0001933414-26-000056
SEC filingMineralys Therapeutics, Inc. (MLYS) reported a net loss of $154.7 million for the fiscal year ended December 31, 2025, an improvement from a net loss of $177.8 million in the prior year. The company has no revenue as it is a clinical-stage biopharmaceutical company focused on developing its lead product candidate, lorundrostat, for hypertension and related cardiorenal conditions. Total operating expenses were $170.6 million, primarily driven by research and development costs of $132.0 million and general and administrative expenses of $38.6 million. The company ended the year with a strong liquidity position, holding $656.6 million in cash, cash equivalents, and investments, which it believes is sufficient to fund operations for at least the next 12 months. Key milestones include the submission of a New Drug Application (NDA) for lorundrostat to the FDA in December 2025, with a PDUFA target action date of December 22, 2026.
Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company with no commercial revenue. For the fiscal year ended December 31, 2025, the company reported a net loss of $154.7 million, an improvement from a net loss of $177.8 million in the prior year. This reduction in net loss was primarily driven by a decrease in research and development expenses, which fell to $132.0 million from $168.6 million in 2024, as the company completed its pivotal clinical program for lorundrostat in the second quarter of 2025. General and administrative expenses increased to $38.6 million from $23.8 million due to higher compensation costs and professional fees. The company ended the period with a strong balance sheet, with total assets of $661.8 million, including $656.6 million in cash, cash equivalents, and investments, and total stockholders' equity of $646.7 million.
The company has not generated any revenue from product sales. Its operations to date have been limited to business planning, raising capital, in-licensing and developing lorundrostat, conducting clinical trials, and research and development activities. The company does not expect to generate revenue unless and until it obtains regulatory approval for lorundrostat. All financing has been through equity offerings, with aggregate gross proceeds of approximately $1.1 billion raised since inception from the sale of common stock, convertible preferred stock, pre-funded warrants, and convertible notes.
As a pre-revenue company, traditional margin analysis is not applicable. The company's operating loss was $170.6 million for FY 2025, consistent with its total operating expenses, as it had no revenue. The cost structure is dominated by research and development, which accounted for approximately 77% of total operating expenses in FY 2025. The decrease in R&D expenses year-over-year reflects the completion of major clinical trials. General and administrative expenses increased as the company expanded its infrastructure in preparation for potential commercialization and operated as a public company.
Net cash used in operating activities was $142.4 million for FY 2025, a decrease from $166.3 million used in the prior year, aligning with the reduced net loss. The company's investing activities used $389.8 million, primarily for purchases of marketable securities. Financing activities provided $591.0 million, mainly from public equity offerings in March and September 2025 and at-the-market sales. The company's balance sheet remains strong with high liquidity: cash and cash equivalents of $172.9 million and investments of $483.7 million. Total current assets were $661.4 million against total current liabilities of only $15.1 million, indicating a robust short-term financial position. The company has an accumulated deficit of $457.2 million.
Based on its current operating plan, management believes existing cash, cash equivalents, and investments will enable the company to fund operations for at least the next 12 months. The key near-term catalyst is the FDA's review of the lorundrostat NDA, with a PDUFA target action date of December 22, 2026. The company plans to use its resources to fund clinical development, manufacturing, and pre-commercialization activities for lorundrostat. Significant risks and uncertainties remain, including the company's dependence on the success of lorundrostat, the lengthy and uncertain clinical development and regulatory approval process, the need for substantial additional capital, intense competition, and the challenges of building commercial capabilities if approval is obtained.