Company: KROS
Filing Date: 2025-08-06
Form Type: 10-Q
Source: 0001664710-25-000070
Chunk: 325

Company: Keros Therapeutics, Inc.
Filing Date: 2025-08-06
Form: 10-Q
Item: Item 8
Chunk 325
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 clinical trials or change the labeling of the product; 

■we may be subject to limitations on how we may promote the product; 

■sales of the product may decrease significantly; 

■we may be subject to litigation or product liability claims; and 

■our reputation may suffer. 

Any of these events could prevent us, our collaborators or our potential future partners from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from the sale of our product candidates, if approved. 

We may find it difficult to enroll patients in our clinical trials, which could delay or prevent us from proceeding with, or otherwise adversely affect, clinical trials of our product candidates. 

Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timely completion of our clinical trials in accordance with their protocols depends, among other things, on our ability to recruit a sufficient number of eligible patients to participate and remain in the trial until its conclusion. Patients may be unwilling to participate in our clinical trials because of negative publicity from adverse events related to novel therapeutic approaches, competitive clinical trials for similar patient populations, the existence of current treatments or for other reasons, including public health crises. Any delays related to patient enrollment or difficulties related to patient retention could result in increased costs, delays in advancing our product candidates, delays in testing the effectiveness of our product candidates or termination of the clinical trials altogether. We may not be able to identify, recruit and enroll a sufficient number of patients, or those with the required or desired characteristics, to complete our clinical trials in a timely manner. Patient enrollment and trial completion is affected by many factors, including the: 

■size and nature of the patient population and process for identifying patients; 

■proximity and availability of clinical trial sites for prospective patients; 

■ability of patients to travel to clinical trial sites;

■eligibility and exclusion criteria for the trial; 

■design of the clinical trial; 

■safety profile, to date, of the product candidate under study; 

■perceived risks and benefits of the product candidate under study; 

■perceived risks and benefits of our approach; 

■approval of competing product candidates currently under investigation for the treatment of similar diseases or conditions, or competing clinical trials for similar product candidates or targeting patient populations meeting our patient eligibility criteria; 

■severity of the disease under investigation; 

■degree of progression of the patient’s disease at the time of enrollment