Mineralys Therapeutics (NASDAQ:MLYS) Issues Quarterly Earnings Results

Mineralys Therapeutics (NASDAQ:MLYS) posted its quarterly earnings results on Wednesday. The company reported ($0.64) earnings per share for the quarter, missing the consensus estimate of ($0.55) by ($0.09), Zacks reports.

Here are the key takeaways from Mineralys Therapeutics’ conference call:

• Mineralys is nearing the December 22 PDUFA target date for lorundrostat, with the FDA review proceeding “at normal course” and launch preparations underway. The company has not yet provided specific guidance on launch timing, pricing, or post-launch reporting metrics.
• New clinical analyses supported lorundrostat’s potential in difficult-to-treat hypertension: 46% of LAUNCH-HTN participants on 50 mg reached the guideline-recommended systolic blood pressure target, while the EXPLORE-OSA trial showed an 11.1 mmHg reduction in morning systolic pressure versus 1.0 mmHg with placebo. EXPLORE-OSA did not show a measurable change in apnea severity.
• The company said its commercial launch preparations are advancing, with its field sales team in place, payer discussions covering most U.S. covered lives, and a patient support program in development. Management expects commercial coverage to lead, with Medicare access initially relying in part on an exception process.
• Mineralys ended the quarter with $624.7 million in cash and investments and expects this to fund planned operations, including a potential launch, into 2028. Third-quarter net loss increased to $57.3 million from $36.9 million a year earlier, largely reflecting higher commercialization-related G&A expenses.
• Management described early uptake of rival baxdrostat as encouraging evidence of demand for aldosterone synthase inhibitors, while noting that its first full quarter is too early to assess net pricing or gross-to-net trends. Mineralys has not finalized development plans for lorundrostat beyond hypertension and said partnership options remain under evaluation.

Mineralys Therapeutics Stock Up 0.6%

NASDAQ:MLYS traded up $0.09 during mid-day trading on Friday, hitting $15.33. 898,284 shares of the company’s stock were exchanged, compared to its average volume of 1,334,646. Mineralys Therapeutics has a one year low of $14.91 and a one year high of $47.65. The company has a debt-to-equity ratio of 0.18, a current ratio of 34.46 and a quick ratio of 34.46. The business has a fifty day moving average price of $23.99 and a 200 day moving average price of $26.70. The company has a market cap of $1.36 billion, a PE ratio of -3.52 and a beta of 0.83.

Analysts Set New Price Targets

A number of brokerages have recently weighed in on MLYS. Zacks Research upgraded Mineralys Therapeutics from a “strong sell” rating to a “hold” rating in a research report on Friday, September 11th. UBS Group started coverage on Mineralys Therapeutics in a report on Sunday, October 11th. They set a “neutral” rating and a $29.00 target price for the company. HC Wainwright reaffirmed a “buy” rating and issued a $56.00 price target on shares of Mineralys Therapeutics in a research note on Monday, October 12th. Weiss Ratings reiterated a “sell (d-)” rating on shares of Mineralys Therapeutics in a report on Thursday, October 15th. Finally, Wall Street Zen downgraded shares of Mineralys Therapeutics from a “sell” rating to a “strong sell” rating in a research report on Saturday, August 15th. Five analysts have rated the stock with a Buy rating, three have given a Hold rating and one has given a Sell rating to the company. According to MarketBeat.com, the stock presently has an average rating of “Hold” and a consensus price target of $45.50.

Insiders Place Their Bets

In other news, insider David Rodman sold 2,170 shares of Mineralys Therapeutics stock in a transaction that occurred on Monday, August 10th. The shares were sold at an average price of $27.09, for a total transaction of $58,785.30. Following the completion of the transaction, the insider directly owned 51,384 shares in the company, valued at approximately $1,391,992.56. This trade represents a 4.05% decrease in their ownership of the stock. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is accessible through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Brian Slingsby sold 104,320 shares of the business’s stock in a transaction that occurred on Tuesday, September 22nd. The stock was sold at an average price of $28.81, for a total value of $3,005,459.20. Following the completion of the sale, the director directly owned 7,805,718 shares in the company, valued at approximately $224,882,735.58. This represents a 1.32% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. In the last quarter, insiders have sold 199,365 shares of company stock valued at $5,461,854. Insiders own 18.94% of the company’s stock.

Mineralys Therapeutics Company Profile

Mineralys Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on developing therapies for cardiovascular and kidney diseases associated with excess aldosterone activity. The company’s research centers on selectively targeting aldosterone production, a mechanism involved in blood-pressure regulation and organ damage.

Mineralys’ lead product candidate is lorundrostat, an oral, selective aldosterone synthase inhibitor being evaluated as a potential treatment for uncontrolled and resistant hypertension.