MLYS

Image source: The Motley Fool. Tuesday, Aug. 11, 2026 at 4:30 p.m. ET Chief Executive Officer - Jon Congleton Chief Financial Officer - Adam Scott Levy Chief Commercial Officer - Eric J. Warren Need a quote from a Motley Fool analyst? Email [email protected] Operator: Welcome to the Mineralys Therapeutics Second Quarter 26 Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Daniel Ferry of LifeSci Advisors. Please go ahead, sir. Thank you. I would like to welcome everyone joining us today for our second quarter 26 conference call. This afternoon, after the close of market trading, we issued a press release providing our second quarter 26 financial results and business updates. A replay of today's call will be available on the Investors section of our website approximately 1 hour after its completion. After our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. Actual results could 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, August 11, 2026. Except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements in light of new information, or future events. I would now like to turn the call over to Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. Jon Congleton: Thank you, Daniel. Good afternoon, everyone. Welcome to our second quarter 26 financial results and corporate update conference call. I am joined today by Adam Scott Levy, our Chief Financial Officer and Eric J. Warren, our chief commercial officer. I will begin with an overview of the business and recent milestones, Eric will then provide a commercial update, and Adam will review our second quarter financial results before we open the call for your questions. Before I get started with the business update, I would like to take a moment to welcome doctor Terry Ferguson to the team. Terry joins us as chief medical officer succeeding doctor David Rodman. Who will continue to play an important role as a full time strategic adviser to the company. Terry brings more than 35 years of experience in cardiovascular medicine, clinical development, and executive leadership. He served as cardiovascular therapeutic area head at Amgen and held senior cardiovascular leadership roles at AstraZeneca and The Medicines Company. He also spent more than 20 years on the faculty of the Texas Heart Institute and in cardiovascular medicine and proven track record of Terry's deep expertise in cardiovascular medicine and proven track record of advancing innovative therapies positions him well to lead our medical and late stage clinical activities as we continue preparing for the potential commercialization of lorundrostat. I am going to thank David for his dedication and hard work over the past several years. During his time as chief medical officer, he guided the development of lorundrostat from proof of concept through the pivotal program and our recent new drug application filing with the FDA. In the second quarter, our focus was on commercial launch readiness. The evaluation of partnering opportunities and the next steps in the clinical development of lorundrostat. In the third quarter, we continue to build our commercial infrastructure as we approach our December 22 PDUFA date. Turning to our clinical progress, our Transform HTN open label extension trial continues to generate valuable long term safety and efficacy data that further supports lorundrostat's potential best-in-class profile. In May, we presented a post hoc analysis from our pivotal LAUNCH-HTN trial at the European Society of Hypertension Annual Meeting. The analysis focused on participants with chronic kidney disease, a high risk and difficult to treat patient population. Despite entering the trial with more severe hypertension and greater use of background antihypertensive therapies, these participants experienced statistically and clinically meaningful blood pressure reductions, comparable to those observed in the broader trial population. In addition, participants with baseline albuminuria, achieved a 52% placebo adjusted reduction in urine albumin to creatinine ratio. An important marker of kidney injury and disease progression. Just a few weeks later, at the Endocrine Society's annual meeting, ENDO 26, we presented late breaking proteomic data from all launch HTN and advanced HTN trials demonstrating that lorundrostat was associated with significant reductions in multiple biomarkers of heart failure risk. While exploratory in nature, these coordinated biomarker changes provide additional biological evidence that lorundrostat use may favorably modulate disease pathways implicated in heart failure. We believe these findings further strengthen our understanding of the broader biological implications of aldosterone, and the potential for lorundrostat to provide benefit in hypertension and related comorbidities. We continue to evaluate further clinical development for lorundrostat, and we will keep you informed on our progress as appropriate. We also completed several corporate actions that enabled our long term value creation objectives. During the quarter, we announced an agreement to repurchase the potential future royalty payments due to Mitsubishi Tanabe Pharma Corporation related to lorundrostat. Under the terms of the agreement, Mineralys agreed to pay Mitsubishi Tanabe $200 million upfront and up to $100 million once certain commercial milestones are met. Our aggregate potential future milestone payments to Mitsubishi Tanabe are now up to $205 million We believe this represented a unique strategic opportunity to enhance the long term value of lorundrostat as we approach commercialization. Concurrently, we completed a $150 million equity offering and entered into a $500 million committed senior secured term loan facility with funds managed by Pharmakon Advisors. Beyond funding the royalty repurchase, this facility provides Mineralys with access to additional capital, and financial flexibility while positioning Mineralys to capture the long term value of lorundrostat. As we look ahead to the remainder of the year, we believe lorundrostat is entering an exciting new phase in its evolution. We have continued to build the clinical evidence supporting lorundestat, enhanced the long term value of the asset, expanded our access to capital, and continue to make meaningful progress preparing for a potential commercial launch. In parallel, we continue to evaluate partnering opportunities and engage in strategic discussions to enhance value and enable us to reach more patients who could benefit from lorundrostat. With that, I will turn the call over to Eric to provide a commercial update. Eric J. Warren: Great. Thank you, John. Approximately 20 million adults in The United States have uncontrolled or resistant hypertension. And despite the availability of numerous antihypertensive therapies, these patients remain unable to achieve their blood pressure goal. These patients face significant increased cardiovascular and cardiorenal risk highlighting the need for new treatment options that address underlying drivers of disease. Our extensive market research continues to reinforce the value proposition lorundrostat could offer if approved. Physicians consistently tell us they are seeking new therapies that deliver meaningful and durable blood pressure reductions demonstrate a favorable tolerability profile, and fit naturally within existing treatment algorithms. We believe lorundrostat's clinical profile aligns well with these expectations and differentiates the compound from both currently available and emerging therapies. Now over the past several quarters, we have systematically executed against the key elements of our commercial launch plan. As a result, many of the foundational components of our commercial infrastructure are now in place, and our efforts are increasingly focused on final launch readiness and execution. First, we have established strong relationships with leading hypertension specialists and key opinion leaders who we believe will play an important role in shaping clinical practice following a potential approval. Second, we have made significant progress in our initial payer engagement activities, The payers we have engaged with to date collectively account for the vast majority of covered lives in The United States. Our discussions have centered on clinical and economic burden associated with uncontrolled hypertension, and the value proposition supported by lorundrostat's clinical data package. These conversations continue to reinforce our belief that payers recognize the unmet need in this patient population. Third, we are well underway in the development of a differentiated launch campaign that is designed to educate both health care providers and patients. We have done extensive research to understand the optimal messaging resources, and communication platforms that will drive rapid adoption. Lastly, we are in the final stages of building the field organization that will support our launch. Our experienced sales leadership team is now in place bringing a track record of successfully launching and commercializing cardiovascular therapies We have also completed detailed geographic mapping to identify the regions with the highest concentrations of physician treating patients with uncontrolled or resistant hypertension, allowing us to optimize field deployment. And perhaps most importantly, expect our sales organization to be staffed in advance of our December PDUFA target date. Positioning us to execute swiftly and decisively following a potential approval. We have built our commercial organization around clear objectives which are to ensure physicians have the educational resources, and support needed to identify appropriate patients, and if approved, make lorundrostat available to those patients as efficiently as possible. We continue to be encouraged by the feedback we are receiving from physicians payers, and thought leaders and believe Mineralys is well positioned to execute a successful commercial launch. I will now turn it over to Adam to review our second quarter financial results. Adam Scott Levy: You, Eric. Good afternoon, everyone. Today, I will discuss select portions of our second quarter 26 financial results. Additional details can be found in our Form 10 Q which will be filed with the SEC today. We ended the quarter with cash, cash equivalents, and investments of $661.4 million as of 06/30/2026 compared to $656.6 million as of 12/31/2025. We believe that our current cash, cash equivalents, and investments will be sufficient to fund our planned operations including the commercial launch of lorundrostat, into 2028. R&D expenses for the quarter ended 06/30/2026 were $221.4 million compared to $38.3 million for the quarter ended 06/30/2025. The increase in R&D expenses was primarily due to the $200 million upfront payment to Mitsubishi Tanabe in June 2026, in connection with the license agreement amendment. The increase was also due to $600 thousand of increased personnel related expenses resulting from headcount growth and increased compensation and $200 thousand of increased clinical supply manufacturing, regulatory, and other costs. These increases were partially offset by $17.8 million of lower preclinical and clinical costs, primarily due to the conclusion of the lorundrostat pivotal program in the second quarter of 25. G&A expenses were $24.7 million for the quarter ended 06/30/2026, compared to $8.5 million for the quarter ended 06/30/2025. The increase in G&A expenses was primarily due to $8 million in higher professional fees, $8 million in increased personnel related expenses resulting from headcount growth, and increased compensation and $200 thousand of increased other administrative expenses. Total other income net was $5 million for the quarter ended 06/30/2026 compared to $3.5 million for the quarter ended 06/30/2025. The increase was primarily due to $2.3 million of increased interest earned on investments as a result of higher average cash balances partially offset by $800 thousand of interest and amortization expenses related to the senior secured term loan entered into in June 2026. Net loss was $241.1 million for the quarter ended 06/30/2026, compared to $43.3 million for the quarter ended 06/30/2025, The increase was primarily due 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. We will now be conducting a question and answer session. Up your handset before pressing the star key. The first question is from Richard Law from Goldman Sachs. Please go ahead. Richard Law: Congrats on all the progress as we approach PDUFA. And I also want to extend our welcome to Terry. And look forward to working with him. So a couple of questions for me. I see that you guys have a lot of postings on the territorial manager positions. How are you finding the quality of candidates after Baxdela's spending launch, which I assume will be competing for talent there as well? And, also, are there any key attributes that you guys are looking for regarding, like, hypertension experience or certain or on certain drugs? And also, when are you guys going to start hiring for the rest of the sales reps given the launch is nearing and in 4 months? Jon Congleton: Richard Rich, this is John for the question. I have to admit it was a little bit garbled, so I am gonna paraphrase your question back and tell me if I got it on point. I think your question is about the field salesforce the phenotype we are looking for, and our likelihood of having those in position ahead of the PDUFA? Is that the paraphrase of your question? Richard Law: Yeah. Exactly. Yeah. Exactly. So, basically, how are you guys finding the quality of candidates? Given that Baxdela's launch already been happening? So I assume there is competition for talent there. So what you guys are looking for in terms of experience? And, also, like, when are you guys going to hire the rest of the Salesforce given that the launch is 4 months away? Jon Congleton: Yeah. I think as Eric alluded to, our goal is to have the team in position ahead of the PDUFA date. I will tell you, I am really excited about the quality of not only the sales representatives, territory managers that we are seeing, but also of the first line sales managers. I think Mineralys represents a kind of exciting opportunity that attracts high level talent. That are energized by the kind of innovation that lorundrostat represents and the impact that it could have on millions of patients. So I think that and of itself, becomes a very exciting offering that attracts high level talent. I will tell you there is not 1 phenotype that we are looking for. I know there is certainly a lot of cardiovascular experience reps that are out there. But we are also looking for those kind of individuals that we believe align to our values, the purpose that we have, and are energized by the opportunity. So I am very comfortable with the quality of candidate, and our ability to hit that target of having the full team in position ahead of the PDUFA. Fantastic. And then just to follow-up on that, and how are you seeing the payers in terms of, are they waiting for lorundrostat's approval before deciding on how to manage both ASI products? And is there anything that you guys are seeing that Baxdela is doing well or not doing well with payers or other commercial aspects that you can do differently or better? Thank you. I will give you a quick thought, then I will turn it over to Eric. I think the feedback we are getting from our national account team that was in place in Q1 of this year continues to be very bullish on access for this kind of innovation, particularly the third and fourth line position. But Eric can give you maybe some more specifics behind that. Eric J. Warren: Yeah, thanks. Thanks, John. Richard, so from a payer perspective, payers, it is still early for baxdrostat, obviously. But I think it is encouraging to see that there is recognition of the innovation that the ASI class brings. We have not seen a lot of payer decisions yet, but we are firmly in a position to believe that both of these agents will be in an equivalent position that will give HCPs the ability to choose and that is where our differentiated profile comes into play. Richard Law: Great. Thank you. Jon Congleton: Thanks, Richard. Operator: Next question is from Michael DiFiore from Evercore ISI. Please go ahead. Michael DiFiore: Hey, guys. Thanks so much for taking my question. 2 for me. You said in the past that label and post marketing conversation typically start a couple of months out prior to PDUFA. Has that process begun, and has anything in the at least your initial conversation changed in terms of what you expect to negotiate in the label? My second question is on pricing. When do you actually plan to lock in that decision, and would you communicate that ahead of the launch or at the launch? Thank you. Jon Congleton: Yes. Thanks, Mike. The label and post-approval commitments, that typically occurs a couple of months ahead of the PDUFA, so I would expect sometime in the October, November time frame. I would say I would characterize the current dialogues with the agency. No surprises from us. I think the data package that we put together was robust. From the pivotal studies launch HTN, Advanced-HTN, including explore CKD in the open label extension. So we feel very confident with the package that we have, and I think the dialogues to date have been regular course. From a pricing standpoint, obviously, we have seen the price of baxdrostat. We are continuing to do, our analysis. We were not overly surprised by the price point they came out with. it is in that nonspecialty tier pricing area. But I would not anticipate us sharing the price until approval and subsequently probably around launch. Thank you. Operator: The next question is from Jason Gerberry from Bank of America. Please go ahead. Jason Gerberry: Hey, guys. Thanks for taking my questions. Couple from me. Just, you know, in terms of the early AstraZeneca launch, any learnings as you interrogate the data so far in terms of perhaps good, bad, or just too early to formulate any conclusions? And then as a follow-up to the point you raised about, confidence around parity payer access. I am not sure you can say much, but directionally, I am just curious, like, your I guess, sort of the gross to net deductions in order to achieve parity access Is that coming in perhaps in line, better, worse than maybe you would have expected, say, you know, 6 to 12 months ago? Thanks. Jon Congleton: Yeah. Jason, I will take the first part and have Eric address your question about payer access. I think your point you made, it is still early days. To gauge, from the numbers that, you know, you see the same things we do publicly on the baxdrostat launch. I will tell you anecdotally, I think there is enthusiasm and excitement for this new class of therapy. it is been over 20 years since there is been a meaningful introduction of an antihypertensive therapy. We know there are, you know, significant patients, 20 million, on 2 or more meds that cannot get to goal right now. We know the implications of that. And so I think the enthusiasm that we are seeing anecdotally in the marketplace for this class of drugs, speaks for the opportunity that I know we are excited about, that we see. But as to the payer dialogues, I will let you comment. Eric J. Warren: So payer dialogues have been very, very positive. I would say the level of rebate that we are hearing that is coming from Baxdela is very consistent. With what we expected and that is obviously on the commercial side. From the Medicare side, so far, it looks like access is via medical exception. Which then allows us to go to label. So far, again, without giving any kind of precise indicators of what we are doing, generally, as we would expect, Jason. Jason Gerberry: Okay. Thank you. Jon Congleton: Thanks, Jason. Operator: The next question is from Seamus Fernandez from Guggenheim Securities. Please go ahead. Evan Wang: Hi, guys. This is Evan Wang on for Seamus Fernandez. Just 2 for me. Just I guess, first off, you know, as you are speaking with KOLs, I have been doing outreach. what is really resonating with KOLs about the profile here? And then second, for congrats, Terry, on joining. I am just curious, you know, I know it is extremely early. But curious what the priority list will be as he gets settled. Thanks. Jon Congleton: Yeah. The question, and again, I apologize. The audio is not the best. I think your question was the profile they get most excited about with the lorundrostat. And I think it is pretty clear it is aligned to the attributes that matter to physicians when treating their patients That is the blood pressure reduction, which we know is extremely meaningful and we think best in class with lorundrostat combined with safety and tolerability. So in other words, the patients need to be able to not only get the blood pressure reduction, but to get it in a way that is safe and can be adhered to over a long period of time. So, you know, we continue to believe that profile that we have seen from our clinical program reinforces, a profile that meets the needs of physicians as they are treating these patients third line and later. As to Terry, yeah, we are very excited. I mean, I am actually thrilled to be able to expand the expertise that we are able to apply to Mineralys and lorundrostat by retaining David in his strategic advisory full time role to really help continue to investigate translational opportunities for lorundrostat. We know aldosterone plays a significant role beyond just hypertension but across cardiorenal metabolic disorders. But having Terry come in with his expertise in ladder stage development and very specifically medical affairs I think, does nothing but just augment and build on the success we have had to date. We have got our medical affairs team in place right now. Adding Terry's expertise over 35 years of either clinical work or industry work. I just think really amplifies the message, the resonance, the relationships he has with KOLs, I think it is going to be a significant build for us as we continue to prepare for successful commercial launch. And, Jon, I just wanted to add 1 thing. Eric J. Warren: So in addition to the efficacy and the safety, the advanced data are really resonating well with the KOL audience. So having a unique dataset, really does differentiate us in their minds. Great. Evan Wang: Thanks. And maybe 1 follow-up. Just curious in terms of anything you can provide in terms of the number of reps you guys are targeting out of the gate. Especially as you are kind of thinking about your efforts here. Thanks. Jon Congleton: Yeah. Our focus is really on those prescribers that are going to control a significant volume of third line or later prescribing. We have talked about in the past. that is, you know, plus or minus 50 thousand physicians. So we will we will ensure that we have a very, strong share of voice within those predominant prescribers of the latter lines of treatment. We have not guided to a specific number, We may in due course, but at this point in time, we just want to hold some of those cards a bit closer to our vest. Thank you. Yeah. Operator: The next question is from Annabel Samimy from Stifel. Please go ahead. Kyle: Hi. This is Kyle speaking for Anabel. Maybe 2 questions on a label. Exactly what are you guys looking for in terms of a differentiated label or in comparison against Baxdela? And then based on I know you mentioned discussions early, but based on your current interactions, what do you think is required for an related language specifically calling out resistant hypertension or CKD. And then do you think having a dedicated randomized controlled trial like ADVANCE or EXPLORE-CKD could be the needle-mover? Thanks. Jon Congleton: Yeah. Kyle, thanks for the question. From a label standpoint, I think there will be a few similarities. I think the indication will look fairly similar and that is for inadequately controlled. Blood pressure on top of background meds. I think we will get the similar treatment as far as the outcomes claim related to that blood pressure reduction that is become standard based on FDA guidance. I think where there is gonna be opportunity for differentiation in all of this, obviously, is dependent upon dialogues with the agency. But is the representation not just of launch which is the largest hypertension trial conducted with an ASI, but also Advanced-HTN, which, as Eric said, is very unique and distinct from frankly, a lot of studies done in the hypertension given the nature of that trial where we were confirming uncontrolled and resistant hypertension based on moving subjects to an approved background treatment and only randomizing after they could not get control even on an optimized treatment. So I think advanced HTN certainly will be a part of our discussions, with the agency as an important dataset to include in the label. On top of launch HTN. And then I believe data from explore CKD is also informative to physicians who are prescribing an ASI and a subject who may have lower kidney function based on eGFR. We know the label for baxdrostat speaks to eGFR. I believe, down to 45. And EXPLORER CKD went down to 30. And so we will be making a point to the agency that it is important physicians have guidance from the label that would reflect that. We know collectively if you look at the efficacy data, even just from LAUNCH-HTN, are clear differentiators based on the absolute and placebo adjusted reductions in systolic BP. As well as milder cases of electrolyte changes. Specifically hyperkalemia. So we believe that the dataset that we have generated to date creates good evidence for differential points within the label, but obviously, those will all be part of discussions with the FDA. Kyle: Okay. Thank you. Jon Congleton: Thanks, Kyle. Operator: The next question is from Mohit Bansal from Wells Fargo. Please go ahead. Mohit Bansal: Great. Thank you very much for taking my question. Before I start, thank you very much, David, for all your help over the years. And congrats, Terry, on the new role. Looking forward to work with you. I have a couple of questions here. So number 1, assuming that you get similar label to Baxdela, is there anything in the clinical data or the trials like ADVANCE-HTN or the differentiated trial or the differentiated trial that you could use to appeal to certain specialties, or you could do you probably be seen more similar than different from that aspect. And the second 1 is AstraZeneca is running this primary aldosterone trial. And that could read out for baxdrostat next year. So how do you see like, that trial in case it is positive? Impacting the class or the specific molecule? Like, how do you see the result of that trial? Impacting the positioning there? Thank you. Jon Congleton: Yeah. Mohit, thanks for the questions. To your first question, I do think there are some distinct points within the label that can create differentiation. I think overall the aldosterone synthase inhibitors are going to be a transformative new introduction of the treatment of hypertension. We are seeing really pronounced and clinically meaningful reductions in similar patient types, you know, those on 2 or more background meds that are failing to get to goal, But within those similarities, and then really the 2 key areas that are fundamental to a prescriber blood pressure reduction and safety signals, specifically hyperkalemia, I think they each have favorable views relative to lorundrostat. And we have seen the market research we have done where we put up the results of Baxdela's HTN relative to launch HTN. there is about a 2-to-1 preference for the profile that emerged with lorundrostat relative to baxdrostat based on those 2 fairly similar trials. And so, again, presuming that data from launch HTN is in the label, which we anticipate, I think that gives us, from a promotional standpoint and an education standpoint, an opportunity to really show the benefit of using the most selective ASI with what we think is an ideal half-life of 10 to 12 hours. So I believe that is how it is going to translate. From a primary aldosterone perspective with the PA study, I think there is a lot of interesting movement as far as how PA was originally characterized to being a secondary form of hypertension to where dysregulated aldosterone is really more of a spectrum. And so I think the data we generated to date will resonate with physicians that are looking to address dysregulated aldosterone, whether it is classified as typical PA or dysregulated or elevated aldosterone. So it will be interesting to see that data. But I know that physicians that are treating patients who have aldosterone as a driver of their uncontrolled or resistant hypertension are certainly excited about the lorundrostat profile. Awesome. Thank you. Thanks, Mohit. Operator: The next question is from Rami Kasuda from LifeSci Capital. Please go ahead. Rami Katkhuda: Hi, guys. Thanks for taking my questions. I guess, given the December PDUFA how should we be thinking about the cadence of payer coverage through 2027? And is there a risk that missing the initial Medicare Part D formulary cycle could make next year more of an access-building year? And then secondly, when do you expect the next major hypertension guideline updates to be? And how important could, formal inclusion of ASIs be for the class? Jon Congleton: I will take the second question, Rami, on the guidelines and Eric can comment on the first 1 as far as the cadence of coverage. We have been identifying and working with the committee members, making sure that they have the in information that is required as they contemplate guideline inclusion. I think probably 5 years ago, there was a more rigorous cadence of every 4 or 5 years and updated the guidelines. What we have heard from those committee members is they are gonna try to be more reactive to new information like the ASIs And so I would anticipate sometime in 2027 an update of those guidelines that would reflect where the ASI should fit within that. I think that is where we made some really discrete and important choices from the clinical development of lorundrostat. Not only LAUNCH-HTN providing real-world kind of case studies, but also advanced HTN for those specialists that are optimally treating patients and are yet still failing to help them get to goal. Advanced HTN that we did with the Cleveland Clinic specifically designed and executed with the guidelines in mind. So I think we have got a very strong case for lorundrostat. That may be a benefit that extends to the class. But I think, fundamentally, the ASIs given the clinically meaningful reduction that we are seeing, will have a really clear place within the guidelines for patients, certainly at latter line of treatment. But Eric can talk about cadence of coverage. Eric J. Warren: Yeah. Yeah. And you have characterized it well. So a progressive increase in coverage over the course of 2027. With that commercial outpacing Medicare But it is important to note, as I said before, that Medicare relies upon medical exception, which has a very favorable approval rate. it is important to note, and I did not say this before, but we will also have a field reimbursement manager team to support prior authorizations and we are making a good emphasis and focus on prior on patient support. To ensure that patients get on therapy quickly. there is tools to help navigate the process. So progressive increase is the core message commercial first. Medicare coming along, but Medicare exceptions are pretty straightforward. Rami Katkhuda: Got it. Thank you. Jon Congleton: Thanks, Rami. Operator: The next question is from Tara Bancroft from TD Cowen. Please go ahead. Tara Bancroft: Hi, good afternoon. So I want to follow-up on 1 of the first questions that was asked. So I am curious in what ways you think you could improve access and adoption as second to market relative to Baxdela, especially as it comes to pricing? So is it possible maybe to price at a discount and take more share that way? I know you have previously communicated the SGLT 2 class as good pricing comps, the street to anchor to, but maybe should we anchor more so to AZ now? Thanks so much. Jon Congleton: Yeah. Let me give some high level thoughts and Eric can follow-up. I think the you know, I have been I have been asked before, does baxdrostat pricing create an anchor? And I do not know if it is an anchor. I think it is informative. I think the key element was in the rationale that we, looking from the outside in, saw with Baxdela's that pricing was non-specialty tier, which we think was critical to ensure access to patients. And so, you know, we will continue to evaluate that. We are gonna continue to do our analysis of it. And maybe Eric can speak to some of that work we are gonna continue to do. Eric J. Warren: Yeah. I mean and, again, I will just reinforce that Baxdela's price is very consistent with the research that we conducted with payers as well as ad boards that we convened From a pricing perspective, we have got a pretty good sense of where we will price, but we are still in the final stages of finalizing that. Again, a core tenet is to maximize ultimate value, not create a kind of downward pricing spiral. So I will not get into too much more than that, but just wanna reinforce that Again, pricing of Baxdela is very consistent with our expectations. And we are finalizing our strategy. But we definitely need to make sure that we are preserving value. Tara Bancroft: Okay. Thank you so much. Jon Congleton: Thanks, Tara. Operator: The next question is from Matthew Caulfield from H. C. Wainwright. Please go ahead. Matthew Caufield: Hi. Hey, guys. 1 question that we have not really covered is looking back to explore CKD. What could be the next important catalysts or possible time frames for further lorundrostat evaluation CKD patients? Is that something on the radar at this stage, kind of above and beyond the PDUFA and launch focus? Thanks. Jon Congleton: Yeah. Matthew, thank you for the question. You know, this is why I am excited to have both Terry and David here. David obviously has 5.5 years experience with lorundrostat, and we are gonna be able to augment that with Terry's cardiovascular experience and medical affairs experience as well as clinical development. We know that at this stage, lorundrostat has a really robust and meaningful reduction in systolic BP and blood pressure. But we also think, and we have talked about this in the past, there are multiple mechanisms that aldosterone can drive Specifically, things like, inflammation, fibrosis, and oxidative stress that I think we have already seen what that translates to. I referred to it in my prepared remarks that in LaunchHTN, we saw a 52% reduction in placebo adjusted UACR, which is a clear marker of kidney protection. We have seen further, within the ENDO presentation benefits from a proteomic standpoint on markers of heart failure. So not only do we have the opportunity to address really the genesis of all of these cardiorenal metabolic syndromes, and that is blood pressure But I think there is an opportunity to really show value beyond just blood pressure reduction, and that is around elements like heart failure, chronic kidney disease, and related conditions. So that is part of what we are continuing to analyze at this point. that is where David and some of his translational science team are really digging into what makes sense for the next clinical development of lorundrostat. I think we have validated the best in class profile as it relates to blood pressure reduction. We know where AstraZeneca and Boehringer Engelheim are going with their ASIS SGLT2 combos. I think there are other interesting opportunities that we could pursue and other indications that we are contemplating. And once we have aligned on those final plans, as appropriate, we will communicate that to the market. Great. Thank you. Very exciting. And looking forward to December. Thanks again. Thanks, Matthew. You bet. Operator: The next question is from Dennis Ding from Jefferies. Please go ahead. Dennis Ding: Hey, Thanks for taking my questions. I have 1 and then 1 follow-up. So, John, you have always alluded to and emphasized that you guys are looking for a global part partner. So can you go through exactly what you are looking for in a partner, at least on the US side? And how important is for a partner to have a presence in nephrology specifically? And, you know, the reason I bring that up is, and this is my follow-up is you have talked about leveraging your CKD data to get earlier line use in the third line. Feel like that could be an area where it can get used more than AstraZeneca. So I am wondering how much overlap with CKD is there in the cardio setting where you can perhaps go after that population with the cardio Salesforce. Maybe it is a priority for you to go into nephrology in a dedicated way either on your own or through a partner? Thanks so much. Jon Congleton: Yeah. Thanks, Dennis. You know, we have stated before, and I think you have kind of alluded to it, goal from a partnering standpoint has tended to be more of a global nature You know, we have stated pretty clearly that, the commercialization of lorundrostat outside of the United States would be through a partner But ideally, we would find a global partner that not only has the commercial interest but also the development interest. As I alluded to in my response to Matthew, I think aldosterone is kind of becoming 1 of those foundational nodes that are going to be really critical to address cardiorenal metabolic disorders. You know, the CKD data that we have is very compelling, very compelling. I do think it does create an opportunity to move earlier in lines of treatment because we know there is just huge overlap of these conditions. And it is not just hypertension and CKD, but it is hypertension, CKD, it is cardiovascular risk. Either in the form of heart failure, just overall cardiovascular risk. So I do not know that there is a specific type or therapeutic area of focus for a partner. I think it is more an understanding of the opportunity that we have near term, with lorundrostat to address uncontrolled and resistant hypertension, but then more broadly, the role that aldosterone plays in cardiorenal metabolic as a frankly, a critical node that needs to be addressed and looking at development opportunities to tap into its full potential. Operator: This concludes the question-and-answer session. I would like to turn the conference back over to John Congleton for closing remarks. Thank you, operator. Jon Congleton: We believe Mineralys is entering an exciting and important period. With our NDA under FDA review, we remain focused on execution as we work towards that December PDUFA target date. I want to thank everybody for joining us today. We look forward to keeping you updated on our progress and we wish everyone a great evening. Thank you. Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. Before you buy stock in Mineralys Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Mineralys Therapeutics wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $409,970!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,381,040!* That performance is why people listen. With a track record of beating the S&P 500 by nearly 5x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 18, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool recommends Mineralys Therapeutics. The Motley Fool has a disclosure policy. Mineralys (MLYS) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Cash Position: Cash, cash equivalents, and investments totaled $661.4 million as of June 30, 2026, compared to $656.6 million as of December 31, 2025. R&D Expenses: $221.4 million for Q2 2026, up from $38.3 million in Q2 2025, primarily due to the $200 million upfront payment to Tanabe Pharma. G&A Expenses: $24.7 million for Q2 2026, up from $8.5 million in Q2 2025, driven by higher professional fees and personnel costs. Net Loss: $241.1 million for Q2 2026, compared to $43.3 million in Q2 2025. Other Income (Net): $5.0 million for Q2 2026, up from $3.5 million in Q2 2025, due to higher interest earned on investments. Warning! GuruFocus has detected 2 Warning Sign with MLYS. Is MLYS fairly valued? Test your thesis with our free DCF calculator. Release Date: August 11, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Mineralys Therapeutics Inc (NASDAQ:MLYS) reported positive clinical data, including a 52% placebo-adjusted reduction in urine albumin-to-creatinine ratio in CKD patients and significant reductions in heart failure biomarkers, supporting lorundrostat's potential in related comorbidities. The company strengthened its financial position with a $150 million equity offering and a $500 million committed senior secured term loan facility, providing capital to fund operations and the commercial launch into 2028. Mineralys Therapeutics Inc (NASDAQ:MLYS) repurchased future royalty payments due to Tanabe Pharma for $200 million upfront and up to $100 million in milestones, enhancing long-term value of lorundrostat. Commercial launch readiness is progressing well, with payer engagement covering the vast majority of US covered lives and a sales force expected to be staffed ahead of the December PDUFA date. The company's clinical profile, including data from the Advance-HTN trial, is resonating with KOLs and physicians, with market research showing a 2-to-1 preference for lorundrostat's profile over baxdrostat. Mineralys Therapeutics Inc (NASDAQ:MLYS) reported a significant net loss of $241.1 million for Q2 2026, driven by the $200 million upfront payment to Tanabe and increased R&D and G&A expenses. The company faces competition from AstraZeneca's baxdrostat, which has already launched, and there is uncertainty regarding payer coverage and pricing strategies in a competitive market. Label and post-marketing discussions with the FDA have not yet begun, with expectations for October/November, creating uncertainty about final label language and potential differentiation. The company has not yet locked in pricing for lorundrostat, and there is a risk of a downward pricing spiral if not managed carefully, as noted by the Chief Commercial Officer. Medicare Part D formulary cycle timing may result in a progressive increase in coverage through 2027, with commercial outpacing Medicare, potentially limiting early adoption in the Medicare population. Q: What is the company's current financial position and how long will it fund operations? A: Adam Levy, CFO, reported cash, cash equivalents, and investments of $661.4 million as of June 30, 2026. He stated that the company believes this is sufficient to fund planned operations, including the commercial launch of lorundrostat, into 2028. Q: What is the status of the FDA label and post-marketing discussions, and when will pricing be locked in? A: Jon Congleton, CEO, stated that label and post-approval commitment discussions typically occur a couple of months ahead of the PDUFA date, expecting them in the October-November timeframe. He noted that current dialogues with the agency have been "regular course" with no surprises. Regarding pricing, he said the company would not anticipate sharing the price until approval and subsequently around launch. Q: How is the company preparing its commercial infrastructure, and what is the status of hiring the sales force ahead of the PDUFA date? A: Jon Congleton, CEO, confirmed the goal is to have the full team in position ahead of the PDUFA date. He expressed excitement about the quality of candidates, noting that the company is not looking for one specific phenotype but is seeking individuals who align with the company's values and are energized by the opportunity. Eric Warren, CCO, added that the sales leadership team is in place and detailed geographic mapping has been completed to optimize field deployment. Q: What are the key differentiators for lorundrostat's profile that resonate with physicians and KOLs? A: Jon Congleton, CEO, highlighted that the profile aligns with what matters to physicians: meaningful and durable blood pressure reduction combined with safety and tolerability. Eric Warren, CCO, added that the unique Advance-HTN data set is resonating well with KOLs and differentiates the compound in their minds. Q: What is the company's strategy regarding payer access and coverage cadence through 2027? A: Eric Warren, CCO, stated that payer dialogues have been very positive and the level of rebates from baxdrostat is consistent with expectations. He outlined a progressive increase in coverage over 2027, with commercial outpacing Medicare. He noted that Medicare relies on medical exception, which has a favorable approval rate, and the company will stand up a field reimbursement manager team to support prior authorizations. Q: How does the company view the potential for label differentiation, particularly regarding CKD and the Explore-CKD data? A: Jon Congleton, CEO, stated that while the indication will likely look similar, there are opportunities for differentiation. He highlighted that Advance-HTN will be an important data set for label discussions, and the company will advocate for including Explore-CKD data to provide guidance for physicians treating patients with lower eGFR (down to 30, versus 45 for baxdrostat). He also cited the efficacy data and milder hyperkalemia rates as potential differentiators. Q: What are the next steps for clinical development of lorundrostat beyond hypertension, particularly in CKD? A: Jon Congleton, CEO, noted that the company is analyzing opportunities beyond blood pressure reduction, citing the 52% placebo-adjusted reduction in UACR from Launch-HTN and proteomic data on heart failure markers. He stated that Dave Rodman's translational science team is exploring next development steps, and the company will communicate plans once aligned. Q: What is the company's strategy for partnering, and what is it looking for in a global partner? A: Jon Congleton, CEO, reiterated that commercialization outside the U.S. would be through a partner, ideally a global partner with both commercial and development interest. He emphasized that aldosterone is becoming a foundational node in cardiorenal metabolic disorders, and the partner should understand the near-term opportunity in hypertension as well as the broader potential of aldosterone modulation. Q: How does the company view the impact of AstraZeneca's primary aldosteronism trial on the class and lorundrostat's positioning? A: Jon Congleton, CEO, stated that dysregulated aldosterone is more of a spectrum than a secondary form of hypertension. He believes the data generated to date will resonate with physicians looking to address dysregulated aldosterone, and the company is well-positioned regardless of the outcome of AstraZeneca's trial. Q: What is the company's approach to pricing, and how does it view baxdrostat's pricing as an anchor? A: Jon Congleton, CEO, stated that baxdrostat's pricing is informative but not necessarily an anchor. Eric Warren, CCO, added that the price is consistent with the company's research and that the core tenant is to maximize ultimate value without creating a downward pricing spiral. The company is finalizing its pricing strategy. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management emphasized the strategic repurchase of future royalty payments from Mitsubishi Tanabe for $200 million upfront, a move intended to maximize the long-term equity value of lorundrostat as it nears commercialization. The company highlighted new clinical data from the LAUNCH-HTN trial showing that lorundrostat achieved a 52% placebo-adjusted reduction in UACR for patients with chronic kidney disease, signaling potential benefits beyond simple blood pressure reduction. Executive leadership was strengthened with the appointment of Dr. Terry Ferguson as CMO, bringing 35 years of cardiovascular expertise to lead late-stage clinical and medical affairs activities. Management attributes the drug's potential best-in-class profile to its high selectivity and 10-12 hour half-life, which they believe optimizes the balance between efficacy and safety compared to competitors. The company secured a $500 million senior secured term loan facility to provide financial flexibility and support the anticipated commercial launch through 2028. Market research conducted by the company suggests a 2-to-1 physician preference for lorundrostat's clinical profile over its primary competitor, baxdrostat, based on efficacy and hyperkalemia safety signals. The company is targeting a December 22, 2026, PDUFA date, with plans to have a full field sales organization staffed and trained in advance of the potential approval. Management expects labeling and post-marketing commitment discussions with the FDA to commence in the October-November 2026 timeframe, focusing on including data for patients with lower kidney function (eGFR down to 30). The commercial strategy prioritizes approximately 50,000 high-volume prescribers in the third-line or later hypertension treatment space to ensure rapid adoption. Payer engagement is expected to follow a cadence of commercial coverage first in 2027, with Medicare access initially managed through medical exceptions while formal formulary cycles are navigated. Strategic discussions for a global partnership remain ongoing, with management seeking a partner capable of expanding lorundrostat's development into broader cardiorenal metabolic indications. R&D expenses spiked to $221.4 million in Q2 2026, primarily driven by the $200 million one-time upfront payment for the royalty repurchase agreement. The company completed a $150 million equity offering in the second quarter to bolster its cash position for launch activities. Management noted that while the competitor baxdrostat has launched, they view its non-specialty tier pricing as a positive indicator for the class's overall market access potential. A new $500 million credit facility with Pharmakon Advisors was established to ensure the company is fully funded for operations into 2028. Management expressed high confidence in attracting top-tier cardiovascular talent despite the ongoing launch of a competitor's product. The company is not looking for a single 'phenotype' but is prioritizing candidates aligned with the drug's innovative profile and the company's values. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Mineralys intends to push for a label that includes data from the ADVANCE-HTN and EXPLORE-CKD trials to differentiate from competitors. Specifically, they aim to show safety and efficacy in patients with eGFR as low as 30, whereas the competitor label only goes down to 45. Management stated they were not surprised by the competitor's pricing and intend to price in the 'non-specialty tier' to ensure broad access. They explicitly stated they do not intend to trigger a 'downward pricing spiral' but will focus on maximizing value through clinical differentiation. Coverage will build progressively through 2027, with commercial payers expected to lead the way. A dedicated field reimbursement manager team will be deployed at launch to assist physicians with prior authorizations and medical exceptions for Medicare patients. The company is evaluating new trials for heart failure and other cardiorenal indications based on positive proteomic data presented at recent medical meetings. Management views aldosterone as a 'foundational node' for multiple diseases, suggesting a broad lifecycle management plan beyond hypertension.

– PDUFA target date of December 22, 2026 for lorundrostat; commercial preparations on-track for launch upon approval – – Appoints accomplished cardiovascular medicine executive Dr. Terry Ferguson as Chief Medical Officer to lead the Company’s medical and late-stage clinical activities – – Strengthened balance sheet and enhanced the long-term economics of lorundrostat through strategic financing initiatives and the repurchase of the Tanabe royalty obligation – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in comorbid conditions such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update. “Mineralys is advancing toward an exciting next chapter as we prepare for the commercial launch of lorundrostat, pending FDA approval. The efficacy and safety profile of lorundrostat supports its potential as a compelling treatment option for patients with uncontrolled or resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys. "We are also excited to welcome Terry Ferguson as our new Chief Medical Officer. His extensive experience in cardiovascular medicine strongly positions him to lead our medical organization. David Rodman, who guided the development of lorundrostat from proof of concept through the pivotal program, as well as our recent new drug application filing with the FDA, will continue to contribute to Mineralys in his full-time role as a Strategic Advisor." “I am very pleased to join the team at Mineralys in advance of the December PDUFA target date,” said Dr. Terry Ferguson, Chief Medical Officer of Mineralys. “Uncontrolled or resistant hypertension is a major driver of cardiovascular morbidity and mortality and a continuing issue for millions of Americans. I look forward to helping bring new treatment options, like lorundrostat, to patients with hypertension and other conditions where modulating dysregulated aldosterone may provide significant benefit.” Recent Highlights and Upcoming Milestones Lorundrostat New Drug Application (NDA) — The U.S. Food and Drug Administration (FDA) continues its review of the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs, with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026. Appointment of New Chief Medical Officer (CMO) — Appointed James J. "Terry" Ferguson III, M.D., as CMO, effective August 10, 2026, succeeding David Rodman, M.D., who will stay on with the Company as a full-time Strategic Advisor. Terry brings more than 35 years of experience in cardiovascular medicine and drug development, including serving as Cardiovascular Therapeutic Area Head at Amgen, nearly a decade in cardiovascular leadership roles at AstraZeneca and The Medicines Company, as well as more than two decades on the faculty of the Texas Heart Institute. Most recently, he served as Chief Medical Officer at Cadrenal Therapeutics. In his new role, Terry will lead Mineralys' medical and late-stage clinical activities. Transform-HTN Open-Label Extension Trial — The Company’s ongoing Transform-HTN open-label extension trial, which supported the NDA submission, continues to enable participants to receive lorundrostat and generate additional long-term safety and efficacy data. Commercial Launch Readiness — The Company continues to advance commercial launch preparations ahead of lorundrostat’s PDUFA target date of December 22, 2026 and remains on track. An experienced commercial leadership team is now in place, initial sales territories and priority geographies have been identified, and engagement continues with leading hypertension experts and payers covering a substantial majority of U.S. lives. The Company expects to have the sales organization established in advance of the anticipated PDUFA target date. Strengthened Balance Sheet and Lorundrostat Economics — During the second quarter of 2026, Mineralys strengthened its financial position and enhanced the long-term economics of lorundrostat through the following transactions: Second Quarter 2026 Financial Highlights Cash, cash equivalents and investments were $661.4 million as of June 30, 2026, compared to $656.6 million as of December 31, 2025. The Company believes that its current cash, cash equivalents and investments will be sufficient to fund planned operations, including the commercial launch of lorundrostat, into 2028. Research and development (R&D) expenses for the quarter ended June 30, 2026 were $221.4 million, compared to $38.3 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily due to the $200.0 million upfront payment to Tanabe in June 2026 in connection with the license agreement amendment. The increase was also due to $0.6 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $0.2 million of increased clinical supply, manufacturing, regulatory and other costs. These increases were partially offset by $17.8 million of lower preclinical and clinical costs, primarily due to the conclusion of the lorundrostat pivotal program in the second quarter of 2025. General and administrative (G&A) expenses were $24.7 million for the quarter ended June 30, 2026, compared to $8.5 million for the quarter ended June 30, 2025. The increase in G&A expenses was primarily due to $8.0 million in higher professional fees, $8.0 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $0.2 million of increased other administrative expenses. Total other income, net was $5.0 million for the quarter ended June 30, 2026, compared to $3.5 million for the quarter ended June 30, 2025. The increase was primarily due to $2.3 million of increased interest earned on investments as a result of higher average cash balances, partially offset by $0.8 million of interest and amortization expense related to the senior secured term loan entered into in June 2026. Net loss was $241.1 million for the quarter ended June 30, 2026, compared to $43.3 million for the quarter ended June 30, 2025. The increase was primarily attributable to the factors impacting the Company’s expenses described above. Conference Call The Company's management team will host a conference call at 4:30 p.m. ET today, August 11, 2026. To access the call, please dial 1-877-704-4453 in the United States or 1-201-389-0920 outside the United States, referencing conference ID 13760792. A live webcast of the conference call may be found here. A replay of the call will be available on the "News & Events" page in the Investors section of the Mineralys website here. About Lorundrostat Lorundrostat is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as related comorbidities, such as CKD, OSA and other diseases driven by dysregulated aldosterone. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, has an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in participants with hypertension. Mineralys has completed six late-stage clinical trials of lorundrostat supporting its efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The clinical program includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic blood pressure by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About Mineralys Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, X and Bluesky. Forward Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on Mineralys’ current beliefs and expectations and include, but are not limited to, statements regarding: the anticipated timing of the FDA's review of Mineralys’ accepted NDA and any subsequent regulatory approval of lorundrostat; the potential therapeutic benefits of lorundrostat; Mineralys’ expectations regarding activities to prepare for the commercial launch of lorundrostat; the capital available under Mineralys’ secured debt facility, including the potential to draw down additional tranches thereunder; Mineralys’ expectations with respect to finalizing an agreement with Tanabe to terminate the license agreement and to have Tanabe’s rights in the licensed intellectual property transferred to Mineralys; and the sufficiency of Mineralys’ cash, cash equivalents and investments to fund its operations. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Mineralys’ business, including, without limitation: any delays in the FDA’s review of Mineralys’ accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel; the results of Mineralys’ clinical trials, including the Launch-HTN and Advance-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA’s review of Mineralys’ NDA submission; the risk that future funding under the secured debt facility may not be available on the timeframe Mineralys expects, or at all, including as a result of its failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the debt facility; Mineralys may not be able to reach agreement on the proposed termination of its license agreement with Tanabe on its expected timeframe, or at all; Mineralys’ future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; Mineralys’ dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; Mineralys’ ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; Mineralys’ reliance on its exclusive license with Tanabe to provide Mineralys with intellectual property rights to develop and commercialize lorundrostat; and other risks described in Mineralys’ filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in its annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Mineralys undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Investor [email protected] Media RelationsMelyssa WeibleElixir Health Public RelationsEmail: [email protected]

Interested in Mineralys Therapeutics, Inc.? Here are five stocks we like better. Mineralys is preparing for a potential lorundrostat launch ahead of the FDA’s Dec. 22 PDUFA target date for uncontrolled hypertension, with regulatory discussions and commercial staffing underway. Clinical analyses showed meaningful blood-pressure reductions in chronic kidney disease patients and a 52% placebo-adjusted reduction in albuminuria, while exploratory data suggested improvements in heart-failure-related biomarkers. The company paid Tanabe $200 million to repurchase potential future royalties and secured $150 million in equity financing plus a $500 million term-loan facility; its second-quarter net loss widened to $241.1 million, primarily due to the Tanabe payment. There's a Lot to Love About Mineralys' Valentine's Day IPO Mineralys Therapeutics (NASDAQ:MLYS) said it is continuing commercial-launch preparations for lorundrostat ahead of its December 22 Prescription Drug User Fee Act target date, while reporting a wider second-quarter loss driven largely by a $200 million upfront payment related to its amended agreement with Tanabe Pharma Corp. Chief Executive Officer Jon Congleton said the company’s priorities during the second quarter included launch readiness, evaluating partnership opportunities and determining additional clinical-development plans for lorundrostat, an aldosterone synthase inhibitor being reviewed by the FDA for uncontrolled hypertension. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat The company also named Dr. Terry Ferguson as chief medical officer, succeeding Dr. David Rodman. Rodman will remain a full-time strategic adviser. Congleton said Ferguson brings more than 35 years of cardiovascular medicine, development and executive leadership experience, including prior roles at Amgen, AstraZeneca and The Medicines Company. Mineralys highlighted analyses of its lorundrostat studies presented during the quarter. At the European Society of Hypertension meeting in May, the company presented a post hoc analysis of patients with chronic kidney disease from its pivotal Launch-HTN trial. → 3 Dividend Champion Utilities for a Market That Can't Sit Still According to Congleton, those participants entered the study with more severe hypertension and more background antihypertensive treatments than the broader study population, but achieved statistically and clinically meaningful blood-pressure reductions comparable with the overall trial results. Patients with baseline albuminuria showed a 52% placebo-adjusted reduction in urine albumin-to-creatinine ratio, a marker of kidney injury and disease progression. At the Endocrine Society’s ENDO 2026 meeting, Mineralys presented exploratory proteomic findings from the Launch-HTN and Advance-HTN trials. The company said lorundrostat was associated with reductions in multiple biomarkers related to heart-failure risk, though Congleton noted the findings were exploratory. → Is Wingstop's Growth Story Losing Steam? During the question-and-answer session, Congleton said discussions with the FDA to date had been “regular course” and that formal label and post-approval commitment discussions are generally expected to occur closer to the PDUFA date, likely in October or November. He said the company expects an indication for inadequately controlled blood pressure on top of background medications to be broadly similar to the indication anticipated for baxdrostat, while it intends to discuss inclusion of data from its Launch-HTN, Advance-HTN and Explore-CKD programs. Congleton said Advance-HTN could provide a differentiating data set because the study confirmed uncontrolled or resistant hypertension after participants were moved to an American Heart Association-approved background regimen and were randomized only if blood pressure remained uncontrolled. He also said Explore-CKD data could inform physicians treating patients with lower estimated glomerular filtration rates. Chief Commercial Officer Eric Warren said approximately 20 million U.S. adults have uncontrolled or resistant hypertension despite available treatments. Mineralys has been building a commercial organization designed to target physicians treating patients in later lines of therapy. The company said it has established relationships with hypertension specialists and key opinion leaders, engaged with payers representing the vast majority of covered U.S. lives, developed launch messaging for providers and patients, and completed geographic mapping for field deployment. Warren said the sales organization is expected to be staffed before the December PDUFA date. Congleton declined to disclose a specific number of representatives but said the company is focused on roughly 50,000 physicians who account for substantial volumes of third-line and later prescribing. Management said early discussions with payers have supported its view that aldosterone synthase inhibitors could receive access in third- and fourth-line treatment settings. Warren said Mineralys expects coverage to build progressively through 2027, with commercial coverage developing ahead of Medicare coverage. He noted that Medicare access has so far relied on medical exceptions, which he described as having a favorable approval rate. The company also plans to establish a field reimbursement manager team to support prior authorizations and patient support programs. On pricing, Congleton said Mineralys continues its analysis and does not expect to disclose lorundrostat’s price until approval or near launch. Management characterized baxdrostat’s pricing as consistent with its expectations and said it did not view that product’s pricing as specialty-tier pricing. Mineralys agreed during the quarter to repurchase potential future royalty payments owed to Tanabe related to lorundrostat. The company will pay Tanabe $200 million upfront and could pay up to $100 million upon achieving certain commercial milestones. Aggregate potential future milestone payments to Tanabe are now up to $265 million. Congleton said the transaction was a strategic opportunity to increase Mineralys’ long-term interest in lorundrostat as the company approaches possible commercialization. Concurrent with the royalty arrangement, Mineralys completed a $150 million equity offering and entered a $500 million committed senior secured term-loan facility with funds managed by Pharmakon Advisors. The company said the financing adds flexibility beyond funding the royalty repurchase. Mineralys ended the second quarter with $661.4 million in cash, cash equivalents and investments as of June 30, compared with $656.6 million at the end of 2025. Chief Financial Officer Adam Levy said the company believes its resources will fund planned operations, including a commercial launch of lorundrostat, into 2028. Research and development expense rose to $221.4 million from $38.3 million a year earlier, primarily reflecting the $200 million Tanabe upfront payment. General and administrative expense increased to $24.7 million from $8.5 million, driven principally by higher professional fees and personnel costs. Net loss widened to $241.1 million, compared with $43.3 million in the prior-year quarter. Mineralys said it continues to consider broader development opportunities for lorundrostat in cardiorenal and metabolic conditions, while seeking a potential global partner that could support both commercialization outside the U.S. and future development efforts. Mineralys Therapeutics, Inc, a clinical-stage biopharmaceutical company that develops therapies for the treatment of hypertension and chronic kidney diseases. It clinical-stage product candidate is lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone. The company was formerly known as Catalys SC1, Inc and changed its name to Mineralys Therapeutics, Inc in May 2020. The company was incorporated in 2019 and is headquartered in Radnor, Pennsylvania. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Mineralys Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide. Mineralys Therapeutics (MLYS) plans to report its second quarter 2026 results on August 11, 2026, accompanied by a conference call and webcast that could clarify how investors view the stock’s recent performance. See our latest analysis for Mineralys Therapeutics. Mineralys Therapeutics’ share price has pulled back recently, with a 30 day share price return of a 4.3% decline and a year to date share price return of a 25.8% decline. However, the 1 year total shareholder return sits at 97.6% and the 3 year total shareholder return at 98.2%, which suggests that long term holders have experienced very different outcomes compared with those focused on short term momentum. If you want to see what else is moving around this part of the market, it could be worth scanning for cardiorenal and hypertension peers within healthcare AI, including the 41 healthcare AI stocks. Mineralys Therapeutics has a lead drug targeting clear cardiorenal needs, yet the stock has swung sharply over different time frames. Is this a strong business now offered at an appealing price, or already fully valued? The most followed valuation narrative for Mineralys Therapeutics puts fair value at about $50.88 a share, compared with the recent close at $26.50. That gap rests on specific assumptions about how lorundrostat and the cardiorenal pipeline could reshape the company’s revenue profile over the next few years. Read the complete narrative. Want to see what sits behind that valuation gap? The narrative leans on rapid revenue scaling, changing margins and a premium future earnings multiple that is usually reserved for stand out growth stories. Result: Fair Value of $50.88 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, Mineralys Therapeutics still faces key questions around lorundrostat approval timing and potential class competition, which could challenge the upbeat valuation narrative. Find out about the key risks to this Mineralys Therapeutics narrative. With sentiment on Mineralys Therapeutics clearly split between risks and rewards, it makes sense to move quickly and test the numbers yourself. To see how those trade offs stack up in one place, review the 2 key rewards and 4 important warning signs If Mineralys Therapeutics has sharpened your focus on where capital could work harder, do not stop with a single stock. Use these focused stock ideas to keep your watchlist fresh and avoid missing opportunities others overlook. Target potential upside in overlooked smaller companies with the 20 elite penny stocks with strong financials that filters for stronger financial profiles among lower priced stocks. Hunt for quality at a discount using the 52 high quality undervalued stocks that highlights stocks combining solid fundamentals with prices that sit below estimated fair value ranges. Prioritise resilience and balance sheet strength through the solid balance sheet and fundamentals stocks screener (49 results) which surfaces companies with healthier financial footing and supportable business models. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include MLYS. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

The FDA accepted the NDA for lorundrostat for uncontrolled or resistant hypertension in combination with other antihypertensive drugs, assigning a PDUFA target date of December 22, 2026. Management attributes the strength of the regulatory submission to a comprehensive data package from five trials demonstrating durable blood pressure reduction and tolerability across diverse populations. Strategic positioning focuses on the 'fourth-line' patient population, where over 20 million U.S. patients fail to achieve goals on three or more medications. Operational efforts have pivoted toward commercial readiness, including early payer engagement, medical science liaison team expansion, and physician advocacy. The company is leveraging the Advance HTN trial as a key differentiator, as it specifically targets a complex, confirmed resistant hypertension population that competitors have not studied. Management continues to evaluate global partnering opportunities while maintaining a 'go-it-alone' capability to maximize the asset's value. Current cash reserves of $646.1 million are projected to fund clinical trials, regulatory activities, and corporate operations into 2028. The commercial strategy assumes an initial entry point in the fourth-line setting, with plans to bridge into the third-line setting via comorbid conditions like CKD. Management anticipates that a competitor's earlier launch will help grow the overall aldosterone synthase inhibitor (ASI) market by increasing physician awareness of the novel class. Future clinical development may explore broader cardiorenal metabolic indications, utilizing lorundrostat as a foundational molecule for conditions like heart failure. Payer access strategy assumes that demonstrating value in high-risk, uncontrolled populations will secure parity coverage alongside competitors. R&D expenses for the quarter were $24.4 million, representing a decrease from the prior year driven by a $15.5 million reduction in costs following the conclusion of the lorundrostat pivotal program, which was partially offset by increased manufacturing and regulatory costs. G&A expenses rose to $21.0 million, driven by higher professional fees and headcount growth to support commercial preparation. The company highlighted the inclusivity of its clinical trials, specifically noting that Black/African American representation ranged from 28% to over 50% across studies. Management expressed confidence in the safety profile ahead of the 120-day safety update, supported by ongoing data collection in the TRANSFORM HTN open-label extension. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is seeking a partner with a global reach and a holistic view of the asset's potential across multiple indications. The company is simultaneously building internal commercial infrastructure to ensure value is maximized regardless of the partnering outcome. Lorundrostat is differentiated by the Advance HTN dataset, which focused on a more complex, 'confirmed' resistant population than the competitor. Physician feedback emphasizes the magnitude of systolic blood pressure reduction (19 mmHg in Launch HTN) and the diversity of the trial participants. Payers have expressed willingness to provide coverage in the fourth-line setting due to the high-risk nature of uncontrolled hypertension and lack of innovation. Management views existing SGLT2 inhibitors as a potential pricing barometer but will wait for the competitor's launch to finalize their own strategy. Significant 'pent-up demand' is evidenced by 8.8 million patients annually switching medications in the third-line or later despite a lack of new options. The company expects the cardiologist and nephrologist segments to be early adopters, with high-prescribing primary care physicians also included in the initial target base. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Mineralys’ NDA for lead candidate lorundrostat was accepted by the FDA with a PDUFA date of December 22, 2026, supported by a comprehensive dataset from LAUNCH‑HTN, ADVANCE‑HTN, TRANSFORM‑HTN and other studies showing clinically meaningful blood pressure reductions and tolerability. The company is preparing for a potential U.S. launch focused on fourth‑line resistant hypertension (patients uncontrolled on ≥3 meds), citing prescriber and payer receptivity and aiming to differentiate via absolute systolic reductions (e.g., ~19 mm in LAUNCH‑HTN) and diverse trial populations. Mineralys ended Q1 with $646.1 million in cash and investments and says resources should fund operations into 2028; Q1 results showed a net loss of $39.3 million, R&D expense down to $24.4 million, and G&A rising to $21.0 million. Interested in Mineralys Therapeutics, Inc.? Here are five stocks we like better. There's a Lot to Love About Mineralys' Valentine's Day IPO Mineralys Therapeutics (NASDAQ:MLYS) highlighted progress toward a potential U.S. launch of its lead candidate lorundrostat and reviewed first-quarter financial results during its May 6 earnings call, following the FDA’s acceptance of the company’s new drug application (NDA). Chief Executive Officer Jon Congleton said the NDA acceptance in the first quarter marked a “significant regulatory milestone” for lorundrostat and reflected what he described as a major team effort. 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. → Tyson Foods' Total Returns: Tasty Treats for Income Investors? Congleton said the NDA is supported by a “comprehensive clinical data package,” including results from the LAUNCH-HTN and ADVANCE-HTN pivotal trials, TRANSFORM-HTN (the open-label extension), and proof-of-concept studies Target-HTN and Explore-CKD. He said the five trials collectively showed clinically meaningful blood pressure reductions, tolerability, and durability across diverse patient groups. Congleton emphasized the company’s view that the breadth of the package could support inclusion in prescribing guidelines and demonstrate economic value for the healthcare system. He also reiterated the company’s focus on uncontrolled and resistant hypertension, which he said impacts more than 20 million people in the U.S. and contributes to cardiorenal complications. → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? Congleton said Mineralys is preparing lorundrostat for a potential U.S. launch while continuing to evaluate partnering opportunities and potential next steps in clinical development. He said the company plans to initially focus on patients with resistant hypertension—generally those uncontrolled on three or more medications—where aldosterone dysregulation can play an important role. Management cited ongoing market research suggesting three themes: Prescribers prioritize magnitude and consistency of blood pressure reduction and have expressed willingness to prescribe lorundrostat in the fourth line, Congleton said. Payers recognize high risk among patients uncontrolled on three or more medications and have expressed willingness to cover lorundrostat, according to Congleton. Patients are seeking sustained reductions that are tolerable and easy to integrate into daily life and have been receptive to novel agents, he said. → A Prada Payday: Is AMC Back in Style? Congleton said the company is working on early market access planning and payer engagement, expanding medical communications efforts, and building out its field-based medical science liaison (MSL) team. He added that Mineralys is also expanding sales and marketing capabilities ahead of the PDUFA date. During the Q&A, Chief Commercial Officer Eric Warren described the company’s go-to-market approach as “all about sequencing,” calling fourth line the entry point while pointing to an opportunity to move toward third line over time, particularly among patients with comorbidities. Warren said parity access with competing aldosterone synthase inhibitors (ASIs) is a focus. Several analysts asked about positioning relative to a competing ASI, baxdrostat, and the potential for differentiation. Congleton said he expects “a level of uniformity” in labeling within the hypertension indication, but argued Mineralys’ clinical dataset differs from competitors’ datasets, repeatedly highlighting ADVANCE-HTN as a distinct study intended to address complicated “confirmed hypertension” patients that cardiologists see. He also pointed to Explore-CKD and the potential importance of proteinuria-related signals for nephrologists, while noting that what ultimately appears in labeling will be part of discussions with the FDA. Warren said physician feedback has emphasized two factors: “the absolute systolic blood pressure reduction” and the diversity of trial populations. He specifically cited “that 19 mm” systolic reduction demonstrated in LAUNCH-HTN and highlighted representation of Black/African American patients, saying trial participation ranged from “between 28 and over 50%” depending on the study. On guidelines, Congleton said Mineralys has been engaging with physicians involved in guideline committees and believes the company has assembled a dataset intended to answer key questions those committees may have. He referenced work with the Cleveland Clinic and investigators Steven Nissen and Luke Laffin on ADVANCE-HTN, saying the study was designed to address questions around whether hypertension is “apparent” or truly confirmed. He also said LAUNCH-HTN, Explore-CKD, and Explore-OSA add context for resistant hypertension complexity. Congleton said Mineralys continues to evaluate partnering opportunities and described the potential benefit of a partner that could add value and reach more patients. When asked directly about timing and the status of discussions, Congleton said the company is “routinely evaluating” opportunities but is not in a position to provide specifics on “the level of dialogues, the timing, the structure.” He reiterated that commercial readiness work is “an important part of those partnering dialogues.” Asked about broader potential beyond hypertension, Congleton said aldosterone is likely to remain a key target “into the 2030s” for hypertension and related comorbidities. He added that blood pressure reduction is a “clear surrogate” for what could be expected regarding cardiovascular risk reduction, while stopping short of offering details on other indications that may be prioritized in partner discussions. Chief Financial Officer Adam Levy reported that Mineralys ended the first quarter with $646.1 million in cash, cash equivalents, and investments as of March 31, 2026, compared with $656.6 million as of Dec. 31, 2025. Levy said the company believes its current resources will be sufficient to fund planned clinical trials and regulatory activities and support corporate operations “into 2028.” Research and development expense was $24.4 million, down from $37.9 million in the year-ago period, primarily due to a $15.5 million reduction in preclinical and clinical costs following the conclusion of the lorundrostat pivotal program in the second quarter of 2025. Levy said the decline was partially offset by higher clinical supply, manufacturing and regulatory costs, and increased personnel expenses tied to headcount growth and compensation. General and administrative expense increased to $21.0 million from $6.6 million, driven mainly by higher professional fees and increased personnel-related expenses, Levy said. Other income, net rose to $6.0 million from $2.2 million due to higher interest earned on investments in money market funds and U.S. Treasuries. Net loss was $39.3 million, compared with $42.2 million in the first quarter of 2025. In closing remarks, Congleton said the company remains encouraged by the NDA acceptance and is focused on pre-commercial readiness while continuing partnering evaluations and considering further clinical development steps for lorundrostat. Mineralys Therapeutics, Inc, a clinical-stage biopharmaceutical company that develops therapies for the treatment of hypertension and chronic kidney diseases. It clinical-stage product candidate is lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone. The company was formerly known as Catalys SC1, Inc and changed its name to Mineralys Therapeutics, Inc in May 2020. The company was incorporated in 2019 and is headquartered in Radnor, Pennsylvania. The article "Mineralys Therapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat.

Image source: The Motley Fool. Wednesday, May 6, 2026 at 4:30 p.m. ET Chief Executive Officer — Jon Congleton Chief Financial Officer — Adam Levy Chief Medical Officer — David Rodman Chief Commercial Officer — Eric Warren Need a quote from a Motley Fool analyst? Email [email protected] 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. Before you buy stock in Mineralys Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Mineralys Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $473,985!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,204,650!* Now, it’s worth noting Stock Advisor’s total average return is 950% — a market-crushing outperformance compared to 203% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 6, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool recommends Mineralys Therapeutics. The Motley Fool has a disclosure policy. Mineralys (MLYS) Q1 2026 Earnings Transcript was originally published by The Motley Fool

– NDA for lorundrostat in adults with hypertension accepted by FDA; assigned PDUFA target date of December 22, 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., May 06, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update. “We continue to make strong progress advancing lorundrostat toward potential approval, moving closer towards our goal of delivering what we believe has the potential to be a best-in-class aldosterone synthase inhibitor for patients with uncontrolled or resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “The FDA’s acceptance of our NDA in the first quarter marks a significant milestone for Mineralys. We continue to advance pre-commercial activities to support a successful launch of lorundrostat while maintaining strategic flexibility.” Recent Clinical Highlights and Upcoming Milestones Lorundrostat New Drug Application (NDA) – The U.S. Food and Drug Administration (FDA) accepted the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs and assigned a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026. The NDA submission included the diverse dataset the Company has built with lorundrostat across five positive clinical trials that demonstrated clinically meaningful blood pressure (BP) reduction, 24-hour control and a favorable safety profile in adults with uncontrolled or resistant hypertension. Transform-HTN Open-Label Extension Trial – The Company’s ongoing open-label extension trial, which supported the NDA submission, enables participants to continue to receive lorundrostat and allows the Company to gather additional long-term safety and efficacy data. Pre-Commercial Activities Underway – The Company is executing on its pre-commercial activities in preparation for the December 22, 2026 PDUFA target date for lorundrostat. This includes engaging in market access discussions, expanded medical advocacy through communications efforts in the field to support broader education of the unmet need in uncontrolled or resistant hypertension, and sales and marketing activities preparing lorundrostat for a successful launch. First Quarter 2026 Financial Highlights Cash, cash equivalents and investments were $646.1 million as of March 31, 2026, compared to $656.6 million as of December 31, 2025. The Company believes that its current cash, cash equivalents and investments will be sufficient to fund its planned clinical trials and regulatory activities, as well as support corporate operations, into 2028. Research and development (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 the 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. General and administrative (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 $0.4 million of 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 money market funds and U.S. Treasuries due to higher average cash balances invested during the quarter ended March 31, 2026. 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 the Company’s expenses described above. Conference Call The Company’s management team will host a conference call at 4:30 p.m. ET today, May 6, 2026. To access the call, please dial 1-877-704-4453 in the United States or 1-201-389-0920 outside the United States. A live webcast of the conference call may be found at (click here). A replay of the call will be available on the “News & Events” page in the Investors section of the Mineralys Therapeutics website (click here). About Hypertension Having sustained, elevated blood pressure (BP) (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019. Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, has an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants. The Company has now completed six late-stage clinical trials of lorundrostat supporting its efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The clinical program includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About Mineralys Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky. Forward Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the anticipated timing of the FDA’s review of our accepted NDA and any subsequent regulatory approval of lorundrostat; the planned future clinical development of lorundrostat and the timing thereof; and the sufficiency of our cash, cash equivalents and investments to fund our operations. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; any delays in the FDA’s review of our accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA’s review of our NDA submission; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Tanabe Pharma Corporation to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Investor Relations [email protected] Media Relations Melyssa Weible Elixir Health Public Relations Email: [email protected]