Mineralys Therapeutics, Inc.

Greetings and welcome to the Mineralis Therapeutics fourth quarter and full year 20 conference call. At this time, all participants are in 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. Please note this conference is being recorded. I will now turn the conference over to your host, Dan Ferry of LifeSci Advisors. Please go ahead.

Thank you, operator. I would like to welcome everyone joining us today for our fourth quarter and full year 2025 conference call. This afternoon, after the close of market trading, we issued a press release providing our fourth quarter and full year 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, March 12, 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 John Collison, Chief Executive Officer of Mineralis Therapeutics. Thank you, Dan.

Good afternoon, everyone, and welcome to our fourth quarter and full year 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 will begin with an overview of the business, our clinical programs, and recent milestones followed by Adam to review our fourth quarter financial results before we open up the call for your questions. We're pleased to have this opportunity to provide a corporate update as this call comes on the heels of our announcing the FDA's acceptance of the NDA for Lurunderstat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs. In connection with the acceptance, the FDA assigned a PDUFA target action date of December 22, 2026. This NDA submission followed a successful clinical program, which culminated in the completion of five positive clinical trials that consistently demonstrated clinically meaningful blood pressure reduction, 24-hour control, and a favorable safety profile. This comprehensive data set has generated broad interest across the medical community, underscoring the significant clinical need in uncontrolled and resistant hypertension and the desire for innovative solutions that help patients meet their blood pressure goals. The NDA includes the positive data from the LaunchHTN and AdvancedHTN pivotal trials, as well as the proof-of-concept trial, ExploreCKD, and our open-label extension trial, Transform-HTN. Each of these trials demonstrate that lorunderstam maintains a durable and clinically meaningful response across diverse patient populations, a key consideration for its potential as a new treatment for patients with hypertension. Uncontrolled and resistant hypertension remain major unmet needs, affecting over 20 million people in the United States, and attributed to nearly 700,000 deaths per year. As we have noted previously, roughly 30% of all hypertension patients have dysregulated aldosterone. We are progressively seeing research and updated guidelines that highlight the need to identify and address aldosterone dysregulation in these patients. Our clinical data highlight the differentiated value of targeting aldosterone with an aldosterone synthase inhibitor like Larunderstat, especially when compared to current third and fourth line treatment options. To catalyze the successful launch of Larunderstat, we have begun market access planning and payer engagement to ensure the value proposition of Larunderstat is understood and appreciated. We have also expanded our medical communications efforts. which will include increased peer-reviewed publications, a larger presence at scientific meetings, and an expanded team of field-based medical science liaisons, which will support broader data dissemination for this potentially transformative therapy. These activities are intended to drive a rapid uptake of Lunderstadt and feed into potential partnering opportunities. I would now like to briefly touch on the other development activities we're pursuing to enhance and extend the Lurundersat profile into hypertension with comorbid conditions, which are largely driven by inadequately controlled blood pressure and dysregulated aldosterone. Earlier this week, we issued a press release announcing the top-line results of our exploratory trial, EXPLORE-OSA. This four-week trial, which enrolled 48 participants, evaluated the safety and efficacy of lorundrastat in participants with moderate to severe obstructive sleep apnea and hypertension. This trial enrolled a high-risk population with an average body mass index of 38, an average apnea hypopnea index, or AHI, of 48, and baseline systolic blood pressure of 142 millimeters of mercury. While Lurunderstad did not demonstrate a clinically meaningful difference relative to placebo on the primary endpoint, AHI, the trial did show clinically meaningful reductions in blood pressure and a favorable safety profile in this population with difficult-to-control hypertension. In the pre-planned parallel arm analysis of the first period, the trial demonstrated an 11.1 millimeter of mercury blood pressure reduction with lorunderstat and a 1.0 millimeter mercury reduction with placebo at four weeks. There was a 6.2 millimeter mercury placebo-adjusted reduction in blood pressure in the crossover analysis. Lorunderstat demonstrated a favorable safety profile and was well-tolerated. with no serum potassium excursions above 5.5 millimoles per liter. Our analysis is ongoing for other endpoints in the trial and will be reported in future publications or medical meetings. Our clinical development strategy has been and will continue to be focused on generating a comprehensive data set that reflects the complexities that physicians face when treating their hypertension patients. We remain focused on fulfilling our mission to develop lorundrastat as a potential best-in-class therapy for patients with uncontrolled or resistant hypertension. We believe the strength of the lorundrastat data generated to date and the significant clinical needs for uncontrolled and resistant hypertension offer substantial opportunity as we prepare for the upcoming milestones. We're continuing to evaluate further clinical development for lorunderstead in comorbidities and other potential indications. We will keep you informed on our progress as appropriate. I'll now turn the call over to Adam to review our financial results for the fourth quarter and full year 2025.