Industry Overview - The biotech sector has been challenging to predict due to the large number of publicly traded stocks that exhibit inconsistent trends, making it difficult to assess the overall market direction [2] - Recent observations indicate that the industry is trading better, with higher lows and a halt in the long-running daily decline, suggesting a potential upward movement [3] - A shift in investor sentiment has been noted, attributed to discussions around the "pharma dilemma," which involves the need for pharmaceutical companies to acquire new assets and improve clinical data [4] Company Highlights - **Galapagos NV (NASDAQ:GLPG)**: - Year-to-Date Performance: 22% - Focuses on next-generation oncology with CAR-T programs and a decentralized manufacturing model for faster treatment delivery [8][9] - GLPG5101, a CAR-T therapy, received RMAT designation from the FDA for relapsed/refractory mantle cell lymphoma, showing a 97% complete response rate in trials [10] - The company is expanding its pipeline to include new cohorts and advancing a second CAR-T candidate, GLPG5301, for multiple myeloma [11][12] - **Caris Life Sciences, Inc. (NASDAQ:CAI)**: - Year-to-Date Performance: 24.32% - Known for precision oncology and AI-powered molecular diagnostics, with a significant FDA approval for its MI Cancer Seek platform [13][14] - The platform allows comprehensive tumor profiling from minimal samples, enhancing accuracy and turnaround time [14] - The company is also advancing blood-based diagnostics and expanding collaborations to enhance multi-technology tumor profiling [15][16] - **Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT)**: - Year-to-Date Performance: 24.41% - Focuses on dermatology with ZORYVE, a steroid-free PDE4 inhibitor for immune-mediated skin conditions [17] - Achieved FDA approval for ZORYVE foam for plaque psoriasis and is seeking to expand its label for pediatric use [18][19] - The company is advancing a late-stage pipeline, indicating long-term growth potential in dermatology [20]

Core Points - The U.S. FDA has granted RMAT designation to GLPG5101, a second generation anti-CD19/4-1BB CAR-T product candidate for relapsed/refractory mantle cell lymphoma [1][2] - RMAT designation aims to accelerate the development and review of promising cell and gene therapies for serious conditions, with GLPG5101 showing preliminary clinical evidence of potential effectiveness [2][3] - Clinical data from the ATALANTA-1 study supports the RMAT designation, demonstrating high objective and complete response rates with a manageable safety profile [3][4] 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 [9] - The company is dedicated to addressing high unmet medical needs and has developed a decentralized cell therapy manufacturing platform to enhance patient experience and treatment delivery [8][9] Study Details - The ATALANTA-1 study is evaluating the safety and efficacy of GLPG5101 in patients with various hematological malignancies, with a primary objective to assess safety and determine recommended dosing [6] - The study includes multiple dose levels and aims to evaluate the Objective Response Rate (ORR) and other secondary endpoints, with patients being followed for 24 months [6] RMAT Designation Benefits - The RMAT designation allows for increased FDA guidance, more frequent interactions, eligibility for accelerated approval, and early discussions on study endpoints, facilitating faster development timelines [4]

About This Report [Report Details and Company Information](index=2&type=section&id=About%20This%20Report_Details) This section details Galapagos NV's legal structure, report terminology, and the investigational status of its drug candidates - Galapagos NV is a limited liability company organized under **Belgian law**[3](index=3&type=chunk) - The term "Galapagos NV" refers to the non-consolidated Belgian company, while "we," "our," "the group," or "Galapagos" include Galapagos NV and its subsidiaries[4](index=4&type=chunk) - The report is published in Dutch and English, with the Dutch version prevailing in case of inconsistency[4](index=4&type=chunk) - All drug candidates mentioned are investigational, except for filgotinib (Jyseleca®), which was approved but transferred to Alfasigma in early 2024[7](index=7&type=chunk) Management Report [Main Events in the First Six Months of 2025](index=5&type=section&id=Main%20Events%20in%20the%20First%20Six%20Months%20of%202025) The first half of 2025 saw strategic shifts, leadership changes, and R&D pipeline advancements in oncology and immunology - The Board **re-evaluated** the proposed separation of the cell therapy business and is now **exploring strategic alternatives**, including **potential divestiture**, to maximize shareholder value[22](index=22&type=chunk) - Executive leadership was strengthened with the appointment of **Henry Gosebruch as CEO** and **Aaron Cox as CFO**, along with other key leadership roles[22](index=22&type=chunk) - GLPG5101 (CD19 CAR-T) demonstrated promising efficacy (**97% complete response rate**) and a favorable safety profile in relapsed/refractory indolent non-Hodgkin lymphoma (iNHL) from the ATALANTA-1 Phase 1/2 study[27](index=27&type=chunk) - GLPG5101 is advancing towards pivotal development in mantle cell lymphoma (MCL), with Biologics License Application (BLA) filing anticipated in **2028** and approval in **2029**[27](index=27&type=chunk) - The company is actively exploring partnership opportunities for GLPG3667, a TYK2 inhibitor in Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM), with topline results expected in **H1 2026**[22](index=22&type=chunk) - As of June 30, 2025, the company held approximately **€3.1 billion** in cash and financial investments, with an updated 2025 cash outlook to be provided with Q3 2025 results[27](index=27&type=chunk) [Financial Highlights](index=8&type=section&id=Financial%20Highlights) H1 2025 reported a significant net loss and increased operating loss, driven by reorganization costs, higher R&D, and negative financial results Consolidated Key Figures (Six months ended June 30) | (thousands of €, if not stated otherwise) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | **Income statement** | | | | Total net revenues | 140,265 | 140,305 | | Operating loss | (215,735) | (71,312) | | Net profit/loss (–) from continuing operations | (259,003) | 28,164 | | Net profit/loss (–) from discontinued operations, net of tax | (148) | 71,041 | | Net profit/loss (–) | (259,151) | 99,205 | | **Balance sheet (end of period)** | | | | Cash and cash equivalents | 71,669 | 72,328 | | Financial investments | 3,019,835 | 3,358,092 | | Total financial investments and cash and cash equivalents | 3,091,504 | 3,430,420 | | **Financial ratios** | | | | Basic and diluted earnings/loss (–) per share | (3.93) | 1.51 | | Total group employees | 558 | 683 | - Total operating loss from continuing operations for H1 2025 was **€215.7 million**, significantly higher than **€71.3 million** in H1 2024, primarily due to **€131.6 million** in strategic reorganization costs (severance, early collaboration termination, asset impairment, deal costs)[35](index=35&type=chunk) - R&D expenses increased to **€278.0 million** in H1 2025 from **€145.2 million** in H1 2024, driven by higher subcontracting costs for CAR-T and small molecule oncology programs, early collaboration termination costs, and increased personnel/severance costs[35](index=35&type=chunk) - Net financial results shifted to a loss of **€45.0 million** in H1 2025 (compared to **€98.3 million** income in H1 2024), mainly due to decreased interest income and **€37.9 million** unrealized currency exchange loss on U.S. dollar holdings[34](index=34&type=chunk) - Cash and cash equivalents and financial investments totaled **€3,091.5 million** as of June 30, 2025, representing a net decrease of **€226.3 million** during the first six months of 2025[40](index=40&type=chunk)[42](index=42&type=chunk) - Operational cash burn improved to **€91.5 million** in H1 2025, down from **€250.0 million** in H1 2024[31](index=31&type=chunk)[47](index=47&type=chunk) [The Galapagos Share](index=12&type=section&id=The%20Galapagos%20Share) Galapagos NV is publicly listed on Euronext Amsterdam and Brussels, and on the Nasdaq Global Select Market - Galapagos NV (ticker: **GLPG**) has been listed on Euronext Amsterdam and Brussels since **May 6, 2005**[48](index=48&type=chunk) - The company is also listed on the Nasdaq Global Select Market since **May 14, 2015**[48](index=48&type=chunk) [Related Party Transactions](index=13&type=section&id=Related%20Party%20Transactions) This section refers to detailed disclosures on related party transactions within the notes to the unaudited condensed consolidated interim financial statements - Information regarding related party transactions is detailed in the "Notes to the unaudited condensed consolidated interim financial statements for the first six months of 2025" section of this report[52](index=52&type=chunk) [Risk Factors](index=13&type=section&id=Risk%20Factors) Principal risks, detailed in the 2024 annual report, cover product development, regulatory, commercial, financial, third-party, IP, competitive, and market aspects - Principal risks and uncertainties include product development and regulatory approval, commercialization, financial position and need for additional capital, reliance on third parties, intellectual property, competitive position, organization, structure and operation, and market risks relating to shares and ADSs[53](index=53&type=chunk) - Readers are referred to the **2024 annual report (pp. 141–158)** and **Form 20-F (pp. 3–61)** for a comprehensive description of risk factors[53](index=53&type=chunk) - The description of the group's financial risk management in the **2024 annual report (pp. 223–225)** remains valid and unaltered[54](index=54&type=chunk) Financial Statements [Unaudited Condensed Consolidated Interim Financial Statements](index=15&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) This section presents the unaudited condensed consolidated interim financial statements for H1 2025, including income, financial position, cash flow, and equity statements, showing a net loss of **€259.151 million** Consolidated Statement of Income and Comprehensive Income/Loss (Six months ended June 30) | (thousands of €, except per share data) | 2025 | 2024 | | :-------------------------------------- | :----- | :----- | | Total net revenues | 140,265 | 140,305 | | Operating loss | (215,735) | (71,313) | | Net profit/loss (–) from continuing operations | (259,003) | 28,164 | | Net profit/loss (–) from discontinued operations, net of tax | (148) | 71,041 | | Net profit/loss (–) | (259,151) | 99,205 | | Basic and diluted earnings/loss (–) per share | (3.93) | 1.51 | Consolidated Statement of Financial Position (June 30, 2025 vs. December 31, 2024) | (thousands of €) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Total assets | 3,818,224 | 4,135,719 | | Total equity | 2,643,819 | 2,896,939 | | Total liabilities | 1,174,405 | 1,238,780 | | Cash and cash equivalents | 71,669 | 64,239 | | Current financial investments | 3,019,835 | 3,053,334 | Consolidated Cash Flow Statement (Six months ended June 30) | (thousands of €) | 2025 | 2024 | | :--------------- | :----- | :----- | | Net cash flow used in operating activities | (147,388) | (188,867) | | Net cash flow generated from investing activities | 159,452 | 95,678 |

Core Insights - Galapagos NV has appointed Sooin Kwon as Chief Business Officer and Dan Grossman as Chief Strategy Officer, effective August 4, 2025, to strengthen its leadership team [1][2][3] Group 1: Leadership Appointments - Sooin Kwon brings nearly 30 years of experience in life sciences, having previously served as a Partner at MTS Health Partners, where she led strategic and financing transactions [2][3] - Dan Grossman has over 20 years of experience in biopharmaceutical strategy and business development, previously working at Boston Consulting Group as Managing Director and Senior Partner [3][4] Group 2: Strategic Goals - The new executives are expected to play a critical role in advancing Galapagos' transformation, adding new pipeline assets through business development, and enhancing the company's impact on global health [2][3] - Kwon emphasized the company's strong balance sheet and partnership with Gilead, positioning Galapagos to execute transactions that will build a portfolio of innovative medicines [3] 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 [5] - The company aims to address high unmet medical needs and is committed to delivering results for patients, employees, and shareholders [5]

Core Insights - Galapagos NV has appointed Dawn Svoronos and Jane Griffiths as Non-Executive Independent Directors, effective July 28, 2025, replacing Peter Guenter and Simon Sturge [1][2] - The appointments are aimed at strengthening the Board and enhancing long-term value creation, with both new directors bringing extensive experience in the biopharmaceutical sector [2] 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 [4] - The company aims to address high unmet medical needs and is committed to developing a pipeline of best-in-class medicines [4] New Directors' Background - Dawn Svoronos has over 30 years of experience in the biopharmaceutical industry, including significant roles at Merck, where she led operations across 30 European markets and was involved in post-merger integration [2][3] - Jane Griffiths has extensive international corporate leadership experience, having served as Global Head of Actelion Ltd and held senior roles at Johnson & Johnson, focusing on corporate governance and sustainability initiatives [3]

Core Insights - The company has appointed a new CEO, CFO, and experienced business development leaders to enhance shareholder value and expand its pipeline [1][2] - Strategic alternatives for the cell therapy business, including a potential divestiture, are under evaluation, while CAR-T programs show positive clinical momentum [1][3] - The company reported a strong cash position of €3.1 billion as of June 30, 2025, providing a solid foundation for growth [1][2] Strategic and Corporate Update - The Board of Directors decided to re-evaluate the previously proposed separation of the company into two entities, focusing on maximizing shareholder value [3][10] - Galapagos Cell Therapeutics has been established as a standalone entity to consolidate all cell therapy activities [3] - Morgan Stanley is acting as a financial advisor for the strategic review process [3] Leadership Changes - Henry Gosebruch has been appointed as CEO, succeeding Dr. Paul Stoffels, and Aaron Cox as CFO, succeeding Thad Huston [3] - Additional leadership appointments include Sooin Kwon as Chief Business Officer and Dan Grossman as Chief Strategy Officer, effective August 4, 2025 [3] Financial Performance - Total net revenues for the first half of 2025 were €140.3 million, unchanged from the same period in 2024 [6][13] - R&D expenses increased by 91% to €278.0 million, primarily due to higher personnel costs and costs related to cell therapy programs [6][13] - The company reported a net loss of €259.1 million for the first half of 2025, compared to a net profit of €99.2 million in the same period of 2024 [9][16] Cell Therapy Pipeline - Galapagos is advancing its cell therapy pipeline, with promising data for GLPG5101 (CD19 CAR-T) showing a 97% complete response rate in a cohort of patients with relapsed/refractory indolent non-Hodgkin lymphoma [8] - The company is also exploring partnership opportunities for GLPG3667, a small molecule TYK2 inhibitor currently in Phase 3-enabling studies [8] Financial Guidance - The company plans to provide an updated cash outlook for 2025 during its third-quarter results, following recent leadership changes and strategic evaluations [19]

Core Insights - Galapagos NV has appointed Mr. Aaron Cox as Chief Financial Officer, effective July 7, 2025, succeeding Mr. Thad Huston, who will assist in the transition until July 31, 2025 [1][2] Group 1: Leadership Transition - Aaron Cox brings over 20 years of experience in biotechnology, capital markets, and M&A, having previously served as CFO at Horizon Therapeutics, where he was instrumental in the company's $28 billion acquisition by Amgen [2] - Cox's role at Galapagos will involve leading Finance, Accounting, Tax, Procurement, Communications, and Investor Relations, and he will be part of the Executive Committee [3] Group 2: Strategic Goals - The CEO of Galapagos expressed confidence in Cox's ability to accelerate pipeline growth through business development and disciplined financial management, aiming to create a new pipeline of innovative medicines [3] - Cox emphasized his excitement to join Galapagos at a pivotal moment, focusing on creating shareholder value and advancing innovations for patients [4] Group 3: Company Overview - Galapagos is a biotechnology company dedicated to transforming patient outcomes through innovative science, with a focus on high unmet medical needs and a commitment to delivering results for patients and shareholders [6]

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]