Mineralys Therapeutics, Inc.

Welcome to MNIRALI's third quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Dan Ferry of LifeSite Advisors. Please begin.

Thank you, operator. Good afternoon, everyone, and welcome to our third quarter 2024 conference call. After the close of market trading today, we issued a press release providing our third 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 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 11th. 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 Cobleton, Chief Executive Officer of Mineralis Therapeutics. John? Thank you, Dan.

Good afternoon, everyone, and welcome to our third 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. Then Adam will review our third quarter financial results before we open up the call for your questions. I want to kick things off with a recap of the progress the Mineralis team has made these past several months, advancing our pivotal clinical development of Larunderstat in hypertension and then discuss the upcoming milestones we anticipate throughout the first half of 2025. We recently completed enrollment in our Pivotal Advanced HTN Trial, which is evaluating the efficacy and safety of lorundrastat for the treatment of uncontrolled or resistant hypertension when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications. Subjects were randomized across three arms, including placebo, lorunderstat 50 milligrams once daily, or lorunderstat 50 milligrams once daily, with the possibility to titrate up to 100 milligrams once daily. We announced the key characteristics of subjects enrolled in a trial include more than 66% of the subjects have a BMI equal to or greater than 30, more than 40% of the subjects are women, and more than 50% of the subjects are Black or African American race. Notably, in terms of demographics, we took extra steps to broaden the diversity of the subjects in this trial to provide a better representation across different populations with the goal of showing equivalency across race and sex. As a reminder, this trial was designed in collaboration with the Cleveland Clinic based on the most rigorous standards. The trial will be utilizing 24-hour ambulatory blood pressure monitoring, or 24-hour ABPM, which is the gold standard for blood pressure measurement and historically has shown lower rates of white coat hypertension and has better managed placebo responses compared to other measurement approaches. Additionally, 24-hour ABPM has the ability to assess nighttime blood pressure and nighttime blood pressure dipping status, which have been shown to play a role in adverse cardiovascular risk and outcomes. Advance-HTN is utilizing smartphone-based technology to track and manage participant compliance with a partner called AI-Cure, which helps ensure the participants take all medication as prescribed under the trial protocol. The primary endpoint for this trial is change in 24-hour ambulatory systolic blood pressure at week 12 from baseline for active cohorts versus placebo. The planned analysis includes several important subset analysis in an effort to identify predictors of enhanced response to Lirunderstad, such as obesity that was demonstrated in the phase two target HTN trial. Subjects with uncontrolled or resistant hypertension were stratified, providing balanced distribution across each of the three arms of the trial to allow us to perform a formal test in each population. We believe demonstrating robust efficacy and confirmed resistant hypertension, the area of highest medical need, will be important in positioning Lurunderstat for rapid access and uptake by payers and physicians. Positioning Lurunderstat for obese uncontrolled hypertension patients who are at increased cardiovascular risk will provide an expanded market opportunity. In addition, as we accrue more experience and data with Lurunderstat, We plan to continue to explore other positive and negative predictive factors, including using artificial intelligence to expand the precision toolkit for targeting lorander stat to individuals with uncontrolled or resistant hypertension who are likely to derive long-term clinical benefit. We look forward to announcing the top line data, which we anticipate sharing in March of 2025. Moving to LAUNCH-HTN, our second pivotal trial, which is designed to be a confirmatory trial with the objective of evaluating lorander stat in a real-world setting when added to a subject's previously prescribed antihypertension regimen. We were excited to announce just a few weeks ago that we completed enrollment in this trial. With enrollment of LAUNCH-HTN completed ahead of schedule, we updated our guidance for top-line data, pulling these results forward to mid-first half 2025. LaunchHTN is a phase three trial of Lurundersat for the treatment of subjects with uncontrolled or resistant hypertension as add-on therapy who failed to achieve blood pressure control on their existing prescribed background treatment of two to five antihypertensive medications. Subjects enrolled in the trial who failed to achieve blood pressure control on their existing prescribed treatment were randomized one to two to one 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 six. The primary endpoint for this trial will be the change in systolic blood pressure as measured by automated office blood pressure at week six for the pooled 50 milligram subjects compared to placebo. This trial is well-powered at six weeks for the primary endpoint as well as subset analysis such as BMI status to inform the clinical label of Lurunderstat. We believe this trial is reflective of clinical practice utilizing the real-world in-office measurement and when Lurunderstat is added to an existing treatment regimen that will be relevant to primary care providers. In addition to our pivotal program in hypertension, we're conducting the Explore CKD Phase 2 clinical trial for lorundrastat when added to background treatment with SGLT2 inhibitor in patients with uncontrolled or resistant hypertension in stage 2 to 3B chronic kidney disease. Enrollment is ongoing, and we anticipate announcing top-line data in the second quarter of 2025. Explore CKD is a within-subject comparison trial designed to demonstrate the benefit of lorundrastat in reducing blood pressure and provide supportive evidence for potential benefit for subjects with chronic kidney disease on the background of stabilized GLT2 inhibitor treatment. This proof-of-concept trial will enroll approximately 60 subjects with hypertension in stage 2 to 3B CKD. Before I turn the call over to Adam, I just want to remind everyone that a replay of the KOL event we hosted October 30th is still available on the investor section of the Mineralis website. We are very fortunate to have three leaders in the hypertension field join us on the call, including Dr. Luke Laughlin of the Cleveland Clinic, Dr. James Luther of Vanderbilt University Medical Center, and Professor Rianne Tooze of McGill University Health Center. They each offered valuable insights on the unmet medical need and uncontrolled and resistant hypertension, as well as the potential for Luranderstad to change the current treatment paradigm. We also included a detailed review of the ongoing advanced HTN and launch HTN pivotal trials and their designs. I'll now turn the call over to Adam to review our financial results for the quarter. Thank you, John.