RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has reported its financial results for the first quarter ended March 31, 2025, alongside major updates on its pivotal clinical trials and corporate progress. The company continues to advance its lead candidate, lorundrostat, a potential treatment for uncontrolled and resistant hypertension, while strengthening its R&D pipeline and operational capabilities.
Positive Clinical Updates
Mineralys highlighted the successful completion of two pivotal Phase 3 clinical trials, Launch-HTN and Advance-HTN, focused on evaluating lorundrostat’s efficacy and safety in patients with hypertension that remains uncontrolled or resistant to existing therapies.
The Launch-HTN trial, which evaluated lorundrostat in combination with other antihypertensive medications, demonstrated a significant reduction in systolic blood pressure, with the 50 mg dose achieving a 16.9 mmHg reduction at six weeks, sustained and ultimately increasing to 19.0 mmHg at twelve weeks. The trial also reported a strong safety profile, with low incidences of hyperkalemia and other adverse effects.
Similarly, the Advance-HTN trial met its primary efficacy endpoints, showing a substantial 15.4 mmHg reduction in systolic blood pressure for the 50 mg dose cohort, measured over 12 weeks using 24-hour ambulatory blood pressure monitoring. “The Advance-HTN late-breaking presentation at the American College of Cardiology meeting and the recent publication in the New England Journal of Medicine underscore the strength of our clinical data and the potentially transformative nature of lorundrostat,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics.
Further trials are underway to explore lorundrostat’s potential in broader applications. The Explore-CKD Phase 2 trial, designed to study the drug in patients with hypertension and chronic kidney disease (CKD), is set to deliver topline results in Q2 2025. Additionally, the Explore-OSA Phase 2 trial, initiated in Q1 2025, will examine lorundrostat as a treatment for those with moderate-to-severe obstructive sleep apnea and hypertension.
Strengthened Operations and Leadership
Mineralys reinforced its commercial strategy with the appointment of Eric Warren as Chief Commercial Officer. “Eric’s proven leadership skills, extensive cardiovascular experience and track record of success will be invaluable to Mineralys as we solidify our commercial and partnering strategy,” said Congleton. Warren brings decades of expertise in cardiovascular-focused commercial operations, bolstering the company’s preparations for eventual product launch and partnerships.
The company also advanced its open-label extension trial, Transform-HTN, allowing ongoing access to lorundrostat for trial participants while gathering additional safety and efficacy data.
Financial Performance
Mineralys closed the first quarter with $343.0 million in cash, cash equivalents, and investments, compared to $198.2 million at the end of 2024. This financial position, bolstered by a public equity financing generating approximately $201.2 million in gross proceeds, is expected to sustain the company’s operations into 2027.
Research and development expenses grew to $37.9 million, reflecting increased clinical and preclinical activities, as well as expanded staff and related compensation costs. General and administrative expenses rose to $6.6 million, driven by investments in personnel and professional services necessary to operate as a public company. With a net loss of $42.2 million in the first quarter, the company remains focused on maintaining financial discipline as it progresses its projects.
Looking Ahead
The advancements achieved in Q1 2025 signal an important year ahead for Mineralys. With a planned pre-New Drug Application meeting with the FDA in late 2025 and further clinical data anticipated from ongoing trials, the company is poised to drive its lead candidate, lorundrostat, closer to market approval.
These milestones not only demonstrate Mineralys’ commitment to addressing high-unmet medical needs but also position the company as a leader in hypertension management. Supported by a robust financial position and expanded leadership, Mineralys is well-equipped to continue advancing its mission of transforming care for patients with complex cardiovascular conditions.
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