Mineralys Therapeutics (MLYS) Q3 2025 earnings summary

Executive summary

• NDA submission for lorundrostat is planned for late Q4 2025 or Q1 2026 following positive pre-NDA FDA feedback, with no surprises reported.

• Lorundrostat demonstrated clinically meaningful and sustained systolic blood pressure reduction and safety in pivotal Launch-HTN and Advance-HTN trials, as well as in CKD and OSA populations.

• Clinical program included diverse populations, with significant representation of Black or African-American patients and those with resistant hypertension.

• Additional development in comorbid conditions (CKD, OSA) with positive EXPLORE-CKD results and ongoing EXPLORE-OSA trial, which completed enrollment and expects topline results in Q1 2026.

• Commercial readiness efforts underway, including payer engagement, expanded medical communications, and ongoing partnering discussions for ex-U.S. commercialization.

Financial highlights

• Cash, cash equivalents, and investments totaled $593.6 million as of September 30, 2025, up from $198.2 million at year-end 2024.

• R&D expenses for Q3 2025 were $31.5 million, down from $54 million in Q3 2024, mainly due to the conclusion of the pivotal program.

• G&A expenses rose to $9.7 million from $6.1 million year-over-year, driven by higher compensation and professional fees.

• Net loss for Q3 2025 was $36.9 million, improved from $56.3 million in Q3 2024; net loss for the nine months ended September 30, 2025 was $122.4 million.

• Public equity financings in 2025 raised over $485 million, including $287.5 million in September.

Outlook and guidance

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

• NDA submission for lorundrostat anticipated by end of 2025 or early 2026; topline results from EXPLORE-OSA trial expected in Q1 2026.

• Expenses and operating losses expected to increase as clinical, regulatory, and commercialization activities expand; additional funding may be required for future development.

• Ongoing focus on maximizing lorundrostat's value through potential partnerships, especially for ex-U.S. commercialization.