Mineralys Therapeutics, Inc.

Welcome to the Mineralis Therapeutics fourth quarter and full year 2023 conference call. At this time, all lines are in 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 operator assistance. This call is being recorded on Thursday, March the 21st, 2024. It is now my pleasure to introduce your host, Dan Ferry of Lysi Advisors. Please go ahead, sir.

Thank you, operator. Good morning, everyone. Welcome to our fourth quarter and full year 2023 conference call. Earlier this morning, we issued a press release providing our fourth quarter and full year 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 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, March 21st. 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 morning, everyone, and welcome to our fourth quarter and full year 2023 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 a brief overview of the business and recent milestones, followed by David, who will discuss our clinical programs, and then Adam will review our fourth quarter and full year financial results before we open up the call for your questions. Looking back over the past year, we've had so much to be proud of at Mineralis. Our entire team worked together to achieve several key milestones on both the clinical and corporate level. I believe this success speaks to the dedication the team has to our exciting programs that target diseases driven by abnormally elevated aldosterone. In 2024, we're working towards achieving several clinical events, which are expected to expand the data package of lorundrastat. We believe excess aldosterone is common and is a significant contributor in approximately 25% of all hypertension patients and is tightly linked to obesity. Aldosterone is also a significant driver of cardiorenal metabolic syndrome and thus our pursuit of an aldosterone-targeted treatment approach that has the potential to benefit millions of patients who are impacted by hypertension, kidney disease, and heart disease. I'm pleased by the significant progress our clinical team continues to make in implementing our development strategy for lorunderstat. Most importantly, we remain on track with our pivotal program for hypertension, which includes the two pivotal clinical trials, ADVANCE-H10 and LAUNCH-H10. ADVANCE-H10 is the only study of an aldosterone-directed therapy that we know of that is utilizing the standardized background treatment approach and we believe will be highly informative to La Rundersat's profile. Since initiating the trial in April of 2023, we have found that the rigorous nature of the trial's design has impacted the pace of enrollment. As we discussed on our earnings call in November, we made some meaningful modifications to the advanced HTM protocol and execution plan, while maintaining our focus on delivering the highest quality data set. Based on our modeling, we have narrowed our guidance for top-line data delivery to the fourth quarter of this year. The trial is designed to allow us to demonstrate the value of lorunderstat when added to standardized, optimized AHA guideline background treatment in patients with uncontrolled or resistant hypertension as confirmed by 24-hour ambulatory BP measurement. We believe this trial has the potential to generate the highest level of evidence that will be important for potential inclusion in hypertension guidelines, for treating physicians, and for creating favorable access via the payers. We then initiated the launch HTN Phase III trial in the fourth quarter of 2023, which is expected to have top-line results in the second half of 2025. The objective of this trial is to model the real-world setting of Lurunderstat when added to existing treatment for uncontrolled or resistant hypertension in the primary care setting. This trial is expected to enroll up to approximately 1,000 adult subjects. Throughout the past year, we've published or presented follow-up data and analysis from the completed Target HTN trial, which was our Phase II trial of lorunderstat in hypertension. These additional data have further supported our strategy for developing lorunderstat as a targeted approach to treat uncontrolled or resistant hypertension, as well as our design of the pivotal program. The latest example of this came in the fourth quarter when we presented the data at the American Hypertension Association Scientific Sessions meeting in 2023. This new analysis showed that increased BMI was correlated with both increased leptin and increased aldosterone production. These data expand our understanding of mechanisms that may link the increasing prevalence of obesity to a parallel increase in uncontrolled and resistant hypertension. Our Explore CKD Phase 2 trial for lorunderstat in patients with hypertension and stage 2 to 3B chronic kidney disease was initiated in late 2023. The intent of this proof-of-concept trial is to demonstrate the benefit of lorunderstat in reducing blood pressure and provide supportive evidence for the potential benefit on chronic kidney disease. The initial design was to compare the efficacy of lorunderstat alone and in combination with an SGLT2 inhibitor in patients naive to SGLT2 inhibitor treatment. The evolving treatment paradigm in CKD resulted in the proportion of CKD patients being treated with SGLT2 inhibitors rapidly increasing over the past year, to the point where identification of SGLT2 naive subjects has proven to be greater than anticipated impediment to trial enrollment. Therefore, we will be modifying this trial design to enroll patients who are either on SGLT2 inhibitors or naive to SGLT2 inhibitor treatment. Additionally, all trial participants will remain on an SGLT2 inhibitor throughout the conduct of the trial. Dave will provide more detail on the trial design changes, but these changes ensure that all trial participants have access to SGLT2 inhibitor treatment while allowing us to achieve our objective of evaluating the benefit of lorundrastat on BP reduction in kidney disease. We continue to anticipate top-line data from this trial within the prior stated guidance of Q4 2024 to Q1 of 2025. As I mentioned earlier, our team has been growing over the past year as we ramped up our clinical activities. We recently appointed Dr. Minji Kim as our new Chief Business Officer. She brings a solid track record of generating value for multiple companies and brings more than two decades of experience in business development, strategic leadership, and scientific research. During her career, she has worked with biotech companies in the U.S. and overseas across broad therapeutic and technical areas. 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 on our clinical strategy. Let me now turn the call over to Dr. David Rodman, Chief Medical Officer of Mineralis Therapeutics, who will provide additional details on our clinical program for Lurenderstadt. Dave?