RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) reported its financial results for the fourth quarter and full year ending December 31, 2024, while sharing significant updates on the development of its flagship investigational therapy, lorundrostat. The announcement underscores the company’s commitment to addressing critical medical needs in hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA).
For the year, Mineralys reported cash, cash equivalents, and investments of $198.2 million, a reduction from $239.0 million at the end of 2023. These resources are expected to sustain the company’s operations and clinical programs through the first quarter of 2026. Research and development (R&D) expenses climbed dramatically to $168.6 million in 2024, up from $70.4 million in 2023, driven by the advancement of lorundrostat’s pivotal trials and related clinical activities. General and administrative (G&A) expenses also rose from $14.3 million in 2023 to $23.8 million in 2024, reflecting strategic investments in staffing and professional services.
The company’s net loss for 2024 totaled $177.8 million, compared to $71.9 million the previous year, as it increased spending to accelerate development milestones for its lead candidate.
Clinical Progress and Key Milestones
Mineralys continues to make strides with lorundrostat, an oral, highly selective aldosterone synthase inhibitor designed to address poorly controlled hypertension (uHTN/rHTN), as well as CKD and OSA. CEO Jon Congleton highlighted the team’s accomplishments, stating, “Over the course of the next several months, we anticipate delivering topline data from our pivotal program to treat patients with uncontrolled or resistant hypertension. Our progress reflects the potentially transformative impact of lorundrostat on the millions of patients who remain underserved by current treatments.”
Major highlights from the company’s development pipeline include the following initiatives:
- Advance-HTN Trial (Phase 3): Topline data from this pivotal trial are expected in March 2025. The study evaluates lorundrostat as an add-on therapy to standard antihypertensive treatments and measures changes in 24-hour ambulatory systolic blood pressure over 12 weeks.
- Launch-HTN Trial (Phase 3): Data from this second pivotal trial, focusing on blood pressure outcomes after six weeks of treatment, are anticipated in the first half of 2025.
- Transform-HTN Open-Label Extension: This trial continues to monitor long-term safety and efficacy for patients enrolled in prior lorundrostat studies.
- Explore-CKD Trial (Phase 2): Following completed enrollment, results are expected in Q2 2025. This trial examines lorundrostat as a treatment for CKD patients with uncontrolled or resistant hypertension on SGLT2 inhibitors.
- Explore-OSA Trial (Phase 2): Set to begin in Q1 2025, this innovative trial evaluates lorundrostat’s potential to address OSA in overweight and obese patients with hypertension.
The Potential of Lorundrostat
With many hypertension patients failing to achieve control using existing treatments, lorundrostat represents a promising new approach. By selectively targeting aldosterone—a key driver of hypertension in approximately 25% of patients—lorundrostat demonstrated meaningful blood pressure reductions in earlier trials, along with a favorable safety profile. Its potential applications extend to CKD, where hypertension is a leading contributing factor, and OSA, which frequently coexists with resistant hypertension.
Looking Ahead
With key clinical milestones on the horizon, including pivotal data from its Advance-HTN and Launch-HTN trials in 2025, Mineralys is poised to further advance its robust pipeline. Lorundrostat’s potential to address critical gaps in hypertension and related conditions places the company at the forefront of innovation in cardiovascular and renal therapeutics.
Mineralys’ investments in science, talent, and operations reflect its long-term strategy to deliver impactful therapies for complex diseases. As topline results emerge, the organization’s strategic focus on high-risk populations continues to shape its mission to improve patient outcomes and quality of life worldwide.
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