SmartKem Inc 2025年度报告

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 Rule405 of the Securities 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 Securities Exchange Act of 1934 during thepreceding 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 90days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 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 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 smaller reporting company, or an emerging growthcompany. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of theExchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section13(a)of the Exchange Act.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect thecorrection 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-based compensation received by any of theregistrant’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 Exchange Act). Yes☐No☒ The aggregate market value of the voting stock and non-voting common equity held by non-affiliates of the registrant as of the last business day of the registrant’s mostrecently completed second fiscal quarter ended June 30, 2025 was $3,596,234 based upon the closing price of the registrant’s common stock of $1.010 on The NasdaqCapital Market as of June 27, 2025. As of April 1, 2026 there were 21,202,911 shares of the registrant’s common stock outstanding. Documents Incorporated by Reference:None. SmartKem, Inc.Form 10-K for the Fiscal Year Ended December 31, 2025Table of Contents PART IBusiness 6Item 1.6Item 1A. Risk Factors14Item 1B. Unresolved Staff Comments30Item 1C.Cybersecurity30Item 2.Properties30Item 3.Legal Proceedings31Item 4.Mine Safety Disclosures31 PART II32Item 5.MarketFor Registrant’s Common Equity,Related Stockholder Matters and IssuerPurchases of Equity Securities32Item 6.[Reserved]32Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations32Item 7A.Quantitative and Qualitative Disclosures about Market Risk37Item 8.Financial Statements and Supplementary Data38Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure68Item 9A. Controls and Procedures68Item 9B.Other Information68Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections68 PART IIIItem 10.Directors, Executive Officers, and Corporate Governance 69Item 11.Executive Compensation74Item 12.Security Ownership of Certain Beneficial Owners and Management and RelatedStockholder Matters78Item 13.Certain Relationships and Related Transactions, and Director Independence80Item 14.Principal Accountant Fees and Services81 PART IV83 Item 15.Exhibits and Financial Statement Schedules 83Item 16.Form 10-K Summary88Signatures89 CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, including the sections entitled “Risk Factors” and “Management’sDiscussion and Analysis of Financial Condition and Results of Operations,” contains express orimplied forward-looking statements that are based on our management’s belief and assumptions and oninformation currently available to our management. Although we believe that the expectations reflectedin forward-looking statements are reasonable, such statements involve known and unknown risks,uncertainties and other factors that may cause our actual results, performance or achievements to bematerially different from any future results, performance or achievements expressed or implied byforward-looking statements. All statements other than statements of historical fact contained in thisReport are forward-looking statements. In some cases, you can identify forward-looking statements byterminologysuch as“may,”“could,”“will,”“would,”“should,”“expect,”“plan,”“anticipate,”“believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “project,” “c