Galapagos(GLPG) Newsfilter·2025-04-23 20:01Core 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]