MLYS

Welcome to the Mineralys Therapeutics first quarter 2026 conference call. It is now my pleasure to introduce your host, Dan Ferry of LifeSci 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 1 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 Jon Congleton, Chief Executive Officer of Mineralys Therapeutics.

Thank you, Dan. Good afternoon, everyone. Welcome to our first quarter 2026 financial results and 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 Levy 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 lorundrostat 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 lorundrostat.

During the first quarter, the FDA accepted the NDA for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs and assigned a PDUFA target date of December 22nd, 2026. This represents a significant regulatory milestone for lorundrostat 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 Advance-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 lorundrostat 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 lorundrostat to be included in prescribing guidelines, the economic value of lorundrostat to the healthcare system, and lorundrostat 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 U.S. and contributing significantly to cardiorenal complications. Aldosterone dysregulation often plays an important role in resistant hypertension, where patients on 3 or more antihypertensive medications fail to achieve their blood pressure goal. The launch of lorundrostat, if approved, will be initially focused on this population with the highest need. Our ongoing market research highlights the following 3 key factors. One, prescribers prioritize magnitude and consistency of blood pressure reduction and have stated a consistent willingness to prescribe lorundrostat in the 4th line.

2, payers recognize the high-risk nature of patients whose hypertension is uncontrolled on 3 or more medications and have expressed a willingness to provide coverage for lorundrostat. 3, 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 lorundrostat that may help them achieve their goal. As we move towards our PDUFA target date, our operational focus will continue to be on preparing lorundrostat for commercial success. Our teams are working on early market access planning and payer engagement to ensure the value proposition of lorundrostat is clearly understood.

In parallel, we continue to invest in physician advocacy with our medical communications capabilities, including broader education of the unmet need in 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 lorundrostat for success. Together, these activities are intended to support awareness of the clinical profile and position lorundrostat 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 lorundrostat. 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, Jon. 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 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 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 31, 2026 were $24.4 million, compared to $37.9 million for the quarter ended March 31, 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 our lorundrostat 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 31st, 2026, compared to $6.6 million for the quarter ended March 31st, 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 US Treasuries due to higher average cash balances invested during the quarter. Net loss was $39.3 million for the quarter ended March 31, 2026, compared to $42.2 million for the quarter ended March 31, 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 one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two 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 DiFiore with Evercore. Your line is now live.

Hey, guys. Thanks so much for taking my question. 2 for me. Number 1, in the scenario where Mineralys launches lorundrostat 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? 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 alone, we from the beginning have been focused on how do we build value with lorundrostat, how do we do that by extension for Mineralys. We have built this organization from the beginning, you know, thinking about our clinical development program with an eye towards how do we 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. I think it's fair to say we're gonna continue to look at ways that we increase value for lorundrostat and Mineralys. If you think about the development program to date, we've done that. Launch-HTN obviously spoke to the real-world population.

Advance-HTN stands out on its own because it's a very distinct, complicated population that no one else has studied with an ASI. Explore-CKD provides information for prescribers looking at the complexity of persistent hypertension and nephropathy or CKD. We've always had an eye towards meeting the physicians where they are, what they need with lorundrostat, and building the appropriate data around that. 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 lorundrostat through business development. To your second question, around the 120 days safety mark, we continue to be very confident in the safety profile of lorundrostat. The Transform-HTN trial or open-label extension continues to collect that data. We think lorundrostat is well-characterized from a durable effect and safety and tolerability profile perspective.

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. Couple questions from me. Do you get a sense that you need to compete with AZ on preferred or exclusive access with payers based on some of the discussions that you're having? Also, what is your confidence level on getting access to that 3 L setting compared to 4th and the 5th L setting? Is your 3 L strategy based on water use or is it more on the smaller niche population? 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 3rd line or later opportunity, both Advance and Launch, looked at that population failing to get to goal on 2 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 4th line. I'll have Eric opine on some of the feedback we've gotten from payers to date. Clearly, it's our feeling that that 4th line setting resistant hypertension payers appreciate the risk that these patients are under and the lack of satisfactory alternatives that are currently available relative to what lorundrostat has shown in our clinical program. Eric, do you want to add some color?

Yeah, Richard. It's all about sequencing, Richard. That fourth line as the entry point, but obviously there is that need for those comorbid patients that are third-line patients. 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. 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 whether we're going to try to position ourself in a different way than baxdrostat. Obviously, there's an opportunity for both ASIs and having parity access is something that's a focus for us.

I see. Got it. Then, a follow-up. We heard that AZ been saying that BAX can potentially achieve like $10 billion peak if we can succeed in other indications beyond hypertension and CKD that they're developing. I also remember, Jon, I think you mentioned that, you know, when you think of a partner, an ideal partner would be the one who would recognize lorundrostat's potential. When I hear that, I think you meant that the potential beyond hypertension.

In your discussion with potential partners, how many of them recognize the value of lorundrostat outside hypertension and, what are these indications that you believe that partners are bullish on and/or the ones that they're not bullish on and, based on the unmet need of the drug's mechanism? Thanks.

Yeah. Thanks, Rich. As we noted before and made in the comments or prepared remarks, you know, there are 20 million patients that are struggling to get to goal on 2 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 lorundrostat has demonstrated in reducing blood pressure, that blood pressure reduction is a clear surrogate for what we could expect as far as a reduction in cardiovascular risk. I'm not surprised by AstraZeneca's bullish position on baxdrostat. 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. Clearly we know that aldosterone is gonna be a key target for the next several years into the 2030s as it relates to not only hypertension, but the related comorbidities.

Great. Thanks, Jon.

Thanks, Rich.

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

Great. Thanks for the question. We're asking you to address the elephant in the room, which is that you guys have been talking about potential partnering for quite some time. You've had the data, now you've had the NDA sort of firmly established in terms of the PDUFA date for, you know, 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? 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, 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 Fernandez, appreciate the question. You know, as we've said in the past, we're interested in finding the right partner. You know, in response to Richard Law'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 dialogues, the timing, the structure, it's something that we're mindful of. We have, you know, as noted, continued to focus on how do we build value going forward. That's why operationally we're focused on commercial readiness for this asset. I think it's an important part of those partnering dialogues. 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. Just which would you say are would be particularly exciting from your perspective to partner with lorundrostat? Thanks.

Shane, it's a great question. You know, I think what's key as an opportunity for Mineralys is we have the core foundational molecule, and that's being lorundrostat 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. 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 dapagliflozin 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 entrée to put lorundrostat forward in a hypertensive nephropathy or CKD population. 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 lorundrostat.

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. One, just as you guys are doing a lot of your pre-launch activities, how are you thinking about, like, 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. Just wondering if you can kind of discuss maybe some of the learnings from the pre-launch activities and how you're thinking about sort of the early adopter.

Jason, thanks for the call. I would say that we've been thinking about this going back 3, 4 years when we framed the pivotal program for lorundrostat. Clearly, there's a primary care portion of the audience that is key prescribers in 4th line. They would be part of a launch target, but cardiologists as well, and that's why Advance-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 Advance-HTN put lorundrostat through, and lorundrostat came through with flying colors. That is a key and distinct data set that AstraZeneca, frankly, does not have. The cardiologist will certainly be a part of that target base.

Nephrology as well. We know that nephrologists deal with uncontrolled and resistant hypertension with comorbid CKD. 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. 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 built out a very distinct and diverse data set that's gonna provide information about how to use lorundrostat, where to use lorundrostat, and the expected benefits they can see in the blood pressure control and beyond, such as proteinuria.

As a follow-up, is there any 1 or 2 things you'll be looking at in the first 3 to 6 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. We'll obviously be looking at AstraZeneca's launch, and we anticipate it's gonna be a successful launch given the significant unmet need here and the lack of innovation in the last 20-plus years. 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. Thank you, guys.

Our next question comes from Annabel Samimy with Stifel. Your line is now live.

Hi. Thanks for taking my question. 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 and CKD and OSAs. Like, 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? Just wanna understand the mechanics behind that.

Yeah, Annabel, 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, again, it's something we contemplated 3 years ago, and it's why we work with the Cleveland Clinic and Steven Nissen and Luke Laffin with Advance-HTN 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 our argumentation for inclusion in the guidelines. Launch-HTN is an important part as well.

I don't wanna dismiss Launch-HTN because it speaks to the primary care physicians. Explore-CKD, Explore-OSA, as you alluded to, each of those provides additional data that's informative, that speaks to the unique complexities, particularly of the resistant hypertension population. 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 lorundrostat to make a compelling argument.

Okay. If I could just follow on the physician segmentation that you're thinking about. Given the Launch-HTN 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. Within that, there are primary care as well as specialists. Eric, you can add some more color.

Yeah. No, well said, Jon. Cardiologists, nephrologists, but there are primary care physicians that function, you know, very, very well within this fourth-line state, 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. One question I have is regarding differentiation. Do you expect to see any kind of differentiation when it comes to labeling between lorundrostat and the competitor here, based on market, your market research? Like, 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. 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 lorundrostat and that of baxdrostat. Certainly Launch-HTN is speaking to the real world audience, again, Advance-HTN, I don't wanna 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. 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'll be part of negotiations with the FDA. Certainly having that data, whether within label for promotion or through medical information, I think it's gonna be very instructive and informative for those distinct physician population prescribers.

Got it. The physician feedback, I mean, the second part.

The physician feedback's been very robust. Eric,

There are two things that 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. Also the diversity and the well representation of our trial populations, and I'll call out the Black African American population, in 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.

Thanks, Mohit.

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

Hi, guys. Thanks for the update today. We covered a couple of my questions, but I think overall the sense is that baxdrostat'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. You know, as I noted previously, Matt, the lack of innovation, I think, speaks to the high interest from physicians to have a novel agent or a novel class of agents. I do think there is an opportunity to see this market opportunity grow as AstraZeneca launches, you know, 6 to 7 months in advance of potential approval for lorundrostat. I think it's important to highlight that we will have voice in the market during that 6 to 7-month period. We've had national account executives in front of payers going back to quarter 1. We have our MSL team in place, going out building advocacy within those top tier and regional tier KOLs.

I think it's really both companies out there progressively talking about the role of aldosterone, the importance of addressing it with an ASI that grows this market opportunity. 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. I think it's a net positive.

Great. Thank you, guys. Appreciate it.

Thanks, Matt.

Our next question comes from Rami Katkhuda with LifeSci Capital. Your line is now live.

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

Yeah, Rami, thanks for the questions. Relative to AZ, 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, it'll be informative for us. I think going back to the differentiation, the payer discussions, we're seeing that right now as we have dialogues with payers. The distinction of the dataset, whether it's Advance-HTN, which I've commented on previously, and a very distinct population that AstraZeneca can 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 dataset that's gonna be very informative for those payers from an access standpoint. 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. They're also interested in having two assets to evaluate. It's not as if from our perspective baxdrostat is gonna 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 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 Gepants, the orals. 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. I think that's an informative analog that we think about as we prepare the commercialization of lorundrostat.

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. I just have a follow-up from Mohit's question before that was helpful to hear about label differentiation, but maybe can you tell us more about how you'll react to bax pricing, especially, you know, when it comes to your pricing strategy? 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. We, you know, we'll see where AstraZeneca comes in with pricing. You know, we've guided in the past that thinking about FARXIGA, Jardiance, WAC or 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 lorundrostat. The key for us at the end of the day is to ensure that patients that physicians believe could benefit from lorundrostat get access to that. There are a lot of different levers we could pull from contracting to what we do with our patient assistance program. 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. You know, as we are looking at this launch, as a proxy to lorundrostat, can you maybe talk about how you would think about cadence of that launch? You know, it's hard without recent hypertension proxies to look at, but, you know, do you expect that there would be initial bolus of patients within the resistant hypertension population or anything like that could help us understand what a good first couple of quarters could potentially look like?

Yeah. I appreciate the question. 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. What we have in our slide deck is 2024 IQVIA data that shows 3rd line or later, there are about 8.8 million patients that are turning over trying new medications. That's in the absence of any innovation, right? That's with existing treatments that have been available for 20-plus years. 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 goal. 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. Fundamentally, that to me is a bit of a proxy. How that translates to baxdrostat's launch, you know, quarter-over-quarter, I don't know that I can opine on that. I know looking at fairly recent data from 2024, there's a lot of movement within this marketplace, I think that creates opportunities for novel agents like lorundrostat.

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 Jon Congleton 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 Q&A. 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 lorundrostat. We believe Mineralys 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 lorundrostat 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, 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.

Greetings, and welcome to the Mineralys Therapeutics, Inc. Fourth Quarter and Full Year 2025 Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. Please note this conference is being recorded. I will now turn the conference over to your host, Dan Ferry of LifeSci Advisors. Please go ahead.

Thank you, operator. I would like to welcome everyone joining us today for our fourth quarter and full year 2025 conference call. This afternoon, after the close of market trading, we issued a press release providing our fourth quarter and full year 2025 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-Ks and subsequent filings. Please note that these forward-looking statements reflect our opinions only as of today, March 12, 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 will now turn the call over to Jon Congleton, Chief Executive Officer of Mineralys Therapeutics, Inc.

Thank you, Dan. Afternoon, everyone, and welcome to our fourth quarter and full year 2025 financial results and corporate update conference call. I am joined today by Adam Levy, our Chief Financial Officer, Doctor David Rodman, Chief Medical Officer, and Eric Warren, our Chief Commercial Officer. I will begin an overview of the business, our clinical programs, and recent milestones, followed by Adam, to review our fourth quarter financial results before we open up the call for your questions. We are pleased to have this opportunity to provide a corporate update. As this call comes on the heels of our announcing the FDA's acceptance of the NDA for lorundestat, the treatment of adult patients with hypertension in combination with other antihypertensive drugs. In connection with the acceptance, the FDA assigned a PDUFA target action date of December 22, 2026. This NDA submission followed a successful clinical program which culminated in the completion of five positive clinical trials that consistently demonstrated clinically meaningful blood pressure reduction, 24-hour control, and a favorable safety profile. This comprehensive data set has generated broad interest across the medical community, underscoring the significant clinical need in uncontrolled and resistant hypertension and the desire for innovative solutions that help patients meet their blood pressure goals. The NDA includes the positive data from the LAUNCH-HTN and ADVANCE-HTN pivotal trials, as well as the proof-of-concept trial EXPLORER-CKD and our open-label extension trial TRANSFORM-HTN. Each of these trials demonstrate that lorundestat maintains a durable and clinically meaningful response across diverse patient populations, a key consideration for its potential as a new treatment for patients with hypertension. Uncontrolled and resistant hypertension remain unmet needs affecting over 20 million people in the United States and attributed to nearly 700,000 deaths per year. As we have noted previously, roughly 30% of all hypertension patients have dysregulated aldosterone. We are progressively seeing research and updated guidelines that highlight the need to identify and address aldosterone dysregulation in these patients. Our clinical data highlight the differentiated value of targeting aldosterone with an aldosterone synthase inhibitor like lorundrostat, especially when compared to current third- and fourth-line treatment options. To catalyze the successful launch of lorundestat, we have begun market access planning and payer engagement to ensure the value proposition of lorundestat is understood and appreciated. We have also expanded our medical communications efforts, which will include increased peer-reviewed publications, a larger presence at scientific meetings, and an expanded team of field-based medical science liaisons which will support broader data dissemination for this potentially transformative therapy. These activities are intended to drive a rapid uptake of lorundrostat and feed into potential partnering opportunities. I would now like to briefly touch on the other development activities we are pursuing to enhance and extend the lorundrostat profile into hypertension with comorbid conditions, which are largely driven by inadequately controlled blood pressure and dysregulated aldosterone. Earlier this week, we issued a press release announcing the top-line results of our exploratory trial EXPLORER-OSA. This four-week trial, which enrolled 48 participants, evaluated the safety and efficacy of lorundestat in participants with moderate to severe obstructive sleep apnea and hypertension. This trial enrolled a high-risk population with an average body mass index of 38, an average apnea-hypopnea index, or AHI, of 48, and baseline systolic blood pressure of 142 millimeters of mercury. While lorundestat did not demonstrate clinically meaningful difference relative to placebo on the primary endpoint, AHI, the trial did show clinically meaningful reductions in blood pressure and a favorable safety profile in this population with difficult-to-control hypertension. In the pre-planned parallel-arm analysis of the first period, the trial demonstrated an 11.1 mmHg blood pressure reduction with lorundrostat and a 1.0 mmHg reduction with placebo at four weeks. There was a 6.2 mmHg placebo-adjusted reduction in blood pressure in the crossover analysis. Lorundrostat demonstrated a favorable safety profile and was well tolerated, with no serum potassium excursions above 5.5 millimoles per liter. Our analysis is ongoing for other endpoints in the trial, and will be reported in future publications or medical meetings. Our clinical development strategy has been and will continue to be focused on generating a comprehensive dataset that reflects the complexities that physicians face when treating their hypertension patients. We remain focused on fulfilling our mission to develop lorundrostat, a potential best-in-class therapy for patients with uncontrolled or resistant hypertension. We believe the strength of the lorundrostat data generated to date and the significant clinical needs for uncontrolled and resistant hypertension offer substantial opportunity as we prepare for the upcoming milestones. We are continuing to evaluate further clinical development for lorundrostat in comorbidities and other potential indications. We will keep you informed on our progress as appropriate. I will now turn the call over to Adam to review our financial results for the fourth quarter and full year 2025.

Thank you, John. Good afternoon, everyone. Today, I will discuss select portions of our fourth quarter and full year 2025 financial results. Additional details can be found in our Form 10, which will be filed with the SEC today, March 12. We ended the year with cash, cash equivalents, and investments of $656,600,000 as of 12/31/2025, compared to $198,200,000 as of 12/31/2024. We believe that our 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 year ended 12/31/2025 were $132,000,000, compared to $168,600,000 for the year ended 12/31/2024. R&D expenses for the quarter ended 12/31/2025 were $24,400,000, compared to $44,600,000 for the quarter ended 12/31/2024. The annual decrease in R&D expenses was primarily driven by a $49,300,000 reduction in preclinical and clinical costs largely attributable to the conclusion of lorundrostat’s pivotal program in 2025. The annual decrease was partially offset by increases of $9,900,000 in compensation expenses resulting from headcount growth, higher salaries and accrued bonuses, and increased stock-based compensation, as well as $3,000,000 in clinical supply and manufacturing and regulatory costs. G&A expenses were $38,600,000 for the year ended 12/31/2025, compared to $23,800,000 for the year ended 12/31/2024. G&A expenses were $13,900,000 for the quarter ended 12/31/2025, compared to $7,200,000 for the quarter ended 12/31/2024. The annual increase in G&A expenses was primarily attributable to $8,900,000 in higher compensation expense driven by headcount growth, higher salaries and accrued bonuses, and increased stock-based compensation. The annual increase was further attributable to $5,300,000 in higher professional fees and $600,000 in other general and administrative expenses. Total other income, net, was $16,000,000 for the year ended 12/31/2025, compared to $14,600,000 for the year ended 12/31/2024. Total other income, net, was $6,000,000 for the quarter ended 12/31/2025, compared to $2,800,000 for the quarter ended 12/31/2024. The annual increase was primarily attributable to higher interest earned on investments in money market funds and U.S. Treasuries, resulting from higher average cash balances invested during the year ended 12/31/2025. Net loss was $154,700,000 for the year ended 12/31/2025, compared to $177,800,000 for the year ended 12/31/2024. Net loss was $32,200,000 for the quarter ended 12/31/2025, compared to $48,900,000 for the quarter ended 12/31/2024. The annual decrease was primarily attributable to factors impacting our expenses described earlier. With that, I will ask the operator to open the call for questions. Operator?

Thank you. We will now be conducting a question-and-answer session. You may press 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. Our first question will come from Michael DiFiore with Evercore ISI.

Congrats on all the continued progress. Two commercial questions for me. Now that the potential launch of lorundrostat is roughly six months behind your direct competitor, what are you hoping to learn from this competitive launch that would optimize the success of lorundrostat’s launch? And second, can you offer any additional color on the prelaunch payer interactions you have been having? Have there been any unexpected changes in anticipated coverage, etc.? Thank you.

Yeah, Mike. Thanks for the questions. We are obviously excited about the timeline we are on now. The Day 74 letter giving us the PDUFA date; we clearly see a significant market opportunity here with, as we stated before, about 20 million patients in the United States alone dealing with uncontrolled and resistant hypertension. We are obviously aware that AstraZeneca potentially is going to be launching in the second quarter. I think there will be some interesting things to identify as far as how they think about pricing and their footprint in the space. But fundamentally, we think this is a large market opportunity. There is certainly room for two novel therapeutics in what I think may be a transformative class overall. We clearly are very bullish on the profile that we have seen with lorundrostat with its best-in-class profile. As it relates to some of the dialogues that we have had with payers, we continue to feel bullish as it relates to access, particularly where we have targeted lorundrostat use. That is that third line or later. We think resistant is the natural opening space, and with experience, both from a physician standpoint and demand growing into the third-line usage. I think it is also important to point out, and I talked about it in my opening remarks, the comprehensive nature of the data set that we have built. When we think about resistant hypertension patients, it is rare that they are isolated to only be dealing with elevated blood pressure. There are so many comorbidities these patients are dealing with. Certainly, that is why we did the EXPLORER-CKD study. That is why we did the EXPLORER-OSA study. Even though we did not achieve a benefit on AHI, we know there is significant overlap, about 50% overlap, with resistant hypertension and OSA. Being able to show the kind of robust, safe benefit we have on blood pressure in this population, we think will have a significant translation into reduced cardiovascular risk for these patients.

Thanks so much. Thanks, Mike.

And our next question comes from Richard Law with Goldman Sachs.

Congrats on the PDUFA date and getting the NDA accepted. A couple of questions from me. So when you look at the results from the Phase II OSA study, do you think the design limited lorundrostat’s potential to show benefit in the AHI primary endpoint? I mean, the study was much shorter than the historical MRA studies with only four weeks, and you allowed CPAP and PAP use. And then the study population was also different from MRA trials. So it is not clear to me the study duration and design tested lorundrostat’s effects one way or the other. How confident are you on the finding, and where do you go from here with regards to OSA? And then I have a follow-up.

Yeah, Rich. Let me give you some opening thoughts, and I will turn it to Dave. As I noted, the reason we did this study was because we think it is important for the prescribers who are going to be utilizing lorundrostat to have a clear sense of both efficacy and safety within these complex patients. Being able to show a really robust reduction in BP and doing so safely in these patients that clearly are high risk, particularly the ones we studied in EXPLORER-OSA with the BMI over 38, with AHI over 48, when severe OSA is ticked off above 30. These are patients that have a pretty high cardiovascular risk when you compound that with elevated blood pressure. For us, it was an important study to complete. Again, we believe that we are going to be able to operate with our existing label within this population, just given the fact that they have uncontrolled hypertension and elevated cardiovascular risk. I will have Dave talk about some of the design features and his thoughts.

Thanks for the question, Rich. Good thoughts. I have a couple of things I want to say. First of all, was it long enough? It is unclear. It could have taken longer than the four weeks, but I think there is probably a major interaction between that and the actual study population demographics. In other words, we saw these people were extremely obese. They had extremely high AHIs, close to 50, and their BMIs were 38 on average. Their AHI was 48. BMI of 38. So we think the mechanism here is you are fluid overloaded; when you lay down, the fluid goes up into the veins of the neck, and that further obstructs the airway. In this population, there is so much extra adipose tissue that it may be that that compartment is already obstructing the airway enough just from that structural piece that you would not see any more with decreasing volume. So I think the thing to look at going forward, should we want to answer the question, is take a more representative population similar to the ones that were used in studies like eplerenone and spironolactone and test it again. But I want to make a different point, if you could just give me a minute, which is this: we did this because we wanted to know about AHI mainly because that is the easier way to register a drug if you want to claim treatment of OSA, but that is not necessarily our objective. Our objective is to know whether we are going to have a benefit on long-term outcomes in patients with OSA. And the interesting point is if you make AHI less than five with CPAP, it does not reduce your blood pressure and there is no compelling evidence that it makes your long-term cardiovascular outcomes any better. So it is really simply a way to look at the regulatory effect. On the other hand, the reduction in blood pressure we saw is comparable to, or predicts rather, and the agency gives you sort of the claim for improved outcomes. And at the 10 mmHg that we saw in the point estimate analysis, that has been shown to have about a 17% incidence of reduced coronary heart disease, 27% of stroke, and 28% of heart failure. So what we learned here was that we have the potential to be disease-modifying in sleep apnea. And as John mentioned, we can get to that point with the label we have or we are going to have already for treatment of uncontrolled or resistant hypertension; it has been reported that 80% of these patients have uncontrolled or resistant hypertension. So that is the long and the short of it. We do not need to prove it works in AHI because our objective is not to make a therapy for upper airway obstruction. It is to make a therapy that makes these people live longer, better lives.

Okay. Got it. And then just for my second question, I know you guys are still exploring the partnership with the PDUFA date now set in December, which is about nine months from now. Can you discuss what kind of commercial capability you have been building, and how large is the commercial team now, and what commercial hires are you still holding back while you are continuing to explore the partnership? And then is there any urgency to build a full commercial capability now in case a partnership may not occur until after the PDUFA date? Thank you.

Yeah. Thanks, Rich. I will take you back five years ago. We have always made discrete investment choices that support this molecule and put it in its best position to deliver value for the most appropriate patients possible. And so early days, it was CMC. That was ClinPharm. Where we are at now is we are making those right investment choices, and we began this late last year, as you are aware. We are continuing that now to ensure that we are preparing the market, and so that is why Eric and his team are beginning to have dialogues with payers. It is why we are expanding our medical affairs capabilities for continued data dissemination. We have just a wealth of clinical data that we accumulated last year and even as recently as the EXPLORER-OSA that we are going to continue to put in the public forum via medical meetings and publications. We are expanding our MSL team. I do not want to give numbers, Rich, other than to say we are continuing to do everything we can to ensure a rapid uptake on the potential approval of lorundestat for uncontrolled and resistant hypertension. And I think fundamentally, that is the right thing for us to do because it also becomes very informative and potentially catalyzes those partnering dialogues. And we have heard that from potential partners, that we need to make sure we are continuing to invest in this asset so upon approval it does have a rapid uptake and a rapid launch.

Got it. Thank you. Thanks, Rich.

We will go next to Seamus Fernandez with Guggenheim Partners.

Thanks. So just to follow up on the commercial side of things, can you help us understand what you believe the number of reps would be to launch lorundrostat effectively versus AstraZeneca? And do you envision having a differentiated approach to market that Astra—if there is a differentiated approach, what would that be?

Yeah. I am not going to give you a specific number, Seamus, and we are continuing to evaluate that. As you have heard us say before, when we look at where we have developed this molecule, third line or later, and in the United States who prescribes there, it is about 60,000 physicians that are responsible for half of the scripts third line or later. So that is kind of a broad way to look at the market. I do not want to give too much on our intended commercial strategy, but I will say that if you look at the comprehensive dataset that we have—ADVANCE-HTN confirmed hypertension (that was the study we did with the Cleveland Clinic), EXPLORER-CKD that looks at hypertension and comorbid chronic kidney disease, then if you look at the OSA population, the data that just came out of the EXPLORER-OSA—that is going to begin to inform how we think about subsegments of physicians that are treating specific types of hypertension with related comorbidities. And so we will begin to look at the broad IMS data, but then also in the context of these subsegments we think can give us rapid uptake within the resistant hypertension population, and then with experience, move rapidly into third line as well.

Great. And then maybe just as a follow-up. Is there kind of a timing-related dynamic? How much of a derisking event, not just for Mineralys Therapeutics, Inc., but perhaps for strategics, would you say the availability of the assignment of a PDUFA date actually is, broadly speaking?

Yeah. I think each step along this journey offers a level of derisking and a level of increasing value. That began last year with the readout of ADVANCE and LAUNCH. It continued with the submission of the NDA last year. I think the Day 74 both acceptance of and PDUFA date for lorundrostat further derisks the molecule and brings value nearer term. Maybe related to that, when is an ideal time to identify a partnership? I think that these partnerships have a life of their own, a timeline of their own. Our goal is to really identify a means to generate the greatest value with lorundrostat, which means getting the molecule in front of the most appropriate patients in the United States and, in due course, outside of the United States. So those are all of the things that go into the calculus as we think about maximizing the value of lorundrostat through partnering. Great. Thanks so much. Thanks, Seamus.

Moving next to Jason Gerberry with Bank of America.

Just wanted to quickly follow up on the payer access discussions. I think the comment was maybe favorable access with a certain segment of payers. So I was wondering if you can expand upon that a little bit, just to get a sense of your confidence in breadth of quality coverage, 3L+ as I guess you have articulated in the past. And then one CFO question here. Just from an R&D perspective, thinking about 2026 R&D relative to 2025, should we be thinking about, I do not know, cash burn mitigation effort? Or is 2025 a good run rate for the company? And then last one for me is just on the OUS regulatory submissions—apologies if I missed this in past commentary from you guys—but is that in any way gated at all by the partnership discussions? If you can give us a sense of when you anticipate the OUS submissions.

Yeah. Thanks. Let me maybe give some quick thought on payer, and then I will have Eric add some additional color. We have done a great deal of research in this area—obviously, probably one of the most critical vectors to ensure that we get lorundrostat to the appropriate patients with as few barriers as possible. I think we continue to feel very strong about the value proposition of lorundrostat, the need specifically in the resistant hypertension population, and so we believe that both the combination of appropriate price and rebate is going to create that access. But Eric, I do not know if you want to add some additional thoughts. I know your team continues to work aggressively on this.

Yeah. And, Jason, I am just back from a large payer conference in Orlando, PCMA. The team was engaging Medicare as well as commercial payers. I will say we are on their radar. They are very well aligned with the positioning that John spoke of, and we are now in the midst of scheduling these pre-approval information exchange, or PIE, discussions. So we have got a favorable footprint and interaction cadence with payers.

And, Jason, I think to your second question, Adam, want to add some thoughts?

Yeah. So, Jason, we have not intended to give guidance on R&D, but I can tell you that in 2025, we were running a number of trials. We had LAUNCH-HTN, ADVANCE-HTN, EXPLORER-CKD for part of that year, EXPLORER-OSA, plus the open-label extension. So it was a heavy lift on R&D for us in 2025. When you roll into 2026, we have been wrapping up the costs on the OSA trial. We still have the open-label extension running. There may be other R&D that we decide to do this year, but I would expect that there is less R&D activity in 2026 than we had in 2025, at least with current or existing plans. Does that help?

Okay, thanks, John.

And, Jason, to your last question, if I recall it right—ex-US and how do partnerships play within that? As we have spoken about in the past, our goal is certainly to try to get lorundrostat to as many patients in the United States as well as outside of the United States as appropriate. We know there are some complexities right now between MFN and tariffs that we are continuing to evaluate. Partnering may play a role in that, and it may play a role beyond just a co-promotion. This is where co-development becomes an interesting opportunity. I think David and his team have done such an excellent job of characterizing lorundrostat not just in hypertension but in so many of these related comorbidities. That creates an opportunity for us to assess what is the appropriate way to introduce lorundrostat outside of the United States. Is it as a monotherapy, as potentially a fixed-dose combination strategy? Those are still things we are evaluating, and once we have made a solid plan relative to that, we will certainly be communicating that. Thanks, Jason.

Moving on to Annabel Samimy with Stifel.

Hi. Thanks for taking my question. Just a little bit more on the commercial side. Maybe you can help. I know it is probably too early to talk about pricing. But is there any scenario where your competitor can angle for third line while you are putting yourself in fourth line first? Are you thinking about the possibility of using pricing as a competitive lever? And what kind of things do you need to do to get yourself into third line? And then as a follow-up to that, just with EXPLORER-CKD and EXPLORER-OSA, are you actually seeking to put it in the label as a differentiating feature or just have the data available for presentation and publication? Thanks.

Yeah. I think it is too early to give you too much specificity on pricing. I cannot really speak to where AstraZeneca may go from a pricing or line-of-treatment approach. I can tell you, as Eric alluded to and I did in my prior comments, that based on the research we have done with payers right now, the value proposition of lorundrostat certainly resonates fourth line, with some payers even third line. I think it is going to be, as I noted, a beachhead at fourth line. That is clearly where there is unmet need. That is clearly where the value resonates. With experience and demand, I think that begins to open up third line. We have talked in the past, Annabel, that as a guidance or a frame for pricing, we have always directed to probably more of an SGLT2-branded price point, Entresto price point, broadly at a WAC, but have not guided as it relates to rebates. To your second question, as I noted in my prepared remarks, we do anticipate having EXPLORER-CKD as part of the NDA application. That will be part of a negotiation as to what portion of that data may be reflected within the label. We believe that the blood pressure reduction data from EXPLORER-CKD is informative for prescribers. That will be part of our positioning from a negotiation standpoint. EXPLORER-OSA was not part of the original NDA application. That may be part of continued safety updates, but the actual data was not available at the time the NDA submission was made. But we do think both of those trials will be very informative to the medical community. We will be using medical meetings, publications, and our medical science liaison team to certainly convey the important messages contained within both of those studies.

Okay. And is there any possibility to share other comorbidities you might be interested in exploring that could be particularly impacted by hypertension-lowering agents?

Yeah. I think I would go a little deeper than hypertension agents—specifically driven conditions. When we talk about 30% of hypertension patients have dysregulated aldosterone, I think by extension that goes into other conditions like CKD, like OSA, as David has spoken about before. Heart failure, we have mentioned, is a place where clearly aldosterone plays a significant role in the risk profile of those patients. There are some other indications that we continue to look at that we have not really spoken about yet, but as I said in a previous response to a question, we believe that there are significant opportunities. Some of those are ones that we would pursue on our own. I think some of those others are ones that we have thought about having partnering involvement with. But at this stage, lorundrostat is extremely well characterized for what it does to aldosterone, how it safely addresses that, and it opens up a lot of other opportunities. As we solidify those development plans, we will be sure to convey those to the market. Okay. Thank you. Thanks, Annabel.

And our next question will come from Mohit Bansal with Wells Fargo.

Great. Thank you very much for taking my question and congrats on all the progress. Just one question. Just trying to double-click on the 60,000 prescriber number, John, you mentioned. Wondering, is this primary care heavy, or are these specialists that you would be targeting? And then what is the sort of role direct-to-consumer marketing-type of mechanism could play for a market like this? Thank you.

Yeah. Mohit, I think it is important that there are two vectors that Eric and his team are looking at, and it is the broad prescriber data that everybody can look at, the IQVIA data, and that is where the 60,000 as a broad target comes from. It is about a 60/40 split, primary care/specialty, the bulk of the specialty being cardiologists. But then there is another vector that we are looking at, and that is for those resistant hypertension patients with comorbidities, who is managing those patients? So hypertension and CKD, hypertension and OSA, confirmed hypertension, and even the Black or African American population because we know we have done a considerable job to make sure we have proper representation within our clinical trials. And so we are taking the broad macro data from a prescribing standpoint, but also informing that with primary market research to see where are the true targets that can really ensure that we are getting lorundrostat as rapidly to as many appropriate patients as possible. And I am sorry, I think you had a second part of your question, Mohit.

Yeah. Thank you for this. The second part was more about the direct-to-consumer marketing sort of mechanism—what sort of a role it could play for a company like yours?

Yeah. I do not know that we are in a position quite yet to talk about the consumer strategy, but obviously, we want to be speaking to patients, reiterating the importance of getting their blood pressure under control, seeking different means to do that, whether it is diet, exercise, or therapeutics, and the benefits specifically of lorundrostat, particularly if they have overlapping comorbidities where we have data that can speak to the opportunity for lorundrostat to help them get to goal and subsequently have hopefully longer lives and better lives. Very helpful. Thank you. Thanks, Mohit.

We will go next to Rami Katkhuda with LifeSci Capital.

Hey guys, thanks for taking my questions as well. I guess I know it was a small study, but did you observe any differential treatment effects in blood pressure reductions or AHI across any kind of key subgroups in EXPLORER-OSA? I guess a particular focus in those receiving and not receiving CPAP? Then maybe secondly, I know you touched upon potential future indications. Is the goal to be first in class for those indications, or are they large enough, similar-type indications, where it does not matter?

Thanks, Rami. So we are in the midst of examining deeper into the data, and one of the things we are doing right now is looking at your question of subsets. You are right, it is a small trial, so it will be hypothesis-generating more than proving hypotheses, but that is still really useful. And we intend to present that kind of analysis at future publications and meeting presentations, so just stay tuned for that. In terms of the CPAP, about a third of the subjects, or a quarter, were on CPAP, and we did not see any difference between those groups. But again, they are pretty small numbers, so I do not want to hang my hat on that.

Yeah. And, Rami, to your follow-up question as it related to—would you repeat it for me one more time? I want to make sure I address it specifically.

Yeah. I just wanted to see if those indications—the goal is to be first in class there, or could you pursue larger indications? I know you mentioned heart failure—are they large enough to encompass multiple winners here in the ASI class?

Yeah. I think what our intent is is to not be a follower. And what do I mean by that? We know that dapagliflozin is going to be generic potentially this year. I think some of what is being done with the ASIs tends to be more life-cycle management combined with an SGLT2. I do not know that we are looking to, frankly, get into that mud fight. I think there is going to be ample opportunity, and with the data that we have, for physicians to use lorundrostat with the SGLT2 of choice if patients have an overlapping comorbidity like CKD with their hypertension. As I noted in a previous response, we know that dysregulated aldosterone plays a significant role across the spectrum of cardiorenal metabolic disorders. That is what is informing how we think about where is the white space, where is the opportunity, for us to take what we believe to be the best-in-class aldosterone synthase inhibitor—either alone or in some distinct combinations—bringing forward solutions for those patients. Got it. Thank you very much.

And going next to Dennis Ding with Jefferies.

Hi. Thank you for taking our questions. This is Georgia Bank on the line for Dennis Ding. Maybe a little bit more on the potential partnerships and if you could talk about what an ideal partnership looks like in terms of capabilities and also creative deal structuring. Obviously, the commercial infrastructure is important, but what other nuances are important to you? Maybe in terms of R&D funding or bigger indications and payer relationships? I know that you mentioned that there is opportunity in pursuing some indications on your own and others maybe partnering on. Any color there would be helpful. Thank you.

Thanks, George. It is a good question, and I will repeat what I have said in the past. We would love to find a partner that sees the opportunity with lorundrostat the way we do. And how is that? That is with the best-in-class aldosterone synthase inhibitor in the near term generating significant value for patients, for physicians, and for the health care community at large and helping to control uncontrolled and resistant hypertension; then also, more broadly, fully realizing the value of the asset from a development standpoint. So co-development—I am not going to talk about what kind of deal structures that would look like—but really extending the value of lorundrostat beyond hypertension and some of its related comorbidities. And then within that becomes addressing the complexity that exists just right now with branded assets that you want to get into the hands of patients outside of the United States. And so what has been informing the dialogues that we have had is finding a partner that thinks more holistically about the opportunity. As we have stated before, lorundrostat has excellent IP out to 2035; patent term extension, probably to 2039. There is a significant time period there to fully realize the value of this asset and bring that value to patients. Got it. Appreciate it. Thank you. Thanks, Georgia.

And this concludes our question-and-answer session. I would like to turn the floor back over to Jon Congleton for closing comments.

Thank you, operator. We believe the strength of the clinical results for lorundrostat show the potential benefit for uncontrolled and resistant hypertension and those related comorbidities. This is an exciting time for our team, the patients with hypertension who may benefit from treatment with lorundrostat, the physicians and researchers that have worked so hard in support of bringing lorundrostat through our clinical trial program, and our shareholders. We look forward to sharing updates with you in the coming quarters, and with that, I will say thank you, operator, and thank you to everyone for joining us today. We will now close the call.

Ladies and gentlemen, thank you for your participation. This concludes today's teleconference. You may disconnect your lines, and have a wonderful day.

Greetings, and welcome to Mineralys Third Quarter 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Dan Ferry. Thank you. You may begin.

Thank you, operator. I would like to welcome everyone joining us today for our third quarter 2025 conference call. Earlier this afternoon, we issued a press release providing our third quarter 2025 financial results and business updates. A replay of today's call will be available on the Investors section of our website approximately 1 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 materially -- 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, November 10, 2025. 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 Jon Congleton, Chief Executive Officer of Mineralys Therapeutics.

Thank you, Dan. Good afternoon, everyone, and welcome to our third quarter 2025 financial results and 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 third quarter financial results before we open up the call for your questions. We're excited to have this opportunity today to provide an update on the progress our team has made over the past couple of months. Last month, we received pre-NDA feedback from the FDA. There were no surprises in this feedback and we're moving ahead with our NDA filing, which we expect to submit either late this quarter or in the first quarter of 2026. In preparation for the submission, we developed a robust data package featuring results from multiple clinical trials across the spectrum of distinct and diverse participants with lorundrostat, which we believe support its potential as a best-in-class treatment for high-risk patients with uncontrolled or resistant hypertension and beyond. Earlier this year, we announced data from the Launch-HTN and Advance-HTN pivotal trials. The results from both trials demonstrate that lorundrostat offers a clinically meaningful and sustained reduction in systolic blood pressure. These data have generated broad interest across the medical community, underscoring the unmet need, the desire for innovation and the management of hypertension and the commercial potential of lorundrostat. These findings form the foundation of our NDA submission, which includes data demonstrating that lorundrostat maintains a durable and clinically meaningful response across diverse patient populations, a key consideration for its potential use in treating uncontrolled and resistant hypertension. This includes subgroup analysis from the Phase III Launch-HTN trial and data from confirmed hypertension patients in the Advance-HTN trial. The Launch-HTN trial enrolled a diverse group of participants. Nearly 1/3 were black or African-Americans, half the participants were women, the majority of participants were overweight or obese and over half had resistant hypertension, requiring 3 or more background antihypertensive medications. Across all subgroups, lorundrostat 50 milligrams once daily demonstrated consistent, statistically significant and clinically meaningful reductions in blood pressure. All systolic BP reductions generated in Launch-HTN were measured at 24 hours after a dose, proving the sustained effect and true once-daily profile. The Advance-HTN trial designed and executed in conjunction with the Cleveland Clinic, enrolled a diverse group of hard-to-treat participants with confirmed uncontrolled and resistant hypertension by design with over half of the subjects being black or African-Americans. Now let me pause for just a second to describe what I mean by confirmed. In any trial that allows participants to remain on their existing background medications such as Launch-HTN, patients may have apparent hypertension, meaning if they optimize their treatment with the existing medications, they may get to goal. In Advance-HTN, participants' existing background medications were removed, and they were started on an optimized background treatment, aligned with the AHA guidelines, confirmed daily compliance with smartphone technology and randomized only if they remained hypertensive after a 3-week run-in, utilizing the measurement of 24-hour ABPM. In these most difficult-to-treat participants, lorundrostat again demonstrated a significant and clinically meaningful reduction in systolic blood pressure and was well tolerated. I would now like to briefly touch on the other development activities we're pursuing to enhance and extend the lorundrostat profile in hypertension with comorbid conditions, which are largely driven by inadequately controlled blood pressure and dysregulated aldosterone, starting with our proof-of-concept Explore-CKD trial, which evaluated the safety and efficacy of lorundrostat in subjects with hypertension and comorbid chronic kidney disease on a background of SGLT2 inhibitor. Last week, we were excited to have data from this trial presented during a late-breaking session at ASN's Kidney Week 2025. Lorundrostat demonstrated a clinically meaningful reduction on systolic BP in 4 weeks and was well tolerated. The key secondary outcome measure of reduction of urinary albumin creatinine ratio, or uACR, an accepted surrogate for renal protection was clinically meaningful and highly statistically significant. Immediately after the release of these data, First Word Pharma surveyed 133 health care professionals, with 77% indicating they would consider prescribing lorundrostat to CKD patients with uncontrolled hypertension on either an ACE inhibitor or an ARB. Turning to the ongoing Phase II Explore-OSA trial. In the third quarter, we completed enrollment in this trial, which is evaluating the safety and efficacy of lorundrostat in participants with moderate-to-severe obstructive sleep apnea and hypertension. We anticipate reporting top line results from the trial in the first quarter of 2026. If the trial is successful, these data would complement the previously announced Explore-CKD results and further our strategy to extend lorundrostat's profile in treating patients with hypertension and comorbid conditions. Our rationale for targeting OSA is clear. A significant portion of patients with obesity and resistant hypertension also have OSA, which is often undiagnosed and untreated. These conditions are biologically linked, as blood pressure and the hypoxia rise during sleep due to upper airway obstruction. Both are drivers of major adverse cardiovascular events, including death. Prior small studies of MRAs or adrenalectomy have demonstrated reduction in AHI, which is the primary endpoint of the Explore-OSA trial. The trial will also test the effect of lorundrostat on nighttime blood pressure using 24-hour ABPM as well as the novel measurement of continuous blood pressure through the evening. While we have already clearly demonstrated lorundrostat's efficacy as a once-daily morning antihypertensive, this trial will explore nighttime dosing since the triggers for aldosterone production in OSA or reduction in oxygen delivery leading to increased sympathetic activation of aldosterone production that occurs in the night during sleep. Uncontrolled and resistant hypertension remain major unmet needs, affecting over 20 million people in the U.S. and contributing significantly to cardiorenal complications. Our clinical data highlight the differentiated value of targeting aldosterone with an aldosterone synthase inhibitor like lorundrostat, especially compared to current third and fourth-line therapies. As we advance toward commercialization, we are prioritizing market access planning and payer engagement to ensure the value of lorundrostat is well understood. We have also expanded our medical communications capabilities to support data dissemination through peer-reviewed publications, scientific meetings and our field-based medical science liaisons. These efforts are central to ensuring commercial readiness for this potentially transformative treatment and the successful launch of lorundrostat. As we near the end of 2025, we've seen significant advances in the ASI space, including multiple trial readouts. As we reflect on these data and their clinical relevance, we are more confident than ever in lorundrostat's best-in-class profile based on the meaningful blood pressure reduction that demonstrated 24-hour control, its benefit across the spectrum of difficult-to-treat patients and its safety and tolerability. As we move forward with our NDA submission, we do so with confidence in the strength of our data, our team and our mission to develop lorundrostat as a potential best-in-class therapy for the high-risk often difficult to treat patients living with uncontrolled or resistant hypertension. I will now turn the call over to Adam to review our financial results for the third quarter of 2025. Adam?

Thank you, Jon. Good afternoon, everyone. Today, I will discuss select portions of our third quarter 2025 financial results. Additional details can be found in our Form 10-Q which will be filed with the SEC later today, November 10. We ended the quarter with cash, cash equivalents and investments of $593.6 million as of September 30, 2025, compared to $198.2 million as of December 31, 2024. 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 September 30, 2025, were $31.5 million compared to $54 million for the quarter ended September 30, 2024. The decrease in R&D expenses was primarily due to a decrease of $26.8 million in preclinical and clinical costs, primarily impacted by the conclusion of the lorundrostat pivotal program in the second quarter of 2025, partially offset by increases of $3.2 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation and $1.1 million in higher clinical supply manufacturing, regulatory and other costs. G&A expenses were $9.7 million for the quarter ended September 30, 2025, compared to $6.1 million for the quarter ended September 30, 2024. The increase in G&A expenses was primarily due to $2.2 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation, $1.3 million in higher professional fees and $0.1 million in other administrative expenses. Total other income net was $4.2 million for the quarter ended September 30, 2025, compared to $3.8 million for the quarter ended September 30, 2024. The increase was primarily attributable to increased interest earned on investments in money market funds and U.S. treasuries as a result of higher average cash balances invested during the quarter ended September 30, 2025. Net loss was $36.9 million for the quarter ended September 30, 2025, compared to $56.3 million for the quarter ended September 30, 2024. The decrease was primarily attributable to the factors impacting our expenses that I described earlier. With that, I will ask the operator to open up the call for questions. Operator?

[Operator Instructions] Our first question comes from Umer Raffat with Evercore.

I have a question on your resistant hypertension population. And my question specifically is, if you don't adjust for the discontinuations, basically, no imputations involved, what would your minus 9-millimeter mercury have been? Presumably something in the teens, but is that a number you guys have evaluated if you were to not do any imputations and only look at completers like Astra did?

Umer, thanks for the question. Maybe Dave can opine on this. But the -- we haven't done that analysis. It wasn't part of the plan. And from our standpoint, you have to account for all subjects enrolled that account for the execution within the study, discontinuations and patient outcomes as well. But Dave, do you want to give some comment to that?

Yes. So you're right, Jon. We did exactly what we negotiated with the FDA should be done in the situation of missing data. As you probably know, numbers above 15% and certainly 20% are extremely problematic. And sometimes those trials can't be evaluated by the agency. So we wanted to make sure. So we really didn't do that. And I will caution you that it's complicated to do any kind of estimates on imputation because you need the raw data. You can't take, say, the [ lead square ] means and try to figure out what it would be. But it can be a reasonably substantial reduction. So you're right, it would -- it can go up or down 3 to 5 millimeters of mercury depending on what sort of imputation you do, et cetera.

Our next question comes from Rich Law with Goldman Sachs.

Congrats on the progress. So one advantage that AstraZeneca has been highlighting for Bax is the longer half-life. So in Bax24 presentation over a weekend, I think we saw -- I mean it was interesting to see that the Bax show 14-millimeter placebo-adjusted SBP reduction for both day and night. Have you guys looked at that the day and night for Advance-HTN? And was there any difference between the 2? And then I have questions later on follow-up.

Rich, the 24-hour control, long-term acceptable tolerability profile, these are all things that physicians are looking for as they're treating the chronic condition like hypertension. With 4 studies completed, we're very confident in the 50-milligram and the 25-milligram once daily, providing that 24-hour control. And with the profile that's going to really aid long-term adherence compliance. I noted it in our prepared remarks, I think it's worth repeating. We have always measured blood pressure in the morning before that day's dose. So we're measuring it at trough. Lorundrostat in Mineralys is the sponsor. We're the first to look at 24-hour ambulatory metrics with an ASI with our Target-HTN study. We're very comfortable with daytime and nighttime blood pressure reduction. Advance-HTN, the most rigorous study down in the truly confirmed population, which is distinct from any other steady population of at least temporal current ASI studies, again, validated the 24-hour control. We've yet to publish or disclose the nighttime, but we're comfortable with what we're seeing from Target-HTN, Advance and really for the entire program and providing 24-hour control for patients.

I see. Got it. And then -- so then, I want to follow up to your previous discussion on the data, the missing data and how to handle that. Based on your understanding of FDA's requirement, are you -- can you exclude any missing data or invalid baseline measurements in the primary analysis? Do you have to consider the entire population, the ITT population and then perform imputation to it? So just curious to see how your -- what your thoughts are in terms of what the FDA require in these scenarios?

As Dave noted, and I'll have him add some color to this. In the case of Advance-HTN, this was pre-discussed with the FDA and set in the SAP. But Dave, do you want to maybe add some color to Rich's question?

Yes. Thanks for the question, Rich. So one thing I'll mention is you can't go back and do it. You have -- it needs to be in the statistical analysis plan and spelled out. And depending on what the circumstances are you will probably have to do a number of different ones. And one is called jump to reference. That means you have to assume every single person randomized to active actually behave like placebo, that's obviously the most conservative, but it's also the one that they're going to want to look at. There are other ones that are more complex. And -- but you have to negotiate all that in advance. And generally speaking, you would do that by looking ahead and seeing what you're missing these numbers are and then decide whether a conversation like that is needed. We did that when we had a risk of missing data and we're able to handle the problem. So it's complicated. But if you haven't already done it before database lock, you can't just do it later and try to make up for it.

Our next question comes from Tim Anderson with Bank of America.

This is Alice on for Tim. So you mentioned there were no surprises in the pre-NDA feedback. But are you able to provide any more color on this feedback? And could you update us on any final steps before filing? And then I have a follow-up as well.

Yes, Alice. We're -- we haven't really disclosed that, but we're comfortable with the feedback. As I noted, there were no surprises. We're very confident in the data set we've put together across Advance-HTN, Launch-HTN and Explore-CKD. As I noted in the past, in public statements, the other critical part is the on-label extension, having sufficient long-term safety data, including the randomized treatment withdrawal, all of that is progressing well. So we're comfortable with the guidance that we've given, and that is mentioned by the end of this year or into Q1 of next year.

And then just following the -- now that you're on track for submission, can you provide any updates on any partnering discussions you may be having?

Thanks, Alice. No, we continue, as we've said in the past, believing that partnering is going to be a key component of the Mineralys story. That is for ex U.S. commercialization opportunity, maximization of value, but also in the United States. We feel very confident in the best-in-class profile that exist with lorundrostat right now. We want to make sure that we give it the appropriate commercial lift in the United States as well as rest of world as well as looking at co-development partnerships. And so I think we have a well-characterized molecule at this point on the cusp of an NDA submission. And I think that continues to support the partnering dialogues that we're having. We're at the end of the day, we're focused on how do we maximize the value of lorundrostat for patients, for physicians and certainly for investors.

Our next question is from Annabel Samimy with Stifel.

This is Jayed, I'm on for Annabel. Just 2 questions. The first one is around the open-label extension trial. What are your expectations there? And when can we expect an update on the data?

Yes. We continue to progress well with the open-label extension. There's been no surprises as we continue -- it's open label, obviously, so we can see data within that, the DSMB continues to review it. We continue to be confident with the safety profile that we're seeing. We will certainly look to publish the results of the open label as well as the randomized treatment withdrawal when the last subject has completed that aspect.

Got it. And then one more on the ongoing Explore-OSA trial. How do you expect to leverage the data that comes out of that trial?

Yes. Our goal with Explore-CKD and Explore-OSA is really an acknowledgment that lorundrostat has a benefit that extends beyond just the reduction of blood pressure. And we know there are comorbid conditions that hypertension patients are dealing with chronically, whether it's proteinuria, whether it's CKD, whether it's OSA in the basically related cardiovascular risk that each carry. And so from our standpoint, adding further data beyond blood pressure reduction to the profile of lorundrostat is going to help its image and view within the prescribing population. It's going to help inform how they think about providing benefits to their patients that don't just deal with blood pressure but are dealing with the related comorbidities. And so I think it really fully round out the profile of lodrundrostat and shows the promise of this molecule for addressing hypertension, but again, for those related comorbidities.

Our next question comes from Mohit Bansal with Wells Fargo.

Congrats on all the progress. So I have 2 questions. So I wonder -- overall, Jon, based on the data we have seen so far with lorundrostat and Bax so far, do you see any major differences between the 2 at this point? Or do you think it kind of validates -- like all those data validate the class? And the related question is, that AstraZeneca has talked about this being a multibillion-dollar opportunity. Some of it is unlocked -- some of it would be unlocked with the combination and all those trials. So to help enable those trials, what kind of partnerships you as a company would be looking at? And what kind of partner would be the better partner for you to collaborate with at this point?

Yes. Thank you, Mohit. I would say -- and going back to my remarks, we've seen a lot of data in 2025 from us with lorundrostat as well as competing ASIs in the space. We feel very comfortable with our best-in-class profile at this point. Clearly, the ASIs are going to be a differential class and addressing the significant unmet need, a population of 20 million just in the United States alone that could benefit from a drug that's targeting the dysregulated aldosterone that we believe is probably accounting for a significant portion of those patients not being able to get to their ideal goal and basically risking poor cardiovascular outcomes if they do not. At this stage, where we have a complete data set from Advance-HTN, where we are truly looking at the most difficult to manage because they are confirmed hypertension to the really broad study Launch-HTN as well as Explore-CKD. We feel very confident in the consistent effect that we're seeing. The magnitude of reduction of systolic blood pressure that builds over time. We see a nice response within 2 weeks that continues to grow out to the 12-week period of these studies. The safety profile, clearly, the on-target safety signals with electrolytes. We believe we've got best-in-class molecule as far as the really modest increase in potassium that's transient upon reducing or discontinuing the drug, and the tolerability of the profile. So again, I think this is an exciting time for us. I think it's going to be informative for our partnering dialogue. It's very easy at this point to say this molecule is being derisked as an aldosterone-reducing agent and doing so safely and effectively. We know that aldosterone plays a critical role in conditions beyond hypertension, such as CKD, such as OSA, conditions like heart failure. We believe that it's that breadth of opportunity that will continue to inform those partnering dialogues, and that's why it's critical for us. We've said it early on. We've not -- we've not had a "for sale sign" in front of this company. We've been developing this molecule to make sure that we maximize the value for that. I think at this stage, we've done so. We think there's continued value that we can unlock on our own, but certainly a partner both in the commercial and the developmental perspective would help inform that and drive that even further.

Our next question comes from Rami Katkhuda with LifeSci Capital.

AstraZeneca seems to have only enrolled a small number of African-American patients in Bax24 at least for the primary endpoint analysis, which doesn't seem super representative of the resistant hypertensive population. Do you think this could have affected the results? And can you remind us how large of a difference in efficacy you see with lorundrostat in this patient population? And then secondly, have you noted what percentage of patients get to goal with lorundrostat in Advance or Launch?

Yes. Rami, thanks for the question. It was with intent that we really wanted to ensure that we had a good diverse representation of patients within our clinical program. We know that black or African-American patients tend to be underrepresented in studies. We also know they carry some of the largest cardiovascular risk for uncontrolled hypertension. So I was really proud of what the team did across the program. In Advance-HTN, over 50% of those studies were black or African-American descent. In the larger global study, Launch-HTN, we're nearly at 30%. And so we have a really clear understanding of the benefit that lorundrostat can provide these patients. In the case of both trials, when we look at forest plots, we see that race is not a determinant of response. In other words, whether you're white or black or African-American, you're going to respond to lorundrostat and have a significant opportunity to get to your respective goal. And so it was important for us to have that population within our clinical program to be able to speak to the effect of lorundrostat to that at-risk population that typically is underrepresented. As to the percent to get to goal, what we have shown in the past was, I believe, 44% in Launch got to goal at week 6, and I believe it was 42% got to goal at week 4 with Advance. I want to make sure I got that right, 44% with Launch, 42% with Advance. And I believe for the placebo groups, they were about half. I do know the odds ratio of getting to goal was over 3 in each study within those time frames that I described. And I hope that answered your question, Rami.

Definitely, yes.

I'll just add -- Rami, it's Eric. I'll just add that the definition of goal was different when you're looking at that Bax24 data, where they used a [ 1 30 ], we used a more stringent [ 1 25 ]. I'll also say that it wasn't just Bax24 that didn't have a high quantity of black or African-American patients. It was also BaxHTN where they were about 8%.

And this is Dave. As long as we're all jumping on this question because it's such an important question. As a developer, my perspective is this. There's a reason why we had a high percentage of people in the Advance-HTN trial of confirmed uncontrolled and resistant hypertension. Black, African-Americans have a higher percentage of not being able to respond to the generic drugs as well as Caucasian patients. And so we have a higher percentage there. The need is higher and yet we showed that the response once they get on our drug is just as good as the Caucasian population. I think that's important distinction because as we've said many times, doing that trial and getting established confirmed hypertension is what the experts ask us to do, and it's what the real gold standard is to know what this drug can do beyond generics. And in African-Americans, it's obviously an extremely effective drug there.

We have reached the end of the question-and-answer session. I'd like to turn the floor back over to Jon for closing comments.

Thank you, operator. We believe the strength of the clinical results for lorundrostat show the potential benefit for uncontrolled and resistant hypertension and related comorbidities such as CKD. We look forward to our upcoming NDA submission and results from Explore-OSA. This is an exciting time for our team. The uncontrolled and resistant hypertension patients who may benefit from treatment with lorundrostat, the physicians and researchers that have worked so hard and supported bringing lorundrostat through our clinical trial program and our shareholders. We're excited for upcoming key milestones and look forward to sharing updates with you in the upcoming quarters. With that said, I'll thank everyone. Thank you for joining us today, and we'll close the call now. Thank you.

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