Good afternoon, and welcome to Miram Pharmaceuticals' second quarter 2026 earnings conference call. My name is Alexandra, and I will be your operator today. All lines are currently in a listen-only mode, and there will be an opportunity for Q&A after management's prepared remarks. I would now like to hand the conference over to Andrew McGibbon, SVP of Strategic Finance and Investor Relations. Please go ahead.

Thank you, Alexandra, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' second quarter 2026 conference call. I'm joined today by our Chief Executive Officer, Chris Peets, our President and Chief Operating Officer, Peter Radovich, and Eric Bierkolt, our Chief Financial Officer. Lara Longpreay, our Chief Development Officer, will be joining us for the Q&A portion of the call. Joanne Kwon, our Chief Medical Officer, could not be with us today due to a family matter. Earlier today, Miriam issued a press release announcing the company's results for the second quarter of 2026. Copies of the press release and our SEC filings are available on the Investors section of our website. Before we start, I'd like to remind you that during the course of this conference call, we will be making certain forward-looking statements based on management's current expectations, including statements regarding Merrim's programs and market opportunities for its approved medicines and product candidates and financial guidance. These statements represent our judgment and knowledge of events as of today and inherently involve risks and uncertainties that may cause actual results to differ materially from the results discussed. we are under no duty to update these things please refer to the risk factors in our latest form 10q and subsequent SEC filings for more information about these risks and uncertainties but that said I'd like to turn the call over to Chris Chris thanks Andrew good afternoon everyone at Mirren we're growing a rare disease leader focused on delivering high-impact medicines for often overlooked diseases this quarter demonstrates continued progress with strong commercial execution on our approved medicines as we head into the potential launch of our fourth commercial medicine later this year we

have a busy pipeline with multiple pivotal readouts in the quarters ahead all delivered with the strength and capital structure and overall financial performance giving us greater capacity to invest throughout the business in the second quarter our commercial business generated 176 million in net product sales reflecting strong demand across the portfolio and excellent execution by our team based on this performance we are increasing our full year 2026 net product sale guidance to 680 to 700 million dollars fueled by this strong commercial performance we're driving towards the next phase of miriam's growth with multiple milestones over the coming months our next commercial milestone will be the potential launch of zeloid asserted for fop with the fiducia date next month this is fast progress for a program added to our rare genetic business only in the second quarter. Peter will cover more of the launch profile on his remotes. Moving to the pipeline for our rare liver business, it's important to spend some time today on Belixabat and PFC, which just had some key U.S. regulatory interactions. First, as a reminder of the background of the VISTA study of Belixabat and Clostatic Puriitis and PFC, we designed this adaptive study with input from the FDA as a pivotal trial for this difficult clinical setting, including alignment on study duration, endpoints, and analysis plans. As we've announced previously and presented at EASL this year, VISTA has met its primary endpoint, showing highly significant improvements in pruritus in the primary cohort, with consistent, significant results also observed in a second cohort of patients with milder baseline pruritus. We are excited to share that the FDA has now granted breakthrough therapy designation for Velixabat in colostatic curitis due to PFC based on these strong results. We see this as recognition of the potential for Velixabat to address a serious unmet need in PFC. As planned, we recently held a pre-NDA discussion with the agency about the submission of an NDA based on the VISTA study. In the meeting, the FDA recommended conducting a phase three study. We believe the VISTA study provides a robust and clear data set to characterize the use of Velixabat in patients with of Pyritis Due to PSC and is a clinically and statistically highly persuasive study. VISTAs is the largest randomized clinical study conducted in patients with Pyritis Due to PSC with an extensive overall data package that includes more than 180 PSC patients randomized, one-year safety exposure data for over 100 PSC patients and growing results from an independent committee evaluating liver safety, all totaling over 600 subjects across the clinical program to date so while we are not currently aligned on the nda submission package we will be engaging in discussions with the fda on how to further supplement our planned submission based on the fista study this engagement will delay the plan timing of our nda submission which we are now targeting for the first half of next year we're positioned to move quickly once we have further clarity from the agency we'll provide updates as we work towards our goal of bringing a much-needed therapy to this unaddressed clinical setting. In parallel, the Vantage study in PDC is progressing well and has completed enrollment, reaching over 330 patients randomized. In PDC, our earlier breakthrough therapy designation has enabled more dialogue with the agency during the conduct of the study. We have recent feedback from FDA for Vantage to serve as a pivotal study of the Lixabat enteritis due to pbc if the study is successful at its first quarter top line readout next year our next clinical readout for the rare liver business is expected to be below it as your one top line results later this quarter this is the readout of the phase three portion following strong results of the phase 2b portion earlier this year and we also continue to expect azure 4 data in the fourth quarter which keeps us on track for a potential dla submission for this breakthrough therapy designated program in the first half of next year. And rounding out the rare liver pipeline highlights, the phase three expand study of Livmarly and additional rare cholestatic conditions remain on track for top line data in the fourth quarter. So putting this all together, we're advancing these clinical programs from a position of financial strength. Our commercial business continues to generate meaningful cash, providing the capacity to invest in potential launches, clinical development opportunistic business development where we see a compelling strategic fit and the potential to create value I'm proud of the team's progress and the promise of our current medicines and pipeline I'm excited about what lies ahead from Iran and with that I'll turn the call over to Peter to discuss our commercial performance and launch readiness in more detail Peter thanks Chris the second quarter was another strong quarter for Merrim's commercial business, with total net product sales of $176 million.

Livmarly and the BioAcid Medicines both continue to perform well, and based on the demand we see, we are increasing our full year 2026 net product sales guidance to $680 to $700 million. Second quarter net product sales for Livmarly were $129 million, with the U.S. contributing $92 million. Allergy growth remains durable, supported by continued new patient starts, sustained persistence on therapy, and weight-based dose increases. PFIT continues to be an important driver of growth, fueled by new diagnoses. We're particularly encouraged by the growing contribution from adult PFIT patients. We're seeing an increase in prescriptions from adult liver providers as awareness of later onset PFIT grows and genetic testing becomes more routine. Based on claims data as well as insights from two years in market, we now estimate an addressable adult PFIT population of at least 2,000 patients in the United States with likely a similar number in Europe. And because genetic testing remains less established in adult practices than in pediatric, we believe the vast majority of of the estimated 2,000 addressable patients don't yet have a PFIC diagnosis. And we see a meaningful opportunity to continue expanding diagnosis through education. Internationally, Livmarly continues to grow across our direct and partner markets, contributing 37 million for the quarter. We are seeing contributions from established markets and expanding reimbursement in additional geographies. On the rare genetic disease side of the business, our bile acid medicines continue to provide a steady contribution, generating $48 million in net product sales for the quarter. Like our rare liver business, our rare genetics business is also poised for growth with the recent addition of Zalurg Assertive for FOP. Data from the pivotal Phase II Progress Study of Zalurg Assertive presented at Endo showed a compelling clinical profile in FOP patients ages 12 and older. Based on the strong efficacy observed and the convenience of oral dosing, we believe Zorgoservative has the potential to offer an attractive profile to patients with this severely debilitating disease. If approved by the FDA, the initial launch opportunity is expected to focus on patients ages 12 and older with potential future expansion into younger patients, supported by additional cohorts in the progress study. And following a recent late-cycle meeting with the FDA, we believe the NDA is proceeding as expected towards the September PDUPA date, and we are preparing for potential U.S. launch in the fourth quarter. The U.S. launch will heavily leverage the rare genetics team we have in place now that that currently markets are biolacid medicines, as the physicians who manage FOP are largely concentrated in the same specialized centers where Setextli and Kolbaum are prescribed, building on the efficiency of our rare genetics business. Also, a marketing application for ZalurgoCertiv has been submitted in Europe, and we will provide updates as this filing progresses. Overall, we are pleased with the continued execution across the commercial organization. We're seeing strong demand throughout the existing portfolio while making the investments necessary to support the next wave of potential launches. We believe that we are well positioned for the remainder of the year and beyond. With that, I'll turn it over to Eric to discuss the financial results.

Thanks, Peter, and good afternoon, everyone. Today, I'll walk through the financials of another excellent quarter from Mirum. Net product sales for the second quarter were $176 million compared to net product sales of $128 million in the second quarter of last year. Cash, cash equivalents, and investments as of June 30th were $561 million compared with $391 million at the beginning of the year. In the second quarter and the first half of 2026, the cash contribution margin from our commercial business was in the high 50 percent, approximately a five percentage point improvement over the year before. Total operating expense for the quarter ended June 30th was $219 million, which includes $16 million of in-process R&D expense associated with the upfront payment of licensing the Lergy Circuit, R&D expense of $76 million, including $29 million related to the development of Brelovitag, SG&A expense of $66 million, and cost of sales of $23 million, all excluding stock-based compensation expense and intangible amortization. Stock-based compensation, intangible amortization, and other non-cash expenses totaled $37 million for the quarter. Operating cash flow was positive in the second quarter despite the expected increase in R&D expenses. During the quarter, we significantly improved our capital structure through the issuance of $690 million aggregate principal amount of 0% coupon convertible notes due in June 2032. Net proceeds from the offering were $672 million. In conjunction with this financing, we settled 75% of the outstanding 2029 notes, added $197 million of cash to the balance sheet, and significantly reduced our interest expense. These transactions further strengthen our balance sheet and extend our financial flexibility to execute our strategy. Our commercial business continues to scale, and our pipeline includes multiple near-term value drives. With that, I'll turn a call back to Chris for closing remarks.

Taking stock of where we are, we are continuing to drive our strategy to bring important medicines to underserved rare disease patients. Commercial business is thriving, now tracking towards $680 to $700 million in net product sales for the year, with Marley is well on its way to realizing its over 1 billion peak revenue potential. And our rare genetics team is thrilled about the potential launch of Solor Dissertib for FOP patients in the coming months. On the pipeline, we are focused on a collaborative discussion with FDA on the VISTA study and PSC. Clinical results are clear, and breakthrough therapy designation gives us further opportunity to engage with FDA. All said, we have a plan to advance folixabat to PSC patients. The balance of the pipeline is firing on all cylinders. Recapping our upcoming clinical milestones, we expect clinical readouts from Phase 3-0-1 and as year 4 studies of Llovitug over the balance of the year, which will enable our planned DLA submission in the first half of next year. Next quarter, we also expect to announce top-line results from the EXPAND study with Marley and additional rare cholestatic diseases, setting up the potential for an SNDA next year as well. And into 2027, we expect top-line results from the Vantage study of Bolixvat at PBC first And finally, we're on track with MRM 3379, the proof-of-concept data in Fragile X Syndrome next year. Importantly, we're building an organization capable of reaching many more people living with overlooked rare diseases while delivering strong financial performance. I want to thank the Miram team for their continued focus and execution, and the patients, families, and physicians who continue to partner with us in this work. With that, operator, please open the call for questions.

We will now begin the question and answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of Ryan Deschner with Raymond James. Your line is now open. Please go ahead.

Hi, good afternoon. Congrats on the strong results. Curious what your overall take is on the potential read-through from the BOLD study evaluating Otavixabat in patients with biliary atresia, and I have a follow-up question.

Thanks, Ryan, for the question. The BOLD study and the study of note in our pipeline that includes biliary atresia patients, the EXPAND study, to put it simply, are asking very different questions. I would equate the BOLD study more to what we ran previously with EMBARC, looking at patients in the very acute setting, trying to reduce bilirubin or extend transplant pre-survival. The question we're asking in EXPAND ties much more to where we've seen IBAT perform quite well in other settings, where we're looking at older patients than what was in BOLD and EMBARC and evaluating puritis changes. It's something that we've seen an impact from IVAT therapy over and over again now in different clinical settings. So we feel there's not really a read-through or connection between old and what we're looking at in the upcoming Expand readout. DR. DR. DR. to reiterate some of the background here, you know, we did extensively discuss the VISTA study design with FDA. You know, back in the pre-ND setting, you know, the FDA acknowledged the pivotal intent, described the design as reasonable, gave direct feedback on duration, analysis plan, all these things that designed the study that we read out so successfully earlier this year. And frankly, the situation now that we've seen is in the meeting, there was a new team from FDA, So we think there's a lot of work to kind of get them up to speed on the backdrop here. So the history, designing and conducting VISTAs, and what the study means in a PSC setting. So we think it's going to be an iterative approach to kind of get them up to speed, not only with the current data package, but with the history of the program. Very helpful. Thanks.

Your next question comes from the line of Gavin Clark Gartner with Evercore ISI. Your line is now open. Please go ahead.

Hey, guys. Thanks for taking the questions. First, what was this new FDA's team's rationale to conduct an additional Phase 3? Like, was it more of a safety database question, or was it more around the efficacy side?

The comments about a Phase 3 recommendation really were not specific. So we don't have great clarity on what specifically they're looking for. There were comments across the board more general on efficacy, which we think VISTAs very clearly addresses, and they actually commented on that in the meeting. On the safety side, the discussion, the couple of things that were brought up were IDD safety in the backdrop with IBAT GI effects and liver safety. Those were designed into VISTAs as key things to evaluate. So we think it's all there in the VISTA study, and it's more this is more about familiarity with study design and some of the questions that were asked another thing i'd point out is that the breakthrough designation actually was issued after the meeting so i think that gives us a great opportunity to go back in and build up familiarity with this data set and work us towards an nda okay that makes sense and just a quick follow-up is this a team that you have engaged with before on any of your other programs do you any experience working with them?

And kind of on a similar point, what other regulatory precedents would support approval based on the similar type of Phase 2B setting? Thank you.

Thanks for the follow-up. In terms of a team, a lot of times the correspondence is written, so you don't have perfect clarity on who's behind some of the written correspondence. So it's difficult to answer that question, to be honest. And in terms of precedent, I mean, really I've looked across all the IBAT settings where you've seen an algeal where the first approval was based on four-week randomized withdrawal data, all the way to the more recent Lenovoi approval and PBC puritis with a six-month placebo-controlled study that, frankly, looks a lot like VISTAs. It's a little bit larger because PBC is a more prevalent indication. So there's pretty clear precedent for IBAT in cholestatic puritis settings that line up with VISTAs. It goes back to the whole way that we designed the study in the prior conversations with the agency.

I'm sorry, I may have misheard something. Did you say that this was only happening via written correspondence, or was this pre-NDA in person with the FDA or virtually?

The pre-NDA was in person. So, when you were asking about prior and other interactions, some of those have been written. So, we don't know who was behind some of the other written correspondence. This meeting was in person.

Okay. Got it. Thanks so much.

Yeah, thanks for the question.

Your next question comes from the line of Mike Olps with Morgan Stanley. Your line is now open. Please go ahead.

Hi, this is Rohit on for Mike. Thanks for taking our questions. Just based on your conversation with the FDA, do you see any read-through to the PBC Vantage study? Is it possible they'll request a phase three trial for that one? And also, in terms of commercial prep for FOP, can you talk about where you currently stand in what's outstanding. Thanks.

Thanks, Rohit. I'll speak to PBC and then pass it over to Peter to talk about FOP. On the Vantage study, as you may recall, we were granted breakthrough designation after the interim analysis in 2024. So that actually gave us a great opportunity to have conversations similar to what we expect to go through here with VISTAs. And so in the correspondence after the breakthrough designation on Vantage, we actually received pretty clear feedback from FDA on what we should do to consider Vantage a pivotal study. And we were able to address those. So primarily the comments related to the overall size, that's part of why we've ended up with over 330 patients in Vantage, and also the analysis plan and some of the specifics on how the curitis endpoint is analyzed.

And, Rohit, yeah, with regards to the commercial prep for those sort of potential approval and launch in Q4, that's going really well. As I mentioned, we were able to drop that in the bags of our rare genetics team and add a couple territories there. A lot of, you know, typical prelaunch activity and profiling accounts and understanding where the treaters are. These patients are well-identified. There's about 300 or so diagnosed and managed in the U.S. in highly specialized centers. Had a good presence at the endo meeting earlier this summer as well. So excited about the progress of the end-day review and working towards launch readiness in Q4. Thank you.

Your next question comes from the line of Brian Scorney with Baird. Your line is now open. Please go ahead.

Hey, good afternoon, team. I'm going to be annoying and also ask a little bit on FDA's issues with VISTAs, just given that it seems like a pretty straightforward data set. Can you just very fresh our memories? The review team here is within the Division of Hepatology. Is Katie Donahue still the office director? Was she involved in the meeting? Is Frank Ananya still the division director? And was he in the meeting? And, you know, I mean, I hear they weren't very specific about why they wanted Phase 3, but I mean did they sort of mention like a need for replication? It just seems like the p-value here is so robust that there's not really another question that could be answered with a phase three other than maybe longer term follow-up. So yeah, any sort of guidance there is helpful.

Thanks Brian for the question. On some of the specifics of people kind of in the room, what I would say, you know, the office leadership we think maybe has changed and leadership was not in the room in our in our review meeting and kind of getting into some of the I mean specifically on efficacy you know the I think it's like you're pointing out I think it's very easily addressed by the VISTAs data and getting breakthrough afterwards I think is a nod in that direction so I given some of the discussion in the room I think that's uh something that we can readily address through iterative conversation with fda

yeah so maybe if i could just ask one thing on the padufa with uh zeller yesterday um i think you would have had probably the late cycle review meeting in the last uh month or so um just any any commentary on on how that went and your level of confidence going into labeling discussions yeah thanks for the question brian that yeah we did have the late cycle meeting.

Meeting went very well. So, you know, we feel the application is progressing quite well towards the Paducah date. So, you know, full systems go to prepare for a potential launch in Q4.

Great. Thank you.

Your next question comes from the line of Calpit Patel with Wolf Research. Your line is now open. Please go ahead.

Yeah. Hey, good afternoon. Thanks for the question um one more on the regulatory interaction here uh in your communication with the agency has there been any dialogue so far on potentially running a post-approval confirmatory study instead of running a phase three um or should investors assume that um you know the phase three is is what's in the works right now thanks for the question i think one The direct answer is that the conversation with FDA didn't get to that level of specifics for post-approval requirements.

I can comment a little bit on the pathway here that using puritis is the basis for full approval. So, we don't expect to have a post-approval study in the sense of kind of confirmatory accelerated approval type format. What we would expect and has been added for other IBAD approvals is some level of post-approval registry or kind of long-term monitoring. And so, we do think that would be appropriate for this setting as well.

Okay.

Your next question comes from the line of James Condollis with Stifle. Your line is now open. Please go ahead.

Hey, thanks for taking my question. and congrats on a great Liv Marley quarter. Just, you know, maybe to be annoying again, one more on PST. I guess, like, to clarify, is a phase three on the table or, you know, are you confident that this can be resolved, you know, through, like you said, iterations on sort of the data? Just wondering sort of, like, what your base case is and, you know, sort of what informs your confidence of guiding to a first half 27 resubmission.

Yeah, thanks for the question, James. And, you know, as we, you know, looked at this proposal for a Phase III, and given the VISTAs results, I think the key question is, what would you learn from another study in this setting? And VISTAs is the largest ever conducted in PSC puritis. Clear definitive results. It's a big enough safety database for a setting like PSC. So we don't see what would be gained by going down that road and find that just the weight of evidence here is really convincing. So I feel good about where we stand now with breakthrough designation to work through this.

Thanks for your question.

Your next question comes from the line of Lisa Walter with RBC. Your line is now open. Please go ahead.

Good afternoon. Thanks for taking our questions. Kind of one more on the NDA filing delay here for Elizabeth. Could this mean that we see more BD in the near term as potentially PSC revenues may now be pushed out. And I just want to ask as well, could you add any clarity on whether the FDA is still accepting a pruritus as an approvable endpoint? Thanks so much.

Thanks for the questions, Lisa. You know, the first thing on the answer is second part first, which is absolute clarity that pruritus It's an approvable endpoint. That's what this discussion is all focused on. So there's no question there. On the BD front, you know, we've always approached BD on being always active and always opportunistic. So don't see this really relating to the overall level of activity we have or our criteria and what we're looking to bring in.

Your next question comes from the line of Joe Schwartz with Leerink Partners. Your line is now open. Please go ahead.

Hi, thanks. Hypothetically, if the FDA doesn't budge, does Vantage PBC have any ability to strengthen the Veluxibat regulatory package for PSC? For instance, if a filing in PBC is an NDA and a filing in PSC as an SNDA, could that order of operations be successful without having to do another Phase III?

Joe, thanks for the question. You know, what I'd say is potentially, and we're getting into some hypotheticals down the road, the base plan is to get the PSC and the NDA submitted first. But as we think about the Vantage data, another large randomized study playing into a very related pyritis condition, I do see like some weight to that, and how we approach that in terms of parallel or sequenced NDAs is something that we'll get to if we end up in that scenario.

Okay, thanks. And then a question for Lovatog. Did any baseline characteristics for patients enrolled in the interim analysis cohort of Azure One appear to correlate with better response in the phase 2B portion of the trial? And how do the baseline characteristics for patients enroll in the full Azure 1 population and Azure 4 compare?

The quick answer to that is no, nothing obvious that really comes out. And we see response for Brilovitug across really all patients. So it's a very broad-based response. And that cuts across baseline viral RNA levels, ALT levels, geography, kind of every way we've looked at it, you consistently see patients responding to rural overtake.

Thank you.

Thanks for the question. your next question comes from the line of jessica fye with jp morgan your line is now open please go ahead hey guys good afternoon thanks for taking my question uh so more on the looks about um when you i think in prepared remarks referred to some options to supplement the vistas trial curious what you could supplement it with and second uh based on where we stand right now What gives you the confidence to outline first half of 27 as the new PSE filing timeline? Thank you.

Thanks for the questions, Jessica. In terms of supplementing it, the real simple one is actually something I mentioned in the prepared remarks as well, is kind of the data cutoff timing, where we're able to pretty easily allow more safety data to approve, to get to 100 patients at the 12-month mark in the open-label follow-up. So, that was one of the kind of quick offerings in there. I think some of the other things could be towards things that were mentioned in earlier questions and what could be offered up for post-marketing registry work and things like that. In terms of the timing, we feel first half is very achievable, and it's really based on having enough room to have an iteration or two with FDA. So, it's less about time we need to prepare the submission, frankly, because things are ready to go quite quickly after we kind of have the input we need. It's more about that iteration with FDA. And really, that's kind of an estimate based on experience. You know, we've done applications like this before, back to the original Al-Gil application, where it took a couple of meetings along the way to kind of build up to that NDA filing for Marley and Alagil. And so it's a type of situation that we've worked through before.

Your next question comes from the line of Joseph Tomey with TD Cohen. Your line is now open. Please go ahead.

Hi there. And thank you for taking my questions. Maybe just in setting expectations in terms of when we should hear next steps on sort of the filing progress, I guess. What are you anticipating in terms of relaying kind of your FDA interactions to the street? And then I think in your prepared remarks, you indicated that this necessarily won't flip over to PBC and that you have some feedback that Vantage will be a registrational study. I guess, to your knowledge, is that this new group that conveyed that information? And then one point of clarification, just on the updated guidance, Is there anything for FOP in your updated product guidance, or would that be above and beyond what you've outlined today? Thank you.

Yeah, thanks for the questions. I'll take the first couple and pass it over for the FOP question. You know, in terms of providing an update, our thinking is that this is likely an iterative process, and so we would plan to give an update when we have kind of a material update. So, you don't want to be sharing the blow by blow on what might be email correspondence even with FDA. And shifting onto the PDC question, those interactions were written correspondence. So, don't know exactly if it's the same exact people behind it, but what gives a lot of comfort there is recency. So, this has happened over the past year that we've had those PDC written correspondence.

And on guidance, the $680 to $700 million does not include FOP, so anything we see in Q4 would be above and beyond, although we really expect the revenue to start more in 2027.

Thank you.

Your next question comes from the line of John Vullivan with Citizen. Your line is now open. Please go ahead.

Hey, Chris. I'm wondering if you could just, you know, talk us through what this iterative dialogue looks like in terms of, you know, using breakthrough therapy or formal meeting status and, you know, scheduling of these just for a little bit more expectations on that flow of information between you and the agency.

Thanks for the follow-up, John. One of the benefits of breakthrough designation is it does allow for more frequent advice from FDA, more frequent interactions. And so, quite simply, that just means we'll be able to reach out more informally and also have more advice meetings how those sequence out really depends on basically how the dialogue with fda progresses so we can't really give too much more specific at this point but we will keep you guys updated as we make progress through it your next question comes from the line of Ramakant Swayampukula with H.C.

Wainwright. Your line is now open. Please go ahead.

Thank you. This is R.K. from H.C. Wainwright. A couple of really quick questions. You know, based on the interactions that you have had so far for the PSC indication, You know, are you planning to make any changes at all in your approach for the PPC indication once the Vantage data comes out? And also, if you do go ahead and submit in the first half of 27, you know, notwithstanding the recommendation you know do you run into a risk of refuse to file kind of a situation and let's say everything goes fine and you still continue to apply would you expect an outcome at the end of this thanks rk for the question um you know in terms of the pbc approach and given the recent interaction i think we have direct input for that indication for

Vantage. So, I feel like that is on a good course. So, it wouldn't make changes at this point to what we're doing in PBC. We've kind of already made recent adjustments to accommodate what FDA asked for for having Vantage being confirmed as a pivotal study. And then on some of these questions about submission risks, I think is how I would describe the question. So, that's the reason for this interactive interaction with FDA is try to work through things that might be an RTF risk and try and get those off the table. And frankly, you know, an adcom, it might be something that could be helpful given the huge impact that Delixabat has shown in a really terrible setting for patients. You know, the relief, puritis relief, improvement and sleep and fatigue that patients experience with felixabat treatment is really life-changing. So I think that could be one way that this gets highlighted.

Thank you. Thanks for answering my questions.

Thanks for the question.

There are no further questions at this time. I will now turn the call back to Chris Peets for closing remarks.

Well, thank you all for joining us today, and I hope you have a great afternoon.

This concludes today's call. Thank you for attending. You may now disconnect.