Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 148

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 148
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 our product candidates. 

67

We have based estimates regarding our cash runway on assumptions that may prove to be incorrect or require adjustment as a result of business decisions, and we could utilize our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, some of which are outside of our control, including:

•the initiation, design, progress, timing, costs and results of drug discovery, preclinical studies and clinical trials of our product candidates, and in particular the clinical trials for Cylembio®;

•the number and characteristics of product candidates that we pursue; 

•the number of clinical trials needed to obtain regulatory approvals from the FDA, the European Commission (based on recommendation from the EMA), and any other regulatory authority; 

•the length of our clinical trials;

•increased costs associated with conducting our clinical trials;

•successfully completing ongoing pre-clinical studies and clinical trials; 

•the outcome, timing and costs of seeking regulatory approvals from the FDA, the European Commission, and any other regulatory authority; 

•the costs of manufacturing our product candidates, the costs of clinical trials in preparation for marketing approval of our product candidates and the costs of  preparing for and implementing potential commercial launches of our product candidates; 

•the costs of any third-party products used in our combination clinical trials that are not covered by such third party or other sources; 

•the costs associated with hiring additional personnel and consultants as our preclinical, manufacturing and clinical activities increase; 

•the receipt of marketing approval and revenue received from any commercial sales of any of our product candidates, if approved; 

•the cost of commercialization activities for any of our product candidates, if approved, including marketing, sales, compliance and distribution costs; 

•the emergence of competing therapies and other adverse market developments; 

•the ability to establish and maintain strategic collaboration, licensing or other arrangements and the financial terms of such agreements; 

•the extent to which we in-license or acquire other products and technologies; 

•the amount and timing of any payments we may be required to make pursuant to our current or future license agreements; 

•the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; 

•our need and ability to retain key management and hire scientific, technical, business, medical, and compliance personnel; 

•our implementation of additional internal systems and infrastructure, including operational, financial, compliance and management information systems; 

•