Mineralys Therapeutics, Inc.

Greetings and welcome to the Mineralis second quarter 2025 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the former presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Thank you. You may begin.

Thank you, Operator. I would like to welcome everyone joining us today for our second quarter 2025 conference call. Earlier this afternoon, we issued a press release providing our second 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 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 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. I would now like to turn the call over to John Cobleton, Chief Executive Officer of Mineralis Therapeutics.

Thank you, Dan. Good afternoon, everyone, and welcome to our second quarter 2025 financial results in 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 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. We're proud to be leading the way in the development of aldosterone synthase inhibitors, or ASIs, for the treatment of hypertension and comorbid cardiomental 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 LaunchHTN and AdvanceHTN. 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 and sustained reductions in systolic blood pressure demonstrated with lorundrastat generated broad interest across the medical community, underscoring the unmet need, the desire for innovation, the management of hypertension, and the commercial potential of lorundrastat. To better understand how our data could translate into clinical use, we surveyed approximately 300 cardiologists and primary care physicians. The key takeaway from that survey was that 95% of these practicing clinicians indicated that based on the data from LAUNCH-HTN and ADVANCE-HTN trials, if Lorunderset 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 La Runderstead apart from agents typically used in the third-line or later treatment position. We've also completed a project with IQVIA that showed nearly 9 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. 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 20 million patients in the United States and directly contributing to adverse cardiorenal risk. Our clinical results reinforce the differentiated clinical impact of targeting aldosterone with an ASI like lorundrastat as compared to the current standard of care used in third and fourth line treatment positions. We're 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 lorundrastat, via publications, medical conferences, and field-based medical science liaisons. These are critical efforts for prelaunch readiness to generate awareness, interest, and enthusiasm for lorunderstab. I would now like to briefly touch on the other development activities we're pursuing to enhance and extend the lorunderstab 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 EXPLORE CKD trial was the central role of uncontrolled blood pressure in chronic kidney disease progression. La Runderstad demonstrated a clinically meaningful reduction on systolic blood pressure in this trial. The key secondary outcome measure of 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 finarinone when combined with an SGLT2 inhibitor. It should be noted that all participants in EXPLORE-CKD were treated with lorunders while on a stable therapeutic dose of SGLT2 inhibitor, most commonly, dapagliflozin. Immediately after the release of these data, First Word Pharma surveyed 133 healthcare professionals and confirmed that these data were clinically meaningful, with 77% of the surveyed healthcare professionals indicating they would consider prescribing lorundrastat 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. A 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 mineral corticoid receptor antagonists or adrenalectomy patients demonstrated an approximate 50% reduction in AHI, which is the primary registration endpoint. Explore OSA is powered for the AHI primary outcome measure and will also test the effect of lorunderstat on nighttime blood pressure using both 24-hour ABPM as well as a novel measurement of continuous blood pressure. We have clearly demonstrated that lorunderstat, 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 lorunderstat dosing at night, the effects on nighttime blood pressure, and 24-hour blood pressure control. Based on the rate of enrollment in Explorer OSA, we anticipate having top-line data in the first half of 2026. The next step in providing LeronderStat to the millions of patients who could benefit from its clinical profile is its regulatory approval. We have a pre-NDA meeting with the FDA scheduled to take place in the fourth quarter of 2025. In summary, we have now demonstrated the clinically meaningful benefit-risk profile of lorundrastat in individuals with uncontrolled or resistant hypertension in four clinical trials. We continue to evaluate lorundrastat'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 second quarter of 2025.