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Mineralys Therapeutics, Inc. (Nasdaq: MLYS) is a clinical-stage biopharmaceutical company based in Radnor, Pennsylvania, dedicated to developing innovative medicines for managing hypertension, chronic kidney disease (CKD), and other conditions driven by abnormally elevated aldosterone levels. The company's flagship product, lorundrostat, is an orally administered, highly selective aldosterone synthase inhibitor. This medication is designed to treat patients with uncontrolled hypertension—defined as those unable to achieve blood pressure below 130/80 mmHg even with two or more antihypertensive medications—and resistant hypertension, affecting those who cannot reach the target BP despite taking three or more medications, including a diuretic.
Mineralys Therapeutics aims to revolutionize hypertension management by moving away from the traditional trial-and-error approach and introducing a more personalized treatment strategy. The company’s recent accomplishments underscore this commitment: the publication of their proof-of-concept study, Target-HTN, in the Journal of the American Medical Association, and the initiation of the Phase 3 Launch-HTN and Phase 2 Explore-CKD trials.
The company recently revealed robust financial results for the third quarter of 2023, reporting cash, cash equivalents, and investments totaling $265.9 million as of September 30, 2023, ensuring sufficient funding for planned clinical studies and operations through mid-2025. Mineralys also saw significant increases in both R&D and G&A expenses, attributed to the ramp-up in clinical activities and the transition to operating as a public company.
Mineralys’ lorundrostat has shown promising results in early trials, demonstrating a substantial reduction in plasma aldosterone concentration and clinically meaningful reductions in blood pressure among participants. The company is actively enrolling subjects in pivotal trials and expects to commence the Launch-HTN trial by the end of 2023, targeting real-world applications and responder profiling through biomarker-driven approaches.
Moreover, Mineralys is also focused on chronic kidney disease, which affects over 10% of the global population. Lorundrostat’s potential to treat CKD by targeting aldosterone—an underlying driver in cardiorenal conditions—positions Mineralys at the forefront of tackling complex, interrelated health issues.
For more information, visit their official website at https://mineralystx.com and follow Mineralys on LinkedIn and Twitter.
Mineralys Therapeutics (Nasdaq: MLYS) reported financial results for 2022, announcing a net loss of $29.8 million, up from $19.4 million in 2021. Cash and equivalents increased to $110.1 million following a successful IPO in February, yielding approximately $202 million in net proceeds. The pivotal clinical program for lorundrostat, targeting uncontrolled hypertension, is set to begin in H1 2023. Recent positive Phase 2 trial data supports this initiation, with topline results expected in 2024. Upcoming trials include a Phase 3 study in H2 2023 and a chronic kidney disease trial mid-2023.
Mineralys Therapeutics announced positive results from the Target-HTN Phase 2 trial for lorundrostat, showing a significant placebo-adjusted reduction in systolic blood pressure (BP) of 16.7 mmHg among obese patients (BMI ≥30 kg/m²) at a dose of 50 mg once daily. The trial indicated safety and efficacy in inadequately controlled hypertensive patients on multiple medications. CEO Jon Congleton emphasized the link between obesity, aldosterone, and hypertension, confirming the company's strategic direction. An additional clinical trial is expected to begin in the first half of 2023, enhancing hopes for lorundrostat's market introduction.
Mineralys Therapeutics (NASDAQ: MLYS) announced its plan to release financial results for the fourth quarter ending December 31, 2022, on March 15, 2023, post-market close. A conference call with management is scheduled for 4:30 p.m. ET on the same day, accessible via 1-877-704-4453 (U.S.) or 1-201-389-0920 (international) with conference ID 13736564. The company is focused on developing treatments for diseases linked to high aldosterone levels, with its lead candidate, lorundrostat, targeting uncontrolled hypertension.
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