Mineralys Therapeutics (MLYS) 2025 Conference Transcript

Summary of Mineralys Therapeutics Conference Call Company Overview - Company: Mineralys Therapeutics (MLYS) - Focus: Targeting aldosterone and cardiorenal metabolic conditions [4][36] Industry Context - Market Size: Approximately 60 million treated patients for hypertension, with 30 million unable to reach treatment goals [37] - Patient Risk: About 20 million patients at risk of stroke, heart disease, or kidney disease due to uncontrolled hypertension [37] Core Points and Arguments - Aldosterone's Role: 25-30% of hypertension patients have dysregulated aldosterone, linked to visceral adiposity [4][5] - Therapeutic Gap: Limited effective therapeutics targeting aldosterone, highlighting the need for new treatments [5] - Positive Study Results: - LAUNCH study showed a 19 mmHg reduction in blood pressure in real-world settings [6] - ADVANCE study demonstrated a 15 mmHg reduction in a rigorous hypertension study [6] - Mechanism of Action: Lorundestat, an aldosterone synthase inhibitor (ASI), targets both sides of aldosterone's effects, offering a dual mechanism of action [9][10] - Selectivity and Efficacy: Lorundestat has best-in-class selectivity for aldosterone over cortisol, with a half-life of 10-12 hours, allowing for effective blood pressure management [10][11] Clinical Data Highlights - Patient Demographics: - 40% of trial patients were uncontrolled on two medications, 60% were resistant to hypertension [14] - 30% were African American, and about 90% were overweight or obese [14] - Statistical Significance: - 17 mmHg absolute reduction in blood pressure at six weeks, with 44% of patients achieving treatment goals compared to 24% on placebo [15][18] - Safety Profile: - Low incidence of serious adverse events (2.4%) and discontinuation (2.6%) [24] - Mild potassium profile changes, with only 0.6% of subjects having confirmed readings above 6 [21][28] Future Studies and Pipeline - Upcoming Studies: - EXPLORER CKD study to assess blood pressure and kidney function in patients with chronic kidney disease [32] - OSA study initiated to explore the relationship between sleep apnea and hypertension [34] - Regulatory Plans: Pre-NDA meeting planned for Q4 2025 following successful study outcomes [36] Financial Position - Cash Balance: $343 million as of Q1 reporting [39] Strategic Developments - Commercial Strategy: Eric Warren appointed as Chief Commercial Officer to enhance commercial opportunities and strategic partnerships [39] Conclusion - Mineralys Therapeutics is positioned to address significant unmet needs in hypertension treatment, with promising clinical data supporting the efficacy and safety of lorundestat, alongside a robust pipeline and strategic leadership to drive future growth [36][39]