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 one hour after its completion. After our prepared remarks, we will open up the call for Q and 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's 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 three 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 three key factors. One, prescribers prioritize magnitude and consistency of blood pressure reduction and have stated a consistent willingness to prescribe lorundrostat in the fourth line.
Two, payers recognize the high-risk nature of patients whose hypertension is uncontrolled on three or more medications and have expressed a willingness to provide coverage for lorundrostat. Three, patients are seeking meaningful and sustained blood pressure reductions that are tolerable and simple to integrate into their daily lives. They're very receptive to novel agents like 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 31st, 2026, compared to $656.6 million as of December 31st, 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 31st, 2026 were $24.4 million, compared to $37.9 million for the quarter ended March 31st, 2025.
The decrease in R&D expenses was primarily driven by a $15.5 million reduction in preclinical and clinical costs following the conclusion of 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 31st, 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 31st, 2026, compared to $42.2 million for the quarter ended March 31st, 2025. The decrease was primarily attributable to the factors impacting our expenses that I just described. With that, I will ask the operator to open the call for questions. Operator?
Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star 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. Two for me. Number one, 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 fourth and the fifth 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 third line or later opportunity, both Advance and Launch, looked at that population failing to get to goal on two or more because I think that's where significant need exists. I think that's where an ASI can add significant value. From a market standpoint and at launch, we think the focus will be fourth line. I'll have Eric opine on some of the feedback we've gotten from payers to date. Clearly, it's our feeling that that fourth 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 two or more meds right now. We know the clear linkage of uncontrolled or resistant hypertension to poor outcomes, whether they're cardiovascular or renal. You know, I think at this stage that we can clearly say that what 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 , 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.
Seamus, 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 three, four years when we framed the pivotal program for lorundrostat. Clearly, there's a primary care portion of the audience that is key prescribers in fourth line. They would be part of a launch target, but cardiologists as well, and that's why 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 one or two things you'll be looking at in the first three to six months of your competitor's launch that may alter your go-to-market strategy?
Well, I don't know if I would say it will alter it. Certainly, it'll be informative, but we've got a view of the data package we have. Eric and his team have done a really nice job of identifying where the unmet need is, who the key prescribers are, where that beachhead indication is for fourth line, and what's important to them in prescribing. 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+ 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 three 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 trial and the fact that primary care is a big prescriber of hypertensive agents, do you expect the focus to be cardiologists, nephrologists and hope for trickle-down into primary care? Or do you expect to, I guess, include high-prescribing primary care physicians within that first set of physician targeting?
Yeah. I'll have Eric add some additional color here. I don't know that our view has changed. We're continuing to narrow in on those prescribers that control, you know, approximately 50% of that third and fourth line, predominantly fourth line. 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 mm 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, six to seven 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 six to seven-month period. We've had national account executives in front of payers going back to quarter one. We have our MSL team in place, going out building advocacy within those top tier and regional tier KOLs.
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 Astra 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 third 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+ 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 and 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.