Corporate and Operational Performance

Jyseleca® commercial & regulatory progress

• Adoption across Europe with reimbursement for reumathoid arthritis (RA) in 15 countries and for ulcerative colitis (UC) in 11
• Sobi, our distribution and commercialization partner in Eastern and Central Europe, Portugal, Greece, and the Baltic countries, launched Jyseleca® in RA in the Czech Republic and Portugal, resulting in €2.0 million milestone payments to Galapagos
• The Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain and the Ministry of Health, Labour and Welfare (MHLW) in Japan approved filgotinib 200mg for the treatment of moderate to severe UC
• The European Medicines Agency’s (EMA) scientific committee, CHMP, adopted the recommendation of the PRAC to add measures to minimize risks of serious side effects with JAK inhibitors used for chronic inflammatory disorders
• Positive opinion issued by the CHMP for Jyseleca®‘s European label update based on testicular function safety data from MANTA/RAy semen parameter studies

Portfolio update

• Initiated preparations to start a Phase 2 program with TYK2 inhibitor GLPG3667 in dermatomyositis (DM) and systemic lupus erythematosus (SLE)
• Discontinued our activities in fibrosis and kidney disease as a result of the new strategic therapy area focus
• Halted development of SIK3 inhibitor GLPG4399; medicinal chemistry activities to identify SIK inhibitors with improved pharmacology continues
• Reported initial encouraging safety and efficacy data at ASH² 2022 from the ongoing ATALANTA-1 Phase 1/2 study in relapsed/refractory non-Hodgkin lymphoma (rrNHL) with CD19 CAR-T candidate, GLPG5101, manufactured at point-of-care

Corporate update

• Appointed Dr. Paul Stoffels as Chief Executive Officer, succeeding Onno van de Stolpe, as of 1 April 2022. Following approval by Galapagos’ shareholders on 26 April 2022, adopted a one-tier governance model. Subsequently, the (new) Board of Directors appointed Dr. Paul Stoffels as Chairman of the Board of Directors
• Implemented new strategic direction to accelerate innovation and time-to-patients, focusing on key therapeutic areas of immunology and oncology, diversifying beyond small molecules to include CAR-T and biologicals, and set up a fit-for-purpose R&D organization
• Entered into the field of oncology through the combined acquisitions of CellPoint B.V. (CellPoint) and AboundBio, Inc. (AboundBio), in all-cash transactions against payment of an upfront amount of €125 million for CellPoint, with an additional €100 million to be paid upon achievement of certain milestones, and against payment of an amount of $14 million for AboundBio
• Received various transparency notifications from EcoR1 Capital LLC and FMR LLC, indicating that their shareholdings in Galapagos changed, crossing the 5% threshold, to 5.2% and 5.9%, respectively, of the current outstanding Galapagos shares
• Raised €6.7 million through the exercise of subscription rights
• Announced changes to the Executive Committee: Dr. Walid Abi-Saab (Chief Medical Officer) and Dr. André Hoekema (Chief Business Officer) retired from the company, and Valeria Cnossen (General Counsel) and Annelies Missotten (Chief Human Resources Officer) appointed as new members of the Executive Committee as of 1 January 2023. We anticipate announcing a Head of R&D and Executive Committee member in the first half of 2023. Until such appointment, Dr. Paul Stoffels will act as Head of R&D ad interim

Post-period events

• The European Commission approved the recommendation of the PRAC to add measures to minimize risks of serious side effects with all JAK inhibitors used for chronic inflammatory disorders
• Obtained reimbursement for Jyseleca® in UC in Italy and Denmark
• Completed MANGROVE Phase 2 study with GLPG2737 in polycystic kidney disease and decided not to-out-license the program due to lack of effect of GLPG2737 on kidney volume and renal progression compared to placebo. The open-label extension study was subsequently stopped
• Data from SELECTION long-term extension (LTE) study of filgotinib in patients with UC presented at annual ECCO congress showed that filgotinib 200mg maintained a consistent safety profile observed in previous SELECTION studies. In addition, symptomatic remission rates and health-related quality of life (HRQoL) improved in patients with moderate to severe active UC who received filgotinib 200mg for nearly four years
• Poster presentation at annual EBMT-EHA congress demonstrating initial encouraging safety and efficacy results from ongoing EUPLAGIA-1 Phase 1/2 study with a fresh point-of-care manufactured CD19 CAR-T candidate, GLPG5201, in patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL) and small lymphocytic lymphoma (rrSLL), with or without Richter’s transformation (RT). All 7 out of 7 eligible rrCLL patients, including 4 patients with RT, responded to treatment (Objective Response Rate of 100%), and GLPG5201 showed an acceptable safety profile with no cytokine release syndrome (CRS) higher than grade 2, or immune effector cell-associated neurotoxicity syndrome (ICAN) observed
• Announced topline results from the DIVERSITY study, a combined induction and maintenance Phase 3 study of filgotinib in Crohn’s disease. While the co-primary endpoints for filgotinib 200mg in the maintenance part of the study were met and the observed safety profile is consistent with its known safety profile, the two induction cohorts missed the co-primary endpoints of clinical remission and endoscopic response at Week 10. Galapagos decided not to submit a Marketing Authorization Application in Europe based on these topline data