Letter to Our Stakeholders
Dear Reader,
At Galapagos, our focus is clear: developing innovative therapies to improve patient outcomes.
This past year has been instrumental in our journey to transform cell therapy. With the FDA’s Investigational New Drug clearance and the compelling clinical data in three relapsed/refractory non-Hodgkin lymphoma indications we presented at ASH for our lead CD19 CAR-T candidate, GLPG5101, we have achieved strong validation of our innovative and globally scalable cell therapy platform.
Our ability to deliver fresh, stem-like early memory ('young') CAR-T treatment in a median vein-to-vein time of just seven days is a game-changer, offering new hope to patients who need it most.
Through our partnership with Lonza, leveraging the Cocoon® platform, and our collaborations with Thermo Fisher Scientific and miDiagnostics to develop an ultra-rapid PCR sterility test, we are further strengthening our unique approach to cell therapy manufacturing.
To expand access to potential life-saving cell therapies, we have significantly grown our decentralized manufacturing network, ensuring we are well-positioned to scale our innovative cell therapy platform globally. In the U.S., we have established strategic collaborations with Thermo Fisher Scientific, Blood Centers of America, Excellos, Landmark Bio, and most recently, Catalent. We also have collaborations with multiple manufacturing partners in key European markets.
In parallel, we further advanced our BCMA-directed CAR-T candidate, GLPG5301, in relapsed/refractory multiple myeloma.
Furthermore, we are expanding our early-stage pipeline of next-generation, multi-targeting, armored cell therapies for hematological and solid tumors, accelerating innovation and driving long-term value creation. Additionally, through our partnership with Adaptimmune, we are progressing uza-cel, a MAGE A4-directed TCR-T candidate for head and neck cancer, reinforcing the potential of our platform and our commitment to delivering transformational therapies.
Beyond cell therapy, we have made strong progress with our small molecule portfolio and further advanced our TYK2 inhibitor, GLPG3667, in two Phase 3-enabling studies in systemic lupus erythematosus and dermatomyositis. Furthermore, we have identified a promising potential best-in-class candidate in immunology to advance into IND-enabling studies.
In early 2025, we announced our intent to separate into two publicly traded entities, Galapagos and SpinCo. This bold move aims to unlock shareholder value and sharpen our focus. It will also provide us with the autonomy to execute our cell therapy growth strategy, while creating sustainable shareholder value, and ensuring that we serve patients as effectively possible, now and in the future.
As part of this planned focus on cell therapy, we are discontinuing our small molecules research activities and are seeking potential partners to take over our small molecule portfolio, including our TYK2 inhibitor, GLPG3667. The strategic reorganization is expected to result in a reduction of approximately 300 positions across the organization in Europe. This is a difficult but necessary step, and we are grateful to our departing employees for their significant contributions and their dedication to making a difference in the lives of patients.
SpinCo, with initially approximately €2.45 billion in cash and Gilead as a strategic partner, will focus on advancing a pipeline of innovative medicines in oncology, immunology, and virology through transformational transactions. With support from the Nomination Committee, our Board is actively recruiting a seasoned executive team and Independent Non-Executive Directors with a strong track record in biotech company-building and strategic transaction execution for SpinCo.
As we enter the next phase for Galapagos, we are preparing for registrational trials and commercial readiness, and plan to initiate pivotal development of GLPG5101 in 2026, with the goal of securing the first approval by 2028 using our decentralized manufacturing approach.
Driven by our mission to make a transformational impact on patients’ lives, we remain inspired by the encouraging clinical results we are seeing with our programs in hematological cancers. With a strong foundation in place, we are focused on building for the future and growing into a global biotech company, delivering potential life-changing cell therapies to patients who need them most.
None of this would be possible without the dedication of our employees, the trust of our shareholders, and the patients who inspire us every day. Thank you for your support as we take the next step in shaping the future of Galapagos.
Sincerely,
Paul Stoffels1
Chair and Chief Executive Officer, Galapagos
1 1Throughout this report, ‘Dr. Paul Stoffels’ should be read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’