Mineralys Therapeutics(MLYS)2025-02-12 18:38Financial Data and Key Metrics Changes - The company ended Q4 2024 with cash, cash equivalents, and investments of 239 million as of December 31, 2023, indicating a decrease in liquidity [25] - R&D expenses for the year were 70.4 million in 2023, with Q4 R&D expenses at 23.7 million in Q4 2023 [26] - Net loss for the year was 71.9 million in 2023, with Q4 net loss at 24.4 million in Q4 2023 [29] Business Line Data and Key Metrics Changes - The company is focused on clinical programs targeting dysregulated aldosterone in patients with uncontrolled and resistant hypertension, with pivotal trials Advance-HTN and Launch-HTN ongoing [10][11] - The Advance-HTN trial enrolled 285 subjects, while the Launch-HTN trial has 1,083 subjects, both designed to evaluate the efficacy and safety of lorundrostat [11][12] Market Data and Key Metrics Changes - The company anticipates announcing top-line data for the Advance-HTN trial in March 2025 and for the Launch-HTN trial in the mid-first half of 2025 [9][50] - The resistant hypertension population is estimated to be about 10% to 15% of the treated population, translating to approximately 7.5 million to 10 million subjects [74] Company Strategy and Development Direction - The company aims to create healthier days for patients with cardiorenal metabolic disorders, focusing on the unmet medical need in uncontrolled and resistant hypertension [10] - The strategic focus includes the development of lorundrostat as a new therapy that could change the current treatment paradigm for hypertension [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts and the potential of lorundrostat to demonstrate meaningful benefits in patients with uncontrolled or resistant hypertension [16] - The company remains enthusiastic about the progress made in 2024 and the upcoming data milestones planned for the first half of 2025 [117] Other Important Information - The company completed enrollment in the Explore-CKD Phase II trial, which evaluates lorundrostat's efficacy in patients with chronic kidney disease [18] - The Explore-OSA Phase II trial is set to evaluate lorundrostat's effect on moderate-to-severe obstructive sleep apnea [20] Q&A Session Summary Question: Confidence in SBP reduction extrapolation from Phase II trial - Management expressed confidence in the 50 mg QD dose based on totality of evidence and previous trial data [34][36] Question: Mechanism of improvement in OSA trial - Management indicated that both fluid volume reduction and non-genomic effects may contribute to improvements in the apnea-hypopnea index [40][42] Question: Guidance on Advance and Launch readout timelines - Management confirmed that Advance-HTN results are expected in March, while Launch-HTN results are anticipated in the mid-first half of 2025 [49] Question: Compliance expectations for ABPM device - Management assured that training and experience with the device would ensure high compliance and quality data collection [54][56] Question: Threshold for hyperkalemia rates in trials - Management indicated that a hyperkalemia rate of 5% or less is viewed favorably, with expectations that diuretics may offset potassium increases [78][82] Question: Differences in treatment effect between pivotal studies - Management noted that while Advance may be more rigorous, it could also be enriched for aldosterone-driven hypertension, making direct comparisons challenging [101][102]