Mineralys Therapeutics (MLYS) Q4 2025 earnings summary

Executive summary

• FDA accepted the NDA for lorundrostat for hypertension, assigning a PDUFA target action date of December 22, 2026.

• Multiple positive clinical trials, including pivotal and exploratory studies, demonstrated lorundrostat's efficacy in blood pressure reduction and safety across diverse populations.

• Market access planning, payer engagement, and expanded medical communications are underway to support a rapid launch.

• Explore-OSA trial showed significant blood pressure reduction but did not meet the primary endpoint for sleep apnea.

• Ongoing evaluation of lorundrostat in comorbidities, new indications, and long-term safety through open-label extension trials.

Financial highlights

• Cash equivalents and investments totaled $656.6 million at year-end 2025, up from $198.2 million at year-end 2024.

• R&D expenses for 2025 were $132 million, down from $168.6 million in 2024, mainly due to the conclusion of pivotal trials.

• G&A expenses rose to $38.6 million in 2025 from $23.8 million in 2024, driven by higher compensation and professional fees.

• Net loss for 2025 was $154.7 million, an improvement from $177.8 million in 2024.

• Other income increased to $16 million in 2025, primarily from higher interest on investments.

Outlook and guidance

• Cash position expected to fund operations, clinical trials, and regulatory activities into 2028.

• Anticipated lower R&D activity in 2026 as major trials conclude.

• Continued focus on payer access, pricing strategy, and potential expansion into third-line hypertension treatment.

• Ongoing evaluation of ex-US regulatory submissions and potential partnerships for broader market reach.

• Awaiting FDA decision on lorundrostat NDA by December 2026.