Mineralys Therapeutics, Inc. (MLYS) May 12, 2026 Conference Transcript

Hello, everyone.

Welcome back to our healthcare conference. My name is Dena Ramadine. I'm one of the U.S. biopharma analysts and pleased to present next company, Mineralis Therapeutics. From Mineralis, I have here with me today John Congleton. John, thanks for joining us. I'm just going to hand it over to John for some opening remarks before we dive into some Q&A.

Thanks, Dena. I appreciate it. I appreciate the opportunity to participate in the Bank of American Conference, always a positive conference for us. So John Congleton, CEO of Mineralis, we've had a very productive year and a half, I would say. Going back to last year with a lot of data readouts culminating in the NDA submission. We had our earnings call last week and announced that, you know, in Q1 we had the acceptance of the NDA, significant milestone for Mineralis. It puts us one step closer to getting lorandrostat to patients that fundamentally need this drug. That NDA, I'm very proud of what the team put together because I think it's a very distinct and differentiated data set that is going in front of the FDA for review. We have effectively five clinical trials showing the very consistent, robust benefit that lorandrostat has on lowering blood pressure, doing so safely with a predictable profile that I think fits easily into the current use case that physicians have for those uncontrolled and resistant hypers.

As we've talked in the past, is that better?

So obviously only you in the room got the opening preamble. So that data set to me is very important because it speaks to the 20 million patients in the United States that are on two or more meds and cannot get to go. For those of you that have met me in the past, you know I started my career as a sales rep in the hypertension space, and so I saw the great innovation and how transformative that was in the 80s and the 90s, but we've lacked innovation, fundamental innovation, for 20, 25 years. Aldosterone is the uncovered target that's going to help a significant portion of those 20 million patients get to goal. We think the data set that we have generated to date shows that benefit. The market research that we do, whether it's with patients or physicians or payers, the demand, the intent to prescribe, the interest, the enablement of access is all there. I think really focusing in on, and we started guiding to this at our earnings call, the resistant hypertension patient population is probably the beachhead. That's the low-hanging fruit. That's where there's just continuous churn within this marketplace that notes the dissatisfaction with currently available treatments, that notes there's still energy and interest in trying to get to goal or get closer to goal and that's where i think lorunderstack can certainly provide benefits so this year with the nda acceptance we're continuing to prepare for a successful launch for this molecule what that means is we've stood up a national account team in q1 we're having those pi or those pre-approval information exchange dialogues with the payers as we speak we've got msls out of the field going deeper into the advocacy space we know Baxter stat has potential FDA action coming up, but I think it's important to realize that while they may have six months ahead of us, we're not silent in that marketplace. We're having the dialogues with the key constituents, both Bayer's and KOL's that are gonna be important to really ensure we have a successful uptake of this drug, presuming positive FDA action later this year.

Great, you can dive a little bit more into some of the commercial things you outlined, behind, you know, looking ahead to LaRondra Strat's approval and potential launch, so with LaRondra Strat being about six months behind Baxter Strat's launch, what are you kind of looking to learn from AstraZeneca's launch? Is year one more about establishing product differentiation or just building out market and awareness for this, you know, new approach in the HTM space?

Yeah, I think it'll be interesting to see the label. It'll give us some insight into the FDA, how they viewed that package. That'll be informative for us as we head into our negotiations with the FDA later this year. What studies were included, the indication, how Section 14, which has all the clinical data. And then beyond just the approval, their launch, how they're thinking about pricing, access, go to market, all of that'll be very informative for us. I think that creates a bit of an advantage, being six months behind, is to see all of those moves and then we can kind of have our counter moves that we have in mind relative to that. The first year I think is going to be a little bit of both. I think it is going to be about building the awareness, building the awareness around the importance of targeting aldosterone, the use of an ASI relative to that, but also the differentiation between these two molecules, between these two data sets. Again, I think that data package that we have is going to speak very distinctly to the constituent prescribers within this resistant hypertension space. We know it's partially made up of cardiologists. It's why we did ADVANCE-HTN, probably the most challenging study done as far as any confirmed resistant and uncontrolled hypertension population. LAUNCH-HTN, the largest ASI hypertension study done to date, will speak to the primary care prescribers. And things like Explore CKD will also speak to the nephrologists who are dealing with patients with a lower AGFR with uncontrolled and resistant hypertension that is the number one target these nephrologists look for to help control CKD, and that is get their blood pressure below, or down to goal where it needs to be.

You put some numbers around kind of physicians that, you know, are responsible for a certain percentage of third line, you know, prescribing about 60K. Physicians are responsible for about 50% of that third line. and HTN prescribing, what is that split between primary care versus specialist, and what role do you see dedicated sales force versus DTC playing?

Yeah, it's, you know, when we think hypertension, we tend to anchor to the 120 million patients that have hypertension in the U.S. alone, and that immediately gives you this view, must be a ton of prescribers, and there are, but when you begin to get further into the lines of treatment, that population narrows. It's a typical pyramid of prescribing. To your point, we've noted about 60,000 doctors control about half of the prescribing third line and later. What's interesting about that is they also influence the other half because these are the top pyramid. They're easily in hypertension centers. Whether they're cardiologists or primary care, they're the ones that are driving the volume and they're influencing the other part of the volume. The split is about 60-40 primary care to cardiologists. It doesn't mean that there won't be nephrologists or even endocrinologists within that mix, but largely it's 60-40 primary care and cardiology. I think, you know, DTC is but a tool to use along this continuum. I think where I get excited about where we're at in 2027, which could be a potential launch year, is there are technologies digital that enable a company like Mineralis to actually act and be bigger than we are by footprint. So certainly we'll have the appropriate size sales force to affect the behavior of those 60,000 physicians, but we can also use digital non-personal power technology to extend the reach, augment those sales reps, get to white spaces where we may choose not to have sales reps, just as far as discrete uses of capital. So DTC, DTP, all of that may play a bit of a mix within that. Part of the goal, again, back to, I think, your question, it's a combination of raising awareness of the role of aldosterone, the need to target aldosterone, and then the differential story of Lerunderstatt.

You've kind of mentioned that fourth-line setting is where you at least initially see uptake for Lerunderstatt. Can you just speak to when we could see or when you expect expansion earlier to third line and what would the drivers behind that could be?

I think the way we view it and what we hear in the market research we do is at launch there could be interest and there even could be access. As we talk to payers, it's not just fourth line and only fourth line. And there are some payers that see the absolute need of helping their patients get to goal. You know, having their constituent, they being the payers, the PBMs, having their constituent population to goal is part of their quality score. So whether it's STARS or HEDIS, we're seeing hypertension, and getting those patients to goal is becoming more and more important to payers. So fourth line is kind of the ideal target. But third line, where it really gets more compelling for payers, for prescribers, is when there are comorbid conditions. So if you have hypertension and CKD, that's why we did the Explorer OSA study, because there's such an overlap of OSA with hypertension. So having those more complex patients, having a data set that speaks to that complex patient population is what I think begins to open third line. But I think also just in due time, that fourth line utilization, having access created, having physicians prescribing is then getting gender utilization earlier in the treatment paradigm. Because fundamentally that dysregulated aldostera doesn't just suddenly appear in a fourth line resistant hypertension patient population. And, frankly, they probably had it throughout their journey of treatment and are finally getting to a point where they need a very exquisitely targeted aldosterone therapy. So getting earlier in the lines of treatment is part of the story that Lerunderstat will have over its life.

And, you know, this is a space where kind of the hypertension guidelines, you know, pretty clear and drive a lot of the prescribing patterns. And so, you know, at what point do you kind of see the hypertension guidelines begin to incorporate the data from the launch and advance trials? And, you know, could it happen before launch? You know, what are your expectations kind of on timing for that?

Yeah, we've been meeting with various constituent bodies, meeting with KOLs who are part of those committees, making sure they're aware of, we'll understand our data set. The guidelines used to be fairly rigid. The guideline committees used to be fairly rigid as far as how frequently they would update the guidelines. I think they're acknowledging now that we're in a bit of a renaissance with new technology, new therapeutics coming in, have become less rigid. In other words, when there's innovations, they want to make sure that they're guiding their constituents on how to think about utilizing those. I don't know the specific timing of it. I do know that that's been something top of mind for us going back five years when we began meeting with Steve Nissen and Luke Laughlin at the Cleveland Clinic. That was why we did the advanced HTN study. Fundamentally, we wanted to go to the guideline committees with the absolute best form of evidence for inclusion. And advanced HTN, frankly, is probably going to be a bit of a lift for Baxterstat as a class, because we anticipate the class will be treated fairly similarly by those guidelines, but we definitely have the data set that will be most informative for those guideline committees and how to think about utilizing Leranderstat and ASIs in third and fourth line.

Mindful, you can't comment necessarily on label, but, and you touched upon this a little bit before, but what are your expectations, or sorry, what are the most important, like, label variables in your view? You know, how are you thinking about, you know, you mentioned comorbidities, the data you have being an important value proposition, and how do you think the Explorer CKD data could be kind of reflected in the label? And maybe your thoughts on doses, like how those would be, you know, is the 25 milligram dose going to be included in the label?

Yeah, I think, you know, it's back to one of your earlier questions, I think seeing the, presuming the positive action with Baxterstat, seeing their label is going to give us a little bit of insight into how the agency's looking at it. I think our working assumption is right now, both of these drugs will have near identical indication. So treatment for uncontrolled blood pressure or inadequately controlled blood pressure on top of background meds. It won't prescribe the number of meds. It won't prescribe resistant hypertension only. It'll just be fairly broad. And that's consistent with what the FDA has talked to us about for five years. So I think the indications will be quite similar. I think the Section 14 is where you'll potentially see some distinction. You know, BACS-H10 is certainly going to be core to that approval. What role does BACS-24 have? Other data they have, how does that get incorporated? From our standpoint, again, it's why we did a very distinct clinical development program for Lerunderstat. I would anticipate both launch and advance being included in Section 14. Explore CKD, the blood pressure reduction, which is, again, a very important thing to be able to convey to a nephrologist in a lower EGFR population. you can safely use this drug and see blood pressure reduction. We did include both 25 and 50 milligrams in the NDA submission. Again, it'll be part of label negotiations with the FDA, but we would anticipate both doses being available. We think that's important because when you get to patients that have more complicated, uncontrolled and resistant hypertension, such as those with lower EGFR, you've got to be mindful of the safety profile, specifically for the on-target adverse events like hyperkalemia, hyponatremia, change in EGFR. And so having the lower dose was important. It's why we tested that. And so I think fundamentally the distinctions that are seen with the clinical development programs have the potential to be seen and revealed within the distinct labels between these two. But again, time will tell, and that'll be part of the negotiations that we'll have with the agency later this year.

You mentioned hyperkalemia, what, do you think there's going to be a need for physician monitoring of potassium levels, if so, how frequently?

Yeah, I think the beauty of the ASIs is they fit within an existing treatment paradigm that physicians already have. And that's driven by ACE inhibitors and ARBs. They have a very similar profile. These are RAS inhibitors. At the end of the day, ASIs are part of that RAS system, and you see a very similar construct of response that fits the current use case. And what does that mean? That means currently when a physician prescribes an ACE or an ARB, they get a blood panel, they do blood pressure draw, they start them on an ACE or an ARB and bring that patient back in two to four weeks. Again they get a blood draw, they look at potassium, they look at sodium, they look a change in EGFR, and then they get a blood pressure measurement. The ACE inhibitors and ARBs tend to have that profile shift within about two to four weeks, and then it stabilizes. What we've seen with lorundristat is a very similar construct. Within two to four weeks, you see 70% or so of the blood pressure reduction. You see any increase in potassium, decrease in sodium, and change in EGFR occur within that two to four-week period and then tends to stabilize. And so that fits very nicely into the existing treatment paradigm that physicians have, and I think we're going to see that reflected in the label as well. So the labels for the ACEs and ARBs follow that construct. Get a blood panel, measure blood pressure, bring them back in two to four weeks, do the same, and then monitor periodically. So I would anticipate that's what the label will guide, and I would anticipate that's likely to be a class effect. I don't think there'll be a distinction between the two.

Maybe turning to the OUS opportunity. How are you thinking about the relative importance of the OUS market versus the U.S. market? And OUS, what, in your view, are the key geographies?

Yeah, the, you know, our goal ultimately, the purpose we talk about at Mineralis a lot is more better days. Three simple words that are fundamentally linked to what better control of blood pressure means for patients. We know, it's frankly why we'll get an outcomes claim if we get approved, because there's such strong linkage between lowering BP and better long-term outcomes. Our goal within that is to get this drug to as many appropriate patients as we can, and that's not just in the United States. That includes outside of the United States. I've been clear in the past that Mineralis will not be the one that will introduce Lerunderstat outside of the United States, that we'll do that through partners. We haven't guided to specific targets, you know, by region or by country, but it is important that we create access for patients, create partnerships that may be global in nature. That's where our main focus has been as opposed to regional, but to ensure that we get this drug to as many appropriate patients as we can.

Can you just give us the latest on your thoughts on the OUS regulatory submission? You know, is it gated by partnership discussions? What's kind of the timeline there? Just kind of, you know, your latest update there.

Yeah, I don't know that it's gated by partnering. I think we have the appropriate data set in hand. Certainly for Europe, Japan, we may need to build some additional in-population data. But even that, I think, is becoming more streamlined. we haven't given specific guidance on the regulatory. Our main focus right now has been on the U.S., on working with the FDA to get Larendra Stad approved in the United States and preparing from a commercial launch standpoint here in the U.S.

And on that commercial launch, maybe on thinking about the size of the field force, gearing up to invest in that, when do you kind of plan to update the street on sales and marketing costs to support your U.S. launch. What are some of the pushes and pulls relative to comp launches that historically might have involved a very large 700-person Salesforce team?

Yeah, we haven't guided on the size of the team yet or specifics around our go-to-market model. Part of that is just, frankly, a little bit of competitive protection so that we don't reveal our strategy too soon. We may do that in future guidance. To date, we haven't done that. If we feel it's appropriate, we want to, I think we've always tried to be as transparent as we can with investors, but we also need to be mindful of the competitive nature of the market we're going in.

Are you turning to pipeline and label expansion opportunities here? For OSA, you shared some data earlier this year. Just maybe curious your thoughts on that data. Did the phase two, you know, study design kind of limit the lower endocrats' ability to show benefit? Curious your thoughts there, and where does OSA kind of go from here? What's the path forward?

Yeah, I think it's important, you know, why did we do that study? We did that study because there's, when you get to a resistant hypertension patient population, you have a convergence of a lot of factors. It's not that patients just in isolation have resistant hypertension. I think about 85% of OSA patients have resistant hypertension. There's massive overlap with obesity within this population. And we saw that within the baseline characteristics of this study. I think the BMI average was somewhere 37, 38. A significant portion were morbidly obese with a BMI over 40. The AHI, which is the index of how severe your OSA is, is 48. Severe OSA begins at 30. That means they had 48 apnea hypotene events per hour, and they were resistant hypertension. This study was intended to be a quick four-week crossover design study. I think it was very informative for us. Again, we saw a very consistent reduction in blood pressure that we've seen, you know, had seen in five studies or four studies preceding that. So while we didn't see a signal in OSA, I don't know that it means the pursuit of that is done, because, frankly, future studies we're going to do, we're going to see that overlap, and we'll be able to continue to dig into that, see if with longer time, maybe in a less affected population, that that translates not only into a benefit on BP reduction, but potentially on the symptoms of OSA. But fundamentally, and make no mistake, lowering the blood pressure is what's improving the cardiovascular response. risk for this population. There have been countless studies, whether it's with CPAP, other agents that lower AHI, but have not impacted blood pressure. And so that does not change their cardiovascular risk profile. It's having that control of BP that fundamentally translates into that reduction in CV risk. And so that's why I think there's a lot of positive data that comes out of the study. It was not part of the NDA's submission, but by virtue of if we get approved for the reduction of blood pressure, we're going to be able to use that study as part of our communication, whether it's promotion or MedCom, because it's all about lowering BP in these more complicated patients.

And you spoke a little bit about this, but do these data impact your view on probability of success for other profiling studies or other adjacencies? heart failure, CKD, kind of those other opportunities for lower understrat?

No, I don't think it does. I mean, certainly CKD, explore CKD, de-risk that. In fact, it gave us a data set that would enable us to go in and speak to physicians who are treating patients with uncontrolled or resistant hypertension and CKD, lower EGFR. And that's why in that study we had a key exploratory was reduction in uacr and just in four weeks we saw a 30 reduction in uacr so clearly we we know there's a benefit with lorundostat on bp on kidney function and if you look at where the medical community is going as far as how they think about kidney disease and heart disease and heart failure they're not in these silos or isolated syndromes which is i think where the medical community was 15, 20 years ago. They're now realizing, and they're even doing the CKM initiative, that these are all interrelated. You go to a heart meeting, you're going to hear about the kidney. You go to a kidney meeting, you're going to hear about the heart. So aldosterone sits at the nexus of that. And I think we've progressively de-risked, obviously, lorandrostat for blood pressure benefit, but even beyond that, what it can do for kidney, for heart, likely for stroke as well. So I think hypertension is the beginning of the story, not the end, and I think where we've taken this molecule to date, de-risked the profile of it, opens up a lot of opportunities for further clinical development.

And on that further clinical development, should we kind of be thinking about, you know, these studies or how you're going to pursue, you know, these indications in the future? Is it about indication expansion versus label boosting?

I think it may be a little bit of both. It's part of the partnering dialogue as well. Partnering is not just about the commercial. It's not just about promotion either US or ex-US, but it's also about how we continue to expand the value of Lirondrastat in these other indications. If I look back at what we've done to date, and again, it's why we did very distinct studies, they really bolstered the hypertension profile itself. because, again, hypertension is not in isolation. It's driving these other conditions, showing a benefit on BP in these other conditions, builds that value prop, but it also is about indication expansion and just growing that value.

And how important are, you know, I know you guys haven't put out kind of a peak sales opportunity or anything there, but how important do you view these comorbidities to, you know, it's learned to stats, multi-billion peak sales opportunity?

I think it's, one, bolstering the use case for hypertension itself. Again, as we go out and speak to physicians and ask what attributes matter to you, we see reflected back that complexity that they're dealing with. And so having data that speaks to not only blood pressure, not only safety, but what's happening with the kidney, can I use this with a comorbid OSA patient, And all of that, I think, takes us deeper into that resistant and eventually uncontrolled and resistant hypertension population, so the penetration of lorunderstat into the use for that uncontrolled and resistant hypertension.

But then I think it also builds into, you know, other categories, kind of the end of the journey, so CKD, heart failure, heart disease. then could you uh discuss where the company's at from financial standpoint kind of cash cash runway um and maybe the importance of a partnership to extend cash runway and where that kind of fits in to um yeah your expectations of kind of gearing up to support the launch yeah our q1 earnings call, we noted we have about $646 million in cash, cash equivalents, and investments.

That takes us into 2028. That includes ongoing clinical development, corporate needs. That obviously includes a presumed commercial launch on successful FDA action. None of that is dependent upon any kind of partnering capital inflow. so that's it's an alternative that we continue to evaluate but we're very comfortable with our cash situation right now and how it covers us into 2028 great thank you so much Sean appreciate you being with us here today yeah happy to thank you