Mineralys Therapeutics Q2 2026 Earnings Report

Mineralys Therapeutics EPS Results

• Actual EPS: -$2.85
• Consensus EPS: -$0.55
• Beat/Miss: Missed by -$2.30
• One Year Ago EPS: N/A

Mineralys Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Mineralys Therapeutics Announcement Details

• Quarter: Q2 2026
• Date: 8/12/2026
• Time: After Market Closes
• Conference Call Date: Tuesday, August 11, 2026
• Conference Call Time: 4:30PM ET

Mineralys Therapeutics (NASDAQ:MLYS), 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.

Mineralys Therapeutics Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Mineralys remains on track for the December 22, 2026 PDUFA date for lorundrostat, with its commercial infrastructure, payer outreach, launch campaign, and sales organization nearing completion.
• Positive Sentiment: New analyses supported lorundrostat’s potential differentiation, including clinically meaningful blood-pressure reductions in chronic kidney disease patients, a 52% placebo-adjusted reduction in albuminuria, and favorable changes in exploratory heart-failure biomarkers.
• Positive Sentiment: Management said payer discussions have been encouraging, with commercial coverage expected to build ahead of Medicare during 2027; the company also plans reimbursement and patient-support teams to facilitate access.
• Positive Sentiment: Mineralys repurchased potential future royalty obligations to Tanabe for $200 million upfront, while raising $150 million in equity and securing a $500 million senior secured term loan. Management believes its cash and investments are sufficient to fund planned operations, including launch activities, into 2028.
• Negative Sentiment: Second-quarter net loss increased sharply to $241.1 million from $43.3 million a year earlier, primarily because of the $200 million Tanabe payment and higher general and administrative costs, with additional interest obligations from the new debt facility.

Presentation

[Operator]

Reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Please go ahead, sir.

[Dan Ferry, Managing Director at LifeSci Advisors]

Thank you. I would like to welcome everyone joining us today for our second quarter 2026 conference call. This afternoon, after the close of market trading, we issued a press release providing our second quarter 2026 financial results and business updates. A replay of today's call will be available on the investors section of our website approximately one hour after its completion. After our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in today's press release and our SEC filings, including our annual report on Form 10-K and subsequent filings.

[Dan Ferry, Managing Director at LifeSci Advisors]

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, CEO at Mineralys Therapeutics]

Thank you, Dan. Good afternoon, everyone. Welcome to our second quarter 2026 financial results and corporate update conference call. I'm joined today by Adam Levy, our Chief Financial Officer, and Eric Warren, our Chief Commercial Officer. I'll 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 Dr. Terry Ferguson to the team. Terry joins us as Chief Medical Officer, succeeding Dr. David Rodman, who will continue to play an important role as a full-time strategic advisor to the company. Terry brings more than 35 years of experience in cardiovascular medicine, clinical development, and executive leadership.

[Jon Congleton, CEO at Mineralys Therapeutics]

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. Terry's deep expertise in cardiovascular medicine and a 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 want 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.

[Jon Congleton, CEO at Mineralys Therapeutics]

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 22nd 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's 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.

[Jon Congleton, CEO at Mineralys Therapeutics]

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 2026, we presented late-breaking proteomic data from our Launch-HTN and Advance-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 benefits 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 initiatives that enabled our long-term value creation objectives.

[Jon Congleton, CEO at Mineralys Therapeutics]

During the quarter, we announced an agreement to repurchase the potential future royalty payments due to Tanabe Pharma Corporation related to lorundrostat. Under the terms of the agreement, Mineralys agreed to pay Tanabe $200 million upfront and up to $100 million once certain commercial milestones are met. Our aggregate potential future milestone payments to Tanabe are now up to $265 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.

[Jon Congleton, CEO at Mineralys Therapeutics]

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 lorundrostat, 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 Warren, CCO at Mineralys Therapeutics]

Great. Thank you, Jon. Approximately 20 million adults in the United States have uncontrolled or resistant hypertension. 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 an underlying driver 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. Over the past several quarters, we have systematically executed against the key elements of our commercial launch plan.

[Eric Warren, CCO at Mineralys Therapeutics]

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.

[Eric Warren, CCO at Mineralys Therapeutics]

Third, we are well underway in the development of a differentiated launch campaign that is designed to educate both healthcare providers and patients.

[Eric Warren, CCO at Mineralys Therapeutics]

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 physicians treating patients with uncontrolled or resistant hypertension, allowing us to optimize field deployment. Perhaps most importantly, we 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.

[Eric Warren, CCO at Mineralys Therapeutics]

We've built our commercial organization around clear objectives, which are to ensure physicians have the education, 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'll now turn it over to Adam to review our second quarter financial results.

[Adam Levy, CFO at Mineralys Therapeutics]

Thank you, Eric. Good afternoon, everyone. Today, I will discuss select portions of our second quarter 2026 financial results. Additional details can be found in our Form 10-Q, which will be filed with the SEC today. We ended the quarter with cash equivalents, and investments of $661.4 million as of June 30th, 2026, compared to $656.6 million as of December 31st, 2025. We believe that our current cash equivalents, and investments will be sufficient to fund our planned operations, including the commercial launch of lorundrostat into 2028.

[Adam Levy, CFO at Mineralys Therapeutics]

R&D expenses for the quarter ended June 30th, 2026, were $221.4 million compared to $38.3 million for the quarter ended June 30th, 2025. The increase in R&D expenses was primarily due to the $200 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. G&A expenses were $24.7 million for the quarter ended June 30th, 2026, compared to $8.5 million for the quarter ended June 30th, 2025.

[Adam Levy, CFO at Mineralys Therapeutics]

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 $0.2 million of increased other administrative expenses. Total other income net was $5 million for the quarter ended June 30th, 2026, compared to $3.5 million for the quarter ended June 30th, 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 in amortization expenses related to the senior secured term loan entered into in June 2026. Net loss was $241.1 million for the quarter ended June 30th, 2026, compared to $43.3 million for the quarter ended June 30th, 2025. The increase was primarily due to the factors impacting our expenses that I just described.

[Adam Levy, CFO at Mineralys Therapeutics]

With that, I will ask the operator to open the call for questions. Operator?

[Operator]

Thank you. We will now be conducting a Q&A session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we pull for questions. The first question is from Richard Law from Goldman Sachs. Please go ahead.

[Richard Law, Analyst at Goldman Sachs]

Hey, guys. Yeah, congrats on all the progress as we approach PDUFA. I also want to extend out welcome to Terry, and look forward to working with him. So a couple questions from 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 baxdrostat launch, which I assume will be competing for talent there as well? Also, are there any key attributes that you guys are looking for regarding hypertension experience or on certain drugs? Also, when are you guys going to start hiring for the rest of the sales reps, given the launch is nearing in four months?

[Jon Congleton, CEO at Mineralys Therapeutics]

Rich, this is Jon. Thanks for the question. I have to admit it was a little bit garbled, so I am going to paraphrase your question back and tell me if I got it on point. I think your question is about the field sales force, 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, Analyst at Goldman Sachs]

Yeah, exactly. So basically, how are you guys finding the quality of candidates, given that baxdrostat launch already been happening? So I assume there's competition for talent there.

[Jon Congleton, CEO at Mineralys Therapeutics]

Yeah, no.

[Richard Law, Analyst at Goldman Sachs]

So what are you guys looking for in terms of experience? Also, when are you guys going to hire the rest of the sales force, given that the launch is four months away?

[Jon Congleton, CEO at Mineralys Therapeutics]

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 the 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 in and of itself becomes a very exciting offering that attracts high-level talent. I will tell you there is not one phenotype that we are looking for. There is certainly a lot of cardiovascular experienced reps that are out there.

[Jon Congleton, CEO at Mineralys Therapeutics]

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.

[Richard Law, Analyst at Goldman Sachs]

Fantastic. Then just to follow up on that, 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? Is there anything that you guys are seeing that baxdrostat doing well or not doing well with payers or other commercial aspects that you can do differently or better? Thank you.

[Jon Congleton, CEO at Mineralys Therapeutics]

I will give a quick thought, and 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 in the third and fourth line position. But Eric can give you maybe some more specifics behind that.

[Eric Warren, CCO at Mineralys Therapeutics]

Yeah. Thanks, Jon. Rich, so from a payer perspective, 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 haven't 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, Analyst at Goldman Sachs]

Great. Thank you.

[Jon Congleton, CEO at Mineralys Therapeutics]

Thanks, Rich.

[Operator]

The next question is from Michael DiFiore from Evercore ISI. Please go ahead.

[Michael DiFiore, Analyst at Evercore ISI]

Hey, guys. Thanks so much for taking my question. Two from me. You said in the past that the 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? 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, CEO at Mineralys Therapeutics]

Yeah. Thanks, Mike. The label and post-approval commitments, that typically occurs a couple of months ahead of the PDUFA. I would expect sometime in the October, November timeframe. 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, Advance-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've seen the price of baxdrostat, and we're continuing to do our analysis. We weren't overly surprised by the price point they came out with. It's in that non-specialty tier pricing area. But I would not anticipate us sharing the price until approval and subsequently probably around launch.

[Michael DiFiore, Analyst at Evercore ISI]

Thank you.

[Operator]

The next question is from Jason Gerberry from Bank of America. Please go ahead.

[Jason Gerberry, Analyst at Bank of America]

Hey, guys. Thanks for taking my questions. Couple from me. Just 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? Then as a follow-up to the point you raised about confidence around parity payer access. I'm not sure you can say much, but directionally, I'm just curious, 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've expected, say, 6-12 months ago? Thanks.

[Jon Congleton, CEO at Mineralys Therapeutics]

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 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 has been over 20 years since there has been a meaningful introduction of an antihypertensive therapy. We know there are significant patients, 20 million, on two or more meds that cannot get to goal right now, and we know the implications of that. 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 with lorundrostat. But as to the payer dialogues, I will let Eric comment.

[Eric Warren, CCO at Mineralys Therapeutics]

Yeah. Payer dialogues have been very positive. I would say the level of rebate that we are hearing that is coming from baxdrostat 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 this 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, Analyst at Bank of America]

Great. Thank you.

[Jon Congleton, CEO at Mineralys Therapeutics]

Thanks, Jason.

[Operator]

The next question is from Seamus Fernandez from Guggenheim Securities. Please go ahead.

[Evan Wang, Analyst at Guggenheim Securities]

Hi, guys. This is Evan Wang on for Seamus Fernandez. Just two from me. Just, I guess first off, as you're speaking with KOLs and doing your outreach, what's really resonating with KOLs about the profile here? Then second, congrats to Terry for joining. I'm just curious, I know it's extremely early, but curious what the priority list will be as he gets settled. Thanks.

[Jon Congleton, CEO at Mineralys Therapeutics]

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. I think it's pretty clear it's 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 get it in a way that is safe and can be adhered to over a long period of time. So, we continue to believe that that profile that we've seen from our clinical program reinforces a profile that meets the needs of physicians as they're treating these patients third line and later.

[Jon Congleton, CEO at Mineralys Therapeutics]

As to Terry, yeah, we're very excited. I'm actually thrilled to be able to expand the expertise that we're able to apply to Mineralys and lorundrostat by retaining Dave in a 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 latter stage development and very specifically medical affairs, I think does nothing but just augment and build on the success we've had to date. We've 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.

[Jon Congleton, CEO at Mineralys Therapeutics]

I think is going to be a significant build for us as we continue to prepare lorundrostat for a successful commercial launch.

[Eric Warren, CCO at Mineralys Therapeutics]

Jon, I just wanted to add one thing. So in addition to the efficacy and the safety, the Advance-HTN data are really resonating well with the KOL audience. So having a unique data set really does differentiate us in their minds.

[Evan Wang, Analyst at Guggenheim Securities]

Great. Thanks. Maybe one 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're kind of thinking about your efforts here. Thanks.

[Jon Congleton, CEO at Mineralys Therapeutics]

Yeah. Our focus is really on those prescribers that are going to control a significant volume of third line or later prescribing. We've talked about in the past, that's ±50,000 physicians. So we'll ensure that we have a very strong share of voice within those predominant prescribers of the latter lines of treatment. We haven't 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 little bit closer to our vest.

[Evan Wang, Analyst at Guggenheim Securities]

Thank you.

[Jon Congleton, CEO at Mineralys Therapeutics]

Yeah.

[Operator]

The next question is from Annabel Samimy from Stifel. Please go ahead.

[Analyst at Stifel]

Hi, this is Kyle speaking for Annabel. Maybe two questions on the label. Exactly what are you guys looking for in terms of a differentiator label in comparison, again, to BAXFENDY? Based on, I know you mentioned discussions are early, but based on your current interactions, what do you think is required to warrant a language specifically calling out resistant hypertension or CKD? Do you think having a dedicated randomized controlled trial like Advance-HTN or Explore-CKD could be the new mover? Thanks.

[Jon Congleton, CEO at Mineralys Therapeutics]

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. 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.

[Jon Congleton, CEO at Mineralys Therapeutics]

I think where there is going to be an opportunity for differentiation in all of this obviously is dependent upon dialogues with the agency, but is the representation not just of Launch-HTN, which is the largest hypertension trial conducted with an ASI, but also Advance-HTN, which as Eric said, is very unique and distinct from, frankly, a lot of studies done in hypertension, given the nature of that trial where we were confirming uncontrolled and resistant hypertension based on moving subjects to an AHA-approved background treatment and only randomizing after they cannot get control even on an optimized treatment. I think Advance-HTN certainly will be a part of our discussions with the agency as an important data set to include in the label on top of Launch-HTN.

[Jon Congleton, CEO at Mineralys Therapeutics]

I believe data from Explore-CKD is also informative to physicians who are prescribing an ASI in a subject who may have lower kidney function based on the eGFR. We know the label for baxdrostat speaks to eGFR I believe down to 45, and Explore-CKD went down to 30. We will be making a point to the agency that it is important that 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, there are clear differentiators based on the absolute and placebo-adjusted reductions in systolic BP, as well as milder cases of electrolyte change, specifically hyperkalemia. We believe that the data set 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.

[Analyst at Stifel]

Okay. Thank you.

[Jon Congleton, CEO at Mineralys Therapeutics]

Thanks, Kyle.

[Operator]

The next question is from Mohit Bansal from Wells Fargo. Please go ahead.

[Mohit Bansal, Analyst at Wells Fargo]

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, for the new role. Looking forward to work with you. I have a couple of questions here. Number one, assuming that you get similar label to baxdrostat, is there anything in the clinical data or the trials like Advance-HTN or the differentiated trial that you could use to appeal to certain specialties? Or it would probably be seen more similar than different from that aspect. The second one is, AstraZeneca is running this primary aldosteronism trial and that could read out for baxdrostat next year. How do you see that trial, in case it is positive, impacting the class or specific molecule? How do you see the result of that trial impacting the positioning there? Thank you.

[Jon Congleton, CEO at Mineralys Therapeutics]

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 to the treatment of hypertension. We're seeing really pronounced and clinically meaningful reductions in similar patient types. Those on two or more background meds that are failing to get to goal. But within those similarities, and in really the two 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.

[Jon Congleton, CEO at Mineralys Therapeutics]

And you've seen the market research we've done where we put up the results of BaxHTN relative to Launch-HTN, and there's about a two to one preference for the profile that emerged with lorundrostat relative to baxdrostat based on those two fairly similar trials. And 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 educational standpoint, an opportunity to really show the benefit of using the most selective ASI with what we think is an ideal half-life of 10-12 hours. So I believe that's how it's going to translate.

[Jon Congleton, CEO at Mineralys Therapeutics]

From a primary aldosteronism perspective with the PA study, I think there's 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. I think the data we generated to date is going to resonate with physicians that are looking to address dysregulated aldosterone, whether it's classified as typical PA or dysregulated or elevated aldosterone. So it'll 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.

[Mohit Bansal, Analyst at Wells Fargo]

Helpful. Thank you.

[Jon Congleton, CEO at Mineralys Therapeutics]

Thanks, Mohit.

[Operator]

The next question is from Rami Katkhuda from LifeSci Capital. Please go ahead.

[Rami Katkhuda, Analyst at LifeSci Capital]

Hi, guys. Thanks for taking my questions as well. I guess given the December PDUFA, how should we be thinking about the cadence of payer coverage through 2027? Is there a risk that missing the initial Medicare Part D formulary cycle could make next year more of an access-building year? Secondly, when do you expect the next major hypertension guideline updates to be, and how important could a formal inclusion of ASIs be for the class?

[Jon Congleton, CEO at Mineralys Therapeutics]

Yeah. I'll take the second question, Rami, on the guidelines, and Eric can comment on the first one as far as the cadence of coverage. We've been identifying and working with the committee members, making sure that they have the information that is required as they contemplate guideline inclusion. I think probably five years ago, there was a more rigorous cadence of every four or five years, an update of the guidelines. What we've heard from those committee members is they're going to try to be more reactive to new information like the ASIs. I would anticipate, sometime in 2027, an update of those guidelines that would reflect where the ASIs should fit within that. I think that's where we made some really discreet and important choices from the clinical development of lorundrostat.

[Jon Congleton, CEO at Mineralys Therapeutics]

Not only Launch-HTN providing real-world case studies, but also Advance-HTN for those specialists that are optimally treating patients and yet still failing to help them get to goal. Advance-HTN that we did with the Cleveland Clinic was specifically designed and executed with the guidelines in mind. I think we've got a very strong case for lorundrostat. That may be a benefit that extends to the class. I think fundamentally, the ASIs, given the clinically meaningful reduction that we're seeing, will have a really clear place within the guidelines for patients, certainly at latter line of treatment. Eric can talk about cadence of coverage.

[Eric Warren, CCO at Mineralys Therapeutics]

Yeah. You've characterized it well. So a progressive increase in coverage over the course of 2027 with commercial outpacing Medicare. It's important to note, as I said before, that Medicare relies upon medical exception, which has a very favorable approval rate. It's important to note, and I didn't say this before, but we'll also stand up a field reimbursement manager team to support prior authorizations, and we're making a good emphasis and focus on patient support to ensure that the patient gets on therapy quickly, and there's 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, Analyst at LifeSci Capital]

Got it. Thank you.

[Jon Congleton, CEO at Mineralys Therapeutics]

Thanks, Rami.

[Operator]

The next question is from Tara Bancroft from TD Cowen. Please go ahead.

[Tara Bancroft, Analyst at TD Cowen]

Hi. Good afternoon. I want to follow up on one of the first questions that was asked. I am curious in what ways you think you could improve access and adoption as second to market relative to baxdrostat, especially as it comes to pricing. Is it possible maybe to price at a discount and take more share that way? I know you have previously communicated the SGLT2 class as good pricing comps for the Street to anchor to, but maybe should we anchor more so to AstraZeneca now? Thanks so much.

[Jon Congleton, CEO at Mineralys Therapeutics]

Yeah. Let me give some high-level thoughts and Eric can follow up. I have been asked before, does baxdrostat pricing create an anchor? 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 the baxdrostat pricing was not specialty tier, which we think was critical to ensure access to patients. We will continue to evaluate that. We are going to continue to do our analysis of it. Maybe Eric can speak to some of that work we are going to continue to do.

[Eric Warren, CCO at Mineralys Therapeutics]

Yeah. I mean, I will just reinforce, the baxdrostat 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 tenant is to maximize ultimate value, not create a downward pricing spiral. I will not get into too much more than that, but just want to reinforce that, again, pricing of baxdrostat is very consistent with our expectations and we are finalizing our strategy. We definitely need to make sure that we are preserving value.

[Tara Bancroft, Analyst at TD Cowen]

Okay. Thank you so much.

[Jon Congleton, CEO at Mineralys Therapeutics]

Thanks, Tara.

[Operator]

The next question is from Matthew Caufield from H.C. Wainwright. Please go ahead.

[Matthew Caufield, Analyst at H.C. Wainwright]

Hi. Thank you, guys. One question that we haven't really covered is looking back to Explore-CKD, what could be the next important catalysts or possible timeframes for further lorundrostat evaluation in CKD patients? Is that something on the radar at this stage, kind of above and beyond the PDUFA and launch focus? Thanks.

[Jon Congleton, CEO at Mineralys Therapeutics]

Yeah. Matt, Matthew, thank you for the call. This is why I'm excited to have both Terry and Dave here. Dave obviously has 5.5 Years experience with lorundrostat, and we're going to 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. We also think, and we've talked about this in the past, there's multiple mechanisms that aldosterone can drive, specifically things like inflammation, fibrosis, and oxidative stress that I think we've already seen what that translates to. I referred to it in my prepared remarks that in Launch-HTN we saw a 52% reduction in placebo-adjusted UACR, which is a clear marker of kidney protection.

[Jon Congleton, CEO at Mineralys Therapeutics]

We've 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's blood pressure, but I think there's an opportunity to really show value beyond just the blood pressure reduction, and that is around elements like heart failure, chronic kidney disease, and related conditions. So that's part of what we're continuing to analyze at this point. That's where Dave and some of his translational science team are really digging into what makes sense for the next clinical development of lorundrostat. I think we've validated the best-in-class profile as it relates to blood pressure reduction. We know where AstraZeneca and Boehringer Ingelheim are going with their ASI SGLT2 combos.

[Jon Congleton, CEO at Mineralys Therapeutics]

I think there are other interesting opportunities that we could pursue and other indications that we're contemplating. Once we've aligned on those final plans, as appropriate, we'll communicate that to the market.

[Matthew Caufield, Analyst at H.C. Wainwright]

Great. Thank you. Very exciting and looking forward to December. Thanks again.

[Jon Congleton, CEO at Mineralys Therapeutics]

Thanks, Matthew.

[Eric Warren, CCO at Mineralys Therapeutics]

You bet.

[Operator]

The next question is from Dennis Ding from Jefferies. Please go ahead.

[Dennis Ding, Analyst at Jefferies]

Hey, guys. Thanks for taking my questions. I have one and then one follow-up. Jon, you've always alluded to and emphasized that you guys are looking for a global partner. Can you go through exactly what you're looking for in a partner, at least on the U.S. side? And how important is it for a partner to have a presence in nephrology specifically? And the reason I bring that up is, and this is my follow-up, is because you've talked about leveraging your CKD data to get earlier line use in the third line. And I feel like that could be an area where you can get used more over AstraZeneca. So I'm wondering how much overlap with CKD is there in the cardio setting where you can perhaps go after that population with a cardio sales force?

[Dennis Ding, Analyst at Jefferies]

Or maybe it's a priority for you to go into nephrology in a dedicated way, either on your own or through partners. Thanks so much.

[Jon Congleton, CEO at Mineralys Therapeutics]

Yeah. Thanks, Dennis. We've stated before, and I think you even kind of alluded to it, our goal from a partnering standpoint has tended to be more of a global nature. We've stated pretty clearly that the commercialization of lorundrostat outside of the United States would be through a partner. But ideally we 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 one of those foundational nodes that are going to be really critical to address cardiorenal metabolic disorders. The CKD data that we have is very compelling, very interesting. 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.

[Jon Congleton, CEO at Mineralys Therapeutics]

It is not just hypertension and CKD, but it is hypertension, CKD, it is cardiovascular risk, be it in the form of heart failure or just overall cardiovascular risk. 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 Q&A session. I would like to turn the conference back over to Jon Congleton for closing remarks.

[Jon Congleton, CEO at Mineralys Therapeutics]

Thank you, operator. 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.

Participants

Executives

• Jon Congleton, CEO
• Adam Levy, CFO

Analysts

• Dan Ferry, Managing Director at LifeSci Advisors
• Eric Warren, CCO at Mineralys Therapeutics
• Richard Law, Analyst at Goldman Sachs
• Michael DiFiore, Analyst at Evercore ISI
• Jason Gerberry, Analyst at Bank of America
• Evan Wang, Analyst at Guggenheim Securities
• Analyst at Stifel
• Mohit Bansal, Analyst at Wells Fargo
• Rami Katkhuda, Analyst at LifeSci Capital
• Tara Bancroft, Analyst at TD Cowen
• Matthew Caufield, Analyst at H.C. Wainwright
• Dennis Ding, Analyst at Jefferies