Mineralys Therapeutics (MLYS) investor relations material

Key milestones and clinical progress

• NDA for lorundrostat accepted in Q1, marking a significant regulatory milestone and moving closer to FDA approval.

• Five clinical trials demonstrated consistent, robust blood pressure reduction and safety for lorundrostat, targeting patients with uncontrolled and resistant hypertension.

• Market research indicates strong demand and intent to prescribe among physicians, payers, and patients, especially in resistant hypertension.

• Launch preparations include establishing a national account team and engaging in pre-approval information exchange with payers.

• Ongoing dialogues with key opinion leaders and payers to ensure successful uptake upon anticipated FDA approval later this year.

Commercial strategy and market positioning

• Lorundrostat is positioned about six months behind a competitor, allowing observation and adaptation of launch strategies.

• Initial focus is on building awareness of aldosterone targeting and differentiating lorundrostat’s clinical data.

• Approximately 60,000 physicians, split 60/40 between primary care and cardiology, control half of third-line hypertension prescribing.

• Digital and non-personal technologies will augment a targeted sales force, extending reach efficiently.

• Expansion from fourth-line to third-line use is expected as payer and prescriber interest grows, especially for patients with comorbidities.

Regulatory and label considerations

• Anticipates a broad label for uncontrolled blood pressure, with both 25 mg and 50 mg doses included, pending FDA negotiations.

• Monitoring requirements for potassium and other labs are expected to mirror current ACE inhibitor and ARB protocols.

• Engagement with guideline committees aims to ensure timely incorporation of lorundrostat data into hypertension treatment guidelines.