Company: KROS
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001664710-25-000089
Chunk: 118

Company: Keros Therapeutics, Inc.
Filing Date: 2025-11-05
Form: 10-Q
Item: Item 1A
Chunk 118
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 during our clinical trials that could delay or prevent our ability to receive marketing approval or commercialize KER-065, elritercept or any future product candidates, including:

■delays in or failure to obtain regulatory authorizations to commence a trial; 

■delays in reaching a consensus with regulatory agencies as to the design or implementation of our clinical trials;

■delays in or failure to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; 

■delays in or failure to obtain institutional review board, or IRB, or positive ethics committee opinions at each site; 

■delays in or failure to recruit a sufficient number of suitable patients to participate in a trial; 

■failure to have patients complete a trial or return for post-treatment follow-up, including disruptions in our ability to treat patients or conduct post-treatment follow-up due to public health crises;

■clinical sites deviating from trial protocol, missing data or dropping out of a trial; 

■delays in adding new clinical trial sites; 

■failure to manufacture sufficient quantities of our product candidates for use in clinical trials in a timely manner; 

■occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits, or safety or tolerability concerns that could cause us or our collaborators, as applicable, to suspend or terminate a trial if we or our collaborators find that the participants are being exposed to unacceptable health risks; 

■failure to perform clinical trials in accordance with the FDA’s or any comparable foreign regulatory authority’s good clinical practices, or GCP, requirements, or regulatory guidelines in other countries; 

■changes in regulatory requirements, policies and guidelines; 

■failure of our third-party research contractors to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; 

■delays in establishing the appropriate dosage levels and frequency of dosing in clinical trials; 

■the quality or stability of our product candidates falling below acceptable standards; and

■business interruptions resulting from geopolitical actions, including war, such as the current Russia-Ukraine war and the war in the Middle East, and terrorism or the perception that such hostilities may be imminent, another outbreak of a contagious disease, or natural disasters including earthquakes, typhoons, floods and fires.

In addition, public health crises may increase the likelihood that we encounter additional difficulties and delays