Company: KROS
Filing Date: 2025-08-06
Form Type: 10-Q
Source: 0001664710-25-000070
Chunk: 401

Company: Keros Therapeutics, Inc.
Filing Date: 2025-08-06
Form: 10-Q
Item: Item 8
Chunk 401
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 trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, the occurrence of which could affect the integrity of clinical trial data; 

•risk that participants enrolled in our clinical trials will acquire any contagious diseases while the clinical trial is ongoing, which could impact the results of the clinical trial, including by increasing the number of observed adverse events; 

•interruptions in preclinical studies due to restricted or limited operations at our research and development laboratory facility or delays in receiving the supplies and materials needed to conduct our preclinical studies; 

•delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees; 

•limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; 

•refusal of the FDA or comparable foreign regulatory authorities to accept data from clinical trials in these affected geographies; and 

•interruption or delays to our sourced discovery and clinical activities. 

To the extent a public health crises adversely affects our business, financial condition and results of operations, it may also have the effect of heightening many of the other risks described in this “Risk Factors” section.

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A variety of risks are associated with operating our business internationally which could materially adversely affect our business. 

We conduct certain research and development and clinical operations in Australia, New Zealand, Europe, the United Kingdom and other foreign countries, and may also conduct certain future clinical trials outside of the United States. Additionally, while we have not taken any steps to enter into any non-U.S. markets, we may do so in the future. Accordingly, we are subject to risks related to operating in foreign countries, including: 

■different standards of care in various countries that could complicate the evaluation of our product candidates; 

■different United States and foreign drug import and export rules; 

■reduced protection for intellectual property rights in certain countries; 

■unexpected changes in tariffs, trade barriers and regulatory requirements; 

■economic weakness, including inflation, or political instability in particular foreign economies and markets; 

■compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad; 

■compliance with the FCPA and other anti-corruption and anti-b