RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) this week announced its financial results for the second quarter ending June 30, 2024, and provided a corporate update, highlighting significant progress in its pivotal clinical trials.
The company reported a 90% enrollment in the Advance-HTN trial, a study assessing lorundrostat for treating uncontrolled (uHTN) or resistant hypertension (rHTN). Top-line data from this trial are expected in the first quarter of 2025. CEO Jon Congleton remarked, “Considering the current pace of enrollment, we anticipate announcing topline data during the first quarter of 2025. To our knowledge, this will be one of the most rigorous trials ever completed for an aldosterone targeted therapy.”
The Launch-HTN Phase 3 trial, another pivotal study, is ahead of schedule. This trial aims to provide top-line data in the second half of 2025, focusing on lorundrostat as add-on therapy for patients failing to control blood pressure with existing medications.
In addition, the Explore-CKD Phase 2 trial is progressing, targeting patients with uHTN or rHTN and Stage 2 to 3b chronic kidney disease (CKD). The company anticipates top-line data from this trial in the first half of 2025. Meanwhile, the Transform-HTN Open-Label Extension Trial continues, collecting extended safety and efficacy data on lorundrostat.
Financially, Mineralys reported cash, cash equivalents, and investments totaling $311.1 million as of June 30, 2024, up from $239.0 million at the end of December 2023. This increase provides sufficient funding for planned clinical studies and corporate operations into 2026.
R&D expenses rose significantly to $39.3 million for the quarter, compared to $11.9 million in the same period last year. This increase resulted from higher clinical and preclinical costs, clinical supply expenditures, regulatory expenses, and compensation costs due to increased headcount and salaries.
G&A expenses also increased to $5.9 million, up from $3.9 million year-over-year, primarily driven by higher compensation and professional fees. Total other income, net was $4.2 million, up from $3.6 million, due to increased interest earned on investments.
The net loss for the quarter was $41.0 million, compared to $12.1 million in the same period last year, largely due to increased R&D and G&A expenses.
Mineralys’ continuous progress with lorundrostat in clinical trials aims to tackle hypertension and chronic kidney disease. The forthcoming data from these studies will play a crucial role in shaping the future landscape of hypertension treatments.
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