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Dec 31, 2022
Mineralys Therapeutics Q4 2022 Earnings Report
Reported fourth quarter and full year 2022 financial results and provided a corporate update.
Key Takeaways
Mineralys Therapeutics reported its Q4 and full year 2022 financial results, highlighting the upcoming pivotal clinical program for lorundrostat and the completion of its IPO in February 2023. The company is focused on developing treatments for diseases driven by elevated aldosterone.
Pivotal clinical program for Lorundrostat is expected to begin in the first half of 2023.
Completed IPO and Nasdaq listing in February 2023, with net proceeds of approximately $202.0 million.
Announced positive topline data from the Target-HTN Phase 2 trial for Lorundrostat in November 2022.
Presented Phase 2 and Phase 1 results at ACC.23/WCC in March 2023.
Mineralys Therapeutics
Mineralys Therapeutics
Forward Guidance
Mineralys Therapeutics plans to initiate multiple clinical trials in 2023, including ADVANCE-HTN Phase 2, a Phase 3 pivotal trial, and a CKD profiling trial, with topline data expected at various points in 2024 and 2025.
Positive Outlook
- Initiate ADVANCE-HTN Phase 2 trial in the first half of 2023, topline data expected in the first half of 2024.
- Initiate Phase 3 pivotal trial in the second half of 2023, topline data expected in mid-2025.
- Initiate CKD profiling trial in mid-2023, topline data expected in the first half of 2024.
- Initiate an open label extension trial for long-term safety exposure in mid-2023.
- Advance clinical development of lorundrostat for the treatment of hypertension.
Challenges Ahead
- Potential delays in the commencement, enrollment, and completion of clinical trials and nonclinical studies.
- Dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing.
- Unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval, and/or commercialization.
- Unfavorable results from clinical trials and nonclinical studies.
- Reliance on exclusive license with Mitsubishi Tanabe for intellectual property rights.