Second Quarter 2025 and Post-Period Update

Strategic and Corporate Update
- On May 13, 2025, we announced that the Board of Directors decided, following regulatory and market developments, to re-evaluate the previously proposed separation. As a result, strategic alternatives for the cell therapy business, including a potential divestiture, are being evaluated, with the goal of maximizing shareholder value:
- To facilitate this process, we established Galapagos Cell Therapeutics as a standalone entity within the Galapagos Group for consolidating all cell therapy activities.
- An update on the strategic process is expected to be provided in conjunction with the third-quarter 2025 results.
- Morgan Stanley is acting as financial advisor in connection with this process.
- Our remaining business is focused on establishing a robust and novel pipeline of innovative medicines through transformational transactions. In recent months, we have taken decisive steps to advance this strategy by strengthening leadership and aligning internal capabilities to deliver on our goals:
- Executive leadership has been reinforced with the appointment of Henry Gosebruch as Chief Executive Officer, succeeding Dr. Paul Stoffels1, and Aaron Cox as Chief Financial Officer, succeeding Thad Huston.
- Ms. Sooin Kwon was appointed as Chief Business Officer (CBO) and Mr. Dan Grossman as Chief Strategy Officer (CStO), effective August 4, 2025. Recruitment for additional key leadership roles to further strengthen our management team is ongoing.
- Dawn Svoronos and Jane Griffiths have been appointed as Non-Executive Independent Directors by way of co-optation, effective July 28, 2025, replacing Peter Guenter and Simon Sturge, who will be stepping down.
- We transferred certain small molecule programs in oncology and immunology to Onco3R Therapeutics and in return, we will receive equity and future milestone-based considerations.
- We are actively exploring partnership opportunities for GLPG3667, a small molecule TYK2 inhibitor currently in Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM). Topline results from ongoing studies with GLPG3667 are expected during the first half of 2026.
Advancing the Cell Therapy Pipeline and Platform Under Current Planning, Subject to Ongoing Strategic Review
- We presented new promising safety, efficacy and manufacturing data for GLPG5101 (CD19 CAR-T) from the completely enrolled cohort in relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) (Cohort 3) of the ongoing ATALANTA-1 Phase 1/2 study at ICML. As of the October 14, 2024 data cut-off, 34 patients with R/R iNHL (follicular lymphoma, FL, n=29; marginal zone lymphoma, MZL, n=5) underwent leukapheresis, of whom 32 (94%) received an infusion of GLPG5101. GLPG5101 demonstrated promising efficacy with robust and durable CAR-T cell expansion. A complete response (CR) rate of 97% (31/32) was observed with 100% of evaluable patients (10/10) being MRD negative at time of CR and the 12-month progression free survival (PFS) rate was 97%. GLPG5101 showed a favorable safety profile, with low rates of severe cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) observed, and no deaths reported.
- We presented new promising pooled safety and manufacturing data from the ongoing ATALANTA-1 Phase 1/2 study for GLPG5101 in 64 patients with R/R NHL at EHA. As of the October 14, 2024 data cut-off date, of the 64 patients enrolled, 61 received treatment, resulting in a 5% attrition rate, significantly lower than industry benchmarks. 95% of patients were infused with fresh, stem-like early memory CD19 CAR-T cells, with 89% receiving treatment within seven days, avoiding the need for cryopreservation and cytotoxic bridging therapy. The data showed that GLPG5101 was well-tolerated with only a single case of Grade 3 CRS and Grade 3 ICANS reported in this heavily pretreated population.
- GLPG5101 is being advanced toward pivotal development in mantle cell lymphoma (MCL), with enrollment expected to start in 2026. Following updates to the clinical study design, the Biologics License Application (BLA) filing is anticipated in 2028 with approval now expected in 2029.
- We recently signed a collaboration agreement with CELLforCURE, by Seqens, to support the decentralized manufacturing of GLPG5101 for clinical development in Paris and the broader France area.
- Our other cell therapy programs continue to progress including GLPG5301, a BCMA CAR-T candidate for relapsed/refractory multiple myeloma; uza-cel, a MAGE A4 TCR-T candidate in head and neck cancer, in collaboration with Adaptimmune; and the early-stage next-generation CAR-T assets.
1 1Dr. Paul Stoffels, acting via Stoffels IMC BV