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

Core Insights - Mineralys Therapeutics announced positive topline results from pivotal trials Launch-HTN and Advance-HTN, demonstrating the efficacy and safety of lorundrostat for treating uncontrolled or resistant hypertension [2][3] - The company anticipates topline data from the Explore-CKD Phase 2 trial in Q2 2025 and has initiated the Explore-OSA Phase 2 trial in Q1 2025 [1][12] - The company reported a net loss of $42.2 million for Q1 2025, an increase from $31.5 million in Q1 2024, primarily due to rising research and development expenses [8][22] Clinical Trials and Results - The Launch-HTN trial achieved a 16.9 mmHg reduction in systolic blood pressure at the 50 mg dose, with a placebo-adjusted reduction of 9.1 mmHg, and sustained benefits through week 12 [3] - The Advance-HTN trial reported a 15.4 mmHg absolute reduction in systolic blood pressure at the 50 mg dose, with a placebo-adjusted reduction of 7.9 mmHg [3] - Both trials demonstrated a favorable safety profile, with low incidences of hyperkalemia at 1.1% and 1.5% for the 50 mg and 50 to 100 mg arms in the Launch-HTN trial, respectively [3] Financial Performance - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $343.0 million, up from $198.2 million at the end of 2024 [5][24] - Research and development expenses for Q1 2025 were $37.9 million, compared to $30.8 million in Q1 2024, driven by increased clinical costs and compensation expenses [6][22] - General and administrative expenses rose to $6.6 million in Q1 2025 from $4.6 million in Q1 2024, attributed to higher compensation and professional fees [7][22] Corporate Developments - Eric Warren has been appointed as Chief Commercial Officer, bringing extensive experience in cardiovascular disease to support the company's commercial strategy [2][12] - The company completed a public equity financing on March 18, 2025, raising approximately $201.2 million to strengthen its balance sheet [12] Upcoming Milestones - The Explore-CKD Phase 2 trial is expected to deliver topline data in Q2 2025, focusing on the safety and efficacy of lorundrostat in patients with chronic kidney disease [1][12] - The Explore-OSA Phase 2 trial has been initiated to evaluate lorundrostat in overweight and obese subjects with moderate-to-severe obstructive sleep apnea and hypertension [1][12]