Mineralys Therapeutics Q2 2025 Earnings Report

Mineralys Therapeutics EPS Results

• Actual EPS: -$0.66
• Consensus EPS: -$0.78
• Beat/Miss: Beat by +$0.12
• One Year Ago EPS: N/A

Mineralys Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Mineralys Therapeutics Announcement Details

• Quarter: Q2 2025
• Date: 8/12/2025
• Time: After Market Closes
• Conference Call Date: Tuesday, August 12, 2025
• Conference Call Time: 4:30PM ET

Mineralys Therapeutics (NASDAQ:MLYS), a clinical-stage biopharmaceutical company that develops therapies for the treatment of hypertension and chronic kidney diseases. It clinical-stage product candidate is lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone. The company was formerly known as Catalys SC1, Inc. and changed its name to Mineralys Therapeutics, Inc. in May 2020. The company was incorporated in 2019 and is headquartered in Radnor, Pennsylvania.

Mineralys Therapeutics Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Phase III trials LAUNCH HTN and ADVANCE HTN demonstrated significant placebo-adjusted systolic blood pressure reductions (up to ~11.6 mmHg) with lorundrostat and low rates of hyperkalemia, highlighting a strong benefit-risk profile.
• Positive Sentiment: A survey of ~300 cardiologists and primary care physicians showed 95 percent would likely prescribe lorundrostat for uncontrolled or resistant hypertension if approved, indicating robust physician demand.
• Positive Sentiment: In the EXPLORER CKD trial, lorundrostat added to an SGLT2 inhibitor achieved clinically meaningful systolic blood pressure reductions and significant UACR decreases comparable to current standards, supporting renal protection benefits.
• Neutral Sentiment: The ongoing EXPLORER OSA study will assess lorundrostat’s impact on apnea-hypopnea index and nighttime blood pressure with topline data expected in 2026, exploring its role in comorbid obstructive sleep apnea.
• Positive Sentiment: The company reported $324.9 million in cash, cash equivalents, and investments at quarter-end, providing a financial runway to fund operations and clinical programs into 2027.

Presentation

[Operator]

Greetings, and welcome to the MINeralis Second Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Thank you. You may begin.

[Daniel Ferry, Managing Director at LifeSci Advisors, LLC]

Thank you, operator. I would like to welcome everyone joining us today for our second quarter twenty twenty five conference call. Earlier this afternoon, we issued a press release providing our second quarter twenty twenty five financial results and business updates. A replay of today's call will be available on the Investors section of our website approximately one hour after its completion. After our prepared remarks, we will open the call for Q and A.

[Daniel Ferry, Managing Director at LifeSci Advisors, LLC]

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 ks and subsequent filings. Please note that these forward looking statements reflect our opinions only as of today, 08/12/2025. 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.

[Daniel Ferry, Managing Director at LifeSci Advisors, LLC]

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

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Thank you, Dan. Good afternoon, everyone, and welcome to our second quarter twenty twenty five financial results and corporate update conference call. I'm joined today by Adam Levy, our Chief Financial Officer Doctor. David Rodman, our Chief Medical Officer and Eric Warren, our Chief Commercial Officer. I will begin with an overview of the business, our clinical programs and recent milestones, followed by Adam to review our second quarter financial results before we open the call for your questions.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

We're proud to be leading the way in the development of aldosterone synthase inhibitors, or ASIs, for the treatment of hypertension and comorbid cardio renal conditions such as chronic kidney disease, or CKD, and obstructive sleep apnea, or OSA. Earlier this year, we became the first company to announce pivotal data for an ASI with the readouts from Launch HTN and Advance HTN. These results have since been presented at leading scientific conferences and published in the New England Journal of Medicine and the Journal of the American Medical Association. The clinically meaningful reductions in systolic blood pressure demonstrated with lorunderstat generated broad interest across the medical community, underscoring the unmet need, the desire for innovation in the management of hypertension, and the commercial potential of lorunderstat. To better understand how our data could translate into clinical use, we surveyed approximately 300 cardiologists and primary care physicians.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

The key takeaway from that survey was that ninety five percent of these practicing clinicians indicated that based on the data from LAUNCH H10 and ADVANCE H10 trials, if lorunderestat is approved, they would likely prescribe it broadly for patients with uncontrolled or resistant hypertension, specifically third line or later. This intent to prescribe was based on the differentiated efficacy and safety profile, which truly set lorundestat apart from agents typically used in the third line or later treatment position. We've also completed a project with IQVIA. This showed nearly nine million patients in 2024 started new treatments in the third line or later position. These data are reflective of the dissatisfaction in the market and the challenges physicians face in addressing uncontrolled hypertension.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Both of these data sets speak to the strong need and demand for innovative solutions that physicians want in their treatment armamentarium to address uncontrolled and resistant hypertension. Uncontrolled and resistant hypertension are significant unmet medical needs impacting more than twenty million patients in The United States and directly contributing to adverse cardio renal risk. Our clinical results reinforce the differentiated clinical impact of targeting aldosterone with an ASI like lorundrostat as compared to the current standard of care used in third and fourth line treatment physicians. We are continuing to focus our pre commercial efforts on market access and payer value assessment for this novel treatment. We've expanded our medical communications team to disseminate the data we're developing on lormandestat via publications, medical conferences, and field based medical science liaisons.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

These are critical efforts for prelaunch readiness to generate awareness, interest, and enthusiasm for lorunderstat. I would now like to briefly touch on the other development activities we're pursuing to enhance and extend the lorunderstat profile in hypertension with comorbid conditions, which are largely driven by inadequately controlled blood pressure and dysregulated aldosterone. Our focus on and rationale behind making reduction in blood pressure the primary outcome measure in the EXPLORER CKD trial was the central role of uncontrolled blood pressure in chronic kidney disease progression. Lorundrostat demonstrated a clinically meaningful reduction on systolic blood pressure in this trial. The key secondary outcome measure reduction of UACR, an accepted surrogate for renal protection, was also highly significant and comparable in magnitude to that observed in trials of vicodrostat and finerenone when combined with an SGLT2 inhibitor.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

It should be noted that all participants in EXPLORER CKD were treated with lorundrostat while on a stable therapeutic dose of SGLT2 inhibitor, most commonly dapagliflozin. Immediately after the release of these data, First World Pharma surveyed 133 healthcare professionals and confirmed that these data were clinically meaningful, with seventy seven percent of the surveyed healthcare professionals indicating they would consider prescribing lorundestat to CKD patients uncontrolled on either ACE inhibitor or ARB with an SGLT2 inhibitor. The rationale for our EXPLORER OSA trial relates to the substantial portion of patients with obesity and resistant hypertension who also have OSA, which is often undiagnosed and untreated. The majority of OSA patients have uncontrolled or resistant hypertension, as well as elevated nighttime blood pressure and hypoxia, which are drivers of major adverse cardiovascular events, including death. Prior small studies of mineralocorticoid receptor antagonists or adrenalectomy patients demonstrated an approximate 50% reduction in AHI, which is the primary registration endpoint.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

EXPLORER OSA is powered for the AHI primary outcome measure and will also test the effect of lorundestat on nighttime blood pressure using both twenty four hour ABPM, as well as a novel measurement of continuous blood pressure. We have clearly demonstrated that lorundestat, dosed once daily in the morning, is a highly effective antihypertensive. Given the contribution of nighttime aldosterone production in OSA patients, the EXPLORER OSA trial will be evaluating lorundersat dosing at night, the effects on nighttime blood pressure, and twenty four hour blood pressure control. Based on the rate enrollment in EXPLORER OSA, we anticipate having top line data in the 2026. The next step in providing lorundestat to the millions of patients who could benefit from its clinical profile is its regulatory approval.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

We have a pre NDA meeting with the FDA scheduled to take place in the 2025. In summary, we have now demonstrated the clinically meaningful benefitrisk profile of lorundrostat in individuals with uncontrolled or resistant hypertension in four clinical trials. We continue to evaluate lorundestat's use in prevalent comorbidities of hypertension, such as OSA and CKD, for which normalizing aldosterone production may result in meaningful clinical benefit. I will now turn the call over to Adam to review our financial results for the 2025.

[Adam Levy, CFO at Mineralys Therapeutics]

Thank you, John. Good afternoon, everyone. Today I will discuss select portions of our second quarter twenty twenty five financial results. Additional details can be found in our Form 10 Q, which will be filed with the SEC later today, August 12. We ended the quarter with cash, cash equivalents and investments of $324,900,000 as of 06/30/2025, compared to $198,200,000 as of 12/31/2024.

[Adam Levy, CFO at Mineralys Therapeutics]

We believe that our current cash, cash equivalents, and investments will be sufficient to fund our planned clinical trials and regulatory activities, as well as support corporate operations into 2027. R and D expenses for the quarter ended 06/30/2025 were $38,300,000 compared to $39,300,000 for the quarter ended 06/30/2024. The decrease in R and D expenses was primarily due to a decrease of $4,500,000 in preclinical and clinical costs driven by the conclusion of the lorundrostat pivotal program in the 2025, partially offset by increases of $2,700,000 in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock based compensation, and $800,000 in higher clinical supply, manufacturing, regulatory, and other costs. G and A expenses were $8,500,000 for the quarter ended 06/30/2025, compared to $5,900,000 for the quarter ended 06/30/2024. The increase in G and A expenses was primarily due to $1,900,000 in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock based compensation, dollars 600,000.0 in higher professional fees, and $100,000 in other administrative expenses.

[Adam Levy, CFO at Mineralys Therapeutics]

Total other income, net, was $3,500,000 for the quarter ended 06/30/2025, compared to $4,200,000 for the quarter ended 06/30/2024. The decrease was primarily attributable to decreased interest earned on investments in money market funds and U. S. Treasuries as a result of lower average cash balances invested during the three months ended 06/30/2025. Net loss was $43,300,000 for the quarter ended 06/30/2025, compared to $41,000,000 for the quarter ended 06/30/2024.

[Adam Levy, CFO at Mineralys Therapeutics]

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

[Operator]

Thank you. We will 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 2 to remove yourself from the queue.

[Operator]

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the And our first question comes from the line of Michael DiFiori with Evercore ISI. Please proceed with your question.

[Michael Difiore, Managing Director at Evercore]

Hi, guys. Thanks so much for taking my questions and congrats on all the progress. Two for me. One question that we get a lot recently is AstraZeneca's full Phase III Vax HTN data that will be coming up later at ESC shortly. My question is any thoughts on how different grade one and grade two hyperkalemia rates would need to be in order for physicians to consider lorundrostat more or less safe?

[Michael Difiore, Managing Director at Evercore]

And my follow-up questions too separate, there's been any updates on partnership discussions and initiatives. Thank you.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Yeah, Mike, thanks for the call. I appreciate it. To your first question, it's tough for me to opine on what AZ's data may look like, what that may translate to from a potassium level in differentiation. You know, we feel very confident in the package that we've developed over the last four and a half years and certainly just in the last six months with the readout of launch HTN, advanced HTN and explore CKD. I think we very well characterized the efficacy of this drug and the safety of this drug in the spectrum of patients, and that was by design.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Launch HTN I think is the perfect trial to really look at where these drugs are going to be used in the vast majority of patients on top of an existing background treatment that, while not optimized, is how physicians in the real world are prescribing antihypertensives. And we know with lorundestat, we saw an 11.7, 11.6 millimeter mercury placebo adjusted change, 19 millimeter absolute, and frankly ACE inhibitor ARB level rates of hyperkalemia above six millimoles per liter of zero point six percent of the patients. So very well characterized, really robust clinical benefit coupled with a very favorable safety profile that I know you've seen the survey that we've done that I referenced in the prepared remarks. 95 of physicians deemed it is likely or very likely to prescribe if they get access to it if the drug gets approved. And so it's, we'll have to see the data, Mike, from Backstage ten because there's so many things that go into that.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

What are the patient demographics? How are they measuring potassium? You know, what's confirmed and what's observed? Just we need to get to the data. It's a fair question, but it's hard to opine on.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

As far as partnering dialogues, as we've alluded to in the past, you know, we're very interested in partnering, certainly ex U. S, where we don't have intention of commercializing lorundestat on our own, but even in The United States. And now the intent in The United States is how can we extend the reach to as many physicians to impact as many patients as possible that we think ultimately can maximize the value of lorandestat, which we think can be significant in the management of uncontrolled and resistant hypertension.

[Michael Difiore, Managing Director at Evercore]

Got it. Thanks very much.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Thanks, Mike.

[Operator]

Thank you. Our next question comes from the line of Rich Law with Goldman Sachs. Please proceed with your question.

[Richard Law, Analyst at Goldman Sachs]

The first is that when you think about lorangestat outside hypertension, do you see any opportunity for lorangestat to combine with other drugs besides SGLT2 inhibitors and CKD? And then I have a follow-up.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Rich, are you saying specific to CKD?

[Richard Law, Analyst at Goldman Sachs]

No, just anything outside hypertension and maybe outside like SGLT2. Is there, any other disease areas or indications that you see potential combination strategy with lorangelstat?

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Yeah, I think the, what we've seen to date with four successful trials is that aldosterone in and of itself is a significant driver, not only of hypertension, but the related comorbidities, right? We know hypertension drives CKD, we know it drives heart failure, we know it drives and is a component of OSA. And in the four studies that we've done, we're seeing robust response. If you think about it relative to just for hypertension, what other agents like alpha blockers, beta renal denervation, endothelin receptor antagonist, you're seeing really compelling clinical benefit with lorundarstat, which I think speaks to the molecule, but it also speaks to the unmet need in dysregulated aldosterone. I think that extends by definition into these related comorbidities.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

So hypertension and CKD, hypertension and OSA. I think given the small molecule nature of lorunderstat, there are some interesting fixed dose combinations that we've contemplated. I can't really get into that at this point in time. But I would say that fixed dose combinations, their acceptance is varied by region. I think in Europe you tend to see an inclination to use fixed dose combinations more frequently than in The United States.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

I think in The United States there's actually more of an inclination to keep drugs as separate treatments to allow physicians to manage dose. And I think that's where it becomes interesting, Rich, specifically the CKD, the dynamics that will be occurring with the SGLT2 market over the next several years with the introduction of likely generics, with SGLT2s quickly becoming standard of care in the treatment of CKD and with the potential launch timing lorunderstat for hypertension and with the data that we've collected to date in hypertension and CKD, there may not be a need for a fixed dose combination to meet the needs of the patients with lorunderstat being able to address the aldosterone aspect of the condition. And, as has been seen, quickly adoption of the SGLT2 standard of care in that population.

[Richard Law, Analyst at Goldman Sachs]

Okay, got it. And then, so, Kai, going back to your previous discussion on the BACS data at ESC, under what scenarios would you think that readout could negatively affect your discussions, with potential partners or the outlook for lorangelstat? And also, do you think that most, you know, partners that you've been talking to see both of these drugs to be likely similar because they have the same MOA, or do you think that they're looking for, a best in class drug over the other?

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Yeah, again, it's hard to opine on what may be seen with the vaxterostat data. I'll go to what we do know. And we know at this point, four successful trials are very well characterized and beneficial clinical profile with verundestat that based on the unmet need in the marketplace, I think stands to generate significant value for patients and commercial value for shareholders. And so that's where we're focused on. As to the placement of or the availability of two ASIs, I think we've always said there's certainly room for two within this marketplace.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

We happen to think that lorundestat has a distinct offering as it relates to its selectivity and its half life and the spectrum of data we generated within the clinical development program. But with twenty million patients failing to get to go on two or more meds, I think there's significant opportunity for more than just one player in this space.

[Richard Law, Analyst at Goldman Sachs]

Got it. That makes sense. But I mean, any comment on potential partners looking, I mean, seeing these drugs to be similar versus, you know, there could be a best in class or there's no such a thing?

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

No. It's it's hard to get into specifics on that, Rich, but we remain confident in the value of lorundestat.

[Richard Law, Analyst at Goldman Sachs]

Okay. Got it. And, thank you.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Yeah. Thanks, Rich.

[Operator]

Thank you. Our next question comes from the line of Seamus Fernandez with Guggenheim Partners. Please proceed with your question.

[Seamus Fernandez, Senior MD & Equity Research Analyst at Guggenheim Partners]

Oh, thanks for the question. So a couple quick ones here. Just in terms of drug drug interactions and anything that could impact an outside assessment of lorundestat, would you guys maybe just help us understand the cited PPI drug drug interaction that you called out in your twenty twenty three ten ks? I think this is a very minor issue, but just wanted to confirm some of the details that you have around the PPI utilization in your trials, as well as just kind of what your market research shows in terms of the frequency of use there, if there are any limitations at all. And then the second question really comes down to this sort of twenty four hour profile. One of the things that AstraZeneca does cite is the prospect of potentially being differentiated in terms of the half life. Just interested to know how you guys think about the profile of lorundestat from a twenty four hour perspective and what you might be hoping to see in your OSA study as well as those data emerge later this year? Thanks.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Thanks, Seamus. From the first part of the question, PPI, from the research that we've done, PPI uses in about ten percent of adults, maybe about fifteen percent in older adults For both our launch and advanced HTN study, we allowed PPIUs three times per week. We recommended if people could to go on an H2 antagonist dosed in the evening, whereas lorundrostat was dosed in the morning. The reason for that is lorundrostat is a basic salt, requires a level of acidity for full bioavailability. So the question is not one, Seamus, of safety, it's about exposure and ensuring coverage of that patient's blood pressure.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Now, as you're aware, the fifty milligram is the intended target starting dose. We have shown in EXPLORER CKD the twenty five milligrams is active. From the EXPLORER CKD we saw about a seven point five millimeter mercury placebo adjusted change at four weeks. And so we believe the twenty five milligram is clearly an active dose, and so if somebody's on fifty, they have to be on a chronic PPI, we would just suggest that the physician monitor their blood pressure, and if they feel they're losing some level of blood pressure control, double the dose. But again, within the two pivotal studies, we allowed periodic use of that and clearly saw robust clinical benefit.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

To your second question about twenty four hour profile, I've heard that before. I would say after four clinical studies where we measure the in office blood pressure the same way, and that is in the morning at trough before that day's dose, we're very confident in the twenty four hour blood pressure control that we provide for patients. So looking at launch H10 with 11.6 millimeter mercury placebo adjusted change, 19 absolute to advanced that had almost eight millimeter mercury placebo adjusted and 15.5 millimeter mercury absolute. Those were all done in the morning and the advanced was the twenty four hours, so we clearly see that. And the numbers that I explained for EXPLORER CKD, the same thing.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Morning measurement, add drops, so we're very confident in the twenty four hour control.

[Seamus Fernandez, Senior MD & Equity Research Analyst at Guggenheim Partners]

And just a question on OSA, your timing for OSA and what you might be hoping to see in that data set.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Yeah, the we said and sorry for missing that. As we said in the prepared remarks, there are interesting, albeit small studies that show with a mineralocorticoid receptor antagonist or a unilateral adrenalectomy that you see improvement of AHI, frankly, in that fifty percent reduction of event range. It's the reason we're doing this study on the one hand is we feel that aldosterone plays a role clearly in OSA, but also the need to address nighttime BP, which we don't believe current treatments like GLP-1s and CPAP do as effectively as patients require. And so that's why we're doing this study right now. That's why AHI is the primary endpoint, which is the registrational endpoint that could inform further clinical development for the program.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

As far as opining on what the blood pressure reduction will be, it's hard to say. The nighttime dosing, as I said in the prepared remarks, is intended to really target the aldosterone surge that we believe is related to those OSA symptoms during the evening hour. And so we're really trying to match or understand to the time of production of more aldosterone.

[Seamus Fernandez, Senior MD & Equity Research Analyst at Guggenheim Partners]

Great. Super helpful. Thanks so much.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Sure.

[Operator]

Thank you. Our next question comes from the line of Tim Anderson with Bank of America. Please proceed with your question.

[Alice Nettleton, VP - US Pharmaceutical & Biotechnology Equity Research at Bank of America]

Thank you. This is Alice on for Tim. A question first question is what percentage of payers do you foresee putting in a step edit, I. E, requiring patients to fail spironolactone before granting access to an ASI? And then the second question is, if there has been any apprehension by potential partners to partner with you, what are the things that they would like more clarity on or what is the biggest debate? Thank you.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Yeah, Alice, thank you for your questions. Let me take the second one and I'll turn it over to Eric for your first one. As to any dialogues with prospective partners, we really haven't gotten into specifics on that. Again, I'll just pivot to the unmet need within this space, which we think is significant, coupled with the clinical profile that we've developed with the four studies to date that we think can be significant as far as addressing the unmet need. As regards to the payers, I'll let Eric provide some Yeah, sure.

[Adam Levy, CFO at Mineralys Therapeutics]

Yeah. Hi, Alex. Thanks for the question. So we do not anticipate a step through spironolactone. In fact, that's something that we specifically ask payers during market research.

[Adam Levy, CFO at Mineralys Therapeutics]

The reason that they don't or they won't put us through spironolactone is, A, about a 2% share in the hypertensive market for spironolactone, and then B, very significant AEs that even the payers recognize. Instead, what's likely to happen is the payers will step us through two generic classes, which then creates an electronic step by edit, is easily navigatable through the cloud. So that's our ultimate goal, is to make sure that utilization management criteria are relatively modest, prescriber friendly, and that we ultimately optimize the net price.

[Alice Nettleton, VP - US Pharmaceutical & Biotechnology Equity Research at Bank of America]

Thank you very much.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

You're welcome.

[Adam Levy, CFO at Mineralys Therapeutics]

Thanks, Alice.

[Operator]

Thank you. Our next question comes from the line of Annabel Samimy with Stifel. Please proceed with your question.

[Jayed Momin, Biopharma Equity Research Associate at Stifel Financial Corp]

Hey. This is Jayed on for Annabel. Thanks for taking our questions. So we've got The first one is around you guys are shifting into a commercial mindset.

[Jayed Momin, Biopharma Equity Research Associate at Stifel Financial Corp]

Have you laid out the strategy of how you enter this market? Who's going to be the initial target audience? And how will you stage the launch given the size of the company and what kind of reach you can have?

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Yeah, I'll go ahead and take that question. I think it's too early to get into the commercial strategy, staging, targeting. As I noted in the prepared remarks, I think the big focus right now is really on two factors. One is just the payer strategy and the value proposition based on the clinical data that we've generated to date. And then the second is really using medical affairs to ensure that we're disseminating the data that we've generated to date through conferences, publications, in a growing, albeit small but growing, medical science liaison group.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

And the intent there is really to grow the awareness, excitement and enthusiasm for lorunderstand.

[Jayed Momin, Biopharma Equity Research Associate at Stifel Financial Corp]

Thanks. And I've got one more here. How are you preparing for the pre NDA meeting with the FDA? You've been pretty collaborative with the Cleveland Clinic and you've also had a lot of comprehensive data in your clinical trials. What expectations do you have coming to the meeting?

[Jayed Momin, Biopharma Equity Research Associate at Stifel Financial Corp]

What kind of questions do you expect the FDA might have?

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

We're confident in the data package that we've put together and that predates, it goes back to the end of phase two meeting, where we have the target HTN data laid out, the intended clinical development program, the purpose behind that, as well as, as you're aware, all the other elements from CMC to non clinical. So we're confident in the package that we've put together and the comprehensive nature of it. I think the intent for the FDA when they review any new drug is a well characterized across distinct populations. And we believe with launch HTN being the existing background, advanced HTN being truly optimized and explore CKD looking at subjects with hypertension and lower eGFR that we have a fairly comprehensive package going into those discussions with the FDA.

[Jayed Momin, Biopharma Equity Research Associate at Stifel Financial Corp]

Great. I'm sorry, do have one more quick one. Just regarding Bactrimstat, I know their data hasn't been published, but they did reach their goal. Is there, can you talk to us about any kind of counter detailing messaging that may be starting?

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

No, think we'll wait and see what their study shows, what the data shows. We're believers as a company that aldosterone is a significant unaddressed target right now in the treatment of not only hypertension but related comorbidities. We would anticipate, seeing positive data as they've alluded to, what that data is going to be as far as the magnitude of effect, the safety profile, I just think it's far, far too early for us to even opine. We need to see the data and again, at the construct of the study, the patient disposition, background meds, how they were doing measurements before we could begin to juxtapose their data relative to ours, which is always a challenge across trials.

[Jayed Momin, Biopharma Equity Research Associate at Stifel Financial Corp]

Thank you so much. Thank

[Operator]

you. Our next question comes from the line of Rami Kathukuda Please proceed with your question.

[Rami Katkhuda, MD & Senior Equity Research Analyst at LifeSci Capital, LLC]

Hey, guys. Thanks for taking my questions as well. Two quick ones for me. First, has AstraZeneca noted whether they're taking the average three blood pressure readings similar to the Synchro Phase II studies? Or are they taking a similar approach to what you guys did in launch in advance?

[Rami Katkhuda, MD & Senior Equity Research Analyst at LifeSci Capital, LLC]

And I guess how could that influence placebo response rates at the end of the day?

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Yeah, Rami, I don't the only thing I know, and it's from CLIN trials, is that it's attended, but I don't know how many measurements they're taking and what they're doing with those measurements. As you're aware, we've followed the guidelines from the American Heart Association on best practices and do unattended measurements with those automated devices, take five measurements and average the last two. So from our standpoint, that practice has paid off as far as helping us control the noise of placebo. I'm not sure what kind of strategies or operational plans that AZ has put in place to try to manage the placebo noise that was a bit of an issue with previous vaxterstat trials, specifically HALO.

[Rami Katkhuda, MD & Senior Equity Research Analyst at LifeSci Capital, LLC]

Got it. And then I know it's a bit of a race to become the first ASI in the market. Has the FDA specified what percentage of patients need to complete fifty two weeks of treatment with lorundestat before you can ultimately file an NDA?

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

No, they don't give specific guidance to that, Rami. It's in consultation with the consultants, which we've got some of the top consultants, I think, the world helping us with this. It's just making sure that we have, what we feel to be an appropriate amount of the safety data for the FDA to begin their review and then not overload that submission with 120 safety update.

[Rami Katkhuda, MD & Senior Equity Research Analyst at LifeSci Capital, LLC]

Makes sense. Thanks again.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Thank you.

[Operator]

Thank you. Our next question comes from the line of Mohit Bansal with Wells Fargo. Please proceed with your question.

[Sadia Rahman, VP & Biopharma Equity Research at Wells Fargo]

Hi. This is Nadia Rahman on for Mohit. Thanks for the questions. For ahead of the bachelorsat data, any trial design differences that you'd highlight for launch compared with bax HTN that could contribute to differences in either the efficacy or on the safety side? And would you expect differences on hyperkalemia rates to be driven more by trial design aspects or by pharmacokinetics of these drugs, for example, the half life differences?

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Yeah, I think the, as the BACS HTN data becomes available, I think if you think about the breadth of our program, the most comparable study is probably launch HTN. The commonalities are both studies are looking at subjects failing to get to go on two or more meds, it's using in office blood pressure measurement, a diuretic must be part of the background treatment. But beyond that, it's hard to opine on what else they may be doing within that study. And to your secondary question, how that may or may not impact from a design standpoint, rates of hyperkalemia. Again, it depends upon how they characterize it, how they capture it, how they go from observed to confirmed.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

So it's just difficult from a design standpoint for me to give a view on that. The pharmacokinetics, specifically the selectivity in the half life we know is distinct from lorunderstat. Our selectivity is about four times more selective for aldosterone than cortisol. The half life of ten to twelve hours we believe is kind of ideal, mirroring the diurnal nature of elevated aldosterone, theirs is twenty five to thirty hours. It'll be interesting and I think that's one of the things that we're interested to see is just how does that all translate into their clinical profile.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

But it's hard to opine ahead of actually seeing the data.

[Sadia Rahman, VP & Biopharma Equity Research at Wells Fargo]

Got it, thanks. And then regarding the open label extension trial, do you plan to release more data from or any data from that trial later this year? And can you talk about the potassium monitoring that you're doing in that trial and what additional data from hyperkalemia we can see?

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Yeah, to broadly answer your question, we're excited about the data we're capturing within TRANSFORM HDN, which is the name of the open label extension. That study will provide not only a longer term view of efficacy and safety, but within that we also have our randomized treatment withdrawal study, which is part of the NDA submission as well. We do plan on continuing to publish data out of that, both of those trials. I can't really give you a timeframe for that because that could be dependent upon conference schedule as well as publication, but we certainly do plan on getting that data out into the public in due course.

[Sadia Rahman, VP & Biopharma Equity Research at Wells Fargo]

Great. Thank you.

[Operator]

Thank you. Our next question comes from the line of Matthew Gauffield with H. C. Wainwright. Please proceed with your question.

[Matthew Caufield, VP - Senior Healthcare Analyst at H.C. Wainwright & Co.]

Hi. Thank you, guys, and great to see the success. So, think KOL takeaways for lorundrostat safety have been that the serum potassium is to be expected, it can be managed and it's not expected to add to accruing levels over time. Could you foresee any reasons the agency could be more scrutinizing of the serum potassium safety assessment as we head into the pre NDA meeting in fourth quarter? Thanks.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

No, Matt, thanks for the call. Again, I think it's why it was important that we built the program the way we did, the way that Dave designed it was to really give us a sense for lorundrosat's profile across the spectrum of patients. And so I think that's something the FDA actually will value and appreciate that we've characterized not only the clinical benefit, but also the safety profile in an existing kind of real world population and an optimized treated population in a population with CKD and proteinuria. And so we're very confident with the package that we have right now to go to the FDA to characterize loendersat's profile in some of these distinct populations.

[Matthew Caufield, VP - Senior Healthcare Analyst at H.C. Wainwright & Co.]

Understood. Very helpful, guys. Thank you.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Thanks, Matt.

[Operator]

Thank you. Our next question comes from the line of Dennis Ding with Jefferies. Please proceed with your question.

[Dennis Ding, VP - Equity Research Analyst at Jefferies Financial Group]

Hi. Thanks for taking my question. I have two real quick. Number one, as you're thinking about commercializing either on your own or with a partner, what do you think are the critical factors, generally speaking, for cardiology that you will build out or are looking for in a partner to help with uptake, assuming the data does look similar between both ASIs, which I think is generally a consensus view. Is that size in the Salesforce duration of relationships with doctors?

[Dennis Ding, VP - Equity Research Analyst at Jefferies Financial Group]

Is that magnitude of rebating? Like, I guess, what specific factors may be hyper focused on to mitigate the commercial delta between you and AstraZeneca? And then my second question is just around R and D synergy for an ASI. I mean, I guess CKD and heart failure are obvious, but what other indications do you think an ASI could add incremental value to on top of standard of care? And, you know, I presume that's something that pharma could potentially be weighing as they think about the NPV and specifically the tail value of loridostep? Thank you.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Dennis, thanks for the question. So the first one, I think what we're looking broadly at within a partner is how we can maximize reach to both prescribers and patients. You know, if we look at how we've developed this molecule to date, it's been with a pretty keen eye towards the commercial marketplace, realizing that it's highly genericized, knowing that going first line would probably have significant barriers. But as you heard Eric will find later or earlier on, in that third line position with proper pricing and rebate strategy, we believe that access, is very manageable. And the reason for that is the significant unmet need there.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Now that prescribing is driven to a fairly large degree, and we note this in our corporate deck by about 47,000 to 50,000 doctors in those top five deciles of third line or later prescribing. And that's a mix of cardiologists and primary care. So as we think about partnering, we factor that into that consideration. And all those elements that you described as far as current coverage, relationships, those are all informative to how we think about partner. To your second question as far as the increment of an ASI and other categories, I don't know that I can share with you all of the different areas that we thought about.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

You highlighted certainly too, CKD and heart failure. From our standpoint, hypertension is a massive overlap with all of those. And that's why we've framed our program the way we have. That's why we think the Explore CKD program is so interesting and exciting because it allows us to operate within those patients that have an overlap. And the ability to actively promote lorundestat for patients who have hypertension as well as comorbid CKD, and we know that there could be a dual benefit of reduction of UACR, which is a known surrogate for renal protection.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

But it's also why we're so excited about OSA. As I said in the prepared remarks, there's significant overlap between not only resistant but uncontrolled hypertension and OSA. And there's good evidence that shows targeting aldosterone will not only be a benefit for the blood pressure, but also for the symptoms of OSA. At this stage, I think we're very comfortable in the profile of this drug as far as what it does to aldosterone, what it does to hypertension, how it does so safely, but also beginning to get indications of the benefits it can have on hypertension comorbidities. And so that's something we'll continue to evaluate as we think about further development of fluorentostatin.

[Dennis Ding, VP - Equity Research Analyst at Jefferies Financial Group]

Got it, thank you. And I had a quick follow-up. I think your competitor AstraZeneca is running a new trial in primary aldosterone. I feel like that could be an area where higher doses will be used and where your better selectivity could eventually come out positive. So are you considering going after that indication and why or why not? Thank you.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Yeah, thanks Dennis. I think I would put PA into some of the other categories. It's certainly something we're contemplating. Clearly, that's probably the extreme edge of hypertension with aldosterone is a driver for that. As it relates to dose, I think it's too early to opine on that, but it's certainly an area of consideration as we look at all the different options that are out there.

[Dennis Ding, VP - Equity Research Analyst at Jefferies Financial Group]

Thanks a lot.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Thank you.

[Operator]

Thank you. And we have reached the end of the question and answer session. I would like to turn the floor back over to CEO, John Connleton for closing remarks.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

Thank you, operator. Appreciate everybody's attention today. We believe the strength of the clinical results for lorundestat showed the potential benefit from uncontrolled and resistant hypertension in those related comorbidities such as CKD and OSA we discussed today. We do look forward to our upcoming pre NDA meeting with the FDA later this year. This is an exciting time for our team, the hypertension patients who may benefit from treatment with lorunderstat, the physicians and researchers that have worked so hard in support of bringing lorundostat through our pivotal program, and most certainly our shareholders.

[Jon Congleton, CEO & Director at Mineralys Therapeutics]

We're excited for key upcoming milestones and look forward to sharing updates with you in the upcoming quarters. With that said, I'll say thank you, operator, and thank you everyone for joining us today. With that, we'll close the call.

[Operator]

Thank you. And ladies and gentlemen, this does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

Participants

Executives

• Jon Congleton, CEO & Director
• Adam Levy, CFO

Analysts

• Daniel Ferry, Managing Director at LifeSci Advisors, LLC
• Michael Difiore, Managing Director at Evercore
• Richard Law, Analyst at Goldman Sachs
• Seamus Fernandez, Senior MD & Equity Research Analyst at Guggenheim Partners
• Alice Nettleton, VP - US Pharmaceutical & Biotechnology Equity Research at Bank of America
• Jayed Momin, Biopharma Equity Research Associate at Stifel Financial Corp
• Rami Katkhuda, MD & Senior Equity Research Analyst at LifeSci Capital, LLC
• Sadia Rahman, VP & Biopharma Equity Research at Wells Fargo
• Matthew Caufield, VP - Senior Healthcare Analyst at H.C. Wainwright & Co.
• Dennis Ding, VP - Equity Research Analyst at Jefferies Financial Group