Mineralys Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Mineralis fourth quarter and four-year 2024 earnings conference call. At this time, all lines are in the listen-only mode. Following the presentation, we will conduct a question-and-answer session. And if at any time during this call you require immediate assistance, please press star zero for the operator. Also note that this call is being recorded on Wednesday, February 12, 2025. And I would like to turn the conference over to Dan Ferry of LifeSci Advisors. Please go ahead, sir.

Thank you, operator. I would like to welcome everyone joining us today for our fourth quarter and full year 2024 conference call. Earlier this morning, we issued a press release providing our fourth quarter and full year 2024 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 up 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, February 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 Congleton, Chief Executive Officer of Mineralis Therapeutics.

Thank you, Dan. Good morning, everyone, and welcome to our fourth quarter and full year 2024 financial results and corporate update conference call. I'm joined today by Adam Levy, our chief financial officer, and Dr. David Rodman, our chief medical officer. I'll begin with an overview of the business. Then Dave will discuss our clinical programs and recent milestones. Then Adam will review our fourth quarter financial results before we open up the call for your questions. And looking back over the past year, it was a tremendous period for the company. I'm very proud of the work our team has done in executing and supporting our clinical strategy of targeting dysregulated or elevated aldosterone in patients with uncontrolled and resistant hypertension. The data for advanced HTN will be available this coming March, and launch HTN will be available mid-first half of this year. We also have our exploratory programs evaluating lorunderset in hypertension and chronic kidney disease, as well as hypertension and obstructive sleep apnea. Our purpose at Mineralis is to create more healthy days for people dealing with cardiorenal metabolic disorders, and the trial readouts we have this year will evaluate the potential of lorunderset to deliver on that promise. The first of the two ongoing pivotal trials is the ADVANCE-HTN trial that is evaluating the efficacy and safety of lorunderstat for the treatment of uncontrolled or resistant hypertension when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications. The trial enrolled 285 subjects, and the rigor of this standardized American Heart Association recommended background regimen was designed to ensure only subjects who were enrolled had confirmed uncontrolled or confirmed resistant hypertension. As noted, we anticipate announcing the top line data for this trial next month. The second pivotal trial is launched in HTN with 1,083 subjects enrolled and is designed to be confirmatory to our target HTN proof of concept trial. The objective is to evaluate the benefit-risk of lorundrastat in a real-world setting when added to a subject's previously prescribed regimen of two to five antihypertensive medications, one of which must be a diuretic. As previously guided, we anticipate top-line data in the mid-first half of this year. Upon completion of the treatment phase in the advanced HTN and launch HTN trials, the Participating subjects were offered the opportunity to enter the TransformHTN open label extension trial. As we await the announcement of these pivotal top-line data, I invite everyone to revisit the KOL event we held last quarter. An archived webcast is available on the investor relations section of our website. This discussion focused on the unmet medical need and uncontrolled and resistant hypertension, the long-term impact of uncontrolled blood pressure, and insights into the treatment of hypertension from these leaders in cardiovascular medicine. In addition, during the event, the KOLs gave their perspectives on our highly selective aldosterone synthase inhibitor, lorundrastat, as a new therapy and its potential to change the current treatment paradigm. To provide more color on our clinical pipeline and recent milestones, I will now turn the call over to Dave. Dave?