Mineralys Therapeutics, Inc.

Greetings and welcome to Mineralis' third quarter's 2025 earnings conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. 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. I would now like to turn the conference over to your host, Dan Ferry. Thank you. You may begin.

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. A replay of today's call will be available on the investor 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 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, 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. I would now like to turn the call over to John Cogleton, Chief Executive Officer of Mineralis Therapeutics.

Thank you, Dan. 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. 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. 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. 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. 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 lorunderstat, which we believe support 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 LAUNCH-HTN and ADVANCE-HTN pivotal trials. The results from both trials demonstrate that lorunderstat offers a clinically meaningful and sustained reduction in systolic blood pressure. These data have 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. These findings form the foundation of our NDA submission. which includes data demonstrating that lorundrastat maintains a durable and clinically meaningful response across diverse patient populations, a key consideration for its potential use in treating uncontrolled and resistant hypertension. This includes subgroup analysis from the Phase III LAUNCH-HTN trial and data from confirmed hypertension patients in the ADVANCE-HTN trial. The LAUNCH-HTN trial enrolled a diverse group of participants. Nearly a third were black or African Americans, half the participants were women, the majority of participants were overweight or obese, and over half had resistant hypertension, requiring three or more background and hypertensive medications. Across all subgroups, lorunder stat 50 milligrams once daily demonstrated consistent, statistically significant, and clinically meaningful reductions in blood pressure. all systolic BP reductions generated in LAUNCH-HTN were measured at 24 hours after a dose, proving the sustained effect and true once-daily profile. The ADVANCE-HTN trial, designed and executed in conjunction with the Cleveland Clinic, enrolled a diverse group of hard-to-treat participants with confirmed uncontrolled and resistant hypertension by design, with over half of the subjects being Black or African Americans. And let me pause for just a second to describe what I mean by confirmed. In any trial that allows participants to remain on their existing background medications, such as LAUNCH-HTN, patients may have apparent hypertension, meaning if they optimize their treatment with the existing medications, they may get to goal. In ADVANCE-HTN, participants' existing background medications were removed, and they were started on an optimized background treatment aligned with AHA guidelines, confirmed daily compliance with smartphone technology, and randomized only if they remained hypertensive after a three-week run-in, utilizing the measurement of 24-hour ABPM. In these most difficult-to-treat participants, LaRunderstead 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 we're pursuing to enhance and extend the Lurunderstad profile in hypertension with comorbid conditions, which are largely driven by inadequately controlled blood pressure and dysregulated aldosterone. Starting with our proof-of-concept EXPLORE-CKD trial, which evaluated the safety and efficacy of Lurunderstad 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 a late-breaking session at ASN's Kidney Week 2025. Lurander's stat demonstrated a clinically meaningful reduction on systolic BP in four weeks and was well-tolerated. The key secondary outcome measure of reduction of urinary albumin creatinine ratio, or UACR, an accepted surrogate for renal protection, was clinically meaningful and highly statistically significant. Immediately after the release of these data, First Word Pharma surveyed 133 healthcare professionals, with 77% indicating they would consider prescribing lorunderstat to CKD patients with uncontrolled hypertension on either an ACE inhibitor or an ARB. Turning to the ongoing Phase II Explore OSA trial, In the third quarter, we completed enrollment in this trial, which is evaluating the safety and efficacy of lorunderstat in participants with moderate to severe obstructive sleep apnea and hypertension. We anticipate reporting top-line results from the trial in the first quarter of 2026. If the trial is successful, these data would complement the previously announced Explore CKD results and further our strategy to extend Lunderstadt's profile in treating patients with hypertension and comorbid conditions. Our rationale for targeting OSA is clear. A significant portion of patients with obesity and resistant to hypertension also have OSA, which is often undiagnosed and untreated. These conditions are biologically linked, as blood pressure and hypoxia rise during sleep due to upper airway obstructions. Both are drivers of major adverse cardiovascular events, including death. Prior small studies of MRAs or adrenalectomy have demonstrated reduction in AHI, which is the primary endpoint of the EXPLORE-OSA trial. The trial will also test the effect of lorunderstat 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 lorunderstat's efficacy as a once-daily morning antihypertensive, this trial will explore nighttime dosing since the triggers for aldosterone production in OSA are reduction in 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 U.S. and contributing significantly to cardiorenal complications. Our clinical data highlight the differentiated value of targeting aldosterone with an aldosterone synthase inhibitor like lorundrastat, especially compared to current third- and fourth-line therapies. As we advance toward commercialization, we are prioritizing market access planning and payer engagement to ensure the value of Lurunderstat 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 liaisons. These efforts are central to ensuring commercial readiness for this potentially transformative treatment and the successful launch of Larunderstat. As we're 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, we're more confident than ever in Larunderstat's 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 strength of our data, our team, and our mission to develop Lurunderstad 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?