Company: OPGN
Filing Date: 2025-08-21
Form Type: 10-K
Source: 0001829126-25-006628
Chunk: 15

Company: OPGEN INC
Filing Date: 2025-08-21
Form: 10-K
Item: Item 1
Chunk 15
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 Annual Report:

“AML” means anti-money laundering.

“Annual Report” means this Annual Report on Form 10-K.

“EIB” means European Investment Bank.

“FATCA” means Foreign Account Tax Compliance.

“FATF” means Financial Action Task Force.

“FINRA” means the U.S. Financial Industry Regulatory Authority.

“GDPR” means the European Union’s General Data Protection Regulation.

“HKEX” means Hong Kong Stock Exchange.

“IPO” means initial public offering.

“KYC” means Know Your Customer.

“MAS” means Monetary Authority of Singapore.

“NOL” means net operating loss.

“NYSE” means New York Stock Exchange.

“PDPA” means Malaysia’s Personal Data Protection Act.

“PIPL” means China’s Personal Information Protection Law.

“SC” means Securities Commission Malaysia.

“SEC” means the U.S. Securities and Exchange Commission.

“Securities Act” means the Securities Act of 1933, as amended.

“SFC” means the Hong Kong Securities and Futures Commission.

“SGX” means Singapore Exchange.

“TSE” means Tokyo Stock Exchange.

Available Information

We maintain a website at www.opgen.com. Our Code of Conduct is available on our website. We are not incorporating our website into this Annual Report. Our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and amendments to those reports, filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, are available free of charge on our website as soon as practicable after electronic filing of such material with, or furnishing it to, the SEC. This information may be read at the SEC website at http://www.sec.gov.

11

Item 1A. Risk Factors

The following are significant factors known to us that could materially harm our business, financial condition or operating results or could cause our actual results to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statement made in this Annual Report. The risks described are not the only risks we face. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial, may also adversely affect our business, financial condition and operating results. If any of these risks actually occur, our business, financial condition, and operating results could suffer significantly.

Risks Related to Our Business

We are a new entrant in our industry and have limited operating experience, which may limit