Mineralys Therapeutics, Inc. (NASDAQ:MLYS) Q2 2023 Results Conference Call August 7, 2023 4:30 PM ET

Company Participants

Dan Ferry - LifeSci Advisors

Jon Congleton - Chief Executive Officer

Adam Levy - Chief Financial Officer and Chief Business Officer

David Rodman - Chief Medical Officer

Conference Call Participants

Michael DiFiore - Evercore

Greg Harrison - Bank of America

Mohit Bansal - Wells Fargo

Rich Law - Credit Suisse

Operator

Greetings, and welcome to the Mineralys Second Quarter 2023 Earnings Call [Operator Instructions]. As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Please go ahead, sir.

Dan Ferry

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 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 Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. Jon?

Jon Congleton

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. Mineralys is focused on addressing aldosterone driven cardio renal 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 rise in 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 lorundrostat 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 Mineralys 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 Advance-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 lorundrostat 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.