Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 154

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 154
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, which is an important factor in the timing of clinical trials, is affected by many factors, including clinical trial site activation, the size and nature of the patient population and competition for patients eligible for our clinical trials with competitors which may have ongoing clinical trials for product candidates that are under development to treat the same indications as one or more of our product candidates, or approved products for the conditions for which we are developing our product candidates. 

Our current clinical trials are fully enrolled, but future trials may be subject to delays as a result of patient enrollment taking longer than anticipated, and current and future trial timelines may be impacted by patient withdrawal. As a result of public health emergencies and resource constraints on CROs, prospective clinical trial sites and others, we may experience longer than expected lead times in clinical trial site activation and patient enrollment in future clinical trials. Furthermore, enrollment for future clinical trials may take longer than anticipated due to other monotherapies and combination therapies being investigated in the first-line setting at this time. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate, enroll and maintain a sufficient number of eligible patients to participate in these trials as required to adequately power our studies in order to draw meaningful conclusions from them or as may be required by the FDA, European Commission (based on recommendation from the EMA), or comparable foreign regulatory authorities. We cannot predict how successful we will be at enrolling subjects in future clinical trials. Subject enrollment is affected by other factors including: 

•the pace of clinical trial site activation;

•the severity and difficulty of diagnosing the disease under investigation; 

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•the eligibility and exclusion criteria for the trial in question; 

•the size of the patient population and process for identifying patients; 

•our ability to recruit clinical trial investigators with the appropriate competencies and experience; 

•the design of the trial protocol; 

•the perceived risks and benefits of the product candidate in the trial, including relating to cell therapy approaches; 

•the availability of competing commercially available therapies and other competing therapeutic candidates’ clinical trials for the disease or condition under investigation, including for melanoma and other cancers in a first-line setting; 

•the willingness of patients to be enrolled in our clinical trials; 

•the efforts to facilitate timely enrollment in clinical trials; 

•the patient referral practices of physicians; 

•the ability to monitor patients adequately during and after treatment; and 

•the proximity and availability of clinical trial sites for prospective patients. 

The FDA may also