Earnings Call: Q4 2019

Mar 9, 2020

Ladies and gentlemen, thank you for standing by, and welcome to the Xenon Pharma 19 Financial Results Earnings Call. Session. As a reminder, today's program is being recorded. I would now like to introduce your host for today's program, Jodi Rates. Please go ahead. Thank you. Good afternoon. Thanks for joining us on our call and webcast to discuss 2019 financial and operating results. Joining me on today's call are Doctor. Simon Pimstone, Xenon Chief Executive Officer and Ian Mortimer, Xenon's President and Chief Financial Officer. Following this introduction, Simon will give an overview of Xenon's clinical programs, and then Ian will review our financial results. After that, we will open up the call to your questions. Please be advised that during this call, we will make a number of statements that are forward looking, including statements regarding trials and preclinical development activities, including those related to our proprietary products and partnered product candidates. The potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates. The anticipated timing of IND or IND equivalent submissions and the initiation of future clinical trials for XEN496. XEN1101, XEN007, and other proprietary products, and those related to NBI 921352, FX 301 and other partnered candidates. The efficacy of our clinical trial designs, our ability to successfully develop and achieve milestones 496N496, XEN1101, XEN007 and other proprietary development programs, the timing and results of our interactions with regulators, the potential to advance certain of our product candidates directly into phase 2 or later stage clinical trials anticipated enrollment in our clinical trials and the timing thereof the progress and potential of our efficient cash to fund operations into 2022 and the timing of potential publication or presentation of future clinical data. Forward looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected on today's call. We undertake no obligation to publicly update any forward looking statements. Today's press release summarizing our 2019 year end results and the accompanying annual report on Form 10 K will be made available under the Investors section of our website at www.xenonpharma.com and filed with the SEC and on SEDAR. Now, I'd like to turn the call over to Simon. Thank you, Jody, and good afternoon, everyone. 2019 was an exciting and transformative year for Xenon. We made significant progress within our clinical stage programs, and entered into important collaborations. As a result, we have a strong balance sheet to support the development plans for our proprietary programs driving them towards critical data inflection points and resources devoted to furthering our preclinical, innovative R and D efforts. Today, I'll provide an overview of each of our proprietary clinical stage programs, including XEN1101, 496007, as well as our earlier stage discovery work and partner programs in order to highlight some of the important milestone events anticipated this year. Obviously, top of mind for businesses is the current uncertainty related to the potential impact of COVID-nineteen. Depending upon the locations of outbreaks, recruitment in clinical trials, transportation of drug product, patients traveled to sites, physicians, participation in investigator meetings, medical meetings, and additional factors in our business could all be affected. It's too early to predict the scope or nature of the impact from COVID-nineteen, but we'll continue to monitor the issue closely and we'll communicate any material changes in our business. Should these occur. I will start my update with XEN1101, which is a differentiated next generation Kv7 potassium channel modulator being developed for the treatment of adult focal epilepsy and potentially other neurological disorders. Patient enrollment for our XEN1101 Phase 2b clinical trial is ongoing in the United States, Canada and Europe. The trial is a randomized double blind placebo controlled multicenter study to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjuvantive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. The long term 6 to 9 month toxicology studies which were recently completed support the ongoing advance of patients into the 12 month open label extension stage of the ongoing Phase 2b clinical trial. Key opinion leaders and investigators are supportive of the Kv7 mechanism of action in epilepsy and feedback from sites to date has been positive. If approved XEN1101 could represent an only drug in class and support refractory epilepsy patients who are seeking effective anti seizure medications. As we've guided previously, depending upon the rates of enrollment top line results are anticipated in the second half of twenty twenty. One pending decision is whether or not we opt to conduct an interim analysis. By way of background, we have made certain statistical modeling assumptions on tolerability and potential dropouts from the study. Depending on the dropout rate data, which we have access to on a blinded basis, we can choose to have a third party statistician review unblinded data and provide guidance on resizing or reallocating to different treatment arms or doses to ensure power is maintained. We expect to make a decision We also continue to explore potential indications for XEN1101 outside of epilepsy, and there are a number of indications which we are actively exploring. We look forward to keeping you updated as these plans develop in the coming months. Also within our portfolio of proprietary epilepsy products, XEN496 is a Kv7 potassium channel modulator that contains the active pharmaceutical ingredient ezogabine, also known as retigabine, that we have reformulated and are developing as a treatment for a rare pediatric neurodevelopmental disorder called KCNQ2 developmental epileptic encephalopathy or KCNQ2DE, which is characterized by multiple daily refractory seizures presenting within the 1st week childhood onset genetic epilepsies reports the incidence of KCNQ2DE as approximately 1 per 17,000 live births which can be compared to to suggest that ezogabine may be efficacious as a treatment for KCNQ2DEEE. This is further supported by non controlled clinical studies as well as anecdotal parental and physician feedback suggesting that XEN496 may be well tolerated and reduce seizure burden with potential to improve development and cognition in this rare pediatric population. We recently presented data in December at the AES Mead King, a survey of patients and caregivers in the KCNQ2DE community, which provided feedback consistent with the Miller chap and Olson clinical case reports and added further strong support for our rationale to develop XEN496 for this rare pediatric developmental epilepsy disorder. The FDA has granted xenon orphan drug designation for XEN496 as a treatment for KCNQ2DE In response to our pre IND briefing package, that included our proposal to study XEN496 in infants and children with KCNQ2DE, FDA supported our proposed safety monitoring plans, including long term follow-up to monitor potential side effects and indicated that a single small pivotal trial could be sufficient provided the study shows evidence of a clinically meaningful benefit in patients with KCNQ2DE. The in vitro and in vivo testing done to date demonstrates that XEN496 acts as an immediate release drug, has similar pharmacokinetics to what was observed with exogamine tablets and has compatibility with common feeding devices used in pediatric dosing such as baby bottles and MG tubes. We presented all of these significant CMC advances at the AES meeting in December, Stability studies for XEN496 are ongoing and no issues have been encountered today. Late last year, we filed an IND application with the FDA related to a pharmacokinetic or PK study testing XEN496, our proprietary pediatric formulation of ezogabine in healthy adult volunteers. In January, this year, we received permission to proceed with the study, which is now ongoing. All subjects have completed dosing in the PK study and we expect to have these PK data later this III clinical design is expected earlier in the second quarter of this year, with the anticipated start of a Phase III clinical trial in KCNQ2 DEEE in 2020. Although the protocol is still being finalized, at a high level, the trial design includes a randomized placebo controlled trial using seizure frequency as the primary endpoint with both dose titration and maintenance phases. We have selected a CRO and begun work in preparation for the phase 3 trial with site selection underway. In addition, our clinical development team is planning for regulatory submissions outside of the U S in select European jurisdictions following the receipt of FDA feedback in order to support Turning now to XEN007 active ingredient of which is flunarizine, which is a CNS acting calcium channel modulator, it modulates CAV 2.1 and T type calcium channels. Other reported mechanisms include dopamine, histamine, and serotonin inhibition. We are considering various development strategies for XEN007 and have entered into key exclusive licensing agreements in order to access regulatory files and drug product manufacturing, both of which may enable advanced clinical development of XEN007. The FDA granted orphan drug designation for the treatment of hemiplegic migraine with XEN007 and granted ODD and a rare pediatric disease or RPD designation for the treatment of alternating hemiplegia of childhood with XEN007. During our analysis of potential neurological indications, we identified childhood absence epilepsy or CAE as a potential indication for XEN007. 7 has demonstrated efficacy in preclinical models of absence seizures, and flunarizine has been shown to be well tolerated clinically. To provide a bit more background on CAE, Approximately 10% of seizures in children with epilepsy are typical absentee seizures. Age of onset ranges from 3 to 13 years with a peak at 6 to 7 years. Abson seizures can have a significant impact on quality of life. Episodes of unconsciousness may occur at any time and usually without warning. Effective children need to take precautions to prevent injury during absence periods. And should refrain from activities that would put them at risk if seizures occurred. Often school staff members are the first to notice the recurrent episodes of absence seizures. And treatment is generally initiated because of the adverse impacts on learning. The physician led phase 2 proof of concept study is now ongoing. To examine the potential clinical efficacy, safety and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed treatment resistant childhood absence epilepsy. It is anticipated that the study will enroll up to approximately 20 patients with CAE in an open label manner after failing standard of care because of lack of efficacy or because of adverse events. Results from this phase 2 study are expected in 2020. Results from the CAE study will help shape our development strategy for XEN007 and may represent a potential orphan indication indication for future development of XEN007. Just briefly, I'd like to also highlight that we continue to make an exciting progress in our early stage discovery work. Our deep knowledge of the genetics of channelopathies combined with our proprietary biology and medicinal chemistry know how have positioned Xenon as a leader in small molecule ion channel drug discovery. Our robust pipeline of early stage preclinical candidates encompasses our work related to a number of sodium and potassium channel targets. For example, our preclinical data suggests that a highly selective small molecule potentiator of NAB1.1 could potentially address the underlying cause of Dravet syndrome using a precision medicine approach and may have utility and other neurological indications where interneuron excitability is impaired. We intend to build upon this promising work and expect to highlight this exciting and novel preclinical work as it matures. We also presented some of our preclinical NaV11 potentiator data at AES in December and the poster is on our website. Turning now to our partnered programs. We have an ongoing collaboration with Neurocrine Biosciences, to develop novel sodium channel inhibitors as treatments for epilepsy. To XEN901, now known as NBI921-352, a clinical stage selective NAV 1.6 sodium channel inhibitor as well as novel selective NAB16 inhibitors and dual NAB1.21.6 inhibitors that are in preclinical development. The agreement also included a multiyear research collaboration to discover, identify and develop additional novel NaV1.6 and have 1.21.6 inhibitors. We believe that this collaboration with Neurocrine was a thoughtful and strategic decision allowing us to invest in and maximize the potential of the later stage potassium channel assets in our pipeline, while still ensuring there is significant investment in the XEN901 and next generation selective sodium channel programs. Both xenon and Neurocrine have a keen interest in precision medicine therapies our combined expertise in neuroscience and ion channel modulation represents a powerful partnership. Neurocrine has indicated a strong interest in addressing the unmet medical needs of patients with SCN8ADE, a rare, extremely severe single gene epilepsy caused by mutations in the SCN8A gene that result in a gain of function in the NaV1.6 sodium channels. SCN8A DEE typically presents with seizure onset between birth and 18 months of age. Most children diagnosed with SCN8AEE of seizures that can occur multiple times a day and are often difficult to treat. Neurocrine plans to conduct placebo controlled study with NBI 921352 and anticipates filing an IND application with the FDA in mid-twenty 20 in order to start a Phase 2 clinical trial in SCN8A DEE patients in the second half of twenty twenty. We are eligible also indicated that NBIN21352 may have potential in a range of seizure disorders, including adult focal epilepsy. Moving now to our partnership with Flexion Therapeutics, which has global rights to develop and commercialize FX301 formally XEN402, and NaV1.7 inhibitor. Flexion's preclinical FX301 program consists of XEN40 2 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of postoperative pain. Flexion has indicated that it anticipates initiating FX301 clinical trials in 2021. I believe that Xenon currently has one of the most exciting epilepsy pipelines currently in development and strong relationships with our valued collaborators. Bolstered by a healthy balance sheet, we are entering a data rich period with the expectation that a number of our product candidates will enter mid to late stage clinical trials or generate important clinical data in 2020. At this point, I'll ask Ian to recap our financial position and to provide some closing commentary before opening up the call to your questions. Ian? Thanks, Simon, and good afternoon, everyone. The specific details within our financial statements are covered in today's press release and also in our 10 K filing. So I'll provide an overview and conclude with a summary of our upcoming milestones. In addition to the advancement of our clinical development programs, which Simon conveyed, 2019 marked an important year for us in the capital markets. The progress made within our proprietary programs as well as the upfront and when we raised over $100,000,000 from an underwritten public offering and from sales under our at the market equity or ATM offering. These efforts resulted in an extension of our cash runway and which include fully supporting the planned clinical development of XEN1101496007 as well as providing support to our preclinical programs, we anticipate having sufficient cash to fund operations into 2022. Excluding any revenue generated from existing partnerships or potential new partnering arrangements. On the call today, I'll session. I'll refer to you to our news release and our 10 K filing for additional detail, especially on revenue and operating expenses. Cash and cash equivalents and marketable securities as of December 31, 2019, were $141,400,000. And this compares to $119,300,000 as of December 31, 2018. As of December 31, 2019, there were approximately 28,100,000 common shares outstanding and approximately 1,000,000 Series 1 preferred shares outstanding. Which are convertible into common shares on a 1 for 1 basis at the option of a holder subject to certain limitations. As I noted, subsequent to December 31, 2019, we raised additional net proceeds of approximately $102,800,000. Net of underwriting discounts and commissions, but before offering expenses. From the sale of common shares under our ATM agreement, and an underwritten public offering. Therefore, raising over $160,000,000 in December January through equity offerings and the Neurocrine transaction places Xenon in a strong financial position to execute on our business over the coming years. I'm extremely proud of the progress to support anticipated milestone events including expected top line data from the ongoing XEN1101 Phase 2b clinical trial in adult focal epilepsy in the second half of twenty twenty and further exploration of other potential clinical indications for this novel Kv7 potassium channel modulator. Completion of the ongoing XEN496 PK study this quarter, followed by anticipated FDA feedback on our phase 3 protocol early within the second quarter, placing us in a position to initiate a phase 3 pivotal trial with XEN496 in patients with KCNQ2DE in 2020. And results from the physician led Phase 2 open label study in treatment resistant CAE with XEN007. We also anticipate important milestone events from our collaborators which provide opportunities for us to earn milestone payments as they advance through development. Our collaborator Neurocrine expects to file an IND in mid-twenty 20 in order to start a phase 2 clinical trial for NBI 921352 in SCN8A DE pediatric patients. Acceptance of this IND would provide a meaningful $25,000,000 milestone payment in cash and equity. And lastly, Flexion continues its development planning for FX 301 and anticipates initiating clinical trials in 2021. We expect that 2020 will be another important year for Xenon, we're excited about keeping you informed of our progress. Certainly. Our first question comes from the line of Paul Matteis from Stifel. Your question please. Great. Thanks for taking my questions and congratulations on all the progress. I have a couple one on 1101 and a couple others on other programs. On 1101, what's downside to conducting an interim analysis? You said you were thinking through whether or not you'll do that. Obviously, the upside if you get more information on the study and how to design it. Is there any downside? Like, are you spending any alpha or anything like that? And then there's a couple of quick follow ups. Thank you. Paul, Simon here, and you may want to provide any additional color. Yeah, I mean, look, there is a small alpha hit. You know, if we were to do it, I don't think that is going to be the driver of the decision. But that would really be, some downside to the interim. As we've said and we've talked about on today's call, we are seeing data on a blinded basis. And so reality is the study is pretty well powered close to 90% to see a 15% difference. And if we meet that, we'll meet statistical significance Obviously, with certain dropouts, assumptions modeled in and certain standard deviation assumptions modeled in. And if dropouts are, you know, substantially lower than what we've modeled, you know, we just don't see a significant need to run that study. And it's not really so much a major positive, a major downside, liability. I'm just not sure, you know, we need to take any alpha hits if we don't need it. Ian, anything Yeah. I mean, the other just kind of practical part of this is to do a real interim analysis, you have to have essentially the database complete at that, at that kind of data. And so by the time you have those patients enrolled with all of the baseline maintenance and then follow-up. And then you actually make sure that you have clean data and you do that analysis, you're essentially complete enrollment in the study anyway. So there's just a practical consideration here. As Simon mentioned, if we go through the analysis and we believe this is a well powered phase 2 study, if there's not going to be a lot of benefit, we get we likely get to top line data a little bit quicker if we don't do the interim analysis. Okay. Is there a futility analysis as part of what you're considering? No. I mean, we haven't formally, model the futility into that. So, no, it was really just a resizing to any of the additional dose or active arms pool. Yeah, I mean, all I'd add is, if Simon's correct, this wasn't designed as futility. It was really more designed that would you reallocate and resize. If you look at the, you'll know the details of the trial design on a 2 to 1 to 1 to 2 basis going from the 20 epo. So if tolerability wasn't good in your top dose, there, the trial isn't designed that you drop down during the study to a lower dose. So you would want to increase some of those other arms if that's a concern. So that's really why the interim analysis, was identified a priority. That said, if the if the if we do go ahead with the interim analysis and, and and the study is futile, then obviously we would have that feedback. We wouldn't want to expose patients to a drug that doesn't have a chance of working, but that's really not that wasn't the purpose going in. Okay. Fair enough. And then one more clinical question and one quick a quick financial question. On 496, in the past, Simon, you've talked about a pivotal study that because of the sample size might have a statistical hurdle at 0.05 might even be more of a kind of numerical comparison or a certain seizure reduction threshold for drug over placebo. I don't know how much you want to get ahead of the FDA meeting or FDA feedback, but I'd be curious where your head is at there. And then, Ian, if you don't mind just quickly, we'd be curious how you guys are planning on accounting for different milestone payments in the Neurocrine agreement. It looks like the one that was received in 4Q wasn't recognized upfront and how that might work going forward with different things like IND filings would be helpful. Thank you. Yes. Paul, thanks, Simon. I'll tackle the first and then we'll tackle the second. Yeah, look, I don't want to get too much ahead of obviously the FDA given we do expect as has been guided today, we expect feedback early in Q2, which isn't too far away. We do, we will be looking and certainly have proposed a protocol that will have a P value, meaning statistical significant, endpoint, and with the modeled assumptions built in, believe we can achieve this with a few dozen patients, Paul. You know, a lot depends obviously on the endpoint being measured the frequency of that endpoint. And so, we clearly are orienting this more towards kids that have a higher frequency or burden of seizures to allow, you know, a meaningful reduction, both clinically as well as statistically in a reasonable period of time. So that is currently contemplated. Yes, we are expecting the FDA will likely want to see a P value hit. And we are expecting, we would want to, as community would want to see a clinically meaningful difference in seizures met. Both of those are important and we believe the model currently incorporates both of those elements satisfactorily. We have had extensive dialogue with a number of KOLs with the patient advocacy group in coming up with a final proposed protocol to the FDA. As I said, we expect to get feedback soon. And depending obviously on material of that feedback and we may or may not require a couple of rounds with the agency We do expect to obviously communicate the what will be the accepted protocol once that is available. So but I hope that answers your question at a high level. Ian, the second was just regard accounting for my Yes. So, not to go into a lot of detail right now on the call and we can follow-up afterwards. So obviously the accounting and revenue recognition with any collaborative agreement is quite complex. And we just posted it, within the last half hour, our 10 K on the website. So I do encourage you to take a look at the notes of the financial statements that walks through the accounting for Neurocrine. You know, just at a high level, you know, for the upfront payment, obviously that's recognized and this is often the case in collaborative agreements that that upfront payment is recognized over a period of time and there's a number of performance obligation under that and the details are in the financial statements and then I can answer any more follow-up questions. Specifically, as it relates to your question around stone payments. Again, it depends on the nature of the milestone payment. I'll make a very general comment. Often milestone payments are recognized in the period in which there earned. But that is just a general comment and we would have to look under all of our collaborative agreements, any milestone payment in and how it was achieved and if there's any additional performance obligations under that milestone. All right. Fair enough. Thank you, both. Appreciate it. Our next question comes from the line of Tim Lugo from William Blair. Your question please. This is Lochwin on for Tim. Thanks for taking the questions. First of all, I was just wondering, you said you're expecting feedback from the FDA early second quarter. If that is positive and they're fine with what you've proposed, are there any other gating factors just getting that trial for 496? Not at the moment. We believe that our drug substance and drug product supply is safe But of course, that's always something depending on, how supply chain is affected with COVID. But we have, we have the drug available. We expect as, again, we've just updated to have the final PK data from the adult volunteer study this quarter as we've previously guided, we would. That is on track. That data is obviously important in helping to finalize the protocol in terms of dosages and titration phase. We're making certain assumptions based on the non clinical in vitro and PK data we have in terms of the performance of the drug. So those are some of the issues we'll have to build in, but we don't see any other gating items per se sites that can participate that may be affected by COVID will obviously have to be understood and monitored and we'd select sites accordingly. So as I'm sure you and others have heard on a number of these types of reports or updates. I think it's just a bit early to know what the impact might be on the full supply chain for our clinical studies, but no other gating items that we're aware of. We've previously, for example, asked the FDA on, whether they believed any additional non clinical tox work for 496 would be required. They said no. So again, things may change at the FDA, but we, you know, we're acting on the base of previous guidance that we've been given. So nothing else that I can think of other than what I've outlined today. Okay, great. Thank you. And in terms of 1101 enrollment, could you just talk through sort of how that's been trending and if there have been any changes Yes. No, we as we always say every quarter, and with investors, we don't give guidance mid study in any of our trials in terms of enrollment. We're expecting data by the second half of this year as we've continued to guide. We're on track for that currently. So again, what the future holds in terms of COVID, I can't speak to, but so far guidance remains. Thank you. Our next question comes from the line of Yatin Snoja from Guggenheim Partners. Your question please. Hey guys, thank you for taking my question. A couple of questions on 1101. With regard to the interim analysis, if that were to happen, like what would be the triggering factor? Like what are you waiting for to decide whether you'll take that look or not? And then how will you communicate to us? Will we just get a PR once it has happened? And at what level of enrollment will that be conducted? So again, it's Ian. The interim analysis initially was planned, after about 60% of the trial had been enrolled. But as Simon mentioned previously, we see blinded safety data on an ongoing basis. So again, if we believe that as we answered at the first question, if we believe that, the trend as well within, how the study was modeled upfront, then we can make that determination at any time. And for us, this is going to be in the near term. We'll make this decision And once the decisions made, yeah, we've had a number of questions from investors and analysts on the interim analysis. And so once we make a definitive decision one way or another internally, then we would communicate that broadly. Okay. That's good. And then maybe just talk about the placebo, what are your expectation for a placebo arm in that trial? Is there a change in how the placebo response has evolved over the last, let's say, 5 to 10 year adult focal epilepsy, how should we think about that? Yes. So two questions there. Maybe I'll answer the last part of your question first. Yes, I mean, I think as with a number of diseases epilepsy is not immune. We've seen an increase in the placebo response rates certainly for focal epilepsy in adults over the last decade or so. The ezogabine pivotal trials saw placebo rates in and around the mid teens to high teens. We have modeled essentially blindly the placebo response rate yet in the sense that the study is powered to detect a 15% difference between the active and the placebo frequency seizure frequency. So if active has a 40% reduction and placebo has a 25% reduction assuming your dropout numbers are fine and assuming your standard deviation is as modeled or better, you'll meet your P value even with a 25% placebo. So we've we've set what we term a floating placebo because of that. I think probably if you had to ask people today, you know, what would they typically model as a placebo rate? Today for focal epilepsy, it's probably in and around 20%. Now it can be a bit higher. It can be a bit lower. It may depend on jurisdiction. But again, we're going to sites that are well versed in these trials. We don't expect surprises, but the fact that we've modeled this difference with a floating rather than a fixed placebo rate, I think helps us, you know, and as I said, if we see that 15% difference with the numbers and standard deviations within what's assumed will meet our P value. Got it. Very helpful. And just one final question for Ian. Ian, could you maybe help us with the P and L? How should we model and D and G and A going forward, is it more going to be back end oriented or should be sort of incremental increase quarter over quarter? Yes. So if you look at our OpEx for 2019, OpEx was about $50,000,000. So that's a breakdown of $39,000,000 in rough terms, $39,000,000 in in R and D and about $11,000,000 in G And A. Although we don't give specific, guidance on OpEx when you just look at the business, in terms of 1101, so obviously that was a big line item of spend in 2019. That'll continue in 2020. And likely increases as more patients roll over into open label extension, because that's another part of that study. And so as we get all the patients enrolled and move over to OLE, those expenses will continue to increase. And then obviously the other big change in our business from 2019 2020 is moving 496 into the pivotal program. So overall, I do expect OpEx to increase in 2020 over 2019. But I still think the kind of key message is when you look at our balance sheet and with that increase in OpEx, we comfortably have more than the 2 years of cash, well into 2022. Thank you. Our next question comes from the line of Maury Raycroft from Jefferies. Your question please. Hey, everyone. Congrats on the progress and thanks for taking my questions. For the 1101 Phase 2b, Just wondering if you can comment on what you're seeing for safety and dropout rates and whether you're seeing anything different across the different doses And then is it possible to start this to stop the study early if you succeed on efficacy at the interim? Yes. Look, Maury, we again, we we don't typically comment mid studies for this or any other trial. It's just been our policy. I mean, we're encouraged by what we're seeing, but we don't give any specifics around dropout rates. Conversion to early safety tolerability, but we do remain very encouraged by what we're observing. Of course, it's all on a blinded basis. So I have no ability to make for infer any association with with safety tolerability or dropout or based on dose groups. You know, we have not made any decisions on stopping study, the study early. We don't expect to, the interim as we had designed it was really for resizing. Should we need to add numbers to some of the lower dose arms based on tolerability. It really wasn't to perform in efficacy review today or when it's done. So I don't think you'll see us stopping the study early no matter what whether interim is done. I don't think you'll see that happen. So that's really, I think the best way I can answer this today. Got it. That's helpful. And then for the 7 trial, I'm just wondering if that study is posted online anywhere And then if you can just remind generally what the design is for that one and provide any general update on how the study is going. If you've actually dosed anybody study yet? So we are dosing. We have patients randomized for a few months already. The study is not posted, but as we have, I think, in our last quarter, we provided a bit more color on that. But we certainly we'll do that again. It really is, these are, it's open label. So it's not controls. These are not randomized to Placebo. These are patients who have either failed current gold standards, which include sodium valpro8s and ethosuximide as the current gold standard for absence epilepsy. So patients have either failed and remain refractory having daily to weekly seizures or intolerant of 1 or both of those agents. So these are refractory patients and or intolerant. They are started at a lower dose and titrated upper dose level based on tolerability. Maintenance, I believe, is for 12 weeks. And with a follow-up visit 1 month after So, again, we haven't guided on numbers and recruitment, but we expect top line to readout this year. I think that's probably sufficient on the study design at this point. Thank you. And this does conclude the question and answer session of today's program. I'd like to hand the program back to Jody Rates for any further remarks. Thanks everyone for joining us today. We look forward to keeping you updated on our progress. Operator, we will now end the call. Thank you. And thank you ladies and gentlemen for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.