We are advancing our pipeline and accelerating innovation through focused execution of our Forward, Faster strategy. We are committed to addressing the high unmet needs of patients through a growing cell therapy and small molecule pipeline with breakthrough potential. This includes more than 20 programs, with four assets in clinical development across 11 indications, and more than 15 preclinical programs in oncology and immunology. We achieved a major regulatory milestone with the FDA clearance of the Inves ...

Board Appointment - Oleg Nodelman appointed as Non-Executive Non-Independent Director to Galapagos' Board of Directors, effective October 7, 2024 [1] - Mr Nodelman replaces Dan G Baker who stepped down on October 6, 2024 [2] - Mr Nodelman is the Founder and Portfolio Manager of EcoR1 Capital LLC, a biotech-focused investment advisory firm [3] - Mr Nodelman holds a Bachelor of Science in Foreign Service with a concentration in Science and Technology from Georgetown University [4] Strategic Impact - The addition of Mr Nodelman marks an important step in Galapagos' ongoing efforts to engage with shareholders and continue to execute on the Forward, Faster strategy to accelerate innovation and create near-and long-term value [2] - Mr Nodelman's deep expertise in biotech and shared goals of unlocking further value for Galapagos will be instrumental in helping the company execute its near- and long-term strategy and deliver superior results for patients, shareholders, employees, and customers [3] - Mr Nodelman brings a wealth of experience in driving shareholder value, strategic transformations, and long-term growth initiatives [3] Company Overview - Galapagos is a biotechnology company with operations in Europe and the US dedicated to transforming patient outcomes through life-changing science and innovation [6] - The company focuses on high unmet medical needs and synergizes compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules and cell therapies in oncology and immunology [6] - Galapagos has capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, and the financial strength to invest strategically for the long-term [6]

Mechelen, Belgium; 16 September 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) received a transparency notification from EcoR1 Capital LLC. Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 13 September 2024 on behalf of Mr. Oleg Nodelman and EcoR1 Capital LLC, who notified that EcoR1 Capital LLC holds 6,713,553 of Galapagos' voting rights, consisting of 839,388 ordinary shares and 5,874,165 American Depository Receipts, further ...

Core Viewpoint - Shares of Galapagos NV are experiencing a rise following FDA clearance for its investigational new drug application for GLPG5101, aimed at treating relapsed/refractory non-Hodgkin lymphoma [1] Company Overview - Galapagos NV is a clinical-stage company focused on developing innovative therapies, including GLPG5101, an autologous CD19 CAR-T cell therapy administered as a single intravenous dose [2] - The company has a robust pipeline that includes small molecules and cell therapies in oncology and immunology, with ongoing studies for other candidates targeting leukemia and myeloma [7] Clinical Study Details - The ATALANTA-1 study will assess the feasibility, safety, and efficacy of GLPG5101 for relapsed/refractory non-Hodgkin lymphoma in the U.S., with early data from ongoing EU studies showing promising results [3][5] - The phase I portion of the trial aims to evaluate safety and initial effectiveness to determine appropriate dosage, while the phase II portion will focus on the objective response rate and other secondary outcomes [4][5] Market Performance - Year to date, shares of Galapagos have declined by 38.8%, contrasting with a 1.6% growth in the industry [5]

Mechelen, Belgium; 20 August 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) received a transparency notification from FMR LLC. Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 16 August 2024 from FMR LLC, who notified that it holds 3,696,750 of Galapagos' voting rights, consisting of 3,693,550 ordinary shares and 3,200 equivalent financial instruments. FMR LLC controls investment funds Fidelity Management & Research Company LLC ...

BridGene Eligible to Receive Up to $159 Million in Total Payments SAN JOSE, Calif., Aug. 1, 2024 /PRNewswire/ -- BridGene Biosciences, Inc., a leader in the discovery of small molecule drugs for traditionally "hard-to-drug" targets, today announced an expansion to its strategic collaboration and licensing agreement with Galapagos NV (Euronext: GLPG) (NASDAQ: GLPG). This new collaboration builds upon the partnership initiated in January 2024, focusing on the discovery of a highly selective oral SMARCA2 small ...

Core Insights - The company is making significant progress on its "Forward, Faster" strategy, focusing on regulatory and clinical milestones, expanding cell therapy manufacturing capabilities, and advancing early-stage programs [1][3][4] Regulatory and Clinical Developments - The company submitted an IND application to the FDA for the Phase 1/2 ATALANTA-1 study of CD19 CAR-T candidate GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) [1][5] - A CTA was submitted to the EMA for the Phase 2 study of GLPG5201 in relapsed/refractory chronic lymphocytic leukemia (R/R CLL) [1][5] - The IND filing for the Phase 1/2 EUPLAGIA-1 study of GLPG5201 is on track for Q4 2024 [1][5] - New Phase 1/2 data for GLPG5101 and GLPG5201 shows promising safety and efficacy for fresh CD19 CAR-T therapies [1][5] Strategic Collaborations - A strategic collaboration with Blood Centers of America has been established to enhance the cell therapy manufacturing network across the U.S., complementing existing partnerships with Landmark Bio and Thermo Fisher Scientific [1][4][5] - The company signed a clinical collaboration agreement with Adaptimmune for next-generation TCR T-cell therapy, with potential milestone payments totaling up to $465 million [7] - An expanded collaboration with BridGene Biosciences aims to develop a selective oral SMARCA2 small molecule in precision oncology [7] Financial Performance - Total net revenues for the first half of 2024 reached €140.3 million, an 18% increase from €118.6 million in the same period of 2023 [6][13] - R&D expenses increased to €145.2 million, up 34% from €108.7 million in the first half of 2023, primarily due to higher costs in oncology programs [10][13] - The company reported a net profit of €99.2 million for the first half of 2024, compared to €28.3 million in the same period of 2023 [10][16] Cash Position and Outlook - As of June 30, 2024, the company had cash and current financial investments totaling €3.4 billion [21] - The cash burn guidance for 2024 is reaffirmed at €280 million to €320 million, with total cash burn including business development projected between €370 million and €410 million [22][1] - The company aims to initiate at least one first-in-human study in 2025 and introduce at least two new clinical candidates annually starting in 2026 [9][1]

GLPG5101 Clinical Trial Data - GLPG5101, a CD19 CAR-T candidate, showed promising results in the Phase 1/2 ATALANTA-1 study for relapsed/refractory non-Hodgkin lymphoma (R/R NHL) [1] - As of December 20, 2023, 34 patients (17 in Phase 1 and 17 in Phase 2) received GLPG5101 with a median vein-to-vein time of seven days [3] - In Phase 1, 14 of 16 efficacy-evaluable patients responded to treatment (ORR 87.5%), with 12 achieving a complete response (CRR 75%) [16] - In Phase 2, 14 of 15 efficacy-evaluable patients responded to treatment (ORR 93.3%), with all responders achieving a complete response (CRR 93.3%) [16] - High ORR and CRR were observed across different lymphoma types: DLBCL (ORR 78%, CRR 56%), FL/MZL (ORR and CRR 94%), and MCL (ORR and CRR 100%) [16] - Durable responses were observed, with 71% of Phase 1 patients and 100% of Phase 2 patients maintaining responses at data cut-off [16] GLPG5101 Safety Profile - GLPG5101 demonstrated an encouraging safety profile, with most treatment-emergent adverse events (TEAEs) being Grade 1 or 2 [16] - Two cases of Grade 3 cytokine release syndrome (CRS) were observed in Phase 1, and one case of Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in Phase 2 [16] - No unexpected safety findings were observed as of the data cut-off date [10] Galapagos' T-Cell Manufacturing Platform - The company's decentralized T-cell manufacturing platform enables a median vein-to-vein time of seven days, eliminating the need for bridging therapy [2] - The platform consists of xCellit® workflow management software, Lonza's Cocoon® automated manufacturing system, and proprietary quality control testing [6] - The final CAR-T product showed a higher proportion of early phenotypes of CD4+ and CD8+ CAR T cells compared to starting material, indicating improved cell quality during manufacturing [2] Non-Hodgkin Lymphoma Overview - Non-Hodgkin lymphoma is a cancer originating from lymphocytes, with B-cell lymphoma accounting for about 85% of cases in the US [5] - The disease can be aggressive (fast-growing) or indolent (slow-growing), with prognosis and treatment depending on the stage and type [5] Presentation Details - The new data will be presented at the European Hematology Association (EHA) 2024 Hybrid Congress by Marie José Kersten, M.D. [18] - The presentation will include updated safety and efficacy data for GLPG5101 in patients with DLBCL, FL, MZL, and MCL, as well as durability and cellular kinetics data [10]

Mechelen, Belgium; 16 May 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announced today that its Board of Directors created 1,614,000 subscription rights under new subscription right plans for the benefit of certain members of the personnel of the company and its subsidiaries. On 16 May 2024, the Board of Directors of Galapagos approved "Subscription Right Plan 2024 BE", intended for members of personnel of the company, "Subscription Right Plan 2024 RMV," intended for the e ...

Core Points - Galapagos NV has created 1,614,000 subscription rights under new plans for its personnel and subsidiaries [1] - The subscription rights have an exercise term of eight years and an exercise price of €26.90 [2] - The company currently has a total share capital of €356,444,938.61 and 65,897,071 voting rights [3] Subscription Rights Plans - Three subscription right plans have been approved: "Subscription Right Plan 2024 BE" for Belgian personnel, "Subscription Right Plan 2024 RMV" for French subsidiary employees, and "Subscription Right Plan 2024 ROW" for other non-Belgian subsidiaries [1] - The rights under the Belgian plan cannot be exercised before January 1, 2028, while the rights under the other two plans vest in installments starting from January 1, 2026 [2] Financial Overview - The total number of rights to subscribe to not yet issued securities is 11,376,759, excluding the newly created subscription rights [3] - Galapagos does not have any outstanding convertible bonds or shares without voting rights [3] Company Profile - Galapagos is a biotechnology company focused on developing transformational medicines, particularly in oncology and immunology [4] - The company emphasizes a deep pipeline of small molecules, CAR-T therapies, and biologics to address high unmet medical needs [4]