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Dec 31, 2023
Mineralys Therapeutics Q4 2023 Earnings Report
Reported financial results for the fourth quarter and full year ending December 31, 2023, and provided a corporate update.
Key Takeaways
Mineralys Therapeutics reported a net loss of $24.4 million for the fourth quarter of 2023, compared to a net loss of $9.1 million for the same period in 2022. Cash, cash equivalents and investments were $239.0 million as of December 31, 2023. The company believes that its current cash, cash equivalents and investments will be sufficient to fund its planned clinical studies, as well as support corporate operations, into 2026.
Initiated the Launch-HTN trial, the second ongoing pivotal trial of lorundrostat for the treatment of patients with uHTN or rHTN, in Q4 2023.
Presented BMI data from Target-HTN Phase 2 trial at the American Heart Association (AHA) Scientific Sessions in Q4 2023.
Appointed Minji Kim, Ph.D. as Chief Business Officer.
Completed a private placement financing for gross proceeds of approximately $120 million subsequent to the end of the fourth quarter.
Mineralys Therapeutics
Mineralys Therapeutics
Forward Guidance
Mineralys Therapeutics anticipates several clinical events in 2024, which are expected to expand the data package for lorundrostat.
Positive Outlook
- Enrollment in the Advance-HTN trial is on track to announce topline data in the fourth quarter of 2024.
- Topline data from the Launch-HTN trial is expected in the second half of 2025.
- The Explore-CKD trial remains on track to report topline data in the fourth quarter of 2024 to the first quarter of 2025.
- The trial design is being modified, including allowing all subjects to use concurrent SGLT2 inhibitors.
- Reducing the eGFR cutoff to 30ml/min/1.73m2 for all trial participants, obviating the need for Part B of the trial.
Challenges Ahead
- Future performance is dependent entirely on the success of lorundrostat.
- Potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies.
- Later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting.
- 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.