Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 120

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 7
Chunk 120
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 and development expenses for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, including investments in conducting clinical trials, manufacturing and otherwise advancing our programs. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. 

Because of the numerous risks and uncertainties associated with product development and the current stage of development of our product candidates and programs, we cannot reasonably estimate or know the nature, timing and estimated costs necessary to complete the remainder of the development of our product candidates or programs. We are also unable to predict if, when, or to what extent we will obtain approval and generate revenues from the commercialization and sale of our product candidates. The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including: 

•successful completion of preclinical studies and of clinical trials for Cylembio, IO112, IO170, and our other current product candidates and any future product candidates; 

•successful enrollment and completion of our Phase 3 clinical trial for Cylembio, Phase 2 basket trials, and any clinical trials for future product candidates; 

•data from our clinical programs that support an acceptable risk-benefit profile of our product candidates in the intended patient populations; 

•acceptance by the FDA, regulatory authorities in Europe, or other regulatory agencies of the IND applications, clinical trial applications and/or other regulatory filings for Cylembio, our other current product candidates and any future product candidates; 

•expansion and maintenance of a workforce of experienced scientists and others to continue to develop our product candidates; 

•successful application for and receipt of marketing approvals from applicable regulatory authorities; 

•obtainment and maintenance of intellectual property protection and regulatory exclusivity for our product candidates; 

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•arrangements with third-party manufacturers for, or establishment of, commercial manufacturing capabilities; 

•establishment of sales, marketing and distribution capabilities and successful launch of commercial sales of our products, if and when approved, whether alone or in collaboration with others; 

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

•effective competition with other therapies; 

•obtainment and maintenance of coverage, adequate pricing and adequate reimbursement from third-party payors, including government payors; 

•maintenance, enforcement, defense and protection of our rights in our intellectual property portfolio