RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has released its financial results for the third quarter ending September 30, 2024, alongside key updates on its clinical trials. The company has made significant strides in its pivotal clinical program for lorundrostat, targeting uncontrolled and resistant hypertension.
Jon Congleton, CEO of Mineralys Therapeutics, stated, “The past several months were very productive for our team, as we made significant progress advancing our pivotal clinical program for lorundrostat for the treatment of uncontrolled hypertension or resistant hypertension.” He highlighted the completion of enrollment for two pivotal trials, Advance-HTN and Launch-HTN, which are expected to deliver topline data in the first half of 2025. These trials will form the foundation for the company’s NDA submission to the FDA, pending positive results.
The Advance-HTN trial completed enrollment and anticipates topline data in March 2025. It assesses lorundrostat’s efficacy and safety as an add-on treatment and boasts diverse participant demographics, offering insights into patient benefits. The Launch-HTN trial, also fully enrolled ahead of schedule, aims to provide results by mid-2025. It targets patients who have not achieved blood pressure control with multiple antihypertensive medications.
In addition, the Explore-CKD Phase 2 trial is ongoing, with topline data expected in Q2 2025. This trial investigates lorundrostat’s potential in treating patients with hypertension and chronic kidney disease. Additionally, the Transform-HTN Open-Label Extension Trial continues to gather further safety and efficacy data.
Financially, Mineralys reported cash, equivalents, and investments totaling $263.6 million as of September 30, 2024. This positions the company to fund planned studies and operations into 2026. R&D expenses rose to $54.0 million, primarily due to the initiation of the lorundrostat pivotal program and related costs. General and administrative expenses increased to $6.1 million, largely driven by higher compensation and professional fees. The company recorded a net loss of $56.3 million, reflecting increased research and development activities.
Overall, Mineralys Therapeutics is on track with its clinical trials and financial management, setting the stage for potential advancements in hypertension treatment.
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