Mineralys Therapeutics, Inc. (NASDAQ:MLYS) is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by dysregulated aldosterone. The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that is being developed for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension and chronic kidney disease (CKD).
Business Overview
Mineralys was incorporated in 2019 and is headquartered in Radnor, Pennsylvania. The company's operations to date have been limited to business planning, raising capital, in-licensing lorundrostat, conducting preclinical and clinical trials, and other research and development activities. Mineralys has not generated any revenue to date and has incurred net losses of $71,898,000 in 2023 and $31,508,000 in the first quarter of 2024. The company's annual operating cash flow was -$81,173,000 in 2023, and its annual free cash flow was also -$81,173,000.Lorundrostat: Targeting Dysregulated Aldosterone
Mineralys' lead product candidate, lorundrostat, is a highly selective ASI that the company is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 25% of hypertensive patients, a significant population as there are an estimated 115 million patients in the United States who have hypertension. Of the 60 million treated patients, more than half fail to achieve their blood pressure goal.Pivotal Hypertension Program
Mineralys has initiated a pivotal clinical program of lorundrostat for the treatment of uncontrolled or resistant hypertension. The company's first pivotal trial, Advance-HTN, is a randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating the efficacy and safety of lorundrostat as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in 261 adult subjects. Topline data from this trial is anticipated in the fourth quarter of 2024.The company's second pivotal trial, Launch-HTN, is a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of lorundrostat as an add-on therapy to subjects' existing, prescribed background treatment of two to five antihypertensive medications in up to approximately 1,000 adult subjects. Topline data from this trial is anticipated in the second half of 2025.
In addition, Mineralys has initiated an open-label extension trial, Transform-HTN, to allow subjects to continue to receive lorundrostat and obtain long-term efficacy and safety data.
Explore-CKD Trial in Chronic Kidney Disease
Mineralys is also conducting the Explore-CKD Phase 2 clinical trial evaluating lorundrostat in patients with hypertension and Stage 2 to 3b chronic kidney disease. This proof-of-concept trial is designed to demonstrate the benefit of lorundrostat in reducing blood pressure and provide supportive evidence for potential benefit on chronic kidney disease on the background of a stable SGLT2 inhibitor treatment. Topline data from this trial is anticipated between the fourth quarter of 2024 and the first quarter of 2025.Financials
As of March 31, 2024, Mineralys had cash, cash equivalents, and investments of $338.6 million. In February 2024, the company completed a private placement financing for net proceeds of approximately $116 million. Mineralys believes that its current cash, cash equivalents, and investments will be sufficient to allow the company to fund its planned clinical trials as well as support corporate operations into 2026.For the first quarter of 2024, Mineralys reported a net loss of $31.5 million, compared to a net loss of $12.6 million in the same period of 2023. Research and development expenses for the first quarter of 2024 were $30.8 million, up from $12.3 million in the first quarter of 2023, primarily due to increases in preclinical and clinical costs, clinical supply and manufacturing expenses, and higher compensation expenses. General and administrative expenses for the first quarter of 2024 were $4.6 million, up from $2.6 million in the first quarter of 2023, mainly due to higher compensation and professional fees associated with operating as a public company.