Mineralys Therapeutics Q3 2026 Earnings Call Transcript
Mineralys Therapeutics (NASDAQ:MLYS) reported third-quarter financial results on Wednesday. The transcript from the company’s third-quarter earnings call has been provided below.
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Summary
Mineralys Therapeutics is preparing for the potential FDA approval of Lorundrostat with a PDUFA target date of December 22, 2026, aiming to address the unmet needs in uncontrolled and resistant hypertension.
The company has presented promising clinical trial data, including results from the Phase 3 Launch HTN trial and Phase 2 EXPLORE OSA trial, demonstrating significant blood pressure reductions in patients with difficult-to-treat hypertension.
Mineralys has ended Q3 2026 with $624.7 million in cash, cash equivalents, and investments, projecting sufficient funds to support operations into 2028 despite increased G&A expenses related to commercialization efforts.
Commercial preparations are underway, with an established sales team, payer engagement covering most US lives, and a patient support program to facilitate access post-approval.
Management acknowledges competition from AstraZeneca’s baxdrostat but remains confident in Lorundrostat’s clinical profile and market potential, emphasizing synergy with existing treatments for patients with hypertension.
No immediate plans for partnerships were disclosed, but the company is open to opportunities that may expand Lorundrostat’s reach.
The company’s commercialization strategy emphasizes rapid access post-launch, targeting both commercial and Medicare pathways, although specific pricing and gross-to-net strategies remain undisclosed.
Full Transcript
OPERATOR
Greetings. Welcome to the Mineralys Therapeutics third quarter 2026 conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press 0 on your telephone keypad. Please note 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 (Investor Relations)
Thank you. I would like to welcome everyone joining us today for our third quarter 2026 conference call. This afternoon, after the close of market trading, we issued a press release providing our third 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 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.
Please note that these forward-looking statements reflect our opinions only as of today, November 4, 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 (Chief Executive Officer)
Thank you, Dan. Good afternoon everyone and welcome to our third quarter 2026 financial results and corporate update conference call. We’ve had an exciting and productive quarter and I look forward to sharing our updates. Today I’m joined by Adam Levy, our Chief Financial Officer, and Eric Warren, our Chief Commercial Officer. I’ll begin with an overview of the business and our recent clinical progress. Eric will then provide a commercial update and Adam will review our third quarter financial results before we open the call for your questions.
We are now just weeks away from our PDUFA target date of December 22nd. While the FDA continues its review of the NDA, our focus is on completing our launch preparations so that we are ready to reach patients soon after the potential approval of Lorundrostat. Approximately 20 million adults with hypertension treated with two or more drugs fail to achieve their blood pressure goal. The implications are clear: if people with hypertension can achieve their blood pressure goals, they are less likely to have poor outcomes that impact their quality of life and longevity.
Providing innovations to help people achieve their blood pressure goals is what drives our work every day. A critical part of that work is the publication and presentation of Lorundrostat data for the medical community to build awareness, understanding, and enthusiasm for its clinical profile. The major medical meetings this fall are giving us a series of opportunities to present data on Lorundrostat that highlight its differentiated profile. We recently presented new data at the AHA Hypertension Scientific Sessions and at ASN Kidney Week, and we have an important late-breaking presentation coming this Sunday at the American Heart Association Scientific Sessions.
We believe the data we have presented to date add to the strength of the data from our clinical program and suggest the potential of Lorundrostat to help patients with difficult-to-treat hypertension reach their guideline-recommended systolic blood pressure goals. These data include a new analysis of our pivotal Phase 3 Launch HTN trial. Participants in Launch HTN had uncontrolled or treatment-resistant hypertension despite being treated with two to five antihypertensive therapies. In this 12-week analysis, 46% of participants treated with Lorundrostat 50 mg achieved the AHA/ACC guideline-recommended office systolic blood pressure target of less than 130 millimeters of mercury, and more than two-thirds achieved a systolic blood pressure reduction of at least 10 millimeters of mercury.
We believe these are compelling data in a population that had previously not been able to reach their goal with existing therapies. We also presented the final results from our Phase 2 EXPLORE OSA trial in overweight or obese adults with moderate to severe obstructive sleep apnea and hypertension. As many as 70% to 80% of adults with resistant hypertension have OSA. Their nighttime blood pressure is often elevated and is considered a significant driver of cardiovascular risk. In EXPLORE OSA, Lorundrostat 50 milligrams taken once daily in the evening reduced morning systolic blood pressure by 11.1 millimeters of mercury at week four compared with a 1.0 millimeter mercury reduction with placebo.
Although we did not observe a measurable change in the apnea-hypopnea index, the blood pressure reduction was consistent with what we saw in our pivotal trials and the safety and tolerability profile was favorable, with no evidence of serious safety events including hyperkalemia. We believe these results further emphasize the potential of Lorundrostat in a high-risk subpopulation in whom blood pressure is particularly difficult to control. New long-term efficacy and safety data from our ongoing TRANSFORM HTN open-label extension trial will be featured in a late-breaking scientific presentation at the American Heart Association Scientific Sessions 2026 on November 8th in Chicago. Durable blood pressure control and a well-characterized long-term safety profile are important considerations for physicians managing a chronic condition like hypertension. We look forward to sharing these data with the medical community.
As we have discussed, aldosterone plays a central role in hypertension as well as other cardiorenal and metabolic disorders. We remain committed to advancing our work in aldosterone-driven disease states and are evaluating the next steps in the clinical development of Lorundrostat. Once we have finalized those plans, we will share them with you. We’re also excited to have two new board members join Mineralys as we prepare for the launch of Lorundrostat. Chris Peterson and Lonald Coates are two experienced executives that bring a wealth of commercial expertise to Mineralys at this juncture of our corporate life. They will be providing their insights, perspective, and experience to our management team as we prepare the market, the asset, and the company for commercialization. As a part of this transition, Derek Durocco, who joined the board while we were a private company, will be concluding his tenure at the end of this year.
I want to thank Derek for his support and guidance over the past several years during our development stage. With that, I’ll turn the call over to Eric to provide a commercial update.
Eric Warren (Chief Commercial Officer)
Thank you, Jon. Our commercial organization continues to execute against our launch preparation plans and we are advancing through the final stages of launch readiness. We believe we are well positioned to support awareness, drive adoption, and create favorable access soon after potential approval. Let me begin with the opportunity. As Jon noted, approximately 20 million adults in the US are living with uncontrolled or resistant hypertension, representing a large and underserved population with meaningful clinical need. Our commercial focus is on clearly communicating the potential value of Lorundrostat for appropriate patients relative to existing treatment options, including its potential to improve blood pressure control, help more patients reach treatment goals, and to do so with a safety profile supported by our clinical data package.
From an execution standpoint, I am pleased to report that our field sales team is now in place. In addition to our seasoned commercial leadership team, we have hired sales representatives with an average industry tenure of approximately 15 years. We have also continued to strengthen our medical affairs and medical science liaison capabilities. As Jon mentioned, our engagement with leading hypertension experts remains active with a focus on education around the unmet need in uncontrolled or resistant hypertension.
On the market access front, our engagement with payers now extends to the majority of US covered lives. Our discussions continue to center on the clinical and economic burden of uncontrolled hypertension and the value proposition supported by Lorundrostat’s clinical data package. These conversations continue to reinforce our view that payers recognize the unmet need in this patient population. In parallel, we are finalizing a full-service patient support program designed to help physicians, their office staff, and patients navigate access efficiently.
Our brand marketing efforts are also well underway, building the launch campaign we described last quarter, which is designed to educate both healthcare providers and patients. Taken together, we believe these efforts reflect launch readiness across the organization. We have built the team, advanced payer and provider engagement, expanded our educational infrastructure, and put the core launch capabilities in place to support the introduction of Lorundrostat, if approved. We remain encouraged by feedback we are receiving from physicians, payers, and patients, and we believe Mineralys is well positioned for launch.
With that, I’ll turn the call over to Adam to review our third quarter financial results.
Adam Levy (CFO & CBO)
Thank you, Eric. Good afternoon everyone. Today I will discuss select portions of our third quarter 2026 financial results. Additional details can be found in our Form 10-Q, which will be filed with the SEC today. We ended the quarter with cash, cash equivalents, and investments of $624.7 million as of September 30, 2026, compared to $656.6 million as of December 31, 2025. We believe that our current cash, cash equivalents, and investments will be sufficient to fund our planned operations, including the commercial launch of Lorundrostat, into 2028.
R&D expenses for the quarter ended September 30, 2026 were $22.7 million, compared to $31.5 million for the quarter ended September 30, 2025. The decrease in R&D expenses was primarily due to $8.5 million of lower preclinical and clinical costs resulting from the conclusion of the Lorundrostat pivotal program in the second quarter of 2025, and $0.3 million of decreased clinical supply, manufacturing, regulatory, and other costs. G&A expenses were $37.4 million for the quarter ended September 30, 2026, compared to $9.7 million for the quarter ended September 30, 2025. The increase in G&A expenses was primarily due to investments to expand our operations in preparation for commercialization, including $15.4 million of higher professional fees, $11.4 million of increased personnel-related expenses resulting from headcount growth and increased compensation, and $0.9 million of increased other administrative expenses.
Total other income, net, was $2.8 million for the quarter ended September 30, 2026, compared to $4.2 million for the quarter ended September 30, 2025. The decrease was primarily due to $3.2 million of increased interest expense related to the senior secured term loan entered into in June 2026, partially offset by $1.8 million of increased interest earned on investments as a result of higher average cash balances. Net loss was $57.3 million for the quarter ended September 30, 2026, compared to $36.9 million for the quarter ended September 30, 2025.
The increase was primarily attributable to the factors impacting our expenses that I described earlier. With that, I will ask the operator to open the call for questions.
OPERATOR
Thank you. We will now be conducting a question-and-answer 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 queue. You may press star two if you would like to be removed 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 poll for questions. Our first question is from Richard Law with Goldman Sachs.
Please proceed with your question.
Richard Law (Analyst)
Hey guys, congrats on the progress. Couple of questions for me. The first is, how do you think about baxdrostat’s launch results so far with that, you know, $9 million revenues in Q3 and then their comment about payer coverage and not expecting Medicare coverage until 2028? Anything stood out to you and anything that you can see can be done differently and improved on as a second to market? And I have a couple more follow-ups.
Jon Congleton (Chief Executive Officer)
Yeah, Rich, thanks for the question. Appreciate it. I think at a high level I’ll have Eric give you some more color. But at a high level I think we’re viewing the baxdrostat launch as a validation of what we’ve been talking about, that the demand is out there for ASIs to address, you know, this uncontrolled and resistant hypertension population, and that access or coverage is out there as well. So I think it’s validating those assumptions. But I’ll have Eric add some additional color.
Eric Warren (Chief Commercial Officer)
Yeah, thanks, Rich. So as you know, Q3 was the first full quarter for them, so it is still really early, and we don’t have any visibility into their rebates and buy-downs, so it’s difficult to form any kind of GTN correlations. But the initial prescription trends look favorable. 12,000 new patient starts is encouraging. I was also encouraged to see both primary care as well as specialists prescribing and the use in both resistant as well as uncontrolled hypertension.
And as you mentioned, most of the business is coming from commercial, but they are getting some Medicare reimbursement now through that exception process that we’ve talked about. And that’s why we deployed our account management team in the first quarter of this year to get an early jump on that payer engagement. We’ve been completing PIE discussions with the vast majority of payers and lives, and we also have that patient support program that I commented on during my opening remarks that are going to make a big difference for us, Rich.
Richard Law (Analyst)
Okay, got it. And then what is the development plan for lorundrostat beyond hypertension? Like, which indication is the top priority that will potentially be the next Phase 3 in development?
Jon Congleton (Chief Executive Officer)
Yeah, Rich, thanks for that. We’re obviously very enthusiastic about lorundrostat. We feel that aldosterone plays a significant role in driving not only hypertension, but frankly, comorbidities related to hypertension. We haven’t provided clarity on that yet. We’re continuing to evaluate it, and once we’ve locked in on a plan, we’ll be sure to share that with the marketplace,
Richard Law (Analyst)
I think. Got it. And there’s one last question to squeeze it in. I know we’ve been talking about partnership for some time. Is some form of partnership deal still on the table ahead of the upcoming launch? Yeah, thanks.
Jon Congleton (Chief Executive Officer)
Yeah, Rich, we’re always interested in getting lorundrostat to as many patients as we can. Partnering may be an aspect of that, and so we’re routinely evaluating that. We’re really not in a position to expand on specific activities at this time, though. Thanks.
OPERATOR
The next question is from Michael DeFiore with Evercore ISI. Please proceed with your question.
Michael DeFiore (Analyst)
Hey guys, thanks for taking my questions and congrats on the progress. Just two for me. Any initial thoughts you could share on the pricing versus access trade-off that you’re optimizing for? In other words, would you accept a meaningfully lower net price in order to secure broad non-exclusive access? And my second question is regarding the launch. I mean, will you allow the reporting of prescription data at launch, and if not, which metrics will be provided to inform progress? Thank you.
Jon Congleton (Chief Executive Officer)
Yeah, Mike, I appreciate the call. You know, as we’ve stated in the past, pricing is something that we’ll communicate, as well as, you know, our thoughts on access, engrossed in that, you know, sometime post-approval, post-launch. Our goal is really to ensure that when physicians and patients decide that lorundrostat is the right choice for them, that they have access to that. Part of that is price, part of that is the rebate strategy, and part of it is what Eric described as the patient support program.
As it relates to metrics that we’ll provide at launch, presuming approval, I think it’s premature to speak to that at this point. We’ll certainly provide that, I would suggest, you know, post-approval and likely subsequent launch, but we’ll try to provide visibility. We’ve tried to be transparent in the past as appropriate. I just don’t think this is the time right now.
Michael DeFiore (Analyst)
Thank you. Yeah.
OPERATOR
The next question is from Jason Durbury with Bank of America. Please proceed with your question.
Dina (Analyst)
Good evening, guys. This is Dina on for Jason. Congrats on the progress this quarter and thank you for taking the question. Just two quick ones from us. If baxdrostat’s PA is positive next year and baxdrostat then gets first-mover evidence in primary aldosteronism, do you see that primarily expanding awareness of the aldosterone biology and benefiting the entire ASI class, or is there a point where molecule-specific evidence begins to create a competitive advantage for baxdrostat, and what would lorundrostat need to do to prevent that?
And then just a quick question on kind of the label and discussions you’re having with FDA. We’re now, you know, inside seven weeks of the PDUFA and, without getting ahead of, you know, the agency, have your label and post-marketing conversations progressed in line with your expectations? And has anything changed in your view of the likely breadth of the label or post-marketing requirements? Thank you.
Jon Congleton (Chief Executive Officer)
Thanks, Dina. You know, we’re obviously very much focused right now on the NDA review with the agency. I would say the dialogues are proceeding at normal course. I would say we continue to anticipate FDA feedback on December 22nd on the PDUFA. As it relates to primary aldosteronism, I think there’s a lot of thinking that’s evolved over the six years I’ve been involved with Mineralys Therapeutics, that dysregulated aldosterone is really more of a spectrum as opposed to defined disease states.
Obviously it’ll be interesting to see that data. I think we’ve built out a very broad and diverse data set with lorundrostat, beginning with the proof-of-concept trial through our two pivotal studies in both apparent and confirmed hypertension, as well as in our EXPLORE programs looking at comorbid conditions such as CKD and OSA. So we feel very comfortable with the profile that’s emerged with lorundrostat. How physicians view accumulating data and what is viewed as class effect and what is viewed as specific, I think it’s a fair question. I think part of that will evolve over time. But we’re obviously very focused on the 20 million patients right now that are struggling to get to goal. We know the implications if they do not, and we think that’s where the imminent near-term opportunity is, presuming approval of lorundrostat.
Dina (Analyst)
Thank you.
OPERATOR
Thank you. Our next question is from Eva Wang with Guggenheim Securities. Please proceed with your question.
Evan Wang (Analyst)
Hey guys, this is Evan Wang. I’m here for Seamus Fernandez at Guggenheim. Just one from us. Curious, you know, just given the feedback from AstraZeneca on Medicare, curious how you guys are thinking about how important Medicare is, and do you see this as an opportunity to really level the playing field with AstraZeneca in terms of timelines? And are there any other considerations from the AstraZeneca side that could impact lorundrostat’s opportunity to compete?
Jon Congleton (Chief Executive Officer)
Evan, do me a favor, can you repeat the second half of your question? I got the first part.
Evan Wang (Analyst)
I was curious if there’s anything, like bundling-wise, that AstraZeneca could do that could negatively impact lorundrostat’s ability to compete. Thanks.
Jon Congleton (Chief Executive Officer)
Yeah, thanks for the question. You know, as Eric indicated, we’ve been obviously watching the baxdrostat uptake. We think it does reflect demand from a physician standpoint to address those patients that are uncontrolled and resistant, as well as access. We’ve gotten questions in the past about, you know, missing the bid cycle, as AstraZeneca did. Presuming we get approved, we won’t hit that bid cycle as well. Whether or not patients on Medicare will get access, they clearly—we know hypertension affects a significant amount of patients that are Medicare-eligible as far as their coverage, and so we’ll be looking forward to expanding that as soon as it’s accepted on the formulary, but it doesn’t preclude patients getting access to it, and so that’s part of where we’ll continue to focus, presuming approval at launch.
If I heard the last part of your question, as far as just competitive dynamics, I think one of the points I’d like to make is that, yes, there’s some natural competitive dynamics between lorundrostat and baxdrostat, and some distinct differences within the data sets. But I think fundamentally our focus is on the 20 million patients, less so on baxdrostat. I think if we got distracted and just thought about comparisons across ASIs, we’re missing the broader opportunity.
The market, I think, is primed at this point for an aldosterone-directed therapy that physicians can utilize with really robust, clinically meaningful blood pressure reduction, and doing so with a nice safety and tolerability profile. And so that’s where our focus is really on as we’re building out our commercial readiness, presuming approval,
OPERATOR
Our next question is from Mohit Banzal with Wells Fargo. Please proceed with your question.
Mohit Banzal (Analyst)
Great. Thank you very much for taking my question, and congrats on all the progress as well from my side. So, Jon, I want to talk a little bit about the segmentation of the market a little bit here, trying to understand in the resistant as well as uncontrolled hypertension, what proportion of the patients are overweight or obese? And I think the related question is that we’ll probably see found AO data next year for hypertension, and I think they’re going after 25 and higher BMI.
So it does look like GLP-1 actually lowers the blood pressure as well. So, like, how do you see the market evolving with your drug and also GLP-1s going in there for the segment of the patients who are overweight and obese?
Jon Congleton (Chief Executive Officer)
Thank you. Yeah, Mohit. Yeah, thank you for your question then. You know, look, at the end of the day, it’s really exciting times, I think, for patients dealing with cardiorenal metabolic disorders. You know, we’re seeing innovations just in the last several years that are making meaningful impact on their lives. We have clearly studied the benefit of lorundrostat in patients, whether they’re normal BMI, overweight, or obese. We’ve seen across that spectrum very consistent reductions in their blood pressure.
Clearly you’re seeing blood pressure reductions with weight loss, whether it’s GLP-1 or some other means. Typically it’s been about 5 millimeters of mercury, which, you know, is beneficial to patients, but certainly not in the realm of what we’ve seen, both in absolute figures of 15 to 19 millimeters of mercury between Advance and Launch, or even the placebo-adjusted figures of 8 to 11.7 or 11.6. Sorry, I don’t know that one precludes the other. Clearly there will be some patients that may be super responders on a GLP-1, but I think the vast majority of patients will likely need the continued benefits of a therapeutic like lorundrostat. And as you know, Mohit, we believe there is a tight correlation between that visceral adiposity and dysregulated aldosterone. And so for those patients, you know, hopefully they see good weight loss, but they likely will still have some level of visceral adiposity as well as elevated systolic BP.
So we think there’s actually some synergy there.
Mohit Banzal (Analyst)
Got it. Thank you, Jon.
OPERATOR
Our next question is from Rami Kakuda with Lifestyle Capital. Please proceed with your question.
Rami Kakuda (Analyst)
Hey guys, thanks for taking my questions as well. I guess building off a few previous questions, how quickly do you anticipate achieving broad payer coverage post launch and how should we think about the payer mix across resistant and uncontrolled hypertension patients? And then secondly, are there any historical CV drug launches that you view as relevant comps for lorundrostat, particularly about the time it could take to reach peak sales?
Jon Congleton (Chief Executive Officer)
Rami, let me have Eric address the first part and I’ll grab the second part of your question.
Eric Warren (Chief Commercial Officer)
Yeah, so from a payer coverage perspective, Rami, definitely commercial will lead the way in terms of providing that access or that coverage initially. But we will, and we do, anticipate Medicare coverage through the exception process. As I mentioned on a prior response, the Medicare exception process typically looks at the label, but it does require some navigation of that, which the PSP that we put forward is designed to support. So commercial will lead the way.
But don’t discount Medicare from the beginning because we will get that through the exception process. We’ll see progressive increases in that Medicare and expect a pretty equal contribution as we get to steady state.
Jon Congleton (Chief Executive Officer)
And Rami, as far as analogs, I think we’re living it right now. I think the baxdrostat launch, again, we’ve characterized that as very encouraging—encouraging on the validation of the demand and the access. So we’re comforted by that, and I think there’s even some signals of that with the oral PCSK9s that were reported recently by Merck. So there’s clearly a need within cardiorenal metabolic disorders for the kind of innovations that have come forward the last several years and we’re excited to be a part of that.
OPERATOR
Our next question is from Tara Brancroft with TD Cowen. Please proceed with your question.
Tara Brancroft (Analyst)
Hi, good afternoon. I have a similar kind of question, but I’m curious then—I didn’t hear in that response anything about guidelines, so maybe you could talk about how you think guideline inclusion will play out both for lorundrostat and in terms of the competitive dynamics of baxdrostat too. Like how soon do you think you could get the guideline inclusion and how important are guidelines for payer coverage and formulary inclusion?
Jon Congleton (Chief Executive Officer)
Thank you, Tara. We have been obviously focused on appropriately conveying the information about lorundrostat’s dataset across the spectrum of patients that we’ve studied, both the apparent confirmed from Advance HTN and our EXPLORER programs. There are at this stage multiple guidelines. Our expectation is that certainly at the beginning it will likely be in that fourth-line resistant hypertension. How the guideline committees reflect the ACEis relative to the MRAs—some of that is yet to play out, but I think there’s obviously compelling clinical evidence to put them on parity.
I would say that’s where our focus has been with the various guideline committee members. From a payer standpoint, I think it’s informative, but it’s not absolute. The payers, in the discussions that we’ve had and even the market research we’ve done going back several years, acknowledge they’ve got a real issue in uncontrolled and certainly in resistant hypertension. They understand the implications for the patients on their healthcare systems and the cost. And that’s why I think you’re seeing the kind of uptake we anticipated. What you’re seeing now with baxdrostat is an acknowledgement of that unmet need.
And so again, I think the guidelines will be informative but not absolute in how the payers make their reimbursement decisions.
Tara Brancroft (Analyst)
Okay, great. Thank you. And I just want to clarify one thing just on timing. When you’re doing contract negotiations with payers, can you start this during pricing labeling discussions or does it solely have to be after approval?
Eric Warren (Chief Commercial Officer)
Yeah, we’ve already started the engagement. We have a pretty good expectation of what payers are looking for, both from a clinical as well as a contracting perspective. Obviously, we haven’t finalized the price yet, so that hasn’t been revealed to the payer. But anticipate once we have approval a relatively quick engagement and to start turning over some of that access in very short term.
Tara Brancroft (Analyst)
Okay, great. Thank you.
OPERATOR
Our next question is from Matthew Caulfield with H.C. Wainwright. Please proceed with your question.
Matthew Caulfield (Analyst)
Hi, thank you. Hi, Jon and team, I appreciate it. What do you view as the top key points to lorundrostat differentiation to help drive the real-world preference at the prospective launch? And separately, can you speak more to the described patient support program, should that program be fully implemented by the possible launch timing? Thanks.
Jon Congleton (Chief Executive Officer)
Yeah, thanks for the questions. I’ll address the first one and have Eric address the second. I think the differentiation I would begin somewhat broadly, and that is we know from meta-analyses with the existing genericized treatments that when you add a third or fourth agent, you typically see a 5 to 6 millimeter mercury reduction in systolic blood pressure. That’s why I think our dataset’s very informative both in Launch and in Advance. When we look at patients, whether they’re on two meds or three or more, we’re seeing very robust reductions—15 to 19 millimeter absolute reductions in BP, which I think just highlights the fact that when patients get to that third or fourth line and still cannot get to goal, aldosterone is likely the culprit that is still keeping them from their goal. And so I think that’s, to me, the big opportunity again to really target those 20 million patients.
We’ve spoken in the past—when we think about how does lorundrostat compare to baxdrostat, I think the selectivity and half-life has yielded what we believe to be a very compelling clinical profile both on systolic blood pressure reduction as well as modest impact on on-target AEs, specifically hyperkalemia, hyponatremia, and eGFR change. So we feel that we’ve got not only compelling data but breadth of data again across apparent confirmed hypertension; based on race, you know that we efforted with intent to have great diversity in the trial with 28% Black or African American in Launch and 53% in Advance HTN. And so I think we’ve got a very compelling argument for physicians somewhat independent of who their patients may be that they’re dealing with regarding the patient support program. Yeah,
Eric Warren (Chief Commercial Officer)
Matt, in terms of timing, shortly after launch you can anticipate that patient support program, and for competitive reasons I won’t get into all the details. But as I did say in the predefined remarks, it’s important that it addresses both the HCP as well as their staff and the patients. So as you see the elements of our PSP unfold, don’t be surprised to see all three of those addressed.
Matthew Caulfield (Analyst)
Excellent. Thank you guys, and really looking forward to December.
Jon Congleton (Chief Executive Officer)
Thanks, Matt.
OPERATOR
Our next question is from Alice Needleton with UBS. Please proceed with your question.
Alice Needleton (Analyst)
Hi, thanks for taking the question. So just assuming FDA approval, how quickly do you expect to launch lorundrostat after the PDUFA date? And then I have a follow up. Thank you.
Jon Congleton (Chief Executive Officer)
Yeah, thanks, Alice. You know, presuming approval, our goal is to get lorundrostat into the hands of patients and access for physicians as soon as possible. We haven’t guided specifically to what that kind of timing would look like. That’s something we may provide post PDUFA date, but we haven’t guided to that yet.
Alice Needleton (Analyst)
Thank you. And then again on the AstraZeneca 3Q number—I think that’s the main focus of investors—it kind of implies a low net price in 3Q if you look at the IQVIA data. And assuming this is relating to payer access still developing and the high patient support burden with their access program, I guess lorundrostat will be launching into probably a stronger ASI coverage in 2027. So should we assume you will have a more favorable gross-to-net at launch, or will early 2027 still be challenging?
Eric Warren (Chief Commercial Officer)
Yeah, Alice, it’s Eric. So still really early and, as you mentioned, a combination of rebates and then some of those buy downs that they’re doing make it pretty difficult to truly discern where that GTN will land. And then in terms of providing comments about our GTN, probably a little premature to do that. But as I said, that payer engagement has been a priority to us—making sure that we have that rapid commercial and then obviously are pulling through that Medicare exception process.
So not going to speculate on our GTN, but we’ll start to reveal those details as we get closer and into launch.
OPERATOR
We have reached the end of the question and answer session. I would like to turn the floor back over to Jon Congleton for closing comments.
Jon Congleton (Chief Executive Officer)
Thank you, operator, and thank you all for joining us today. We are now just weeks away from our December 22nd PDUFA target date. Our focus is squarely on being ready to reach patients soon after potential approval. The new data we shared at AHA HTN and ASN Kidney Week add to the data supporting lorundrostat in uncontrolled or resistant hypertension, and we look forward to presenting long-term data from TRANSFORM HTN open-label extension trial at the American Heart Association Scientific Sessions this coming Sunday.
Our commercialization plans are on track, our engagement with physicians and payers continues, and we look forward to the potential to bring lorundrostat to millions of patients in need. On behalf of the entire Mineralys team, thank you for your continued interest and support, and we look forward to updating you on our progress.
OPERATOR
This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.
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