OpGen Inc 2024年度报告

(Mark one)☒ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year endedDecember 31, 2024 ☐TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number001-37367 OPGEN, INC.(Exact name of registrant as specified in its charter) Delaware06-1614015(State or other jurisdiction ofincorporation or organization)(I.R.S. EmployerIdentification No.) (240)813-1260(Registrant’s telephone number, including area code) Securities registered or to be registered pursuant to Section12(b) of the Act: Securities registered or to be registered pursuant to Section12(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 if the registrant is not required to file reports pursuant to Section13 or Section15(d) of the Act. YES☐NO☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section13 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 Rule405 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 definitions of “large accelerated filer,” “accelerated filer,” “smaller reportingcompany,” and “emerging growth company” in Rule12b-2 of the Exchange Act. Large accelerated filer☐Non-accelerated filer☒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 Section13(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 Section404(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 Section12(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 registrant is a shell company (as defined in Rule12b-2 of the Act). YES☐NO☒ The aggregate market value of the voting common stock held by non-affiliates of the registrant June 30, 2024, was $3.3million (basedupon the last reported sale price of $2.58 per share on June 30, 2024), on The Nasdaq Capital Market. As of August 20, 2025,10,071,293shares of common stock of the registrant were outstanding. DOCUMENTS INCORPORATED BY REFERENCE OPGEN, INC. ANNUAL REPORT ON FORM 10-K For the Year Ended December31, 2024TABLE OF CONTENTSPagePART IItem 1.Business1Item 1A.Risk Factors12Item 1B.Unresolved Staff Comments17Item 1C.Cybersecurity17Item 2.Properties18Item 3.Legal Proceedings18Item 4.Mine Safety Disclosures18PART IIItem 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of EquitySecurities19Item 6.[Reserved]19Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations20Item 7A.Quantitative and Qualitative Disclosures About Market Risk29Item 8.Financial Statements and Supplementary Data29Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure30Item 9A.Controls and Procedures30Item 9B.Other Information30Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections30PART IIIItem 10.Directors, Executive Officers and Corporate Governance31Item 11.Executive Compensation37Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters41Item 13.Certain Relationships and Related Person Transactions, and Director Independence47Item 14.Principal Accounting Fees and Services48PART IVItem 15.Exhibits and Financial Statement Schedules49Item 16.Form 10-K Summary58Signatures59Consolidated Financial StatementsF-1i INFORMATION REGARDING FORWARD-LOOKING STATEMENTS This annual report on Form 10-K f