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Date

Wednesday, May 6, 2026 at 4:30 p.m. ET

Call participants

  • Chief Executive Officer — Jon Congleton
  • Chief Financial Officer — Adam Levy
  • Chief Medical Officer — David Rodman
  • Chief Commercial Officer — Eric Warren

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Takeaways

  • NDA status -- The FDA accepted the New Drug Application (NDA) for lorundrostat as an add-on therapy for adult hypertension and set a PDUFA target date of December 22, 2026.
  • Clinical data package -- The NDA submission was supported by positive results from five clinical trials, including pivotal (Launch HTN, Advance HTN), an open-label extension (TRANSFORM HTN), and proof-of-concept studies (TARGET HTN, EXPLORE CKD), showing clinically meaningful blood pressure reductions and good tolerability.
  • Market focus -- Initial launch efforts will concentrate on patients with resistant hypertension who are uncontrolled on at least three antihypertensive medications.
  • Commercial preparation -- Pre-launch initiatives include market access planning, payer engagement, medical science liaison (MSL) team buildout, and expanded sales and marketing capabilities.
  • Cash position -- Cash, cash equivalents, and investments stood at $646.1 million as of March 31, 2026, compared to $656.6 million as of December 31, 2025; the company asserts this is sufficient to fund operations, clinical trials, and regulatory activities into 2028.
  • R&D expenses -- Research and development expenses for the quarter were $24.4 million, down from $37.9 million in the prior year, primarily due to a $15.5 million reduction in preclinical and clinical costs after the lorundrostat pivotal program ended in 2025, partially offset by $1.1 million higher clinical supply/manufacturing and regulatory costs, and $800 thousand in personnel-related increases.
  • G&A expenses -- General and administrative expenses rose to $21.0 million from $6.6 million, driven by $7.9 million higher professional fees, $6.1 million increased personnel-related expenses, and $400 thousand from other G&A expenses.
  • Other income -- Total other income (net) was $6.0 million versus $2.2 million, reflecting higher interest earned on investments from elevated average cash balances.
  • Net loss -- Reported net loss was $39.3 million, improving from $42.2 million a year ago, reflecting reduced R&D spend.
  • Payer and prescriber insights -- Market research confirms prescriber willingness to use lorundrostat in the fourth-line setting, payer readiness to provide access for high-risk resistant hypertension patients, and patient interest in novel agents with sustained effect.
  • Target audience segmentation -- Commercial targeting includes primary care physicians, cardiologists, and nephrologists managing patients in third- and fourth-line settings, with a focus on those handling resistant hypertension and comorbid conditions.
  • Differentiation data -- The company emphasized Launch HTN and Advance HTN trials as unique, and highlighted strong systolic blood pressure reduction (19 mmHg in Launch), as well as high representation of Black/African American patients (28%-50% depending on trial).
  • Business development -- Management continues strategic partnering discussions and may pursue additional value creation through clinical development and business development, regardless of go-it-alone or partner-backed commercial strategy.

Summary

Mineralys Therapeutics (MLYS +2.87%) advanced lorundrostat's regulatory timeline with FDA NDA acceptance and a set PDUFA decision date, while maintaining operational focus on a targeted resistant hypertension launch and deepening commercial readiness. Management disclosed that current finances support activities through 2028, underscoring sustainability ahead of potential commercialization. Key data from both pivotal and diverse population-based trials reinforce the product's clinical profile and support commercial and payer positioning.

  • Executives noted ongoing interaction with prescribing guideline committees, signifying strategic efforts to influence future hypertension treatment standards.
  • Commercial analogs considered include recent novel oral therapies (e.g., in migraine), with management pointing out the cardiovascular field's unmet need and pent-up prescribing demand for new antihypertensive classes.
  • The company is actively monitoring competitor launches for market dynamics and potential insights, but does not anticipate major go-to-market changes based on initial competitive activity.
  • Pricing strategies will be guided by precedents such as Farxiga and Jardiance WAC levels, with flexibility in contracting and patient support approaches as more information becomes available on the competitor’s launch tactics.
  • Partnering discussions are ongoing, with a preference for a global partner capable of maximizing lorundrostat’s potential in hypertension and related comorbidities, though management is prepared for a solo launch if needed.

Industry glossary

  • ASI (Aldosterone Synthase Inhibitor): A drug class targeting aldosterone production, specifically developed for patients with hypertension and certain cardiovascular or renal comorbidities.
  • PDUFA (Prescription Drug User Fee Act) date: The target date by which the FDA agrees to complete its review of a drug’s NDA or biologics license application.
  • MSL (Medical Science Liaison): Professionals focused on scientific engagement and education with key opinion leaders and prescribers to support pre- and post-launch activities.
  • WAC (Wholesale Acquisition Cost): The manufacturer’s list price to wholesalers or direct purchasers, used as a benchmark for pharmaceutical drug pricing.

Full Conference Call Transcript

Jon Congleton: Thank you, Dan. Good afternoon, everyone, and welcome to our first quarter 2026 financial results and corporate update conference call. I am joined today by Adam Levy, our Chief Financial Officer, David Rodman, our Chief Medical Officer, and Eric Warren, our Chief Commercial Officer. I will begin with an overview of the business, clinical programs, and recent milestones, followed by Adam to review our first quarter financial results before we open up the call for your questions. Our NDA acceptance in the first quarter has been the culmination of a massive effort by our team and our mission to provide more healthy days to patients with cardiovascular disease.

From an operational perspective, we are 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 22, 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 health care system, and lorundrostat as a differentiated novel therapy.

Uncontrolled and resistant hypertension continue to represent areas of unmet medical need, affecting over 20 million people in the United States and contributing significantly to cardiorenal complications. Aldosterone dysregulation often plays an important role in resistant hypertension where patients on three or more antihypertensive medications fail to achieve their blood pressure goal. The launch of 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 are 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.

Adam Levy: 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, cash equivalents, and investments of $646.1 million as of March 31, 2026, compared to $656.6 million as of December 31, 2025. We believe that our current cash, cash equivalents, and investments will be sufficient to fund our planned clinical trials and regulatory activities as well as support corporate operations into 2028. R&D expenses for the quarter ended March 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 2025. This decrease was partially offset by $1.1 million of increased clinical supply manufacturing and regulatory costs and $800 thousand of increased personnel-related expenses resulting from headcount growth and increased compensation. G&A expenses were $21.0 million for the quarter ended March 31, 2026, compared to $6.6 million for the quarter ended March 31, 2025. The increase in G&A expenses was primarily driven by $7.9 million of higher professional fees, $6.1 million of increased personnel-related expenses resulting from headcount growth and increased compensation, and $400 thousand from other general and administrative expenses.

Total other income, net, was $6.0 million for the quarter ended March 31, 2026, compared to $2.2 million for the quarter ended March 31, 2025. The increase reflects higher interest earned on investments in our money market funds and U.S. Treasuries due to higher average cash balances invested during the quarter. Net loss was $39.3 million for the quarter ended March 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?

Operator: Thank you. At this time, we will be conducting a question-and-answer session. 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.

Michael DiFiore: Hey, guys. Thanks so much for taking my question. Two for me. Number one, in the scenario where Mineralys Therapeutics, Inc. 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? And separately, as you near the day 120 safety update, it may have already passed, I am not sure. Can you comment on whether safety remains consistent with the past and whether there are updated plans to publish data from the OLE? Thank you.

Jon Congleton: Yes, Mike. Thanks for the questions. To the first one, in the event that we launched alone, we, from the beginning, have been focused on how we build value with lorundrostat and how we do that by extension for Mineralys Therapeutics, Inc. We have built this organization from the beginning thinking about our clinical development program with an eye towards how we generate the greatest value from a commercial standpoint launching, whether it is on our own, with a partner, or through someone else. And so I think it is fair to say we are going to continue to look at ways that we increase value for lorundrostat and Mineralys Therapeutics, Inc.

If you think about the development program to date, we have done that. Launch HTN, obviously, spoke to the real-world audience. Advance HTN stands out on its own because it is 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 resistant hypertension and nephropathy or CKD. So we have always had an eye towards meeting the physicians where they are, what they need with lorundrostat, and building the appropriate data around that.

So we will continue to look at opportunities to build value from a clinical development perspective, and we will continue to look at opportunities to expand the value of lorundrostat through business development. To your second question around the 120-day safety mark, we continue to be very confident in the safety profile of lorundrostat. The TRANSFORM HTN trial, our open-label extension, continues to collect that data. We think lorundrostat is well characterized from a durable effect and safety and tolerability profile perspective. And as we have noted in the past, we will be looking to get that long-term data published in due course.

Michael DiFiore: Great. Thanks so much.

Operator: Thanks, Mike. Our next question comes from Richard Law with Goldman Sachs. Your line is now live.

Richard Law: Hey, guys. Good afternoon. A couple of 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 are having? And, also, what is your confidence level on getting access to that 3L setting compared to fourth and fifth line settings? Is your 3L strategy based on broader use, or is it more on the smaller niche population? And then I have a follow-up.

Jon Congleton: Yeah, Rich, thanks for the questions. As we have 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 that is where significant need exists. I think that is where an ASI can add significant value. From a market standpoint, in a launch, we think the focus will be fourth line. It is our feeling that in that fourth-line resistant hypertension setting, 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 more?

Eric Warren: Yeah, hey, Richard. It is all about sequencing. The fourth line is 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 are going to try to position ourselves in a different way than baxdrostat.

Obviously, there is an opportunity for both ASIs, and having parity access is something that is a focus for us.

Richard Law: I see. Got it. And then a follow-up. We heard that AZ has been saying that baxdrostat can potentially achieve something like $10 billion peak if they can succeed in other indications beyond hypertension and CKD that they are developing. And I also remember, Jon, I think you mentioned that when you think about a partner, an ideal partner would be the one who would recognize lorundrostat’s potential. So when I hear that, I think you meant 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 partners are bullish on or not bullish on based on the unmet need and the drug's mechanism? Thanks.

Jon Congleton: Thanks, Rich. As we noted before and in the prepared remarks, 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 are cardiovascular or renal. I think at this stage we can clearly say that what lorundrostat has demonstrated in reducing blood pressure is a clear surrogate for what we could expect as far as a reduction in cardiovascular risk. So I am not surprised by AstraZeneca's bullish position on baxdrostat. I would say we have shared that view given the fact that, just in the United States alone, there are 20 million patients at risk.

We have talked in the past about having a partner that is more global in nature and has a holistic view of this asset. I do not think that view has changed. I cannot really opine on how some of those discussions have looked at different indications. But, clearly, we know that aldosterone is going to be a key target for the next several years into the 2030s as it relates to not only hypertension, but the related comorbidities.

Operator: Thanks, Rich. Our next question comes from Seamus Fernandez with Guggenheim Partners. Your line is now live.

Seamus Fernandez: So I guess I will address, or ask you to address, the elephant in the room, which is you guys have been talking about potential partnering for quite some time. You have had the data and now you have had the NDA firmly established in terms of the PDUFA date for some time. What is it that you are looking for at this point in a potential partner that perhaps you are seeking but has not quite matched up? Or should we anticipate that you are in active discussions along those lines? I think we are all just trying to metric what is the timing for either selection of a partner or a potential go-it-alone strategy in the U.S.

Thanks so much.

Jon Congleton: Yeah, Seamus, appreciate the question. And, as we have said in the past, we are interested in finding the right partner. In response to Rich’s question, I talked about the global nature of that. We are routinely evaluating those partnering opportunities. As you can imagine, and I think appreciate, we are not in a position to provide color or specifics around the level of dialogues, the timing, or the structure. But it is something that we are mindful of. We have, as noted, continued to focus on how we build value going forward, and that is why, operationally, we are focused on commercial readiness for this asset. I think it is an important part of those partnering dialogues.

But, clearly, looking for a partner to build on that value continues to be something we are focused on.

Seamus Fernandez: Great. Maybe if I can just ask one follow-up question. As you look at the opportunities to partner your asset with other mechanisms, specifically, what would you say are the core mechanisms that you are particularly excited about? We have a whole host of new cardiometabolic mechanisms that are advancing and potentially looking to emerge outside of hypertension. Which would you say would be particularly exciting from your perspective to partner with lorundrostat? Thanks.

Jon Congleton: Yes, Seamus, it is a great question. I think what is key as an opportunity for Mineralys Therapeutics, Inc. is we have the core foundational molecule, that being lorundrostat as an ASI. Given the nature of aldosterone to be a driver of not only hypertension, which is the beginning point of many other cardiorenal metabolic disorders, but also the role that aldosterone plays in CKD and heart failure and other disorders, it begins with the fact that we have the core foundational molecule. There are other mechanisms. Certainly, the SGLT2s are what our competitors are looking at.

I think the fact that dapagliflozin is generic at this point, given the data that we have generated to date within our pivotal studies and specifically EXPLORE CKD, gives us an entrée to put lorundrostat forward in a hypertensive nephropathy or CKD population. But there are other mechanisms that we are looking at from a cardiorenal standpoint. We are not in a position right now to opine on those. But I would come back to the fact that we have the core product that really addresses the key driver of pathology, and that is lorundrostat.

Operator: Thanks, guys. Appreciate it. Our next question comes from Jason Gerberry with Bank of America. Your line is now live.

Jason Gerberry: Hey, guys. Thanks for taking my question. As you are doing a lot of your prelaunch activities, how are you thinking about the physician segments that you think are going to be the most likely to drive early adoption, especially in that fourth-line setting where it sounds like maybe you will not be focusing on doctors that focus on comorbidities like CKD, but maybe more cardiology-driven hypertension? Can you discuss some of the learnings from the prelaunch activities and how you are thinking about the early adopter?

Jon Congleton: Yes, Jason, thanks for the question. I would say that we have been thinking about this going back three to four years when we framed the pivotal program for lorundrostat. Clearly, there is 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. That is why Advance HTN is such a critical, differentiating piece of our data story. These are the patients that a cardiologist is truly seeing. They are maximized with treatment. They have 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 dataset 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 kidney disease is to get their patients’ blood pressure to goal.

We have been thinking about the target population, the prescribers and the use cases they have, and that is why we built out a very distinct and diverse dataset that provides information about how to use and where to use lorundrostat, and the expected benefits they can see in blood pressure control and beyond, such as proteinuria.

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

Jon Congleton: I do not know if I would say it will alter it. Certainly, it will be informative. We have 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 is important to them in prescribing. We will obviously be looking at AstraZeneca's launch, and we anticipate it is going to be significant given the unmet need here and the lack of innovation in the last 20-plus years.

But given the data that we have generated, and specifically speaking to the different prescribers that your first question alluded to, we are very confident in our ability to tap into that, assuming approval and launch very quickly after that.

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

Annabel Samimy: Hi. Thanks for taking my question. I would love for you to talk about who you 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 a tremendous amount of data across the spectrum of patients as well as safety, CKD, and OSA. How important is it to have that wealth of data to drive those conversations, or do you think that it is the first to market that drives the conversations? Just want to understand the mechanics behind that.

Jon Congleton: Yeah, Annabel, thanks for the question. I think it is safe to say that we have been interacting with those physicians that are part of the guideline committees, appropriately sharing the information that we have. It is something we contemplated three years ago, and it is why we worked with the Cleveland Clinic and Steve 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 the study that addresses all of the questions guideline committees are going to have about whether it is apparent or truly confirmed resistant hypertension.

That dataset is going to be an instrumental component of the argument for inclusion in the guidelines. Launch HTN is an important part as well. It speaks to the primary care physicians. EXPLORE CKD and EXPLORE OSA, as you alluded to, provide additional data that is informative and speaks to the unique complexities of the resistant hypertension population. We are in front of the right physicians who are part of those guideline committees, and we have the right data and dataset with lorundrostat to make a compelling argument.

Annabel Samimy: If I could just follow on the physician segmentation that you are 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 and nephrologists and hope for trickle-down into primary care, or do you expect to include high-prescribing primary care physicians within that first set of physician targeting?

Jon Congleton: I do not know that our view has changed. We are continuing to narrow in on those prescribers that control approximately 50% of that third- and fourth-line, predominantly fourth-line, segment, and within that there are primary care as well as specialists. Eric, you can add some more to that.

Eric Warren: Well said, Jon. Cardiologists, nephrologists, but there are primary care physicians that function very well within this fourth-line state. They are actively prescribing. We have looked at the segmentation. We have looked at the deciling, and there will be primary care included in that initial go-to-market strategy.

Operator: Great. Thank you. Our next question comes from Mohit Bansal with Wells Fargo. Your line is now live.

Mohit Bansal: 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 your market research? What feedback are you getting from physicians that they see any differentiation between these molecules? Thank you.

Jon Congleton: Yeah, Mohit, thanks for the question. On the label, I think there will be a level of uniformity, certainly within the indication. But I will step back to a point that I have been making. There is a distinct difference between the datasets that we generated with lorundrostat and that of baxdrostat. Launch HTN speaks to the real-world audience, but, again, Advance HTN is a very distinct and differentiated dataset that provides information to cardiologists specifically who are dealing with very difficult, confirmed resistant hypertension patients. Then EXPLORE CKD. We know that proteinuria and having a benefit on proteinuria is a key attribute in physicians' minds when they think about an antihypertensive and how they view its utilization.

Certainly for nephrologists, having a benefit on proteinuria is 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 and what portions of those studies get into the actual label will be part of negotiations with the FDA. But having that data, whether within label for promotion or through medical information, is going to be very instructive and informative for those distinct prescriber populations.

Mohit Bansal: And the physician feedback, the second part?

Jon Congleton: The physician feedback has been very robust. Eric?

Eric Warren: Two things I will highlight, Mohit. Number one, the absolute systolic blood pressure reduction. That is really what shines from a physician perspective. That 19 mmHg that we demonstrated in Launch, but also the diversity and the well-represented trial populations. I will call out the Black/African American population at between 28% and over 50% of our patients depending upon the trial. Physicians really appreciate the inclusivity of our populations.

Mohit Bansal: Got it. Very helpful. Thank you.

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

Matthew Coleman Caufield: Hi, guys. Thanks for the updates today. You covered a couple of my questions, but I think overall the sense is that baxdrostat's possible approval mid-year helps overall ASI receptivity and awareness. 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?

Jon Congleton: I think there is significant opportunity within this space. As I noted previously, Matt, the lack of innovation speaks to the high interest from physicians to have a novel agent or novel class of agents. I do think there is an opportunity to see this market grow as AstraZeneca launches six to seven months in advance of potential approval for lorundrostat. I think it is important to highlight that we will have a voice in the market during that six to seven month period. We have had national account executives in front of payers going back to Q1. We have our MSL team in place, going out and building advocacy within those top-tier and regional-tier KOLs.

So I think it is really both companies out there progressively talking about the role of aldosterone, the importance of addressing it within the ASI class. That grows this market opportunity. Whether you look at it from a revenue projection that AZ guided to, or the 20 million patients that we target, this is a massive market opportunity. There is significant interest in the novelty of the class of drugs. So I think it is a net positive.

Matthew Coleman Caufield: Great. Thank you, guys. Appreciate it.

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

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

Jon Congleton: Yes, Rami, thanks for the questions. Relative to AZ, presuming approval, they will be setting the initial price point. I have been asked whether that is an anchor point. I think it is a guiding point. I have no idea where they are going to price it at this stage. Clearly, they are bullish on the revenue opportunity, but it will be informative for us. Going back to differentiation and the payer discussions, we are seeing that right now.

As we have dialogues with payers, the distinction of the dataset—whether it is Advance HTN, which I have commented on previously in a very distinct population that AstraZeneca cannot speak to, or the Black/African American population that Eric alluded to—we know that is a critical high-risk population. We believe we have the dataset that is very informative for payers from an access standpoint. The feedback we have gotten from payers to date is they are open and willing to create access in this fourth-line setting and potentially, in due course, third line. They are also interested in having two assets to evaluate.

So it is not as if, from our perspective, baxdrostat will launch and secure all access from a payer standpoint. On commercial analogs, it is a fair question and hard to answer because there has not been a lot of innovation within cardiovascular for quite some time. An interesting analog for me, although it is a GenMed category and not cardiovascular, is migraine with the gepants, the orals. When you come out with something truly novel from a clinical profile standpoint and match that to a market with significant unmet need, you can see significant commercial uptake. That is an informative analog we think about as we prepare the commercialization of lorundrostat.

Operator: Thanks. Our next question is from Analyst with TD Cowen. Your line is now live.

Analyst: Hi, thanks and good afternoon. A follow-up from Mohit’s question. It was helpful to hear about label differentiation. Can you tell us more about how you will react to baxdrostat pricing, especially when it comes to your pricing strategy? We know how important access is to physicians, but we are curious about the strategy you are thinking there. Could you launch with a lower WAC price? Should we assume rebates would be the primary mechanism to drive access, or something else? More thoughts there would be helpful. Thank you.

Jon Congleton: Yeah, thanks. I appreciate the question. I hope you appreciate that it is really early to opine too much on that. We will see where AstraZeneca comes in with pricing. We have guided in the past that thinking about Farxiga and Jardiance WAC, or list price, is probably a good barometer to work from. We will see where they go from a pricing standpoint and 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 it.

There are a lot of different levers we could pull, from contracting to what we do with our patient assistance program, but it is too early to give you the level of color your question would require.

Analyst: Okay, great. That makes sense. Maybe then I can ask a different question. As we are looking at this launch as a proxy to lorundrostat, can you talk about how you would think about the cadence of that launch? It is hard without recent hypertension proxies, but do you expect that there would be an initial bolus of patients within the hypertension population, or anything that could help us understand what a good first few quarters might look like?

Jon Congleton: Looking at 2024 IQVIA data that shows, in third line or later, there are about 8.8 million patients that are turning over and trying new medications, and that is in the absence of any innovation—that is with existing treatments that have been available for 20-plus years. As an old marketer, to me, that tells me there is a market with a great deal of dissatisfaction. Physicians have not given up. They continue to trial existing medications to help patients get to goal. There is significant pent-up demand and appreciation of the risk these patients are under if they do not get to goal. Fundamentally, that is a proxy.

How that translates to baxdrostat’s launch quarter over quarter, I cannot opine on that. I just know, looking at fairly recent data from 2024, there is a lot of movement within this marketplace, and that creates opportunities for novel agents like lorundrostat.

Operator: We have reached the end of the question-and-answer session. I would now like to turn the call over to Jon Congleton for closing comments.

Jon Congleton: Thank you. In closing, we remain encouraged by the FDA acceptance of our NDA based on a strong clinical data package that I have just spoken about through the question and answers. From an operational perspective, we are 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 Therapeutics, Inc. 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, and we look forward to providing further updates in the quarters ahead. With that, we will close the call. Have a nice day, everyone.

Operator: This concludes today's conference. You may disconnect your lines at this time. We thank you for your participation.