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Xenon Pharmaceuticals Inc. Q1 FY2022 Earnings Call

Xenon Pharmaceuticals Inc. (XENE)

Earnings Call FY2022 Q1 Call date: 2022-05-10 Concluded

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Operator

Good day. Thank you for being here, and welcome to the Xenon Pharmaceuticals First Quarter Results Call for 2022. All participants are currently in a listen-only mode. After the presentation, there will be a question-and-answer session. I would now like to turn the conference over to Ms. Sherry Aulin, Chief Financial Officer of Xenon Pharmaceuticals. Please go ahead.

Thank you. Good afternoon, everyone. Thank you for joining us on our call and webcast to discuss Xenon's first quarter 2022 financial and operating results. Joining me are Ian Mortimer, Xenon’s President and Chief Executive Officer; Dr. Chris Kenney, Xenon’s Chief Medical Officer; and Dr. Chris Von Seggern, Xenon’s Chief Commercial Officer. Please be advised that during this call, we will make a number of statements that are forward-looking, including statements regarding our and our collaborators' development plans; anticipated regulatory interactions and submissions; anticipated results and timelines; the potential efficacy, safety profile, addressable market and commercial potential of our proprietary and partnered product candidates; the efficacy of our clinical trial designs and anticipated enrollment; the potential receipt of milestone payments and royalties from our collaborators; our expectation of having sufficient cash to fund operations into at least 2024; and the timing of potential release 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 Xenon's first quarter 2022 financial results and the accompanying quarterly report on Form 10-Q will be made available under the Investors section of our website at www.xenon-pharma.com and filed with the SEC and on SEDAR. Now I'd like to turn the call over to Ian.

Thanks, Sherry. Good afternoon, everyone. Thanks for joining our call. Today I will provide a high-level update on our proprietary pipeline programs and then I'll turn the call over to Chris Kenney, who will provide additional color around the new developments and next steps within our XEN1101 program, including the newly initiated XEN1101 Phase 2 clinical trial in major depressive disorder or MDD. Sherry will conclude our call by providing an update on our partner programs and briefly summarizing our financial results and anticipated key milestone events ahead. Within our own proprietary pipeline, we continue to support our ongoing XEN496 Phase III EPIK pediatric clinical trial, which is a randomized double-blind placebo-controlled parallel group clinical trial evaluating the efficacy, safety and tolerability of XEN496 in approximately 40 pediatric patients, aged one month to less than six years with KCNQ2-DEE. Based on published physician case studies with ezogabine and its Kv7 mechanism of action, we believe that XEN496 has the potential to address an important unmet medical need. We continue to receive encouraging feedback from clinicians, caregivers and patient advocates on our XEN496 program including most recently at the Pediatric Academic Societies Conference in Denver. There is significant interest in the opportunity to provide a precision medicine which has the potential to positively impact the lives of these young patients. We continue to build momentum with new sites and jurisdictions coming on board and we expect to complete the XEN496 EPIK Phase 3 clinical trial in 2023. Turning now to our XEN1101 program. We have made significant progress advancing XEN1101 into a broad clinical development program, in both epilepsy and depression. Building on our topline Phase 2b X-TOLE results in adult focal epilepsy from last fall, we continue to accrue compelling evidence from various subgroup analyses of the X-TOLE data and the safety and efficacy data from the ongoing X-TOLE open-label extension study or OLE. Most recently at Ascent 2022, the annual meeting hosted by the American Society for Experimental Neurotherapeutics, we presented additional data showing that XEN1101 has demonstrated substantial efficacy in a difficult-to-treat patient population, with even more impressive efficacy in subgroup analysis of patients with less severe disease. Later this year, we expect to be in a position to share additional XEN1101 X-TOLE data both from additional subgroup analyses including a time course to efficacy analysis, as well as data from the ongoing X-TOLE OLE. As we analyze additional XEN1101 data, our confidence continues to grow based on robust compelling and consistent data across seizure reduction endpoints and subgroups and in the OLE indicating that XEN1101 could play a key role in treating adult patients with focal epilepsy. We are excited to be able to share additional data, augmenting the already impressive profile of XEN1101. In addition to its robust efficacy, the tolerability profile of XEN1101 is consistent with an active CNS drug and its adverse event profile is in line with other anti-seizure medications. XEN1101 also presents other differentiating attributes including its unique potassium channel mechanism, and a dosing regimen of one pill, once a day with no titration required. Our team is excited to continue to advance this program and has made considerable progress over the last quarter. We have finalized the proposed trial designs for our two Phase 3 clinical trials along with completing CRO vendor selection. Our end of Phase 2 meeting with the US FDA taking place this quarter also marks an important milestone. We look forward to providing an update from this important regulatory interaction after we receive written FDA minutes. In addition, we anticipate providing further details around the potential expansion into another epilepsy-related indication in the coming months. We have also made great progress in our work examining indications outside of epilepsy. We are excited that our Xenon-sponsored Phase 2 clinical trial, which we are calling X-NOVA is now underway to assess if XEN1101 improves depressive symptoms in patients with MDD and anhedonia. In addition, the investigator-led Phase 2 MDD study with our collaborators at Mount Sinai continues to progress. So in summary, this is an incredibly exciting time at Xenon, with a number of mid- and late-stage clinical trials ongoing and more on the horizon. On behalf of the entire team, we look forward to keeping you posted on our progress. So I'll pause here and ask Chris Kenney to provide some more details on X-NOVA and other developments within our clinical programs. Chris?

Speaker 3

Thanks a lot, Ian. We've made a lot of progress driving forward multiple ongoing clinical trials and planning for XEN1101 Phase 3 initiation. Let me start by providing further details about the Xenon-led XEN1101 MDD trial. As background, we've built a strong scientific rationale to support our exploration of XEN1101 as a treatment for symptoms of depression in anhedonia. Published preclinical studies suggest that increased activity of KCNQ type potassium channels reverses depressive phenotypes following chronic social defeat stress. We conducted our own preclinical work with XEN1101, including data published at the 2021 Ascent Conference that demonstrated a potential benefit of XEN1101 in mood disorders. Further, the efficacious doses in plasma concentrations from the rodent depression and anhedonia and epilepsy-related MES studies overlap, suggesting that the exposure concentrations of XEN1101 in epilepsy patients may also provide appropriate drug exposure to have a beneficial impact on mood. In addition, a paper published in the American Journal of Psychiatry outlined statistically significant clinical results generated from a randomized placebo-controlled clinical trial that explored the targeting of KCNQ channels as a treatment for MDD and anhedonia using ezogabine. The results from our own X-TOLE Phase 2b epilepsy clinical trial showed an efficacy signal in focal onset seizures with all doses, including the low dose of 10 milligrams which had an excellent tolerability profile. So you will see within our MDD trial design, we intend to further study the 10-milligram dose alongside the 20-milligram dose. X-NOVA will enroll approximately 150 subjects who will be randomized on a 1:1:1 basis into three treatment arms; 10 milligrams, 20 milligrams and placebo. The primary objective is to assess the efficacy of 10 milligrams and 20-milligram doses of XEN1101 compared to placebo on improvement of depressive symptoms and subjects diagnosed with moderate to severe MDD, using the Montgomery-Åsberg Depression Rating Scale, or MADRS, change through week six. Secondary endpoints include improvement of anhedonia as assessed by the Snaith-Hamilton Pleasure Scale, or SHAPS, through week six, as well as improvement of anxiety using the Beck Anxiety Inventory Scale. We anticipate topline results from the X-NOVA study in 2023. In parallel, our collaborators at the Icahn School of Medicine at Mount Sinai are conducting an investigator-led clinical trial examining XEN1101 in approximately 60 subjects with MDD. Their primary objective is to look at the effect of XEN1101 on the brain reward circuit, as measured by the change in bilateral ventral stratum activity using functional MRI. Secondary measures will look at the effect of XEN1101 compared to placebo on depression and anhedonia using the MADRS and SHAPS scales respectively. We believe there's a strong medical need for new therapies and modalities to treat depression and importantly, depression commonly exists as a comorbidity in epilepsy patients. Our belief is bolstered by the market research we conducted to better understand the treatment landscape and unmet medical need in MDD. Physicians indicated the need for new treatments with alternative mechanisms of action for patients inadequately managed with SSRIs and SNRIs. We believe the Kv7 mechanism may offer a compelling clinical alternative for these patients in the future and I look forward to keeping you up to date on our progress as we further explore the use of XEN1101 as a treatment for MDD. In summary, and as Ian noted, in addition to MDD, we're excited to move forward with our Phase 3 plans for XEN1101 in focal onset seizures. Our end of Phase 2 meeting with the FDA allows us to obtain agreement on our Phase 3 program and the overall data package you need for NDA filing. After incorporating this feedback, we intend to engage European regulators through scientific advice to obtain agreement on the XEN1101 Phase 3 program. Our indication expansion efforts also continue and I look forward to updating these plans in the coming months as well. I would like to now turn it over to Sherry to summarize our partnered programs, financial position and briefly recap upcoming milestones. Sherry?

Thanks, Chris. Before I make a few comments on our Q1 financials, I'm pleased to report progress from our partnered programs with Neurocrine Biosciences and Pacira Biosciences. Of note, we received a milestone payment from Neurocrine Biosciences in connection with successfully reaching a collaborative milestone within the quarter. Both collaborators have clinical studies underway. Pacira is conducting a Phase 1b proof-of-concept trial that's evaluating the safety and tolerability of PCRX301 administered as a single dose in patients undergoing bunionectomy. And Neurocrine now has two separate Phase 2 clinical trials underway evaluating NBI-921352 in adult patients with focal onset seizures and pediatric patients with SCN8A-related epilepsy. And Neurocrine has guided that they expect to have data from the focal epilepsy study in 2023. We look forward to keeping you updated as these partners programs reach important milestones. Next, I'll briefly touch on the highlights from this quarter's financial statements. Please refer to our news release and 10-Q report filed today for more detailed information from Xenon's financial statements. Cash and cash equivalents and marketable securities as of March 31, 2022 were $537.9 million compared to $551.8 million as of December 31, 2021. Based on current assumptions which include fully supporting the planned XEN1101 clinical development program, XEN496 and preclinical and discovery programs we anticipate having sufficient cash to fund operations into at least 2024 excluding any revenue generated from existing partnerships or potential new partnering arrangements. Looking ahead there are a number of key objectives and milestone opportunities within the Xenon pipeline. So following our end of Phase 2 meeting in the second quarter and receipt of final FDA minutes we anticipate being in a position to share our final Phase 3 plans for XEN1101. In parallel, we'll continue to evaluate and plan for an XEN1101 program in another epilepsy indication and expect to be in a position to outline our plans in the coming months. We'll provide continued support for both X-NOVA and the ongoing investigator-led study examining XEN1101 in MDD and with the ongoing advancement of our EPIK Phase 3 clinical trial in pediatric patients with KCNQ2-DEE, our team is driving towards study completion in 2023. In summary, we intend to continue to build on the positive momentum and excitement generated since the release of our top-line Phase 2b X-TOLE results last fall. We're grateful for the ongoing support of our shareholders and Ian and I have had the pleasure of conducting in-person meetings at recent conferences with some of you on the call. With a strong balance sheet and prudent management of capital, we believe Xenon is well positioned to support our business objectives across our proprietary programs and we look forward to reporting our progress in the coming quarters. I'll now ask the operator to open the line for any questions.

Operator

Your first question comes from Andrew Tsai from Jefferies. You can now ask your question.

Speaker 4

Hi, very good. Thanks and good afternoon. Thank you for taking my question. My first one is on 1101. Clearly, the base case for you guys for your Phase 3 program is to do two studies regardless. Although you will see if the FDA is willing to consider X-TOLE as a pivotal study. So, my question is are there precedents out there where the FDA kind of explicitly told the sponsor we'll consider your Phase 2 as a pivotal study. So, in other words could we expect that level of detailed confirmation from the FDA? Thanks.

Thank you for the question. I'm happy to address it. We have been consistent in our messaging and communication with investors. We believe the X-TOLE data are very strong, and we plan to ask the FDA at the end of our Phase 2 meeting if X-TOLE can be considered one of the two registration studies. Regardless of the outcome, we have made it clear that we will conduct two Phase 3 clinical trials. As for clarity, we will seek to understand what we can receive from the FDA once we have the meeting minutes, and then we will be able to share that information publicly. In terms of precedent, we do not have access to regulatory minutes from other companies, but we have observed other companies' disclosures that suggest it is possible to communicate whether their Phase 2 study has been recognized as a registration study based on efficacy.

Speaker 4

Makes sense. Thank you. And my follow-up is on the MDD program that you started up. Can you kind of talk about the powering assumptions whether both doses need to work for the study to succeed? And how have you tailored your MDD study to succeed in terms of the trial design? Any differences here for the X-NOVA study versus ezogabine's prior placebo-controlled study for instance? Thank you guys again.

Sure. Chris Kenney do you want to walk through both kind of our company-sponsored design and some of the things that we're doing a little bit differently as well as the powering question?

Speaker 3

Sure. Happy to do so Ian. So I mean I think the first thing just to kind of take a step back I mean you have with ezogabine you have a drug that demonstrated improvement in focal onset seizures. And now we've done the same with a similar mechanism using XEN1101. And when we think about the differences in the potencies and we think about it there's a significant difference there but we think that there's overlap in terms of the doses that we use and the doses that they use that was effective in FOS. And same thing with MDD that we're currently using doses that were quite similar when you take into account differences in potency with what ezogabine used in the small proof-of-concept study that was positive in MDD that was alluded to earlier. And the difference there is that they were able to demonstrate statistical significance in a study with about half the number of patients per treatment arm. So in the context of that we think that there's a reasonable chance that if XEN1101 is effective in MDD that we'll see it. I mean do you want me to go further in terms of that, or do you want me to leave it there and then go back to the study design?

Yes, let's discuss the study design a bit. There are always questions about how to manage the placebo rate, so I can address that and then we can dive deeper into the powering calculations if you'd like. I'm happy to go through those as well.

Speaker 3

In planning for the success of this study, we are taking several careful steps. Firstly, we are limiting the number of sites and ensuring that each selected site maintains the highest possible quality. We have observed variations in placebo effects across different regions, but I can confirm that all chosen sites are located in the US. Selecting a reputable Contract Research Organization was essential, and we undertook a thorough process to make that selection. We are collaborating with CT&I to conduct a remote eligibility review for patients. Once a site identifies that a patient qualifies for the study, that patient undergoes a remote review based on the information provided, which includes an independent assessment confirming the diagnosis of Major Depressive Disorder (MDD) and evaluating the severity of the MDD. This review team, comprised of psychiatrists and psychologists from Mass General, will also assist in training the raters and monitor the process over time. We are implementing various strategies to ensure a successful trial. Additionally, having twice the number of patients per arm compared to the previous positive study with ezogabine should also contribute positively to the results.

Thanks, Chris. Let’s move on to the next question.

Operator

Your next question comes from the line of Paul Matteis from Stifel. Your line is now open.

Speaker 5

Thank you for taking my question. I have a couple of inquiries. Regarding XEN1101 in epilepsy, based on FDA and EMA feedback, do you think the EMA will favor a responder analysis as the main endpoint, or might the FDA show a preference for median seizure reduction, and are there any other differences you anticipate? Additionally, about the other seizure indication, I’m curious—while I don't want to speculate on your plans—if you consider pursuing generalized seizures or similar conditions, could you highlight other seizure populations that could significantly impact the practical use of this drug? In other words, if you obtain a label for both procedures, would you need a broader indication to effectively expand prescriptions within the refractory population? Lastly, in MDD, how are you managing the use of concomitant antidepressants or the impact of prior antidepressant treatment in refractory cases? Thank you.

Thanks, Paul. I'll address the first question, and then Chris Von Seggern can discuss the market opportunity and other seizure disorders beyond focal. After that, Chris Kenney can answer the content question about MDD. Regarding your first question about regulators in the US versus Europe, you accurately pointed out that we anticipate US regulators, specifically the FDA, will focus on MPC, which is the primary endpoint of the X-TOLE study and will also be the primary endpoint in the Phase III program. In contrast, European regulators will emphasize the responder analysis or RFD, which is crucial and was the first secondary endpoint in X-TOLE. We can perform that analysis and review it under the statistical analysis plan. Given the robustness of the data with 1101, we observe significant consistency across both endpoints, and we see strong statistical significance for both, as expected with a highly effective drug based on these analyses. Now, Chris Von Seggern will expand on the market opportunity beyond focal.

Speaker 6

Absolutely. As mentioned earlier, focal onset represents the largest portion of the epilepsy opportunity, accounting for about 60% of treated and managed patients. However, there is still a significant segment of the market that involves generalized forms of epilepsy. This area is more fragmented, with various conditions leading to different manifestations that can be grouped under a broader general category, though they are treated in similar, yet distinct ways. There are products that target both the focal onset and the primary generalized markets. Therefore, we believe that expanding the clinical label is crucial for two main reasons: first, having clinical data for unique patient populations is essential because not all products are broad spectrum. We want to be positioned to have data that specifically supports use in adjacent patient populations. Second, we believe this is a promotionally sensitive market, and effectively communicating that data through commercial and medical channels will be vital for establishing a product's positioning, even with a possible broad-spectrum outcome. For these reasons, we strongly advocate for the exploration of generating data and pursuing labeling if the results are positive.

Thanks Chris. Chris Kenney on the MDD question.

Speaker 3

Yeah, hey Paul. So with regard to the medication, so patients entering the study will not be allowed to be taking an antidepressant. And in terms of eligibility, it's okay to have failed one antidepressant in the current depressive episode but no more than one. And then any failure of greater than three antidepressants at any point in time will be exclusionary as well.

Speaker 5

All right. Thank you all very much.

Thanks Paul.

Operator

Your next question comes from the line of Brian Abrahams from RBC Capital Markets. Please go ahead.

Speaker 7

Hi, good afternoon. Thanks for taking my questions. It sounds like you mentioned your confidence is continuing to grow on 1101 as the data continue to evolve. So I'm actually curious if you could talk maybe a little bit more about the emerging data. I know the specifics around the open-label extension update that are going to be presented later this year. But maybe if you could just remind us how far along patients are at this point on dosing? And maybe qualitatively what you're seeing out of that that helps shape your confidence? And then secondarily you did mention we were going to see updated cuts from X-TOLE later this year. And I'm just curious if you could maybe talk broadly about how some of those analyses such as the time to efficacy could further help differentiate 1101's profile? Thanks.

Thank you, Brian. Chris, I will share a few thoughts and then turn it over to you. I’d like to provide some insights into the open-label extension, and I'm not sure if you have the information readily available regarding the number of patients with 12 to 24 months of exposure. One of the strengths of the overall data set is its remarkable consistency and intuitiveness, regardless of how we analyze it. The subgroup analyses in patients with less severe disease show even more impressive results, which aligns with our expectations, highlighting that consistency. We are exploring the timeline for efficacy given that there’s no titration involved. While this mechanism is novel, we believe it may offer leading efficacy compared to other available anti-seizure medications. We've been examining how efficacy manifests during the eight-week study on a weekly basis. Our hypothesis is that we might observe efficacy earlier than with other drugs since the drug isn't titrated. This is an area of interest for us. Now, Chris may want to provide additional details on the OLE data, as we're just beginning to analyze it. Initially, we concentrated on the OLE safety data in preparation for our end of Phase 2 meeting, but we are also starting to consider the efficacy analyses that we plan to share later this year. Chris?

Speaker 6

Sure. The key point is that when we examine the data, the double-blind results consistently show a signal. This is part of what reassures us. Additionally, we will communicate more clearly about the open-label data in the latter half of this year as we begin to analyze it. It's a dynamic situation because this is an ongoing study, and patients gain more exposure each day. Not all patients have completed their first year yet, as the last enrollments happened in the summer last year. Overall, we are nearing a few hundred patients who have been in the study for a year, and about 50% have been in for over two years. This provides us with a relatively strong data set. We are currently reviewing this data with respected key opinion leaders to ensure we present a balanced view of our findings.

Speaker 7

Great. Thanks Chris.

Operator

Your next question comes from Marc Goodman from SVB Securities. Your line is now open.

Speaker 8

Hi. Thanks for taking my questions. It's Rudy on the line for Marc. Just a quick follow-up question for the X-NOVA study, for 1101, can you provide more color on the powering of the study? Like, what are your expectations for the magnitude of effect in matters for both placebo and 1101? And secondly, given the enrollment criteria it seems like we are targeting monotherapy instead of adjunctive use. Maybe can you provide more color here on the clinical setting for 1101? Thanks.

Yes. Chris, do you want me to do powering, or do you want to do the powering in the monotherapy?

Speaker 6

I'm happy to make it start it off and then maybe you can add color to it afterwards. So I sort of alluded to the fact that we're going to have about twice the number of patients that were in the ezogabine proof-of-concept study. So from like a go in deep perspective you got – you're shooting for an effect size around 0.5. But in terms of the separation between active and placebo, where the powering assumptions assume that there would be about a 5-point separation between active and placebo and that that would give us an 80% power to detect a change for each one of the doses compared to placebo. So that's the powering. And then in terms of the monotherapy you're – yes I mean you have it right. So these patients will not be on an additional antidepressant and so we're looking for a signal in patients who are not being treated with another antidepressive at the same time.

Speaker 8

Got it. That’s very helpful. Thank you.

Operator

Your next question comes from Yatin Suneja from Guggenheim. Please go ahead.

Speaker 9

Hey, guys. Just a couple of questions from me on the MDD side. Can you just talk about the dose selection there using a 10-milligram dose there? It's just curious how did you come up with the lower dose? And then did you mention the effect size that you are looking at 0.5. Can you just talk about how did you derive at that 0.5? The effect size and fight for delta and your pausing assumptions?

Speaker 6

Yes. So Ian do you want me to go?

Yes. Why don't you start and I'm happy to add.

Speaker 6

Yes. So the 10-milligram dose in the focal onset seizure study demonstrated efficacy and tolerability and a safety signal that made it difficult to extinguish the 10-milligram group from placebo. So really good tolerability and evidence of efficacy. And so we want to take that forward into MDD and see if the same would be true within MDD. And then as far as the powering I think it's probably better to just focus on this is an MDD study. We're expecting a fairly pronounced placebo effect as has been the case historically despite efforts to keep it minimized. And then the separation between active and placebo we're assuming it's five points and a standard deviation that's about twofold higher than that. And that's a little bit less than what we've seen with the ezogabine proof-of-concept study completed in two sites. We're going to be going to more sites. So that signal may become less robust as we do that. So that's the powering background.

Speaker 9

Got it. And do you have any clarity on when you make the data from the investigator-initiated MDD study?

So yes, it's still early days. The Mount Sinai study started in Q4 of last year and we're not giving specific guidance on it. And I will mention just because it's publicly available on clinicaltrials.gov. They say that it's going to be early '24 when that study completes. So our expectation has always been that our company-sponsored study, although it has started after the MST will read out before the IST because we expect data from our study in 2023.

Operator

Next question is from the line of David Hoang from SMBC. Please go ahead.

Speaker 10

Hi. Thanks for taking the question. So, I had one and then a follow-up. So, first in terms of 1101 in MDD, if we think about how it might be positioned and adopted in the real-world setting, do you think about the low-hanging fruit as epilepsy patients with comorbid MDD, or is this really more of something for the broad all-comer MDD population that could be conceivably used in anyone who had maybe failed an SSRI?

Chris Von Seggern, do you want to talk about the opportunity?

Speaker 6

Yeah. No absolutely. So first let's start with MDD, that indication while it does have numerous available agents as you've mentioned an overwhelming number of patients will be treated with an SSRI or SNRI, but many of those patients will fail first or second-line therapy. And just like in the FOS space, there is a sizable percentage of patients that require an alternative mechanism. In this situation predominantly, monotherapy to address their depression symptoms and we do believe that there is an opportunity for a novel agent with a novel mechanism of action that has a good safety tolerability profile to fit in nicely despite the competitive dynamic that sits in that space. Your second question, though, relates to the fact that within the FOS patient population, there is a sizable percentage of patients that have comorbid depression. It's one of the most common comorbidities within the epilepsy space and there certainly is the opportunity to differentiate with appropriate data in that segment of the patient population where you can imagine that you can be a go-to agent with compelling antidepressive effects as well as best-in-class efficacy as we've seen with XEN1101.

Speaker 10

That's helpful. Thanks. And then just quickly, if I may. In terms of the IST study, which will read out after your company-sponsored study, are there any key learnings that you expect to glean from that study that may not be apparent in the company-sponsored study?

I don't think so. I mean Chris mentioned in his prepared remarks, and if you look at the ezogabine publication from a year ago from the study, so it was the same group out of Mount Sinai and Baylor that ran the ezogabine study that was published last year. And then, they're the same ones running the RIST, or the IST with 1101. They're interested in a functional endpoint a functional MRI at primary because they're interested based on some of the preclinical data and where the expression is the increased expression of Kv7.3 in the brain. And so that's going to be an endpoint that we're not replicating. So that will be new information from their study, but then when they get into their secondary endpoints in terms of the clinical scales of depression and anhedonia that will be consistent with our study. So I'm not sure that we learn a lot David from their study that would be a read-through in terms of our future development.

Operator

Okay. Thank you. That ends our question-and-answer session. I'll turn the call back over to Sherry Aulin for closing remarks.

Thank you everyone for joining our call and webcast to discuss our first quarter 2022 results. Operator, you may now end the call.

Operator

Ladies and gentlemen, that concludes this conference call. Thank you all for participating. You may now disconnect.