Mineralys Therapeutics, Inc. (NASDAQ:MLYS) Q4 2025 Earnings Call Transcript

Mineralys Therapeutics, Inc. (NASDAQ:MLYS) Q4 2025 Earnings Call Transcript March 12, 2026

Mineralys Therapeutics, Inc. beats earnings expectations. Reported EPS is $-0.4, expectations were $-0.51625.

Operator: 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.

Dan Ferry: 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.

Jon Congleton: 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.

Adam Levy: 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?

Q&A Session

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.

Michael DiFiore: 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.

Jon Congleton: 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.

Michael DiFiore: Thanks so much. Thanks, Mike.

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

Richard Law: 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.

Jon Congleton: 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.

David Rodman: 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.

Richard Law: 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.

Jon Congleton: 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.

Richard Law: Got it. Thank you. Thanks, Rich.

Operator: We will go next to Seamus Fernandez with Guggenheim Partners.

Seamus Fernandez: 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?

Jon Congleton: 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.

Seamus Fernandez: 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?

Jon Congleton: 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.

Operator: Moving next to Jason Gerberry with Bank of America.

Jason Gerberry: 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.

Jon Congleton: 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.

Eric Warren: 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.

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

Adam Levy: 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?

Jason Gerberry: Okay, thanks, John.

Jon Congleton: 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.

Operator: Moving on to Annabel Samimy with Stifel.

Annabel Samimy: 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.

Jon Congleton: 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.

Annabel Samimy: 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?

Jon Congleton: 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.

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

Mohit Bansal: 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.

Jon Congleton: 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.

Mohit Bansal: 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?

Jon Congleton: 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.

Operator: We will go next to Rami Katkhuda with LifeSci Capital.

Rami Katkhuda: 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?

David Rodman: 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.

Jon Congleton: 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.

Rami Katkhuda: 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?

Jon Congleton: 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.

Operator: And going next to Dennis Ding with Jefferies.

Dennis Ding: 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.

Jon Congleton: 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.

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

Jon Congleton: 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.

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