Good morning, everyone. My name is Daniel Faga. I'm one of the analysts on this mid-cap biotech team. It's my pleasure to introduce Chris Posner from Cara Therapeutics. Following his presentation, rest of management will come up to the front podium. You can ask questions, or you can ask through the portal as well. Without further ado, Chris. Well, thank you, Daniel, and good morning, everyone. Before we dig in, quickly on slide two, just a necessary reminder of our forward-looking statements in this presentation, and you could refer to this, and you could also refer to our filings, our regulatory filings on our website. Let's dig in. What's our mission? Our mission at Cara is to be the world leader when it comes to the treatment of pruritus. Pruritus is more than just an itch. It's a significantly debilitating condition, and it really impacts a patient's quality of life. Despite this, despite this, millions of patients, you know, suffer. There's been very little innovation in this space. We believe at Cara, with our focus and with the assets we have in development, we think we could really significantly have an impact on these patients. We have centered our R&D efforts on difelikefalin. All our efforts stem from difelikefalin really being the platform that feeds our R&D engine. Difelikefalin, very briefly, is unique. You know, it's a predominantly peripheral-acting kappa opioid receptor agonist, and its design includes specific characteristics that limit its penetration to the blood-brain barrier that really allows it to avoid some of the typical CNS side effects, you know, like dysphoria or hallucinations. Also the kappa opioid receptor agonist, difelikefalin, has high selectivity for the kappa receptor. This allows it to avoid very classic mu-opioid-like side effects like euphoria, respiratory depression. Now, as a kappa opioid receptor agonist, its mechanism of action turns off the itch sensation by acting on the sensory nerves that really sense pruritus. That's the central hypothesis of our development program, right? Our central hypothesis driving our development is that by acting on the peripheral nerves that sense pruritus, difelikefalin plays a role downstream and may be able to address pruritus regardless of the disease area. With difelikefalin, you know, we have a validated mode of action, and we have demonstrated its activity treating pruritus across multiple disease areas. We have an approved product, KORSUVA injection, and that's with our IV formulation. It's for the treatment of patients undergoing dialysis that suffer from moderate severe pruritus. We also have our pipeline that is centered on the oral formulation of difelikefalin, and we have demonstrated its activity across multiple different diseases. Now, with this background in mind, our strategy is focused on expanding the utility of difelikefalin across two core franchises, nephrology and dermatology. We believe, you know, with the asset we have, we could really create significant both near-term and long-term value. The pieces are squarely in place, and I'll 1st start with nephrology and our nephrology franchise. Now, the foundation is in place with our approved product, Korsuva injection, and the launch commenced in the 2nd quarter of 2022. The approval represents the 1st and only drug approved by the FDA for the treatment of pruritus in adults suffering from moderate severe pruritus that are undergoing dialysis. This is a significant pool of patients, roughly 200,000 addressable, that are currently being dialyzed that suffer from moderate severe pruritus. Our goal in nephrology is to expand this franchise, and we have taken our oral formulation of difelikefalin and initiated a phase three program in the pre-dialysis advanced chronic kidney disease population. You know, there are no approved therapies there either. This suggests roughly 300,000 patients suffer from this condition. We have a real opportunity to expand our nephrology franchise here. Turning to our dermatology franchise, we are pursuing two indications, one in atopic dermatitis and one in notalgia paresthetica. Let me comment 1st on atopic dermatitis. You know, based on our phase II data as well as interactions with the FDA following that, you know, we initiated a registration program in the 1st part of last year. We certainly, you know, with atopic derm, you know, it's one of the most common of the inflammatory dermatologic conditions, and pruritus is the central symptom, quite frankly. Roughly 12 million patients suffer, adult patients suffer from atopic derm, but the bulk of them reside in the mild to moderate space. We think we have a significant opportunity there because around 3 million patients in this phenotype, we, which we call itch dominant, still have lasting chronic pruritus. We feel like we have a real opportunity of where we're gonna play and where we're gonna win in that segment. Now, turning to notalgia paresthetica, our NP program. Notalgia paresthetica is a neuropathic disorder that is characterized by significant pruritus in the upper to middle back. We estimate roughly 650,000 patients are currently under the treatment of a healthcare provider. Again, a significant unmet medical need in this space where there are no approved treatments. Again, when you look at our dermatology portfolio, you know, again, we have a terrific opportunity in both atopic dermatitis and notalgia paresthetica. I would tell you the bottom line is that we could build two sizable franchises both in nephrology and dermatology. Let's talk 1st around our launch. I'll talk about the progress we have made. Think it 1st deserves some time to spend on some of the critical success factors driving our launch and why we're so encouraged and expecting significant long-term creation here. You know, the 1st, it starts with the product. You know, we have a product where we could proudly say 1st and only. That's what all pharma manufacturers try to do, develop a product with significant differentiation. Well, 1st and only signals significant differentiation. We have a product that we launched in the U.S. in the 2nd quarter of 2022, and this 1st and only tag also carries over to Europe. We received approval in EMA in April of last year, sorry, in 2022, as well as some other countries. Again, 1st and only carries forward. We have strong commercial partnership with CSL Vifor. They are the premier nephrology company, and most times, you know, in my experience, launches rise or fall with execution. Here with CSL Vifor, we have the right commercial partner with deep knowledge of the nephrology space. They also come with it a significant powerful relationship with Fresenius Medical Care. Fresenius is one of the top two providers of dialysis in the United States. In fact, they just deployed their sales force promoting KORSUVA in the 3rd quarter of last year. Lastly, on the reimbursement, you know, in typical pharma marketing and pharma product launches, you know, reimbursement, you're waiting, you're waiting constantly for new payers to come online and put you on formulary like Express Scripts, et cetera. This is a Medicare population, and we have reimbursement via CMS under the designation called TDAPA, the Transitional Drug Add-on Payment Adjustment. It's now reimbursed outside the bundle. That was given to us at the start of April of last year. We've also been quite encouraged, and we have this for two years, which would expire next year, but we also are really encouraged with the progress we have made with CMS in the post TDAPA period. Now, you know, what we saw in the 2023 rulemaking that came out in June of last year is that now CMS acknowledges that in the post TDAPA environment, this could cause some concerns and some challenges of providing access to this medicine and innovative medicines, moving forward. In that rulemaking process, they initiated a request for information with four different methodologies that all talked about continuing an add-on payment in some form or fashion. We're again, quite excited with where we are with CMS. We'll continue those policy initiatives with CSL Vifor throughout this year. Where are we with the launch? You know, for the 1st two quarters, I'm gonna speak 1st on net sales. For the 1st two quarters, we recorded or CSL Vifor recorded $33 million in net sales. That reflects shipments from CSL Vifor to the wholesaler. We recorded $15 million in profit share revenue. Now what's important here is that that split, that roughly 45% split of Cara profit sharing revenue will hold true quarter to quarter in that range. That's based on a contractual relationship we have with CSL Vifor. Now, in terms of demand, the best proxy we have for demand in this marketplace are vials being shipped from the wholesaler to the clinics. Again, in the U.S., there's roughly 7,500 or so clinics in the United States. Through the 1st two quarters of launch, Q2 and Q3, 186,000 vials were shipped from the wholesalers to the clinics, namely to Fresenius. We saw a significant step change in Q3 with the amount of product being shipped to the Fresenius clinics, and their intent was to really spur and accelerate trial in their clinics. Now, I will say we would expect some quarter-to-quarter variability, you know, as the demand between clinics and patients and wholesaler inventory till that smooths out. I would expect in the next, you know, two or three quarters, that to really smooth out. I would also point out here that we're really encouraged with what our partner and what we're hearing from patients and providers on, you know, basically, does this product hold up in the clinic? I think the resounding answer right now is yes. It holds up in the clinic. Patients are getting benefit from it. Providers are liking what they see. We're quite encouraged. Again, qualitative feedback to date, but we're quite encouraged what we see. Not on this slide, but I will briefly speak to Europe. You know, Europe, again, we got approval in April last year. We launched the product in two countries late last year, Germany and Austria. Qualitative feedback to date, again, quite encouraged, especially in Germany. In fact, you know, what we're hearing in Germany from patients and providers are very consistent to what we hear in the U.S. Also in Germany, you know, it's called Kapruvia under that trade name in Europe. They put Kapruvia on the 1st-line recommendations in their guidelines. They also see the need. Net net, we feel very strongly, we have the full support of CSL Vifor. They're doing a very good job. They have the commercial rights for it outside the US and in the US. Fresenius is really supporting this product. Turning to our pipeline, you know, let me 1st start out with our nephrology franchise, and I'll focus 1st on our oral difelikefalin in the pre-dialysis advanced chronic kidney stage. You know, again, significant unmet need here. We're gonna really focus on stage four and five chronic kidney disease patients that are not on dialysis. Roughly 1.2 million patients, you know, are in this stage. We estimate roughly 300,000 of them would be addressable for a product like oral difelikefalin. No approved therapies, significant clinical unmet need. As you look at our, you know, development program here, you know, we had positive phase II data, had a great interaction with the FDA, and we initiated our phase III registrational program in the 1st quarter of 2022. You can see here by the cartoon on the slide, we're conducting two double-blind randomized placebo-controlled trials over 12 weeks, called KICK 1 and KICK 2. We would expect a readout, top-line readout in the 1st half of 2024. Again, quite excited about how we're accelerating this program, and it really expands our nephrology franchise from dialysis to pre-dialysis. Pretty logical expansion. Turning to our dermatology franchise, you know, I'll start 1st with atopic derm. You know, pruritus is certainly the hallmark of atopic dermatitis. Estimate roughly 12 million adults suffer from atopic derm. The bulk of these folks reside in the mild to moderate space. That's where we intend to play. In fact, we've narrowed that space a bit more where we believe there's this phenotype emerging where the mainstays of treatment still are topical therapies, namely topical steroids. Yet about 3 million patients still suffer from moderate to severe pruritus. They have nowhere to go. We think we offer a solution to these patients. Now we'll double-click on this a bit 'cause this is a question I get a lot of where we intend to play in atopic dermatitis. You know, atopic derm is the space I come from, previous to Cara. It's certainly in the press a lot. Big pharma has invested a significant amount of dollars in atopic dermatitis and have brought really significant innovative therapies to the market. They really focused on the moderate, the severe disease state with oral JAK inhibitors and biologics. You know, if you look at this chart, where we intend to focus is on the mild to moderate space, where topical therapies, namely steroids, are still the mainstay. Certainly, they clear up skin lesions. Certainly, they do. They have limitations and also a significant number of patients, we estimate roughly 3 million patients still suffer from moderate to severe pruritus despite utilizing topical steroids. As you look at our study, and we commenced our registrational program in the 1st quarter of 2022, we have really focused on, 1st of all, a dose-ranging part where we are now studying this on top of topical steroids. I would remind you that for atopic dermatitis, we showed and we demonstrated positive efficacy in the mild to moderate space, and that was in monotherapy. Now we're going into a registrational program utilizing difelikefalin on top of topical steroids, which really mimics real-world utilization. We intend to complete the dose selection process by the 2nd half of this year and swiftly move into the confirmatory trials. Now on to rounding out our dermatology franchise. Rounding out that is our notalgia paresthetica. You know, notalgia paresthetica is a sensory neuropathic syndrome affecting the upper to middle back. It's pruritus is the main symptom of notalgia paresthetica. Significant impact on a patient's quality of life, no approved therapies in this space, and we estimate roughly 650,000 of these patients are currently being treated by a provider. This is certainly has flown under the radar, not in the press like atopic dermatitis, but when you talk to a dermatologist, they see this condition. Our program, you know, after we announced our positive phase II proof-of-concept study data in the 2nd quarter of last year, in June of last year, where we were quite pleased with what we with what occurred in the clinic in terms of efficacy and safety, we've initiated our registrational program, or we will initiate that in the 1st quarter of this year. It's going to look pretty similar in terms of design to AD. We're going to do a dose selection process over eight weeks, and then we'll swiftly follow that into confirmatory trials. Again, quite excited about where we are in notalgia paresthetica. Now, in terms of the catalyst that is going to drive long-term growth over the next three years, you know, I'll 1st focus on KORSUVA injections. Certainly, that launch is ongoing. Various countries, most of the European countries will come online in 2023. We'll obviously pay close attention to that, but again, very encouraged of where we are with that launch. In terms of 2023 catalyst, you know, you're gonna see is, 1st of all, what I just mentioned, we're gonna initiate the notalgia paresthetica registrational trial this quarter. We'll also have the dose selection internal readout in the 2nd half of 2023 in atopic dermatitis. You can see later on as we move through 2024 and 2025, namely 2024, you'll see, you know, the readout of our nephrology development program in the pre-dialysis stage. Again, a very catalyst-rich 1st couple of years. You know, onto our balance sheet. Onto our balance sheet, I mean, we have guided at the end of Q3 to $180 million in cash. That takes us well into the 1st half of 2024, I would say this is on the conservative end. You know, we include in this calculation, our CFO is here, will be able to take questions after. We include in this calculation, the quarter three revenue we got from KORSUVA around $7 million annualized. It does include KORSUVA revenue at what we saw in Q3. I would say this is on the very much the conservative end. With that, you know, I would conclude by saying, well by saying we're really, really excited about where we are as a company, for sure. I mean, focus and execution are what drive success. We have a very clear mission and a clear, very clear purpose of who we are as a company and what we wanna achieve, and that's to be the world leader in pruritus. You know, 1st of all, we've done, I believe what a lot of companies have not managed to do, and that's to bring a novel compound, you know, through development into approval as a 1st-in-class therapy. You know, we now have an approved product. We have a really strong commercial partner, and we're really excited about where we are in terms of the expectation of long-term, you know, potential here. You know, we have a long-term positioning with our development program that, you know, with oral difelikefalin that we believe, you know, presents a significant larger commercial opportunity as we move forward. With that, I'll conclude. I see I'm out of time, Daniel. I'll conclude. I'll ask Ryan Maynard, our CFO, and Dr. Jo Gonsalves, our CMO, to come up and address any questions you may have. Thank you. Should I sit? Oh, yeah. All right. We can start the question and answer. I think there's someone raised their hands over there. Thanks for the presentation. Quick question on sales. Q1, Q2, and Q3, you saw kind of like a flat sale on the revenue side. What are your expectations for Q4 and going forward? Yeah, thanks for the question. you know, we're obviously, at this point, not gonna provide, you know, Q4 results yet. We have a partner in CSL Vifor, and we'll do that as we announce earnings in March. I mean, here's what we're seeing in the market right now. You know, I'll just speak to demand 1st and then I'll dovetail that to sales. In demand, we saw a significant step-up in demand, i.e., product being shipped to the clinics in Q3. That's where we saw, you know, a real step up. What we're expecting in Q4 moving forward is that product was brought into the Fresenius clinics mainly. They're in that trial phase, I would expect that trial to continue, and we're also seeing clinics beginning to adopt that product. We're kind of in that trial to adoptions phase, jumping off of the Q3 step up in orders. You know, in terms of sales, again, how we recognize revenue is that's when CSL ships product to the wholesaler. You know, as demand starts to kind of move through that trial to adoption stage, that's when I would expect to see the sales will converge and follow suit. Yeah. If I can ask the question? Sure. What can you tell us about the order rate from Fresenius and DaVita clinics? How would you characterize if there are any reorders and maybe related to that persistency of scripts, in for the course of injection? Yeah. Daniel, I mean, and you know, there, this is a two company market. Fresenius and DaVita dominate the dialysis in the United States. They have different approaches to bring in new product, and thus, what we've seen is a different approach to KORSUVA in terms of their launch uptake. With Fresenius, as I mentioned, they deployed their sales force in Q3. And what we really saw was this big step up in orders. You know, it was a significant 180,000 vials, essentially. Basically, what happened is Fresenius, you know, supporting this product, brought product in, and all their clinics pretty much ordered the product to try it and accelerate that trial to adoption sequence. That's what we're seeing now with Fresenius. With DaVita, it's been more gradual. DaVita is more organic. They don't have their own internal sales force. We're seeing with DaVita, they came online about the same time as Fresenius, and what we're seeing is a number of their clinics ordering. We're really encouraged, as I'll speak for CSL Vifor as well, is that the reorder rates on those that are ordering, the majority do reorder. It's a very good signal. The curves are different. The way they adopt new products are different. Can you just talk about how the reimbursement works? Oh, sorry. Talk about. Yeah. the financials work to the... whether it's CSL or the clinics who are- Sure. Paying for the drug. Yeah. The drug, you know. You know, in the dialysis market, it's a capitated system where you get a flat fee per session. I think it's roughly $257. And the way innovative drugs like KORSUVA, which is now, you know, got the TDAPA designation, it's reimbursed outside the bundle at ASP. ASP was just made public for the 1st quarter of 2023 based on 3rd quarter. The ASP is roughly $144-$145, I believe. The WAC price is $150, you could see the delta there. Right now it's if you write the product, you get reimbursed at ASP. That's the way the reimbursement works during this TDAPA period. Well, I mean, CSL Vifor does do contracting on the acquisition price with the dialysis organization, certainly. That's why you see some of the discounting even in the ASP versus WAC. Yes, there is some discounting. There's certainly a financial incentive, you know, for these, for these clinics and these organizations. With a large shift in demand, do you think it's possible to rationalize on an ongoing basis what drives the revenue reported in the U.S. as profit share? That is it wholesaler shipment to dialysis centers, or is it shipment to distributors? Ultimately it'd be shipment to the clinics. That's demand. Demand drives the whole supply chain, the whole product flow chain, right? Early on in the launch, given the launch dynamics, that, you know, that's a bit different, right? In early on in the launch, and you saw this in Q2, Daniel, that the channel, the trade, you know, takes on product anticipating demand. That's what we saw in Q2. They took in about $17 million in net sales, and actually what shipped to the clinic was only 1,800 vials. You know, as it was really the MDOs, the midsize and independents that really came online early. We've now started to see that largely converge. You know, 186,000 vials, if you total up both quarters, you know, and $33 million in sales of shipments from CSL to Vifor, that's largely converged. End of the day, it's gonna be about demand. And it's gonna be about moving from, you know, what's in the clinics to the patients and, you know, we believe strongly that that cadence will continue to increase over time. How should we then think about the shape sorry, the peak market opportunity for KORSUVA, keeping in mind the TDAPA period. Mm-hmm. Potentially the extension that could come with CMS's CMMI negotiation? Let's 1st focus on the, you know, the size of the population and what's currently out there for these patients. First of all, there's about 200,000 or so patients that are suffering from moderate to severe pruritus that are undergoing dialysis. We know the patient population addressable is significant. There are no approved therapies for these patients. They continue to predominantly get antihistamines, or just go untreated. What we're seeing now is that urgency to treat increasing as we've brought a new treatment to bear. You know, we think strongly in terms of, you know, in terms of the population that's addressable. We think very strongly that the expectations should be strong for this product, given that there's nothing out there for these folks. Now, TDAPA, you know, how this is going to be reimbursed after TDAPA, you know, like I mentioned in my prepared remarks, I mean, we're encouraged with the dialogue we've had with CMS. I would say, what's the proof point behind that? Well, in the rulemaking cycle just last year, they put a whole section, as you know, a request for information, where they actually teed up four different methodologies that talked about continuing an add-on payment in some shape or form. You know, that was encouraging. That was very encouraging because there's no need for them to do that. They could've just stuck with the current rule. You know, I think net-net to me, Daniel, is that, you know, I'm really encouraged. I'm optimistic on the long-term potential of this drug and the durability of this drug. You mentioned four methodologies. Maybe can you go over, you know, what those four potential outcomes could be, and do you consider all four outcomes as significant? Yeah. I got asked that question earlier. All four methodologies they proposed have some form of an add-on payment. For me and for our company, and I'll even speak for the other manufacturer or partner, I'd take any of those four. I think they're all supportive of ensuring that this product, you know, has the additional reimbursement it needs to continue on a very steep trajectory. Again, we're encouraged. I can't give odds on what the government's gonna do. We feel strongly that CMS has an open mind, and they acknowledge that this post-TDAPA environment could be challenging for dialysis providers. Any questions? I will continue. You are in the process of launching in Europe, and you mentioned, you know, Germany and France, but maybe can you briefly cover the opportunity there and, you know, approach to commercialization on a country-by-country basis following reimbursement? Sure. I mean, you know, the actual opportunity in Europe is not that dissimilar to the U.S. I mean, we estimate roughly 150,000 patients addressable in Europe. Our commercial partner is CSL Vifor. They have the full commercial rights to this product in Europe. They've already started to launch in several countries, namely last year, Austria and Germany. You know, and Germany obviously is one of the biggest, if not the biggest European country. Again, quite encouraged, early days. You know, we'd expect, you know, these countries to come online, the bulk of the EU countries to come online as they secure reimbursement from their governments, in 2023. You know, in terms of the effort, you know, it's really not that dissimilar to the U.S. I mean, we're building a market, and when you build a market, you know, the major task is really convincing nephrologists and nurses to systematically screen and identify patients and give them Kapruvia in Europe, KORSUVA in the U.S. That behavioral objective is no different in U.S. than in Europe. I mean, the systems are a little different. Reimbursement's different in Europe by country, right? There's no TDAPA. You know, so somebody said, "Well, slow and steady in Europe and have a lot of durability." Maybe. We'll see how that goes in 2023. You know, already in Germany, I'll tell you, we've been quite encouraged, especially when the guidelines came out and put Kapruvia as a 1st-line choice in the guidelines at launch. That's a really good sign. That's a really good sign. You know, I'd also point this out, Daniel. For Cara, you know, the economics are a little different in Europe with our partner CSL Vifor more than in the U.S. In Europe, you know, we receive a low mid-double-digit royalty on net sales. In U.S., we have a profit-sharing split with them, as you could see by the $33 million and the $15 million, we get about 45% of the net sales. It'll be a little different in Europe and probably more modest to our top line in 2023 than U.S. Okay. One of the catalysts is approval of KORSUVA in Japan that's expected in 2023. Should we expect any financial milestones coming to Cara in this year? Yeah. I mean, Ryan... yeah. Daniel, there is a financial milestone for that, and we feel pretty confident that it will be approved in Japan in the 2nd half, and that's $2 million to us when that happens. Great. If there's no any questions on, Maybe I can move on to oral KORSUVA next. Okay. you know, maybe, like, as a bigger picture, can you walk us through the decision process to focus on derm indications for the development of oral DFK? Given in 2022, you had other options and other trials. What made you ultimately decide to focus on derm indications? Yeah. I'll start out and maybe turn it to Jo for some comments there. I mean, our, you know, our focus as a company was looking at oral difelikefalin across systemic dermatologic and neurologic diseases. In the systemic, as you know, we were focused on chronic kidney. We also had a proof of concept program in chronic liver, namely primary biliary cholangitis. Dermatologic, you know, we had AD, and we were waiting for the proof of concept study in NP. I would say that's part neurologic as well, obviously. Really, what we've decided as a company mid-last year when notalgia paresthetica data came back quite positive in the proof of concept stage, that really provided, you know, what we needed to really go two feet in on dermatology. We also at the same time, you know, stopped our study in primary biliary cholangitis and obviously the reason is what we had said were, you know, it was very hard to recruit. We stopped that trial, and we preserved the optionality to continue if we want to. You know, right now with our company, you know, this nephrology franchise that we're exploring, you know, with the oral difelikefalin in phase three in pre-dialysis, dermatology, the NP data really rounded that franchise strategy, and that's where our focus is gonna be. I don't know, Jo, if you wanted to comment on that. No, just to add that it supports our clinical development strategy. That the intent was always to demonstrate that the drug worked broadly across different disease areas, and that's what NP did. It was able to demonstrate in a very different disease area that, which was neuropathically driven, that the drug now works broadly. It fits into the dermatology franchise, which then supports the focus on the nephrology and dermatology. You highlighted the unmet need in AD, even with current biologics, you know, approved. Can you maybe elaborate for us the clinical data that suggests that, you know, that patient population you're targeting, AD, can be addressed by an oral or a DFK? The majority of patients with atopic dermatitis have mild to moderate atopic dermatitis, which is these skin lesions. Although these skin lesions may be more on the mild side, they still have very itchy skin, with moderate to severe pruritus. The mainstay of treatment here is still topical corticosteroids. The only therapies approved for this patient population are topical therapies. As I said, the mainstay and the gold standard are your topical corticosteroids, which have limitations. We know that there's a need for an oral antipruritic therapy because we see an abundant use of oral antihistamines. The pruritus in atopic dermatitis is not histaminergically driven. In addition, our data in our phase II study demonstrated that the difelikefalin effect was strongest in this mild to moderate patient population. Taking all of that into account, that mild to moderate atopic dermatitis patient with moderate to severe pruritus is really the optimal positioning for difelikefalin. As such, that's how our phase III studies are designed, focusing on that patient population. Maybe focusing on that phase III, you have an internal readout coming up for KICK 1 Part A. You know, in terms of the readout, what do you wanna see? What's the bar to base your decision on regarding the selected dose and, you know, move on to Part B and also KICK 2? We will select the dose based on the most favorable benefit risk profile, whereby we will be looking at efficacy as well as safety data. The efficacy is predominantly looking at the four-point analysis. We have internal thresholds that we'll be looking at, which will guide us in the selection of that dose, as well as looking at the treatment effect to guide us on the estimation of the sample size. We are all on track on that for the 2nd half of this year. Will you press release the fact that you're moving forward, or how will the investors know that you have made that decision? Yeah. Once we have the data and we've made the internal decision, we will share that. Yeah. Okay. yep. Thanks. I think I heard that the trial design included a topical corticosteroid. Correct. Which one, talk a little bit about why you selected that one and how the interplay happens there. Sure. We have selected a mid-potent, it's betamethasone valerate cream. We selected that because it was important to have something that was effective for the skin lesions and that gets used abundantly as well, so just mimics real life. It was important for us to provide that drug so that we can ensure that we limit any variability as well. We felt that that was the most appropriate drug, and also had to take into account that that drug is available globally once we start moving into some of the ex-U.S. sites. That was an important factor as well. How would you determine what the steroids are doing versus your model? Ultimately, we look at the pruritus, as an endpoint, as the primary endpoint. There is an arm that is just a topical corticosteroid arm, so we would be able to see that. Got it. Thank you. Maybe as a last question. Mm-hmm. Between kick and KICK 1 and KICK 2, you know, are you seeing different rates of enrollment or, do you expect both to read out at the same time if enrollment is going up, you know, equally between the two trials? Yes. Daniel, so the studies are enrolling nicely and as anticipated. We are on track on reading out in 2nd half of 2024 for both the studies. Okay, great. Thank you very much. Thank you. Thank you, everyone. Thank you. Thank you.