Mineralys Therapeutics (MLYS) investor relations material

Clinical development and data highlights

• Lorundrostat has shown successful pivotal clinical outcomes in hypertension, with 12-month safety and efficacy data forthcoming and an FDA filing imminent.

• Trials have demonstrated efficacy across diverse populations, including those with comorbidities like chronic kidney disease (CKD) and obstructive sleep apnea (OSA); OSA trial data is expected in the first quarter of next year.

• About 30% of hypertension patients have elevated aldosterone, and lorundrostat has shown significant blood pressure reduction compared to other third- and fourth-line treatments.

• The Advance-HTN trial used rigorous methodology, standardizing background medications and measuring compliance, supporting guideline inclusion.

• No new safety concerns, such as hyperkalemia, are anticipated in the 12-month data; additional analyses and OSA data will be shared with the FDA and at conferences.

Market strategy and commercialization plans

• Initial market entry is planned for fourth-line hypertension, with expansion to third-line over time; approximately 10 million resistant and another 10 million third-line patients are potential targets in the U.S.

• Inclusion in treatment guidelines is being pursued with key opinion leaders, but success does not hinge solely on guideline changes.

• A focused commercial approach targets about 60,000 high-prescribing physicians, making the launch manageable, though partnership is preferred for broader reach.

• Survey data indicates two-thirds of physicians would prefer lorundrostat over Baxdrostat.

• The company is open to U.S. and ex-U.S. partnerships to maximize patient access and shareholder value.

Competitive landscape and differentiation

• Recent phase III data for Baxdrostat supports the aldosterone synthase inhibitor class, but lorundrostat demonstrated numerically favorable results in 24-hour blood pressure control.

• Specificity and 24-hour efficacy are key differentiators; longer half-life of competitors did not translate to better outcomes and may increase hyperkalemia risk.

• The competitive reaction in the market reflects strong interest and validation of the class rather than outsized concern.

• AstraZeneca's resources are acknowledged, but lorundrostat's focused prescriber base and clinical profile are seen as competitive strengths.