Mineralys Therapeutics, Inc.

Welcome to the Minor Alice Therapeutics first quarter 2026 conference call. It is now my pleasure to introduce your host, Dan Ferry of Life Science Advisors. Please go ahead, sir.

Thank you. I would like to welcome everyone joining us today for our first quarter 2026 conference call. This afternoon, after the close of market trading, we issued a press release providing our first quarter 2026 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, May 6, 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 Congleton, Chief Executive Officer of Mineralis Therapeutics.

Thank you, Dan. Good afternoon, everyone, and welcome to our first quarter 2026 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'll begin with an overview of the business, our clinical programs, and recent milestones. followed by Adam to review our first quarter financial results before we open up the call for your questions. Our NDA acceptance in the first quarter has been the culmination of a massive effort by our team and our mission to provide more healthy days to patients with cardiovascular disease. From an operational perspective, we're focused on preparing La Runderstadt for a successful launch in the United States. While we continue to evaluate partnering opportunities, and consider the next steps in the clinical development of lorunderstat. During the first quarter, the FDA accepted the NDA for lorunderstat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs and assigned a PDUFA target date of December 22, 2026. This represents a significant regulatory milestone for lorunderstat that moves us meaningfully closer to our goal of delivering a potentially best-in-class therapy to patients with uncontrolled or resistant hypertension. The NDA is supported by a comprehensive clinical data package, including positive results from the launch HTN and advanced HTN pivotal trials, Transform HTN, our open-label extension trial, and the proof-of-concept trials, Target HTN and Explore CKD. Collectively, these five trials demonstrated that Larunderstat delivers clinically meaningful reductions in blood pressure, is well-tolerated, and maintains a durable response across diverse patient populations. We believe this data package supports the potential for Larunderstat to be included in prescribing guidelines, the economic value of Larunderstat to the healthcare system, and Larunderstat as a differentiated novel therapy. Uncontrolled and resistant hypertension continue to represent areas of significant unmet medical need, affecting over 20 million people in the United States and contributing significantly to cardiorenal complications. Aldosterone dysregulation often plays an important role in resistant hypertension, where patients on three or more antihypertensive medications fail to achieve their blood pressure goal. The launch of Lurunderstat, if approved, will be initially focused on this population with the highest need. Our ongoing market research highlights the following three key factors. One, prescribers prioritize magnitude and consistency of blood pressure reduction and have stated a consistent willingness to prescribe Lurunderstat in the fourth line. Two, payers recognize the high-risk nature of patients whose hypertension is uncontrolled on three or more medications and have expressed a willingness to provide coverage for Larunderstat. Three, patients are seeking meaningful and sustained blood pressure reductions that are tolerable and simple to integrate into their daily lives. They're very receptive to novel agents like Larunderstat that may help them achieve their goal. As we move towards our PDUFA target date, our operational focus will continue to be on preparing Larunderstat for commercial success. Our teams are working on early market access planning and payer engagement to ensure the value proposition of La Ronda's debt is clearly understood. In parallel, we continue to invest in physician advocacy with our medical communications capabilities, including broader education of the unmet need and uncontrolled or resistant hypertension through peer-reviewed publications, increased participation in scientific meetings, and the continued build-out of our field-based medical science liaison team. We are also expanding our sales and marketing capabilities to Ready La Runderstadt for success. Together, these activities are intended to support awareness of the clinical profile and position La Runderstadt for a potential commercial launch. We continue to evaluate partnering opportunities and engage in strategic discussions. The right partner could provide enhanced value and enable us to reach more patients who could benefit from Lurunderstat. Our focus on preparing for a strong commercial launch is invaluable to potential business development partners. I will now turn the call over to Adam to review our financial results for the first quarter 2026.