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Sep 30
Mineralys Therapeutics Q3 2025 Earnings Report
Mineralys Therapeutics reported its third quarter 2025 financial results, highlighting a decrease in net loss and R&D expenses, alongside a significant increase in cash and cash equivalents.
Key Takeaways
Mineralys Therapeutics reported a net loss of $36.9 million for Q3 2025, a notable improvement from $56.3 million in the prior year. This was primarily driven by a decrease in research and development expenses due to the conclusion of the lorundrostat pivotal program. The company also significantly strengthened its balance sheet with cash, cash equivalents, and investments reaching $593.6 million, up from $198.2 million at the end of 2024, following a public equity financing.
Net loss for Q3 2025 decreased to $36.9 million from $56.3 million in Q3 2024.
Research and Development expenses decreased to $31.5 million in Q3 2025 from $54.0 million in Q3 2024, primarily due to the conclusion of the lorundrostat pivotal program.
Cash, cash equivalents and investments significantly increased to $593.6 million as of September 30, 2025, from $198.2 million as of December 31, 2024, bolstered by a $287.5 million public equity financing.
The company anticipates submitting a New Drug Application (NDA) for lorundrostat in late-2025/Q1 2026 and expects topline results from the Explore-OSA trial in Q1 2026.
Mineralys Therapeutics
Mineralys Therapeutics
Forward Guidance
Mineralys Therapeutics is at a pivotal stage, preparing for an NDA submission for lorundrostat and advancing its clinical pipeline, with sufficient funding to support operations into 2028.
Positive Outlook
- Submission of New Drug Application (NDA) for lorundrostat planned for late-2025/Q1 2026.
- Topline results from the Explore-OSA trial anticipated in Q1 2026.
- Current cash, cash equivalents and investments are sufficient to fund planned clinical trials, regulatory activities, and corporate operations into 2028.
- Continued evaluation of lorundrostat's use in prevalent comorbidities of hypertension, such as CKD and OSA, to expand market opportunity.
- Positive topline data from the Phase 2 Explore-CKD trial has already been achieved.
Challenges Ahead
- Potential delays in the commencement, enrollment, and completion of clinical trials and nonclinical studies.
- Later developments with the FDA may be inconsistent with pre-NDA feedback, potentially impacting the proposed pivotal program for registration.
- Any delays in the FDA’s review of the planned NDA submission, including due to government shutdowns or funding reductions.
- The results of clinical trials may not be deemed sufficient by the FDA for NDA submission or regulatory approval.
- Dependence on third parties for manufacturing, research, and clinical/nonclinical testing.