Mineralys Therapeutics Inc 2026年季度报告

FORM 10-Q (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March31, 2026OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______Commission file number 001-41614 MINERALYS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware84-1966887(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.) 888-378-6240 (Registrant's telephone number, including area code) (Former name, former address and former fiscal year, if changed since last report): NA Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports);and (2) has been subject to such filing requirements for the past 90 days. YesNo Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit such files). YesNo Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smallerreporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filerAccelerated filerNon-accelerated filerSmaller reporting companyEmerging growth company If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YesNo As of April27, 2026, there were 82,498,101 shares of the registrant’s common stock outstanding. Mineralys Therapeutics, Inc.Table of Contents PagePart I - Financial Information1Item 1. Financial Statements1Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations13Item 3. Quantitative and Qualitative Disclosures About Market Risk24Item 4. Controls and Procedures25Part II - Other Information26Item 1. Legal Proceedings26Item 1A. Risk Factors26Item 2. Unregistered Sales of Equity Securities and Use of Proceeds26Item 3. Defaults Upon Senior Securities26Item 4. Mine Safety Disclosures26Item 5. Other Information26Item 6. Exhibits27Signatures Mineralys Therapeutics, Inc.Condensed Balance Sheets(in thousands, except share and per share amounts) Mineralys Therapeutics, Inc.Condensed Statements of Operations(in thousands, except share and per share data)(unaudited) Mineralys Therapeutics, Inc.Condensed Statements of Stockholders’ Equity(in thousands, except share data)(unaudited) Mineralys Therapeutics, Inc.Condensed Statements of Cash Flows(in thousands)(unaudited) The accompanying notes are an integral part of these condensed financial statements. Mineralys Therapeutics, Inc.Notes to Condensed Financial Statements(unaudited) Note 1. Nature of Business Mineralys Therapeutics, Inc. (the Company) is a biopharmaceutical company focused on developing medicines to targetdiseases driven by dysregulated aldosterone. The Company’s product candidate, lorundrostat, is a proprietary, orally administered,aldosterone synthase inhibitor that the Company is developing for the treatment of cardiorenal conditions affected by dysregulatedaldosterone, including hypertension and related comorbidities, such as chronic kidney disease and obstructive sleep apnea. TheCompany has completed two pivotal clinical trials of lorundrostat for hypertension, one Phase 2 clinical trial in hypertensiveparticipants with chronic kidney disease, and one Phase 2 clinical trial in hypertensive participants with obstructive sleep apnea. TheCompany submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in December2025 forlorundrostat for the treatment of hypertension in combination with other antihypertensive drugs. The FDA accepted the NDAsubmission and provided the Company with a Prescription Drug User Fee Act target date of December22, 2026 for lorundrostat. TheCompany was incorporated as a Delaware corporation in May 2019, and it is headquartered in Radnor, Pennsylvania. The Company’soperations to date have been limited to business planning, raising capital, in-licensing, conducting preclinical and clinical trials, andperforming research and development and other activities. Liquidity and Capital Resources Since its ince