Mineralys Therapeutics Q2 2024 Financial Results and Corporate Update

Mineralys Therapeutics, Inc., a clinical-stage biopharmaceutical company based in Radnor, Pennsylvania, has made significant strides in its mission to develop treatments for hypertension and chronic kidney disease (CKD), among other conditions linked to dysregulated aldosterone. The company recently announced financial results for the second quarter ending June 30, 2024, alongside a corporate update that highlights their ongoing clinical trials and financial health.

In the first half of 2024, the company advanced its pivotal development program for lorundrostat, targeting uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). The Advance-HTN trial, which is nearly 90% enrolled, is anticipated to provide topline data in the first quarter of 2025. This trial aims to evaluate the effectiveness and safety of lorundrostat when added to existing antihypertensive treatments.

Another critical effort is the Launch-HTN Phase 3 trial, where enrollment is ahead of schedule. This trial focuses on patients with uHTN or rHTN who have not achieved blood pressure control despite taking two to five antihypertensive medications. Topline data from this trial is expected in the second half of 2025.

The Explore-CKD Phase 2 trial, which examines lorundrostat's efficacy and safety when combined with SGLT2 inhibitors for treating patients with uHTN or rHTN and Stage 2 to 3b CKD, is also ramping up enrollment. Topline data from this trial is anticipated in the first half of 2025.

Additionally, the Transform-HTN Open-Label Extension Trial is ongoing. This trial allows participants to continue receiving lorundrostat, thus providing more data on its long-term safety and efficacy.

From a financial perspective, Mineralys Therapeutics reported having $311.1 million in cash, cash equivalents, and investments as of June 30, 2024, a significant increase from $239.0 million at the end of 2023. This financial cushion is expected to support the company's clinical studies and corporate operations through 2026.

Research and Development (R&D) expenses surged to $39.3 million in the second quarter of 2024, up from $11.9 million in the same period in 2023. This increase is primarily attributed to the costs associated with initiating the lorundrostat pivotal program and the Explore-CKD trial. General and Administrative (G&A) expenses also rose to $5.9 million from $3.9 million in the previous year, driven by higher compensation and professional fees.

The company’s net loss for the quarter was $41.0 million, compared to $12.1 million in the same quarter of 2023. The increased expenses were the primary factor behind this widened loss.

Mineralys Therapeutics is dedicated to addressing the challenges posed by hypertension and CKD. Hypertension remains a significant health issue, leading to heart disease, heart attacks, and strokes. In 2020, hypertension was a primary or contributing factor in over 670,000 deaths in the U.S. Dysregulated aldosterone levels are known to drive hypertension in about 25% of hypertensive patients. Similarly, CKD affects over 10% of the global population and is a leading cause of mortality worldwide. Early detection and treatment are crucial to managing CKD, which can progress to kidney failure requiring dialysis or transplantation.

Lorundrostat, Mineralys Therapeutics' flagship product candidate, is an orally administered aldosterone synthase inhibitor. Designed to reduce aldosterone levels, lorundrostat has shown promise in clinical trials, demonstrating significant blood pressure reductions in patients with uncontrolled hypertension.

In summary, Mineralys Therapeutics is making substantial progress in its clinical trials and maintains a strong financial position to continue its research and development efforts. The company's focus on lorundrostat offers hope for effective treatments for hypertension and CKD, conditions that affect millions globally.

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