Mineralys Therapeutics (MLYS) Stifel 2025 Healthcare Conference summary

Clinical development and data highlights

• Two pivotal studies, Advance-HTN and Launch-HTN, showed significant blood pressure reductions in resistant and uncontrolled hypertension populations, with lorundrostat achieving 15–19 mmHg reductions, outperforming current therapies.

• Lorundrostat demonstrated robust efficacy across diverse subpopulations, including strong representation and positive outcomes in Black or African American patients, a high-risk group for hypertension.

• Safety profile remains favorable, with open-label extension data supporting long-term use and minimal risk of hyperkalemia compared to competitors.

• The drug fits seamlessly into current clinical workflows, with rapid onset of action and early safety monitoring aligning with standard hypertension management.

• Ongoing and future data, including 12-month safety and efficacy, will further inform regulatory filings and support label expansion.

Competitive landscape and differentiation

• Lorundrostat exhibits best-in-class selectivity for aldosterone synthase, with a 374:1 selectivity ratio over cortisol, compared to 101:1 for Baxdrostat.

• Clinical trials show lorundrostat has greater blood pressure reduction and lower rates of hyperkalemia than Baxdrostat, with more interpretable data due to proper statistical handling of missing values.

• The half-life of lorundrostat (10–12 hours) matches the diurnal pattern of aldosterone, potentially enhancing safety and efficacy.

• Both drugs are likely to be used in resistant and uncontrolled hypertension, but lorundrostat’s data and safety profile may drive earlier adoption.

• The robust dataset in high-risk populations and clear efficacy/safety advantages position lorundrostat as a leading candidate in the ASI class.

Market opportunity and commercialization strategy

• The initial target market includes 10 million resistant and 10 million uncontrolled hypertension patients in the U.S., with uptake expected first in the resistant population.

• Market research indicates strong physician and payer interest, with minimal anticipated access barriers if pricing is competitive.

• Lorundrostat is expected to be used as a third- or fourth-line therapy, with potential to move earlier in the treatment paradigm as experience grows.

• Compliance is expected to be higher than with current fourth-line options due to better tolerability and safety.

• Commercialization may involve selective partnerships, especially for global reach, but the company is prepared to launch independently if needed.