Mineralys Therapeutics, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Mineralis Therapeutics 3rd Quarter 2023 Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star-zero for the operator. It is now my pleasure to introduce your host, Dan Ferry. of LifeSci Advisors. Please go ahead.

Thank you, Operator. Good afternoon, everyone, and welcome to our third quarter 2023 conference call. Today, after the market closed, we issued a press release providing our third quarter 2023 financial results and business updates. A replay of today's call will be available on the Investors 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, November 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 Colleton, Chief Executive Officer of Mineralis Therapeutics. John? Thank you, Dan.

Good afternoon, everyone, and welcome to our third 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 third quarter financial results before we open up the call for your questions. It was only 12 months ago when we first announced the positive top-line results from our Phase 2 target HTN trial of lorundersat in individuals with uncontrolled or resistant hypertension. We have since published additional data from the full analysis of the trial, which provided valuable insights supporting the potential use of lorundersat to treat uncontrolled or resistant hypertension. Most recently, We announced the full data from this trial were published by JAMA, and last week we presented a new analysis further providing additional data showing obesity was predictive of an enhanced response to lorundrastat across the continuum of BMI in a late-breaking poster presented at ASN's Kidney Week 2023. The data in these recent publications support our strategy of developing lorundrastat as a targeted treatment for hypertension and CKD. Now, let me provide some highlights from each of our clinical programs, and Dave will cover further details in a moment. Starting with ADVANCE-HTN, which is one of the most rigorous hypertension trials ever undertaken. The trial is designed to allow us to demonstrate the value of lorunderset when added to standardized background medication in confirmed, uncontrolled, or resistant hypertension subjects. We believe this trial has the potential to generate the highest level of evidence that will be important for potential inclusion in the hypertension guidelines, for treating physicians, and for access via payers. Based on the addition of a washout period at the end of Advance HTN, which David will discuss, and current enrollment trends, we are changing our guidance for top-line data from the first half of 2024 to the second half of 2024. We've learned a great deal over the past several months and continue to identify ways to optimize this trial, both in speed of execution and in selection of the right subjects. The LAUNCH-HTN phase three trial is the second of the two trials in our pivotal program for hypertension. We remain on track to initiate this trial by the end of 2023. The objective of this trial is to model the real-world setting of lorundrastat when added to existing treatment for uncontrolled or resistant hypertension in the primary care setting. We recently finalized the trial's primary endpoint to be automated office blood pressure, the same primary endpoint we used in the Target HTN trial, which demonstrated proof of concept for lorundrastat in hypertension. Launch HTN is anticipated to enroll up to approximately 1,000 adult subjects, and we now expect to be able to share top-line results in the second half of 2025. EXPLORE-CKD is our two-part Phase 2 clinical trial for lorundrastat as a potential therapy to treat hypertension patients with Stage 2 to 3B CKD. We expect to initiate the trial by the end of 2023 with top-line data available in Q4 2024 to Q1 2025. Details of this trial's design were also recently modified, which includes a few updates from the proposed design mentioned on our last call, which David will discuss in detail in a moment. Lastly, the ongoing open-label extension trial is designed to allow subjects from our hypertension and TKD trials to continue to receive Lurunderstat, which will provide long-term safety and efficacy data on Lurunderstat. We're also pleased to add two new independent members to the Mineralis Board of Directors. Daphne Caritas and Glenn Splendorio both bring a depth of experience, knowledge, and expertise that will be beneficial to the company as we continue on our path to bring targeted treatment to patients with hypertension, CKD, and beyond. As you can see, we've built up a lot of momentum in our clinical program over the past year and are well-positioned to continue executing our clinical strategy. Let me now turn the call over to Dr. David Robin, Chief Medical Officer of Mineralis Therapeutics, who will provide additional details on our clinical program for lorundrastat. Dave?