Mineralys Therapeutics Q4 2023 Earnings Call Transcript

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Provided by Quartr
March 21, 2024

There are 9 speakers on the call.

Operator

Welcome to the Mineralis Therapeutics 4th Quarter and Full Year 2023 Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. This call is being recorded on Thursday, March 21, 2024. It is now my pleasure to introduce your host, Dan Thary of LifeSci Advisors.

Operator

Please go ahead, sir.

Speaker 1

Thank you, operator. Good morning, everyone, and welcome to our Q4 and full year 2023 conference call. Earlier this morning, we issued a press release providing our Q4 and full year 2023 financial results and business updates. A replay of today's call will be available on the Investors section of our website approximately 1 hour after its completion. After our prepared remarks, we will open the call for Q and A.

Speaker 1

Before we begin, I would like to remind everyone that this conference call and webcast contain forward looking statements about the company. Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business. These forward looking statements are qualified by the cautionary statements contained in today's press release and our SEC filings, including our Annual Report on Form 10 ks and subsequent filings. Please note that these forward looking statements reflect our opinions only as of today, March 21. 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.

Speaker 1

I would now like to turn the call over to John Cogglinton, Chief Executive Officer of Mineralis Therapeutics. John?

Speaker 2

Thank you, Dan. Good morning, everyone, and welcome to our Q4 and full year 2023 financial results and corporate update conference call. I'm joined today by Adam Levy, our Chief Financial Officer and Doctor. David Rodman, our Chief Medical Officer. I'll begin with a brief overview of the business and read some milestones, followed by David, who will discuss our clinical programs, and then Adam will review our Q4 and full year financial results before we open up the call for your questions.

Speaker 2

Looking back over the past year, we've had so much to be proud of at Mineralis. Our entire team worked together to achieve several key milestones on both the clinical and corporate level. I believe this success speaks to the dedication the team has to our exciting programs that target diseases driven by abnormally elevated aldosterone. In 2024, we're working towards achieving several clinical events, which are expected to expand the data package of lorondristat. We believe excess aldosterone is common and is a significant contributor in approximately 25% of all hypertension patients and is tightly linked to obesity.

Speaker 2

Aldosterone is also a significant driver of cardiorenal metabolic syndrome and thus our pursuit of an aldosterone targeted treatment approach that has the potential to benefit millions of patients who are impacted by hypertension, kidney disease and heart disease. I'm pleased by the significant progress our clinical team continues to make in implementing our development strategy for lorondristat. Most importantly, we remain on track with our pivotal program for hypertension, which includes the 2 pivotal clinical trials ADVANCE H10 and LAUNCH H10. ADVANCE H10 is the only study of an aldosterone directed therapy that we know of that is utilizing the standardized background treatment approach and we believe will be highly informative to lirondersat's profile. Since initiating the trial in April of 2023, we have found the rigorous nature of the trials design has impacted the pace of enrollment.

Speaker 2

As we discussed on our earnings call in November, we made some meaningful modifications to the Advanced HTM protocol and execution plan, while maintaining our focus on delivering the highest quality data set. Based on our modeling, we have narrowed our guidance for top line data delivery to the Q4 of this year. The trial is designed to allow us to demonstrate the value of lorondristat when added to standardized, optimized guideline background treatment in patients with uncontrolled or resistant hypertension as confirmed by 24 hour ambulatory BP measurement. We believe this trial has the potential to generate the highest level of evidence that will be important for potential inclusion in hypertension guidelines for treating physicians and for creating favorable access via the payers. We then initiated the launch HTN Phase 3 trial in the Q4 of 2023, is expected to have top line results in the second half of twenty twenty five.

Speaker 2

The objective of this trial is to model the real world setting of loroderstat when added to existing treatment for uncontrolled or resistant hypertension in the primary care setting. This trial is expected to enroll up to approximately 1,000 adult subjects. Throughout the past year, we published or presented follow-up data and analysis from the completed TARGET HTN trial, which was our Phase 2 trial of lirondristat in hypertension. These additional data have further supported our strategy for developing lirondristat as a targeted lirunderstat

Speaker 3

as a targeted approach

Speaker 2

to treat uncontrolled or resistant hypertension, as well as our design of the pivotal program. The latest example of this came in the 4th quarter when we presented the increased BMI was correlated with both increased leptin and increased aldosterone production. These data expand our understanding of mechanisms that may link the increasing prevalence of obesity to a parallel increase in uncontrolled and resistant hypertension. Our EXPLORER CKD Phase 2 trial for loranderstat in patients with hypertension in Stage 2 to 3b chronic kidney disease was initiated in late 2023. The intent of this proof of concept trial is to demonstrate the benefit of lirondrastat in reducing blood pressure and provide supportive evidence for the potential benefit on chronic kidney disease.

Speaker 2

The initial design was to compare the efficacy of lorondristat alone and in combination with an SGLT2 inhibitor in patients naive to SGLT2 inhibitor treatment. The evolving treatment paradigm in CKD resulted in the proportion of CKD patients being treated with SGLT2 inhibitors rapidly increasing over the past year. To the point where identification of SGLT2 naive subjects has proven to be greater than anticipated impediment to trial enrollment. Therefore, we will be modifying this trial designed to enroll patients who are either on SGLT2 inhibitors or naive to SGLT2 inhibitor treatment. Additionally, all trial participants will remain on an SGLT2 inhibitor throughout the conduct of the trial.

Speaker 2

Dave will provide more detail on the trial design changes, but these changes ensure that all trial participants have access to SGLT2 inhibitor treatment, while allowing us to achieve our objective of evaluating the benefit of lorondrastat on BP reduction in kidney disease. We continue to anticipate top line data from this trial within the prior stated guidance of Q4 2024 to Q1 of 2025. As I mentioned earlier, our team has been growing over the past year as we ramped up our clinical activities. We recently appointed Minji Kim as our new Chief Business Officer. She brings a solid track record of generating value for multiple companies and brings more than 2 decades of experience in business development, strategic leadership and scientific research.

Speaker 2

During her career, she has worked with biotech companies in the U. S. And overseas across broad therapeutic and technical areas. As you can see, we've built up a lot of momentum in our clinical program over the past year and are well positioned to continue executing on our clinical strategy. Let me now turn the call over to Doctor.

Speaker 2

David Rodman, Chief Medical Officer of Mineralis Therapeutics, who will provide additional details on our clinical program for lorondristat. Dave?

Speaker 3

Thank you, John, and good morning, everybody. Today, I'll provide an update on the pivotal clinical program for lorondristat and then I'll give a summary update on the revised Phase 2 EXPLORER CKD trial of lorondristat for hypertension and CKD. We were very pleased to announce at the end of the 4th quarter that we had dosed the first subject in our pivotal launch HTN trial. As John mentioned earlier, this is the second part of our pivotal clinical program for lorondrastat for treatment of hypertension. Total enrollment is expected to approximately 1,000 subjects.

Speaker 3

LAUNCH HTN is a randomized, double blind, placebo controlled 3 arm trial. The design is similar to the target HTN proof of concept trial enrolling subjects who will remain on their previously prescribed background regimen of 2 to 5 antihypertensives. Subjects will be randomized 1 to 2 to 1 to either placebo, once daily 50 milligrams of lirondrastat or once daily 50 milligrams of lirondrastat, but with the option to titrate up to 100 milligrams once daily as needed after week 6. The primary endpoint for this trial will be the change in systolic blood pressure as measured by automated office blood pressure, which was the same primary endpoint we used in target HTN. We believe this endpoint reflects a real world measurement that will be relevant to the primary care provider this trial targets.

Speaker 3

In addition, subjects from this trial will be offered the opportunity to roll over into an ongoing open label extension trial. Now turning to the pivotal ADVANCE HTN trial, we're progressing on track after implementation of the protocol changes and operational enhancements we discussed in our Q3 2023 earnings call. As John noted in his comments, Advance HTN is a state of the art, extremely rigorous hypertension trial designed and executed in collaboration with the very experienced cardiovascular research team at the Cleveland Clinic. We placed all trial participants on a standardized guidelines directed treatment regimen at maximum tolerated doses. In addition, we used real time we're using real time monitoring of adherence and blood pressure assessment utilizing the gold standard 24 hour ambulatory BP measurement.

Speaker 3

In this way, we exclude any subjects whose poor blood pressure control is due to non compliance, inadequate doses or choice of background medications or white coat hypertension. This ensures that an extremely high proportion of trial participants truly have uncontrolled or resistant hypertension. We also believe given the broad targeting of other standard mechanisms of hypertension, the randomized trial population will be enriched with aldosterone dependent hypertensive subjects more likely to derive benefit from lirondrastat. We believe that the overlap between obesity associated hypertension and aldosterone mediated mechanisms is fundamental and our pre specified analysis of the target HTN data presented in our JAMA paper last year supports that hypothesis. The planned analysis of the ADVANCE HTN trial includes a well powered confirmatory test of the predictive value of obesity on the efficacy of lorondrastat.

Speaker 3

We believe that in the clinical setting inability of an optimized 2 or 3 drug standard antihypertensive regimen to reduce blood pressure sufficiently to goal in the setting of obesity will be a straightforward approach to identifying candidates for treatment with lorongestat. In addition, we plan to continue to explore other positive and negative predictive tools using an unbiased artificial intelligence model to expand the repertoire of useful tools for targeting lorondristat to individuals most likely to derive long term clinical benefit. We expect to announce top line data from the ADVANCE HTN trial in the Q4 of 2024 and top line data from Launch HTN in the second half of twenty twenty five. Moving on to our hypertension and CKD program. As John mentioned earlier, we're making some modifications to our Phase 2 EXPLORER CKD trial ensuring all trial participants have access to an SGLT2 inhibitor.

Speaker 3

We believe this amendment better reflects the current treatment approach for subjects who have CKD. We'll be reducing the lower limit of baseline eGFR from 45 to 30 ml per minute per 1.73 meters squared, which will allow us to eliminate the original Part B profiling portion of this trial. Lastly, the treatment periods will be reduced from 8 weeks to 4 weeks, which we believe will still provide ample time to demonstrate clinical benefit on blood pressure as well as insights into kidney benefit assessed by albuminuria. The primary objective remains reduction in elevated systolic blood pressure, which we believe is an important contributor to progression of CKD, particularly in individuals with obesity and cardiovascular renal metabolic syndrome. In terms of how we'll be treating subject enrolled to date, they will be separately analyzed and offered participation in the open label extension trial contributing to the characterization of long term safety.

Speaker 3

We maintain our expectation to announce top line data in the Q4 of this year or the Q1 of 2025. We look forward to keeping you apprised of the status of lorunderstat development program. I will now turn the call over to Adam, who will provide a financial review for the Q4 and full year 2023. Adam?

Speaker 4

Thank you, Dave. Good morning, everyone. Today, I will discuss select portions of our Q4 and full year 2023 financial results. Additional details can be found in our Form 10 ks, which was filed with the SEC earlier today. We ended the year with cash, cash equivalents and investments of $239,000,000 compared to $110,100,000 as of December 31, 2022.

Speaker 4

In February 2024, we completed a private placement financing for gross proceeds of approximately $120,000,000 before deducting fees and expenses. We believe that our cash, cash equivalents and investments will be sufficient to allow us to fund our planned clinical trials as well as support corporate operations into 2026. R and D expenses were $70,400,000 for the year ended December 31, 2023 compared to $26,300,000 for the prior year. R and D expenses for the quarter ended December 31, 2023 were 23,700,000 dollars compared to $7,800,000 for the same quarter of 2022. The annual increase in R and D expenses was primarily due to increases of $21,400,000 in preclinical and clinical costs driven by the initiation of the loranderstat pivotal program beginning in the Q2 of 2023, dollars 9,000,000 in license fees achieving development milestones of lorondrastat in 2023, dollars 7,800,000 in clinical supply manufacturing and regulatory costs, $5,600,000 in higher compensation expenses resulting from additions to headcount and stock based compensation and $300,000 in other research and development expenses.

Speaker 4

G and A expenses were $14,300,000 for the year ended December 31, 2023 compared to $5,200,000 for the prior year. G and A expenses were $4,000,000 for the quarter ended December 31, 2023 compared to $2,200,000 for the same quarter of the prior year. The annual increase in G and A expenses was primarily due to $3,800,000 in higher professional fees associated with operating as a public company, $3,400,000 in higher compensation expenses resulting from additions to headcount and stock based compensation, $1,100,000 of higher insurance expenses primarily associated with new director and officer insurance policies and $800,000 in higher other administrative expenses. Total other income was $12,800,000 for the year ended December 31, 20 23 compared to $1,700,000 for the prior year. Total other income was $3,300,000 for the quarter ended December 31, 2023 compared to $900,000 for the same quarter of 2022.

Speaker 4

The annual increase was primarily attributable to increased interest earned on our investments in money market funds and U. S. Treasuries. Net loss was $71,900,000,000 for the year ended December 31, 2023 compared to $29,800,000 for the prior year. Net loss was $24,400,000 for the quarter ended December 31, 2023 compared to $9,100,000 in the same quarter of 2022.

Speaker 4

The annual increase was primarily attributable to the factors I described earlier. With that, I'll ask the operator to open the call for questions. Operator?

Operator

Our first question comes from the line of Michael DiFiori of Evercore ISI. Please go ahead. Your line is open.

Speaker 5

Hi, guys. Thanks so much for taking my question and congrats on all the progress. A few for me. Number 1, regarding the advanced HTN trial, any color on what we could expect in terms of placebo effect here, just given the standard background regimen, if we assume that equal amounts of patients will be on 2 versus 3 background drugs. I mean, I think that the literature suggests around 6 millimeters of mercury for non resistant hypertension versus 9 millimeters in resistant patients, but just want to get your view on that.

Speaker 5

And I have 2 follow-up questions.

Speaker 3

So just so I'm sure we're both on the same page. There's a run-in period on the background regimen during which we'll establish a new baseline due to those medicines. And then after that is when they'll enter a placebo be a it could be that there'd be a little residual effect, but I don't think it'll change much from what we saw. And in the target HTN study using ABPM, our placebo effect was under 2 millimeters of mercury. So I think it will be in that under 5 millimeter mercury range for most likely, not the larger numbers that you quoted.

Speaker 5

Very helpful. Other question too. Earlier this week, a competitor antihypertensive drug recently got approved with its label having a black box warning, a REMS program and other notable safety warnings. Despite all of this, and only having a 4 point roughly 4 point treatment effect, the drug was approved in a seemingly broad population. Just want to get your views on the KOL appetite for this drug given its benefit risk profile and how this approval bodes for lorongestrat?

Speaker 2

Yes. Mike, this is John. I think the introduction of any kind of new modalities is not a bad thing. We've seen an absence of innovation for well over 20 years in this space. We know the unmet need with roughly 50% of the treated population on getting the goal means that we need to have new approaches.

Speaker 2

As far as the KOL appetite for it, I think it's more broadly we haven't really dug into the details around interest in EPRIS and Tintan. The label was interesting and that creates a bit of a challenge. But again, I think the unmet need be met with new innovation. I think that's going to be valued by KOLs, certainly probably not in the first line category. But for us, our focus has always been on how do we bring a targeted approach, how do we bring that toolkit for prescribers so they can really identify those subjects that will have an enhanced response to lirondrastat.

Speaker 2

We're very confident what we've seen to date as it relates to the safety and tolerability profile of lirondrastat. That's why we're doing the broader pivotal program that we're doing to fully characterize that. But again, I think we're on the cusp of a lot of innovation that's needed given where the unmet need exists in this space right now.

Speaker 5

Got it. And one final question. Any color you could provide on OpEx guidance this year? On

Speaker 2

Mike, I'm sorry, OpEx guidance?

Speaker 4

Yes, Mike, this is Adam.

Speaker 5

Are you providing it? Yes.

Speaker 4

We haven't provided any guidance going forward on expenses. What we have said is that our cash runway brings us into 2026. We'll be running several clinical trials this year. So burn is expected to continue to ramp up.

Speaker 5

Thanks so much.

Speaker 2

Thanks Mike. Thank

Operator

you. Thank you. Our next question comes from the line of Greg Harrison at Bank of America. Please go ahead. Your line is

Speaker 6

open. Hi, good morning. This is Mary Kate on for Greg. Thanks for taking our question. Looking at the top line data expected later this year, what are your expectations for the advanced top line readout?

Speaker 6

And maybe what would be a success for you here?

Speaker 2

Yes. Mary Kate, this is John. It's hard to forecast forward. I think the if we look back at target HTN, we saw about an 8 millimeter to 10 millimeter placebo adjusted reduction in systolic BP across the whole population. We saw an enhanced response for those on a diuretic and obviously those with increased BMI.

Speaker 2

I think the way that we have framed the boat pedal programs to mitigate the risk is likely guiding to a similar response that 8 millimeter to 10 millimeter mercury reduction. Bear in mind that both advanced HTN and launch HTN have diuretic required as part of a background and we know that we saw an enhanced response with diuretic and lorondrastat. So I think that's a positive read through. The market research that we've done and we've done a pretty exhaustive amount of that with primary care as well as specialist. If you're in that 8 millimeter to 10 millimeter mercury improvement on a uncontrolled or resistant population, that's extremely meaningful.

Speaker 2

That's something they currently don't have access to when you're looking at the 3rd or 4th line agent being added. Typically with what's currently available when you add a 3rd or 4th agent, you get about a 5 millimeter to 6 millimeter mercury production based on extensive meta analysis. So that's why that 8 millimeter to 10 millimeter mercury resonates with prescribers. And particularly if we can bring forward the tool kit again to identify those subjects like an obese hypertensive subject that's going to have an enhanced response and we saw the 12 to 16 millimeter mercury improvement in target HTN. We'll see if that's replicated within this study.

Speaker 2

I think a point that it's why we're doing ADVANCE HTN in a more rigorous conduct and launch HTN with that standardized background is we truly are identifying subjects that are on the right drug at the right dose compliant and yet still uncontrolled and resistant. And I think applying lirondristat to that rigorous kind of study really gives us a chance to replicate and possibly improve upon the data that we saw in target HTN. But in a data set or a population, particularly for specialist, that's clearly uncontrolled and resistant without any questions around proper dose, proper compliance or white coat hypertension.

Speaker 6

Great. Thank you.

Operator

Thank you. Our next question comes from the line of Seamus Fernandez at Guggenheim Securities. Please go ahead. Your line is open.

Speaker 7

Great. Thanks for the question. So and congrats on all the progress. Just one of the questions we're getting from investors is the importance and impact of GLP-1s, specifically on the two things. Number 1, the flow trial is going to be presented at ACC.

Speaker 7

And I think there's some enthusiasm within the, I guess, cardiology and endocrinology community for those results and its impact of 1 milligram of semaglutide on the outcomes in patients with limitations in disease there. Just wanted to know what your thoughts are on the impact of GLP-1s on both weight loss and in a CKD patient population. And then second question is really on the baseline patient characteristics in advanced HTN. I assume that you've got a pretty good feel for what the baseline patient characteristics are kind of shaping up to. But just hoping that you'll reveal the baseline patient characteristics prior to the publication.

Speaker 7

And maybe you could just share with us what you think are the important measures that you'll be looking at in exploratory analysis? Thanks.

Speaker 2

Yes. Seamus, thanks for the question. The GLP-1s and the GLP-1 GIP and the GGGs are all obviously presenting really interesting data as it relates to weight loss and then as it relates to the corollary benefits to comorbidities. We like others are interested to see the full data set. I don't think it's overly surprising that you see weight loss reduction, you see improvement in overall cardiorenal metabolic health.

Speaker 2

I think that's been known for a long time through diet, exercise and everything else. I think the and I'll maybe have Dave add a point to this. From what we've seen of some of the data presented, I think it was with tirzepatide and some of the prior data over the last 3 to 6 months, there still remains significant residual risk that needs to be addressed. We think that addressing that broader cardiovascular and renal risk is going to be multifactorial. We know from frankly decades of research that aldosterone is a significant driver of hypertension, of CKD, of heart failure and heart disease.

Speaker 2

And that's where we think an ASI like lorondristat becomes a really interesting component of that broader treatment to get as much of the residual risk reduced as possible. But Dave, do you have any additional thoughts you want to add to that?

Speaker 3

Well, thanks John. I'm going to add a little bit to that and then I'll answer your second part of your question following that. So we get this question a lot. It's a really interesting question, right, that weight loss is going to be important in reducing risk. But what John referred to is this, the trial that he spoke about reported a 20% reduction in cardiovascular events, major cardiovascular events.

Speaker 3

But that really translated going from 8% incidence to 6.5%. So 8 per 100 versus 6.5 per 100. That's 20%. But in the real world, it's 1.5%. And there's still more than 6% event rate to improve upon.

Speaker 3

Weight loss is only part of it. John mentioned healthy lifestyle, exercise, all of these things, avoiding tobacco, these things all add together. And just having a drug that allows you to lose weight is not by itself a replacement for that. And so what we'll see over time is that people will look at this as a multifactorial treatment. The ideal would be these lifestyle changes, but in reality, there's a room for other medications to be combined.

Speaker 3

And that's what we're seeing in everything in cardiovascular, renal, metabolic, 34 drugs together making the difference. We believe our drug is going to be an important component of that. We will regardless of weight loss have the potential to lower all cause cardiovascular risk. There's a reason why Aldosterone targeted therapies are useful in things like heart failure. Our drug is a next generation approach to that.

Speaker 3

So I hope that just gives you some color for where we think it's not an either or and we're going to be obviously very interested in discussing this with companies that are focused on GLP-1s going forward. Now your second question was characteristics. What I can I'm not going to go into that in deeply, but what I'll tell you is this that we had a really nice demographic profile in the target HTN trial. 40% African American, about fifty-fifty male, female. We had about 50% on 2 drugs, 50% on 3 drugs.

Speaker 3

So our aspiration is to be in that range. And so far we've seen no reason to think we won't be in that range using the inclusion exclusion criteria we have.

Speaker 7

Great. And then if I could ask one follow-up. As you know, the reduction in the baseline eGFR from 45 down to 30, Can you maybe just talk a little bit more about the importance of that inclusion criteria?

Speaker 3

Sure, I can. So from a practical standpoint, the trial sites where we go to for trials like this are referral sites that have primary care doctors referring the patients to more specialized centers with chronic kidney disease. And so they tend to see enrichment with people with GFRs below 45, so Stage 3b. And so it will be much more efficient to include those in one arm instead of 2 different arms of the trial. Now one might ask the question though, since Part B also had a dose range discussion, are we is it important for us to be looking at dose ranging?

Speaker 3

One of the advantages of making sure everybody is on an SGLT2 is SGLT2s lower your potassium. And that's why there are 2 competitors in the space, let's say, AstraZeneca and Boehringer Ingelheim who are both committed to CKD trials now are looking at the combination. And so we'll be doing the same thing. So it's just a practical thing. Those two practical changes, everybody on an SGLT2 inhibitor in the trial and allowing the EGFRs down to 30 is going to be a much broader population, a much more efficient way to recruit the trial and will give us the same information we were looking for in terms of safety, efficacy of the combination.

Speaker 7

Great. Thanks so much. Appreciate it guys.

Speaker 2

Thanks, Seamus.

Operator

Thank you. And our next question comes from the line of Mohit Bansal of Wells Fargo. Please go ahead. Your line is open.

Speaker 8

Hey, this is Adam on for Mohit. Thanks for taking our question. My questions are for David with regard to the OLE study. So I'm trying to understand, firstly, instead of running a single arm OLE, you're pursuing one that includes a treatment withdrawal substudy. So I want to understand what you could ultimately drop from that approach there.

Speaker 8

And then secondly, does the inclusion of CKD patients in the OLE give importance around hyper kalemia risk or was this pursued for another reason?

Speaker 3

Okay. Well, thanks for the questions. And so just to break it down in its component parts. The first question was about the randomized treatment withdrawal. So the FDA requires that we do a randomized treatment withdrawal.

Speaker 3

And what that means is anybody who is in the open label extension on active and obviously they're on active drug who has a benefit on blood pressure, so they're informative, would then have be randomized to either stay on drug or go on placebo. They don't tell you how many, but it will be in the hundreds of subjects that go through that. The purpose of it is just to see what you would refer to as an on off on approach. In other words, they come out on a certain amount of drug, they go off it, then they go back on it. How reversible are these things?

Speaker 3

What time course, etcetera? We know our drug has a major advantage in that it's only got about a 10 to 12 hour half life, meaning that things like hyperkalemia, we can turn off and on very quickly. But we also can restore normal circadian rhythm. So aldo goes up and down the way it's supposed to. And so that's what that's for.

Speaker 3

So we expect to learn a lot about those details, but primarily it's because it's a requirement as well. So let me just stop there for a second. Did that answer your question, that

Speaker 6

part? Yes, thanks.

Speaker 3

Okay. So, another part of your question was about putting CKD patients in. What we're doing from a logistics standpoint is having 1 omnibus open label extension. But we don't we have to have an integrated safety database of every single patient who got even one dose of drug and they're going to be included in that. But beyond that, they're going to be a separate cohort that's analyzed within the trial.

Speaker 3

And so we'll be able to say, for instance, in subjects whose eGFR started at 30 to 45, what was their relative risk of a change in potassium? And that's very important because when we talk to experts at these referral center sites I mentioned, they're not in the least bit worried about potassium. They deal with it all the time. They use the new potassium binders and they just want that blood pressure to go down. So we'll be able to provide those data in that subset.

Speaker 3

And then for primary care docs who may see somebody with an EGFR of 60, they really don't want that patient's potassium to go up over a certain threshold because they're in a different space in terms of management. And so we're going to have very, very good control over saying in this subset, here's the safety profile. In this other subset, here's the safety profile. So I don't think we have concerns about suddenly getting a warning that you might get a high potassium. In fact, just the opposite.

Speaker 3

We're going to have a very informative set of data to go into the label.

Speaker 8

Appreciate the detail.

Operator

Thank you. And there are no further questions in the queue at this time. So this concludes the question and answer session. And I'd like to turn the call back to John Congleton for the closing remarks.

Speaker 2

Thank you, operator, and thank you everyone for joining us today. We're very excited about the progress we've made over the past year and advancing our clinical programs and remain enthusiastic about the upcoming 2024. We look forward to updating you as our pivotal program for lirondristat continues to advance. With that, we'll close the call.

Operator

Thank you. This now concludes the conference. Thank you all very much for attending. You may now disconnect your lines.

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Mineralys Therapeutics Q4 2023
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