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

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 25
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able in final product testing. If we or our vendors and operators are unable to reliably produce product candidates to specifications acceptable to the FDA, the EMA or comparable regulatory authorities, or in accordance with the 

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strict regulatory requirements, we may not obtain or maintain the approvals we need to commercialize our cell therapy product candidates. 
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Even if we obtain regulatory approval for any of our cell therapy product candidates, there can be no assurance that either we or our third party vendors or operators will be able to manufacture the approved product to specifications acceptable to the FDA, the EMA, the MHRA, the MHLW/PMDA or any comparable regulatory authority, to produce it in sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand. Deviations from manufacturing requirements may further require remedial measures that may be costly and/or time-consuming for us or a third party to implement and may include the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business.
A failure to comply with regulatory requirements may result in regulatory enforcement actions against our vendors or operators or us, including fines and civil and criminal penalties.
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Patients receiving T cell-based immunotherapies, have in the past and may in the future experience serious adverse events, including neurotoxicity (ICANS) and cytokine release syndrome (CRS). Serious adverse events or undesirable side effects associated with our cell therapy product candidates may result in delays, clinical holds, or terminations of our preclinical or clinical trials, impact our ability to obtain regulatory or marketing approval, and impact the commercial potential of such product candidates, which will significantly harm our business, financial condition and prospects.
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We are currently developing several cell therapy product candidates in multiple indications, including (1) GLPG5101, a CD19 CAR-T product candidate, currently in the ATALANTA-1 Phase1/2 trial in multiple relapsed/refractory non-Hodgkin lymphoma (R/R NHL) indications including mantel cell lymphoma (MCL), marginal zone lymphoma, follicular lymphoma (MZL/FL), diffuse large B-cell lymphoma (DLBCL), high-risk first line DLBCL, Burkitt lymphoma (BL), primary CNS lymphoma (PCNSL), double-refractory chronic lymphocytic leukemia (CLL) and Richter transformation (RT) of CLL; ; and