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]

As filed with the Securities and Exchange Commission on January 18, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MINERALYS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 84-1966887 (I.R.S. Employer Identification No.) 150 N. Radnor Chester Road, Suite F2 ...