Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 259

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1B
Chunk 259
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 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; 

•avoidance of infringement, misappropriation or other violations with respect to others’ intellectual property or proprietary rights; and 

•maintenance of a continued acceptable safety profile of our products following receipt of any marketing approvals. 

We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our preclinical studies and clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. A change in the outcome of any of these factors could mean a significant change in the costs and timing associated with the development of our current and future preclinical and clinical product candidates. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development, or if we experience significant delays in execution of or enrollment in any of our preclinical studies or clinical trials, we could be required to expend significant additional financial resources and time on the completion of preclinical and clinical development. 

Research and development activities account for a significant portion of our operating expenses. We expect to incur significant research and development expenses for the foreseeable future as we continue to implement our business strategy, which includes advancing Cylembio® through clinical development and other product candidates further into clinical development, expanding our research and development efforts, including hiring additional personnel to support our research and development efforts, and seeking regulatory approvals