RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has unfurled its financial banners for the fourth quarter and full year closing December 31, 2023. Alongside these fiscal results, the company used this opportunity to update its corporate status, offering a retrospective look at its key achievements over the year.
In 2023, Mineralys accomplished significant milestones that paved the way to implementing their pivotal development strategy for lorundrostat. This treatment, aimed at hypertension and related conditions like chronic kidney disease, is a focus of the company’s efforts, according to Jon Congleton, CEO of Mineralys Therapeutics. He stated “In 2024, we look forward to several clinical events projected to magnify the data package for lorundrostat. We posit that aldosterone, much like obesity, is a significant catalyst for cardiorenal metabolic conditions. Our quest to develop a targeted approach against aldosterone holds the potential to benefit millions of patients affected by such conditions”.
One of the company’s highlights includes the initiation of the Launch-HTN trial in the fourth quarter of 2023. This phase 3 trial is the second pivotal study of lorundrostat for treating patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).
In addition to their financial update, Mineralys announced several upcoming milestones. These include enrollment progress in their Advance-HTN trial, topline data from their Launch-HTN trial expected in the latter half of 2025, and modifications to their Explore-CKD Phase 2 trial, which remains on track to report topline data towards the end of 2024 or early 2025.
As of December 31, 2023, Mineralys’s cash equivalents and investments stood at $239.0 million, up from $110.1 million the previous year. These funds are anticipated to sustain their clinical studies and corporate operations until 2026, following a successful private placement financing in February 2024 that raised roughly $120 million, pre-fees and expenses.
Research and Development (R&D) expenses for 2023 were $70.4 million – a notable rise from $26.3 million in 2022. This increase essentially reflects the uptick in preclinical and clinical costs related to lorundrostat’s pivotal program.
General and Administrative (G&A) expenses were $14.3 million for 2023, compared to a modest $5.2 million in 2022. This surge can be attributed mainly to professional fees associated with operating as a publicly listed company and compensation expenses due to an increase in headcount, among other factors.
Net loss for the year ended at $71.9 million, a jump from $29.8 million in 2022. This increase was primarily driven by the factors affecting the company’s expenses. However, indications show the therapeutics firm steering a course towards a strong financial position to support its ambitious research and development initiatives.
These financial highlights and clinical milestones spotlight Mineralys’s continued dedication to its mission: using the science of aldosterone to transform the treatment landscape for cardiorenal metabolic conditions. With several key clinical events on the horizon, industry watchers eagerly anticipate the company’s next significant strides in 2024.
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