Company: KROS
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001664710-25-000046
Chunk: 7

Company: Keros Therapeutics, Inc.
Filing Date: 2025-05-06
Form: 10-Q
Item: Item 1A
Chunk 7
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 clinical supply for our clinical trials and commercial manufacturing, if any of our product candidates are approved; 

■obtaining and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates, both in the United States and internationally; 

■successfully scaling a sales and marketing organization and launching commercial sales of our product candidates, if approved; 

■acceptance of our product candidates’ benefits and uses, if approved, by patients, the medical community and third-party payors;

■maintaining a continued acceptable safety profile of our product candidates following approval; 

■effectively competing with companies developing and commercializing other therapies in the indications which our product candidates target; 

■obtaining and maintaining healthcare coverage and adequate reimbursement from third-party payors; and 

■enforcing and defending intellectual property rights and claims.

If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize cibotercept, KER-065, elritercept or any future product candidates we develop, which would materially harm our business. If we do not receive marketing approvals for our current and future product candidates, we may not be able to continue our operations. 

All of our product candidates are in preclinical or clinical development stages. Clinical trials are difficult to design and implement, and they involve a lengthy and expensive process with uncertain outcomes. We may experience delays in completing, or ultimately be unable to complete, the development and commercialization of cibotercept, KER-065, elritercept or any future product candidates. 

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process and our future clinical trial results may not be successful. We cannot guarantee that any of our ongoing and planned clinical trials will be conducted as planned or completed on schedule, if at all. Moreover, even if these trials are initiated or conducted on a timely basis, issues may arise that could result in the suspension or termination of such clinical trials. For example, in January 2025, we announced the early termination of our TROPOS trial evaluating cibotercept in patients with PAH, based on an ongoing safety review due to the unanticipated observation of pericardial effusion adverse events in the trial

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To date, we have not completed any pivotal clinical trials required for the approval of any of our product candidates. Although we have completed our Phase