Mineralys Therapeutics, Inc.

And welcome to the Mineralis second quarter 2023 earnings call. At this time, all participants are in a listen-only mode. A brief 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. It is now my pleasure to introduce our host, Dan Ferry of LifeSci Advisors, Please go ahead, sir.

Thank you, operator. Good afternoon, everyone, and welcome to our second quarter 2023 conference call. Today, after the market closed, we issued a press release providing our second quarter 2023 financial results and business updates. A replay of today's call will be available on the investor's 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 7th. 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. John?

Thank you, Dan. Good afternoon, everyone, and welcome to our second quarter 2023 financial results and corporate update conference call. I'm joined today by Adam Levy, our Chief Financial Officer and Chief Business Officer, and Dr. David Rodman, our Chief Medical Officer. I'll begin with a brief overview of the business and recent milestones, followed by David, who will discuss our clinical programs, and then Adam will review our second quarter financial results before we open up the call for your questions. Generalis is focused on addressing aldosterone-driven cardiorenal disorders that now include both hypertension and chronic kidney disease, or CKD. We believe the growing prevalence of abnormal aldosterone levels is linked to the rising obesity epidemic. This shift in the underlying biology of hypertension, and we believe in CKD as well, requires new therapeutics that reduce circulating aldosterone. Based on our preclinical phase 1 and phase 2 data, we believe we have a highly selective, effective, and well-tolerated aldosterone synthase inhibitor in lorundrastat to address this growing need and make a meaningful difference in the lives of millions of patients. The first half of the year has been a very productive one for the Mineralis team, and we're expecting this momentum to continue through the second half of 2023 and into 2024. The most significant amongst our recent milestones is the initiation of patient dosing for the advanced HTN trial during the second quarter. This is the first of two clinical trials under the planned pivotal program to evaluate the safety and efficacy of lorunderstat for the treatment of uncontrolled or resistant hypertension. And we expect to have top-line data in the first half of 2024. The second pivotal trial, LAUNCH-HTN, which will enroll a larger population of uncontrolled or resistant hypertension subjects, is expected to begin in the second half of 2023. We expect data from the LAUNCH-HTN trial in mid-2025. In addition, after completing either of the pivotal trials, subjects will be offered the opportunity to participate in an open label extension trial, which has already begun enrollment. This trial will contribute to our long-term safety data set. Last month, we announced the expansion of our clinical development of lorunderstat as a potential therapy to treat patients with stage 2 to stage 4 chronic kidney disease. The role of aldosterone in the progression of chronic kidney disease is well established. This study is anticipated to begin enrollment before the end of this year, And we'll have top-line data readout in Q4 2024 to Q1 2025. More than 35 million adults in the United States suffer from chronic kidney disease. And we believe the Orunder stat has the potential to provide significant clinical benefit for many of these patients, given the role that abnormally elevated aldosterone plays in the progression of this disease. Let me now turn the call over to Dr. David Rodman, Chief Medical Officer of Mineralis Therapeutics, who will provide additional details on our ongoing clinical program for lorundrastat. Dave?