Coya Therapeutics Inc. 2025年季度报告

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant toRule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes☐No☒The number of shares of Registrant’s common stock outstanding as of May 9, 2025 was16,724,998. Table of Contents PART IFinancial Information Item 1.Financial Statements Condensed Balance Sheets as of March 31, 2025 (Unaudited) and December 31, 20243Condensed Unaudited Interim Statements of Operations for the Three Months Ended March 31, 2025 and 20244Condensed Unaudited Interim Statements of Stockholders’ Equity for the Three Months Ended March 31, 2025and 20245Condensed Unaudited Interim Statements of Cash Flows for the Three Months Ended March 31, 2025 and 20246Notes to the Condensed Unaudited Interim Financial Statements7 Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations18Item 3.Quantitative and Qualitative Disclosures About Market Risk27Item 4.Controls and Procedures28 PART IIOther Information Item 1.Legal Proceedings29Item 1A.Risk Factors29 Part I – Financial Information Per share information: COYA THERAPEUTICS, INC.NOTES TO CONDENSED UNAUDITED INTERIM FINANCIAL STATEMENTS 1. Organization and description of business Coya Therapeutics, Inc. (“Coya”, or the “Company”) is a clinical-stage biotechnology company focused on developingproprietary new therapies to enhance the function of Regulatory T cells (“Tregs”). Coya’s initial developmental programs arefocused on neurodegenerative, chronic inflammatory, autoimmune, and metabolic diseases of high unmet medical need. Going concern and liquidity The Company has incurred losses since inception, negative cash flows from operations and has an accumulated deficit of$48.0millionas of March 31, 2025. The Company anticipates incurring additional losses until such time, if ever, that it cangenerate significant sales of its product candidates currently in development. Substantial additional financing will be needed by the The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting StandardsCodification (“ASC”) Topic 205-40, Presentation of Financial Statements—Going Concern, which requires management toevaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’sability to continue as a going concern for one year after the date that the financial statements are issued (or when applicable, oneyear after the date that the financial statements are available to be issued). The Company's cash and cash equivalents of$35.5 The accompanying financial statements have been prepared on a going-concern basis, which contemplates the realizationof assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments Risks and uncertainties The Company is subject to a number of risks associated with companies at a similar stage, including dependence on keyindividuals, competition from similar products and larger companies, volatility of the industry, ability to obtain adequate financing 2. Basis of presentation and significant accounting policies Basis of presentation The accompanying condensed unaudited interim financial statements have been prepared in conformity with U.S.generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP In the opinion of management, the accompanying condensed unaudited interim financial statements include all normal andrecurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements)considered necessary to present fairly the Company’s balance sheet as of March 31, 2025, and its statements of operations,stockholders’ equity (deficit), and its cash flows for the three months ended March 31, 2025 and 2024. Operating results for thethree months ended March 31, 2025 and 2024, are not necessarily indicative of the results that may be expected for the year ending Use of estimates The preparation of the financial statements in conformity with GAAP requires management to make estimates andassumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of thefinancial statements and reported amounts of expenses during the reporting period. Due to the uncertainty of factor