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 pivotal and Phase 2 trials completed and ongoing extension and OSA trials underway.

• Lorundrostat demonstrated clinically meaningful and sustained systolic blood pressure reduction in pivotal Launch-HTN and Advance-HTN trials, including diverse and high-risk populations, and showed efficacy and safety in CKD.

• Additional development activities include trials in hypertension with comorbid CKD and OSA, with positive results in CKD and OSA data expected in Q1 2026.

• Market access planning and payer engagement are underway to support commercial readiness.

• No products approved or revenue generated; operations funded by equity offerings and private placements, raising ~$1.0 billion to date.

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 pivotal programs.

• G&A expenses increased 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, compared to $128.9 million for the same period in 2024.

• Public equity financing in September 2025 raised approximately $287.5 million before fees.

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.

• Top-line results from the 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.

• Continued focus on partnering for ex-U.S. commercialization and potential U.S. co-development.