Mineralys Therapeutics, Inc.

Welcome to the Minor Alice Therapeutics first quarter 2026 conference call. It is now my pleasure to introduce your host, Dan Ferry of Life Science Advisors. Please go ahead, sir.

Thank you. I would like to welcome everyone joining us today for our first quarter 2026 conference call. This afternoon, after the close of market trading, we issued a press release providing our first quarter 2026 financial results and business updates. A replay of today's call will be available on the investor section of our website approximately one hour after its completion. After our prepared remarks, we will open up the call for Q&A. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in today's press release and our SEC filings, including our annual report on Form 10-K and subsequent filings. Please note that these forward-looking statements reflect our opinions only as of today, May 6, 2026. Except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements in light of new information or future events. I would now like to turn the call over to John Congleton, Chief Executive Officer of Mineralis Therapeutics.

Thank you, Dan. Good afternoon, everyone, and welcome to our first quarter 2026 financial results in corporate update conference call. I'm joined today by Adam Levy, our Chief Financial Officer, Dr. David Rodman, our Chief Medical Officer, and Eric Warren, our Chief Commercial Officer. I'll begin with an overview of the business, our clinical programs, and recent milestones. followed by Adam to review our first quarter financial results before we open up the call for your questions. Our NDA acceptance in the first quarter has been the culmination of a massive effort by our team and our mission to provide more healthy days to patients with cardiovascular disease. From an operational perspective, we're focused on preparing La Runderstadt for a successful launch in the United States. While we continue to evaluate partnering opportunities, and consider the next steps in the clinical development of lorunderstat. During the first quarter, the FDA accepted the NDA for lorunderstat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs and assigned a PDUFA target date of December 22, 2026. This represents a significant regulatory milestone for lorunderstat that moves us meaningfully closer to our goal of delivering a potentially best-in-class therapy to patients with uncontrolled or resistant hypertension. The NDA is supported by a comprehensive clinical data package, including positive results from the launch HTN and advanced HTN pivotal trials, Transform HTN, our open-label extension trial, and the proof-of-concept trials, Target HTN and Explore CKD. Collectively, these five trials demonstrated that Larunderstat delivers clinically meaningful reductions in blood pressure, is well-tolerated, and maintains a durable response across diverse patient populations. We believe this data package supports the potential for Larunderstat to be included in prescribing guidelines, the economic value of Larunderstat to the healthcare system, and Larunderstat as a differentiated novel therapy. Uncontrolled and resistant hypertension continue to represent areas of significant unmet medical need, affecting over 20 million people in the United States and contributing significantly to cardiorenal complications. Aldosterone dysregulation often plays an important role in resistant hypertension, where patients on three or more antihypertensive medications fail to achieve their blood pressure goal. The launch of Lurunderstat, if approved, will be initially focused on this population with the highest need. Our ongoing market research highlights the following three key factors. One, prescribers prioritize magnitude and consistency of blood pressure reduction and have stated a consistent willingness to prescribe Lurunderstat in the fourth line. Two, payers recognize the high-risk nature of patients whose hypertension is uncontrolled on three or more medications and have expressed a willingness to provide coverage for Larunderstat. Three, patients are seeking meaningful and sustained blood pressure reductions that are tolerable and simple to integrate into their daily lives. They're very receptive to novel agents like Larunderstat that may help them achieve their goal. As we move towards our PDUFA target date, our operational focus will continue to be on preparing Larunderstat for commercial success. Our teams are working on early market access planning and payer engagement to ensure the value proposition of La Ronda's debt is clearly understood. In parallel, we continue to invest in physician advocacy with our medical communications capabilities, including broader education of the unmet need and uncontrolled or resistant hypertension through peer-reviewed publications, increased participation in scientific meetings, and the continued build-out of our field-based medical science liaison team. We are also expanding our sales and marketing capabilities to Ready La Runderstadt for success. Together, these activities are intended to support awareness of the clinical profile and position La Runderstadt for a potential commercial launch. We continue to evaluate partnering opportunities and engage in strategic discussions. The right partner could provide enhanced value and enable us to reach more patients who could benefit from Lurunderstat. Our focus on preparing for a strong commercial launch is invaluable to potential business development partners. I will now turn the call over to Adam to review our financial results for the first quarter 2026.

Thank you, John. Good afternoon, everyone. Today I will discuss select portions of our first quarter 2026 financial results. Additional details can be found in our Form 10-Q, which will be filed with the SEC today. We ended the quarter with cash, cash equivalents, and investments of $646.1 million as of March 31, 2026, compared to $656.6 million as of December 31, 2025. We believe that our current cash, cash equivalents, and investments will be sufficient to fund our planned clinical trials and regulatory activities, as well as support corporate operations into 2028. R&D expenses for the quarter ended March 31st, 2026 were $24.4 million, compared to $37.9 million for the quarter ended March 31st, 2025. The decrease in R&D expenses was primarily driven by a $15.5 million reduction in preclinical and clinical costs following the conclusion of the Runderstatt Pivotal Program in the second quarter of 2025. This decrease was partially offset by $1.1 million of increased clinical supply, manufacturing, and regulatory costs, and $0.8 million of increased personnel-related expenses resulting from headcount growth and increased compensation. G&A expenses were $21 million for the quarter ended March 31, 2026. compared to $6.6 million for the quarter ended March 31, 2025. The increase in G&A expenses was primarily driven by $7.9 million of higher professional fees, $6.1 million of increased personnel-related expenses resulting from headcount growth and increased compensation, and $0.4 million from other general and administrative expenses. Total other income net was $6 million for the quarter ended March 31, 2026, compared to $2.2 million for the quarter ended March 31, 2025. The increase reflects higher interest earned on investments in our money market funds and U.S. Treasuries due to higher average cash balances invested during the quarter. Net loss was $39.3 million for the quarter ended March 31st, 2026, compared to $42.2 million for the quarter ended March 31st, 2025. The decrease was primarily attributable to the factors impacting our expenses that I just described. With that, I will ask the operator to open the call for questions. Operator?

Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for questions. Our first question comes from Michael DeFore with Evercore. Your line is now live.

Hey, guys. Thanks so much for taking my question. Two for me. Number one, in the scenario where Mineralis launches LanderStat itself without a partner, will you conduct any more significant R&D activity or business development, or will you preserve funds just to support the launch and focus on the launch? And separately, As you near the day 120 safety update, it may have already passed. I'm not sure. Can you comment on whether safety remains consistent with the past and whether there's updated plans to publish data from the OLE? Thank you.

Yeah, Mike, thanks for the questions. To the first one, you know, in the event that we launch the loan, we, from the beginning, have been focused on how do we build value with runner's data, how do we do that by extension for Mineralis. We have built this organization from the beginning, you know, thinking about our clinical development program with an eye towards how do we generate the greatest value from a commercial standpoint launching, whether it's on our own with a partner or through someone else. And so I think it's fair to say we're going to continue to look at ways that we increase value for La Runderstadt and Mineralis. If you think about the development program to date, We've done that. LaunchHTN obviously spoke to the real-world population. AdvanceHTN stands out on its own because it's a very distinct, complicated population that no one else has studied with an ASI. ExploreCKD provides information for prescribers looking at the complexity of resistant hypertension and nephropathy or CKD. So we've always had an eye towards meeting the physicians where they are, what they need with Lurunderstat, and building the appropriate data around that. So we'll continue to look at opportunities to build value from a clinical development perspective, and we'll continue to look at opportunities to expand the value of Lurunderstat through business development. To your second question around the 120-day safety mark, we continue to be very confident in the safety profile of Lurunderstat. The Transform HTN trial or open-label extension continues to collect that data. We think La Renderstead is well characterized from a durable effect and safety and tolerability profile perspective. And as we've noted in the past, we'll be looking to get that long-term data published in due course.

Great. Thanks so much.

Thanks, Mike.

Our next question comes from Richard Law with Goldman Sachs. Your line is now live.

Hey, guys. Good afternoon. A couple questions from me. Do you get a sense that you need to compete with AV on preferred or exclusive access of payers based on some of the discussions that you're having? And also, what is your confidence level on getting access to that 3L setting compared to 4th and the 5th L setting? Is your 3L strategy based on broader use, or is it more on the smaller niche population? And then I have a follow-up question.

Yeah, Rich, thanks for the questions. You know, as we talked about in the past, our clinical development program looked at that third line or later opportunity, both advance and launch, looked at that population failing to get to goal on two or more, because I think that's where significant need exists. I think that's where an ASI can add significant value. From a market standpoint and at launch, we think the focus will be fourth line. I'll have Eric opine on some of the feedback we've gotten from payers to date, but Clearly, it's our feeling that that fourth line setting, resistant to hypertension, payers appreciate the risk that these patients are under and the lack of satisfactory alternatives that are currently available relative to what we're understood is shown in our clinical program. But Eric, do you want to add something?

Yeah. Yeah. Hey, Richard. So it's all about sequencing, Richard. So that fourth line is the entry point. But obviously, there is that need for those comorbid patients that are third line patients. So the opportunity will be to gain that experience, gain that confidence, and then make that transition to the third line using that comorbid condition as a bridge. And this has been well vetted with payers in research and advisory boards, and as our team is now out there engaging payers with our account executives. You also asked about payers. whether we're going to try to position ourselves in a different way than BACs or STAT. Obviously, there's an opportunity for both ASIs, and having parity access is something that's a focus for us. I see. Got it.

And then a follow-up. So we heard that AZ been saying that BACs can potentially achieve like 10 billion peak if we can succeed in other indications beyond hypertension and CKD that they're developing. And I also remember, John, I think you mentioned that, you know, when you think of a partner, an ideal partner would be the one who would recognize Lorenzo Seth's potential. So when I hear that, I think you meant that the potential beyond hypertension. So in your discussion with potential partners, how many of them, like, recognize the value of Lorenzo Seth? outside hypertension, and what are these, like, indications that you believe that, you know, partners are bullish on or the ones that they're not bullish on and based on the unmet need of the drugs mechanism? Thanks.

Yeah, thanks, Rich. As we noted before and made the comments or prepared remarks, you know, there are 20 million patients that are struggling to get to goal on two or more meds right now. we know the clear linkage of uncontrolled or resistant hypertension to poor outcomes, whether they're cardiovascular or renal. You know, I think at this stage that we can clearly say that what Lurunderstad has demonstrated in reducing blood pressure, that that blood pressure reduction is a clear surrogate for what we could expect as far as a reduction in cardiovascular risk. So I'm not surprised by AstraZeneca's bullish position on Baxter stat. I would say we've shared that given the fact that just in the United States alone, there are 20 million patients at risk. You know, we've talked in the past about having a partner that is more global in nature and has a holistic view of this asset. I don't think that view has changed. I can't really opine on how some of those discussions have looked at different indications, but clearly we know that aldosterone is going to be a key target in for the next several years into the 2030s as it relates to not only hypertension, but the related comorbidities.

Great.

Thanks, John. Thanks, Rich.

Our next question comes from Seamus Fernandez with Guggenheim Partners. Your line is now live.

Oh, great. Thanks for the question. So I guess I'll address the – or ask you to address the elephant in the room, which is, You guys have been talking about potential partnering for quite some time. You've had the data, and now you've had the NDA sort of firmly established in terms of the BDUFA date for some time. What is it that you're looking for at this point in a potential partner you know, that perhaps you're seeking but hasn't quite matched up, or should we anticipate that you are in active discussions along those lines? I think we're all just trying to kind of metric what is the timing for either selection of a partner or that go-it-alone, a potential go-it-alone strategy in the U.S. Thanks so much.

Yeah, Seamus, appreciate the question, and You know, as we've said in the past, we're interested in finding the right partner. You know, in response to Rich's question, I talked about the global nature of that. We're routinely evaluating those partnering opportunities. As you can imagine, and I think appreciate, we're not in a position to really provide color or specifics around the level of dialogue, the timing, the structure, but it's something that we're mindful of. We have you know, as noted, continue to focus on how do we build value going forward. And that's why operationally we're focused on commercial readiness for this asset. I think it's an important part of those partnering dialogues. But clearly looking for a partner to build on that value continues to be something we're focused on.

Great. Maybe if I can just ask one follow-up question. As you kind of look at the sort of opportunities to partner your asset with other mechanisms specifically. What would you say are kind of the core mechanisms that you're particularly excited? We've got a whole host of new cardiovascular mechanisms that are advancing and potentially looking to emerge outside of hypertension. So just which would you say would be particularly exciting from your perspective to partner with La Rundestat? Thanks.

Yeah, Sam, it's a great question. I think what's key as an opportunity for mineralis is we have the core foundational molecule, and that's being lorunderstat as an ASI. Given the nature of aldosterone to be a driver of not only hypertension, which is the beginning point of all of these other cardiorenal metabolic disorders, but also just the role that aldosterone plays in CKD and heart failure and other disorders. So I think it begins with the fact that we've got really the core foundational molecule there. There are other mechanisms. Certainly the SGLT2s are what our competitors are looking at. I think the fact that dapagliflozone is going generic or is generic at this point, given the data that we've generated to date within our pivotal studies, but specifically explore CKD, I think gives us an entree to put a runner set forward in a hypertensive nephropathy or CKD population. But there are other mechanisms that we're looking at from a cardiorenal standpoint. We're not in a position right now to opine on those, but I would come back to the fact that we've got the core product that really addresses the key driver of pathology, and that's lorundrastat.

Great. Thanks, guys. Appreciate it.

Thank you.

Our next question comes from Jason Gerberry with Bank of America. Your line is now live.

Hi, guys. Thanks for taking my question. As you guys are doing a lot of your prelaunch activities, how are you thinking about the physician segments that you think are going to be the most likely to drive early adoption, especially in that fourth line setting where it sounds like maybe you won't be focusing on doctors that maybe focus on comorbidities like CKD, but maybe more cardiology-driven hypertension. So just wondering if you can kind of discuss maybe some of the learnings from the prelaunch activities and how you're thinking about sort of the early adopter.

Yeah, Jason, thanks for the call. I would say that we've been thinking about this going back three, four years when we framed the pivotal programs. clearly there's a primary care portion of the audience that is key prescribers in fourth line. They would be part of a launch target, but cardiologists as well, and that's why advanced HTN is such a critical differentiating piece of our data story. Now, these are the patients that a cardiologist is truly seeing. They're maximized with treatment. They've tried various alternatives and still cannot get to goal. That was the test that advanced HTN put lorundersat through, and lorundersat came through with flying colors. And that is a key and distinct data set that AstraZeneca, frankly, does not have. And so the cardiologist will certainly be a part of that target-based. Nervology as well. We know that nephrologists deal with uncontrolled and resistant hypertension with comorbid CKD. And as we speak to those nephrologists, the number one goal for them to try to arrest the progression of their kidney disease is to get their blood pressure to goal. And so I think we've been thinking about the target population, thinking about the prescribers and the use cases they have, and I think that's why we've built out a very distinct and diverse data set that's going to provide information about how to use lorundrastat, where to use lorundrastat, and the expected benefits they can see in the blood pressure control program. and beyond, such as proteinuria.

And as a follow-up, is there any one or two things you'll be looking at in the first three to six months of your competitor's launch that may alter your go-to-market strategy?

Well, I don't know if I would say it will alter it. Certainly, it'll be informative, but we've got a view of the data package we have. Eric and his team have done a really nice job of identifying where the unmet need is, who the key prescribers are, where that beachhead indication is for fourth line, and what's important to them in prescribing. And so we'll obviously be looking at AstraZeneca's launch, and we anticipate it's going to be a successful launch given the significant unmet need here and the lack of innovation in the last 20-plus years. But given the data that we've generated and specifically speaking to the different prescribers that the first part of your question alluded to, I think we're very confident in our ability to tap into that, assuming approval and launch very quickly after that.

All right. Thanks, guys.

Our next question comes from Annabelle Sammy with Staple. Your line is now live.

Hi. Thanks for taking my question. So I'd love for you to talk about who you might think might be driving the process of guideline changes that would position the new ASI class as the next drug to try after third-line agents have failed. You have just a tremendous amount of data across the spectrum of uncontrolled and resistant patients, as well as safety, CKD, and OSAs. How important is it to have that wealth of data to drive those conversations, or do you think that it's the first-to-market that drives the conversations? I just want to understand the mechanics behind that.

Yeah, Annabelle, thanks for the question. I think it's safe to say that we've been interacting with those physicians that are part of the guideline committees, appropriately sharing the information that we have, to your point. And, again, it's something we contemplated three years ago, and it's why we work with the Cleveland Clinic and Steve Nissen and Luke Laughlin with Advance H10, because we knew there had been a lack of innovation in this space. This is a heavily genericized space, and the guidelines would be a critical component. Advance HTN becomes that study that addresses all of the questions the guideline committees are going to have about, is it apparent or is it truly confirmed hypertension? That data set, I think, is going to be an instrumental component of argumentation for inclusion in the guidelines. Launch HTN is an important part as well. I don't want to dismiss Launch HTN because it speaks to the primary care physicians. Explore CKD, Explore OSH, as you alluded to, each of those provides information additional data that's informative, that speaks to the unique complexities, particularly of the resistant hypertension population. So from that standpoint, we're in front of the right physicians who are part of those guideline committees, and we have the right data and data set with what we're understat to make a compelling argument.

Okay. And if I could just follow on on the physician segmentation that you're thinking about. Given the launch trial and the fact that primary care is a big prescriber of hypertensive agents. Do you expect the focus to be cardiologists, nephrologists, and hope for trickle-down into primary care, or do you expect to, I guess, include high-prescribing primary care physicians within that first set of physician targeting?

Yeah, I'll have Eric add some additional color here. I don't know that our view has changed. We're continuing to narrow in on those prescribers that control, you know, approximately 50% of that third and fourth line, predominantly fourth line. And within that, there are primary care as well as specialists.

But Eric, you can add some more color. Yeah, no, well said, John. So cardiologists, nephrologists, but there are primary care physicians that functioned you know, very well within this fourth-line state. So they're actively prescribing. We've looked at the segmentation. We've looked at the deciling. And there will be primary care that's included in that initial go-to-market strategy.

Great. Thank you.

Thanks, Annabel.

Our next question comes from Mohit Bansal with Wells Fargo. Your line is now live.

Great. Thank you very much for taking my question. So one question I have is regarding differentiation. So do you expect to see any kind of differentiation when it comes to labeling between lorandostrat and the competitor here based on your market research? What feedback are you getting from physicians that they see any differentiation between these molecules? Thank you.

Mohit, thanks for the question. to the first part on the label. I think there'll be a level of uniformity, certainly within the indication, but I'll step back to a point that I've been making here. There's a distinct difference between the data sets that we generated with La Runder stat and that Baxter stat. Certainly LAUNCH-HTN is speaking to the real world audience, but again, ADVANCE-HTN, I don't want to be redundant here, but is a very distinct and differentiated data set. that really provides information to cardiologists specifically who are dealing with these very difficult confirmed hypertension case patients. And then explore CKD. We know that proteinuria and having a benefit on proteinuria is a key attribute in physicians' minds when they think about an antihypertensive and how they view its utilization. Certainly for nephrologists, Having a benefit on proteinuria, it's a key signal or surrogate, if you will, for slowing renal progression. Launch HTN, Advance HTN, and Explore CKD, as well as our long-term open-label extension, Transform HTN, were all part of our submission in the NDA. Now, what language, what portions of those studies get into the actual label, that will be part of negotiations with the FDA. But certainly, having that data, whether within label for promotion or through medical information, I think it's going to be very instructive and informative for those distinct physician population prescribers.

Got it. And the physician feedback, I mean, the second part? The physician feedback's been very robust.

Eric, you want to? Yeah, so there's two things I'll highlight. MOHIT is, number one, the absolute systolic blood pressure reduction. That is really what shines from a physician perspective, that 19 millimeter that we demonstrated in launch, but also the diversity and the well-representation of our trial populations. And I'll call out the black African-American population, between 28 and over 50% of our patients, depending upon the trial. Physicians really appreciate the inclusivity of our populations.

Got it. Very helpful. Thank you.

Our next question comes from Matthew Caulfield with H.C. Wainwright. Your line is now live.

Hi, guys. Thanks for the update today. So we covered a couple of my questions, but I think overall the sense is that BaxterSAT's possible approval mid-year helps the overall ASI receptivity and awareness just at a high level. Do you anticipate there being any headwinds with that approval, or do you see it only as a positive as we get closer to the December PDUFA?

I think there's certainly significant opportunity within this space. As I noted previously, Matt, the lack of innovation, I think, speaks to the high interest from physicians to have a novel agent or novel class of agents. So I do think there is an opportunity to see this opportunity grow as AstraZeneca launches six to seven months in advance of potential approval for Lurunderstat. I think it's important to highlight that we will have voice in the market during that six to seven month period. We've had national account executives in front of payers going back to quarter one. We have our MSL team in place going out building advocacy within those top tier and regional tier KOLs. And so I think it's really both companies out there progressively talking about the role of aldosterone, the importance of addressing it within the ASI that grows this market opportunity. And I think it's important to realize this is, whether you look at it from a revenue projection that AZ guided to, whether you look at it from the 20 million patients that we target, this is a massive market opportunity that is sitting on significant, interest in the novelty of this class of drugs. And so I think it's a net positive.

Great. Thank you, guys. Appreciate it.

Thanks, Matt.

Our next question comes from Rami Kuhara with LifeSite Capital. Your line is now live.

Hey, guys. Thanks for taking my questions as well. I guess, given that Astro will likely set the initial pricing benchmark for the ASI class with Baxterstat, I guess, are there any other market access levers that you can pull to differentiate Lurunderstat? And then maybe secondly, I know there's not many recent cardiovascular launches, but what do you view as the most relevant commercial analog for Lurunderstat at this point?

Yeah, Rami, thanks for the questions. Relative to Daisy, certainly, you know, presuming approval, they'll be setting the initial price point. You know, I've been asked, is that an anchor point? I think it's a guiding point. I have no idea where they're going to price it at this stage. Clearly, they're bullish on the revenue opportunity, but it'll be informative for us. I think going back to the differentiation and the payer discussions, we're seeing that right now as we have dialogues with payers, the distinction of the data set whether it's advanced HTN which I've commented on previously in a very distinct population that AstraZeneca can't speak to, whether it's the black African American population that Eric just alluded to, we know that's a critical high risk population. We believe we have the data set that's gonna be very informative for those payers from an access standpoint. And I think the feedback that we've gotten from payers to date is they're open and willing to create access in this fourth line setting and potentially in due course third line, and they're also interested in having two assets to evaluate, so it's not as if, from our perspective, BaxterStat is going to launch and secure all access from a payer standpoint. Rami, can you comment? The second question was commercial analogs. Is that right?

Exactly, yeah.

Yeah, I think it's It's a fair question. It's hard to answer because there just hasn't been a lot of innovation within the cardiovascular space for quite some time. I think an interesting analog for me, it's a gen med category. It's not cardiovascular. It's probably migraine with the G-pans, the orals. And so I think when you come out with something that's truly novel from a clinical profile standpoint, match that to a market with significant unmet need, you can see significant commercial opportunity. And so I think that's an informative analog. that we think about as we prepare the commercialization of La Runderstadt. Got it. Thank you.

Thanks.

Our next question is from Tara Bancroft with TD Cowen. Your line is now live.

Hi, thanks, and good afternoon. So I just have a follow-up from Moet's question before that was helpful to hear about label differentiation. Can you tell us more about how you'll react to BAC's pricing, especially when it comes to your pricing strategy? And I know how important access is to physicians, as you've been saying, but we're curious about the strategy that you're thinking there. Like, could you launch with a lower WAC price, or should we assume rebates would be the primary mechanism to drive access or something else? Just more thoughts there would be really helpful. Thank you.

Yeah, Tara, I appreciate the question. And I hope you appreciate that it's really early to opine too much on that. You know, we'll see where AstraZeneca comes in with pricing. You know, we've guided in the past that thinking about a Farsega, Jardiance, WAC, or a list price is probably a good barometer to work from. We'll see where they go from a pricing standpoint. We'll evaluate what makes sense for La Runders. The key for us at the end of the day is, is to ensure that patients that physicians believe could benefit from or understand get access to that. And there are a lot of different levers we could pull from contracting to what we do with our patient assistance program. But I would say it's too early to give you maybe the level of color that your question would require.

Okay, great. That makes sense. I guess maybe then I can ask a different question. So, you know, as we are looking at this this launch as a proxy to lorundrastat. Can you maybe talk about how you would think about cadence of that launch? It's hard without recent hypertension proxies to look at, but do you expect that there would be initial bolus of patients within the resistant hypertension population or anything like that that could help us understand what a good first couple of quarters could potentially look like?

Yeah, I appreciate the question. Again, I think the best proxy, and we have this in our non-con deck that's on our website, the best proxy is if you look at the turnover within this space right now. So what we have in our slide deck is 2024 IQ via data that shows Third line or later, there are about 8.8 million patients that are turning over trying new medications, and that's in the absence of any innovation, right? That's with existing treatments that have been available for 20-plus years. And so as an old marketer, to me, what that tells me is that there's a market that has a great deal of dissatisfaction. Physicians that haven't given up, they continue to trial their existing medications, helping patients get to goals. So there's... I think significant pent-up demand, there's significant focus and appreciation of the risk these patients are under if they don't get to goal. And so fundamentally, that to me is a bit of a proxy. Now, how that translates to BaxterStats launch quarter over quarter, I don't know that I can opine on that. I just know looking at fairly recent data from 2024, there's a lot of movement within this marketplace, and I think that creates opportunities for novel agents like lorunderstat.

Okay, great. Really appreciate that.

Thanks.

We have reached the end of the question and answer session. I'd now like to turn the call back to John Coglinson for closing comments.

Thank you, Rob. In closing, we remain encouraged by the FDA acceptance of our NDA based on a strong clinical data package that I've just spoken about through the question and answers. From an operational perspective, we're focused on executing on our pre-commercial readiness strategy while in parallel evaluating partnering opportunities and considering the next steps in the clinical development of Lorunderstat. We believe Mineralis is entering an important next phase in its evolution. This reflects the dedication of our entire team, the physicians and researchers who have supported the Lorunderstat program, and most critically, the patients whose needs continue to guide our daily work. Thank you to everyone for joining us today. We appreciate the continued interest and support, and we look forward to providing further updates in the quarters ahead. With that, we will close the call. Have a nice day, everyone.

This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.