2024 Achievements and Post-Period Events

In 2024, we further advanced our pipeline through focused execution of our innovation strategy, bringing us closer to delivering transformational medicines to patients.

2024 Achievements

ONCOLOGY

GLPG5101 (CD19 CAR-T) program to expand to eight aggressive B-cell malignancies, broadening patient reach and impact

• The U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for the Phase 1/2 ATALANTA-1 study of GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (R/R NHL).
• We presented new data from the ongoing ATALANTA-1 Phase 1/2 study at the 2024 Annual Meeting of the American Society of Hematology (ASH). The oral presentation included updated data on patients with mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) / follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL). As of the data cut-off on April 25, 2024, 49 patients had received cell therapy infusion, and safety and efficacy results were available for 45 patients and 42 patients, respectively. High objective response rates (ORR) and complete response rates (CRR) were observed in the pooled Phase 1 and Phase 2 efficacy analysis and GLPG5101 showed an encouraging safety profile, with the majority of Grade ≥ 3 treatment emergent adverse events being hematological. One case of cytokine release syndrome (CRS) Grade 3 was observed in Phase 1 and one case of immune effector cell-associated neurotoxicity syndrome (ICANS) Grade 3 was observed in Phase 2. The preliminary results also demonstrated the potential of Galapagos’ innovative decentralized manufacturing platform to deliver fresh, stem-like early memory CD19 CAR-T therapy in a median vein-to-vein time of seven days.
• Beyond MZL/FL, DLBCL and MCL, the ATALANTA-1 study was further expanded in Europe to include patients with additional aggressive B-cell malignancies such as high-risk first line DLBCL, Burkitt lymphoma (BL), and primary CNS lymphoma (PCNSL).

GLPG5201 (CD19 CAR-T) in relapsed/refractory chronic lymphocytic leukemia (R/R CLL) and Richter transformation

• We presented encore data from the EUPLAGIA-1 Phase 1/2 study of GLPG5101 at the annual meetings of the European Society for Blood and Marrow Transplantation (EBMT), the European Hematology Association (EHA) and ASH. As of the data cut-off on February 21, 2024, patient recruitment of the Phase 1 dose-finding part of EUPLAGIA-1 has been completed and, 15 patients (6 at dose level 1 (DL1); and 9 at dose level 2 (DL2)) were enrolled, all of whom were diagnosed with R/R CLL, and 9 with additional Richter Transformation (RT). All 15 Phase 1 batches were manufactured using Galapagos’ decentralized platform and infused as a single fresh, fit product within a median vein-to-vein time of seven days, with 80% of patients receiving the product in seven days. Safety and efficacy results were available for 15 patients and demonstrated that at DL2, 8 of 8 patients responded to treatment (ORR of 100%), 5 of 8 patients achieved a Complete Response (CRR of 63%), and 6 of 6 patients with RT responded to treatment (ORR of 100%). GLPG5201 showed an encouraging safety profile with most treatment emergent adverse events of Grade 1 or 2, mostly hematological. No CRS Grade ≥ 3 or any ICANS were observed. Two deaths occurred in patients with RT: one event of cytomegalovirus colitis 14.5 months post-infusion in a patient with complete response (CR), and one death due to disease progression 110 days post-infusion.

GLPG5301 (BCMA CAR-T) in relapsed/refractory multiple myeloma (R/R MM)

• We voluntarily temporarily paused enrollment in the PAPILIO-1 Phase 1/2 study and submitted a protocol amendment to the European regulatory authorities following one observed case of Parkinsonism.
• We resumed enrollment in the Phase 1 part of the PAPILIO-1 Phase 1/2.

Early-stage pipeline comprising ten potential best-in-class cell therapies in hematology and solid tumors as well as multiple small molecule assets in precision oncology

• We further developed our proprietary early-stage, next-generation cell therapy pipeline, providing a strong foundation for sustainable value-creation. It comprises multi-targeting, armored cell therapy constructs designed to improve potency, prevent resistance, and improve persistence of CAR-Ts in hematological and solid tumors. The first armored, bi-specific CAR-T candidate was selected to progress towards clinical development.
• We presented strong preclinical proof-of-concept data at ASH for uza-cel, a MAGE-A4 directed TCR T-cell therapy candidate in head and neck cancer, in partnership with Adaptimmune. The data demonstrated that Galapagos’ decentralized cell therapy manufacturing platform can produce uza-cel with features that may result in improved efficacy and durability of response in the clinic compared with the existing manufacturing procedure.
• We advanced our early-stage precision oncology small molecule programs, focusing on biologically validated targets to develop potential best-in-class therapeutics in areas of high unmet medical needs.

IMMUNOLOGY

• We further progressed our TYK2 inhibitor, GLPG3667, in two Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM).
• We advanced the early-stage small molecule pipeline and selected one potential best-in-class small molecule candidate to advance into IND-enabling studies.

OPERATIONAL

• Through our partnership with Lonza, leveraging the Cocoon® platform, and our collaborations with Thermo Fisher Scientific and miDiagnostics to develop an ultra-rapid PCR sterility test, we are further strengthening our unique approach to cell therapy manufacturing.
• We significantly expanded our network of decentralized cell therapy manufacturing units (DMUs) across the U.S. through collaborations with Thermo Fisher Scientific (San Francisco area), Blood Centers of America (nationwide), Landmark Bio (Boston area), and Excellos (San Diego area).

EXTERNAL INNOVATION

• We signed a clinical collaboration agreement with an option to exclusively license Adaptimmune’s next-generation TCR T-cell therapy (uza-cel) targeting MAGE-A4 for head and neck cancer, and potential future solid tumor indications, using Galapagos’ cell therapy manufacturing platform.
• We successfully completed the transfer of the Jyseleca® (filgotinib) business to Alfasigma S.p.A., including the European and UK Marketing Authorizations, as well as all commercial, medical affairs, and development activities. As part of the transaction, approximately 400 Galapagos employees across 14 European countries transitioned to Alfasigma. The transfer is expected to generate annualized savings of approximately €200 million.
• We established strategic collaboration and licensing agreements with BridGene Biosciences in precision oncology.

CORPORATE

• The Board of Directors appointed Mr. Oleg Nodelman as Non-Executive Non-Independent Director by way of cooptation effective October 7, 2024, replacing Dr. Dan Baker who stepped down on October 6, 2024.
• At the Annual and Extraordinary Shareholders’ Meetings held on April 30, 2024, all proposed resolutions were approved, including the revised 2024 Remuneration Policy and 2023 Remuneration Report.
• The Board of Directors appointed Mr. Andrew Dickinson as Non-Executive Non-Independent Director by way of cooptation effective March 27, 2024. Andrew Dickinson, Gilead’s Chief Financial Officer, replaced Daniel O’Day, Gilead’s Chairman and Chief Executive Officer, who was a member of the Galapagos Board of Directors from October 22, 2019 to March 26, 2024. Mr. Andrew Dickinson’s appointment has been confirmed at our Annual Shareholders’ Meeting of April 30, 2024.

POST-PERIOD EVENTS

Corporate

• On January 8, 2025, we announced a plan to separate into two publicly traded entities aimed at unlocking shareholder value and creating strategic focus.
  • SpinCo, a newly formed company (to be named later), will have approximately €2.45 billion in current Galapagos cash, focusing on building a pipeline of innovative medicines through transformational transactions, with Gilead as a strategic partner.
    • SpinCo will establish a Board of Directors with the majority of its members being independent. SpinCo will be led by a small seasoned executive team with a proven track record in biotechnology company-building and strategic transaction execution.
    • SpinCo plans to apply for listing on Euronext Amsterdam and Brussels and on Nasdaq, with all Galapagos shareholders receiving SpinCo shares on a pro rata basis, proportional to their ownership of Galapagos shares as of a record date to be established.
    • As of the separation, the global option, license and collaboration Agreement with Gilead (OLCA) will be assumed by SpinCo. For future transactions, Gilead has committed to negotiating in good faith, amendments to the OLCA, on a transaction-by-transaction basis to achieve positive value for SpinCo and all of its shareholders. To date, Gilead has demonstrated flexibility in amending the key financial and structural terms of the OLCA to support Galapagos in its assessment of potential business development opportunities to enable value creation. We expect incentives between SpinCo and Gilead to be aligned such that SpinCo can pursue high-quality assets, fund development and invest in its portfolio, so that potential significant future value creation is retained for SpinCo and all of its shareholders.
  • Galapagos will focus on unlocking the broad potential of its innovative decentralized cell therapy manufacturing platform, enabling the delivery of fresh, early stem-like memory cell therapy within a median vein-to-vein time of seven days, and advancing its cell therapy pipeline of potentially best-in-class assets, which will not be subject to the OLCA as of the separation. To drive long-term value creation in oncology cell therapy, Galapagos will streamline its business and seek strategic partnerships for its small molecule assets, as part of its focused strategy and optimized capital allocation. The planned reorganization is expected to result in a 40% workforce reduction, impacting approximately 300 positions across Europe. Galapagos will continue to operate from its main hubs in Princeton and Pittsburgh (U.S.), Leiden (Netherlands), and Mechelen (Belgium). At the time of the anticipated SpinCo spin-off, Galapagos is expected to have €500 million in cash, securing a cash runway to 2028.

Cell therapy portfolio

• Building on the encouraging data for GLPG5101, our investigational CAR-T therapy for relapsed/refractory non-Hodgkin lymphoma (NHL) indications, and in line with our goal to streamline the business, we announced on February 12, 2025, that we are focusing our resources on accelerating GLPG5101 as our flagship CD19 CAR-T program. Pending the advancement of GLPG5101 in additional indications, we are deprioritizing activities for GLPG5201, our second CD19 CAR-T candidate. With the addition of double-refractory chronic lymphocytic leukemia (CLL) and Richter transformation (RT) of CLL, both indications with significant unmet needs, GLPG5101 would be developed across eight aggressive B-cell malignancies, further unlocking its broad potential to address significant unmet medical needs. Patient enrollment is ongoing in Europe and patient screening has begun at activated U.S. clinical sites for the ATALANTA-1 study.
• In January 2025, we entered into a strategic collaboration with Catalent, a global contract development and manufacturing organization (CDMO). Catalent’s commercial cell therapy manufacturing facility in Princeton, New Jersey, will support manufacturing for Galapagos’ upcoming clinical studies in New Jersey, New York, and surrounding areas.
• In February 2025, we entered into a strategic collaboration with NecstGen, a leading CDMO dedicated to cell and gene therapies located at the Leiden Bio Science Park, the Netherlands, to support decentralized manufacturing of our candidate cell therapy products.

Small molecule portfolio

• We are advancing our TYK2 inhibitor, GLPG3667, in two Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM). Patient randomization for the SLE study was completed ahead of schedule in February 2025. Topline results for the entire GLPG3667 program are anticipated in the first half of 2026.
• Following the planned strategic reorganization as announced early this year, we are seeking potential partners to take over our small molecule assets, including GLPG3667 for SLE, DM, and other potential auto-immune indications.