Mineralys Therapeutics, Inc. Q3 FY2024 Earnings Call
Mineralys Therapeutics, Inc. (MLYS)
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Auto-generated speakersGreetings. Welcome to Mineralys' Third Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce Dan Ferry of LifeSci Advisors. Please begin.
Thank you, operator. Good afternoon, everyone and welcome to our third quarter 2024 conference call. After the close of market trading today, we issued a press release providing our third quarter 2024 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 in 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 11. 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?
Thank you, Dan. Good afternoon, everyone and welcome to our third quarter 2024 financial results and corporate update conference call. I'm joined today by Adam Levy, our Chief Financial Officer; and Dr. David Rodman, our Chief Medical Officer. I'll begin with an overview of the business, our clinical programs and recent milestones. Then Adam will review our third quarter financial results before we open up the call for your questions. I want to kick things off with a recap of the progress the Mineralys team has made these past several months, advancing our pivotal clinical development of lorundrostat in hypertension and then discuss the upcoming milestones we anticipate throughout the first half of 2025. We recently completed enrollment in our pivotal Advance-HTN trial which is evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled or resistant hypertension when used as an add-on therapy to a standardized background treatment of 2 or 3 antihypertensive medications. Subjects were randomized across 3 arms, including placebo, lorundrostat 50 milligrams once daily, or lorundrostat 50 milligrams once daily with the possibility to titrate up to 100 milligrams once daily. We announced the key characteristics of subjects enrolled in the trial include more than 66% of the subjects having a BMI equal to or greater than 30, more than 40% of the subjects are women and more than 50% of the subjects are Black or African-American. Notably, in terms of demographics, we took extra steps to broaden the diversity of the subjects in this trial to provide a better representation across different populations, with the goal of showing equivalency across race and sex. As a reminder, this trial was designed in collaboration with the Cleveland Clinic based on the most rigorous standards. The trial will be utilizing 24-hour ambulatory blood pressure monitoring or 24-hour ABPM, which is the gold standard for blood pressure measurement and historically has shown lower rates of white coat hypertension and has better managed placebo responses compared to other measurement approaches. Additionally, 24-hour ABPM has the ability to assess night-time blood pressure and night-time blood pressure dipping status which have been shown to play a role in adverse cardiovascular risk and outcomes. Advance-HTN is utilizing smartphone-based technology to track and manage participant compliance to lorundrostat with a partner called AiCure which helps ensure that participants take all medication as prescribed under the trial protocol. The primary endpoint for this trial is change in 24-hour ambulatory systolic blood pressure at week 12 from baseline for active cohorts versus placebo. The planned analysis includes several important subset analyses in an effort to identify predictors of enhanced response to lorundrostat, such as obesity that was demonstrated in the Phase II Target-HTN trial. Subjects with uncontrolled or resistant hypertension were stratified, providing balanced distribution across each of the 3 arms of the trial to allow us to perform a formal test in each population. We believe demonstrating robust efficacy in confirmed resistant hypertension, the area of highest unmet medical need, will be important in positioning lorundrostat for rapid access and uptake by payers and physicians. Positioning lorundrostat for obese uncontrolled hypertension patients who are at increased cardiovascular risk will provide an expanded market opportunity. In addition, as we accrue more experience and data with lorundrostat, we plan to continue to explore other positive and negative predictive factors including using artificial intelligence to expand the precision toolkit for targeting lorundrostat to individuals with uncontrolled or resistant hypertension who are likely to derive long-term clinical benefit. We look forward to announcing the top line data which we anticipate sharing in March of 2025. Moving to Launch-HTN, our second pivotal trial which is designed to be a confirmatory trial with the objective of evaluating lorundrostat in a real-world setting when added to a subject's previously prescribed anti-hypertension regimen. We were excited to announce just a few weeks ago that we completed enrollment in this trial. With enrollment of Launch-HTN completed ahead of schedule, we updated our guidance for top line data, pulling these results forward to mid-first half 2025. Launch-HTN is a Phase III trial of lorundrostat for the treatment of subjects with uncontrolled or resistant hypertension as add-on therapy who failed to achieve blood pressure control on their existing prescribed background treatment of 2 to 5 antihypertensive medications. Subjects enrolled in the trial who failed to achieve blood pressure control on their existing prescribed treatment were randomized 1 to 2 to 1 to either placebo, once daily 50 milligrams of lorundrostat, or once daily 50 milligrams of lorundrostat with the option to titrate to 100 milligrams once daily as needed at week 6. The primary endpoint for this trial will be the change in systolic blood pressure as measured by automated office blood pressure at week 6 for the pooled 50-milligram subjects compared to placebo. This trial is well powered at 6 weeks for the primary endpoint as well as subset analysis such as BMI status to inform the clinical label of lorundrostat. We believe this trial is reflective of clinical practice, utilizing the real-world in-office measurement and when lorundrostat is added to an existing treatment regimen that will be relevant to primary care providers. In addition to our pivotal program in hypertension, we are connecting the Explore-CKD Phase II clinical trial for lorundrostat when added to background treatment with SGLT2 inhibitor in patients with uncontrolled or resistant hypertension in Stage 2 to 3b chronic kidney disease. Enrollment is ongoing and we anticipate announcing top line data in the second quarter of 2025. Explore-CKD is a within-subject comparison trial designed to demonstrate the benefit of lorundrostat in reducing blood pressure and provide supportive evidence for potential benefit for subjects with chronic kidney disease on the background of stabilized SGLT2 inhibitor treatment. This proof-of-concept trial will enroll approximately 60 subjects with hypertension in Stage 2 to 3b CKD. Before I turn the call over to Adam, I just want to remind everyone that a replay of the KOL event we hosted October 30 is still available on the Investors section of the Mineralys website. We are very fortunate to have 3 leaders in the hypertension field join us on the call, including Dr. Luke Laffin of the Cleveland Clinic, Dr. James Luther of Vanderbilt University Medical Center, and Professor Rhian Touyz of McGill University Health Center. They each offered valuable insights on the unmet medical need in uncontrolled and resistant hypertension as well as the potential for lorundrostat to change the current treatment paradigm. We also included a detailed review of the ongoing Advance-HTN and Launch-HTN pivotal trials and their designs. I will now turn the call over to Adam to review our financial results for the quarter.
Thank you, Jon. Good afternoon, everyone. Today, I will discuss select portions of our third quarter 2024 financial results. Additional details can be found in our Form 10-Q which will be filed with the SEC tomorrow, November 12. We ended the quarter with cash, cash equivalents and investments of $263.6 million as of September 30, 2024, compared to $239 million as of December 31, 2023. The company believes that its current cash, cash equivalents and investments will be sufficient to fund its planned clinical trials as well as support corporate operations into 2026. R&D expenses for the quarter ended September 30, 2024, were $54 million compared to $22.5 million for the same quarter of 2023. The increase in R&D expenses was primarily due to increases of $26.1 million in preclinical and clinical costs, driven by the initiation of the lorundrostat pivotal program in the second quarter of 2023; $3.4 million in clinical supply, manufacturing and regulatory costs; $1.7 million in higher compensation expenses as resulting from additions to headcount, increases in salaries and accrued bonuses; and increased stock-based compensation of $0.3 million and other research and development expenses. G&A expenses were $6.1 million for the quarter ended September 30, 2024, compared to $3.8 million for the same quarter of the prior year. The increase in G&A expenses was primarily due to $1.7 million in higher compensation expenses, resulting from additions to headcount; increases in salaries and accrued bonuses and increased stock-based compensation; and $0.8 million in higher professional fees, partially offset by a decrease of $0.2 million in other administrative expenses. Total other income was $3.8 million for the quarter ended September 30, 2024, compared to $3.5 million for the same quarter of 2023. The increase was primarily attributable to increased interest earned on the company's investments in money market funds and U.S. treasuries. Net loss was $56.3 million for the quarter ended September 30, 2024, compared to $22.8 million for the same quarter of 2023. The increase was primarily attributable to the factors I described earlier. With that, I'll ask the operator to open the call for questions.
Our first question is from Michael DiFiore with Evercore ISI.
Congrats on all the progress. Three for me. First one is just in reviewing the Target-HTN data set, looking at the night-time blood pressure results and in the sensitivity analysis, even after the white coat hypertension patients were eliminated, you noticed that there wasn't any nocturnal dipping at 8 weeks in the 50-milligram QD group. Any color to explain that would be great. And then I have 2 follow-ups.
So this is Dave Rodman. Why don't I take that question. So first of all, you're absolutely right that the big value driver in 24-hour ambulatory measurements is, first of all, you get a lot of measurements, so you get much quieter data, a lot less noise. But you also get to segment it into night-time and daytime. And as you mentioned, night time is particularly important because untreated nocturnal hypertension is a big risk factor for adverse cardiovascular outcomes and MACE. So if I can point you first to the 100-milligram cohort where we had very little white coat hypertension, there, the night-time response to lorundrostat was comparable to what was seen in wakefulness, even though the dose was taken in the morning and those measurements were in the evening. And so that's what you would expect. The 50-milligram is a little more problematic to interpret because there was a very high proportion of patients who on the ABPM appear to have kind of lower blood pressure than they had with AOBP or so-called white coat hypertension. So we had to subtract all those people out to do the sensitivity analysis and when we did that, it was about a 50% reduction compared to daytime. I think it's unlikely that that's true because the numbers got too small. I do think the 100-milligram is probably a better guidepost. But in any event, we'll be looking and controlling for that in the trial. So we'll have the accurate answer for that.
I appreciate the information, Dave. I have two follow-up questions. We're currently examining the early safety data from the first-in-human study. I noticed that in the Phase I MAD trial, there was one instance of sinus tachycardia at 360 milligrams. How significant is the safety margin in relation to the NOAEL for 360 milligrams? Additionally, the same data set shows one case of dysgeusia at 40 milligrams. I'm curious about this because it could lead to a functional unblinding. Any insights on these two adverse events would be appreciated.
The first question pertains to the 360 milligrams dosage. This is a significant amount. The drug works by causing volume loss, leading to the excretion of sodium and water. This results in sinus tachycardia as a response to dehydration or volume depletion. This is not a safety issue but rather a pharmacodynamic effect observed in a healthy volunteer experiencing excessive volume depletion. We don't anticipate this effect at lower doses, particularly among hypertensive patients. Regarding your second question about dysgeusia, I don't have any information on that. It hasn’t reoccurred in our trials, and whether it relates to unblinding or not, it hasn't presented as a functional issue.
Very helpful.
Anything else, Mike?
No, that's it. Appreciate it.
Our next question is from Richard Law with Goldman Sachs.
A couple of questions from me. The first one is for Advance-HTN. You guys are tracking and proactively enforcing adherence. Can you discuss what is the adherence rate for Target-HTN? And how much do you think that adherence can improve in Advance-HTN?
So the question was what's the adherence rate in the Target-HTN trial versus Advance or... Jon Congleton: No, you're looking for what is the goal? Rich, can you restate your question again? Sorry.
Yes. For Advance-HTN, you are monitoring and actively promoting adherence, but you did not do this for Target-HTN. I am curious about the adherence rate for Target-HTN and how much you believe it could improve in Advance-HTN with proactive tracking and enforcement.
Sure. We only conducted pill counts when participants came in to check if they had taken their medication. We tried some technologies but didn't really utilize the data from them, which is why we ultimately opted for the AiCure method we are currently using. I can't provide accurate information about adherence since pill counts tend to be unreliable; people are aware of these checks and might just dispose of the pills. In the Launch trial, we are also monitoring adherence, but we aren't actively engaging with participants beyond normal reminders. We plan to conduct a subset analysis to address your question about the impact of non-adherence on responses, and we will perform a sensitivity analysis on participants who took more than 75% of their medication. So, I can't comment too much on the Target trial, but we will have an answer for you.
I see. Got it. And then another question. You guys mentioned a lower absolute SBP value with the ABPM measurement. How do you think about the placebo-adjusted ABPM and how would that change compared to placebo-adjusted AOBP, for example, in Advance-HTN? Is it safe to assume that both are very similar if the study is well controlled?
I'll quickly summarize that, Rich. Typically, with 24-hour ambulatory measurements, we see a variation of about 1 to 2 millimeters of mercury with the placebo. However, the 24-hour AOBP shows slightly more variability since it's an in-office measurement taken at a single point in time. In our Target-HTN study, using our method of taking 5 measurements in a quiet, unattended room and averaging the last two, we observed a change of about 4 millimeters of mercury. Previous studies with different methods, like the CinCor trials, reported even higher figures. Following AHA recommendations, we're consistently applying our technique for in-office measurements, not only focusing on 24-hour ambulatory data in Advance but also including in-office and in-home measurements. This gives us three different measures in Advance-HTN along with our in-office practice for Launch-HTN. We're confident we've managed the variables across these different techniques, which stems from our work with Target-HTN.
Rich, one other comment here is that the measurements with ABPM, because they average in night-time which tends to be lower in people that don't have say sleep apnea, tend to be about 5 millimeters mercury lower. And response to hypertension drugs is proportionate to the level of baseline blood pressure. So if you have a lower baseline blood pressure, you can go down less, so you have a little bit smaller response. So most people say you have 1 or 2 millimeters smaller placebo-adjusted treatment effect when you do ABPM versus AOBP. And then as Jon mentioned, those numbers are just shifted up with the ABPM. But there's more variability in the placebo effect there, so they're just a little bit noisier. Maybe that was more than you wanted to know but just thought I'd pass it on.
No, I think that helps a lot. So you're saying about 5 or so on an absolute basis. But once you adjust for placebo, that should be about 1 to 2?
I'm not entirely certain about that, but the key difference with ABPM is that due to the multiple measurements, the placebo effect tends to be quite small. Based on what I've seen in the literature, I would estimate it to be between 1 and 4. In a sufficiently large study, it's likely to be 1 or 2, which aligns with our Target study. With ABPM, we observed reductions of up to 7 millimeters of mercury. In the case of baxdrostat, they had a reduction of 9 in their first trial, which is quite significant. A reduction of up to 7 is generally acceptable, and we achieved a reduction of 4. We invested considerable effort to ensure we gathered the best possible data. However, as you conduct larger trials across more sites, you may encounter slightly increased variability. I'm not entirely sure I captured your question, but I hope this provides the clarity you were seeking.
Okay. Got it. And then just one final question. You guys mentioned greater than 66% of patients with BMI greater than 30. What is the power assumption for that like greater than 30 and less than 30 BMI group from that 66% number? I think you guys mentioned a 90% powering assumption for the overall group. So I just want to see what that powering assumption looked like once you go down to these prespecified subgroups.
Yes, Rich, thanks for the questions. Advance-HTN overall is 90% power for 7-millimeter mercury change relative to placebo. Launch-HTN, greater than 95% power for the same reduction. And we haven't disclosed at this point in time any of the subset analysis power calculations.
Our next question is from Annabel Samimy with Stifel.
I want to clarify a couple of things. For Advance-HTN, the main endpoint is at 12 weeks, with titration starting at 4 weeks. In Launch, the titration begins at 6 weeks, but the primary endpoint continues to 12 weeks, if I'm interpreting your presentation correctly. Is the 6-week period enough for that separation, considering the potential additional noise from real-world background medications? How are you handling the placebo response in this situation? Could there be more confounding results? And is 6 weeks sufficient? Why not extend it to 12 weeks with that level of background variability?
Yes, Annabel, appreciate the question. I think it's important to think of Launch-HTN very much as a confirmatory study to Target-HTN. There are a lot of similarities as far as the construct. As you know, in Target as in Launch, we allow subjects to stay on their background medication of 2 to 5 antihypertensive treatments. We have that 2-week run-in period on placebo, when we get them compliant to their existing background meds. We're using AOBP in Launch-HTN, same techniques, same technology that we used in Target. What we saw in Target-HTN was about 70%, plus or minus, of the effect at week 2. And by week 4, the vast majority of the effects. So we're comfortable that, that 6-week data readout, we're not going to be missing really any significant reduction in blood pressure within that time course, just based on what we saw within Target-HTN at week 4. And I'll just highlight that maybe one of the biggest distinctions between the 2 studies is we definitely saw a potential synergy with a diuretic in Target, where about half the subjects were on a diuretic. And by design, both in Advance and in Launch-HTN, all subjects are on a diuretic. So I think we've factored in the profile of lorundrostat within this confirmatory design of Launch-HTN that we don't feel we're going to be missing anything. Plus, as part of the secondaries, we will be looking at that 12-week time point for both the 50-milligram arm and the 50 up titrated to 100-milligram arm.
Okay. Understood. To revisit the previous question, I realize you haven't provided information on the data for obese compared to non-obese individuals. Is there a chance we could observe a statistically significant distinction between the two groups?
I believe we will be examining the prespecified subsets in both Advance and Launch, and the main advantage of moving the primary endpoint of Launch-HTN from week 12 to week 6 was not about power for the primary endpoint, but rather for those subset analyses. Therefore, we are very confident that if the trend continues as observed in Target-HTN, we will have the statistical power to demonstrate that. However, we need to review the data, as it will be part of the prespecified analysis, similar to what we did in Target-HTN.
Okay. Got it. And then to clarify, should we anticipate any dose response between the 50 and 100 milligram groups? Or is the focus more on ensuring patients reach the appropriate exposure to elicit a response, rather than specifically looking for a dose response? Should we simply be aiming for blood pressure control overall?
Yes, that's a great question. There are two ways to approach this. In the Advance study at 12 weeks, there will be three groups: a placebo group, a group that continues on the 50 mg dose, and a group that increases to 100 mg if they haven't achieved their goals. If individuals didn't have enough exposure to the 50 mg dose due to absorption issues, the 100 mg dose might address that. Additionally, if there is significant aldosterone production that isn't fully suppressed at 50 mg, the 100 mg dose could help. However, we won't know whether the issue is related to drug exposure or individual biological factors until we analyze future mechanistic biomarkers, which will take some time. I hope that answers your question, and you are absolutely correct.
Our next question is from Mohit Bansal with Wells Fargo.
This is Sadia on for Mohit. So you've outlined patient demographics for the Advance trial. I'm wondering if in Launch, you're targeting similar demographics in terms of the percentage of obese patients and the percentage of African-Americans. Will they be similar? Or should we expect differences in any of these? And can you remind us how these rates in Advance compare to the population that was enrolled in Target?
We haven't provided an update on the demographics of Launch-HTN yet, but we may do so in the future. For Target-HTN, the average BMI was 31 kilograms per meter squared. Among the Black or African-American population, it was around 39%, which is similar to what we saw in Advance. It’s important to note that both Advance and Target likely have a higher representation of Black or African-American participants than typically seen. We believe it's crucial to show equivalency in hypertension treatment response between Caucasian and Black or African-American patients, as disparities in response can occur with some anti-hypertensives. We aimed to evaluate this in our precision toolkit. Launch-HTN is a global study, and although there have been concerns about how this might affect the BMI impact, obesity's correlation with hypertension remains strong worldwide. Therefore, we don't expect the demographics of Launch-HTN to vary significantly from those in Target-HTN, even though it involves a global population compared to the U.S. focus of Target.
Jon, I'd like to add that there is a distinction between African-Americans and Black Africans, as well as the European population, which generally does not share the same mix of Caucasian genes. As a result, African-Americans tend to be more sensitive to aldosterone, and lower levels of aldosterone can lead to higher hypertension rates. This pattern is not observed in Europe. Therefore, since we have European sites included in our study, we will need to differentiate between these two groups, and we will do so.
Got it. That's helpful. And then with respect to the number of sites and geographies that are being enrolled in Launch versus the other trials, how are you thinking about the placebo response in Launch? Do you think there could be a higher placebo response? And was that part of your powering assumption for Launch?
Launch is highly effective due to the scale of the study and the similar effect size. If the concern is whether an increase in the placebo effect, which would impact both groups, will lead to more variability and reduce the study's power, the answer is that it won't pose a significant issue given the size and power of the trial.
Our next question is from Rami Katkhuda with LifeSci Capital.
Just a couple of quick ones from me. I guess, based on the inclusion criteria, Advance and Launch are recruiting patients with lower eGFR than those in Target? Does that have the potential to affect hyperkalemia rates at all in the pivotal studies?
You're right, Rami. We looked at 60 eGFR and above for Target. Based on that, we were comfortable going down to the 45 for both Launch and Advance. I think it's too early to tell at this point. We'll have to see what the data indicates. But we know from the 50-milligram arm in Target-HTN, we really saw a modest change in potassium similar to what you would expect with an ACE or an ARB. The Explore-CKD study where we're going down to an eGFR of 30 is allowable. We've actually reduced the dose to 25 milligrams QD. I think it's within that population that we want to move cautiously as we investigate lorundrostat in both the benefits as well as the safety profile, specifically related to this pharmacological effect on sodium and potassium.
Got it. Makes a lot of sense. And then in Launch, obviously, compliance is not being enforced as it is in Advance. Do you plan to do kind of an analysis of those patients who were compliant throughout the trial versus those who were not?
Yes. The technology of AiCure has been validated and represents a significant advancement in ensuring patients take their medication. For those who may not know, participants are required to photograph not only their background medications but also either the placebo or the active drugs, which are assigned randomly. They must also record themselves taking the medication. This method is being utilized in both Advance and Launch. In Advance, we actively follow up with participants who may not be compliant and remind them of the importance of adherence. In Launch, we are not doing that. However, we will conduct a prespecified analysis focusing on compliance, comparing those who are above 75% compliant with those below that threshold. This will allow us to assess the impact more effectively. Additionally, as Dave mentioned, we observed good compliance in Target-HTN, although we used less advanced technologies that are not entirely reliable. For instance, pill counts, while standard, can be manipulated by patients. We are continually working to implement technology that aids patients in fulfilling one of their key responsibilities, which is medication adherence. Currently, we are utilizing state-of-the-art validated technology to address a significant concern that has been prevalent in other contemporary hypertension studies.
Our next question is from Matthew Caufield with H.C. Wainright.
So you kind of touched on this with the powering. But for Advance-HTN, during the KOL event, it was mentioned that 6 to 8 millimeters of ambulatory BP benefit could be clinically meaningful. Does that range translate the same to potential target ranges or better for Launch and Explore to be considered successful?
Yes. Matt, I appreciate the call. Yes, I think the KOL call was really instructive because I think they started by highlighting the fact that 1 or 2-millimeter mercury change, particularly in a truly resistant or even uncontrolled hypertension patient, is meaningful as far as reducing cardiovascular risk. So it's always important to put that into context. I think the 6 to 8-millimeter that Luke Laffin alluded to in a broad population is absolutely on point. There's a clear correlation to reduced risk from an outcome standpoint. Based on the market research we've done with payers and with physicians, that's certainly within the realm of what's important and transformative for them. We've always guided that, that 8 to 10-millimeter mercury change that we saw in Target-HTN, if replicated in Advance and within Launch, would be truly meaningful to the market. And that's based on meta-analysis that show with currently available generic treatments, when you add a third or fourth-line agent, you typically get a 5-millimeter mercury further reduction in systolic. New advances like renal denervation or aprocitentan have found 4 to 6-millimeter mercury reduction. So that replication of 8 to 10 is truly meaningful. And if we find subsets, such as an obese population that have a more pronounced effect, that becomes even more transformative. And ultimately, the goal is getting patients below their prescribed BP goal. And that's something we'll be looking at within both of these studies as well. It's not only the absolute and placebo-adjusted reduction but what is the percent of subjects actually getting to goal and having a foundational shift in their cardiovascular risk profile.
Very helpful. And you would say that applies to Explore-CKD as well?
Yes, I think it does. It certainly does. In Explore, it's not only that benefit from a BP standpoint but really investigating what we think is now a de-risked benefit of an ASI in combination with an SGLT2 on renal function as well.
With no further questions in the queue, I would like to turn the conference back over to Jon for closing remarks.
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 2024 in advancing our clinical programs. And we remain enthusiastic about the upcoming data milestones planned for the first half of 2025. We look forward to updating you as our pivotal program for lorundrostat continues to advance. With that, we will close the call.
Thank you. This does conclude today's conference. You may disconnect at this time and thank you for your participation.