Mineralys Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

Core Insights - Mineralys Therapeutics is focused on developing lorundrostat, a treatment for hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA) [2][18] - The company anticipates significant clinical data releases in 2025, including topline data from pivotal trials for lorundrostat [1][5] Clinical Development - The pivotal Advance-HTN trial is expected to report topline data in March 2025, evaluating lorundrostat for uncontrolled or resistant hypertension [5] - The Launch-HTN Phase 3 trial is set to report topline data in the first half of 2025, focusing on patients who do not achieve blood pressure control with existing medications [5] - Enrollment for the Explore-CKD Phase 2 trial has been completed, with topline data anticipated in Q2 2025 [1][5] - A new Phase 2 trial for lorundrostat in patients with moderate-to-severe OSA and hypertension is planned to initiate in Q1 2025 [1][5] Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and investments totaling $198.2 million, down from$239.0 million in 2023 [4] - Research and Development (R&D) expenses for 2024 were $168.6 million, significantly higher than$70.4 million in 2023, primarily due to increased clinical costs [5][6] - General and Administrative (G&A) expenses rose to $23.8 million in 2024 from$14.3 million in 2023, driven by higher compensation and professional fees [7] - The net loss for 2024 was $177.8 million, compared to$71.9 million in 2023, reflecting increased operational expenses [9][22] Market Context - Hypertension affects a significant portion of the population, with less than 50% of patients achieving their blood pressure goals with current medications [12] - Dysregulated aldosterone levels contribute to hypertension in approximately 25% of hypertensive patients, indicating a potential market for aldosterone-targeting therapies like lorundrostat [12][16] - CKD affects over 10% of the global population, with diabetes and hypertension being major contributors [13] - OSA impacts nearly one billion people globally, with a significant overlap with hypertension, particularly in resistant cases [15]