Company: KROS
Filing Date: 2025-08-06
Form Type: 10-Q
Source: 0001664710-25-000070
Chunk: 317

Company: Keros Therapeutics, Inc.
Filing Date: 2025-08-06
Form: 10-Q
Item: Item 8
Chunk 317
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sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; 

■receiving regulatory approvals or authorizations for conducting our planned clinical trials or future clinical trials; 

■commencement of and successful patient enrollment in, and completion of, additional clinical trials on a timely basis; 

■our ability to demonstrate to the satisfaction of the FDA or any comparable foreign regulatory authority that the applicable product candidate is safe and effective as a treatment for our targeted indications or, in the case of an applicable product candidate which is regulated as a biological product, that the applicable product candidate is safe, pure, and potent for our targeted indications; 

■our ability to demonstrate to the satisfaction of the FDA or any comparable foreign regulatory authority that the applicable product candidate’s risk-benefit ratio for its proposed indication is acceptable; 

■timely receipt of marketing approvals for our product candidates from applicable regulatory authorities; 

■the extent of any required post-marketing approval commitments to applicable regulatory authorities; 

■establishing and scaling up, either alone or with third-party manufacturers, manufacturing capabilities of 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 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