Core Insights - Lorundrostat has shown significant efficacy in reducing blood pressure in patients with uncontrolled or resistant hypertension, achieving a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction at week 12 [1][3] - The drug is a highly selective aldosterone synthase inhibitor, targeting aldosterone biosynthesis rather than blocking mineralocorticoid receptors, positioning it as a potential best-in-class treatment for high-risk patients [1][12] - The favorable safety and tolerability profile of lorundrostat, with low discontinuation rates and manageable on-target effects, supports its use in a specialist setting for complex hypertension cases [6][7] Efficacy Results - The Advance-HTN trial was a randomized, double-blind, placebo-controlled Phase 2 trial assessing lorundrostat's efficacy as an add-on therapy to existing antihypertensive medications [3][14] - At week 4, lorundrostat 50 mg demonstrated an 11.5 mmHg absolute change and a 5.3 mmHg placebo-adjusted change in 24-hour average systolic blood pressure [4] - A significant proportion of patients (41%) achieved a 24-hour average systolic blood pressure of less than 125 mmHg at week 4 compared to 18% on placebo [5] Safety and Tolerability Results - Lorundrostat exhibited a favorable safety profile with modest changes in potassium, sodium, and estimated glomerular filtration rate (eGFR), and a low incidence of serious adverse events [6][10] - The incidence of hyperkalemia was confirmed at 2.1% and 3.2% for the 50 mg and 50 to 100 mg doses, respectively, after excluding spurious results [10] - The study population included a high proportion of historically underrepresented individuals, with 40% women and 53% Black patients, highlighting the drug's potential impact on diverse demographics [7] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea driven by dysregulated aldosterone [15] - The company plans to present additional data from the pivotal Phase 3 Launch-HTN trial at upcoming medical conferences and in peer-reviewed publications [7] - Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific, emphasizing its commitment to addressing significant unmet needs in hypertension care [15]

Core Insights - Lorundrostat 50 mg achieved a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction in blood pressure at week 12, demonstrating a favorable safety and tolerability profile [1][3] - Lorundrostat is a selective aldosterone synthase inhibitor that targets aldosterone biosynthesis, making it a potential best-in-class treatment for high-risk patients with uncontrolled or resistant hypertension [1][12] - The Advance-HTN trial results support lorundrostat's clinical utility across diverse care settings, addressing a significant unmet need in hypertension management [2][7] Efficacy Results - The Advance-HTN trial was a randomized, double-blind, placebo-controlled Phase 2 trial evaluating lorundrostat's efficacy and safety in patients with uncontrolled or resistant hypertension [3][14] - The primary endpoint was the change in 24-hour average systolic blood pressure (SBP) at week 12, with significant reductions observed [4][14] - Key secondary endpoints included a 7.9 mmHg placebo-adjusted change at week 4, with a notable proportion of patients achieving SBP < 125 mmHg [5][4] Safety and Tolerability - Lorundrostat exhibited a favorable safety profile with modest changes in potassium, sodium, and estimated glomerular filtration rate (eGFR), alongside a low discontinuation rate [6][7] - The incidence of serious adverse events was very low, reinforcing lorundrostat's potential as a well-tolerated therapy for high-risk patients [7][10] - Hyperkalemia incidence was confirmed at 2.1% and 3.2% for the 50 mg and 50 to 100 mg arms, respectively, after validation procedures [10] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea driven by dysregulated aldosterone [15] - The company is based in Radnor, Pennsylvania, and aims to address significant health issues related to hypertension, which has a substantial economic burden in the U.S. [9][15] - Mineralys plans to present additional data from the Phase 3 Launch-HTN trial at upcoming medical conferences [7]

Core Insights - Mineralys Therapeutics announced positive topline data from its pivotal Launch-HTN Phase 3 and Advance-HTN Phase 2 trials for lorundrostat, demonstrating significant efficacy and safety in treating uncontrolled and resistant hypertension [2][3] Efficacy Results - The Launch-HTN trial achieved a 16.9 mmHg reduction in systolic blood pressure at week 6 and a 19.0 mmHg reduction at week 12, with placebo-adjusted reductions of 9.1 mmHg and 11.7 mmHg respectively (p-value < 0.0001) [1][5] - The Advance-HTN trial reported a 7.9 mmHg placebo-adjusted reduction in systolic blood pressure at week 12 [1][6] - Both trials demonstrated clinically meaningful and statistically significant results, supporting the potential of lorundrostat as a new treatment option for approximately 15 to 20 million patients with uncontrolled hypertension in the U.S. [3][4] Safety and Tolerability - Lorundrostat exhibited a favorable safety and tolerability profile across both pivotal trials, with low incidences of serious adverse events and manageable side effects [8][14] - The incidence of hyperkalemia was reported at 1.1% and 1.5% in the Launch-HTN trial and 5.3% and 7.4% in the Advance-HTN trial [14] Future Developments - Full results from the Advance-HTN trial are scheduled to be presented on March 29, 2025, at the American College of Cardiology Scientific Sessions [1][7] - The ongoing Transform-HTN open-label extension trial will continue to gather safety and efficacy data for lorundrostat [10] Company Overview - Mineralys Therapeutics is focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea, with lorundrostat being its lead candidate [2][19] - The company aims to address the significant unmet medical need in hypertension, where less than 50% of patients achieve their blood pressure goals with current medications [12][13]

Table of Contents As filed with the Securities and Exchange Commission on April 19, 2023. Registration No. 333-269775 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 WINDTREE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 2836 (Primary Standard Industrial Classification Code Number) 94-3171943 (I.R.S. Em ...

As filed with the Securities and Exchange Commission on February 2, 2023 Registration No. 333-269282 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO 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 Identific ...

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 ...