Mineralys Therapeutics (NASDAQ:MLYS) Announces Earnings Results

Mineralys Therapeutics (NASDAQ:MLYS) issued its quarterly earnings results on Wednesday. The company reported ($0.64) earnings per share for the quarter, missing analysts’ consensus estimates 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 Down 8.1%

Shares of NASDAQ:MLYS traded down $1.38 during trading on Thursday, hitting $15.62. 1,342,174 shares of the company’s stock traded hands, compared to its average volume of 1,331,238. The company has a current ratio of 34.46, a quick ratio of 34.46 and a debt-to-equity ratio of 0.18. The company has a 50-day moving average price of $24.20 and a 200-day moving average price of $26.78. Mineralys Therapeutics has a 52 week low of $15.33 and a 52 week high of $47.65. The company has a market cap of $1.38 billion, a price-to-earnings ratio of -3.70 and a beta of 0.83.

Analyst Ratings Changes

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

Insider Buying and Selling at Mineralys Therapeutics

In other Mineralys Therapeutics news, insider David Rodman sold 2,170 shares of the firm’s 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 sale, 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 position. The sale was disclosed in a filing with the SEC, which is accessible through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, insider Eric Warren sold 7,438 shares of Mineralys Therapeutics stock in a transaction that occurred on Monday, September 21st. The shares were sold at an average price of $28.12, for a total transaction of $209,156.56. Following the completion of the transaction, the insider directly owned 38,400 shares in the company, valued at approximately $1,079,808. The trade was a 16.23% decrease in their position. The disclosure for this sale is available in the SEC filing. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders sold 199,365 shares of company stock worth $5,461,854 in the last quarter. Company insiders own 18.94% of the company’s stock.

About Mineralys Therapeutics

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.