Mineralys Therapeutics Q1 2024 Financial Results and Corporate Update

Mineralys Therapeutics, Inc., a clinical-stage biopharmaceutical firm, has reported its financial outcomes for Q1 2024, alongside a corporate update. The company, which targets hypertension, chronic kidney disease (CKD), and other conditions linked to dysregulated aldosterone, also highlighted its ongoing trials and financial status.

Mineralys Therapeutics' pivotal clinical trials are making significant progress. The Advance-HTN trial, which examines lorundrostat's efficacy and safety for uncontrolled hypertension (uHTN) and resistant hypertension (rHTN), is underway and expects topline data by Q4 2024. Similarly, the Phase 3 Launch-HTN trial, which targets the same conditions but includes patients not achieving control with two to five medications, anticipates topline data in the latter half of 2025. Additionally, the Explore-CKD Phase 2 trial is evaluating lorundrostat for CKD patients, with data expected between Q4 2024 and Q1 2025.

CEO Jon Congleton highlighted the promising potential of lorundrostat in addressing dysregulated aldosterone, a contributor to obesity and hypertension. He emphasized the company's strategic advancements in clinical trials and their commitment to developing therapies for hypertension and CKD.

The company has recently introduced notable updates in its clinical research. The Explore-CKD trial now permits concurrent use of SGLT2 inhibitors, reflecting the current standard care in CKD, and has adjusted the estimated glomerular filtration rate cutoff for participants. An ongoing open-label extension trial, Transform-HTN, continues to gather additional safety and efficacy data for lorundrostat.

Financially, Mineralys completed a private placement financing in Q1 2024, yielding net proceeds of approximately $116 million. This has bolstered their balance sheet, with cash, cash equivalents, and investments reaching $338.6 million as of March 31, 2024, up from $239.0 million at the end of 2023. The company believes these funds will support their clinical studies and corporate operations through 2026.

Research and Development (R&D) expenses rose to $30.8 million in Q1 2024 from $12.3 million in the same period in 2023. The increase was driven by higher preclinical and clinical costs, manufacturing, regulatory expenses, and additional compensation due to increased headcount and stock-based compensation. General and Administrative (G&A) expenses also increased to $4.6 million from $2.6 million, primarily due to higher compensation, professional fees, and insurance costs.

Total other income stood at $3.9 million for Q1 2024, compared to $2.3 million in Q1 2023, mainly due to higher interest from investments. The net loss for the quarter was $31.5 million, up from $12.6 million in the previous year, largely due to increased operating expenses.

Hypertension continues to be a significant health issue, increasing the risk of heart disease, stroke, and other conditions. Despite available treatments, less than half of patients achieve their blood pressure targets. Dysregulated aldosterone is a key driver in about 25% of hypertensive patients.

Chronic Kidney Disease (CKD), affecting over 10% of the global population, leads to gradual kidney function loss. Diabetes and hypertension contribute to two-thirds of CKD cases. Early detection and treatment can prevent progression to kidney failure, which requires dialysis or transplant.

Lorundrostat, Mineralys' proprietary aldosterone synthase inhibitor, is being developed to treat uHTN and CKD by reducing aldosterone levels. It has demonstrated significant aldosterone reduction and potential in lowering blood pressure in Phase 2 trials. Adverse events included increased serum potassium, decreased kidney function, and urinary tract infections.

Mineralys Therapeutics, based in Radnor, Pennsylvania, aims to develop medicines for conditions driven by dysregulated aldosterone, with lorundrostat as its leading candidate.