Prepared remarks
Welcome to the Mineralys Therapeutics Second Quarter 2026 Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Daniel Ferry of LifeSci Advisors. Please go ahead, sir.
Thank you. I would like to welcome everyone joining us today for our second quarter 2026 conference call. This afternoon, after the close of market trading, we issued a press release providing our second quarter 2026 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&A. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in today's press release and our SEC filings, including our annual report on Form 10-K and subsequent filings. Please note that these forward-looking statements reflect our opinions only as of today, August 11, 2026. Except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements in light of new information, or future events. I would now like to turn the call over to Jon Congleton, Chief Executive Officer of Mineralys Therapeutics.
Thank you, Daniel. Good afternoon, everyone. Welcome to our second quarter 2026 financial results and corporate update conference call. I am joined today by Adam Scott Levy, our Chief Financial Officer, and Eric J. Warren, our Chief Commercial Officer. I will begin with an overview of the business and recent milestones, Eric will then provide a commercial update, and Adam will review our second quarter financial results before we open the call for your questions. Before I get started with the business update, I would like to take a moment to welcome Dr. Terry Ferguson to the team. Terry joins us as Chief Medical Officer succeeding Dr. David Rodman, who will continue to play an important role as a full-time strategic adviser to the company. Terry brings more than 35 years of experience in cardiovascular medicine, clinical development, and executive leadership. He served as cardiovascular therapeutic area head at Amgen and held senior cardiovascular leadership roles at AstraZeneca and The Medicines Company. He also spent more than 20 years on the faculty of the Texas Heart Institute in cardiovascular medicine. Terry's deep expertise in cardiovascular medicine and proven track record of advancing innovative therapies positions him well to lead our medical and late-stage clinical activities as we continue preparing for the potential commercialization of lorundrostat. I want to thank David for his dedication and hard work over the past several years. During his time as Chief Medical Officer, he guided the development of lorundrostat from proof of concept through the pivotal program and our recent New Drug Application filing with the FDA. In the second quarter, our focus was on commercial launch readiness, the evaluation of partnering opportunities, and the next steps in the clinical development of lorundrostat. In the third quarter, we continue to build our commercial infrastructure as we approach our December 22 PDUFA date. Turning to our clinical progress, our TRANSFORM HTN open-label extension trial continues to generate valuable long-term safety and efficacy data that further supports lorundrostat's potential best-in-class profile. In May, we presented a post hoc analysis from our pivotal LAUNCH-HTN trial at the European Society of Hypertension Annual Meeting. The analysis focused on participants with chronic kidney disease, a high-risk and difficult-to-treat patient population. Despite entering the trial with more severe hypertension and greater use of background antihypertensive therapies, these participants experienced statistically and clinically meaningful blood pressure reductions, comparable to those observed in the broader trial population. In addition, participants with baseline albuminuria achieved a 52% placebo-adjusted reduction in urine albumin-to-creatinine ratio, an important marker of kidney injury and disease progression. Just a few weeks later, at the Endocrine Society's annual meeting, ENDO 2026, we presented late-breaking proteomic data from LAUNCH-HTN and ADVANCED-HTN trials demonstrating that lorundrostat was associated with significant reductions in multiple biomarkers of heart failure risk. While exploratory in nature, these coordinated biomarker changes provide additional biological evidence that lorundrostat use may favorably modulate disease pathways implicated in heart failure. We believe these findings further strengthen our understanding of the broader biological implications of aldosterone, and the potential for lorundrostat to provide benefit in hypertension and related comorbidities. We continue to evaluate further clinical development for lorundrostat, and we will keep you informed on our progress as appropriate. We also completed several corporate actions that enabled our long-term value creation objectives. During the quarter, we announced an agreement to repurchase the potential future royalty payments due to Mitsubishi Tanabe Pharma Corporation related to lorundrostat. Under the terms of the agreement, Mineralys agreed to pay Mitsubishi Tanabe $200 million upfront and up to $100 million once certain commercial milestones are met. Our aggregate potential future milestone payments to Mitsubishi Tanabe are now up to $205 million. We believe this represented a unique strategic opportunity to enhance the long-term value of lorundrostat as we approach commercialization. Concurrently, we completed a $150 million equity offering and entered into a $500 million committed senior secured term loan facility with funds managed by Pharmakon Advisors. Beyond funding the royalty repurchase, this facility provides Mineralys with access to additional capital and financial flexibility while positioning Mineralys to capture the long-term value of lorundrostat. As we look ahead to the remainder of the year, we believe lorundrostat is entering an exciting new phase in its evolution. We have continued to build the clinical evidence supporting lorundrostat, enhanced the long-term value of the asset, expanded our access to capital, and continue to make meaningful progress preparing for a potential commercial launch. In parallel, we continue to evaluate partnering opportunities and engage in strategic discussions to enhance value and enable us to reach more patients who could benefit from lorundrostat. With that, I will turn the call over to Eric to provide a commercial update.
Great. Thank you, Jon. Approximately 20 million adults in the United States have uncontrolled or resistant hypertension. And despite the availability of numerous antihypertensive therapies, these patients remain unable to achieve their blood pressure goal. These patients face significantly increased cardiovascular and cardiorenal risk, highlighting the need for new treatment options that address underlying drivers of disease. Our extensive market research continues to reinforce the value proposition lorundrostat could offer if approved. Physicians consistently tell us they are seeking new therapies that deliver meaningful and durable blood pressure reductions, demonstrate a favorable tolerability profile, and fit naturally within existing treatment algorithms. We believe lorundrostat's clinical profile aligns well with these expectations and differentiates the compound from both currently available and emerging therapies. Over the past several quarters, we have systematically executed against the key elements of our commercial launch plan. As a result, many of the foundational components of our commercial infrastructure are now in place, and our efforts are increasingly focused on final launch readiness and execution. First, we have established strong relationships with leading hypertension specialists and key opinion leaders who we believe will play an important role in shaping clinical practice following a potential approval. Second, we have made significant progress in our initial payer engagement activities. The payers we have engaged with to date collectively account for the vast majority of covered lives in the United States. Our discussions have centered on the clinical and economic burden associated with uncontrolled hypertension, and the value proposition supported by lorundrostat's clinical data package. These conversations continue to reinforce our belief that payers recognize the unmet need in this patient population. Third, we are well underway in the development of a differentiated launch campaign that is designed to educate both healthcare providers and patients. We have done extensive research to understand the optimal messaging, resources, and communication platforms that will drive rapid adoption. Lastly, we are in the final stages of building the field organization that will support our launch. Our experienced sales leadership team is now in place, bringing a track record of successfully launching and commercializing cardiovascular therapies. We have also completed detailed geographic mapping to identify the regions with the highest concentrations of physicians treating patients with uncontrolled or resistant hypertension, allowing us to optimize field deployment. And perhaps most importantly, we expect our sales organization to be staffed in advance of our December PDUFA target date, positioning us to execute swiftly and decisively following a potential approval. We have built our commercial organization around clear objectives which are to ensure physicians have the educational resources and support needed to identify appropriate patients, and if approved, make lorundrostat available to those patients as efficiently as possible. We continue to be encouraged by the feedback we are receiving from physicians, payers, and thought leaders and believe Mineralys is well positioned to execute a successful commercial launch. I will now turn it over to Adam to review our second quarter financial results.
Thank you, Eric. Good afternoon, everyone. Today, I will discuss select portions of our second quarter 2026 financial results. Additional details can be found in our Form 10-Q which will be filed with the SEC today. We ended the quarter with cash, cash equivalents, and investments of $661.4 million as of 06/30/2026 compared to $656.6 million as of 12/31/2025. We believe that our current cash, cash equivalents, and investments will be sufficient to fund our planned operations, including the commercial launch of lorundrostat, into 2028. R&D expenses for the quarter ended 06/30/2026 were $221.4 million compared to $38.3 million for the quarter ended 06/30/2025. The increase in R&D expenses was primarily due to the $200 million upfront payment to Mitsubishi Tanabe in June 2026 in connection with the license agreement amendment. The increase was also due to $0.6 million of increased personnel-related expenses resulting from headcount growth and increased compensation, and $0.2 million of increased clinical supply, manufacturing, regulatory, and other costs. These increases were partially offset by $17.8 million of lower preclinical and clinical costs, primarily due to the conclusion of the lorundrostat pivotal program in the second quarter of 2025. G&A expenses were $24.7 million for the quarter ended 06/30/2026, compared to $8.5 million for the quarter ended 06/30/2025. The increase in G&A expenses was primarily due to $8 million in higher professional fees, $8 million in increased personnel-related expenses resulting from headcount growth and increased compensation, and $0.2 million of increased other administrative expenses. Total other income, net, was $5 million for the quarter ended 06/30/2026 compared to $3.5 million for the quarter ended 06/30/2025. The increase was primarily due to $2.3 million of increased interest earned on investments as a result of higher average cash balances, partially offset by $0.8 million of interest and amortization expenses related to the senior secured term loan entered into in June 2026. Net loss was $241.1 million for the quarter ended 06/30/2026, compared to $43.3 million for the quarter ended 06/30/2025. The increase was primarily due to the factors impacting our expenses that I just described. With that, I will ask the operator to open the call for questions. Operator?
Questions and answers
Thank you. We will now be conducting a question-and-answer session. Please press the star key followed by the digit one on your telephone to ask a question. The first question is from Richard Law from Goldman Sachs. Please go ahead.
Congrats on all the progress as we approach PDUFA. And I also want to extend our welcome to Terry and look forward to working with him. A couple of questions for me. I see that you guys have a lot of postings on the territorial manager positions. How are you finding the quality of candidates given AstraZeneca's launch of baxdrostat, which I assume will be competing for talent? Also, are there any key attributes you are looking for regarding hypertension experience or certain drugs? And when are you planning to start hiring the rest of the sales reps given the launch is nearing and is about four months away?
Richard, thanks for the question. I have to admit parts of your question were a little garbled, so I am going to paraphrase it back and tell me if I got it on point. I think your question is about the field salesforce, the phenotype we are looking for, and our likelihood of having those individuals in position ahead of the PDUFA. Is that a fair paraphrase?
Yeah, exactly. How are you finding the quality of candidates given that baxdrostat's launch has been happening and there is competition for talent? What experience are you looking for and when will you hire the rest of the salesforce given the launch is four months away?
I think, as Eric alluded to earlier, our goal is to have the team in position ahead of the PDUFA date. I'm really excited about the quality of not only the sales representatives and territory managers we are seeing, but also the first-line sales managers. I think Mineralys represents an exciting opportunity that attracts high-level talent who are energized by the innovation lorundrostat represents and the potential impact on millions of patients. There isn't a single phenotype we're looking for. There are certainly many reps with cardiovascular experience, but we are also looking for individuals who align with our values and purpose and are energized by the opportunity. I am very comfortable with the quality of candidates and our ability to hit the target of having the full team in position ahead of the PDUFA.
Fantastic. And then, as a follow-up, how are you seeing payers? Are they waiting for lorundrostat's approval before deciding how to manage both ASI products? Is there anything you are seeing that baxdrostat is doing well or not doing well with payers or other commercial aspects that you can do differently or better?
I'll give you a quick thought, then I'll turn it over to Eric. The feedback we are getting from our national account team that was in place in Q1 of this year continues to be positive on access for this kind of innovation, particularly for third- and fourth-line positioning.
Thanks, Richard. From a payer perspective, it's still early for baxdrostat, obviously, but it's encouraging to see recognition of the innovation the ASI class brings. We have not yet seen a lot of payer decisions, but we believe both agents will be in an equivalent position that will give healthcare providers the ability to choose, and that's where our differentiated profile comes into play.
Great. Thank you.
Thanks, Richard.
The next question is from Michael DiFiore from Evercore ISI. Please go ahead.
Hey, guys. Thanks so much for taking my question. Two for me. You said in the past that label and post-marketing conversations typically start a couple of months out prior to PDUFA. Has that process begun, and has anything in your initial conversations changed in terms of what you expect to negotiate in the label? My second question is on pricing. When do you actually plan to lock in that decision, and would you communicate that ahead of the launch or at launch? Thank you.
Thanks, Mike. The label and post-approval commitments discussions typically occur a couple of months ahead of the PDUFA, so I would expect sometime in October or November. I would characterize the current dialogues with the agency as routine; no surprises from us. The data package we put together was robust, including the pivotal studies LAUNCH-HTN and ADVANCED-HTN, and data from the open-label extension in CKD. We feel very confident with the package, and dialogues to date have been regular course. From a pricing standpoint, we have seen baxdrostat's price and we are continuing our analysis. We were not overly surprised by the price point they came out with; it is in that non-specialty tier pricing area. I would not anticipate us sharing our price until approval and subsequently probably around launch.
The next question is from Jason Gerberry from Bank of America. Please go ahead.
Hey, guys. Thanks for taking my questions. Couple from me. Any learnings from the early AstraZeneca launch as you interrogate the data so far in terms of good, bad, or too early to tell? And as a follow-up to the parity payer access point, directionally, are gross-to-net deductions to achieve parity access coming in in line, better, or worse than you might have expected six to 12 months ago? Thanks.
Jason, I'll take the first part and let Eric address payer access. It's still early days to gauge from the public numbers on the baxdrostat launch, but anecdotally there is enthusiasm and excitement for this new class. It's been over 20 years since a meaningful antihypertensive therapy introduction. We know there are significant patient populations—about 20 million—on two or more medications that cannot get to goal. That creates material opportunity. The enthusiasm we are seeing in the marketplace for this class of drugs underscores the opportunity we see for lorundrostat. I'll let Eric comment further on payer dialogues.
Payer dialogues have been very positive. The level of rebate we are hearing that is coming from baxdrostat is consistent with our expectations. From the Medicare side, so far it looks like access is via medical exception, which then allows access consistent with label. Again, without giving precise indicators, this aligns with what we would expect.
Okay. Thank you.
Thanks, Jason.
The next question is from Seamus Fernandez from Guggenheim Securities. Please go ahead.
Hi, guys. This is Evan Wang on for Seamus Fernandez. Two for me. First, as you're speaking with KOLs, what is really resonating with them about the profile here? Second, congrats to Terry on joining—what will be his early priorities as he gets settled? Thanks.
Thanks, Evan. The profile that resonates most with KOLs aligns to attributes physicians care about: meaningful blood pressure reduction and safety/tolerability. Physicians want durable, meaningful reductions they can achieve safely and maintain long term. We believe lorundrostat's profile meets those needs, particularly for third-line and later patients. Regarding Terry, we are thrilled to expand our expertise. Retaining David as a strategic adviser while adding Terry's 35-plus years of cardiovascular and development experience strengthens our medical and medical affairs capabilities. Terry brings deep relationships with KOLs and experience in later-stage development and medical affairs, which will amplify our preparedness for commercial launch and our translational science initiatives.
In addition to efficacy and safety, our advanced data are resonating well with KOLs. Having a unique dataset differentiates us in their minds.
Thanks. One follow-up: any color on the number of reps you are targeting out of the gate?
Our focus is on the prescribers who will control significant volume of third-line or later prescribing. We've discussed in the past that this is roughly plus or minus 50,000 physicians. We want to ensure a very strong share of voice within those predominant prescribers. We have not guided to a specific rep number at this time and are keeping some of those details close to the vest.
The next question is from Anabel Samimy from Stifel. Please go ahead.
Hi. Maybe two questions on the label. What are you looking for in terms of a differentiated label versus baxdrostat? Based on current interactions, what do you think is required for related language specifically calling out resistant hypertension or CKD? And do you think having a dedicated randomized controlled trial like ADVANCE or EXPLORE-CKD could be a needle-mover? Thanks.
Thanks, Kyle. From a label standpoint, I would expect similarities, with an indication for inadequately controlled blood pressure on background meds. We anticipate similar treatment regarding outcomes claims tied to blood pressure reduction per FDA guidance. Where differentiation could emerge depends on discussions with the agency and the data we present. We will emphasize LAUNCH-HTN, the largest hypertension trial conducted with an ASI, and ADVANCED-HTN, which is unique. ADVANCED-HTN is distinct because it confirmed uncontrolled and resistant hypertension after optimizing background therapy prior to randomization. We expect ADVANCED-HTN to be an important dataset in label discussions alongside LAUNCH-HTN. Additionally, data from EXPLORER-CKD is informative for physicians treating patients with lower kidney function based on eGFR. The baxdrostat label speaks to eGFR down to 45, while EXPLORER-CKD included patients down to 30. We will make the case to the agency that physicians should have label guidance reflecting that. Collectively, efficacy data from LAUNCH-HTN and ADVANCED-HTN, including absolute and placebo-adjusted systolic BP reductions and milder electrolyte changes like hyperkalemia rates, support differentiation. Those datasets will be part of discussions with the FDA.
Okay. Thank you.
The next question is from Mohit Bansal from Wells Fargo. Please go ahead.
Great. Thank you and thanks to David for his help over the years, and congrats to Terry. Two questions: First, assuming you get a similar label to baxdrostat, is there anything in your clinical data or trials like ADVANCED-HTN or others that you could use to appeal to certain specialties or will you be seen more similar than different? Second, AstraZeneca is running a primary aldosteronism trial that could read out next year. If it's positive, how do you see that impacting the class or specific molecules and positioning? Thank you.
Thanks, Mohit. To your first question, I do think there are distinct points within our data that create differentiation. The ASI class is transformative for hypertension. We are seeing pronounced and clinically meaningful reductions in similar patient types—those on two or more background meds who are failing to get to goal. The two fundamental areas for prescribers are blood pressure reduction and safety signals, mainly hyperkalemia. We believe lorundrostat is favorable on both fronts. In market research comparing baxdrostat's HTN data to LAUNCH-HTN, there's roughly a two-to-one preference for the profile that emerged with lorundrostat based on those two similar trials. If LAUNCH-HTN data is in the label, that supports a promotional and educational opportunity to present lorundrostat as the most selective ASI with an ideal 10-to-12-hour half-life. Regarding the primary aldosteronism study from AstraZeneca, it's interesting because the field is moving from viewing PA as a secondary cause of hypertension to dysregulated aldosterone as a spectrum. Physicians treating patients where aldosterone is a driver of uncontrolled or resistant hypertension are excited about lorundrostat's profile. It will be interesting to see the PA study data, but we believe lorundrostat's data to date will resonate with physicians addressing dysregulated aldosterone across a spectrum of disease.
The next question is from Rami Katkhuda from LifeSci Capital. Please go ahead.
Hi, guys. Given the December PDUFA, how should we think about the cadence of payer coverage through 2027? Is there a risk that missing the initial Medicare Part D formulary cycle could make next year more of an access-building year? Second, when do you expect the next major hypertension guideline updates to be, and how important could formal inclusion of ASIs be for the class?
I'll take the guideline question. We've been engaging with guideline committee members to ensure they have the information they need as they contemplate guideline inclusion. Historically, guideline updates occurred every four to five years. Committee members have indicated they will try to be more reactive to new information like ASIs. I would anticipate sometime in 2027 an update that reflects where ASIs should fit. We made discrete choices in lorundrostat's clinical development with that in mind—LAUNCH-HTN and ADVANCED-HTN were designed to be informative for guideline consideration. We have a strong case for lorundrostat, which could benefit the whole class, but ASIs in general should have a clear place in guidelines for latter-line treatment.
On cadence of coverage, expect a progressive increase in coverage over 2027, with commercial outpacing Medicare. Importantly, Medicare relies on medical exceptions, which have a very favorable approval rate. We will also have a field reimbursement manager team to support prior authorizations and emphasize prior authorization and patient support to ensure patients get on therapy quickly. The core message is progressive increase: commercial first, Medicare coming along, but Medicare exceptions are straightforward.
Got it. Thank you.
The next question is from Tara Bancroft from TD Cowen. Please go ahead.
Hi, good afternoon. Following up on an earlier question: in what ways could you improve access and adoption as a second-to-market product relative to baxdrostat, especially around pricing? Is it possible to price at a discount and take more share that way? You previously referenced SGLT2s as comps, but should we anchor more to AstraZeneca now? Thanks.
Let me give some high-level thoughts and then Eric can follow up. We have been asked whether baxdrostat's pricing creates an anchor. I wouldn't call it an anchor so much as informative. From the outside, the rationale we saw for baxdrostat's pricing was that it was in a non-specialty tier to ensure access to patients, which is a critical consideration. We will continue to evaluate pricing and are analyzing the landscape.
Baxdrostat's price is very consistent with our payer and advisory board research. We have a solid sense of where we will price lorundrostat, but we are finalizing details. Our core tenet is to maximize ultimate value and avoid creating a downward pricing spiral. We are finalizing our strategy and need to ensure we preserve value.
Okay. Thank you so much.
The next question is from Matthew Caulfield from H.C. Wainwright. Please go ahead.
Hi. One question we haven't covered: looking back to EXPLORER-CKD, what could be the next catalysts or possible time frames for further lorundrostat evaluation in CKD patients? Is that on the radar beyond PDUFA and launch focus? Thanks.
Thanks, Matthew. This is a major reason we're pleased to have Terry join and to retain David as an adviser. Lorundrostat has shown robust systolic BP reductions, and we see signals beyond BP—mechanisms where aldosterone can drive inflammation, fibrosis, and oxidative stress. In LAUNCH-HTN, we saw a 52% placebo-adjusted reduction in UACR, a clear marker of kidney protection, and proteomic signals in ENDO suggesting benefits on heart failure markers. We believe there is opportunity to show value beyond BP reduction in areas like heart failure and chronic kidney disease. David and our translational team are analyzing next development steps, and we are considering additional indications and combination strategies, such as ASI with SGLT2s, which others are exploring. Once we've aligned on plans, we'll communicate them to the market.
The next question is from Dennis Ding from Jefferies. Please go ahead.
Thanks for taking my questions. First, you've emphasized you're looking for a global partner. Can you describe what you're looking for in a partner on the U.S. side? How important is a partner having a presence in nephrology specifically? Second, you mentioned leveraging CKD data to drive earlier line use—how much overlap is there between cardiology and nephrology where your cardiology salesforce could go after that population versus needing a dedicated nephrology approach or partner?
Thanks, Dennis. We've said before our goal is ideally a global partner that brings both commercial and development capabilities. Commercialization outside the United States would be through a partner, and a global partner would be ideal. From a therapeutic area perspective, we don't require a partner to be exclusively nephrology-focused; rather, we want a partner that understands the broader opportunity. Aldosterone is a foundational node in cardiorenal metabolic disorders. Our CKD data is compelling and could support moving earlier in lines of treatment because of the overlap between hypertension, CKD, and cardiovascular risk, including heart failure. We're looking for partners who appreciate near-term opportunities in uncontrolled and resistant hypertension and the broader potential across cardiorenal metabolic disease, and who have the capability and interest to pursue development opportunities to realize that potential.
This concludes the question-and-answer session. I would like to turn the conference back over to Jon Congleton for closing remarks. Please go ahead.
We believe Mineralys is entering an exciting and important period. With our NDA under FDA review, we remain focused on execution as we work towards that December PDUFA target date. I want to thank everybody for joining us today. We look forward to keeping you updated on our progress and we wish everyone a great evening. Thank you.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.