Company: KROS
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001664710-25-000089
Chunk: 116

Company: Keros Therapeutics, Inc.
Filing Date: 2025-11-05
Form: 10-Q
Item: Item 1A
Chunk 116
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 and any future product candidates we develop, which may never occur. KER-065, elritercept and any future product candidates we develop will require additional preclinical and clinical development, management of clinical, preclinical and manufacturing activities, marketing approval in the United States and other jurisdictions for specific indications for use, demonstrating effectiveness to pricing and reimbursement authorities, obtaining sufficient manufacturing supply for both clinical development and commercial production, building of a commercial organization and substantial investment and significant marketing efforts before we generate any revenues from product sales. The success of our current and future product candidates will depend on several factors, including the following:

■successful and timely completion of clinical trials and preclinical studies for which the U.S. Food and Drug Administration, or the FDA, or any comparable foreign regulatory authority agree with the design, endpoints or implementation; 

■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