Milestone Scientific Inc 2025年度报告

FORM 10-K (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025Or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from Commission file number 001-14053 Milestone Scientific Inc. (Exact name of registrant as specified in its charter) 425 Eagle Rock Avenue, Roseland, NJ 07068(Address of principal executive offices) Registrant’s telephone number, including area code: 973-535-2717. Securities registered pursuant to Section 12(b) of the Act: Securities registered pursuant to section 12(g) of the Act: NONE. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.☐Yes☒No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.☐Yes☒No 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. 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 has filed a report on and attestation to its management’s assessment of the effectivenessof its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registeredpublic accounting firm that prepared or issued its audit report.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of theregistrant included in the filing reflect the correction of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-basedcompensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes☐No☒ As of June 30, 2025, the last business day of the registrants most recently completed second fiscal quarter, the aggregate market valueof the common stock held by non-affiliates of the issuer was $39,730,497 This amount is based on the closing price of $0.64 per shareof the registrant’s common stock as of such date, as reported on the NYSE American. As of March 31, 2026, the registrant has a total of 80,453,116 shares of Common Stock, par value $0.001 per share outstanding. DOCUMENTS INCORPORATED BY REFERENCENone MILESTONE SCIENTIFIC INC.Form 10-K Annual ReportTABLE OF CONTENTS PART IItem 1.Business4Item 1A.Risk Factors9Item 1B.Unresolved Staff Comments24Item 1CCybersecurity25Item 2.Description of Property25Item 3.Legal Proceedings25Item 4.Mine Safety Disclosure25PART IIItem 5.Market for Common Equity, Related Stockholder Matters, and Small Business Issuer Purchases of EquitySecurities26Item 6.Selected Financial Data26Item 7.Management’s Discussion and Analysis or Plan of Operations27Item 7A.Quantitative and Qualitative Disclosure about Market Risk33Item 8.Financial Statements33Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure33Item 9A.Controls and Procedures34Item 9B.Other Information34Item 9C.Disclosure regarding Foreign Jurisdiction that Prevents inspections34PART IIIItem 10.Directors, Executive Officers, Promoters, and Control Persons and Corporate Governance; Compliance withSection 16 (a) of the Exchange Act35Item 11.Executive Compensation41Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters47Item 13.Certain Relationships and Related Transactions, and Director Independence48Item 14.Principal Accounting Fees and Services50PART IVItem 15.Exhibits and Financial Statement Schedules51Item 16.Form 10-K Summary51SIGNA