Q3 2025 Mineralys Therapeutics Inc Earnings Call
Speaker #1: Great readings, and welcome to Minerals' third quarter 2025 earnings conference call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation.
Speaker #1: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.
Speaker #1: I would now like to turn the conference over to your host, Dan Ferry. Thank you. You may begin.
Speaker #2: Thank you, Operator. I would like to welcome everyone joining us today for our Third Quarter 2025 conference call. Earlier this afternoon, we issued a press release providing our Third Quarter 2025 financial results and business updates.
Speaker #2: 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&A.
Speaker #2: 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 materially differ from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.
Speaker #2: These forward-looking statements are qualified by the cautionary statements contained in today's press release and/or SEC filings, including our annual report on Form 10-K and subsequent filings.
Speaker #2: Please note that these forward-looking statements reflect our opinions only as of today, November 10, 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.
Speaker #2: I would now like to turn the call over to John Congleton, Chief Executive Officer of Minerals Therapeutics.
Speaker #3: Thank you, Dan.
Speaker #2: Good afternoon, everyone, and welcome to our Third Quarter 2025 financial results and corporate update conference call. I'm joined today by Adam Levy, our Chief Financial Officer; Dr. David Rodman, our Chief Medical Officer; and Eric Warren, our Chief Commercial Officer.
Speaker #2: I'll begin with an overview of the business, our clinical programs, and recent milestones, followed by Adam to review our third quarter financial results, before we open up the call for your questions.
Speaker #2: We're excited to have this opportunity today to provide an update on the progress our team has made over the past couple of months. Last month, we received pre-NDA feedback from the FDA.
Speaker #2: There were no surprises in this feedback, and we're moving ahead with our NDA filing, which we expect to submit either late this quarter or in the first quarter of 2026.
Speaker #2: In preparation for the submission, we developed a robust data package featuring results from multiple clinical trials across the spectrum of distinct and diverse participants with Lorunder stat.
Speaker #2: Which we believe supports its potential as a best-in-class treatment for high-risk patients with uncontrolled or resistant hypertension and beyond. Earlier this year, we announced data from the LaunchHTN and AdvanceHTN pivotal trials.
In these most difficult-to-treat participants, launderers again demonstrated a significant and clinically meaningful reduction in systolic blood pressure and was well tolerated.
I would now like to briefly touch on the other development activities aimed at enhancing and extending the Lunder set profile in hypertension with comorbid conditions, which are largely driven by inadequately controlled blood pressure and disregulated aldosterone.
Starting with our proof of concept Explorer CKD trial, which evaluated the safety, and efficacy of lorand in subjects with hypertension and comorbid, chronic kidney disease on a background of sglt2, inhibitor?
Last week, we were excited to have data from this trial presented during late breaking session at ASN kidney week 2025.
Landers that demonstrated a clinically meaningful reduction in systolic BP in 4 weeks and was well tolerated.
The key secondary outcome measure of reduction of urinary of human cranon ratio or uacr and accepted surrogate. For renal protection was clinically meaningful and highly statistically significant.
We anticipate reporting Topline results from the trial and the first quarter of 2026.
That's profile and treating patients with hypertension and comorbid conditions.
Our rationale for targeting, Osa is clear, the significant portion of patients with obesity and resistant. Hypertension. Also have Osa which is often undiagnosed and untreated
These conditions are biologically linked as blood pressure and the hypoxia rise during sleep due to Upper Airway obstruction.
Both are drivers of major adverse, cardiovascular events, including death.
Prior small studies of mastectomy or adrenalectomy have demonstrated a reduction in AHI, which is the primary endpoint of the Explorer OSA trial. The trial will also test the effect of Lorstat on nighttime blood pressure using 24-hour ABPM, as well as the novel measurement of continuous blood pressure through the evening.
While we have already clearly, demonstrated launderer stats efficacy as a 1, daily morning. Anti-hypertensive, this trial will explore nighttime dosing. Since the triggers for Aldrin production in Osa are reduction in the oxygen. Oxygen delivery, leading to increased sympathetic activation of aldosterone production that occurs in the night during sleep.
Uncontrolled and resistant. Hypertension remain, major unmet needs affecting over 20 million people in the US and contributing significantly to cardio renal complications.
Our clinical data highlights the differentiated value of targeting. All done with an alldone synthase inhibitor like Launderer Stat, especially compared to current third and fourth line therapies.
As we advance toward commercialization, we are prioritizing market access planning and engaging payers to ensure the value of our product is well understood.
We have also expanded our medical communications capabilities to support data dissemination through peer-reviewed publications, scientific meetings, and our field-based Medical Science Liaison.
These efforts are Central to ensuring commercial Readiness for this potentially transformative treatment and the successful launch of lorat.
As we near the end of 2025, we've seen significant advances in the ASI space, including multiple trial readouts.
As we reflect on these data and their clinical relevance, where more confident than ever in lundra stats best-in-class profile based on the meaningful blood pressure reduction.
The demonstrated 24-hour control.
Its benefit across the spectrum of difficult-to-treat patients and its safety and tolerability.
As we move forward with our NDA submission, we do so with confidence in the data, our team, and our mission, to develop lenders debt. As a potential best-in-class therapy for the high-risk, often difficult to treat patients living with uncontrolled or resistant, hypertension.
I will now turn the call over to Adam to review our financial results for the third quarter of 2025 Adam.
Thank you, John. Good afternoon, everyone. Today, I will discuss select portions of our third quarter 2025 financial results. Additional details can be found in our Form 10-Q, which will be filed with the SEC later today, November 10th.
We ended the quarter with cash, cash equivalents, and investments of $593.6 million as of September 30, 2025, compared to $198.2 million as of December 31, 2024. 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 our operations into 2028. R&D expenses for the quarter ended September 30, 2025, were $31.5 million, compared to $54 million for the quarter ended.
On September 30th. 2024, the decrease in R&D expenses was primarily due to a decrease of 26.8 million in pre-clinical and clinical costs, primarily impacted by the conclusion of the launderer stat, pivotal program in the second quarter of 2025 partially offset by increases of 3.2 million. In higher compensation. Expense, resulting from additions to headcount increases in salaries and recruit bonuses and increase stock based compensation and 1.1 million dollars in higher clinical Supply, manufacturing Regulatory, and other costs,
Due to $2.2 million in higher compensation expense resulting from additions to headcount, increases in salaries and recruitment bonuses, and an increase in stock-based compensation of $1.3 million in higher professional fees, and $0.1 million in other administrative expenses. Total other income, net, was $4.2 million for the quarter ended September 30, 2025, compared to $3.8 million for the quarter ended September 30, 2024. The increase was primarily attributable to increased interest earned on investments in money market funds and U.S. Treasuries as a result of higher average cash balances invested during the quarter ended September 30, 2025.
Net loss was 36.9 Million for the quarter ended September 30th 2025 compared to 5 6. 3 3.
With that, I will ask the operator to open up the call for questions. Operator.
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1 moment, please, while we pull for questions.
Our first question comes from Umar rapid with evercore, please proceed with your question.
I guys thanks for taking my question. Um I have a um I have a question on your resistant hypertension population and um my my question specifically is if you don't adjust for the discontinuation, basically no amputations involved. What would your minus 9? Mm, Mercury have been um presumably something in the teens but as that is that a number you guys have evaluated if you were to not do any amputations and only look at completers like Astra did
No, I remember, thanks for the question, you know, maybe Dave can opine on this but you know, the we haven't done that analysis, it wasn't part of the plan and from our standpoint, you have to account for, uh, all subjects enrolled in account for um, the execution within the study, um, you know, discontinuation and patient.
Uh, outcomes as well. But Dave, do you want to give some comment to that?
Yeah, so you're right John.
we um, we did exact
With the FDA, what should be done in the situation of missing data? As you probably know, um,
Numbers above 15%. And certainly 20% are extremely, uh, problematic. And sometimes those trials, can't be evaluated by the agency. Um, so we wanted to make sure. Um, so we really didn't do that and I will caution you that it's complicated to do, uh, any kind of estimates on amputation because you need the raw data. You can't take say the, um, least Square means and try to figure out what it would be. Um, but it can it can be a reasonably uh, substantial reduction. So you're right. It would you know it can go up or down 3 to 5 millimeters of mercury depending on what sort of amputation you do Etc.
Thanks very much.
Our next question comes from Rich law. With Goldman Sachs, please proceed with your question.
Hey guys uh congrats on the progress, so 1 1 Advantage that uh as for Sonic have been highlighting for bags is the longer Half-Life. So in the back 24 presentation over the weekend, I think we saw, you know, I mean it was interesting to see that the backs Show, 14 millimeter Placebo adjusted uh SBP reduction for both day and night. Have you guys looked at that uh the day and night for advanced htn and was there any difference between the 2 and then I have questions later on. Follow up. Yeah, Rich. Yeah. Rich the, you know, 24-hour control, um, you know, long-term acceptable, tolerability profile. These are all things that, you know, Physicians are looking for is they're treating the chronic condition like hypertension with 4 studies completed. We're very confident in the 50 milligram and the 25 milligram once daily providing that 24-hour control. And with the profile, that's going to really Aid long-term, adherence to compliance. I, I noted that
Prepared remarks.
Uh, I think it's worth repeating. We have always measured blood pressure in the morning before that day's dose, so we're measuring it at trough. Uh, LorendaStat in Mineralys is the sponsor who is the first to look at 24-hour ambulatory metrics with an ASI, um, with our Target HTN study. Um, we're very comfortable with daytime and nighttime blood pressure reduction. Advanced HTN is the most rigorous study done in a truly confirmed population, which is distinct from any other study population of at least temporal current ASI studies. Uh, again, validated the 24-hour control. Uh, we've yet, uh, to publish or disclose the nighttime data. But we're comfortable with what we're seeing from Target HTN Advance and really, for the entire program, in providing 24-hour control for patients.
I think got it and then uh, so then want to follow up to your previous discussion on the the, the data, the missing data, and how to handle that, uh, based on your understanding of fda's requirement, uh, are you can you exclude any missing data or invalid Baseline measurements in the primary analysis? Do you have to consider the entire population? The IDT population and then perform imputation to it. So just curious to see how your uh, what what your thoughts are in terms of what the FDA require in decent areas.
As Dave noted, and I'll have him add some color to this, in the case of advanced HTM, this was predisposed with the FDA and said in the SAP. But Dave, do you want to maybe add some color to Rich's question?
Yeah, thanks for the question, Rich. So, 1 thing I'm going to mention is you can't go back and do it. You have you. It needs to be in the statistical analysis plan and spelled out. Um, and depending on
That's obviously the most conservative, but it's also the 1 that they're going to want to look at um,
and, and then decide whether a conversation like that is needed, um, we did that and when we had a risk of missing data and were able to handle the problem, um, so it's complicated, but if you haven't already done it before database lock
You can't just do it later and try to make up for it.
Okay, got it. Thanks guys.
Thanks Rich.
Our next question comes from Tim Anderson with Bank of America. Please proceed with your question.
Hi. This is Alice on the term. Thank you for taking our questions. Uh, so you mentioned there were no surprises in the pre-nda feedback um but you are, are you able to provide any more color on this feedback and could you update us on any final steps before filing? And then I have a follow-up as well. Thank you.
Yeah, Alice. We're we haven't really disclosed that but we're, we're comfortable with, um, the feedback. Uh, as I noted there were no surprises. Uh, we're very confident in the, the data set. We've put together across Advanced HD and launch, hdn and explore CKD. Um, as I noted in the past,
Uh, in public statements the uh, the other kit. Critical part is the open label extension. Having sufficient long-term safety data, uh, including the randomized treatment withdrawal, uh, all of that is progressing. Well, uh, so we're we're comfortable with the guidance that we've given and that is submission by the end of this year or into q1 of next year.
Thank you. And then just following the, you know, now that you're on track for submission. Can you provide any updates on any partnering discussions? Uh, you may be having thank you.
Uh, thanks Alice know. We continue as we've said in the past uh believing that partnering is the going to be a key component of the mineralisation opportunity maximization value but also in the United States. Uh, we feel very confident in the best-in-class profile.
As well as Lincoln and Co development Partnerships. And so I think we have a well-characterized molecule at this point on the cusp of an NDA submission. And I think that continues uh, to support the partnering dialogues that we're having we're at the end of the day we're focused on. How do we maximize the value of land for patients for Physicians? And, uh, certainly for investors?
Our next question is from Annabelle. Sammy with staple. Please. Proceed with your question.
Hi. This is Diana. I'm on for Annabelle. Just uh just 2 questions. Um the first 1 is around the open label extension trial, um you know what are your expectations there and when can we expect an update on the on the data?
Yeah, we uh, we continue to progress well, with the open label extension. Uh, there's been no surprises as we continue its open label obviously. So we can see data within that, uh, the DCB continues to review it, uh, we can just continue to be confident with the the safety profile that we're seeing. Uh, we will certainly look to publish uh the results of the open label as well as the randomized treatment withdrawal. Uh, when the last subject is completed that aspect.
Got it. Um, and then 1 more on the, the going Explorer, Osa trial, how do you expect to leverage the data that comes out of that trial?
Yeah, our goal with Explorer CKD and Explore Osa is really an acknowledgement that
Lure understand has a benefit that extends Beyond just the reduction of blood pressure. And we know there are comorbid conditions. That hypertension patients are dealing with chronically. Whether it's pronia, whether it's CKD. Uh, whether it's Osa in the, um, basically related, cardiovascular risk that each carry. And so from our standpoint adding further data Beyond blood pressure reduction, to the profile of the runner's, dad is going to help its image and view within the prescribing population. Uh, it's going to help inform how they think about providing benefits to their patients that don't just deal with blood pressure but are dealing with the related comorbidities and so I think it really fully rounds up the profile of the runner's dad and shows the promise of this molecule
for addressing hypertension but again for those co uh, related comorbidities
Great, got it. Thank you so much.
Thank you.
Our next question comes from moje pantel with Wells Fargo, please proceed with your question.
Great. Thank you very much for taking my question and congrats on all the progress. Uh, so I ask you questions. So 1 is, uh, overall John, uh, based on the data, we have seen so far with Lura and back so far, do you see any major differences between the 2 at this point, or do you think it kind of validates like all those data validate the class and the related question is that you know has talked about this being a multi-billion dollar opportunity. Uh, some of it is unlocked or some of it would be unlocked with the combination and all those trials. So, uh, to help enable those trials, uh, what kind of Partnerships you as a company would be looking at and and what kind of partner you would be, would be the better partner for you to, uh, uh, collaborate with at this point. Thank you.
Yeah, thank you, Mohead. Um, I would say in going back to my remarks, we’ve seen a lot of
Um, a lot of data in 2025 from uh from us with lstat um, as well as competing Asus in the space, we feel very comfortable with our best-in-class profile at this point. Clearly the Asus are going to be a differential class.
Um, in addressing the significant unmet need of population of 20 million just in the United States alone, uh, that could benefit from a drug. That's targeting. The disregulated alast that we believe is
probably accounting for a significant portion of those patients not being able to get to their ideal goal and basically risking poor cardiovascular outcomes if they do not, uh, at this stage where we have,
Uh we see a a nice response within 2 weeks that continues to grow out to the 12-week period of these studies.
Um, the safety profile. Uh, clearly the On Target. Um,
Safety signals with electrolytes. We believe we've got best-in-class molecule as far as the really modest increase in potassium. That's transient upon. Um, you know, reducing or discontinuing the drug and the tolerability of the profile. So again, I I think this is a an exciting time for us. I think it's going to be informative for our partnering dialogues.
Um,
It's very easy at this point to say this molecule has been de-risked as an aldosterone-reducing agent, doing so safely and effectively. We know that aldosterone plays a critical role in conditions beyond hypertension.
Such as ckds, such as Osa conditions like heart failure.
We believe that it's that breadth of opportunity that will continue to inform those partnering dialogues and that's why it's critical for us. We've we've said it early on, we've not
We've not had a for sale sign, quote unquote.
In front of this company, we've been developing this molecule to make sure that we maximize the value for that. I think at this stage, we've done so. We think there's continued value that we can unlock on our own, but certainly a partner, both in the commercial and the developmental perspective, would help inform that and drive that even further.
Thanks.
Thanks mohead.
Our next question comes from Rami Kahura with Life Side Capital. Please proceed with your question.
Hey guys, thanks for taking my questions as well. Astragin seems to have only enrolled the small number of African-American patients in back 24. At least for the primary endpoint analysis, which doesn't seem super representative of the of the resistant. Hypertensive population. Do you think this could have affected the results and can you remind us how large of a difference in efficacy? You see with our understanding this patient population?
And then secondly have you noted? What percentage of patients get the goal with lender stat in advance or launch.
Yeah. Um,
Romy. Thanks for the question.
It was with intent that we we really wanted to ensure that we had a good diverse representation of patients within our clinical program.
We know that Black or African American patients tend to be underrepresented in studies. We also know they carry some of the largest cardiovascular risk for uncontrolled hypertension. So, I was really proud of what the team did across the program; in Advance HTN, over 50% of those studied were of Black or African American descent. In the larger global study, Launch HTN, we're nearly at 30%, and so we have a really clear understanding of the benefits that Lauren can provide these patients.
In the case of both trials, when we look at Forest plots we see that race is not a determinant of response. In other words whether you're white or black or African-American you're going to respond to the renderers that and have um a significant opportunity to get to your respective goal. And so it's it was important for us to have that population within our clinical program, to be able to speak to the effective Runner stat to that at risk population, that typically is underrepresented.
As to be percent to get to goal.
And what we have shown in the past, uh, was I believe 44% in launch. Got the goal at week 6 and I believe it was 42%. Got to goal at week 4. Uh, with Advanced, I want to make sure I got that right 44% with launch 42%, uh, with Advanced. And I believe for the placebo groups they were about half, I do know the odds ratio of getting to goal, was over 3 in each study. Uh, within those time frames that I described, and I hope that answered your question Romy.
Definitely. Thank you guys. Yeah I'll I'll just add Romy and Tara. Okay, I'll just add that the uh the definition of gold uh was different. Uh when you're looking at that back 24 data where they used a 130, uh we used a more uh stringent 125. I'll also say uh that it wasn't just back 24 uh, that
To have a, a high quantity of black, or African-American patients. It was also back to htn where there were about 8%
and,
Confirmed.
Uncontrolled and resistant hypertension black African-Americans, have a higher percentage of not being able to respond to the generic drugs, as well as Caucasian patients. And so we have a higher percentage there. The need is higher. And yet we showed that the response once they get on our drug is just as good as the Caucasian population. I think that's an important distinction because, um, you know, as as we've said, many times doing that trial, and getting established confirmed hypertension is what the experts asked us to do. And it's what the real gold standard is to know what this drug can do Beyond generics. And in African-Americans, it's obviously an extremely effective drug there.
Thanks Dave.
We have reached the end of the question and answer session. I'd like to turn the call back over to John for closing comments.
We look forward to our upcoming, NDA submission and results from Explorer, Osa.
This is an exciting time for a team: the uncontrolled and resistant hypertension patients, who may benefit from treatment with lorand; the physicians and researchers that have worked so hard and supported bringing little runners out through our clinical trial program; and our shareholders.
We're excited for upcoming key, milestones and look forward to sharing updates with you in the upcoming quarters.
With that said, I'll thank everyone, thank you for joining us today.
And we'll close the call now. Thank you.
This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.