Paul Stoffels
Analyst · UBS. Please go ahead. Your line is open
Thank you, Sofie, and good afternoon, everyone. I would like to take a moment to share the strong foundation that we are building and how we have set up Galapagos for value creation. Today, we are a pure-play biotech with a renewed R&D strategy to accelerate and bring innovative medicines to patients. We are moving forward faster with the focused, differentiated and expanding R&D pipeline and competitive technology platforms. We're also making important regulatory and operational progress with our decentralized CAR-T network in Europe and the U.S. This slide summarizes our efforts to build a robust product pipeline that will enable us to accelerate future growth and drive value creation for all stakeholders. In doing so, we will focus on our key therapeutic areas of oncology and immunology to advance our R&D pipeline of potential best-in-class cell therapies and small molecule drugs. Today, we are developing four clinical candidates for 11 indications, and we have more than 15 preclinical programs. For further expansion and progress of our pipeline, we take a collaborative approach combining internal and external innovation. And finally, our strategy is supported by a strong cash position of EUR3.3 billion at the end of September 2024. In the third quarter of this year, we delivered on several important milestones. Let's start with the regulatory achievements. We are very pleased to have received the IND clearance from the FDA for GLPG5101, for which we have generated encouraging results in the Phase I/II ATALANTA study in Europe. We now plan to enroll our first patient in the U.S. in the Phase II expansion part of ATALANTA study in non-Hodgkin lymphoma before year-end. Obtaining the IND clearance for our seven day vein-to-vein fresh CAR-T decentralized manufacturing process was a crucial achievement for expanding the development of our cell therapies in the U.S. In Europe, we resumed recruitment for the GLPG5301 Phase I/II study in multiple myeloma following the announcement during our half year results of a study pause. We are confident that we have put the right measures in place to resume the study. We are making significant progress with our proprietary pipeline that includes more than 15 programs, and we have selected two early-stage pipeline candidates for clinical development. I will provide more information on this in the following slides. We continued the enrollment for the GLPG3667 Phase II studies in dermatomyositis and lupus, with top line data expected in 2025 and 2026, respectively. We also selected the first decentralized manufacturing unit, Excellos in San Diego within the nation-wide network of Blood Centers of America. This is an important step in the expansion of the footprint of our cell therapy manufacturing network across the U.S. Let's come back to the key achievements on the regulatory front. The FDA's IND clearance of the ATALANTA study for GLPG5101 in patients with non-Hodgkin lymphoma produced on a decentralized manufacturing platform marking an essential step towards realizing our vision of transforming patient outcomes through life-changing science and innovation. As a brief reminder, our decentralized cell therapy platform is a novel point-of-care solution that offers the potential for efficient medium seven day vein-to-vein time and avoids complex logistics, thereby addressing important limitations of current CAR-T treatments. The proprietary platform consists of our end-to-end workflow management and monitoring software system, a decentralized functionally closed automated manufacturing platform for cell therapies and the proprietary quality control testing and release strategy. Together, this allows for greater physician oversight and for production model near the patient that is globally scalable. Currently, we have three clinical trials running on the cell therapy platform. With IND cleared, we can now start recruiting U.S. patients into the Phase II expansion cohort of the ATALANTA study and we are actively initiating clinical trial sites in Boston region and we plan to start enrolling patients with non-Hodgkin's lymphoma in the study before year-end. We will leverage the learnings from GLPG5101 prior to the submission of the GLPG5201 IND for the EUPLAGIA study in CLL, which we will now target to submit in early 2025. Before we move over to our pipeline overview, we wanted to highlight a recent publication in blood advances that analyze several large CAR-T clinical trials. The analysis points to vein-to-vein time as an important predictor of patient outcomes, where reducing vein-to-vein time can substantially improve life expectancy by up to 3.2 years. The paper states that aiming for short manufacturing product release shipping and infusion times may be key to further improve outcomes for patient treatment with CAR-T. We believe that these data underscore the importance of our efforts in this field. Let's look at our clinical pipeline. In oncology, we are progressing our Phase I/II CAR-T program, GLPG5101 in NHL. As you know, ATALANTA is a basket trial in a number of indications, which you see listed here on the slide. We are also progressing GLPG5201 in CLL and Richter's transformation. And as mentioned earlier, we have resumed recruitment into the Phase I/II GLPG5301 study in multiple myeloma. I'm also pleased to announce that we will present new data from the ATALANTA and EUPLAGIA studies at the American Society of Hematology Annual Meeting in December. We added TCR T cell therapy to our pipeline following the clinical collaboration agreement with Adaptimmune that was announced at the end of May. The agreement gives Galapagos the option to exclusively license Adaptimmune's next-generation TCR T therapy, uza-cel, targeting MAGE-A4 for head and neck cancer and potentially future solid tumor indications. Initial in-vitro results suggest that uza-cel developed by Adaptimmune and produced on Galapagos decentralized manufacturing platform yields fresh fit early phenotype T cells. These cells could potentially improve efficacy and durability compared to the uza-cel centrally manufactured on Adaptimmune's platform. Together with Adaptimmune, we will present these preclinical data at ASH. In immunology, we are progressing our Phase II study with GLPG3667 in dermatomyositis and lupus with top line results expected in 2025 and 2026, respectively. As we work to advance our programs in development, we are also investing in our discovery portfolio to identify future programs. We are making important progress in all our therapeutic areas. We have more than 15 internal programs in discovery across oncology and immunology with cell therapies and small molecules. From this discovery portfolio, we selected the differentiated next-generation armed bispecific CAR-T candidate in hemato-oncology. In addition, we selected the potential best-in-class small molecule candidate in immunology, targeting clinical development in '25 '26. We also continue to scout for external innovation to further build our early-stage pipeline. In 2025, we expect to initiate at least four IND or CTA-enabling studies and at least one first in human study. From 2026 onwards, our aim is to fuel the clinical pipeline with at least two new clinical assets annually across cell therapy and small molecules. I now will pass it over to Thad for the financial update.