Mineralys Therapeutics Inc. 2025年季度报告

(Mark One)xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period endedMarch31, 2025OR ¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from ______ to ______ MINERALYS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) 150 N. Radnor Chester Rd,Suite F200,Radnor,PA19087(Address, including zip code, of principal executive offices)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); Indicate by check mark whether the registrant has submitted electronically and posted on its corporate web site, if any, everyInteractive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during thepreceding 12 months (or for such shorter period that the registrant was required to submit and post such files).YesxNoo 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,” “smaller 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.o Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). YesoNox As of May8, 2025, there were65,175,287shares of the registrant’s common stock outstanding. Mineralys Therapeutics, Inc.Condensed Statements of Operations(in thousands, except share and per share data) Mineralys Therapeutics, Inc.Condensed Statements of Stockholders’ Equity Mineralys Therapeutics, Inc.Notes to Condensed Financial Statements Note 1.Nature of Business Mineralys Therapeutics, Inc. (the Company) is a clinical-stage biopharmaceutical company focused on developing medicinesto target diseases driven by dysregulated aldosterone. The Company’s clinical-stage product candidate, lorundrostat, is a proprietary,orally administered, aldosterone synthase inhibitor that the Company is developing for the treatment of cardiorenal conditions affectedby dysregulated aldosterone, including hypertension, chronic kidney disease, and obstructive sleep apnea. The Company hascompleted two pivotal clinical trials of lorundrostat for the treatment of uncontrolled or resistant hypertension. The Company is alsoconducting a Phase 2 trial of lorundrostat in hypertensive patients with Stage 2 to 3b chronic kidney disease and a Phase 2 trial of Liquidity and Capital Resources Since its inception, the Company has not generated any revenue from product sales or other sources and has incurredsignificant operating losses and negative cash flows from operations. The Company’s primary uses of cash to date have been to fundresearch and development activities, business planning, establishing and maintaining the Company’s intellectual property portfolio,hiring personnel, raising capital, and providing general and administrative support for these operations. As of March31, 2025, the From inception to March31, 2025, the Company has funded its operations by raising aggregate gross proceeds ofapproximately $700.0million from the sale of the Company’s common stock, convertible preferred stock, convertible notes, and pre-funded warrants. The Company has a limited operating history, and the sales and income potential of its business is unproven. TheCompany expects to continue to incur substantial losses in the foreseeable future as a result of the Company’s research anddevelopment and other activities. Additional funding will be required in the future to continue with the Company’s planned research Note 2.Summary of Significant Accounting Policies Basis of Presentation The unaudited condensed financial statements have been prepared in accordance with accounting principles generallyaccepted in the United States (U.S. GAAP) and applicable rules and regulations of the U.S. Securities and Exchange Commission(SEC) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information normallyincluded in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These condensed financialstatements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all Table of Contents Mineralys Therapeutics, Inc.Notes to Condensed