are advancing rapidly: a Phase I trial of XEN11020 (KV7 opener for pain) is underway, a first-in-human study of XEN1101 (Nav1.7 inhibitor) is expected in Q3, and IND-enabling work continues for a Nav1.1 potentiator targeting Dravet syndrome.
  • As of March 31, 2025, Xenon reported $691.1 million in cash and equivalents (Q1 revenue of $7.5 million), providing a funding runway into 2027 to support both late-stage Phase III programs and continued early-stage development.
  • The company plans June R&D webinars on its pain programs and anticipates filing an NDA for ezetucaliner about six months after positive Phase III data, marking its evolution from clinical to potential commercial stage.
AI Generated. May Contain Errors.
Earnings Conference Call
Xenon Pharmaceuticals Q1 2025
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