Good day. Thank you for standing by. Welcome to Cara Therapeutics Corporate Update Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automatic message advising your hand is raised. Please note that today's conference is being recorded. I would now like to introduce Matt Murphy, Cara's Manager of Investor Relations. Please go ahead. Thank you, operator, and good morning. This morning, Cara issued a news release announcing the company's corporate strategy, focus, and update. Copies of this news release and the associated SEC filing can be found in the investor section of our website at www.caratherapeutics.com. Before we begin, let me remind you that during this conference call, we will be making certain forward-looking statements about Cara and our programs based on management's current plans and expectations. These statements are being made under the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties. Actual results may differ materially due to various factors, and Cara undertakes no obligation to update or revise these statements publicly as a result of new information or future results or developments. Investors should read the risk factors set forth in Cara's 10-K for the year ended December 31, 2022, and any subsequent reports filed with the SEC, including its Form 10-Q for the quarter ended September 30, 2023. With that said, I'd like to turn the call over to Chris Posner, Cara's Chief Executive Officer. Chris? Thanks, Matt, and welcome everyone to our corporate strategy update conference call. With me today are Ryan Maynard, our Chief Financial Officer, and Dr. Joana Goncalves, our Chief Medical Officer. Today, we have set Cara Therapeutics on a focused and differentiated path to deliver value in the near and long term. Our actions and sharpened strategy will make us a streamlined company, concentrating our available cash and resources on the program that we believe has the highest potential for success in the clinic and in the marketplace. We now have extended our cash runway into 2026, and with our unique focus on the late-stage notalgia paresthetica program, Cara will be leading the way in a prevalent, yet unexplored and underserved medical dermatology condition. We expect prioritization of NP will allow us to execute all the program's expected value inflection points within our cash runway, putting us in a position to begin work on an NDA. I'll provide details on the exciting NP program and briefly touch on the decision to close the oral CKD program and our strategy to streamline the company. After that, we'd be happy to take your questions. Cara has an opportunity to become a pioneer in medical dermatology with our high-value, late-stage program in notalgia paresthetica. NP ticks all the boxes for a breakout program for a growth-oriented biotech, a differentiated asset targeting a therapeutic area with no FDA-approved therapies and which we believe has a high probability of success. An unexplored condition with high unmet need, NP has significant commercial potential due to a sizable target population, no approved or effective therapies, and no current competition in development. We estimate an addressable U.S. market of 650,000 patients who are currently in the care of a physician, and there could be more, as we estimate a much larger population who are undiagnosed or undertreated. As I said, our strategic decision to focus on our NP program follows our belief in its high probability of clinical and regulatory success. Oral difelikefalin's mechanism is ideally suited for NP because of its neuromodulatory activity and antipruritic action. NP is a neuropathic disorder for which chronic pruritus is the hallmark. Our positive proof of concept data, published in the New England Journal of Medicine, has generated buzz in the dermatology community, attracting significant interest across treating physicians, patients, and other stakeholders. This interest has driven rapid enrollment in our ongoing clinical trial. We are now tracking ahead of our internal timelines for our phase 2/3 trial. The NP program is expected to deliver a succession of clinical milestones over the next 18 months. This includes data from the dose-finding portion of the phase 2/3 trial in Q3 2024, final top-line results for the first pivotal study by the end of 2025, and results from the second pivotal study in early 2026. We expect our clear strategic focus will now give us the resources to complete all necessary clinical activities for our NP clinical program with our cash on hand. We believe these value inflection points will put the company on strong footing, such as positioning us to begin work on an NDA if the final results are positive. To give us a runway to get there, we've decided to discontinue our phase 3 program for oral DFK in advanced chronic kidney disease. I want to stress that this decision was based on the strength and potential of the NP program and our desire to prioritize resources for it... We remain confident in oral difelikefalin's mechanism in CKD and its potential more broadly. In light of our decision to discontinue the oral CKD program and focus on NP, we have also made the decision to implement a significant workforce reduction effective January 31. Overall, our actions to streamline the company, including the planned headcount reductions, give us a sharp focus on value creation. This strategy is designed to take advantage of our strengths in identifying novel indications, designing creative clinical development programs, and effectively managing our cash to create momentum for building a sustainable future. In conclusion, while the actions we are taking are difficult, we believe we are making the right calls necessary to put Cara Therapeutics in the best position to win in the near term and in the long term. Our strategy prioritizes our differentiated late-stage clinical program in NP, which we believe has the best commercial potential and a high likelihood of success. We are extending our cash runway into 2026. Our extended runway is expected to give us the firepower to complete all planned clinical trials and reach key value inflection points in the NP program. Focusing on this unexplored indication creates a differentiated opportunity to be a real pioneer in medical dermatology. The drumbeat of inflection points enabled by our runway will be the gateway to more options and a future as a sustainable growth biotech company. And now, with that, we will be happy to take your questions. Livia, please, open the line for Q&A. Thank you. Ladies and gentlemen, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, you may press star one one again. Please stand by while we compile the Q&A roster. Now, first question coming from the line of Joseph Stringer with Needham. Your line is open. Hi, good morning. Thanks for taking our questions. Two from us. First, just briefly on the decision to discontinue the CKD program. Just curious, maybe you could provide a little bit more color on it. Just curious, you had, I think, a planned readout coming up this year, but you mentioned it was mostly based on cash runway. Just curious if you had a look at the blinded data or any type of look at the data from that program? And I have a follow-up question. Yeah, sure, Joe. Good morning. So first, on the CKD trials, they remain blinded. So our decision to discontinue the program is solely based on our strategy to prioritize the NP program that we believe has the greatest long-term value. And so, you know, discontinuing the CKD program, Joe, we could extend our cash runway into 2026. And what was really important to us, it gives us the operating capital over two years to achieve, you know, the completion of this program and really prepare for the NDA. Thank you. Then the follow-up, just a general question on the NP program. You mentioned the commercial opportunity, and I guess maybe help frame for us and investors where you see the potential of this program, what a positive readout would look like in phase 3, and is this something that you think you could develop on your own? Yeah. So, Joe, let me tackle the commercial side of this, and maybe I'll let Jo comment on the clinical trials themselves. So like I mentioned, the addressable population is we estimate right now it's 650,000 people. They're currently under the care of a physician, namely a dermatologist. There are no FDA, you know, FDA-approved treatments. So we have the opportunity to really be a category creator. And like I mentioned in my prepared remarks, it really ticks all the boxes of an innovative biotech company. So we're really excited about that. And, you know, I also mentioned the enrollment. The enrollment in our phase 2/3 is going really, really well. You know, I think it speaks to kind of the buzz that was generated with the New England Journal. You know, we continue to, you know, be very, very optimistic about that. Jo, let me turn it to you, maybe comment to Joe's question. Yeah. Hi, Joey. So for phase 3 program, we would expect to show statistical significance compared to the placebo arm. And our primary endpoint, as a reminder, the primary endpoint is the 4-point responder analysis. So a statistical significance versus the placebo in that endpoint is what we would be seeking. Great. Thank you very much for taking our questions. Thank you. One moment for next question. Our next question coming from the line of Annabel Samimy with Stifel. Your line is open. Hi, thanks for taking my question. Just wanted a little bit of clarification on the timelines. You mentioned that you were enrolling the study more rapidly. Is there any possibility of changing the timelines to completion? Where are you in enrollment? And could you potentially complete the trial earlier than what you might have expected? Yeah. Hi, Annabel. Good morning. So, in terms of the timelines, you know, like I said in the prepared remarks, we, we are seeing, you know, excellent, excellent traction on enrollments. You know, the current timelines would put us to Q3 2024, for the first readout of the, of the phase 2 portion of that, the dose finding portion. And then we also mentioned we expect, you know, given those, given the current timelines, to see top line results, within our cash runway, you know, namely at the end of 2025, early 2026. That's kind of where we are right now. Certainly, we'll provide much more, you know, updates as we kind of move through the enrollment, but that's kind of where we are right now. Okay. And then, when you think about the clinical trials and being able to get through with the cash runway, do you have a good sense of the size of the phase 3 trials already? Because I think the current phase 2/3 still has some dose finding in it. So how is it that you get a sense of what the size of the phase 3 could be? Yeah, we've made some estimates based on what we saw in the proof of concept study and based on what we expect to see in the phase 2 study in terms of the treatment difference. So that's led us to make some estimates in terms of what we're going to go forward with in the pivotal programs. So that's how we kind of calculated that. Okay. And then one last question for me. Mm-hmm. I'm just going back to a question that was asked previously. Is there any thought to, I guess, monetize this asset in any way or get a partner? Mm-hmm to work with you with this asset, just given the potential, you know, size of the trial? But, I mean, clearly you have the runway, but is there... It's quite a large market, so, any thought to that? Yes. Well, specifically on our NP, I mean, Annabel, I think I've mentioned a couple of times before, you know, our intent is not to commercialize this asset outside the U.S. So certainly we'd be, you know, looking for partnerships, commercial partnerships outside the U.S. That, that's still going to be the intent. In the U.S., you know, we have every intention to retain as much of the economic rights as possible. It's an indication that we feel, you know, we obviously have the expertise to commercialize, you know, upon obviously the phase three data and the NDA and hopeful approval. So that would be our intent moving forward. Okay, great. Thank you. Thanks, Annabel. Thank you. And our next question coming from the line of Suman t Kulkarni from Canaccord Genuity. Your Your line is open. Good morning. Thanks for taking my questions. I have two. The first one is, do you have any quantitative metrics you might be able to share on what might be considered successful on the dose-finding part you expect to read out in the third quarter? Hey, Sumant, let me, let me give that to Jo, and she could talk about the, the primary endpoint, et cetera. Go ahead, Jo. Yeah. Hi, Sumant. Yeah. So, the dose-finding study, as just to remind everyone, is a study to assess and to try and determine what dose to take forward. We wouldn't really be expecting to show any statistical significance here. It's really just to see a trend with the doses, so we can then take forward the most favorable dose, and also just to be able to assess that treatment effect as well. So that's really how the study is designed. As you may recall, this is a 200-patient study with 50 patients per arm. Got it. And then if your phase 3 program were to mimic the safety profile you saw for the product in the phase 2 program so far, would that be considered favorable enough of a benefit risk profile for the product to see real world usage in NP, especially as no product is approved for that indication? Yeah, I mean, you may recall- Sure. Yeah. You may recall, Sumant, we had a really nice benefit-risk profile in our proof of concept study. We were very pleased with the data and the safety profile being very consistent with what we've seen to date. And that was with the higher 2 mg twice daily. So very pleased with that and think, of course, there'll be a strong path forward into our phase 3 program. Thank you. Thank you. Our next question coming from the line of Oren Livnat with HC Wainwright. Your line is open. Thanks. I have a couple questions. Just to back up first for more context around the decision to terminate the CKD program. I mean, you said you still believe in the mechanism there, and there's clearly an unmet need. So can you just help us understand, did you potentially try to out-license that program to secure enough funding, just to at least get it through completion since it was, you know, relatively near term? Or did you just think that it wasn't worth, you know, commercially even pursuing at this point, certainly compared to NP? And then on NP, can you just clarify for the part A dose finding portion in third quarter, are you expecting to give us a full readout like you decided to do with the AD program, albeit hopefully successfully, or is that just going to be an internal readout? And I actually have one follow-up, but I'll let you go from there. Yeah, sure, Oren. So in the last one, yes, we will provide full transparency on the data for the NP program. On the first one, around CKD, we did explore. I mean, we've been looking at opportunities for partnering the CKD program, but the possible timing and return really didn't make sense from a business perspective for Cara. You know, we decided then to allocate our capital to the program that we believe has the highest probability of both clinical and commercial success. And bottom line, extending our cash runway was a very, very high priority, and streamlining our focus and operations extends now our runway into 2026, and that allows us to, you know, on our timelines, our expected timelines, to finish all the clinical trials for the NP program to prepare for an NDA. You know, bottom line, Oren, given that extending the runway was a key priority, a CKD partnership would have had to fund the development program and provide care of value upon commercialization. Okay. And just on the NP opportunity, obviously, you believe it's a much bigger market than the 650,000. First, can you clarify, is that 650,000, is the vast majority of that in the dermatology space now, in terms of treatment and diagnosis and treatment versus primary care? And if it's successful in phase 3, is this potentially a much larger primary care indication for this older population? And thus, are you likely to maybe partner this thing or co-promote, you know, I guess, work in partnership to fully maximize this after good data? Yeah. So I mean, right now, our estimates from our work suggest about 650,000 are currently being treated by physicians, namely dermatologists. So that, that's what we see right now in the work we've done. In terms of your question around primary care, I mean, again, these are mostly treated by dermatologists. You know, given that this, this condition is really just beginning to gain kind of its recognition, and I've seen, you know, science drives recognition. And the New England Journal, you know, I mentioned that before, is a really important, you know, kind of catalyst for this. So, you know, we'll, we'll continue to do some of the market research work to really, you know, kind of understand where the best opportunities for this program long term may be. But, but in the near term, it's certainly in medical dermatology. Dermatologists treat this condition, they see this condition, and like I also mentioned, there are no other assets approved by the FDA for this condition. So it's quite a unique indication that I... Again, I use the word category creative. So I'm really, and I know we're really excited about this as a company. All right. Thanks. I'll follow up with you. You got it. I appreciate it. Yep. Thank you. As a reminder, ladies and gentlemen, if you'd like to ask a question, please press star 1 1. Our next question coming from the line of Dennis Ding with Jefferies. The line is open. Hi, this is Anthea on for Dennis. Just wondering, what are your thoughts around getting more value from KORSUVA at this moment, given the bundling dynamic? Thank you. Yeah. Hey, Anthea, good morning. So IV KORSUVA is still being commercialized by CSL. The TDAPA period will expire at the end of March, and then, you know, given the new rule, or the new 2024 rule by the CMS, you know, we expect obviously reimbursement now to be included in more of a bundled fashion. And like we mentioned in the previous call, I believe the Q3 earnings call, you know, that we do not expect significant revenue contribution given these reimbursement dynamics. I mean, bottom line is, obviously, it's got a lot of utility for these patients. But unfortunately, the way CMS has decided to deal with innovative drugs, it's simply not gonna provide the reimbursement to catalyze real demand generation. Thank you. You're welcome. Thank you. One moment for the next question. Our next question coming from the line of David Amsellem with Piper Sandler. Your line is open. Hey, thanks. This is Tim on for David. How are you thinking about strategic options? I know you touched on partnering the asset for NP outside the U.S., but what about an outright sale of the business? Thanks. Yeah. So, hey, Tim, good morning. Yeah, so we... You know, listen, I mean, we've made a strategic decision to focus our resources on a, we believe, you know, a critical value-creating asset, which we think is gonna have a significant long-term growth potential and really be the benefit of the company and the shareholders. So that's a decision we made right now, and we think it's the right decision from a value creation standpoint. So that's our sole focus right now. Got it. Thanks. You're welcome. Thank you. That's all for the questions in the queue at this time. I will now turn the call back over to Mr. Posner for any closing remarks. Well, thank you very much, Livia. This is a new day for our company, and we look forward to sharing these updates in the quarters ahead on the fruits of this new focused corporate strategy. Thanks again for joining us, and have a great day. Ladies and gentlemen, that does end our conference for today. Thank you for your participation. You may now disconnect.