Company: IOBT
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001193125-25-180860
Chunk: 2

Company: IO Biotech, Inc.
Filing Date: 2025-08-14
Form: 10-Q
Item: Item 1A
Chunk 2
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Our business is subject to numerous risks. You should carefully consider the following risks and all other information contained in this Quarterly Report, as well as general economic and business risks, together with any other documents we file with the SEC. If any of the following events actually occur or risks actually materialize, it could have a material adverse effect on our business, operating results and financial condition and cause the trading price of our common stock to decline.

Summary of the Material and Other Risks Associated with Our Business

Our business is subject to numerous material and other risks and uncertainties that you should be aware of in evaluating our business. These risks include, but are not limited to, the following:

•We have a limited operating history, have incurred net losses since our inception, and anticipate that we will continue to incur significant losses for the foreseeable future. We may never generate any revenue or become profitable or, if we achieve profitability, may not be able to sustain it.

•We have substantial doubt about our ability to continue as a going concern and we will need to obtain substantial additional funding to continue our operations and complete the development and commercialization of our product candidates. If we are unable to raise this capital when needed, we may not be able to continue as a going concern or we may be forced to delay, reduce or eliminate our product development programs or other operations.

·	None of our product candidates, including IO102-IO103, our lead investigational therapeutic cancer vaccine candidate, which in the U.S. is now known as Cylembio® (imsapepimut and etimupepimut, adjuvanted),  have received marketing approval. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.

•We may never receive regulatory approval for commercial sale of Cylembio, and even if we do, we may face a longer than expected pathway to commercialize Cylembio in the U.S., which could materially adversely affect our business condition, prospects, competitive position and financial results.

·	Our preclinical studies and clinical trials, including our Phase 3 clinical trial for Cylembio, may fail to sufficiently demonstrate the safety and efficacy of our product candidates, or may identify serious adverse or unacceptable side effects, which could prevent, delay or limit the scope of regulatory approval of our product candidates, limit their commercialization, increase our costs and/or necessitate the abandonment or limitation