Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 168

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 168
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 and any future product candidates will be harmed, and our ability to generate product revenue from such product candidates could be delayed or prevented. 

Our future growth depends, in part, on our ability to penetrate multiple markets in which we would be subject to additional regulatory burdens and other risks and uncertainties. 

Our future profitability will depend, in part, on our ability to commercialize our product candidates, if approved, in markets in the United States, Europe, the United Kingdom, and other countries where we maintain commercialization rights. As we begin to commercialize our product candidates, if approved, in multiple markets, we are subject to additional risks and uncertainties, including: 

•foreign currency exchange rate fluctuations and currency controls; 

•economic weakness, including inflation, or political instability in particular economies and markets; 

•potentially adverse and/or unexpected tax consequences, including penalties due to the failure of tax planning or due to the challenge by tax authorities on the basis of transfer pricing and liabilities imposed from inconsistent enforcement; 

•the burden of complying with complex and changing regulatory, tax, accounting and legal requirements, many of which vary between countries; 

•different medical practices and customs in multiple countries affecting acceptance of drugs in the marketplace; 

•differing payor reimbursement regimes, governmental payors or patient self-pay systems and price controls; 

•tariffs, trade barriers, import or export licensing requirements or other restrictive actions; 

•compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; 

•workforce uncertainty in countries where labor unrest is common; 

•reduced or loss of protection of intellectual property rights in some foreign countries, and related prevalence of generic alternatives to therapeutics; and 

•becoming subject to the different, complex and changing laws, regulations and court systems of multiple jurisdictions and compliance with a wide variety of foreign laws, treaties and regulations. 

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These and other risks associated with international operations may adversely affect our ability to attain or maintain profitable operations. Future sales of our products or our product candidates, if they are approved, will be dependent on purchasing decisions of and reimbursement from government health administration authorities, distributors and other organizations. As a result of adverse conditions affecting the global economy and credit and financial markets, including disruptions due to political instability, geopolitical conflict or otherwise, these organizations may defer purchases, may be unable to satisfy their purchasing or reimbursement obligations, or may affect milestone payments or royalties for our products or any of our product candidates that are approved for commercialization in the future. Should any