Mineralys Therapeutics (NASDAQ:MLYS) Issues Quarterly Earnings Results

Mineralys Therapeutics (NASDAQ:MLYS) released its 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%

MLYS traded up $1.01 during trading on Wednesday, hitting $17.00. 1,924,213 shares of the stock traded hands, compared to its average volume of 1,777,510. Mineralys Therapeutics has a twelve month low of $15.33 and a twelve month high of $47.65. The company has a quick ratio of 34.46, a current ratio of 34.46 and a debt-to-equity ratio of 0.18. The business has a 50 day moving average price of $24.20 and a 200 day moving average price of $26.78.

Insider Transactions at Mineralys Therapeutics

In other news, CEO Jon Congleton sold 75,000 shares of the business’s stock in a transaction on Wednesday, September 30th. The stock was sold at an average price of $25.46, for a total transaction of $1,909,500.00. Following the completion of the transaction, the chief executive officer owned 528,621 shares of the company’s stock, valued at approximately $13,458,690.66. The trade was a 12.43% decrease in their position. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is accessible through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, insider Eric Warren sold 7,438 shares of the business’s stock in a transaction on Monday, September 21st. The stock was sold at an average price of $28.12, for a total value of $209,156.56. Following the transaction, the insider directly owned 38,400 shares of the company’s stock, valued at $1,079,808. This trade represents 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. In the last 90 days, insiders have sold 199,365 shares of company stock worth $5,461,854. 18.94% of the stock is owned by insiders.

Wall Street Analyst Weigh In

Several research firms have recently issued reports on MLYS. HC Wainwright reissued a “buy” rating and set a $56.00 target price on shares of Mineralys Therapeutics in a report on Monday, October 12th. Zacks Research raised Mineralys Therapeutics from a “strong sell” rating to a “hold” rating in a research note on Friday, September 11th. 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. Weiss Ratings reaffirmed a “sell (d-)” rating on shares of Mineralys Therapeutics in a research 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 note on Saturday, August 15th. Five investment analysts have rated the stock with a Buy rating, three have assigned a Hold rating and one has assigned a Sell rating to the company’s stock. According to MarketBeat.com, the stock has a consensus rating of “Hold” and an average 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.