Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 151

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 151
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•setting acceptable prices for our product and obtaining coverage and adequate reimbursement from third-party payors; 

•acceptance of our products, if and when approved, by patients, the medical community and third-party payors; 

•manufacturing our product candidates at an acceptable cost; and 

•maintaining and growing an organization of scientists, medical and clinical professionals and business professionals who can develop and commercialize our products and technology.  

Many of these factors are beyond our control, including the time needed to adequately complete clinical testing, the regulatory submission process and potential threats to our intellectual property rights. It is possible that none of our product candidates will ever obtain regulatory approval, even if we expend substantial time and resources seeking such approval. If we do not achieve one or more of these factors in a timely manner or at all, or any other factors impacting the successful development of biopharmaceutical products occur, we could experience significant delays or an inability to successfully develop our product candidates, which would materially harm our business. 

The results of preclinical studies and early clinical trials are not always predictive of future results. Any product candidate that we advance in clinical trials, including Cylembio®, may not achieve favorable results in later-stage clinical trials, if any, or receive marketing approval. 

The research and development of drugs and biological products is extremely risky. Only a small percentage of product candidates that enter the development process ever receive marketing approval. Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidates in humans. The outcome of clinical testing is uncertain. We may face unforeseen challenges in our product candidate development strategy, and we ultimately may not be successful in our current and future clinical trials or that our product candidates will be able to receive regulatory approval. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. For example, it is not uncommon for product candidates to exhibit unforeseen safety or efficacy issues when tested in humans despite promising results in preclinical animal models. In particular, Cylembio in combination with an anti-PD-1 monoclonal antibody has been investigated in a Phase 1/2 trial in 30 metastatic melanoma patients at University Hospital of Herlev, Copenhagen, but we do not know how Cylembio will perform in our ongoing Phase 3 clinical trial combining Cylembio with an anti-PD-1 monoclonal antibody