Mineralys Therapeutics, a clinical-stage biopharmaceutical company, has recently released its 10-Q report. The company is primarily focused on developing treatments for hypertension and chronic kidney diseases. Its clinical-stage product candidate, lorundrostat, is an orally administered, highly selective aldosterone synthase inhibitor designed to address cardiorenal conditions affected by abnormally elevated aldosterone. Mineralys Therapeutics was formerly known as Catalys SC1, Inc. and changed its name to Mineralys Therapeutics, Inc. in May 2020. The company was incorporated in 2019 and is headquartered in Radnor, Pennsylvania.
In the 10-Q report, Mineralys Therapeutics provided an overview of its financial condition and results of operations. As of September 30, 2024, the company had cash, cash equivalents, and investments of $263.6 million. Since its inception in May 2019, the company has raised approximately $498.8 million in aggregate gross proceeds from the sale of common stock, convertible preferred stock, convertible notes, and pre-funded warrants. Notably, the company completed its initial public offering (IPO) in February 2023, generating aggregate net proceeds of approximately $201.4 million.
Mineralys Therapeutics has not yet generated any revenue as it does not have any products approved for sale. The company has incurred net losses since its inception, with net losses for the nine months ended September 30, 2024, amounting to $128.9 million. As of September 30, 2024, the company had an accumulated deficit of $253.6 million. The report also highlighted that the company's net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of its clinical development activities and other research and development activities.
The company emphasized that it believes its current cash, cash equivalents, and investments will be sufficient to fund its operations for at least twelve months. However, Mineralys Therapeutics does not expect to generate revenue from product sales unless and until it successfully completes the development of lorundrostat and obtains regulatory approval. Therefore, the company anticipates financing its cash needs through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses, and similar arrangements.
Mineralys Therapeutics also provided details about its license agreement with Mitsubishi Tanabe Pharmaceutical Company. The agreement grants the company an exclusive, worldwide, royalty-bearing, sublicensable license under Mitsubishi Tanabe’s patent and other intellectual property rights to exploit products incorporating lorundrostat for various medical purposes. The company has made upfront payments and has future obligations, including milestone payments and royalties to Mitsubishi Tanabe.
The 10-Q report also outlined the clinical highlights, including the ongoing clinical trials for lorundrostat, such as the Advance-HTN, Launch-HTN, Explore-CKD, and Transform-HTN trials. These trials are aimed at evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled or resistant hypertension and chronic kidney disease.
Following these announcements, the company's shares moved -2.1%, and are now trading at a price of $14.6. If you want to know more, read the company's complete 10-Q report here.
