Mineralys Therapeutics Q3 2023 Earnings Call Transcript

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November 7, 2023

There are 8 speakers on the call.

Operator

Good afternoon, ladies and gentlemen, and welcome to the Mineralis Therapeutics Third Quarter 2023 Conference Call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question and answer session. It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Please go ahead.

Speaker 1

Thank you, operator. Good afternoon, everyone, and welcome to our Q3 2023 conference call. Today, after the market closed, we issued a press release providing our Q3 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 up the call for Q and A.

Speaker 1

Before we begin, I would like to remind everyone that this 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 ks and subsequent filings. Please note that these forward looking statements reflect our opinions only as of today, November 7. 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 Cogleton, Chief Executive Officer of Mineralis Therapeutics. John?

Speaker 2

Thank you, Dan. Good afternoon, everyone, and welcome to our Q3 2023 financial results and corporate update conference call. I'm joined today by Adam Levy, our Chief Financial Officer and Chief Business Officer and Doctor. 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, And then Adam will review our Q3 financial results before we open up the call for your questions.

Speaker 2

It was only 12 months ago when we first announced The positive top line results from our Phase 2 target HTN trial of lorondersat in individuals with uncontrolled or resistant hypertension. We have since published additional data from the full analysis of the trial, which provided valuable insights supporting the potential use of lorondrastat to treat Uncontrolled or resistant hypertension. Most recently, we announced the full data from this trial were published by JAMA. And last week, we presented a new analysis further providing additional data showing obesity was predictive of an enhanced response to lirondirstat Across the continuum of BMI in a late breaking poster presented at ASN's Kidney Week 2023. The data in these recent publications support our strategy of developing lirondrastat as a targeted treatment for hypertension in CKD.

Speaker 2

Now let me provide some highlights from each of our clinical programs and Dave will cover further details in a moment. Starting with ADVANCE HTN, which is one of the most rigorous hypertension trials ever undertaken. The trial is designed to allow us We believe this trial has the potential to generate the highest level of evidence that will be important for potential inclusion in the hypertension guidelines for treating physicians and for access via payers. Based on the addition of a washout period at the end of advanced HTN, which David will discuss, And current enrollment trends, we are changing our guidance for top line data from the first half of twenty twenty four to the second half of twenty twenty four. We've learned a great deal over the past several months and continue to identify ways to optimize this trial, both in speed of execution and in selection of the right subjects.

Speaker 2

Launch HTN Phase 3 trial is the second of the 2 trials in our pivotal program for hypertension. We remain on track to initiate to existing treatment for uncontrolled or resistant hypertension in the primary care setting. We recently finalized the trial's The same primary endpoint we used in target HTN trial, which demonstrated proof of concept for lorondrastat in Hypertension. Launch HTN is anticipated to enroll up to approximately 1,000 adult subjects, And we now expect to be able to share top line results in the second half of twenty twenty five. EXPLORER CKD is our 2 part Phase 2 clinical trial for lorondrastat is a potential therapy to treat hypertension patients with Stage II to IIIb CKD.

Speaker 2

We expect to initiate the trial by the end of 2023 with top line data available in Q4 2024 to Q1 2025. Details of this trial's design were also recently modified, which includes a few updates from the proposed design mentioned on our last call, which David will discuss in detail in a moment. Lastly, the ongoing open label extension trial is designed to allow subjects From our hypertension and CKD trials to continue to receive lirondristat, which will provide long term safety and efficacy data on lirondristat. We're also pleased to add 2 new independent members to the Mineralis Board of Directors. Kathy Kuridis and Glenn Splendorio, both Bringing depth of experience, knowledge and expertise that will be beneficial to the company as we continue on our path to bring targeted treatment to patients with hypertension, CKD and beyond.

Speaker 2

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 our clinical strategy. Let me now turn the call over to Doctor. David Robin, Chief Medical Officer of Mineralis Therapeutics, We'll provide additional details on our clinical program for lorondristat. Dave?

Speaker 3

Thank you, John, and good afternoon, everyone. Today, I'll provide an update on the pivotal clinical program for lirendrastat and then I'll give a summary overview of the planned Phase 2 trial of lorendrastat for chronic kidney disease that we've named EXPLORER CKD. The ongoing ADVANCE HTN trial continues to enroll subjects. As a reminder, this trial, which we designed in partnership with the Cleveland Clinic, is a randomized double blind placebo controlled designed that will enroll up to approximately 300 adult subjects with uncontrolled or resistant hypertension. Patients who have failed to achieve their blood pressure goal on 2 to 5 antihypertensive medications are placed on an optimized 2 or 3 drug regimen along with real time compliance monitoring.

Speaker 3

This is one of the most rigorously designed trials to be conducted in hypertension, Optimizing for inclusion of truly uncontrolled or resistant hypertensive subjects. Subjects who fail to are then randomized into the trial. 1 third of subjects will be randomized to placebo, 1 third to 50 milligrams of lorongestat once daily and 1 mg of lorongestat once daily That has then increased to 100 milligrams based on pre specified criteria. The primary endpoint of the trial will be change We have classified 2 key secondary endpoints including the percent of subjects achieving 125 millimeters of mercury or below On the 24 hour ABPM and the correlation of change in 24 hour ABPM to BMI Body Mass Index in order to reinforce the obesity positioning relative to our targeted therapeutic strategy and potential label inclusion. For subjects in the ADVANCE HTN trial, the treatment withdrawal component of the program has been moved forward From week 48 of treatment in the open label extension trial to week 12 of the ADVANCE HEN trial, This amendment was implemented to add further value to the advanced HTN trial by characterizing the durability of changes in blood pressure, Pharmacodynamic and other laboratory assessments following the double blind treatment period.

Speaker 3

As John mentioned earlier, we revised our expectations on timing for the top line data from the trial. In consultation with our collaborators at Cleveland Clinic, We've implemented several changes to the protocol and in the operation of the trial. These changes resulted from an analysis of the inclusion and exclusion criteria and were designed to increase our randomization rate, while maintaining the rigor of the trial design. The second part of our pivotal program for lirondrastat is the larger launch HTN trial, which we continue to anticipate initiation in the second half of twenty twenty three. This randomized double blind placebo controlled 3 on trial This plan to have a similar design to the successful TARGET HTN trial enrolling subjects who will remain on their previously prescribed Background regimen of 2 to 5 antihypertensives.

Speaker 3

Up to approximately 1,000 adult subjects will be enrolled in this trial. Subjects will be randomized 1 to 2 to 1 to either placebo, once daily 50 milligrams of lorondrastat or once daily 50 milligrams of lorondrastat, but with the option to titrate in a matter similar to the ADVANCE HTN trial. The primary endpoint for this trial will be change in systolic blood pressure As measured by automated office blood pressure, which was the same primary endpoint as in the target HTN trial, We believe this endpoint reflects the real world measurement that will be most relevant to the primary care provider this trial targets. AOBP was the primary outcome measure in target HTN and performed similarly to ABPM. Given the objective of this trial is confirmation of the target HTN TROT results, we feel this is the appropriate primary endpoint.

Speaker 3

In addition, subjects from each of our trials will be offered the opportunity to roll over into the ongoing open label extension trial. As Kyle mentioned earlier, we recently finalized the protocol for the 2 part Phase 2 trial of lorondrastat In hypertensive subjects with Stage II to IIIb chronic kidney disease, as you may recall, on our previous call, we were considering including patients with and without hypertension. However, after discussion with our chronic kidney disease advisors, assessment of the unmet market need and the hemodynamic Profile of lirondrastat, we felt the inclusion of CKD subject with systolic blood pressure of 135 Millimeters of mercury or greater provides the greatest insight and value. Part A of the trial will be a proof of concept trial With the primary outcome measure being change in systolic blood pressure relative to placebo and the key secondary endpoint will be change in albuminuria, which is a surrogate endpoint that supports long term benefit in CKD. Part A is a randomized double blind placebo trial that will consist of 2 treatment periods.

Speaker 3

We plan on enrolling subjects with Stage II to IIIA chronic kidney disease And albuminuria despite treatment with an ACE inhibitor or an angiotensin receptor blocker, subjects will receive either once Daily combination treatment with lirondrastat plus 10 milligrams of dapagliflozin For placebo for 8 weeks, After a 4 week washout period, there will be a second 8 week treatment period during which subjects in the active arm will receive placebo and the subjects in the placebo arm from the 1st 8 week period will crossover to receive lorondristat alone. We will also be utilizing 25 once daily of lorondristat in this cohort based on our continued assessment of the target HTN data and the specific needs of this population. And as a reminder, we saw good activity for leurondrastat with a total daily dose of 25 milligrams in the target HTN trial. So we are confident in this adjustment to the dosing. Part B of the trial will characterize the safety profile of lorondristatin in a more renally compromised Population.

Speaker 3

The second part of the trial is an open label single arm dose escalation trial that will enroll approximately 20 subjects with Stage 3b CKD with hypertension despite treatment with an ACE inhibitor or an ARB. Subjects will receive 4 weeks of treatment once daily 12.5 milligrams of lirondristat followed by an increase in dose to 25 milligrams of lirondristat for another 4 weeks. Please note that the final trial dose in Part B is updated from the previously As subjects will now receive 12.5 milligrams and 25 milligrams once daily doses of lirondrastat Instead of the 25 milligram and 50 milligram doses, this decision is also in line with feedback from KOLs, The data from the TARGET HTN trial and with consideration for safety as the subjects in Part B will have even more severe chronic kidney disease. We're really pleased with the progress made in the strengthening of our plan for this new approach to treating hypertension and associated Aldosterone mediated complications like chronic kidney disease and heart failure. We look forward to keeping you appraised of the status of the lorondrostat development and Program.

Speaker 3

I'll now turn the call over to Adam, who will provide a financial review for the Q3 of 2023. Adam?

Speaker 4

Thank you, Dave. Good afternoon, everyone. Today, I will discuss select portions of our Q3 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 Q3 with cash, Cash equivalents and investments of $265,900,000 compared to 110,100,000 dollars as of December 31, 2022.

Speaker 4

We believe that our cash, cash equivalents and investments As of September 30, 2023, will be sufficient to allow us to fund our planned clinical trials as well as support corporate operations through mid-twenty 25. R and D expenses were $22,500,000 for the quarter ended September 30, 2023, compared to $6,100,000 for the quarter ended September 30, 2022. This was primarily due to increases of $12,400,000 in preclinical and clinical costs driven by the initiation of the lorondrastat Pivotal program in 2023, dollars 2,300,000 in clinical supply, manufacturing and regulatory costs and $1,700,000 in higher compensation expenses as a result of additions to headcount. G and A expenses were $3,800,000 for the quarter ended September 30, 2023 compared to $1,400,000 for the quarter ended September 30, 2022. The increase in G and A expenses was primarily due to $1,200,000 in higher professional fees associated with operating as a public company, $800,000 in higher compensation expense as a result of additions to headcount, dollars 300,000 of higher insurance expense associated with new director and officer insurance policies and $100,000 in higher other administrative expenses.

Speaker 4

Total other income was $3,500,000 for the quarter ended September 30, 2023 compared to $700,000 for quarter ended September 30, 2022, which was primarily attributable to increased interest earned on the company's investments in money market funds and U. S. Treasuries. Net loss was $22,800,000 for the quarter ended September 30, 2023, compared to $6,700,000 for the quarter ended September 30, 2022. The increase was primarily attributable to the factors described earlier.

Speaker 4

With that, I'll ask the operator to open up the call for questions. Operator?

Operator

Questions will be taken in the order received. Your first question is from Michael DiFiori from Evercore ISI. Please ask your question.

Speaker 5

Hi, guys. Thanks so much for taking my questions and congrats on all the progress. A few from me. On the advanced hypertension study, Just curious how many patients were already past the 12 week endpoint and had not undergone treatment withdrawal and would therefore need to be censored? And I have two follow ups.

Speaker 2

Yes. Mike, this is John. I appreciate the question. We haven't disclosed the number of subjects enrolled or at different points. So that's just something we haven't addressed at this point in time.

Speaker 5

Okay. Fair enough. So with regards to your Phase 2 CKD trial, I think on last call you said that SGLT2s alone reduced Proteinuria by 30% to 40% over 12 weeks and that the potential bogey for the combination regimen would be around a 50% plus reduction, which AstraZeneca's ZENITH trial of zybo-ten ten plus dapagliflozin Met at this past weekend ASN Conference this past weekend, I think the reduction was around 52.5. So based on your market research and conversations with KOLs like what's the willingness or appetite amongst cardiologists to use an effective anticancer treatment In this setting over an Aldosterone synthase inhibitor such as lorondristat?

Speaker 2

Yes. Mike, I appreciate the question. I think the 50% figure we've talked about before, I think that's kind of what we have in mind. Obviously, ASN this weekend, there was a lot of interesting data for both endothelin receptor agonists as well as ASIs from Boehringer Ingelheim. I don't know that we've gotten a lot of color from physicians on their interest in or not in using something like zybo-ten It was an interesting safety profile with that.

Speaker 2

From our standpoint, We think the BI data was confirming. I would say we anticipated seeing what BI reported with an ASI on top SGLT2 inhibitor, it's what has informed our thinking. I think the main takeaway for us, Mike, as we've been talking to KOLs is the need to have more than just say, one benefit. So in other words, rather than just have a benefit on CKD, having a new innovation that can provide benefit on hypertension while also providing benefit on proteinuria. That's where our focus has really been Drilling in on the last several months as we've spoken with KOLs as we've done our market research and that's where we think loranderstat really has a unique Profile and a unique opportunity to provide benefit for those patients that have progressive kidney disease, but also have concomitant hypertension.

Speaker 2

And then as we've spoken about in And then as we've spoken about in the past, there's pretty significant overlap between those 2. And so that's why we've made the adjustment we did in our trial because we think that's what the market really needs

Speaker 5

You actually preempted my question on Boehringer Ingelheims. I think that trial was 14 weeks long in combination with empagliflozin, which only showed about a 40% To the extent that you can, could you provide any color on if there's any fundamental potency differences between your drug and That drug which may explain why this 50% bogey wasn't met?

Speaker 2

Yes. A couple of thoughts on that, Mike. The interesting thing is if you dig into that data, empagliflozone Actually performed a little bit less than you would typically think, right? You made the comment about 25% to 30%. And when you look at that study, I think empagliflozin had about an 11% reduction in UACR and so the aldosterone synthase inhibitor, I think, As a delta performed probably equivalent to what was seen, if not maybe a bit better than XAVO-ten ten.

Speaker 2

The thing that was Interesting to note from our standpoint was the presence of adrenal insufficiency, which could be related to the selectivity of that Aldosterone synthase inhibitor. As you may recall, even at the highest doses in the target The study when we did ACTH testing, we saw no evidence of adrenal insufficiency even at the highest dose. So that was an interesting finding. I think the Comparing to cross trials can be somewhat challenging. I think the innovations with both are informative As we move into further development, I know for us, it was kind of a final piece of the puzzle with our thinking of EXPLORER CKD to see all of this data.

Speaker 2

But we're very excited to progress into that study. And again, we think the dual benefit of reduction in systolic BP as well as proteinuria It could be a really interesting component of the Lirunderstat story.

Speaker 5

Super helpful, John. Thanks for all the color. Appreciate it.

Operator

Thank you. Your next question is from Greg Harrison from Bank of America. Please ask your question.

Speaker 6

Hi, this is Mary Kate on for Greg. Thanks for taking our question. And also with your recent late breaking ASM presentation and anticipated presentation at I guess how do these analyses here highlight the potential target market for lorangestrat if approved in terms of target population and anticipated impact? Thank you.

Speaker 3

Well, this is Dave. Thanks for the question. Our theory from the beginning was that the really the highest unmet need was actually People with visceral obesity that are more and more populating what we used to call hyperaldosteronism. It's really a complication of obesity. And so we were gratified in our target trial to see that was true in the categorical evaluation we did Above and below 30 BMI.

Speaker 3

In the paper that we recently presented, the poster we presented, we did a continuous analysis looking from a BMI of 20 up to 40. And what we saw was there was a linear relationship, the higher the BMI, The greater the response and where it really became prominent in the regression line was at a BMI of 30 just like the Categorical, but what it also showed was there are people who are overweight, but not obese who are also good responders. And when we Paired it down, what we found was that about a third of the subjects in the trial had exceptional responses, 30 or more millimeters of mercury median response, really truly exceptional responders. Right now, we know that obesity is one of the key factors driving that to a lesser extent its exposure when you take the drug, Hence that's why we're moving the dose up to 50 up to 100 in people who don't achieve goal. And we're using other techniques including artificial intelligence now To identify other factors and ultimately our plan is to deliver a toolkit to practitioners to figure out who these people are.

Speaker 6

Great. Thank you so much.

Speaker 3

Thanks, Mary Kate.

Operator

Thank you. Your next question is from Jack Petrovano from Stifel. Please ask

Speaker 7

Hi, this is Jack on for Annabel. Thanks for taking our questions. So now that lorondostat has had data published and presented at multiple medical meetings, how is this exposure kind of help with the interest level for the ASI class overall? And do you think that cardiologists And primary care providers are more aware of the importance of targeting aldosterone now than they were before?

Speaker 2

Yes. Jack, this is John. I appreciate your question. I think we're absolutely seeing An increase in awareness, I think there's this growing groundswell of interest and focus on Aldosterone As really a driver of cardiorenal disorders, whether it's hypertension, whether it's CKD, whether it's heart failure, We're seeing that grow more and more in awareness and appreciation. I think that's Certainly tied to some of the really compelling data that's been put out.

Speaker 2

Some of it was a bit mixed Earlier with baxdrostat, I think with our data that's been very robust and showing a targeted effort and even some of the recent data by BI. So I think there's definitely an increase in interest and it's across the spectrum. It's cardiologists, it's endocrinologists certainly, nephrologists and primary care. I think that will just continue to grow as we continue to see more and more data published from subsequent studies from this exciting new class of therapy.

Speaker 7

Great. And then a follow-up, if I may. And this may be a longer term shift in the market, But how do you see GLP-1s changing the opportunity for you given their impact on obesity and on cardiovascular factors as they've been shown to reduce blood pressure themselves by a not insignificant amount.

Speaker 2

Yes. I think it's a really interesting point you make. As we think about The market writ large and maybe on that diabetes hypoglycemic side, As it relates to cardiorenal, I would say the blood pressure responses, while not insignificant or likely not as robust is what we have seen in the past, what we're understaffed and what we're after in 2 in a targeted approach. And again, that's where If you track some of the recent conferences, Jack, there's this growing focus not just on hypertension alone, not Just on CKD alone, not just on the heart failure, but on this cardiorenal metabolic syndrome and the fact that there's an interplay across all of These conditions and frankly, we think Aldosterone is probably one of the key contributors to that broader syndrome And having a drug that can have an effect across those conditions, we think it's going to be a true differentiating factor. And the GLP ones may be a part of that, But we certainly believe that ASIs are beginning to show a profile that's very robust at this stage on blood pressure reduction And potentially on proteinuria and we'll see beyond that.

Speaker 7

Great. Thank you.

Speaker 6

You mentioned some changes to the advanced HTN protocol amendments to increase randomization rates. Could you provide a little more color there? And if these are considerations you'll be taking forward to launch HTN trial design 2. And then secondly, we've touched on some of the competitors CKD readouts. But are there any learnings from these

Speaker 2

Yes. Let me maybe take The first one on the CKD learnings and I'll turn it over to Dave on the changes of advance and implications to launch. The CKD, I think as I alluded to in one of the prior questions, what we saw with the BI data was frankly somewhat anticipated. We know that aldosterone plays a role again in multiple conditions, CKD being one of them. I think The duration of our study that we have planned fits within the profile that we saw within the BI data as far as time to response.

Speaker 2

I think the additivity with an SGLT2 inhibitor was anticipated. That's why we built it within our program. So I would say largely what We saw presented this past week at ASN was affirming to the design considerations we put into EXPLORER CKD. Let me have Dave address your question about Advance and launch.

Speaker 3

Well, Dewey. Hi, Colleen. So, good question. When we went into design and execution on the ADVANCE trial, this was a trial that was a design that Had only seldom been used, but always acknowledged as the absolute ideal design. If what you want at the end is to be able to definitively say you have a treatment for resistant hypertension and hard to control hypertension.

Speaker 3

And so we were committed to it and remain committed to it. Now we understood though that Whatever estimations we made on enrollment, we're only going to be just that an estimation. And so we always plan to be evaluating that in real time And have the agility to put a protocol amendment in place once we felt like there was justification. And that's really what happened here. Let me give you two examples.

Speaker 3

So one sort of unanticipated thing was we put people on a very rigorous regimen and it includes a diuretic called Now, engapamide is somewhat like chlorthalidone. It's very potent. It's not often used even though it's admittedly or I guess the consensus is it's probably the most powerful one. And what we found was that so many people were actually on hydrochlorothiazide And they didn't want to stop it and neither did their doctors that that was the sole reason why they didn't want to be screened and entered in the trial. And so one of the learnings we have was that if we just allow people to use the maximum tolerated dose of hydrochlorothiazide, we could Fairly significantly increased the number of people who are willing to be screened to go in the trial.

Speaker 3

So that's one change we made easy to understand, Simple and it should have a pretty positive effect. Now if you look at the next date here, if you will, we put everybody on this very powerful regimen And quite a few people, even though they were on what looked like an okay regimen, their hypertension comes under control with these Easily prescribed medications. Now the other thing we do by the way is we do real time adherence monitoring. So everybody has to take their drug or we know it in real time. Between adherence and a better regimen, we lose a lot of people because they become under control.

Speaker 4

But what

Speaker 3

we noticed was if they start out with a blood pressure historically of over 145 millimeters of mercury systolic, Then they had a much higher prevalence of still having hypertension and getting randomized into the trial. So that's the second thing we've done, which is to provide a guidance to our sites to start screening pre screening the records for people whose blood pressures are on the higher side and only put them into the screening and stabilization standard regimen protocol. Those are just two examples. There are others, but those are pretty easy to understand and we expect that to have a fairly strong effect On increasing our screening and randomization rate. Oh, yes.

Speaker 3

You wanted to know about launch. I I forgot. Let me answer your last question, Colleen, I'm sorry, real quickly. The LAUNCH trial is designed to be a validation, Essentially a confirmatory trial for target HTN. So we're trying to keep it as close to target HTN as possible.

Speaker 3

We have a really good database there on This the inclusion exclusion criteria screening and randomization probabilities there. So We're using a few of the learnings, but we don't expect that trial to have the same spectrum of challenges that we're seeing And treating and handling now in the ADVANCE trial.

Operator

Thank you. Your next question is from Mohit Bansal from Wells Fargo. Please ask your question.

Speaker 6

Hi. This is Serena on for Mohit. Thanks for taking our question. I wanted to ask about CKD and How you're thinking about whether lorongestat would be best combined with diuretics to maximize reduction of pressure on the kidneys or SGLT to which would confer kidney benefits beyond the impact on blood pressure?

Speaker 3

This is Dave again. Thanks for that question. It's complicated, right? What drug should they be on? But the standard of care right now is for everybody to be on an ACE or an ARB And a diuretic, often a thiazide, but sometimes a loop diuretic.

Speaker 3

So those things are sort of a given. They're going to be used. And so our treatment would be add on to that. Right now SGLT2s are approved and known to be effective, But they're pretty expensive and access is still kind of limited. So the percentage of people on an SGLT-two is somewhat less.

Speaker 3

So But we anticipate by the time we launch, they'll be much more prevalent and also in standard of care. So the trial we're running will have people either on all three of those or just on the ASR and diuretics. So we'll be able to answer your question with data At that point and we're looking forward to seeing those data at that point. One thing I will mention though is the SGLT2 is lower your serum potassium And so there is an advantage to that combination because you have even less of a hyperkalemia risk, although we Haven't really seen that as a problem yet with lirondristat. Was there a second part to your question?

Speaker 3

No.

Operator

Thank you so much.

Speaker 4

You're welcome.

Speaker 2

Thanks, Serena.

Operator

Thank you. There are no further questions at this time. I will now hand the call back to John Kunkelton for the closing remarks.

Speaker 2

Thank you, operator, and thank you to everyone for joining us today. We're very excited about Progress we made thus far in 2023 and advancing our clinical programs and we remain enthusiastic about the upcoming milestones for the rest of the year and into 2024. We look forward to updating you as our pivotal program for lorunderstat continues to advance. With that, we'll close the call. Thank you.

Operator

Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. You may all disconnect.

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