Mineralys Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update

Core Insights - Mineralys Therapeutics, Inc. announced positive results from pivotal trials for lorundrostat, a treatment for hypertension and related conditions, and plans to meet with the FDA for a pre-NDA meeting in Q4 2025 [1][3][4] Clinical Developments - The Launch-HTN Phase 3 trial met its primary endpoint, demonstrating efficacy and safety for lorundrostat in uncontrolled or resistant hypertension [4] - The Advance-HTN trial also met its primary endpoints, reinforcing the favorable benefit-risk profile of lorundrostat in high-risk populations [4] - The Explore-CKD Phase 2 trial showed significant reductions in systolic blood pressure (9.25 mmHg) and urine albumin-to-creatinine ratio (30.51%) [4] - Ongoing Explore-OSA Phase 2 trial is expected to report topline results in 1H 2026 [1][4] Financial Performance - As of June 30, 2025, the company reported cash, cash equivalents, and investments of $324.9 million, up from $198.2 million at the end of 2024, sufficient to fund operations into 2027 [5][31] - R&D expenses for Q2 2025 were $38.3 million, a decrease from $39.3 million in Q2 2024, primarily due to the conclusion of the lorundrostat pivotal program [6] - General and Administrative expenses increased to $8.5 million in Q2 2025 from $5.9 million in Q2 2024, driven by higher compensation and professional fees [7] - The net loss for Q2 2025 was $43.3 million, compared to $41.0 million in Q2 2024 [9][29] Market Context - Hypertension affects a significant portion of the population, with less than 50% of patients achieving blood pressure goals with current medications [11][12] - Chronic kidney disease (CKD) affects over 10% of the global population and is closely linked to hypertension, increasing cardiovascular risks [13][15] - Obstructive sleep apnea (OSA) is prevalent among hypertensive patients, with untreated cases contributing to resistant hypertension [17][18] Product Overview - Lorundrostat is a selective aldosterone synthase inhibitor designed to treat uncontrolled and resistant hypertension, CKD, and OSA [19][21] - The drug has shown a 40-70% reduction in plasma aldosterone concentration in hypertensive participants [19][20]