雅虎香港財經 Mineralys Therapeutics, Inc. (NASDAQ:MLYS) Q3 2023 Earnings Call Transcript
Mineralys Therapeutics, Inc. (NASDAQ:MLYS) Q3 2023 Earnings Call Transcript November 12, 2023
Operator: Good afternoon, ladies and gentlemen, and welcome to the Mineralys Therapeutics Third Quarter 2023 Conference Call. [Operator Instructions]. It is now my pleasure to introduce your host, Dan Ferry, of LifeSci Advisors. Please go ahead.
Dan Ferry: 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 7, 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 Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. Jon?
Jon Congleton: 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 lorundrostat 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 lorundrostat 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 lorundrostat 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 lorundrostat 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 Advanced-HTN, which is one of the most rigorous hypertension trials ever undertaken. The trial is designed to allow us to demonstrate the value of lorundrostat 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 hypertension guidelines for treating physicians and for access via payers. Based on the addition of a washout period at the end of advanced age 10, 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. Launch-HTN Phase III 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 lorundrostat 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 to Target-HTN trial, which demonstrated proof of concept for lorundrostat in hypertension. Launch-HTN is anticipated to enroll up to approximately 1000 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 lorundrostat as a potential therapy to treat the 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 all 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 CKD trials to continue to receive lorundrostat, which will provide long term safety and efficacy data on lorundrostat. We're also pleased to add two new independent members to the Mineralys Board of Directors. Kathy Karidis and Glenn Sblendorio 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 Rodman, Chief Medical Officer of Mineralys Therapeutics, who will provide additional details on our clinical program for lorundrostat. Dave?
David Rodman: Thank you, Jon, and good afternoon, everyone. Today, I'll provide an update on the pivotal clinical program for lorundrostat, and then I'll give a summary overview of the plan Phase 2 trial of lorundrostat for chronic kidney disease that we've named Explore-CKD. The ongoing Advanced-HTN trial continues to enroll subjects. As a reminder, this trial which we designed in partnership with the Cleveland Clinic is a randomized double blind placebo controlled design that will enroll up to approximately 300 adult subjects with uncontrolled or resistant hypertension. Patients who have failed to achieve their blood pressure goal on 2 to 5 anti-hypertensive medications are placed on an optimized 2 or 3 drug regimen along with real time compliance monitoring.
This is one of the most rigorously designed trials to be conducted in hypertension, optimizing for inclusion of truly uncontrolled or resistant hypertensive subjects. Subjects who failed to achieve 24-hour ambulatory or ABPM systolic blood pressure of 130 milligrams or lower are then randomized into the trial. One-third of subjects will be randomized to placebo, one-third to 50 milligrams of lorundrostat one day at once daily, and 100 milligrams of lorundrostat once daily that has been increased to a 100 milligrams based on pre-specified criteria. The primary endpoint of the trial will be change in systolic blood pressure as measured by 24-hour ambulatory monitoring at week 12, in the two active arms versus placebo. We have classified two key secondary endpoints, including the percent of subjects achieving 125 millimeters of mercury or below on the 24-hour ABPM, and the correlation of change in 24-hour ABPM to BMI or Body Mass Index in order to reinforce the obesity positioning relative to our targeted therapeutic strategy and potential label inclusion.
For subjects in the Advanced-HTN trial, the treatment withdrawal component of the program has been moved forward from week 48 of treatment in the open label extension trial to week 12 of the Advanced-HTN trial. This amendment was implemented to add further value to the Advanced-HTN trial by characterizing the durability of changes in blood pressure, pharmacodynamic, and other laboratory assessments following the double blind treatment period, period. As Jon mentioned earlier, we revised our expectations on timing for the top line data from the trial. In consultation with our collaborators at Cleveland Clinic, we've implemented several changes to the protocol and in the operation of the trial, these changes resulted from an analysis of the inclusion and exclusion criteria and we're designed to increase our randomization rate while maintaining the rigor of the trial design.
The second part of our pivotal program for lorundrostat is the larger Launch-HTN trial, which we continue to anticipate initiation in the second half of 2023. This randomized double-blind placebo-controlled 3 on trial is planned to have a similar design to the successful Target-HTN trial enrolling subjects, who will remain on their previously prescribed background regimen of 2 to 5 antihypertensives. Up to approximately 1000 adult subjects will be enrolled in this trial. Subjects will be randomized 1 to 2 to 1 to either placebo once daily 50 milligrams of lorundrostat or once daily 50 milligrams of lorundrostat but with the option to titrate in a manner similar to the Advanced-HTN trial. The primary endpoint for this trial will be change in systolic blood pressure as measured by automated office blood pressure, which has the same primary endpoint as in the Target-HTN trial.
We believe this endpoint reflects the real world measurement that will be most relevant to the primary care provider this trial targets. AOBP was the primary outcome measure in Target-HTN and performed similarly to ABPM given the objective of this trial as confirmation of the Target-HTN trot results, we feel this is the appropriate primary endpoint. In addition, subjects from each of our trials will be offered the opportunity to roll over into the ongoing open label extension trial. As Jon mentioned earlier, we recently finalized the protocol for the two-part Phase 2 trial of lorundrostat in hypertensive subjects with stage 2 to 3B chronic kidney disease. As you may recall, on our previous call, we were considering including patients with and without hypertension.
However, after discussion with our chronic kidney disease advisors, assessment of the unmet market need and the hemodynamic profile of lorundrostat, we felt the inclusion of CKD subject with systolic blood pressure of 135 mmHg or greater provides the greatest insight and value. Part A of the trial will be a proof of concept trial with the primary outcome measure being change in systolic blood pressure relative to placebo, and the key secondary endpoint will be change in albuminuria, which is a surrogate endpoint that supports long-term benefit in CKD. Part A is a randomized double-blind placebo-controlled trial that will consist of two treatment periods. We plan on enrolling subjects with stage 2 to 3A chronic kidney disease and albuminuria despite treatment with an ACE inhibitor or an angiotensin receptor blocker.
Subjects will receive either once daily combination treatment with lorundrostat plus 10 milligrams of dapagliflozin or placebo for 8 weeks. After a 4 week washout period, there will be a second 8 week treatment period during which subjects in the active arm will receive placebo and the subjects in the placebo arm from the first 8-week period will cross over to receive lorundrostat alone. We will also be utilizing 25 milligrams once daily of lorundrostat in this cohort based on our continued assessment of the Target-HTN data and the specific needs of this population. And as a reminder, we saw good activity for lorundrostat with a total daily dose of 25 milligrams in the Target-HTN trial. So we are confident in this adjustment to the dosing. Part B of the trial will characterize the safety profile of the lorundrostat in a more renally compromised population.
This second part of the trial is an open label single arm dose escalation trial that will enroll approximately 20 subjects with stage 3B CKD with hypertension despite treatment with an ACE inhibitor or an ARB. Subjects will receive 4 weeks of treatment once daily 12.5 milligrams of lorundrostat, followed by an increase in dose to 25 milligrams of lorundrostat for another 4 weeks. Please note that the final trial dose in Part B is updated from the previously proposed design as subjects will now receive 12.5 milligrams and 25 milligrams once daily doses of lorundrostat instead of the 25 milligram and 50 milligram doses, This decision is also in line with feedback from KOLs, the data from the Target-HTN trial, and with consideration for safety as the subjects in Part B will have even more severe chronic kidney disease.
We are really pleased with the progress made in the strengthening of [Inaudible] for this new approach to treating hypertension and associated aldosterone media complications like chronic kidney disease and heart failure. We look forward to keeping you apprised of the status of the lorundrostat development program. I'll now turn the call over to Adam who will provide a financial review for the third quarter of 2023. Adam?
Adam Levy: Thank you, Dave. Good afternoon, everyone. Today, I will discuss select portions of our third quarter 2023 financial results. Additional details can be found in our Form 10Q, which will be filed with the SEC later today. We ended the third quarter with cash, cash equivalents and investments of $265.9 million compared to $110.1 million as of December 31, 2022. We believe that our cash, cash equivalents, and investments as of September 30, 2023 will be sufficient to allow us to fund our planned clinical trials as well as support corporate operations through mid-2025. R&D expenses were $22.5 for the quarter ended September 30, 2023 compared to $6.1 million for the quarter ended September 30, 2022. The increase in R&D expenses was primarily due to increases of $12.4 million in preclinical and clinical costs, driven by the initiation of the lorundrostat pivotal program in 2023; $2.3 million in clinical supply, manufacturing and regulatory costs; and $1.7 million and higher compensation expenses as a result of additions to headcount.
G&A expenses were $3.8 million for the quarter ended September 30, 2023, compared to $1.4 million for the quarter ended September 30, 2022. The increase in G&A expenses was primarily due to $1.2 million in higher professional fees associated with operating as a public company, $0.8 million in higher compensation expense as a result of additions to headcount, $0.3 million of higher insurance expenses associated with new director and officer insurance policies, and $0.1 million in higher other administrative expenses. Total other income was $3.5 million for the quarter ended September 30, 2023 compared to $0.7 million for the quarter ended September 30, 2022, which was primarily attributable to increased interest earned on the company's investments and money market funds and US treasuries.
Net loss was $22.8 million for the quarter ended September 30, 2023 compared to $6.7 million for the quarter ended September 30, 2022. The increase was primarily attributable to the factors described earlier. With that, I'll ask the operator to open up the call for questions. Operator?
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