Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 13

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 13
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 ethics committee approval at each clinical trial site;
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●   obtaining regulatory concurrence on the design and parameters for the trial;
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●   obtaining approval for the designs of our clinical development programs for each country targeted for trial enrollment;
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●   recruiting suitable patients to participate in a trial, which may be impacted by the number of competing trials that are enrolling patients;
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●   having patients complete a trial or return for post-treatment follow-up;
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●   clinical sites deviating from trial protocol or dropping out of a trial;
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●   failing to comply with GCP or other regulatory requirements;
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●   adding new clinical trial sites;
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●   for our cell therapy product candidates, adding and setting up new decentralized cell therapy manufacturing sites;
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●   manufacturing sufficient quantities of product candidate or obtaining sufficient quantities of comparator drug for use in clinical trials;
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●   the availability of adequate financing and other resources.
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11

We could encounter delays if a clinical trial is suspended or terminated by us, our collaboration partners, by the IRBs or ethics committees of the institutions in which such trials are being conducted, or by the FDA, competent authorities of the EU member states, the MHRA, MHLW/PMDA, or any other comparable regulatory authority, or recommended for suspension or termination by the Data Monitoring Committee, or the DMC, for such trial. A suspension or termination, including in some cases a clinical hold, may be imposed due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA, competent authorities of the EU member states, the MHRA, MHLW/PMDA, or other comparable regulatory authorities, safety issues or adverse side effects, including those seen in the class to which our product candidates belong, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions, manufacturing issues or lack of adequate funding to continue the clinical trial. For example (without limitation), it is possible that safety issues or adverse side effects could be observed in trials for GLPG5101 or GLPG5301 in oncology, and for GLPG3667 in immunology, which could result in a delay, suspension or termination of the ongoing trials of GLPG5101, GLPG5301 and GLPG3667. If we experience delays in the completion of, or experience