Mineralys Therapeutics (NASDAQ:MLYS) Releases Quarterly Earnings Results, Misses Expectations By $0.09 EPS

Mineralys Therapeutics (NASDAQ:MLYS) announced its quarterly earnings results on Wednesday. The company reported ($0.64) EPS 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 Price Performance

Shares of MLYS stock traded up $1.01 on Wednesday, hitting $17.00. The company’s stock had a trading volume of 1,924,213 shares, compared to its average volume of 1,777,510. 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 stock’s 50 day moving average is $24.20 and its 200-day moving average is $26.78. Mineralys Therapeutics has a fifty-two week low of $15.33 and a fifty-two week high of $47.65.

Insider Buying and Selling at Mineralys Therapeutics

In other Mineralys Therapeutics news, insider Eric Warren sold 7,438 shares of the business’s stock in a transaction dated Monday, September 21st. The shares were sold at an average price of $28.12, for a total value of $209,156.56. Following the completion of the sale, the insider owned 38,400 shares of the company’s stock, valued at $1,079,808. The trade was a 16.23% decrease in their position. The transaction was disclosed in a document filed with the SEC, which is available at 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 stock in a transaction that occurred on Tuesday, September 22nd. The stock was sold at an average price of $28.81, for a total transaction of $3,005,459.20. Following the transaction, the director owned 7,805,718 shares in the company, valued at approximately $224,882,735.58. The trade was a 1.32% decrease in their position. The disclosure for this sale is available in the SEC filing. Insiders sold 199,365 shares of company stock valued at $5,461,854 in the last quarter. Company insiders own 18.94% of the company’s stock.

Wall Street Analysts Forecast Growth

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

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.