On Wednesday, Goldman Sachs reaffirmed its Buy rating on Mineralys Therapeutics, Inc. (NASDAQ:MLYS) with a steady price target of $29.00. The firm's stance comes after MLYS disclosed its second-quarter financial results, which included a GAAP EPS of -$0.83. Research and Development (R&D) expenses amounted to $39.3 million, while General and Administrative (G&A) costs were reported at $5.9 million. The company's cash and cash equivalents, approximately $311 million, are anticipated to fund operations into 2026.
Mineralys announced that its Advance-HTN trial has reached approximately 90% enrollment, although the data readout is now expected in the first quarter of 2025, a shift from the previously anticipated fourth quarter of 2024. Similarly, the Explore-CKD trial's results are now slated for release in the first half of 2025, rather than the initial timeframe of the fourth quarter of 2024 to the first quarter of 2025.
Despite the slight postponement of the Advance-HTN trial, the company has noted that the Phase 3 Launch-HTN trial is recruiting participants ahead of schedule. The topline data for this trial is still projected to be available in the second half of 2025. Goldman Sachs highlighted that the overall regulatory timeline remains unaffected, with no changes to the expected launch dates as per their model.
An additional point of interest is the decision to maintain the primary endpoint for the Advance-HTN trial at a 12-week change in systolic blood pressure (SBP), instead of the initially planned 4-week mark. This alteration follows guidance from the FDA, given that the study had already enrolled more than half of its participants. Nonetheless, a complete data analysis at the 4-week interval will still be conducted. Management also confirmed that the primary endpoint for the Launch-HTN trial will remain at 6 weeks.
Goldman Sachs' price target for MLYS is based on the potential outcomes from the Advance-HTN trial's readout in the first quarter of 2025, which the firm believes still offers an upside.
In other recent news, Mineralys Therapeutics has been making significant progress in its clinical trials and corporate developments. The company recently announced Q1 2024 financial results, highlighting a robust funding of $338.6 million and the potential of its lead drug candidate, lorundrostat, to significantly lower blood pressure in patients with uncontrolled or resistant hypertension.
Stifel has maintained its Buy rating and $45.00 price target for Mineralys, citing confidence in the company's steady enrollment pace for its pivotal program. H.C. Wainwright also initiated coverage on the company, emphasizing the potential of lorundrostat which is currently in Phase 3 pivotal development. Topline data from trials are expected in late 2024 and mid-2025.
In corporate developments, Mineralys announced the appointment of Dr. Alexander M. Gold to its Board of Directors, bringing extensive experience from his tenure at multiple biopharmaceutical firms. Concurrently, Dr. Olivier Litzka resigned from the board, a decision unrelated to any disagreements with the company's operations.
The company is currently enrolling participants for its ADVANCE-HTN Phase 2/3 trial and LAUNCH-HTN Phase 3 trial, both focusing on lorundrostat's effectiveness in treating hyperaldosteronism. Additionally, the EXPLORE-HTN trial is evaluating lorundrostat in patients with compromised kidney function, with results anticipated in the first half of 2025. These developments represent Mineralys Therapeutics' recent strides in its ongoing efforts to impact the hypertension and kidney disease treatment landscape.
InvestingPro Insights
As Mineralys Therapeutics, Inc. (NASDAQ:MLYS) navigates through its clinical trials and financial milestones, InvestingPro data and tips offer a deeper understanding of the company's current market position. With a market capitalization of approximately $587.34 million, MLYS is a company that investors are closely monitoring. Notably, the company holds more cash than debt on its balance sheet, which aligns with their reported cash and cash equivalents of $311 million, providing a solid runway to fund operations into 2026.
Despite the positive outlook from Goldman Sachs, it's important to note that two analysts have revised their earnings downwards for the upcoming period, as per InvestingPro Tips. Additionally, the company's net income is expected to drop this year, and analysts do not anticipate MLYS to be profitable within this timeframe. This is reflected in the company's negative P/E ratio of -5.87 and adjusted P/E ratio for the last twelve months as of Q1 2024 of -6.47, indicating that investors are valuing the company's earnings potential cautiously.
The stock's performance over the last month has seen a decline of 18.3%, which may have been influenced by the delayed trial data readouts and the revised timelines for the Advance-HTN and Explore-CKD trials. However, the InvestingPro Fair Value estimate stands at $9.93, suggesting a potential undervaluation at the current price of $11.83. For investors seeking more comprehensive analysis, additional InvestingPro Tips are available, providing further insights into MLYS's financial health and market prospects.
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