Mineralys Therapeutics (NasdaqGS:MLYS) FY Conference Transcript

Summary of Mineralys Therapeutics FY Conference Call Company Overview - Company: Mineralys Therapeutics (NasdaqGS:MLYS) - Event: FY Conference on November 11, 2025 - Key Speaker: Jon Congleton, CEO Industry Context - Industry: Hypertension treatment and drug development - Unmet Need: Hypertension remains a leading modifiable risk factor globally, causing approximately 10.8 million deaths annually due to related comorbidities [4][5][6] Core Points and Arguments 1. Hypertension Treatment Landscape: - There has been a lack of innovation in hypertension treatments over the past 20-25 years, with existing therapies not adequately addressing patient needs, particularly regarding dysregulated aldosterone [5][36] - Current treatment goals have become more stringent, with the target blood pressure now set at 130/80 mmHg for most patients and 120 mmHg for those with comorbidities [5] 2. Lorundrostat's Mechanism and Efficacy: - Lorundrostat is positioned as a best-in-class aldosterone synthase inhibitor (ASI) with a selectivity ratio of 374:1 for aldosterone over cortisol, which is critical for minimizing side effects [9][42] - Clinical trials (ADVANCE HTN and LAUNCH HTN) show significant blood pressure reductions of 15-19 mmHg, which are transformative compared to typical improvements of 5-6 mmHg seen with other agents [15][31] 3. Market Opportunity: - The potential market for lorundrostat is estimated at 20 million patients in the U.S., with 10 million classified as resistant hypertension and another 10 million as uncontrolled hypertension [36][37] - There is a strong demand for innovative treatments, with 95% of surveyed physicians indicating intent to prescribe lorundrostat if available [38] 4. Safety Profile: - Lorundrostat has a favorable safety profile, with lower rates of hyperkalemia compared to competitors, which may be attributed to its selectivity and pharmacokinetics [41][42] 5. Regulatory Timeline: - Mineralys plans to file for regulatory approval by the end of 2025 or Q1 2026, with expectations of overlapping review cycles with competitors like AstraZeneca [43] Additional Important Insights - Patient Demographics: The ADVANCE HTN study included a significant proportion (53%) of Black or African American patients, who are known to have more challenging hypertension profiles [28] - Measurement Techniques: The study utilized multiple blood pressure measurement methods, including 24-hour ambulatory monitoring, to ensure accurate assessment of treatment efficacy [16][17] - Physician Engagement: The company has conducted market research indicating that physicians are primarily focused on absolute blood pressure changes rather than placebo-adjusted figures, which influences prescribing behavior [31][32] This summary encapsulates the key points discussed during the conference call, highlighting the strategic positioning of Mineralys Therapeutics in the hypertension treatment landscape and the promising potential of lorundrostat as a novel therapeutic option.