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Jun 30
Mineralys Therapeutics Q2 2025 Earnings Report
Mineralys Therapeutics reported its second quarter 2025 financial results, highlighting continued progress in its clinical programs for lorundrostat and providing a corporate update.
Key Takeaways
Mineralys Therapeutics reported a net loss of $43.3 million for the second quarter of 2025, an increase from $41.0 million in the same period last year. The company's cash, cash equivalents, and investments significantly increased to $324.9 million, providing funding into 2027. Research and development expenses slightly decreased, while general and administrative expenses rose.
Net loss for Q2 2025 was $43.3 million, compared to $41.0 million in Q2 2024.
Cash, cash equivalents, and investments increased to $324.9 million as of June 30, 2025, up from $198.2 million at December 31, 2024.
Research and Development expenses decreased to $38.3 million in Q2 2025 from $39.3 million in Q2 2024.
General and Administrative expenses increased to $8.5 million in Q2 2025 from $5.9 million in Q2 2024.
Mineralys Therapeutics
Mineralys Therapeutics
Forward Guidance
Mineralys Therapeutics anticipates a pre-NDA meeting with the FDA in the fourth quarter of 2025 and expects topline results from the Explore-OSA Phase 2 trial in the first half of 2026. The company believes its current cash, cash equivalents, and investments are sufficient to fund operations into 2027.
Positive Outlook
- Pre-NDA meeting with the FDA scheduled for 4Q 2025, indicating progress towards regulatory submission.
- Explore-OSA Phase 2 trial topline results anticipated in 1H 2026, providing future data catalysts.
- Current cash, cash equivalents, and investments are sufficient to fund planned clinical trials, regulatory activities, and corporate operations into 2027.
- Positive results from Launch-HTN and Advance-HTN pivotal trials published and presented, strengthening lorundrostat's profile.
- Explore-CKD Phase 2 trial successfully achieved statistical significance in reducing systolic BP and UACR with a favorable safety profile.
Challenges Ahead
- Future performance is entirely dependent on the success of lorundrostat.
- Potential for delays in the commencement, enrollment, and completion of clinical trials and nonclinical studies.
- FDA feedback from the end of Phase 2 meeting may not be consistent with later developments, impacting NDA submission.
- Results of clinical trials may not be deemed sufficient by the FDA for NDA submission or regulatory approval.
- Unexpected adverse side effects or inadequate efficacy of lorundrostat could limit its development, regulatory approval, and/or commercialization.