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

Mineralys Therapeutics (NASDAQ:MLYS) released 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 Trading Up 6.3%

NASDAQ MLYS traded up $1.01 during trading 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. Mineralys Therapeutics has a 52 week low of $15.33 and a 52 week high of $47.65. The firm has a 50 day moving average price of $24.20 and a 200 day moving average price of $26.78. The company has a debt-to-equity ratio of 0.18, a quick ratio of 34.46 and a current ratio of 34.46.

Wall Street Analyst Weigh In

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

Insider Buying and Selling

In related news, Director Daphne Karydas sold 3,000 shares of the business’s stock in a transaction on Tuesday, September 15th. The shares were sold at an average price of $28.58, for a total transaction of $85,740.00. Following the transaction, the director owned 6,200 shares of the company’s stock, valued at approximately $177,196. The trade was a 32.61% decrease in their ownership of the stock. The sale was disclosed in a legal filing with the SEC, which is available through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, insider David Rodman sold 2,170 shares of the business’s stock in a transaction on Monday, August 10th. The stock was sold at an average price of $27.09, for a total transaction of $58,785.30. Following the transaction, the insider directly owned 51,384 shares in the company, valued at $1,391,992.56. This trade represents a 4.05% 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 valued at $5,461,854 in the last ninety days. 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.