Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 2

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 2
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1, GLPG5301, GLPG3667 and other product candidates will be completed in a timely manner, or at all, or that we will be able to obtain approval from the FDA, the EMA, the MHRA, the MHLW/PMDA, or any other comparable regulatory authority for any of these product candidates. We cannot be certain that we will advance any other product candidates into clinical trials. If any of GLPG5101, GLPG5301, GLPG3667 or any future product candidate is not approved and commercialized, we will not be able to generate any product revenues for that product candidate. Moreover, any delay or setback in the development of any product candidate could adversely affect our business and cause the price of the ADSs, or our ordinary shares to fall.
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Due to our limited resources and access to capital, we have prioritized the development of certain product candidates and may have forgone the opportunity to capitalize on product candidates or indications that may ultimately have been more profitable or for which there was a greater likelihood of success.
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Due to our limited resources, we have in the past been required to prioritize the development of product candidates over others. As of year-end 2022, we implemented a new innovation R&D model focusing on the therapeutic areas of oncology and immunology. Following a strategic review announced in August 2023, we transferred the commercial, medical affairs and development activities regarding filgotinib (which is marketed as Jyseleca® in the EU, the U.K. and Japan) to Alfasigma S.p.A, or Alfasigma, in January 2024. In January 2025, we announced our intention to separate into two publicly traded entities: a newly to be formed company (to be named at a later date, herein “SpinCo”), which would focus on building a pipeline of innovative medicines through transformational transactions, and Galapagos, which would continue to advance its global cell therapy leadership in addressing high unmet medical needs in oncology. To achieve that focus, we are discontinuing our small molecule research activities in immunology and oncology and are seeking partners to take over our small molecule assets, including GLPG3667. Consequently, our goal is to become a more focused and streamlined organization. As such, we are optimizing our CD19 CAR-T portfolio by prioritizing our resources on advancing and expanding the clinical development of GLPG5101. In parallel, we are advancing our other clinical-stage CAR-T programs,