Mineralys Therapeutics, Inc. (MLYS) Q2 2026 Earnings Call Transcript

Welcome to the Mineralis Therapeutics second quarter 2026 conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. Should anyone require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Please go ahead, sir.

I would like to welcome everyone joining us today for our second quarter 2026 conference call. This afternoon, after the close of market trading, we should have a press release providing our second quarter 2026 financial results and business updates. A replay of today's call will be available on the investors section of our website approximately one hour after its completion. After our prepared remarks, we will open 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, August 11, 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 Completon, Chief Executive Officer of Mineralis Therapeutics.

Thank you, Dan. Good afternoon, everyone. Welcome to our second quarter 2026 financial results and corporate update conference call. I'm joined today by Adam Levy, our chief financial officer, and Eric Warren, our chief commercial officer. I'll begin with an overview of the business and recent milestones. Eric will then provide a commercial update, and Adam will review our second quarter financial results before we open the call for your questions. Before I get started with the business update, I would like to take a moment to welcome Dr. Terry Ferguson to the team. Terry joins us as Chief Medical Officer, succeeding Dr. David Rodman, who will continue to play an important role as a full-time strategic advisor to the company. Terry brings more than 35 years of experience in cardiovascular medicine, clinical development, and executive leadership. He served as cardiovascular therapeutic area head at Amgen and held senior cardiovascular leadership roles at AstraZeneca and the medicines company. He also spent more than 20 years on the faculty of the Texas Heart Institute, and in cardiovascular medicine, a proven track record of Terry's deep expertise in cardiovascular medicine and a proven track record of advancing innovative therapies positions him well to lead our medical and late-stage clinical activities as we continue preparing for the potential commercialization of lorundrastat. I want to thank David for his dedication and hard work over the past several years. During his time as Chief Medical Officer, he guided the development of Lorunderstat from proof of concept through the Pivotal program and our recent new drug application filing with the FDA. In the second quarter, our focus was on commercial launch readiness, the evaluation of partnering opportunities, and the next steps in the clinical development of Lorunderstat. In the third quarter, we continue to build our commercial infrastructure as we approach our December 22nd PDUFA date. Turning to our clinical progress, our TRANSFORM HTN Open Label Extension Trial continues to generate valuable long-term safety and efficacy data that further supports LoranderStat's potential best-in-class profile. In May, we presented a post-hoc analysis from our pivotal launch HTN trial at the European Society of Hypertension's annual meeting. The analysis focused on participants with chronic kidney disease, a high risk and difficult to treat patient population. Despite entering the trial with more severe hypertension and greater use of background antihypertensive therapies, these participants experienced statistically and clinically meaningful blood pressure reductions comparable to those observed in the broader trial population. In addition, participants with baseline albinaria achieved a 52% placebo-adjusted reduction in urine albumin-to-creatin ratio, an important marker of kidney injury and disease progression. Just a few weeks later, at the Endocrine Society's annual meeting, Endo-2026, we presented late breaking proteomic data from our LAUNCH-HTN and ADVANCE-HTN trials, demonstrating that lorunderstat was associated with significant reductions in multiple biomarkers of heart failure risk. While exploratory in nature, these coordinated biomarker changes provide additional biological evidence that lorunderstat use may favorably modulate disease pathways implicated in heart We believe these findings further strengthen our understanding of the broader biological implications of aldosterone and the potential for lorunderset to provide benefits in hypertension and related comorbidities. We continue to evaluate further clinical development for lorunderset and will keep you informed on our progress as appropriate. We also completed several corporate initiatives that enabled our long-term value creation objectives. During the quarter, we announced an agreement to repurchase the potential future royalty payments due to Tanabe Pharma Corporation related to Lurundersat. Under the terms of the agreement, Mineralis agreed to pay Tanabe $200 million up front and up to $100 million once certain commercial milestones are met. Our aggregate potential future milestone payments to Tanabe are now up to $265 million. We believe this represented a unique strategic opportunity to enhance the long-term value of Lerunderstat as we approach commercialization. Concurrently, we completed a $150 million equity offering and entered into a $500 million committed senior secured term loan facility with funds managed by Pharmacon Advisors. Beyond funding the royalty repurchase, this facility provides Mineralis with access to additional capital and financial flexibility while positioning Mineralis to capture the long-term value of Lerunderstat. As we look ahead to the remainder of the year, we believe Lerunderstat is entering an exciting new phase in its evolution. We have continued to build the clinical evidence supporting Lerunderstat, enhanced the long-term value of the asset, expanded our access to capital, and continue to make meaningful progress preparing for a potential commercial launch. In parallel, we continue to evaluate partnering opportunities and engage in strategic discussions to enhance value and enable us to reach more patients who could benefit from Lerunderstat. With that, I'll turn the call over to Eric to provide a commercial update.

Thank you, John. Approximately 20 million adults in the United States have uncontrolled or resistant hypertension, and despite the availability of numerous antihypertensive therapies, these patients remain unable to achieve their blood pressure goal. These patients face significant increased cardiovascular and cardiorenal risk, highlighting the need for new treatment options that address an underlying driver of disease. Our extensive market research continues to reinforce the value proposition Lorunderstat could offer if approved. Physicians consistently tell us they are seeking new therapies that deliver meaningful and durable blood pressure reductions, demonstrate a favorable tolerability profile, and fit naturally within existing treatment algorithms. We believe Lerunderstat's clinical profile aligns well with these expectations and differentiates the compound from both currently available and emerging therapies. Now, over the past several quarters, we have systematically executed against the key elements of our commercial launch plan. As a result, many of the foundational components of our commercial infrastructure are now in place, and our efforts are increasingly focused on final launch readiness and execution. First, we've established strong relationships with leading hypertension specialists and key opinion leaders who we believe will play an important role in shaping clinical practice following a potential approval. Second, we've made significant progress in our initial payer engagement activities. The payers we have engaged with to date collectively account for the vast majority of covered lives in the United States. Our discussions have centered on clinical and economic burden associated with uncontrolled hypertension and the value proposition supported by Lerunderstat's clinical data package. These conversations continue to reinforce our belief that payers recognize the unmet need in this patient population. Third, we're well underway in the development of a differentiated launch campaign that's designed to educate both healthcare providers and patients. We've done extensive research to understand the optimal messaging, resources, and communication platforms that will drive rapid adoption. Lastly, we're in the final stages of building the field organization that will support our launch. Our experienced sales leadership team is now in place, bringing a track record of successfully launching and commercializing cardiovascular therapies. We've also completed detailed geographic mapping to identify the regions with the highest concentrations of physicians treating patients with uncontrolled or resistant hypertension, allowing us to optimize field deployment. And perhaps most importantly, we expect our sales organization to be staffed in advance of our December PDUFA target date, positioning us to execute swiftly and decisively following a potential approval. We've built our commercial organization around clear objectives, which are to ensure physicians have the education, resources, and support needed to identify appropriate patients and And if approved, make Lerunderstat available to those patients as efficiently as possible. We continue to be encouraged by the feedback we are receiving from physicians, payers, and thought leaders, and believe Mineralis is well positioned to execute a successful commercial launch. I'll now turn it over to Adam to review our second quarter financial results.

Thank you, Eric. Good afternoon, everyone. Today, I will discuss select portions of our second quarter of 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 $661.4 million as of June 30, 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 operations, including the commercial launch of Lerunderstat, into 2028. R&D expenses for the quarter ended June 30, 2026 were $221.4 million, compared to $38.3 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily due to the $200 million upfront payment to Tanabe in June 2026 in connection with the license agreement amendment. The increase was also due to $0.6 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $0.2 million of increased clinical supply, manufacturing, regulatory, and other costs. These increases were partially offset by $17.8 million of lower preclinical and clinical costs, primarily due to the conclusion of the Lurundra-Stadt Pivotal Program in the second quarter of 2025. G&A expenses were $24.7 million for the quarter ended June 30, 2026, compared to $8.5 million for the quarter ended June 30, 2025. The increase in G&A expenses was primarily due to $8 million in higher professional fees, $8 million in increased personnel-related expenses resulting from headcount growth, an increased compensation, and $0.2 million of increased other administrative expenses. Total other income net was $5 million for the quarter ended June 30, 2026, compared to $3.5 million for the quarter ended June 30, 2025. The increase was primarily due to $2.3 million of increased interest earned on investments as a result of higher average cash balances, partially offset by $0.8 million of interest in amortization expenses related to the senior secured term loan entered into in June 2026. Net loss was $241.1 million for the quarter ended June 30, 2026, compared to $43.3 million for the quarter ended June 30, 2025. The increase was primarily due to the factors impacting our expenses that I just described. With that, I will ask Operator to open the call for questions. Operator?

Thank you. We will now be conducting a question and answer session. If you would 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 would 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 keys. One moment, please, while we pull for questions. The first question is from Richard Law from Goldman Sachs. Please go ahead.

Well, hey, guys. Yeah, congrats on all the progress as we approach PDUFA. And I also want to extend out welcome to Terry and look forward to working with him. So a couple of questions for me. I see that you guys have a lot of postings on the territorial manager positions. How are you finding the quality of candidates after Backspend's launch, which I assume will be competing for talent there as well? And also, are there any key attributes that you guys are looking for regarding like hypertension experience or on certain drugs? And also, when are you guys going to start hiring for the rest of the sales reps given the launch of Sneering in four months?

Rich, this is John. Thanks for the question. I have to admit it was a little bit garbled, so I'm going to paraphrase your question back and tell me if I got it on point. I think your question is about the field sales force, the phenotype we're looking for, and our likelihood of having those in position ahead of the PDUFA. Is that the paraphrase of your question?

Yeah, exactly. So basically, how are you guys finding the quality of candidates given that Beck's Fendi's launch already been happening? So I assume there's competition for talent there. So what you guys are looking for in terms of experience. And also, like, when are you guys going to hire the rest of the sales force, given that the launch is four months away?

Yeah, I think, as Eric alluded to, our goal is to have the team in position ahead of the Padufa day. I'll tell you, I'm really excited about the quality of not only the sales, sales representatives, territory managers that we're seeing, but also of the first-line sales managers. I think Mineralis represents the kind of exciting opportunity that attracts high-level talent, that are energized by the kind of innovation that Larenderset represents and the impact that it could have on millions of patients. So I think that in and of itself becomes a very exciting offering that attracts high-level talent. I will tell you there's not one phenotype that we're looking for. You know, there's certainly a lot of cardiovascular experience reps that are out there, but we're also looking for those kind of individuals that we believe align to our values, the purpose that we have, and are energized by the opportunity. So I'm very comfortable with the quality of candidate and our ability to hit that target of having the full team in position ahead of the PDUFA.

Fantastic. And just to follow up on that, and how are you seeing the payers in terms of are they waiting for LaurentioSat's approval before deciding on how to manage both ASI products? Is there anything that you guys are seeing that Backstrand is doing well or not doing well with payers or other commercial aspects that you can do differently or better? Thank you.

I'll give you a quick thought, and then I'll turn it over to Eric. I think the feedback we're getting from our national account team that was in place in Q1 of this year continues to be very bullish on access for this kind of innovation, particularly the third and fourth line position. But Eric can give you maybe some more specifics behind that. Yeah, thanks, John.

Yeah, Rich, so from a payer perspective, payers, it's still early for Baxterstedt, obviously, but I think it's encouraging to see that there's recognition of the innovation that the ASI class brings. We haven't seen a lot of payer decisions yet, but we're firmly in a position to believe that both of these agents will be in an equivalent position that will give HCPs the ability to choose, and that's where our differentiated profile comes into play.

Great. Thank you.

Thanks, Reg. Next question is from Michael DeFiori from Evercore ISI. Please go ahead.

Hey, guys. Thanks so much for taking my question. Two for me. You said in the past that label and post-marketing conversations typically start a couple months out prior to Bidufa. Has that process begun and has anything in the, at least your initial conversation changed in terms of what you expect to negotiate in the label? And then second question is on pricing. When do you actually plan to lock in that decision and would you communicate that ahead of the launch or at the launch? Thank you.

Yeah, thanks, Mike. The label and post-approval commitments, That typically occurs a couple of months ahead of the PDUFA, so I would expect sometime in the October-November time frame. I would say I would characterize the current dialogues with the agency, no surprises from us. I think the data package that we put together was robust from the pivotal studies, launch HTN, advance HTN, including Explore CQD and the open label extension. So we feel very confident with the package that we have, and I think the dialogues to date have been regular course. From a pricing standpoint, obviously we've seen the price of BaxterStat. We're continuing to do our analysis. We weren't overly surprised by the price point they came out with. It's in that non-specialty tier pricing area. but I would not anticipate us sharing the price until approval and subsequently probably around launch.

The next question is from Jason Gerberry from Bank of America. Please go ahead.

Hey, guys. Thanks for taking my questions. A couple from me. In terms of the early AZ launch, any learnings as you interrogate the data so far in terms of perhaps good, bad, or just too early to formulate any conclusions? And then as a follow-up to the point, you know, you raised about confidence around parity, payer access, I'm not sure you can say much, but directionally, I'm just curious, like, your, I guess, sort of the gross to net deductions in order to achieve parity access, is that coming in perhaps in line, better, worse than maybe you would have expected, say, you know, six to 12 months ago? Thanks.

Yeah, Jason, I'll take the first part and have Eric address your question about payer access. I think your point you made, it's still early days to gauge from the numbers that, you know, you see the same things we do publicly on the Baxter stat launch. I will tell you anecdotally, I think there's enthusiasm and excitement for this new class of therapy. It's been over 20 years since there's been a meaningful introduction of an antihypertensive therapy, We know there's, you know, significant patients, 20 million on two or more meds that cannot get to goal right now, and we know the implications of that. And so I think the enthusiasm that we're seeing anecdotally in the marketplace for this class of drugs speaks for the opportunity that I know we're excited about, which we're understand. But as to the payer dialogues, I'll let you comment.

Yeah, so payer dialogues have been very, very positive. of, I would say, the level of rebate that we're hearing that's coming from Baxterstead is very consistent with what we expected, and that's obviously on the commercial side. From the Medicare side, so far it looks like access is this medical exception, which then allows us to go to label. So far, again, without giving any kind of precise indicators of what we're doing, generally as we would expect, Jason. Great. Thank you. Thanks, Jason.

The next question is from Seamus Fernandez from Guggenheim Securities. Please go ahead.

Going on for Seamus Fernandez. Just, I guess, first off, you know, as you're speaking with KALS and doing your outreach, what's really resonating with KALS about the profile here? And then second, you know, congrats to Terry for joining. I'm just curious, you know, I know it's extremely early, but curious what the priority list will be as you get settled.

Yeah, the question, and again, I apologize. The audio is not the best. I think your question was the profile they get most excited about with the Lorander stat, and I think it's pretty clear it's aligned to the attributes that matter to physicians when treating their patients, and that is the blood pressure reduction, which we know is extremely meaningful and we think best in class with the Lorander stat, combined with safety and tolerability. So, in other words, the patients need to be able to not only get the blood pressure reduction, but get it in a way that is safe and can be adhered to over a long period of time. So, you know, we continue to believe that that profile that we've seen from our clinical program reinforces a profile that meets the needs of physicians as they're treating these patients third line and later. As to Terry, yeah, we're very excited. I mean, I'm actually thrilled to be able to expand the expertise that we're able to apply to mineralis and lorunderstat by retaining Dave in his strategic advisory full-time role to really help continue to investigate translational opportunities for lorunderstat. We know aldosterone plays a significant role beyond just hypertension but across cardiorenal metabolic disorders. But having Terry come in with his expertise in latter-stage development and very specifically medical affairs, I think does nothing but just augment and build on the success we've had to date. We've got our medical affairs team in place right now, adding Terry's expertise over 35 years of either clinical work or industry work, I just think really amplifies the message, the resonance, the relationships he has with KOLs. I think it's going to be a a significant build for us as we continue to prepare a little runner stat for a successful commercial launch.

And John, I just wanted to add one thing. So in addition to the efficacy and the safety, the advanced data are really resonating well with the KOL audience. So having a unique data set really does differentiate us in their minds.

Maybe one follow-up.

I'm just curious in terms of anything you provide in terms of the number of reps you guys are targeting out of the gate. especially as you're kind of thinking about your efforts here thanks yeah we're our focus is really on those prescribers that are going to control a significant volume of third line or later prescribing we've talked about in the past that's you know plus or minus 50,000 physicians so we'll we'll ensure that we have a very strong share of voice within those predominant prescribers of the ladder lines of treatment we haven't guided to a specific number um we may in due course but at this point in time we just want to hold some of those cards a little bit closer to our best

the next question is from annabelle samini from stifle please go ahead hi this is kyle speaking for annabelle uh maybe two questions on a label uh exactly what are you guys looking for in terms of a differentiated label for uh in comparison against specs fendi and then based on i know you mentioned discussions early, but based on your current interactions, what do you think is required to warrant a language, specifically calling out resistant hypertension or CKD? And then do you think having a dedicated randomized controlled trial like ADVANCE or explore CKD could be the new mover? Thanks.

Yeah, Kyle, thanks for the question. From a label standpoint, I think there'll be a few similarities. I think the indication will look fairly similar. That's for inadequately controlled blood pressure on top of background meds. I think we'll get the similar treatment as far as the outcomes claim related to that blood pressure reduction that's become standard based on FDA guidance. I think where there's going to be an opportunity for differentiation, and all of this obviously is dependent upon dialogues with the agency, but is the representation not just of LAUNCH-HTN, which is the largest hypertension trial conducted with an ASI, but also ADVANCE-HTN, which, as Eric said, is very unique and distinct from, frankly, a lot of studies done on hypertension, given the nature of that trial, where we were confirming uncontrolled and resistant hypertension based on moving subjects to an AHA-approved background treatment and only randomizing after they cannot get control even on an optimized treatment. So I think advanced HTN certainly will be a part of our discussions with the agency as an important data set to include in the label on top of launch HTN. And then I believe data from Explore CKD is also informative to physicians who are prescribing an ASI in a subject who may have lower kidney function based on EGFR. We know the label for BaxterStat speaks to EGFR, I believe, down to 45, and Explore CKD went down to 30. And so we'll be making a point to the agency that it's important that physicians have guidance from the label that would reflect that. We know collectively, if you look at the efficacy data, even just from LaunchHTN, there are clear differentiators based on the absolute and placebo-adjusted reductions in systolic BP, as well as milder cases of electrolyte change, specifically hyperkalemia. So we believe that the data set that we've generated today creates good evidence for differential points within the label, but obviously those will all be part of discussions with the FDA.

Thanks, Kyle.

The next question is from Mohit Bansal from Wells Fargo. Please go ahead.

Great. Thank you very much for taking my question. Before I start, so thank you very much, David, for all your help over the years. And congrats, Terry, for the new role. Looking forward to work with you. So, I have a couple of questions here. So, number one, assuming that you get similar label to BACS, is there anything in the clinical data or the trials, like Advanced HDN or the differentiated trial, that you could use to appeal to certain specialties? or it would probably be seen more similar than different from that aspect. And the second one is AZ is running this primary aldosteronism trial, and that could read out for BEX next year. So how do you see that trial, in case it is positive, impacting the class or a specific molecule? So, like, how do you see the results of that trial impacting the positioning there?

Yeah, Mohit, thanks for the questions. To your first question, I do think there are some distinct points within the label that can create differentiation. I think overall the aldosterone synthase inhibitors are going to be a transformative new introduction to the treatment of hypertension. We're seeing really pronounced and clinically meaningful reductions in similar patient types, You know, those on two or more background meds that are failing to get to goal. But within those similarities and in really the two key areas that are fundamental to a prescriber, blood pressure reduction and safety signals, specifically hyperkalemia, I think they each have favorable views relative to lorunderstat. And you've seen the market research we've done where we put up the results of BACS-HTN relative to launch-HTN. Then there's about a two-to-one preference for the profile that emerged with the lorunderstat relative to baxterstat based on those two fairly similar trials. And so, again, presuming that data from LAUNCH-HTN is in the label, which we anticipate, I think that gives us, from a promotional standpoint and an educational standpoint, an opportunity to really show the benefit of using the most selective ASI with what we think is an ideal half-life of 10 to 12 hours. So I believe that's how it's going to translate. From a primary aldosterone perspective with the PA study, I think there's a lot of interesting movement as far as how PA was originally characterized to being a secondary form of hypertension to where dysregulated aldosterone is really more of a spectrum. And so I think the data we generated to date is going to resonate with physicians that are looking to address dysregulated aldosterone, whether it's classified as typical PA or dysregulated or elevated aldosterone. So it'll be interesting to see that data, but I know that physicians that are treating patients who have aldosterone as a driver of their uncontrolled or resistant hypertension are certainly excited about the Lurundersat profile.

The next question is from Rami Kasuda from LifeSci Capital. Please go ahead.

Hi, guys. Thanks for taking my questions as well. I guess, given the December PDUFA, how should we be thinking about the cadence of payer coverage through 27? And is there a risk that missing the initial Medicare Part D formulary cycle could make next year more of an access building year? And then secondly, when do you expect the next major hypertension guideline upsates It's to be in how important could formal inclusion of ASIs be for the class.

Yeah, I'll take your second question, Rame, on the guidelines, and Eric can comment on the first one as far as the cadence of coverage. We've been identifying and working with the committee members, making sure that they have the information that is required as they contemplate guideline inclusion. I think probably five years ago, there was a more rigorous cadence of every four or five years an update of the guidelines. What we've heard from those committee members is they're going to try to be more reactive to new information like the ASIs. And so I would anticipate sometime in 2027 an update of those guidelines that would reflect where the ASIs should fit within that. I think that's where we made some really discreet and important choices from the clinical development of Lorunderstat, not only launch HTN, providing real-world kind of case studies, but also advance HTN for those specialists that are optimally treating patients and yet still failing to help them get to goal. Advance HTN that we did with the Cleveland Clinic was specifically designed and executed with the guidelines in mind. So I think we've got a very strong case for lorunderstat. That may be a benefit that extends to the class. But I think fundamentally the ASIs, given the clinically meaningful reduction that we're seeing, will have a really clear place within the guidelines for patients, certainly at the latter line of treatment. But Eric can talk about cadence of coverage.

Yeah, and you've characterized it well. So a progressive increase in coverage over the course of 2027 with commercial outpacing Medicare, but it's important to note, as I said before, that Medicare relies upon medical exception, which has a very favorable approval rate. It's important to note, and I didn't say this before, but we'll also stand up a field Reimbursement Manager team to support prior authorizations, and we're making a good emphasis and focus on patient support to ensure that the patient gets on therapy quickly, and there's tools to help navigate the process. So progressive increase is the core message, commercial first, Medicare coming along, but Medicare exceptions are pretty straightforward.

Got it. Thank you. Thanks, Rami.

The next question is from Tara Bancroft from TD Cowan. Please go ahead.

Hi, good afternoon. So I want to follow up on one of the first questions that was asked. So I'm curious in what ways you think you could improve access and adoption as a second to market relative to backs, especially as it comes to pricing. So is it possible maybe to price at a discount and take more share that way? I know you've previously communicated the SGLT2 class as good pricing comps for the street to anchor to, but maybe should we anchor more so to AZ now? Thanks so much.

Yeah, let me give some high-level thoughts, and Eric can follow up. I think the, you know, I've been asked before, does BaxterStat pricing create an anchor? And I don't know if it's an anchor. I think it's informative. I think the key element was in the rationale that we, looking from the outside in, saw with BaxterStat pricing was not specially tier, which we think was critical to ensure access to patients. And so, you know, we'll continue to evaluate that. We're going to continue to do our analysis of it. And maybe Eric can speak to some of that work we're going to continue to do.

I mean, and again, I'll just reinforce the Baxter-Step price is very consistent with the research that we conducted with payers as well as ad boards that we convened. And from a pricing perspective, we've got a pretty good sense of where we'll price, but we're still in the final stages of finalizing that. Again, a core tenet is to maximize ultimate value, not create a kind of a downward pricing spiral. So I won't get into too much more than that, but I just want to reinforce that. Again, pricing of Baxter side is very consistent with our expectations, and we're finalizing our strategy, but we definitely need to make sure that we're preserving value.

Okay, thank you so much.

Thanks, Tara.

The next question is from Matthew Caulfield from H.C. Wainwright. Please go ahead.

Hi, thank you, guys. Nice. One question that we haven't really covered is looking back to explore CKD, what could be the next important catalysts or possible timeframes for further lorandrostat evaluation in CKD patients? Is that something on the radar at this stage, kind of above and beyond the FIDUFA and launch focus? Thanks.

Yeah, Matthew, thank you for the call. You know, this is why I'm excited to have both Terry and Dave here. Dave obviously has five and a half years' experience with lorandrostat, and we're going to be able to augment that with Terry's cardiovascular experience and medical affairs experience, as well as clinical development. We know that at this stage, lorandrostat has a really robust and meaningful reduction in systolic BP and blood pressure, but we also think, and we've talked about this in the past, there's multiple mechanisms that aldosterone can drive, specifically things like inflammation, and fibrosis, and oxidative stress, that I think we've already seen what that translates to. I referred to it in my prepared remarks that in launch HTN we saw a 52% reduction in placebo-adjusted UACR, which is a clear marker of kidney protection. We've seen further within the endo presentation benefits from a proteomic standpoint on markers of heart failure. So not only do we have the opportunity to address really the genesis of all of these cardiorenal metabolic syndromes, and that's blood pressure, but I think there's an opportunity to really show value beyond just the blood pressure reduction, and that is around elements like heart failure, chronic kidney disease, and related conditions. So that's part of what we're continuing to analyze at this point. That's where Dave and some of his translational science team are really digging into what makes sense for the next clinical development of lorundersat. I think we've validated the best-in-class profile as it relates to blood pressure reduction. We know where AstraZeneca and Berger-Ingelheim are going with their ASIS-GLT2 combos. I think there are other interesting opportunities that we could pursue and other indications that we're contemplating. And then once we've aligned on those final plans, as appropriate, we'll communicate that to the market.

Great. Thank you. Very exciting and looking forward to December. Thanks again. Thanks, Matthew.

The next question is from Dennis Ding from Jefferies. Please go ahead.

Hey, guys. Thanks for taking my questions. I have one and then one follow-up. So, John, you've always alluded to and emphasized that you guys are looking for a global partner. So can you go through exactly what you're looking for in a partner, at least on the U.S. side, and how important is it for a partner to have a presence in nephrology specifically? And, you know, the reason I bring that up is, and this is my follow-up, is because you've talked about leveraging your CKD data to get earlier line use in the third line, and I feel like that could be an area where it can get used more over AstraZeneca. So I'm wondering how much overlap with CKD is there in the cardio setting where you can perhaps go after that population with a cardio sales force? Or maybe it's a priority for you to go into nephrology in a dedicated way, either on your own or through a partner's. Thanks so much.

Yeah, thanks, Dennis. You know, we've stated before, and I think you've kind of alluded to it, our goal from a partnering standpoint has tended to be more of a global nature. You know, we've stated pretty clearly that the commercialization of Lurunderstad outside of the United States would be through a partner, but ideally we find a global partner that not only has the commercial interest, but also the development interest. As I alluded to in my response to Matthew, I think aldosterone is kind of becoming one of those foundational nodes that are going to be really critical to address cardiorenal metabolic disorders. You know, the CKD data that we have is very compelling, very interesting. I do think it does create an opportunity to move earlier in lines of treatment because we know there is just huge overlap of these conditions. And it's not just hypertension and CKD, but it's hypertension, CKD, it's cardiovascular risk, be it in the form of heart failure, just overall cardiovascular risk. So I don't know that there's a specific type or therapeutic area of focus for a partner. I think it's more an understanding of the opportunity that we have near-term with Lerunderstat to address uncontrolled and resistant hypertension, but then more broadly the role that aldosterone plays in cardiorenal metabolic as, frankly, a critical node that needs to be addressed and looking at development opportunities to tap into its full potential.

This concludes the question and answer session. I would like to turn the conference back over to John Congleton for closing remarks.

Thank you, Operator. We believe Mineralis is entering an exciting and important period. With our NDA under FDA review, we remain focused on execution as we work towards that December PDUF target date. I want to thank everybody for joining us today. We look forward to keeping you updated on our progress, and we wish everyone a great Thank you.

This concludes today's teleconference. you may disconnect your lines at this time. Thank you for your participation.