Hi, good afternoon, and welcome to Needham's 23rd Annual Healthcare Conference. I'm Serge Belanger, one of the healthcare analysts here at Needham, and we're happy to have, for our next session, Zevra Therapeutics. And we have the company's CEO, Neil McFarlane, with us, who's gonna tell us more about Zevra. So before I hand it over to Neil for the presentation, just wanna let everybody know, listening online, they do have the option to submit questions via the portal that you're watching the presentation on. So we'll be asking questions after the presentation. So Neil, I'll hand it over to you and for the slide presentation, and then we'll proceed to questions.
Thanks, Serge, and really appreciate you and Needham having us here today. Before I get started, let me just start by saying I'm gonna be making some forward-looking statements, and I wanna make sure that you take a look at our most current SEC filings to get the most up-to-date information. So let's talk a little bit about Zevra. Zevra is on a mission to becoming a leading rare disease company. You know, we have been a company that's been put together through a number of transactions with a clear mission on bringing life-changing therapeutics to people living with rare diseases. There are three real pillars that will help us achieve this next growth phase for us.
One, we have an experienced team that's got deep rare disease experience. We have commercial excellence, as we've become a commercial organization important to be able to ensure that our patients have access to therapeutics by having those systems and processes in place. And we also have a growing pipeline with the potential to be able to bring new products to the forefront. On this next slide, you see that we have deep experience with the commercial team. The team has worked in companies like Genzyme, BioMarin, Astellas, Takeda, Retrophin, and launched a number of rare disease therapeutics in those rare spaces as well. This is one of the key hallmarks of our organization.
We, we take the opportunity to be able to partner with the rare disease, thought leaders in the advocacy space, very well. When we talk about being, patient first, and we talk about making decisions based on, the impact that we can make in the lives of the people we serve with rare diseases, these foundations that we work with are the core of the information that we get to be able to develop and deliver our products. So we're really proud to be able to work with a broad, range of groups, across the areas we're working with in, specific rare diseases, but also, those areas that are more broadly based, policy and/or just global, types of rare disease partners. With that, I wanna talk a little bit about our portfolio.
A lot of those rare disease groups you saw previous, on the previous slide, make up a lot of the areas in which we're focused on. Our pipeline today has OLPRUVA, which is sodium phenylbutyrate. It is currently an approved product. It is for the treatment of urea cycle disorders, and we're in full-scale U.S. commercial launch as of February of this year after our acquisition of Acer Therapeutics. We have a phase... We have an NDA that has been filed with the agency for a product called arimoclomol, and that product is being developed for Niemann-Pick disease type C.
We have a current PDUFA date that is September 21, 2024, and we're actively working towards what we have been informed of, the intent to have an AdCom, and we're actively working towards preparing for the AdCom and the commercial preparation of arimoclomol to deliver to patients with Niemann-Pick C. We have a program that came with the Acer transaction in a disease called vascular Ehlers-Danlos syndrome, and that product is called celiprolol. That is an ongoing phase IIIA program that we've prioritized to continue moving forward as we're reviewing our portfolio of all of the products that have come over from the various acquisitions we've made. We have a program in idiopathic hypersomnia, which is a rare sleep disorder, called KP1077.
That phase II data was completed a few weeks ago. We announced top-line data that will be presented at... The top-line data that we announced will also be presented in more detail at the Sleep 2024 conference in June. We're evaluating additional potential phase III programs with the end- of- phase II meeting in that disease area. We have a phase I program that is in narcolepsy. It's a bit bundled with our sleep disorder program. We are leveraging the data on both idiopathic hypersomnia and narcolepsy to evaluate the potential phase III programs across the portfolio. That portfolio is underlined with a product that was developed in the company and is now being commercialized by a commercial partner in Corium.
It's called AZSTARYS, and it is for attention deficit hyperactivity disorders, ADHD, and we're very proud and pleased with the performance that the team over at Corium is doing. We get royalties and milestones that from that license agreement and they continue to make solid progress. So maybe just paying a little bit more attention to our commercial program here. We've developed since our Acer acquisition what we believe is at the hallmark of what good looks like around launching and ensuring patient access to rare disease therapeutics.
It's really built around having rare disease sales specialist, patient reimbursement services that make it easy for patients to be able to receive the products, marketing to identify the appropriate patients, as well as positioning our products in the appropriate place in the landscape. And then account management and contracting teams to make sure we have market access at the, and allows the physicians and patients to have access to the product. And then separate from our commercial infrastructure, but our medical affairs and patient advocacy organizations that are really driving the scientific exchange and the direct patient contact with the advocacy organizations.
We've built this post our Acer acquisition and launched all of our field-facing components of our group in the end of January, and really kicked it off in earnest in the first few weeks of February. Keeping on our commercial product, OLPRUVA. OLPRUVA, as I mentioned, a nitrogen scavenger, removes excess ammonia. It is a product that treats a disease called urea cycle disorders. Urea cycle disorders cause hyperammonemia. As you can see on the slide, there are a number of enzymes in the urea cycle that filter nitrogen and ammonia.
If any of these enzymes are partially affected or fully affected, or multiple enzymes are affected, you can have buildup of ammonia, and that can create hyperammonemic crisis, and it can also damage the liver. The hallmark of UCDs is this hyperammonemic crisis, but elevated ammonia levels can be neurotoxic. They can have neurocognitive damages, they can have neurocognitive impairments. They can lead to, dependent upon the severity of the urea cycle disorders, to transplantation or even death if untreated. A lot of times this brain damage that happens with the severity of the hyperammonemic crisis can lead to hospitalization on a regular basis for these patients if they're not treated appropriately.
OLPRUVA, uh, is a nitrogen scavenger that actually removes the excess ammonia without going into the urea cycle, uh, and allows it to be metabolized and filtered in other areas. There's a significant unmet need in urea cycle disorders. Uh, like I mentioned, uh, it, it-- the poor adherence to therapy is one of the major drivers that lead to this hyperammonemic crisis. There are approximately, uh, 1,100 patients diagnosed, uh, in the US. About 800 of these patients are currently on treatment. Uh, about 80% of these patients have common, uh, mutations with CPS, OTC, or, or AS, which are the enzymes that, uh, are primarily affected. All sodium phenylbutyrates, uh, are approved to... or sodium phenylbutyrates, in general, are approved to treat UCD, uh, but there are some unmet needs.
The odor and route of administration and the palatability of certain products has created a need where compliance becomes an issue because the patients just have a difficult time tolerating it. And about 25% of these hyperammonemic crises stem from poor adherence. So OLPRUVA, which is a unique formulation that we have now commercialized since February, is a novel formulation of phenylbutyrates. It's a kind of dual polymer coated formulation that delays release of the product in water for up to 5 minutes. It rapidly dissolves in the stomach. It comes in a convenient dose that allows for patients to be able to put the dose in their package. They can mix it in water with the mix-aid solution and be able to drink it like through a glass of water.
It is an FDA-approved treatment to adjunctive therapy, in addition to diet, and, and for the most part, long-term management of adults and children. It's got competitive advantages, as I mentioned, to other products that are on the market today around better palatability, less odor, and ease of administration, which we believe that clinical differentiation from the other products that are on the market will allow us to compete and drive share in this, in this market today, which we estimate at $350 million-$400 million, which is dominated by, you know, 80% of that market by a single player. Let me move and shift gears quickly into our pipeline and get a little deeper from the first pipeline study that we talked about.
As I mentioned, Niemann-Pick disease type C is a neurodegenerative lysosomal storage disorder. It leaves these breakdowns in in these genetic factors breakdown and provide for the lysosome to not efficiently metabolize cholesterol, where you'll then get a buildup of cholesterol in the cell. And this lipid accumulation can ultimately lead to cell death, organ dysfunction in visceral organs, the spleen, the liver, as well as motor and psychiatric disorders. It's heterogeneous in nature, where you may have patients who come with different presentations. Some may have psychiatric, some may have psychiatric disorders, along with speech disorders or fine motor movement, but it also happens differently in children versus, you know, teens versus adults.
This is a fatal disease that we have been building a treatment for. Before I get into the treatment, though, let me quickly talk about there's no approved treatment in the U.S. today. Its prevalence is about 1,800 patients between the U.S. and Europe. About 900 patients estimated in the U.S., and of those 900 patients, approximately 300-350 of those patients are currently diagnosed or treated. As I mentioned, these are irreversible changes that are fatal, and the mean age of death is 13 years of age.
The evidence indicates so far that arimoclomol is positioned to become a first-line treatment and has been shown to, on multiple fronts, help reduce lipid buildup in the cells and improve lysosomal function of metabolizing lipids. It is potential to be foundational therapy in the U.S. for NPC, if approved. It's an oral capsule that can be swallowed whole and mixed with food and liquids, and actually also delivered through feeding tube. We've got extensive clinical experience, and the product has been in over 600 patients through its development course in a number of other rare diseases, including Niemann-Pick C. The pivotal study demonstrated that there's reduced disease progression.
We have some long-term data, as well as natural history data controls, as well as an ongoing global expanded access program with about 150 patients currently being treated with arimoclomol between the U.S. and Europe, that we've also been able to deliver that data to the agency in support of our approval. There's some regulatory advantages as well. It is an orphan drug. It is eligible for a pediatric review voucher, which today is estimated at approximately $100 million. One thing that's really important as we look around, the arimoclomol approval is, you know, we've pulled forth our investment into OLPRUVA and building a commercial infrastructure and medical affairs infrastructure in the 40 centers of excellence, in the metabolic treatment centers that surround those 40 centers of excellence.
But it's the same call point. The synergies and scale with OLPRUVA and the customer-facing teams will be able to support arimoclomol if approved as well, and we see that leverage as a really important... You know, commercializing medicines in our space is not easy. Commercializing medicines with the same call point and your ability to leverage the infrastructure, we see as key to creating value. Another one of the programs that we have is our vascular Ehlers-Danlos syndrome. This is a connective tissue disorder that leads to vascular ruptures of the arterial moderate-sized arteries. And celiprolol is a product that's being developed to reduce the mechanical stress on these collagen fibers within the arterial walls. It is VEDS or EDS type four.
It's characterized by aneurysms or dissections or ruptures of vessels, usually medium to large-sized vessels. It is an autosomal dominant disorder in about 50%, and spontaneous mutations in about 50%. There is a confirmed mutation in COL3A1 gene, and these events of the dissections and aneurysms occur in about 25% of the patients before 20, and about 90% of the patients by the age of 40. These patients, the median survival age is about 51 years old, with arterial rupture as being the most common cause of sudden death. This is an unmet need. There is no approved product in the United States. The prevalence is about 7,500 diagnosed patients in the U.S.
The current treatment is focused on identifying these dissections prior to them rupturing and surgical interventions, and/or, unfortunately, these patients will rupture and a lot of times die from these types of, you know, spontaneous ruptures or dissections. Celiprolol is a product that is not new. It's a product that is familiar in Europe and has been utilized off-label for the treatment of VEDS in several European countries. As I mentioned, the mechanism of action is thought to be through smooth muscle relaxation and vascular dilation, which stops this, reduces the stress of mechanical stress on the wall from the heartbeat, and it's got a very unique pharmacological profile.
It's got a lot of clinical experience, as I mentioned, being utilized in Europe, and the BBEST study showed a 76% reduction in risk of arterial events observed in this COL3A1 subpopulation. So we are moving forward with a DiSCOVER phase III trial. It's decentralized, meaning that it's virtual, and it is a pivotal study that's ongoing under a special protocol assessment. And we have just recently prioritized this product of our portfolio, and we're driving the program forward. It's got intellectual property out to 2038, but we actually believe that this program will take a little bit more time. So we'll have some clearer guidance on this program as we get it up and going again, after bringing it over from Acer.
Idiopathic hypersomnia is our KP1077 program, and it is being developed for IH, which really causes a lot of excessive daytime sleepiness. It's got a hallmark of sleep inertia. You just can't get patients up in the morning, along with that cognitive, you know, fogginess and brain fog.
The hypothesis we have with KP1077 is that it is an opportunity to provide an optimal exposure of serdexmethylphenidate or d-methylphenidate at night, where you're able to give a stimulant at night, but it actually has a release profile that allows you to get a high level in the morning when you need to wake up, and you're having this sleep inertia, that then keeps you through the day and allows you to have a less daytime sleepiness and better cognitive function. That's the hypothesis that we went into our phase II study with.
We were able to deliver our phase II top-line results a few weeks ago and delivered clinically meaningful endpoints across these scales that you see on the slide here today. This is an unmet need. There is one product available in IH. The prevalence is about 37,000 patients, a lot more than all the other patients in the previous portfolio that we've talked about combined. But we also believe that the population may be much larger for those who have some overlapping symptoms between hypersomnolent patients that have been diagnosed with narcolepsy versus IH. I think that's an area that we'll have to work on as we move our program forward.
But the current treatments just don't address the current needs. Patients have rated current medications' effectiveness as poor, even with an approved product, and the ability to bring a tolerable stimulant treatment that is able to get to the levels at which we believe we can get to now in our phase II data are just inappropriate with the current stimulants on the market today. So there are other drug-drug interactions with contraceptives, and antidepressants, and antihistamines with the currently available therapy that we can overcome with our serdexmethylphenidate program. As I mentioned, serdexmethylphenidate is a prodrug of dexmethylphenidate, and it has the potential to address the primary IH symptoms.
We explored two dosing regimens, once at night, and then that same dose split between once at night and once in the morning, of which we saw clinically meaningful impacts across the top-line data. The more material data and the quantitative data will be delivered at the Sleep Conference in June, at Sleep 2024. So again, the clinical differentiation that we see with KP1077 is this unique pharmacokinetic profile to overcome some of these key symptoms. Better tolerability, lower cardiovascular effects, which we did see in the tolerability and safety components of our study. And again, this drug-drug interactions and with hormonal contraceptives, especially for women of childbearing age, is very important, and the interactions with antidepressants as well.
It has orphan drug designation, IP through 2037, potentially beyond, based on some, some approaches we could take. I think very importantly, serdexmethylphenidate is designated as a Schedule IV controlled substance, where most other stimulants and other products are a Schedule II. So we do believe that, the differentiation of serdexmethylphenidate , the hypothesis that we have, the data that was just driven, from our top-line phase II data, will really allow us to be able to inform what a phase III program looks like.
We're moving forward with an end-of-phase II meeting now, along and a parallel track of exposing the data to our advocacy advisory committees, as well as our patient, our physician advisory committees, to understand how we can unlock this potential product in sleep disorders in the future. Just in closing, I think what I've said today is a lot for a small company, but it doesn't change our mission, and our mission is to bring life-changing therapeutics to people living with rare diseases. We have a strong team, a solid track record of success in drug development, overcoming regulatory challenges, and delivering product to patients. Growing our capabilities in line with our vision is really important to us.
These patients you see here are patients that have the products that we're developing to try and overcome and improve their quality of lives. And our immediate focus is on driving awareness and demand for OLPRUVA, and preparing for an arimoclomol launch, and preparing and growing our pipeline with our KP1077 program, and moving forward into our end-of-phase II meeting, and the data being presented at Sleep 2024. So all of this is underpinned by a strong financial strength to be able to execute on these key priorities that we've talked about today. I'll thank you, and thank Serge for the Q&A section that's coming up next.
Thank you, Neil. So yeah, for those listening online, you can submit questions via the portal. I guess, Neil, the first one on OLPRUVA. If I recall, this is a market that's dominated by Ravicti. So maybe just highlight some differentiation between OLPRUVA and Ravicti, and is the opportunity there a switch opportunity, or is it to capture newly diagnosed patients as they come along?
Yeah, thanks, Serge. So the opportunity here is for us to be able to bring a clinically differentiated profile to the UCD market. You know, what we saw with the patient feedback and the physician feedback, Ravicti is a great product. The other sodium phenylbutyrate products are great products, but they all work about the same. The challenges that came up were around palatability, the taste, the ability for patients to be able to pull up the dose, have to put, you know, it's got a pretty offensive odor and taste that goes along with it. Then, you know, we see that there are a number of, a percentage of patients who have these hyperammonemic crisis, even on therapy, and we understand that about 20% of those are because of noncompliance.
OLPRUVA, with its polymer coating, that's a double polymer coating, that allows for patients to be able to have a package that is a one dose. It's by dose. You have a number of body weight dosing that comes with all of these products. And we believe that the ability to get a product that's been developed to mask the taste of sodium phenylbutyrate, or from phenylbutyrate, and then put it in water and drink it, will allow these patients to actually have, you know, hopefully, at the end of the day, better compliance.
We do not have data to that regard right now, but we believe that better palatability, the ability for you to be portable, and have your dose, your specific dose with you at all times is something we're bringing to the marketplace. You also asked, is this Ravicti conversion patients, or is this you know de novo patients? The market today is approximately $400 million market. Ravicti does you know occupy 80% of that market, approximately. And we believe that it's both a conversion opportunity and the ability to bring the product to patients.
But as we've seen in our few, you know, small, short time in the market here today, and seen some of the patients who have come through, we've seen conversion from Ravicti. We've also seen de novo patients, which have not been on other products before. But we do believe that active patient that is out there that is having some of these challenges, that's why the product was developed in the first place, our clinically differentiated profile really can make an impact to them. But we got to get the awareness out, which is what we're doing now.
Okay. One question that's come in is, I think this product was delayed either with the CRL, before final approval. Just, I guess, what was the reason for that delay?
Yeah, there was some manufacturing hiccups, the original product that then the product became commercially available sometime at the end of last summer, where the company actually ran into financial constraints and wasn't unable to really put feet on the street and launch the product, which is when we announced that we would acquire the product. We acquired the product in November of last year, and within a six-eight-week period, we hired, trained, certified, and got our field customer-facing teams out in the marketplace, calling on the centers of excellence and the broader metabolic and metabolic centers as well.
Okay. So product's been... You've had the product now for nine months, I think you said?
No, since November.
Oh, yeah, sorry.
Yeah, no, no. But our team's only been on the ground for-
Since February. Got it. Yeah.
Yeah, since February. This is very early days for us, and you know, what we anticipated was we have a clinically differentiated product, but we knew the awareness was low. And we're making a lot of headway as we're learning from the field, you know, making changes and then learning, making changes. So this is a dynamic process. To show you one example of that, we actually knew the awareness was low, and one of the things we established was a quick start program. So physicians and patients can have access to the product for a free trial, that they can then see if OLPRUVA is good for them and get them on product moving forward. But we're making progress.
Okay.
We're learning a lot along the way, which is nice.
Yeah. I imagine this is not a product that has, I mean, it's a product that should have broad payer access and coverage. So at this point, where does that stand with OLPRUVA?
Yeah. So when we acquired OLPRUVA, the previous organization had actually gotten approximately 50% of covered lives. So they were working on the market access side and doing some really good things. Since we've acquired the product, we've actually brought that up to approximately 70% covered lives, which is, you know, it puts us on par with the other products. So we can compete effectively by getting that awareness out and driving, you know, use and trial of the product. So we've done a lot of good work there. Very proud of the team and what they're delivering on the access side.
Okay. And then on the arimoclomol for NPC, actually, the question that came in was about that FDA delay. It did receive-
Ah!
... did receive a CRL that I'm sure you've been asked about in the past, but, I'll ask again. What was the reason for that CRL, and how was it addressed?
... Yeah, great. Thank you. Funny, I was thinking arimoclomol, but I think I heard OLPRUVA. That is correct. The product, a number of years ago, actually, under the previous company, had a CRL, and that CRL was based in three areas. The first one was the validated scale, the Niemann-Pick Disease Severity Scale, had some major endpoints and some minor endpoints, but the major endpoints are around fine motor movement, swallowing, cognition, and a few of those others. The FDA, as part of their review of the package, actually said, "You know, cognition doesn't really move in a 12-month period.
So we'd, you know, we'd like to be able to see you remove cognition." And then in the swallowing domain, they asked for the ability to rescore the swallowing domain based on some additional numbers, which we did, and that data remained consistent. The other part was what to do with missing data and the estimand, if you will, on the statistics. We were able to work with the agency and actually deliver to the agency the primary preferred analysis or the FDA-preferred analysis, I should say, along with our analysis, which we were able to provide. And the last one was around the confirmatory evidence. This took a little bit more time.
The confirmatory evidence is how you put your non-clinical data, your in vitro and in vivo studies to what, you know, the current clinical data that's out there, and then making sure that there's a very clear line to your phase II I results. That's an area where we put together some new non-clinical studies to tell the story of the mechanism of action in regards to the cholesterol metabolism. And then we're able to continue that story with expanded access data that came through our program, up to four years' worth of data in our expanded access program, where we have about 140 patients across the U.S. and Europe, about 70 on either side.
And deliver that data, as well as, natural history data, that ties a very clear story now between the non-clinical, the clinical data that we've been able to add to the story, all the way through our clinical trial data. So that's part of this robust resubmission that we've filed with the agency and are now, in review.
Okay. And I think earlier this year, they announced... Well, they accepted your resubmission, and then a little time after that, announced that there was, they were going to schedule an AdCom?
Yes. Yeah, that's great. So we think that the, we did, submit one of our core goals at the end of, of, Q4 last year, was to get the resubmission of the arimoclomol dossier done, which we did. And, we got a PDUFA date originally of, the 21st of June. As part of our information request that we've got through the year, or through the last number of months, one of the original information request that we got, actually, the agency came back to us and said, "Based on that information," which was very minor information we were able to answer within the timeframe, that they were going to extend the review cycle to give us a PDUFA of, September 21st. So that is our PDUFA date, that the 3-month extension happened.
Our PDUFA date is the 21st of September. As part of that, they informally said that we still intend to have, and bring us to an AdCom, of which we're preparing for. Feel very good about our preparation and our mocks and our briefing books, and, and, and we'll be prepared for. But I think that also provides me the opportunity to talk a little bit about the patient advocacy community. I spoke about a lot about that throughout the, this, the presentation. The Niemann-Pick C community has galvanized and has come together and put forth an informal petition to the agency, that had almost 1,000 signatures of patients, physicians, caregivers, and family members in support of arimoclomol, arimoclomol's approval.
That was sent to the division director and acknowledged, and we believe that with an AdCom, if we do have an AdCom, we absolutely are going to that AdCom with a wave of support from our advocacy partners and a robust clinical, you know, resubmission to the regulators that gives us our best shot for approval.
Okay. Obviously, it hasn't been scheduled yet. I forget-
It's not.
What are typical... How much time do they normally need to give you, but before scheduling it? Is it a month or a couple of months?
I have to tell you, I think that's the reason why they said that they intend to schedule it on the day we got it. So that way, they intend to, but, you know, they have to review the data. The agency's got a lot on their plate, but we sent a lot of data in the resubmission. It's high quality, a lot of data. They're gonna need to roll up their sleeves and get it done. So we weren't surprised with the delay, but we're also... Quite frankly, it provides us with a little more confidence that we've given them enough to continue to chew on, that we can expect, you know, an AdCom. And if they don't, then, you know, hopefully, that's also good for us.
Yeah. Okay. And then just one on the VEDS program. So you talked about the DiSCOVER phase III trial that's ongoing, and you did get an SPA from the agency for it. Is the goal here to kind of replicate what was done in or replicate what you saw in the BBEST trial?
Yeah, it's a good question. And it tells me that we probably, as we digest the core areas of OLPRUVA, arimoclomol, and our KP1077 program, you know, this program with the VEDS program is under SPA, as you mentioned. It's an event-driven trial. It's time to event. It's a virtual, you know, a decentralized trial, and the primary endpoint is just that, time to event. So it's a little bit outside of the window of how we're operating today, but it's also such an unmet need with such a large patient population that we felt like it was the right thing for us to continue to put that into our prioritization. But it is just that. It is an event-driven trial.
You have to have an event, and it's time to event is the primary endpoint. So we've kind of, you know, for lack of a better word, we've dusted off a lot of the protocols. We're starting to get things back in motion. When we get those back in motion, we understand a little bit more from the KOLs since we inherited this program, and we're in a prioritization of our portfolio. Now that we believe that this has intense value that can be created, we'll get a better handle on this in the next couple of quarters and understand how to provide some guidance on the study completion and timelines, and what have you.
Okay. And then I guess just lastly, 'cause I think we're gonna run out of time here. On your idiopathic hypersomnia program, what have you disclosed from the phase II trial results at this point? Or do we need to wait until the sleep meeting to get all the goods?
Well, you know, this is a question we get on a regular basis, and we had submitted the abstract, you know, months before we even got our top-line data, and the top-line data is in, you know, under embargo until we can get it presented at sleep. But we did send out, you know, our top-line data and showed that we had clinically meaningful impact across both those dose options and across a number of the secondary endpoints and exploratory endpoints. The study performed and delivered exactly what we needed. What we were trying to understand is the safety and tolerability, could we get to the high levels of serdexmethylphenidate and keep patients safe? We were able to demonstrate that.
And then we also got some clinically meaningful benefits across some of the EDS, IHSS, and the brain fog scales that we feel are meaningful enough for us to be able to have that conversation with the agency in an end-of-phase two meeting on how to unlock it. But we also didn't, you know, deliver a phase two trial that was set up to be statistically significant and all those other things. So all that data will be delivered at Sleep. We're excited about it and feel that we've got exactly what we needed, which is enough information to inform KOLs, get information from patients, in parallel, drive an end-of-phase two meeting, and understand how we can unlock this serdexmethylphenidate franchise.
Great. All right, well, I think we'll have to wrap it up there. We're actually over time, so I wanna thank you for spending time with us this afternoon and giving us an overview of your great pipeline and portfolio.
Serge, thanks for a great meeting. We had a wonderful amount of meetings today with investors, and we appreciate what you and Needham have done for us.
Great.
Well, thank you.
Thank you.
Take care.