Mineralys Therapeutics(MLYS) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended the first quarter of 2025 with cash, cash equivalents, and investments of $343 million, compared to $198.2 million as of December 31, 2024, indicating a significant increase in liquidity [23] - R&D expenses for the quarter were $37.9 million, up from $30.8 million in the same quarter of 2024, primarily due to increased preclinical and clinical costs [24] - The net loss for the quarter was $42.2 million, compared to $31.5 million for the same period in 2024, reflecting higher expenses [25] Business Line Data and Key Metrics Changes - The pivotal trials for lorundrostat, including LAUNCH HTN and ADVANCE HTN, achieved statistically significant results in reducing systolic blood pressure in patients with uncontrolled and resistant hypertension [6][9] - The LAUNCH HTN trial demonstrated a placebo-adjusted reduction in systolic blood pressure of 9.1 mmHg at week six and maintained a reduction of 11.7 mmHg at week twelve [14] - The ADVANCE HTN trial showed a placebo-adjusted reduction of 7.9 mmHg in systolic blood pressure, confirming the efficacy of lorundrostat in a high-risk population [17] Market Data and Key Metrics Changes - A survey indicated that 95% of physicians are likely to prescribe lorundrostat if approved, particularly for third and fourth-line treatment of hypertension [9] - The company is targeting approximately 47,000 physicians who account for a significant portion of prescriptions for uncontrolled and resistant hypertension [49] Company Strategy and Development Direction - The company aims to submit a New Drug Application (NDA) for lorundrostat, incorporating data from multiple pivotal trials, including the ongoing EXPLORER CKD trial [9][35] - The appointment of Eric Warren as Chief Commercial Officer is part of the strategy to prepare for potential FDA approval and to enhance commercial efforts [11] - The company is exploring the use of lorundrostat in treating comorbid conditions such as obstructive sleep apnea and hypertensive nephropathy, indicating a broader strategic focus [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the clinical profile of lorundrostat and its potential to address significant unmet medical needs in hypertension [9][93] - The company plans to engage with the FDA in a pre-NDA meeting in Q4 2025 to discuss the path forward for lorundrostat's approval [9] - Management highlighted the importance of the benefit-risk profile of lorundrostat, especially in populations with advanced kidney disease [28] Other Important Information - The company completed a public equity financing that raised approximately $201.2 million, strengthening its balance sheet [12] - The EXPLORER CKD trial is designed to evaluate the safety and efficacy of lorundrostat in patients with chronic kidney disease, which is a critical area of focus for the company [19] Q&A Session Summary Question: What would be the max level of grade two hyperkalemia that would be acceptable if lorundestat yields a high single-digit placebo-adjusted SBP reduction? - Management indicated that specialists are more comfortable with higher potassium levels if there is a significant benefit in blood pressure and kidney function [28] Question: Do you expect similar efficacy and safety with lorundestat as seen with other treatments? - Management anticipates clinically meaningful reductions in blood pressure based on previous studies, but specifics are too early to determine [30] Question: How does the EXPLORER CKD study fit into the strategy for regulatory submission? - The EXPLORER CKD study will be part of the NDA submission, providing clinical support for patients with lower eGFR [35] Question: What are the gating factors to finalizing and filing the NDA? - Key factors include the completion of the open-label extension study and the collection of sufficient data to support the NDA submission [53] Question: Can you discuss any early discussions with potential partners? - Management has not provided updates on partnering discussions but believes that partnerships will be part of the company's strategy moving forward [60] Question: What are the primary objectives for the EXPLORER CKD study? - The primary focus is on safety and clinically meaningful reductions in blood pressure in the CKD population [70] Question: What is the expected timeline for hypertension guidelines to include data from the LAUNCH and ADVANCE HTN studies? - Management noted that it is too early to predict when guidelines will be updated but emphasized the importance of the data for informing treatment paradigms [68]