Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 15

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 15
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 any other comparable regulatory authority may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has 

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shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities. Average review times at the FDA have fluctuated in recent years as a result. If a prolonged government shutdown occurs, including as a result of reaching the debt ceiling, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, government shutdowns could impact our ability to access the public markets and obtain additional capital in the future.
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Certain of our product candidates require specific shipping, storage, handling and administration at the clinical trial sites, which could subject our product candidates to risk of loss or damage.
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Certain of our product candidates, including our investigational cell therapies GLPG5101 and GLPG5301, are sensitive to temperature, storage and handling conditions. Our decentralized cell therapy platform is designed to allow us to harvest, transport, manufacture and deliver fresh cell therapy product candidates near the cancer treatment centers, in a median vein-to-vein time of seven days. 
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Such processes are complex and require That the storage, handling and administration of the therapy product must be performed according to specific instructions, typically using specific storage and shipping conditions, disposables, specific bags and in some steps within specific time periods. Failure to correctly handle our product candidates, including failure to administer our product candidates within the specified period could negatively impact the efficacy and or safety of our product candidates, or cause a loss of product candidates. 
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The process of manufacturing cell therapies is inherently susceptible to contamination. If microbial, viral or other contaminations are discovered in any product candidate or manufacturing facility, such manufacturing facility may need to be closed for an extended period of time to allow us to investigate and remedy the contamination. The process of developing products that can be commercialized may be particularly challenging, even if they otherwise prove to be safe and effective.
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The rates at which we complete our scientific studies and clinical trials depend on many factors, including, but not limited to, patient enrollment.
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Patient enrollment and enrollment rate are significant factors impacting the duration and completion of clinical trials. These are affected by many factors including the size and nature of the patient population,