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DATE

Tuesday, Aug. 11, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer - Jon Congleton
• Chief Financial Officer - Adam Scott Levy
• Chief Commercial Officer - Eric J. Warren

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TAKEAWAYS

• Cash, Cash Equivalents, and Investments -- $661.4 million as of June 30, 2026, compared to $656.6 million at the end of 2025, reflecting strategic financing activities.
• Net Loss -- $241.1 million, or $2.85 per share, driven primarily by an upfront payment for royalty repurchase obligations.
• Research and Development Expenses -- $221.4 million, reflecting a $200 million upfront payment to Mitsubishi Tanabe Pharma Corporation to eliminate future royalty obligations.
• General and Administrative Expenses -- $24.7 million, an increase from $8.5 million in the prior year due to higher professional fees and personnel costs for launch readiness.
• PDUFA Target Date -- Dec. 22, 2026, representing the FDA action date for the lorundrostat New Drug Application for hypertension treatment.
• Mitsubishi Tanabe Milestone Obligations -- up to $255 million in the aggregate, payable upon the first commercial sale and the achievement of specific annual sales targets.
• Equity Offering Proceeds -- $150 million gross, generated through the issuance of 5,660,378 shares of common stock in the second quarter.
• Senior Secured Term Loan Facility -- up to $500 million, with an initial $100 million tranche drawn in June 2026.
• CKD Patient UACR Reduction -- 52% placebo adjusted reduction, observed in participants with baseline albuminuria during the LAUNCH-HTN trial.
• Aldosterone Synthase Selectivity -- 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro.
• Lorundrostat Half-Life -- 10 to 12 hours, supporting the candidate's observed clinical profile.
• Plasma Aldosterone Reduction -- 40% to 70%, demonstrated in clinical trial participants with hypertension.
• U.S. Hypertension Population -- 20 million adults, identified as having uncontrolled or resistant hypertension despite existing therapies.
• Target Physician Audience -- approximately 50,000 providers, representing the primary prescribers of third-line and later hypertension treatments.
• G&A Professional Fees -- $8 million increase, driven by launch preparation and corporate development activities.
• G&A Personnel Expenses -- $8 million increase, reflecting headcount growth and compensation adjustments.
• R&D Personnel Expenses -- $600,000 increase, resulting from clinical and medical organization expansion.
• R&D Preclinical and Clinical Costs -- decreased by $17.8 million, following the conclusion of the lorundrostat pivotal program in the prior year.
• Interest Income -- $5 million, reflecting higher average cash balances and investment yields.
• Interest and Amortization Expense -- $800,000, associated with the senior secured term loan entered into in June 2026.
• Cash Runway -- expected to fund planned operations, including the commercial launch of lorundrostat, into 2028.
• Clinical Supply and Regulatory Costs -- $200,000 increase, supporting the preparation for commercialization.
• Other Administrative Expenses -- $200,000 increase, contributing to the overall rise in G&A spending.
• Common Stock Weighted-Average Shares -- 84,727,282 shares, used in computing the net loss per share for the quarter.

SUMMARY

Management at Mineralys Therapeutics, Inc. (MLYS +2.15%) reported that the regulatory review of lorundrostat is proceeding toward the scheduled action date in the fourth quarter of 2026. The company dedicated the second quarter to commercial launch preparations, which involved establishing leadership teams and initiating discussions with national U.S. payers. Strategic financial initiatives included a public stock offering and the establishment of a senior secured loan facility to fund the repurchase of future royalty obligations from Mitsubishi Tanabe Pharma Corporation. Additionally, the transition to a new chief medical officer aligns with the company's focus on late-stage clinical activities and medical affairs ahead of the anticipated launch.

• CEO Congleton indicated that dialogue with the FDA has been "regular course" with "no surprises" regarding the data package submitted for review.
• Warren noted that the Medicare access strategy relies on "medical exception, which has a very favorable approval rate," allowing for physician-driven adoption at launch.
• CEO Congleton stated that the recruitment of territory managers and first-line sales managers is attracting high-level talent energized by the innovation represented by lorundrostat.
• Management confirmed that the sales organization is expected to be fully staffed in advance of the PDUFA date to ensure rapid execution upon a potential approval.
• Warren reported that initial payer engagement efforts have reached entities representing "the vast majority of covered lives in the United States."
• CEO Congleton noted that the company is evaluating further clinical development for lorundrostat in areas such as heart failure and chronic kidney disease beyond the initial hypertension indication.
• Management appointed Terry Ferguson as chief medical officer, succeeding David Rodman who will continue as a strategic advisor for translational opportunities.

INDUSTRY GLOSSARY

• Aldosterone: A hormone that regulates salt and water balance in the body; abnormally elevated levels are a driver of cardiorenal diseases.
• Aldosterone Synthase Inhibitor (ASI): A class of drugs designed to lower aldosterone levels by inhibiting the enzyme responsible for its production.
• eGFR (Estimated Glomerular Filtration Rate): A test used to check how well the kidneys are filtering waste from the blood.
• NDA (New Drug Application): A formal proposal for the FDA to approve a new pharmaceutical for sale and marketing in the U.S.
• PDUFA (Prescription Drug User Fee Act) Date: The deadline by which the FDA must complete its review and provide a decision on a drug application.
• Proteomics: The large-scale study of proteins, used in this context to identify biomarkers of disease progression or treatment response.
• UACR (Urine Albumin to Creatinine Ratio): A marker used to identify kidney damage by measuring the amount of albumin protein in the urine.

Full Conference Call Transcript

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.