Mineralys Therapeutics (NasdaqGS:MLYS) 2025 Conference Transcript

Summary of Mineralys Therapeutics Conference Call Company Overview - Company: Mineralys Therapeutics (NasdaqGS: MLYS) - Focus: Development of aldosterone synthase inhibitors (ASI) targeting cardiorenal metabolic disorders, primarily hypertension [1][2] Industry Context - Market Opportunity: Approximately 20 million patients in the U.S. suffer from resistant and uncontrolled hypertension, with 10 million specifically identified as resistant hypertension patients [4][5] - Competitive Landscape: The ASI class is emerging as a new treatment option for hypertension, with recent data from competitors like AstraZeneca's Baxdrostat [2][3] Key Clinical Data - Clinical Trials: Successful outcomes from pivotal studies LAUNCH HTN and ADVANCE HTN, with significant blood pressure reductions observed [1][2] - Efficacy: Lorundrostat demonstrated a 15-19 mmHg reduction in blood pressure compared to the typical 5 mmHg improvement seen with existing treatments [5][6] - Patient Demographics: Strong representation of Black or African American patients in trials, addressing a high-risk population for hypertension [9][10] Drug Profile - Selectivity: Lorundrostat shows a selectivity ratio of 374:1 for aldosterone over cortisol, compared to Baxdrostat's 101:1, indicating a better safety profile [11][12] - Half-Life: Lorundrostat has a half-life of 10-12 hours, aligning with the diurnal pattern of aldosterone secretion, which may enhance safety [12][13] - Safety Signals: Lower incidence of hyperkalemia compared to Baxdrostat, with 8% incidence above 5.5 mEq/L for lorundrostat versus 11% for Baxdrostat [15][16] Market Strategy - Target Population: Initial focus on resistant hypertension, with plans to expand into uncontrolled hypertension as prescriber comfort increases [27][30] - Commercialization Approach: Open to partnerships but emphasizes the importance of selecting the right partner to maximize the drug's potential [45][46] - Market Size: Targeting a broad market of 120 million people with hypertension, with a focus on the top 60,000 prescribers [46][47] Future Developments - NDA Filing: Anticipated NDA filing by the end of 2025, with ongoing collection of safety and efficacy data beyond the initial 12-week trials [37][38] - Additional Studies: Ongoing studies in chronic kidney disease (CKD) and obstructive sleep apnea (OSA) to explore additional benefits and potential label expansions [42][43] Conclusion - Investment Potential: Mineralys Therapeutics is positioned with a best-in-class molecule in a growing market, with strong clinical data supporting its efficacy and safety, making it a compelling investment opportunity in the pharmaceutical sector [19][50]