Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 150

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 150
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 and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed. 

The clinical trials of Cylembio®, or any other future clinical trials of our product candidates, may not be successful or generate positive clinical data and we may not receive marketing approval from the FDA, European Commission (based on recommendation from the EMA), or other regulatory authorities for any of our product candidates. We have limited experience submitting INDs to the FDA. The FDA may not permit any of our future INDs, including any IND submitted for IO112, to go into effect in a timely manner or at all. Without an IND for a product candidate, we will not be permitted to conduct clinical trials in the United States for such product candidate. 

Biopharmaceutical development is a difficult, long, time-consuming, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. For example, we have historically experienced longer than expected lead times in clinical trial site activation and patient enrollment in our clinical trials. Failure to obtain regulatory approval for our product candidates will prevent us from commercializing and marketing our product candidates. The success in the development of our product candidates will depend on many factors, including:  

•timely and successful completion of preclinical studies; 

•sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; 

•obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for our product candidates and otherwise protecting our rights in our intellectual property portfolio; 

•submission of INDs and CTAs for and receipt of allowance to proceed with our planned clinical trials or other future clinical trials; 

•initiating, enrolling, and successfully completing clinical trials, including investigator-initiated clinical trials over which we have limited control; 

•obtaining positive results from our preclinical studies and clinical trials that support a demonstration of efficacy, safety, and durability of effect for our product candidates; 

•receiving approvals for commercialization of our product candidates from applicable regulatory authorities; 

•the outcome, timing and cost of meeting regulatory requirements established by the FDA, European Commission (based on recommendation from the EMA), and other regulatory authorities; 

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•establishing sales, marketing and distribution capabilities and successfully launching commercial sales of our products, if and when approved, whether alone or in collaboration with others; 

•maintaining a continued acceptable safety, tolerability and efficacy profile of any approved products;