Mineralys Therapeutics, Inc.

Welcome to the Mineralis Therapeutics Second Quarter 2024 Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the 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 your host, Dan Ferry of LifeSci Advisors. Please go ahead, sir.

Thank you, Operator. Good afternoon, everyone, and welcome to our second quarter 2024 conference call. After the close of market trading today, we should have press release providing our second quarter 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, August 13. 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 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, our clinical programs, and recent milestones, followed by Adam, who will review our second quarter financial results before we open up the call for your questions. Let me start out by saying that during the first half of the year, we made tremendous progress advancing the development program for our lead asset, Marunderstat. Specifically, we've been steadily moving towards several key milestones for our registration program in hypertension, which is comprised of two pivotal clinical trials titled Advance-HTN and Launch-HTN. An open-label extension trial called Transform-HTN to capture long-term safety and efficacy data, and the proof-of-concept trial EXPLORER-CKD, evaluating lorundrastat in hypertensive CKD subjects. Enrollment continues to progress in the ADVANCE-HJN trial. As noted previously, this is an extremely rigorous hypertension trial designed to demonstrate the value of lorundrastat when added to standardized, optimized American Heart Association guideline treatment. While we typically do not provide enrollment updates for our clinical trials, we are approximately 90% enrolled in advanced HTN, and our projections place top-line data readout in the first quarter of 2025. While we're disappointed with the change in top-line data timing, we remain laser-focused on executing the best-in-class trial and ensuring high-quality data readout. We continue to work with our partners at the Cleveland Clinic to ensure we deliver the most robust data set possible. In addition, we recently met with the FDA and aligned on maintaining the original primary endpoint of the advanced HTN trial, given that we have already accumulated or accrued substantial trial data. As such, we will maintain the original 12-week time point of change in 24-hour ambulatory systolic blood pressure from baseline for active cohorts versus placebo. We will still collect and analyze all relevant efficacy measures at the four-week and 12-week time points. This does not impact the timing of the data readout for advanced HTN. The planned analysis of advanced HTN trial includes several important subset analysis. Subjects with uncontrolled hypertension, those on baseline regimen of two antihypertensives, and resistant hypertension on three baseline antihypertensive treatments were separately randomized, allowing us to perform a formal test in each population. This will provide optionality and independent support for each population. We believe that demonstrating efficacy in confirmed resistant hypertension, the area of highest unmet medical need, will be important in positioning lorunderstat for individuals with presumed aldosterone-mediated hypertension, including obesity. We believe positioning lorunderstat as an important option for obese individuals with increased cardiovascular risk due to resistant hypertension will be a straightforward message to prescribers, payers, and patients. In addition, as we accrue more experience and data with lorunderstat, we plan to continue to explore other positive and negative predictive factors using artificial intelligence to expand the precision toolkit for targeting lorundrastat to individuals with uncontrolled and resistant hypertension who are likely to derive long-term clinical benefit. Moving to LAUNCH-HTN, which is our second pivotal trial that was initiated in the fourth quarter of 2023, We are pleased to announce that enrollment in this trial is currently ahead of schedule, and we continue to expect top-line data to be available in the second half of 2025. However, the time to data may accelerate, and we will keep you informed as we move forward. LAUNCH-HTN is a Phase III trial of lorunderstab for the treatment of subjects with uncontrolled or resistant hypertension as add-on therapy. who fail to achieve blood pressure control on their existing prescribed background treatment of two to five antihypertensive medications. LaunchHTN will enroll up to approximately 1,000 adult subjects. It is designed with the objective of evaluating Runderstat in a real-world setting when added to a subject's previously prescribed antihypertension regimen. Subjects who fail to achieve blood pressure control on their prescribed background treatment during the run-in period will be randomized 1 to 2 to 1 to either placebo, once daily 50 milligrams of lorundrastat, or once daily 50 milligrams of lorundrastat, with the option to titrate to 100 milligrams once daily as needed at week 6. The primary endpoint for this trial will be the change in systolic blood pressure as measured by automated office blood pressure. We believe this endpoint reflects real-world measurements that will be relevant to the primary care provider this trial targets. Subjects from these two trials will be offered the opportunity to roll over into the ongoing open-label extension trial called TRANSFORM-HTN. In addition to our pivotal program in hypertension, we are conducting the EXPLORE-CKD Phase II clinical trial for lorundrastat when added to background treatment with SGLT2 inhibitor in patients with uncontrolled or resistant hypertension, and stage 2, 2, 3B chronic kidney disease. The amended protocol has been implemented, and enrollment is ramping up. We anticipate announcing top-line data in the first half of 2025. X4CKD is a within-subject comparison trial designed to demonstrate the benefit of lorunderstat in reducing blood pressure, and provide supportive evidence for potential benefit on chronic kidney disease on the background of stable SGLT2 inhibitor treatment. This proof-of-concept trial will enroll approximately 60 subjects with hypertension in stage 2 to 3B CKD. We look forward to keeping you apprised of the status of the Lunderstatt Development Program over the coming weeks and months. Let me now turn the call over to Adam, who will provide a financial review for the second quarter of 2024.