Mineralys Therapeutics (MLYS) Jefferies Global Healthcare Conference 2026 summary

Key financial transactions and funding

• Repurchased royalties from Tanabe for $200 million upfront and $100 million in potential milestones, extinguishing escalating royalties up to 10%.

• Raised $150 million in equity and secured a $500 million debt facility, with $100 million funded at closing and $400 million available in tranches tied to FDA approval and sales milestones.

• Pro forma, $100 million in new commercial milestones and $165 million in existing milestones remain.

• Fully funded for commercialization based on current cash, financing, and debt facility.

• As of Q1, held $646 million in cash and 83 million shares outstanding.

Clinical development and efficacy highlights

• Lorundrostat, a selective aldosterone synthase inhibitor, targets uncontrolled and resistant hypertension, with about 30% of such patients having elevated aldosterone.

• Demonstrated 24-hour blood pressure control, benefits in CKD, and efficacy in obese and OSA patients.

• NDA filed and accepted, with a PDUFA date of December 22, 2026.

• Five clinical studies over five years show best-in-class efficacy and safety, with robust reductions in systolic BP (15–19 mmHg).

• ADVANCE-HTN and LAUNCH-HTN pivotal trials showed 41–44% of patients reached BP goals, with strong results in diverse populations.

Market opportunity and physician sentiment

• U.S. hypertension market includes 120 million patients, with 20 million on two or more meds not at goal—target addressable market.

• 2024 IQVIA data: 65 million patients received hypertension prescriptions, with 52% on third-line or later treatments.

• Physician surveys show 95% intent to prescribe lorundrostat; two-to-one preference over competitors in blinded studies.

• Fourth-line therapy seen as initial entry point, with potential to expand earlier in treatment as evidence builds.

• Payers open to innovation in third-line or later space due to high costs of uncontrolled hypertension.