Mineralys Therapeutics (MLYS, Financial) has reported encouraging outcomes from its pivotal Phase 2 Advance-HTN trial. The study, which focused on patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), examined the efficacy of lorundrostat. The findings, recently published in the New England Journal of Medicine, highlight significant improvements in blood pressure management.
Lorundrostat, administered at a 50 mg dose, achieved a notable 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted decrease in 24-hour ambulatory blood pressure by week 12 of the trial. Importantly, the drug demonstrated effectiveness across various groups, including patients on two or more baseline medications, as well as among different demographics such as men, women, whites, and blacks.
The treatment not only showed promising results in managing blood pressure but also maintained a favorable safety profile. Observed changes in potassium, sodium, and estimated glomerular filtration rate (eGFR) were modest, indicating good tolerability.
Mineralys is set to release further data from the pivotal Phase 3 Launch-HTN trial at an upcoming medical conference, with plans to publish the results in a peer-reviewed journal. The ongoing Transform-HTN open-label extension trial continues to offer participants the opportunity to receive lorundrostat, allowing for the collection of additional safety and efficacy data.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 7 analysts, the average target price for Mineralys Therapeutics Inc (MLYS, Financial) is $40.00 with a high estimate of $52.00 and a low estimate of $26.00. The average target implies an upside of 195.64% from the current price of $13.53. More detailed estimate data can be found on the Mineralys Therapeutics Inc (MLYS) Forecast page.
Based on the consensus recommendation from 8 brokerage firms, Mineralys Therapeutics Inc's (MLYS, Financial) average brokerage recommendation is currently 1.6, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
MLYS Key Business Developments
Release Date: February 12, 2025
- Cash Equivalents and Investments: $198.2 million as of December 31, 2024, down from $239 million as of December 31, 2023.
- R&D Expenses (Annual): $168.6 million for the year ended December 31, 2024, up from $70.4 million for the year ended December 31, 2023.
- R&D Expenses (Quarterly): $44.6 million for the quarter ended December 31, 2024, up from $23.7 million for the quarter ended December 31, 2023.
- G&A Expenses (Annual): $23.8 million for the year ended December 31, 2024, up from $14.3 million for the year ended December 31, 2023.
- G&A Expenses (Quarterly): $7.2 million for the quarter ended December 31, 2024, up from $4 million for the quarter ended December 31, 2023.
- Total Other Income (Annual): $14.6 million for the year ended December 31, 2024, up from $12.8 million for the year ended December 31, 2023.
- Total Other Income (Quarterly): $2.8 million for the quarter ended December 31, 2024, down from $3.3 million for the quarter ended December 31, 2023.
- Net Loss (Annual): $177.8 million for the year ended December 31, 2024, up from $71.9 million for the year ended December 31, 2023.
- Net Loss (Quarterly): $48.9 million for the quarter ended December 31, 2024, up from $24.4 million for the quarter ended December 31, 2023.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Mineralys Therapeutics Inc (MLYS, Financial) is on track to announce top-line data from its pivotal Advance-HTN trial in March and Launch-HTN trial in the mid-first half of 2025.
- The company has completed enrollment in the Explore-CKD Phase 2 trial, which evaluates lorundrostat for hypertension in patients with chronic kidney disease.
- Mineralys Therapeutics Inc (MLYS) has a strong cash position, with $198.2 million in cash equivalents and investments as of December 31, 2024, sufficient to fund operations through Q1 2026.
- The company is exploring innovative approaches, such as continuous blood pressure monitoring during sleep, in its Explore-OSA Phase 2 trial for obstructive sleep apnea.
- Mineralys Therapeutics Inc (MLYS) has received positive feedback from payers regarding the potential market positioning of lorundrostat, particularly in resistant hypertension.
Negative Points
- Mineralys Therapeutics Inc (MLYS) reported a significant increase in net loss for 2024, amounting to $177.8 million compared to $71.9 million in 2023.
- Research and development expenses have more than doubled, reaching $168.6 million in 2024, driven by increased clinical and pre-clinical costs.
- The company faces challenges in ensuring compliance with 24-hour ambulatory blood pressure monitoring devices, which could affect trial data quality.
- There is uncertainty regarding the extrapolation of Phase 2 trial results to larger pivotal studies due to small sample sizes in earlier trials.
- Mineralys Therapeutics Inc (MLYS) anticipates potential challenges in differentiating lorundrostat from existing mineralocorticoid receptor antagonists, particularly regarding efficacy and safety profiles.
