Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 170

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 170
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As product candidates are developed through preclinical studies to later-stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are optimized along the way to support continuous improvement. Such changes may also require additional testing, or notification to, or approval by the FDA, European Commission, EMA, or a comparable foreign regulatory authority. This could delay completion of clinical trials, require the conduct of bridging clinical trials or studies, require the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our current product candidates and any future product candidates and/or jeopardize our ability to commence product sales and generate revenue. 

Even if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success. 

Even if we obtain marketing approvals from the FDA, European Commission (based on recommendation from the EMA), or other comparable foreign regulatory agencies and are able to initiate commercialization of our clinical-stage product candidates or any other product candidates we develop, the product candidate may not achieve market acceptance among physicians, patients, hospitals, including pharmacy directors, cancer treatment centers, and third-party payors and, ultimately, may not be commercially successful. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including: 

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•the clinical indications for which our product candidates are approved; 

•physicians, hospitals, cancer treatment centers, and patients considering our product candidates as a safe and effective treatment; 

•the potential and perceived advantages of our product candidates over alternative treatments; 

•the prevalence and severity of any side effects; 

•product labeling or product insert requirements of the FDA, European Commission, EMA, or other comparable foreign regulatory authorities; 

•limitations or warnings contained in the labeling approved by the FDA, European Commission, EMA, or other comparable foreign regulatory authorities; 

•the timing of market introduction of our product candidates as well as competitive products; 

•the cost of treatment in relation to alternative treatments; 

•the amount of upfront costs or training required for physicians to administer our product candidates; 

•the availability of coverage from, adequate reimbursement from, and our ability to negotiate pricing with, third-party payors and government authorities; 

•the willingness of patients to pay out-of-pocket in the absence of comprehensive coverage and reimbursement by third-party payors