Strategic Transformation - Galapagos is executing a strategic transformation, including the intention to wind down the cell therapy business, subject to works council consultations[13, 17] - The company expects to be cash flow neutral to positive by YE26, excluding BD and currency fluctuations[18] - A lean organization of 35-40 employees is expected by YE26, focused on transformative business development[18, 60] Financial Performance & Outlook - Nine-month total revenues increased by 6% to €211.4 million[64] - R&D expenses increased by 48% to €351.9 million[64] - An impairment loss of €204.8 million was recorded for the Cell Therapy business[64, 70] - The company anticipates approximately €2.975 - €3.025 billion in cash and investments at YE25[24] Business Development Strategy - Business development is a core strategy, leveraging a unique partnership with Gilead[37, 38] - The company is open to opportunities across diseases, modalities, geographies, and deal types[51] - A disciplined approach to capital deployment aims to maximize near- and long-term value creation[39, 40]

Financial Performance - Galapagos reported total net revenues of €211.4 million for the first nine months of 2025, a 6% increase from €200.1 million in the same period of 2024[12]. - Supply revenues increased by 53% to €29.3 million, while collaboration revenues rose by 1% to €182.1 million[7]. - The company incurred an operating loss of €462.2 million for the first nine months of 2025, compared to a loss of €125.6 million in the same period of 2024, largely due to a €204.8 million impairment related to the cell therapy business[10]. - Net loss from continuing operations for the first nine months of 2025 was €463.0 million, compared to a loss of €20.4 million in the same period of 2024[14]. - The company reported a net profit from discontinued operations of €1.7 million for the first nine months of 2025, a significant decrease from €69.2 million in the same period of 2024[15]. - Basic and diluted loss per share for the nine months ended September 30, 2025, was €7.00, compared to earnings of €0.74 per share in 2024[27]. - The total comprehensive loss for the period was €(467,806) thousand, primarily due to a net loss of €(461,262) thousand[33]. Research and Development - Research and development expenses increased by 48% to €351.9 million, driven by higher personnel costs and impairment on fixed assets[12]. - Research and development expenses increased to €351,909 thousand in 2025, up 47.6% from €238,270 thousand in 2024[27]. - The company reported an impairment of the cell therapy business amounting to €204,753 thousand in 2025[27]. Cash and Investments - Galapagos expects to end 2025 with approximately €2.975 billion to €3.025 billion in cash and financial investments, excluding business development activities[19]. - Financial investments and cash totaled €3,050.1 million as of September 30, 2025, down from €3,317.8 million at the end of 2024[17]. - Cash and cash equivalents remained stable at €64,458 thousand as of September 30, 2025, compared to €64,239 thousand at the end of December 2024[29]. - Cash and cash equivalents at the end of the period were €64,458 thousand, up from €55,523 thousand[31]. - The company made a net sale of financial investments amounting to €152.4 million during the reporting period[34]. Operational Changes - The planned wind down of the cell therapy business could result in an operating cash impact of €100 million to €125 million from Q4 2025 through 2026[19]. - The company anticipates being cash flow neutral to positive by the end of 2026 if the wind down is completed[19]. - The company anticipates a transformation strategy that includes winding down its cell therapy business, which may involve workforce reductions and site closures[24]. Cash Flow - The operational cash burn for the first nine months of 2025 amounted to €145.1 million, with an increase in cash and cash equivalents of €3.3 million[34]. - Net cash flows used in operating activities were €(209,995) thousand, compared to €(260,657) thousand in the previous period[31]. - Net cash flows generated from investing activities were €216,191 thousand, an increase from €152,237 thousand in the prior period[31]. - Interest received was €22,310 thousand, a decrease from €60,523 thousand in the previous period[31]. - The company issued a convertible loan to a third party amounting to €20,000 thousand[31]. Assets and Equity - Total assets decreased to €3,511,914 thousand as of September 30, 2025, from €4,135,719 thousand at the end of December 2024[29]. - Total equity fell to €2,446,963 thousand as of September 30, 2025, down from €2,896,939 thousand at the end of December 2024[29].

Core Insights - Galapagos NV has concluded its strategic review process, deciding to wind down its cell therapy business to optimize capital allocation for a sustainable future [1][4] - The company has a robust balance sheet with €3.05 billion in cash and financial investments as of September 30, 2025, and expects to end the year with approximately €2.975 billion to €3.025 billion [1][15] - Leadership changes have been made to align with the new strategic direction, enhancing corporate and business development capabilities [3][6] Financial Performance - Total net revenues for the first nine months of 2025 reached €211.4 million, a 6% increase from €200.1 million in the same period of 2024 [5][9] - The company reported an operating loss of €462.2 million for the first nine months of 2025, significantly higher than the €125.6 million loss in the same period of 2024, primarily due to a €204.8 million impairment related to the cell therapy business [7][10] - Net loss from continuing operations was €463.0 million for the first nine months of 2025, compared to a net loss of €20.4 million for the same period in 2024 [10][12] Strategic Focus - The management aims to strategically deploy capital in a disciplined manner, focusing on value-accretive transactions, particularly in small molecule and biologics programs in immunology and oncology [1][4] - The company is actively evaluating opportunities and believes its partnership with Gilead provides a strategic advantage in pursuing these opportunities [1][4] Operational Changes - The wind down of the cell therapy business is expected to impact approximately 365 employees across various locations, with the remaining organization projected to consist of 35-40 employees by the end of 2026 [4][15] - The company anticipates being cash flow neutral to positive by the end of 2026, excluding any business development activities and currency fluctuations, if the wind down is successfully implemented [1][15] Clinical Pipeline - Galapagos is advancing its clinical pipeline, including GLPG5101, a CD19 CAR-T candidate in Phase 1/2 trials, and GLPG3667, a small molecule TYK2 inhibitor in Phase 3-enabling studies [5][6]

Core Insights - The article discusses the presentation of new Phase 2 data for GLPG5101, a CAR-T cell therapy candidate by Galapagos, at the upcoming ASH Annual Meeting, highlighting its potential in treating high-risk relapsed/refractory mantle cell lymphoma and large B-cell lymphoma [1][2][3] Group 1: Clinical Data Presentation - Two abstracts will present new Phase 2 data for GLPG5101 in relapsed/refractory mantle cell lymphoma (R/R MCL) and large B-cell lymphoma (R/R DLBCL) [2] - The oral presentation will showcase high complete response rates and minimal residual disease negativity, with low rates of severe grade toxicities, demonstrating the therapy's effectiveness [5][6] - The data supports the hypothesis that rapid delivery of fresh, early-memory enriched CAR-T cells can improve patient outcomes [3][5] Group 2: Manufacturing and Administration - GLPG5101 is manufactured using an innovative platform that allows for a median vein-to-vein time of seven days, facilitating broader access to cell therapy [1][9] - The manufacturing process includes a decentralized, automated system that enhances the quality control and patient experience [9] - The therapy is administered as a single fixed intravenous dose, with ongoing evaluations of safety and efficacy in the ATALANTA-1 study [8][9] Group 3: Company Showcase and Future Directions - Galapagos will host a company showcase titled "Fast, Fresh, Fit," focusing on the transformative potential of their cell therapy approach [2] - The ATALANTA-1 study is currently enrolling patients in the U.S. and Europe, with a primary objective to evaluate the Objective Response Rate (ORR) [8] - The company is also considering proposals for acquiring its cell therapy business during its ongoing transformation [13]

Core Insights - Galapagos NV has announced changes to its Board of Directors to enhance governance and align with its strategic direction focused on business development and novel medicines [1][10] Board Composition Changes - Dr. Neil Johnston has been appointed as a Non-Executive Independent Director, and Devang Bhuva as a Non-Executive Non-Independent Director, both effective November 1, 2025 [2] - An additional Non-Executive Independent Director is expected to be appointed soon to ensure a balanced and diversified Board [2] Departures from the Board - Non-Executive Independent Directors Dr. Elisabeth Svanberg and Dr. Susanne Schaffert, along with Non-Executive Non-Independent Director Andrew Dickinson, will step down from their positions effective November 1, 2025 [3] Leadership Statements - Jérôme Contamine, Chair of the Board, expressed confidence that the new directors' financial leadership and strategic transaction experience will be crucial for the company's transformation and value creation [4] - CEO Henry Gosebruch emphasized the importance of these changes for steering the company towards sustainable growth and enhancing stakeholder value [4] Director Backgrounds - Dr. Neil Johnston has extensive experience in biopharma, previously serving as Executive Chair at Yellowstone Biosciences and holding senior roles at Novartis [5] - Devang Bhuva has a strong background in corporate development and investment banking, currently serving as Senior Vice President at Gilead [6]

Core Viewpoint - Galapagos NV is set to present new in vitro pharmacological data for its selective TYK2 inhibitor, GLPG3667, at the ACR Convergence 2025, highlighting its differentiation from other TYK2 inhibitors in clinical dose regimens [1][2]. Group 1: Study Overview - GLPG3667 is currently being evaluated in two Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM) [5]. - The GALACELA study is a randomized, double-blind, placebo-controlled trial assessing GLPG3667's efficacy and safety in adults with active SLE over 48 weeks [6]. - The GALARISSO study is also a randomized, double-blind, placebo-controlled trial focusing on GLPG3667's efficacy and safety in adults with DM over 24 weeks [9]. Group 2: Key Findings - At the clinical dose of 150 mg once daily, GLPG3667 demonstrated comparable inhibition of the IFN-α and IL-23 pathways to currently approved TYK2 inhibitors, with a more pronounced inhibition of the IL-12 pathway [7]. - GLPG3667 showed no measurable inhibition of IL-10-mediated signaling at concentrations significantly above clinical levels, unlike other TYK2 inhibitors [7]. - The primary endpoint for the GALACELA study is the proportion of patients achieving the SLE responder index (SRI)-4 response at Week 32, with secondary endpoints including various lupus assessment scores [6][8].

Core Insights - Galapagos NV is shutting down its cell and gene therapy (CGT) division after unsuccessful attempts to sell it, reflecting a broader trend of retreat in the biotech sector due to lost momentum and high costs [1][3] Company Summary - The Belgian biotech will close its CGT division, resulting in approximately 365 job losses across its operations in the Netherlands, Switzerland, the US, and China [2] - The restructuring is expected to incur operational costs of €100–€125 million ($115 million-145 million) and reconstruction costs of €150–€200 million by the end of 2026 [2] - Galapagos remains open to offers for a partial or full acquisition of the CGT unit during the wind-down period [3] Industry Summary - The CGT industry is experiencing a significant pullback in investment as companies face high manufacturing costs, scalability challenges, and uncertain commercial returns [3][6] - Recent examples of companies retreating from CGT include Novo Nordisk, which abandoned its R&D cell therapy division, and Takeda, which shifted focus back to small molecules and biologics [4] - Gilead Sciences' Kite Pharma also terminated a collaboration valued at over $2.3 billion for off-the-shelf cell therapies [5] - Despite challenges, the CGT market is projected to grow, with an estimated worth of around $79 billion by 2030 [7] - The industry calls for improved collaboration between regulators and companies, as well as the use of contract development and manufacturing organizations (CDMOs) to enhance development quality [8]

Core Viewpoint - Biotechnology firm Galapagos will cease its cell therapy business after unsuccessful attempts to sell it, resulting in the loss of 365 jobs across Europe, China, and the U.S. [1] Company Summary - Galapagos is winding down its cell therapy operations due to failed sale efforts [1] - The decision will impact 365 employees in multiple regions, including Europe, China, and the U.S. [1] Industry Summary - The biotechnology sector is facing challenges, as evidenced by Galapagos' decision to exit a segment of its business [1]

Core Viewpoint - Galapagos NV intends to wind down its cell therapy business to optimize capital allocation and focus on new transformational business development opportunities [1][3][11] Strategic Review and Decision - The decision follows a comprehensive strategic review that included exploring potential divestiture options, but no viable proposals were received [3][4] - The Board of Galapagos unanimously approved the wind down, with the exception of two Directors appointed by Gilead who recused themselves [4] Operational Impact - The wind down is expected to affect approximately 365 employees across Europe, the U.S., and China, and will involve the closure of sites in Leiden, Basel, Princeton, Pittsburgh, and Shanghai [5] - The remaining organization will focus on long-term growth through new business development while maintaining a presence in Mechelen, Belgium [5] Financial Implications - If the wind down proceeds, the company anticipates incurring operating costs of €100 million to €125 million from Q4 2025 through 2026, along with one-time restructuring costs of €150 million to €200 million in 2026 [6] - An updated cash outlook for 2025 will be provided with the company's third-quarter earnings report in early November [6] Future Focus - The company aims to enhance operational efficiencies and build a pipeline of novel therapeutics under the leadership of its new management team [2][3] - Galapagos will continue to consider any viable proposals for the cell therapy business during the wind down process [4]

Core Viewpoint - Galapagos NV has appointed Fred Blakeslee as Executive Vice President and General Counsel, effective October 16, 2025, succeeding Valeria Cnossen, who will leave the company after a transition period [1]. Group 1: Leadership Transition - Fred Blakeslee brings extensive legal expertise and global business transaction experience, particularly in the biopharma sector, which is expected to be valuable for Galapagos' transformation journey [1]. - The CEO, Henry Gosebruch, expressed gratitude towards Valeria Cnossen for her leadership and contributions over the past three years [1]. Group 2: Fred Blakeslee's Background - Blakeslee previously served as Vice President, Transactions, Legal at AbbVie, where he led legal teams in complex mergers and acquisitions, including AbbVie's $63 billion acquisition of Allergan PLC [1][2]. - He has a strong background in advising on private equity, corporate, and securities transactions, having started his career at Kirkland & Ellis LLP [2]. Group 3: Company Overview - Galapagos is a biotechnology company focused on transforming patient outcomes through innovative science and technology, with operations in Europe, the U.S., and Asia [3]. - The company aims to address high unmet medical needs and has a commitment to delivering results for patients, employees, and shareholders through a deep pipeline of best-in-class medicines [3].