Mineralys Therapeutics(MLYS) - 2025 Q1 - Quarterly Report

Clinical Trials and Efficacy - The pivotal trials Launch-HTN and Advance-HTN demonstrated statistically significant and clinically meaningful efficacy for lorundrostat in treating uncontrolled hypertension, with a placebo-adjusted systolic BP reduction of -9.1 mmHg at week 6 and -11.7 mmHg at week 12 for the Launch-HTN trial [99][100]. - The Launch-HTN trial enrolled 1,083 participants, with 63% having a BMI ≥30 kg/m² and 29% identifying as Black or African American, reflecting a diverse patient population [100]. - The Advance-HTN trial involved 285 participants, achieving a placebo-adjusted reduction of -7.9 mmHg in systolic BP at week 12, with 66% of subjects having a BMI ≥30 kg/m² [102]. - The company is exploring lorundrostat's potential in treating hypertension associated with chronic kidney disease (CKD) and obstructive sleep apnea (OSA), addressing multiple cardiorenal metabolic disorders [92][97]. - The FDA cleared the investigational new drug application for the Explore-OSA trial, which will evaluate lorundrostat's effects on overweight and obese subjects with moderate-to-severe OSA and hypertension [98]. - Safety data from the Launch-HTN trial indicated a low incidence of treatment-emergent serious adverse events (SAEs) at 2.2% for the 50 mg arm, supporting a favorable benefit-risk profile [104]. - The ongoing Transform-HTN trial allows subjects to continue receiving lorundrostat, generating additional long-term safety and efficacy data [92]. - The company plans to present the results of the Launch-HTN trial at the 2025 European Society of Hypertension Meeting, emphasizing its commitment to sharing clinical findings with the medical community [93]. Financial Performance and Projections - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $343.0 million [107]. - The net losses for the three months ended March 31, 2025, and 2024 were$42.2 million and $31.5 million, respectively, with an accumulated deficit of$344.7 million as of March 31, 2025 [108]. - The company has no products approved for sale and does not expect to generate revenue until lorundrostat is developed and approved [109]. - The company expects to significantly increase research and development expenses as it continues the development of lorundrostat [120]. - The company anticipates increased general and administrative expenses to support its research and development and commercialization efforts [121]. - Research and development expenses increased by $7.1 million to$37.9 million for the three months ended March 31, 2025, compared to $30.8 million in the same period of 2024 [126][127]. - General and administrative expenses rose by$2.0 million to $6.6 million for the three months ended March 31, 2025, compared to$4.6 million in the same period of 2024 [128]. - Net loss increased by $10.7 million to$42.2 million for the three months ended March 31, 2025, compared to a net loss of $31.5 million in the same period of 2024 [126]. - Net cash used in operating activities was$45.5 million for the three months ended March 31, 2025, compared to $19.1 million in the same period of 2024, reflecting an increase of$26.3 million [138]. - Net cash used in investing activities was $92.9 million for the three months ended March 31, 2025, compared to$56.0 million in the same period of 2024, an increase of $36.9 million [139]. - Net cash provided by financing activities increased to$189.3 million for the three months ended March 31, 2025, compared to $116.2 million in the same period of 2024 [140]. - The company raised approximately$700.0 million from various equity offerings since inception, including $188.7 million from a March 2025 stock sale [107][112]. - Future capital requirements will depend on various factors, including the progress of clinical trials and regulatory approvals for lorundrostat [134]. - The company anticipates continuing to incur net losses and negative cash flows from operations for the foreseeable future [130]. Obligations and Agreements - The company is obligated to pay Mitsubishi Tanabe up to$155.0 million in commercial milestone payments upon first commercial sale and meeting certain sales targets [110]. - The company entered into an ATM Equity Offering Sales Agreement with a potential offering price of up to $100 million [113]. - The company plans to use net proceeds from the private placement to fund research and development of lorundrostat and for working capital [115]. - The company has incurred no development or commercial expenses under the Mitsubishi License during the three months ended March 31, 2025, and 2024 [110]. Economic and Market Conditions - The company is exposed to interest income sensitivity due to changes in U.S. interest rates, but a hypothetical 10% change would not materially affect operations [149]. - The company contracts with vendors outside the U.S., exposing it to foreign currency exchange rate fluctuations, though these have not been significant to date [150]. - A hypothetical 10% change in foreign exchange rates would not materially impact the company's results of operations [150]. - Inflation has increased costs related to labor and research and development contracts, but has not materially impacted financial results to date [151]. - Future inflationary costs may adversely affect the company's business, financial condition, and results of operations [151]. Market Need - Approximately 120 million patients in the U.S. suffer from hypertension, with over 30 million not achieving their BP goals despite treatment, highlighting a significant unmet medical need [90]. - The company anticipates a pre-new drug application (NDA) meeting with the FDA in Q4 2025 for lorundrostat, targeting treatment for uncontrolled and resistant hypertension [91].