Mineralys Therapeutics (MLYS) investor relations material

Targeting aldosterone in cardiorenal diseases

• Lorundrostat is a selective aldosterone synthase inhibitor (ASI) aimed at treating hypertension and cardiorenal diseases, with demonstrated efficacy in patients with chronic kidney disease (CKD) and obstructive sleep apnea (OSA).

• Dysregulated aldosterone is a key driver in 30% of uncontrolled and resistant hypertension (u/rHTN), impacting multiple biological pathways and contributing to cardiorenal disorders.

• Lorundrostat has shown meaningful 24-hour blood pressure reduction and safety with once-daily dosing.

• NDA for lorundrostat has been accepted, with a PDUFA target action date of December 22, 2026.

Clinical efficacy and safety

• Lorundrostat demonstrated clinically meaningful reductions in systolic blood pressure across multiple trials, including in patients with CKD and OSA.

• Achieved robust clinical benefit with 44% of lorundrostat and 24% of placebo patients reaching BP goals in real-world settings.

• Very low rates of serious adverse events and treatment discontinuations were observed across patient types.

• Potassium profile is mild and predictable, similar to ACE inhibitors and ARBs, with increases typically resolving within two weeks.

Market opportunity and commercial strategy

• Approximately 20 million people in the U.S. have uncontrolled or resistant hypertension, with significant overlap in CKD and OSA populations.

• 8.8 million u/rHTN patients per year try new treatments, indicating dissatisfaction with current therapies and opportunity for lorundrostat.

• Majority of primary care physicians, cardiologists, and nephrologists are likely to prescribe lorundrostat based on efficacy and safety data.

• Launch plan targets both generalists and specialists, leveraging inclusion in treatment guidelines and proven efficacy in high-risk subgroups.