Core Insights - The ATALANTA-1 Phase 1/2 study of GLPG5101 shows promising efficacy and safety in treating relapsed/refractory indolent non-Hodgkin lymphoma, with a 97% complete response rate and 100% minimal residual disease negativity in evaluable patients [1][3][4] - The study highlights the advantages of a decentralized manufacturing platform, allowing for fresh CAR-T cell administration within seven days, which mitigates disease progression risks and spares patients from additional chemotherapy [2][5] Efficacy and Safety - In Cohort 3, 34 patients were enrolled, with 32 receiving GLPG5101; 94% received fresh CAR-T cells, and 93% were treated within seven days of manufacturing [1][3] - The complete response rate was 97%, with 31 out of 32 patients responding to treatment, and 100% of evaluable patients being MRD negative [3][4] - The 12-month progression-free survival rate was reported at 97%, with no relapses noted [3][4] Manufacturing and Administration - The decentralized manufacturing platform enables a median vein-to-vein time of seven days, allowing for timely treatment without the need for cytotoxic bridging therapy [2][5] - The final product showed a significant increase in early phenotype CD4+ and CD8+ CAR-T cells compared to the starting material [3] Study Design and Objectives - The ATALANTA-1 study is evaluating GLPG5101 in multiple hematological malignancies, focusing on safety, efficacy, and the feasibility of decentralized manufacturing [4] - The primary objective of the Phase 1 part is to assess safety and determine the recommended dose for Phase 2, while the Phase 2 part aims to evaluate the Objective Response Rate [4]

Core Insights - The ongoing ATALANTA-1 Phase 1/2 study of Galapagos NV's investigational CD19 CAR T-cell therapy, GLPG5101, shows low rates of high-grade toxicities in heavily pretreated relapsed refractory non-Hodgkin's lymphoma patients [1][2] - The study highlights the effectiveness of a decentralized manufacturing platform that allows for rapid delivery of fresh CAR-T cells, significantly reducing patient attrition rates [2][8] Group 1: Study Overview - The ATALANTA-1 study includes 64 patients with various subtypes of relapsed refractory non-Hodgkin's lymphoma, demonstrating the feasibility of delivering fresh, stem-like early memory cell therapy with a median vein-to-vein time of seven days [3][5] - 95% of patients received fresh GLPG5101 without the need for cytotoxic bridging therapy, with 89% receiving treatment within 7 days post-leukapheresis [5][6] Group 2: Safety and Efficacy Data - The study reported a 5% attrition rate, significantly lower than the up to 30% rates seen in other clinical trials, indicating a manageable safety profile [2][5] - The majority of treatment-emergent adverse events were hematological, with low incidences of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) [5][6] Group 3: Manufacturing and Delivery Innovations - Galapagos' decentralized manufacturing platform enables shorter vein-to-vein times and the use of fresh, early memory phenotype cells, potentially expanding CAR-T therapy access [2][8] - The platform utilizes an end-to-end workflow management system and automated manufacturing, enhancing patient experience and physician visibility [8][9] Group 4: Future Directions - The ATALANTA-1 study is currently enrolling patients in the U.S. and Europe, with plans to amend the protocol to include chronic lymphocytic leukemia [7][12] - The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR), while secondary objectives include safety and feasibility assessments [7]

Core Points - Galapagos NV has created 925,000 subscription rights under a new plan aimed at senior management compensation [1][2] - The subscription rights have an exercise term of eight years and an exercise price of €25.64, with restrictions on early exercise [2] - The total share capital of Galapagos is €356,444,938.61, with 65,897,071 voting rights currently outstanding [3] Summary by Sections Subscription Rights Plan - The Board of Directors approved "Subscription Right Plan 2025 (A)" for personnel, creating 925,000 subscription rights [1] - Each subscription right allows the holder to subscribe to one new share of Galapagos [2] - The rights cannot be exercised before the third anniversary of issuance [2] Financial Overview - Galapagos' total share capital is €356,444,938.61, with 65,897,071 voting rights [3] - There are 11,866,245 subscription rights from various employee plans, excluding the new rights created [3] - Gilead Therapeutics holds a subscription right to maintain a 29.9% shareholding after exercise [3] Company Profile - Galapagos is a biotechnology company focused on addressing high unmet medical needs through innovative science and technology [4] - The company operates in Europe, the U.S., and Asia, aiming to improve patient outcomes and quality of life [4] - Galapagos is committed to delivering best-in-class medicines and has a decentralized cell therapy manufacturing platform [4]

Core Insights - Galapagos NV announced new data from the ATALANTA-1 Phase 1/2 study of GLPG5101 in relapsed/refractory non-Hodgkin lymphoma, accepted for oral presentations at two major conferences in June 2025 [1][2][6] Group 1: Study Details - The ATALANTA-1 study focuses on GLPG5101, a second-generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose [6][8] - The study evaluates safety, efficacy, and feasibility of decentralized manufacturing of GLPG5101, with 64 patients involved in the oral presentation at EHA [6][8] - The primary objective of the Phase 1 part is to evaluate safety and determine the recommended dose for Phase 2, while the Phase 2 part aims to evaluate the Objective Response Rate (ORR) [8] Group 2: Presentation Information - The EHA presentation will cover low rates of high-grade toxicities associated with GLPG5101 in non-Hodgkin lymphoma patients [4][5] - The ICML presentation will highlight high Complete Response (CR) and Minimal Residual Disease (MRD) negativity rates with GLPG5101, showcasing full results from Cohort 3 [4][5] Group 3: Company Mission and Technology - Galapagos is committed to expanding access to transformative cell therapies for patients with serious hematological and solid tumors, addressing high unmet needs [2][10] - The company utilizes an innovative decentralized cell therapy manufacturing platform, allowing for fresh cell administration within a median vein-to-vein time of seven days [9][10]

Core Viewpoint - Galapagos is re-evaluating its previously announced separation into two entities due to regulatory and market developments, focusing on maximizing resources for transformative business development transactions [3][4]. Group 1: Strategic Update - The company plans to explore all strategic alternatives for its existing businesses, including cell therapy, to enhance resource allocation for business development [3][4]. - The Board of Directors has appointed Mr. Henry Gosebruch as the new CEO, effective immediately, succeeding Dr. Paul Stoffels, who will retire in April 2025 [4][6]. - Mr. Jérôme Contamine has been appointed as the Chair of the Board of Directors, replacing Dr. Paul Stoffels [5][7]. Group 2: Leadership Transition - Mr. Gosebruch will lead the strategic evaluation process for Galapagos' current business while also focusing on building a pipeline of innovative medicines [4][6]. - Dr. Paul Stoffels will remain with the company in an advisory role, assisting in evaluating strategic options for the cell therapy pipeline, including the flagship program GLPG5101 [6][7]. Group 3: Future Directions - The company is currently assessing strategic options regarding its clinical programs and other assets, including potential mergers, divestitures, and out-licensing [7]. - The goal is to leverage the company's strong balance sheet and cash resources to pursue transformative business development opportunities [4][7].

Group 1 - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and offers a model portfolio of small and mid-cap stocks [1][2] - The service includes over 600 biotech investing articles and live chat features to assist healthcare investors in making informed decisions [2] - A promotional offer is available for new subscribers, including a two-week free trial and a discounted annual subscription price [1] Group 2 - The author previously wrote about Galapagos NV and its potential impact on the biotech landscape with its product GLPG5101 [2] - The article emphasizes the importance of thorough research and analysis in the biotech sector for investment decisions [2]

Core Insights - The first U.S. patient has been dosed in the ATALANTA-1 study of GLPG5101, targeting mantle cell lymphoma (MCL) as the lead indication, with pivotal development planned to start in 2026 and aiming for approval in 2028 [1][2][4] - Significant executive leadership changes are occurring, including the retirement of Dr. Paul Stoffels as CEO and the appointment of Henry Gosebruch as the Founding CEO of the new subsidiary SpinCo [1][12] - As of March 31, 2025, the company reported €3.3 billion in cash and financial investments, with a normalized annual cash burn guidance of €175 million to €225 million reaffirmed [1][20] Clinical Pipeline - The ATALANTA-1 Phase 1/2 study of GLPG5101 is focused on CD19 CAR-T therapy for eight hematological malignancies with high unmet needs, showing promising safety and efficacy in heavily pre-treated patients [3][4] - Enrollment is progressing across European clinical trial sites, with additional cohorts for Richter transformation and chronic lymphocytic leukemia planned for the near future [3][4] Financial Performance - Total net revenues for Q1 2025 were €75.0 million, a 20% increase from €62.4 million in Q1 2024, driven by a significant rise in supply revenues [10][13] - The company reported an operating loss of €158.7 million for Q1 2025, compared to a loss of €33.1 million in Q1 2024, largely due to costs associated with strategic reorganization [11][15] - Cash and cash equivalents totaled €3,297.3 million as of March 31, 2025, reflecting a net decrease of €20.5 million during the first quarter [18][19] Corporate Update - The planned separation of Galapagos into two independent entities, with SpinCo focusing on oncology, immunology, and virology, is expected to be completed by mid-2025 [7][20] - SpinCo will be funded with approximately €2.45 billion in cash and will pursue opportunities to build a pipeline of innovative medicines [7][20] Strategic Initiatives - The company is establishing operations in China to accelerate the development of its next-generation cell therapy pipeline [2][9] - Collaborations with Lonza and Thermo Fisher Scientific are being leveraged to scale up decentralized manufacturing capabilities [9][10]

Core Viewpoint - Galapagos NV is undergoing a planned separation into two independent entities, with Mr. Henry Gosebruch appointed as the founding CEO of the new subsidiary, SpinCo, which will focus on innovative medicines and is initially funded with approximately €2.45 billion in cash and cash equivalents [2][3]. Group 1: Leadership Changes - Dr. Paul Stoffels, the current CEO and Chair of the Board of Directors at Galapagos, plans to retire as CEO within the next 12 months but will remain as Chair, ensuring leadership continuity [1][3]. - The Board of Directors will search for a successor CEO for Galapagos, who will lead the company into its next phase of growth and innovation as a focused cell therapy company [3][4]. Group 2: SpinCo's Focus and Strategy - SpinCo will concentrate on building a pipeline of innovative medicines with demonstrated proof-of-concept, aiming to elevate the standard of care for patients through transformative transactions [2][3]. - The new entity will leverage a strong balance sheet and pursue opportunities that create significant value for shareholders [3][5]. Group 3: Background of Mr. Henry Gosebruch - Mr. Gosebruch has extensive experience in M&A, business development, and venture capital, previously serving as President and CEO at Neumora and Executive Vice President at AbbVie [6][7]. - At AbbVie, he was instrumental in completing over 100 business development transactions, including the acquisition of Allergan [7][8]. - His background includes over 20 years at J.P. Morgan, where he co-headed the North American M&A Group and worked on transactions exceeding $375 billion [8]. Group 4: Galapagos' Strategic Direction - Galapagos aims to transform into an R&D-driven biotech company with a focus on oncology, utilizing a decentralized manufacturing platform for cell therapies [4][9]. - The company is advancing its pipeline of potentially best-in-class assets, with ongoing Phase 2 clinical studies targeting aggressive hematological malignancies and solid tumors [4].

Core Points - Galapagos NV announced the departure of CFO and COO Thad Huston, effective August 1, 2025, for personal and professional reasons [1][2] - Huston joined Galapagos in 2023 to aid in its transformation into a cell therapy company, focusing on a decentralized cell therapy platform [2][3] - CEO Paul Stoffels expressed gratitude for Huston's contributions and emphasized the importance of a smooth transition before his departure [3] Company Overview - Galapagos NV is a global biotechnology company dedicated to transforming patient outcomes through innovative science [1] - The company is currently undergoing a transformation into a focused cell therapy business, leveraging its unique platform to deliver CAR-T therapy with a vein-to-vein time of seven days [3] Future Developments - Galapagos plans to announce Huston's successor in the coming months [2] - The company is also involved in a strategic separation into two public companies, which is expected to bring anticipated benefits and synergies [4]

Mechelen, Belgium; March 27, 2025, 21:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today publishes its annual report for the financial year 2024 and announces its Annual Shareholders’ Meeting (AGM) to be held on Tuesday, April 29, 2025 at 14:00 CET at the registered office of the Company. The annual report for the financial year 2024, including a review of figures and performance, is available online at https://www.glpg.com/financial-reports and can also be downloaded as PDF. The ...