Mineralys Therapeutics(US:MLYS)2025-11-10 22:11Clinical Trials and Efficacy - The pivotal trials, Launch-HTN and Advance-HTN, demonstrated statistically significant reductions in systolic blood pressure (BP) with lorundrostat, achieving a placebo-adjusted reduction of -9.1 mmHg at week 6 and -11.6 mmHg at week 12 in the Launch-HTN trial[102][103] - In the Advance-HTN trial, lorundrostat achieved a placebo-adjusted reduction of -7.9 mmHg at week 12, with a primary endpoint p-value of 0.001[107] - The Phase 2 Explore-CKD trial showed highly statistically significant results for lorundrostat in treating hypertension in patients with chronic kidney disease (CKD)[98] - The FDA cleared the investigational new drug application for the Explore-OSA trial, evaluating lorundrostat in patients with obstructive sleep apnea (OSA) and hypertension[101] - The Explore-CKD trial showed a placebo-adjusted change in systolic BP of -7.5 mmHg (p=0.0024) and a -25.60% change in UACR (p=0.0015) with lorundrostat 25 mg[112] Patient Demographics and Safety - Key characteristics of participants in the Launch-HTN trial included approximately 63% having a BMI ≥ 30 kg/m² and 29% being Black or African American[104] - The Advance-HTN trial enrolled participants who were on a standardized regimen of antihypertensive medications, reflecting a high-risk population[106] - Clinical safety findings from the pivotal trials support a favorable benefit-risk profile for lorundrostat, including monitoring of serum potassium and estimated glomerular filtration rate (eGFR)[108] - In the Launch-HTN trial, the incidence of treatment-emergent serious adverse events (SAEs) was 2.2% in the 50 mg arm and 0.7% in the 50 to 100 mg arm, compared to 3.0% in the placebo arm[109] - In the Advance-HTN trial, the incidence of treatment-emergent SAEs was 6.4% in the lorundrostat 50 mg arm and 8.4% in the 50 to 100 mg arm, compared to 2.1% in the placebo arm[110] Financial Overview - As of September 30, 2025, the company had cash, cash equivalents, and investments totaling $593.6 million[118] - The company raised approximately $1.0 billion in gross proceeds since inception, with net proceeds of approximately $269.6 million from a stock sale in September 2025[118] - The net losses for the nine months ended September 30, 2025, and 2024 were $122.4 million and $128.9 million, respectively, with an accumulated deficit of $424.9 million as of September 30, 2025[119] - The company expects expenses and operating losses to increase substantially as it conducts ongoing clinical trials and seeks regulatory approval for lorundrostat[119] - The company has no products approved for sale and does not expect to generate revenue until lorundrostat is developed and approved[121] Ongoing Trials and Future Plans - The ongoing Transform-HTN extension trial is evaluating the long-term efficacy, safety, and tolerability of lorundrostat, with topline results from the Explore-OSA trial anticipated in Q1 2026[117] - The company is exploring the application of lorundrostat for other indications related to dysregulated aldosterone biology, including OSA[100] Expenses and Cash Flow - For the three months ended September 30, 2025, research and development expenses decreased by $22.5 million to $31.45 million compared to $53.99 million in the same period of 2024[138] - General and administrative expenses increased by $3.6 million for the three months ended September 30, 2025, totaling $9.68 million compared to $6.12 million in 2024[141] - The net loss for the three months ended September 30, 2025, was $36.93 million, a decrease of $19.41 million from a net loss of $56.34 million in the same period of 2024[138] - Research and development expenses for the nine months ended September 30, 2025, decreased by $16.4 million to $107.61 million compared to $124.01 million in 2024[143] - General and administrative expenses for the nine months ended September 30, 2025, increased by $8.1 million to $24.72 million compared to $16.62 million in 2024[145] Cash Flow Activities - Net cash used in operating activities was $104.5 million for the nine months ended September 30, 2025, compared to $99.5 million for the same period in 2024, reflecting an increase of $5.1 million[155] - Net cash used in investing activities was $286.3 million for the nine months ended September 30, 2025, compared to net cash provided of $31.4 million in 2024, driven by a $236.7 million increase in purchases of marketable securities[156] - Net cash provided by financing activities was $494.3 million for the nine months ended September 30, 2025, significantly higher than $116.1 million in 2024, with $270.2 million from a public offering in September 2025[157] Market Risks and Economic Factors - The company is exposed to market risks related to interest rate changes, but a hypothetical 10% change in interest rates would not have a material effect on operations[167] - The company is also exposed to foreign currency exchange risks due to contracts with vendors outside the U.S., but fluctuations have not been significant to date[168] - Inflation has increased costs related to labor and research and development, which may impact future financial conditions and results of operations[169] - Operating activities cash flow was affected by increased clinical trial expenses and personnel costs, with a $19.8 million change in working capital[155] - The company has not had a formal hedging program for foreign currency, and believes that exchange rate fluctuations have not significantly impacted operations[168]