Mineralys Therapeutics - Q2 2023

Transcript

Operator (participant)

Welcome to the Mineralys second quarter 2023 earnings call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce our host, Dan Ferry of LifeSci Advisors. Please go ahead, sir.

Dan Ferry (Managing Director)

Thank you, operator. Good afternoon, everyone, and welcome to our second quarter 2023 conference call. Today, after the market closed, we issued a press release providing our second quarter 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&A. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in today's press release and our SEC filings, including our annual report on Form 10-K and subsequent filings.

Please note that these forward-looking statements reflect our opinions only as of today, August seventh. 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?

Jon Congleton (CEO)

Thank you, Dan. Good afternoon, everyone, welcome to our second quarter 2023 financial results and corporate update conference call. I'm joined today by Adam Levy, our Chief Financial Officer and Chief Business Officer, Dr. David Rodman, our Chief Medical Officer. I'll begin with a brief overview of the business and recent milestones, followed by David, who will discuss our clinical programs, then Adam will review our second quarter financial results before we open up the call for your questions. Mineralys is focused on addressing aldosterone-driven cardiorenal disorders that now include both hypertension and chronic kidney disease or CKD. We believe the growing prevalence of abnormal aldosterone levels is linked to the rising obesity epidemic. This shift in the underlying biology of hypertension, we believe in CKD as well, requires new therapeutics that reduce circulating aldosterone.

Based on our preclinical phase I and phase II data, we believe we have a highly selective, effective, and well-tolerated aldosterone synthase inhibitor in lorundrostat to address this growing need and make a meaningful difference in the lives of millions of patients. The first half of the year has been a very productive one for the Mineralys team, and we're expecting this momentum to continue through the second half of 2023 and into 2024. The most significant amongst our recent milestones is the initiation of patient dosing for the ADVANCE-HTN trial during the second quarter. This is the first of 2 clinical trials under the planned pivotal program to evaluate the safety and efficacy of lorundrostat for the treatment of uncontrolled or resistant hypertension, and we expect to have top-line data in the first half of 2024.

The second pivotal trial, LAUNCH-HTN, which will enroll a larger population of uncontrolled or resistant hypertension subjects, is expected to begin in the second half of 2023. We expect data from the LAUNCH-HTN trial in mid-2025. In addition, after completing either of the pivotal trials, subjects will be offered the opportunity to participate in an open label extension trial, which has already begun enrollment. This trial will contribute to our long-term safety data set. Last month, we announced the expansion of our clinical development of lorundrostat as a potential therapy to treat patients with Stage two to Stage four chronic kidney disease. The role of aldosterone in the progression of chronic kidney disease is well established. This study is anticipated to begin enrollment before the end of this year and will have top-line data readout in Q4 2024 to Q1 2025.

More than 35 million adults in the United States suffer from chronic kidney disease, and we believe lorundrostat has the potential to provide significant clinical benefit for many of these patients, given the role that abnormally elevated aldosterone plays in the progression of this disease. Let me now turn the call over to Dr. David Rodman, Chief Medical Officer of Mineralys Therapeutics, who will provide additional details on our ongoing clinical program for lorundrostat. Dave?

David Rodman (CMO)

Thank you, Jon. Good afternoon, everyone. Today, I'll provide an overview of the pivotal clinical program for lorundrostat that, as Jon touched on earlier, has commenced enrollment. I will then provide a summary overview of the planned phase II trial of lorundrostat for chronic kidney disease. Since the initiation of the ADVANCE-HTN trial, we remain on track. During this time, we have continued to onboard additional sites and randomize subjects into the trial. As a reminder, it is a randomized, double-blind, placebo-controlled pivotal trial that will enroll up to approximately 300 adult subjects with uncontrolled or resistant hypertension. Patients failing to achieve their blood pressure goal on 2-5 antihypertensive medications are eligible for the trial.

One-third of subjects will be randomized to placebo, one-third to 50 milligrams lorundrostat once daily, and one-third to 50 milligrams of lorundrostat once daily, and then increased to 100 milligrams at week 4 if the blood pressure goal has not yet been achieved and if they meet certain safety criteria. The primary endpoint of the trial will be change in systolic blood pressure, as measured by 24-hour ambulatory monitoring at week 12 in the 2 active arms versus placebo. We anticipate having top-line data from this trial in the first half of 2024. The second part of our pivotal program for lorundrostat is the larger LAUNCH-HTN trial, which is expected to be initiated in the second half of 2023.

This randomized, double-blind, placebo-controlled, three-arm trial is planned to have a similar design as the ADVANCE-HTN pivotal trial, except subjects will remain on their previously prescribed background regimen of 2 to 5 antihypertensives, including a thiazide or thiazide-like diuretic. In the LAUNCH-HTN trial, randomization will be stratified by body mass index less than 30 kilograms per meter squared versus greater or equal to 30 milligrams per meter squared. Approximately 1,000 subjects will be randomized 1 to 1 to 1 to either placebo, once daily 50 milligrams of lorundrostat, or once daily 50 milligrams of lorundrostat, with the option to titrate in a manner similar to the ADVANCE-HTN trial. The top-line data from the LAUNCH-HTN trial are expected in mid-2025. In addition, subjects from both pivotal trials will be offered the opportunity to roll over into an ongoing open-label extension trial.

As Jon mentioned earlier, we recently announced plans to initiate an expanded phase II trial of lorundrostat alone and in combination with an SGLT2 inhibitor as a potential therapy to treat patients with stage 2 to 3A chronic kidney disease. This trial will be conducted in 2 parts. Part A will be a proof-of-concept trial, with the primary outcome measure being change in proteinuria at week 12 compared to placebo. A very good surrogate for the registration endpoint, which is reduction in the rate of decline in glomerular filtration rate. Part A is a randomized, double-blind, placebo-controlled trial that will consist of 2 treatment periods. We plan on enrolling up to 100 subjects with mild to moderate kidney disease and persistent proteinuria, despite treatment with an ACE inhibitor or an angiotensin receptor blocker.

Subjects will receive either once daily combination treatment with 50 milligrams of lorundrostat plus 10 milligrams of Farxiga or placebo for 12 weeks. This will be followed by a second 12-week treatment period, during which subjects in the active arm will receive 50 milligrams of lorundrostat alone. As I mentioned, Part A of the trial will evaluate the benefit of lorundrostat in combination and alone on proteinuria in this population. Part B of the trial will be for profiling subjects with lower kidney function. This second part of the trial is an open-label, single-arm dose escalation trial that will enroll approximately 20 subjects with moderate to severe chronic kidney disease, with or without hypertension, despite treatment with an ACE inhibitor or an ARB.

Subjects will receive 4 weeks of treatment, once daily of 25 milligrams lorundrostat, followed by an increase in dose to 50 milligrams of lorundrostat for another 4 weeks. Part B of the trial will characterize the safety profile of lorundrostat in a more renally compromised population. As this is an exploratory trial, we may conduct interim analyses of the data at 1 or more time points. We expect to have top-line data from this trial between the fourth quarter of 2024 and the first quarter of 2025. The progress we continue to make this year speaks directly to the quality of our cross-functional team members, the equally important teams at our trial sites, and most importantly, trial subjects who anxiously wait for a new approach to treating their hypertension and associated aldosterone-mediated complications like chronic kidney disease and heart failure.

We look forward to keeping you appraised of the status of our pivotal program as progress on our journey to transform the antihypertension landscape unfolds. Now I'll turn the call over to Adam, who will provide a financial review for the second quarter of 2023. Adam?

Adam Levy (CFO)

Thank you, Dave. Good afternoon, everyone. Today, I will discuss select portions of our second quarter 2023 financial results. Additional details can be found in our Form 10-Q, which will be filed with the SEC later today. We ended the second quarter with cash, cash equivalents and investments of $282.8 million, compared to $110.1 million as of December 31, 2022. The company believes that its cash, cash equivalents, and investments as of June 30, 2023, will be sufficient to allow the company to fund its planned clinical trials, as well as support corporate operations through mid-2025. R&D expenses were $11.9 million for the three months ended June 30, 2023, compared to $5.6 million for the same period last year.

The increase in R&D expenses was primarily due to increases of $4 million in preclinical and clinical costs, driven by the initiation of the lorundrostat pivotal program in the second quarter of 2023, $1.3 million in higher compensation expenses as a result of additions to headcount, and $1 million in clinical supply, manufacturing, and regulatory costs. G&A expenses were $3.9 million for the three months ended June 30th, 2023, compared to $0.9 million for the same period last year.

The increase in G&A expenses was primarily due to $1.4 million in higher compensation expenses as a result of additions to headcount, $1.1 million in higher professional fees associated with operating as a public company, $0.3 million of higher insurance expense associated with new director and officer insurance policies, and $0.2 million in other administrative expenses. Total other income was $3.6 million for the quarter ended June 30th, 2023, compared to $0 for the same period last year, which was primarily attributable to interest earned during the three months ended June 30th, 2023, on the company's investments in money market funds and U.S. Treasuries.

Net loss was $12.1 million for the quarter ended June 30, 2023, compared to $6.5 million for the same period last year. The increase was primarily attributable to the factors described earlier. I'll ask the operator to open the call for questions. Operator?

Operator (participant)

Thank you. We'll 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 question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from Michael DiFiore with Evercore. Please go ahead.

Michael DiFiore (Equity Research Analyst)

Hi, guys. Thanks so much for taking my questions, congrats on all the progress. Two for me. I'll just... The first one regarding the phase III LAUNCH-HTN trial. It's, again, the, the design is similar to phase II, except that in this phase III trial, patients could be on as much as 5 background meds instead of the three that they are capped in in phase II. Could this non-standardized background regimen that could include up to five drugs cause a greater placebo effect? How should we think about the placebo effect here versus the much smaller, more tightly controlled phase II trial? I have a follow-up.

Jon Congleton (CEO)

Yeah, Mike, let me try to give you a background on that. Both ADVANCE-HTN and LAUNCH-HTN allow patients on 2-5 background meds. Now, we know in ADVANCE-HTN, we're taking them off of their prescribed treatment and putting them on a standardized treatment. As it regards LAUNCH-HTN, they could be on 2-5 meds. We will stabilize them on that prescribed background through a 2-week placebo run-in period. We believe that 2-week placebo run-in period should largely take care of what your question points out. Whether they're on two, three, four, or five meds, we'll make sure they're compliant, and we will use our AiCure smart technology to ensure that compliance.

If at that point, compliant on whatever the regimen is, from 2-5, they no longer hit the criteria of being hypertensive, then they would not be randomized. We think that stabilization on their background will give us a true sense of their blood pressure. If they continue to be above, I think it's 135 millimeters of mercury, then they'd be randomized. We're not overly concerned about the number of meds causing a odd reaction within the placebo group.

Michael DiFiore (Equity Research Analyst)

Got it. Very helpful.

Jon Congleton (CEO)

That's... And, Mike, I'd be remiss if I didn't say that's very similar to what we had with TARGET-HTN. TARGET-HTN was greater than 2 background meds, so we know that we had patients in TARGET-HTN on 2, 3, 4, or even 5 background meds, so it's a very similar construct. It's, at the end of the day, Mike, it's kind of the real-world version where we're tightly curating ADVANCE-HTN, generating Class 1 evidence. LAUNCH-HTN probably has a little bit more of a real-world feel.

Michael DiFiore (Equity Research Analyst)

Got it. Super helpful. Second question is, more of a big picture one. With the recent update to the CKD trial, it seems as if, you're no longer 100% certain that you'll be pursuing a separate, dedicated CKD indication, that it'll be dependent on how this phase II goes, and that this phase II's primary purpose is to support the, the hypertension indication. Just what led to the sudden change in, in, in expansion, wanting to expand the, CKD trial?

Jon Congleton (CEO)

Yeah, Mike, I appreciate the question. I'll go back to really the genesis of the company. Our focus has been from the beginning, how do we bring a targeted solution to both hypertension and beyond? Beyond for us was broadly cardiorenal indications. In the case of CKD, that's our first step into that beyond world of cardiorenal.

The reason CKD is such a natural fit is that we know that change in proteinuria is a really good marker to predict clinical response. For a CKD indication, that clinical response, as you heard Dave say, is slowing the rate of decline of glomerular filt, filtration rate. It's a really good marker for us to get a, a keen sense for the benefit that lorundrostat can add. I'll also point out that the CKD proof of concept study really serves two purposes, and one is to give us a de-risked view of what lorundrostat could do in CKD. We know that aldosterone plays a role there based on the therapeutics, based on research, and we know that lorundrostat does, you know, 65%-70% reduction in circulating aldosterone.

It'll give us an indication of the pot, the potential value in chronic kidney disease, but it will also show us the value in reducing proteinuria for the hypertension population writ large because we know there's significant overlap. We've done qualitative research with physicians, from endocrinologists, nephrologists, cardiologists, and really, next to the reduction of blood pressure and safety, probably the third rated attribute is benefit on proteinuria. This study basically serves two purposes. I think it really bolsters the attributes of lorundrostat as an antihypertensive, but it also gives us a real clear sense of what the benefit would be in the CKD population to inform future development in chronic kidney disease.

Michael DiFiore (Equity Research Analyst)

Got it. Very helpful. Thank you.

Jon Congleton (CEO)

Yeah, absolutely.

Operator (participant)

Our next question comes from Greg Harrison with Bank of America. Please go ahead.

Greg Harrison (VP ad Senior Research Analyst)

Hey, good afternoon. Thanks for taking the question. One on, on CKD. With that trial starting, and getting some interim looks, you know, in a little over a year from now, hopefully, what are you looking for in terms of proteinuria reduction that you think would be meaningful, and, and how that could translate, into eGFR benefit? Kind of related to that, how would you expect the efficacy you see there in CKD to be affected by, BMI, and how would that affect your later-stage development?

Jon Congleton (CEO)

Yeah, let me, Greg, appreciate the question. Let me answer the first part, and maybe I'll have Dave talk about the BMI component for it. You know, and I, I'm not going to guide to a range. I, I think there's a lot of evidence out there that that says if you can mitigate aldosterone, you see a benefit. We think reducing circulating aldosterone is a more complete way to do it. What you typically see with an SGLT2 inhibitor is a 30%-40% reduction in proteinuria over, you know, a 12-week period, which is the duration of our proof of concept study. We're looking for a clinically meaningful reduction beyond that. Don't know that I want to guide to that just yet.

As far as how that would directly translate to benefit in eGFR, I think it's premature to opine on that as well. We're clearly looking to find a meaningful addition. You know, we think there's significant need that remains, even though the SGLT2 inhibitors are quickly being adopted in the treatment of CKD. There remains a lot of unmet need, even with their advances. Let me turn it over to Dave, and he can address your question on BMI.

David Rodman (CMO)

Sure. Your question was, do we expect to see something similar to hypertension, where larger BMI results in more aldosterone and a better response? It's an interesting question. Typically, people who have proteinuria in this group of patients are often going to have type 2 diabetes, which is a product of obesity. I think the majority of subjects are going to be obese, and therefore, we probably won't have much of an opportunity to test at a statistical level whether the non-obese patients have a very different response. Also, the mechanisms that increase aldosterone in chronic renal disease are often related to just volume through the more classical pathways as opposed to obesity. Good question. We'll be looking for that, and we'll let you know.

Greg Harrison (VP ad Senior Research Analyst)

Great. Thanks for taking my question.

Jon Congleton (CEO)

Yeah.

Operator (participant)

Our next question comes from Jack Padovano with Stifel. Please go ahead.

Jack Padovano (Biopharmaceutical Equity Research Associate)

Hi, this is Jack on for Annabelle. Thanks for taking our question. Firstly, the ADVANCE-HTN study doesn't necessarily enrich for BMI, but in TARGET-HTN, the lower BMI patients had less of a benefit in systolic blood pressure reduction. Do you have any pre-specified analyses to identify the better efficacy in patients with BMI over 30? Are you sufficiently powering the trial to reach that sig, even if the 25-30 BMI patients turn out not to have that hyperaldosteronism link?

David Rodman (CMO)

Well, another great question. Well, your question was, since we're not stratifying for BMI, are we going to be able to look at the BMI effect? Just for clarification, we're stratifying for 2 drugs versus 3, and the reason we chose to do that is because it's critical in understanding whether this drug has a place as the third-line agent for hypertension, and we believe it will in people with high aldosterone, who, as you mentioned, are often obese. We do have pre-planned analyses looking at BMI as a categorical again, BMI less than 30 versus greater than or equal to 30 kilogram per meter squared, and we'll be looking for that. Now, your last question is a great question, which was: Are we powered for that?

That has as much to do with effect size as it has to do with the size of the trial. If we see a similar effect size difference to what we saw in TARGET-HTN, yes, we're powered for that, but it's not a primary, it's a secondary.

Jack Padovano (Biopharmaceutical Equity Research Associate)

Got it. Then a follow-up, if I may. On a more broad scale, can, can you talk about the level of monitoring you might anticipate will be required for lorundrostat compared to MRAs regarding hyperkalemia? Would you anticipate that to be as burdensome for physicians to monitor their patients?

David Rodman (CMO)

No, it won't be any more burdensome than the MRAs, and we'll be looking to see whether there's any evidence that our strategy, which is to, instead of blocking aldosterone production for the entire day with 50 milligrams, we do have a bit of a window so that subjects can excrete potassium later in the 24-hour period. There's reason to be optimistic that it will be low burden. What we're thinking will happen is that patients will be put on this drug, and as standard of care, they'll come back in 2 to 4 weeks for a blood pressure, and if at that time they'll have another serum potassium checked, they can be titrated, and the same thing will happen.

Then after that, unless there's a change or unless they have a very low eGFR, I think the burden would be pretty small, certainly no worse than an MRA.

Jack Padovano (Biopharmaceutical Equity Research Associate)

Got it. Thank you.

Operator (participant)

Our next question comes from Mohit Bansal with Wells Fargo. Please go ahead.

Mohit Bansal (Managing Director and Co-Head of Therapeutics Research)

Great, thank you for taking my question, congrats on all the progress. I have 2 questions. First one, what is the overlap between CKD and hypertension? I'm asking this because, if having some level of proteinuria data ahead of your hypertension launch could be helpful in the marketplace.

Jon Congleton (CEO)

Yeah, there's... Appreciate the question, and, and as you can imagine, there's a lot of different cuts of data. I think the data that we've reviewed and kind of the position we look at broadly for the market, it's probably 25, call it a quarter to a third of the hypertension population have some form of CKD. Conversely, probably 60%-80% of the CKD population have hypertension. Pretty significant overlap either way, and I think that's why, as we did our initial target product profile research with physicians focused on hypertension, proteinuria was an attribute that was very critical to them because of the significant overlap.

Mohit Bansal (Managing Director and Co-Head of Therapeutics Research)

Got it. This is very helpful. Just wanted to touch base on the enrollment progress so far, especially in the ADVANCE-HTN trial. Could you comment something on that front? How comfortable do you feel about the first half 2024 long data readout at this point?

Jon Congleton (CEO)

Yeah, we, we continue to feel good about first half 2024 top-line results from ADVANCE-HTN, continue to feel confident about mid-2025 for LAUNCH-HTN. Yeah, things are progressing as we anticipated, and that's why we're continuing to guide to data readout in the first half of 2024 for ADVANCE-HTN.

Mohit Bansal (Managing Director and Co-Head of Therapeutics Research)

Awesome. Thank you very much. Congrats on the progress again. Thank you, Jon.

Jon Congleton (CEO)

Yeah, absolutely.

Operator (participant)

Our next question comes from Rich Law with Credit Suisse. Please go ahead.

Rich Law (Equity Research Analyst)

Hey, guys. Good afternoon. I have 2 questions. Based on your discussion with the FDA so far, what do you, what do you need to demonstrate in order to get approval for the higher 100 mg dose? Also, what is the comparator arm for that based on your design? I, I also have 2 more questions.

Jon Congleton (CEO)

Rich, say the last part of your question. Based on the discussions, what would be required for what? For the 100-milligram dose approval?

Rich Law (Equity Research Analyst)

Yeah. For 100 mg dose approval and also what's the comparator arm for that dose?

David Rodman (CMO)

The way we're doing it is everybody's gonna get dose escalated with either placebo or drug, depending on which arm they're in. N- they won't know what arm they're in, and if they're on placebo, at 4 weeks, they'll get dose escalated to 2 placebos. The same thing for the 50-milligram group, only in the third arm will they get 50 milligrams active. That's how we blind it. Now, your second part of your question was, is there a specific set of guidelines for registering that arm as opposed to the 50-milligram arm? There isn't, and this is a very common label to do this sort of thing. The reason is it's always benefit risk. The benefit obviously can be greater when the exposure's greater.

Because you start at 50 milligrams, anyone who develops, say, mild hyperkalemia above the normal range won't be dose escalated. The safety profile will essentially be similar, if not the same, to 50 milligrams. It won't be the same as we saw in the TARGET-HTN trial, where we started everybody on 100 milligrams, because some of those people would have also responded to 50 milligrams, those people will no longer go up to 100. It'll be same rules, I think the safety will be similar to 50 milligrams, is my, is our thought. We don't know for sure, of course.

Rich Law (Equity Research Analyst)

Okay, got it. Just wanna confirm, so you guys would have 2, it's a 2 different placebo arms, one with the 50 mg and then one is the 50 mg that gets uptitrated to another placebo? So basically, there's 2.

David Rodman (CMO)

So let me-

Rich Law (Equity Research Analyst)

Sorry.

David Rodman (CMO)

Let me explain it. I'm sure I didn't, I didn't explain it clearly. There's only three arms. Everybody in this study is on one tablet that looks the same for four weeks, and then they all go to two tablets that look the same for the last eight weeks. The same people are on one tablet of placebo and then go to two tablets of placebo, but it's the same placebo group. The same thing happens in the other arms. It's one arm all the way along. It's one pill in each arm for four weeks, and then two pills in each arm for the last eight weeks.

Rich Law (Equity Research Analyst)

Okay, got it.

David Rodman (CMO)

Did I do any better?

Rich Law (Equity Research Analyst)

Yeah, no, I, I get it. A couple more other questions, too. How important is this second dose in the commercial strategy? How many patients or proportion of patients do you think would get this dose in a commercial or clinical trial setting?

Jon Congleton (CEO)

Yeah, Rich, this is Jon. I, I think it, its importance lies in, in what we saw in TARGET-HTN. We know that at a subject variability level, exposures can change, you know, from one individual to the next. We know that some patients, the 50 milligrams was, was a great dose, gave them a great clinical response, both from an efficacy and safety standpoint. We believe that for other patients, just because of how they metabolize the drug, and react to it, that they're gonna need a higher dose. So it, it becomes important to address that patient variability. Frankly, to fit in with, you know, an existing paradigm in hypertension, that is to titrate to dose.

We think it's, you know, providing clinicians and patients that flexibility, is invaluable to really acknowledge the individual, individuality of a subject. The latter part of your question, Rich, remind me again.

Rich Law (Equity Research Analyst)

The proportion?

Jon Congleton (CEO)

That I can't...

Rich Law (Equity Research Analyst)

Yeah.

Jon Congleton (CEO)

Yeah, it's, it's hard to say right now, Rich. I think we'll, with the size and scale of the pivotal program, we'll be able to obviously communicate that. We'll see that, right, to that third arm for patients that were on 50, they got to goal safely and those that required a higher dose. Right now, I wouldn't even want to hazard a guess. I don't know that fundamentally it will matter. The key for us is just getting the right dose for the right patient to get the right response.

Rich Law (Equity Research Analyst)

Okay, got it. Thank, thank you. Just one last question from me. I think you guys mentioned Particula as a SGLT2 partner or combo partner. Is there, like, how do you guys select this agent? Is there any potential to do other agents?

Jon Congleton (CEO)

Yeah, it's, it's a good question. You know, as we worked with our KOLs, Rich, it became really evident to us that there's a, a, a high level of similarity, you know, whether it's empagliflozin, dapagliflozin, canagliflozin. There, the responses that have been seen in CKD have been very positive but very consistent. For us, it was just a matter of let's pick the molecule that has a good safety profile, has a good body of evidence in CKD, and so dapagliflozin was the one for us. We also needed to make sure that we picked one to standardize the background response. Future studies that may become more open field to be on an SGLT2 inhibitor writ large, so it could be any of them. That'll be something we'll evaluate down the road.

For this proof of concept and to hold something constant, like background meds, we chose dapagliflozin.

Rich Law (Equity Research Analyst)

Great. Thank you so much.

Jon Congleton (CEO)

Yeah, absolutely.

Operator (participant)

There are no further questions at this time. I would like to turn the floor back over to Jon Congleton for closing comments. Please go ahead, sir.

Jon Congleton (CEO)

Thank you, operator, and thank you to everyone for joining us today. We're very excited about the progress we've made thus far in 2023 in advancing our clinical programs, and we remain enthusiastic about the upcoming milestones for the rest of the year. We look forward to updating you as our pivotal program for lorundrostat continues to advance. With that, we'll close the call. Have a nice day, everyone.

Operator (participant)

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.