Mineralys Therapeutics, Inc.

Greetings and welcome to Minor List First Quarter 2023 Earnings Conference Call. At this time, all participants are on a listen-only mode. A 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 turn the conference over to your host, Dan Ferry. Thank you. You may begin.

Thank you, Operator. Good afternoon, everyone, and welcome to our first quarter 2023 conference call. Today, after the market closed, we issued a press release providing our first 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 up the call for Q&A. Before we begin, I would like to remind everyone that this comments 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, May 15. 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 first 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 first quarter financial results before we open up the call for your questions. Thus far in 2023, we've continued to make significant progress advancing our clinical development program for lorundrastat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor. We're initially developing lorundrastat for the treatment of patients with uncontrolled hypertension or resistant hypertension, with the goal of expanding to other cardiorenal diseases. Building off the positive data from our target HTN Phase II study that were presented at the end of last year, We recently announced the dosing of the first patient in the pivotal trial named Advanced HTN. As David will discuss in detail momentarily, this is the first trial in our pivotal program to evaluate the safety and efficacy of lorundrastat for the treatment of uncontrolled or treatment-resistant hypertension. It is notable that many of the sites from the target HTN study are already active or slated to participate in the Advanced HTN study and are familiar with lorundrastat. This is an exciting milestone for the company as we continue to execute our strategy, and we continue to expect to read out top-line data from the trial in the first half of 2024. In addition, under the Pivotal program, we also plan to initiate a second Pivotal trial named Launch HTN in the second half of 2023, which is expected to read out top-line data in mid-2025. The open-label extension trial for our long-term safety data set should begin enrollment in the middle of 2023. We're also on track to begin our chronic kidney disease, or CKD, profiling study, extending the use of lorundrastat to individuals with stage 3b CKD during the middle of 2023, with expected data readout in the first half of 2024. The PIVOTL program is designed to provide additional data supporting our belief that normalizing aldosterone levels can provide an effective and more targeted approach for the control of hypertension. As with target HTN study, the PIVOTL program is specifically addressing patients with uncontrolled hypertension, which we believe represents a significant unmet need as over 50% of treated patients fail to achieve their goals. And it's worth noting that these patients have a substantial risk of developing heart disease, stroke, and kidney disease. We believe that a lack of innovation in new therapies is at least partially to blame, as many of the currently approved therapies for hypertension were introduced several decades ago. When the incidence of obesity was below 20%, and abnormal aldosterone production affected less than 10% of the hypertension population. As a result, we believe these therapies failed to adequately address the shifting biology of hypertension, as the obesity rate has skyrocketed to over 40% of U.S. adults, and abnormal aldosterone production is thought to be prevalent in at least 25% of all hypertension patients. The shift in the underlying biology of hypertension requires new innovations, like Larunderstat, to provide hope for patients struggling to control their blood pressure, particularly in the obese population. We look forward to providing updates on the progress of our Pivotal Program through the course of 2023. Let me now turn the call over to Dr. David Rodman, Chief Medical Officer of Mineralis Therapeutics, who will offer a review of our clinical data and ongoing clinical program for La Runderstadt. Dave, the floor is yours.