Company: KROS
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001664710-25-000089
Chunk: 17

Company: Keros Therapeutics, Inc.
Filing Date: 2025-11-05
Form: 10-Q
Item: Item 4
Chunk 17
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 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; 

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■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 and throughout the clinical trial; 

■ability to obtain and maintain patient consent; 

■risk that enrolled patients will drop out before completion of the trial; 

■patient referral practices of physicians; and 

■ability to adequately monitor patients during and after treatment. 

Enrollment risks are heightened with respect to indications that are rare or orphan diseases, which may limit the pool of patients that may be enrolled in our planned clinical trials. In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site. 

Delays related to patient enrollment and difficulties related to patient retention may result in increased costs or may affect the timing or outcome of our future clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates. 

Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material