Galapagos NV

Good day and thank you for standing by. Welcome to the Galapagos Q1 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sophie van Geesel. Please go ahead.

Thank you, operator. And thank you and welcome to the audio webcast of Galapagos' first quarter 2023 results. I'm Sophie van Geesel, Investor Relations, representing the reporting team at Galapagos. This recorded webcast is accessible via the Galavgos website homepage and will be available for download and replay later on today. I would like to remind everyone that we will be making forward-looking statements during today's webcast. These forward-looking statements include remarks concerning future developments of the pipeline and our company and possible changes in the industry and competitive environments. Because these forward-looking statements involve risks and uncertainties, Calabco's actual results may differ materially from the results expressed or implied in these statements. Today's speakers will be Paul Sofos, CEO, and Bart Filius, President, CEO, and CFO. Paul will discuss the Q1 highlights and provide an update on our immunology and oncology portfolio. Bart will go over the commercial and financial results. You will see a presentation on screen. We estimate that the pre-paid remarks will take about 20 minutes. Then we'll open it up to Q&A with Paul and Bart, joined by Michele Mantel, Chief Commercial Officer, and Daniele D'Ambrosio, Head of Immunology. And with that, I'll now turn over to Paul.

Thank you, Sophie. Good morning, good afternoon, and thank you for joining our Q1 results highlights. Let's take a moment to look at the highlights as presented on the slide here. To first take on immunology, while we were very disappointed with the outcome of the Crohn's disease study, We are happy that we recently dosed the first patient in the phase 3 registrational study with Fulgotinib in actual spondyloarthritis, a potential third indication for Yoselica. In addition, we are opening clinical sites for our phase 2 study with a TIK2 inhibitor and should dose the first patient in the coming days or weeks. Moving to oncology, we presented very encouraging safety and efficacy results for 5201, a CAR-T CD9 CAR-T in CLL at the EHA meeting in February. We'll come back to this data later in the presentation. Meanwhile, we are expanding our Cocoon network and making good progress in opening additional sites in Europe and our first sites in the US. On a corporate level, we took important steps in executing the strategic reorientation of our company. Importantly, we successfully transferred our drug discovery and research activities in Romainville, France, to Novalix, a French drug discovery-focused contract research organization. We are extremely pleased with this transfer, as Novalix is a good home for our French colleagues, and it fits very well with our strategy to build fit-for-purpose R&D organizations. Here you see our pipelines. As mentioned, the pipeline is refocused on two therapeutic areas, immunology and oncology. And I will go in a little detail over different programs. I'll summarize them. In immunology, as mentioned, unfortunately, the Crohn's disease did not give us the expected results. But we have RA and UC on the market with a registrational trial in AXPAR out of the gates now. We are progressing Arctic 2 in SLE and AIM. in TIK2 in dermatomyositis, sorry, and also in SLE, and aim to start a patient study with our CD19 CAR-T in SLE later this year. Meanwhile, we are working on multiple preclinical targets that we are eager to push forward and see if we see a better class profile. In oncology, we are making good progress with the CD19 programs. Happy to report that this morning we received the approval to start a clinical trial with our BCMA program in multiple myeloma. And meanwhile, with the bound, as well as via external collaborations, we are progressing with multiple new targets, developing our new next generation CAR T's for the point of care units. In immunology, we are focusing on all steps of the research progress. initiating new preclinical research programs on best-in-class targets. We are merging our CAR-T capabilities with our immunology team in the CD9 team for lupus. The TIK2 is progressing as a late-stage molecule, and filgotinib is expanding the indication. So we keep strongly focused on immunology. A little bit more explanation on axial spondyloarthritis study. AXPA is a disease with inflammation of spine and the sacroiliac joints. It's a very heterogeneous disease. It affects young people with low remission rates today. Patients have limited option with currently available drugs and there are no new modes of actions expected in the coming years. The Tortuga data in AXPA was communicated in 2018 and published in the Lancet provide the comfort to go into AXPA with filgotinib. And this is also shown in a graph on the slide. The 200 milligrams show strongly significant effect size in mean change from baseline in the ASDA score compared to placebo. Early onset of action is visible already at week one of the treatment with continued response till week 12. So good hopes in this indication. The start of the Olinguito phase three in AXPA with filgotinib is in non-radiographic and radiographic disease. A total of 238 patients will be included, either in placebo, as you see on the slide, or 200 mg filgotinib. The primary endpoint, ASAS40, is at week 16, and patients will be able to enter into an open-label part of the study until week 52, which will report also stop-line results. Start anticipate next quarter, the second quarter, with top line in 2025. From week 52 in the study to week 104, we plan to re-randomize the patients who achieved low disease activity at week 52 to study either the 100 milligram or 200 milligram until week 1-4. The design is endorsed by the authorities and good to go. As indicated, the TIK2 study, the GALARISO trial, is currently active underway and set out in the fields to start recruiting patients. It's also a placebo-controlled study in 62 patients for 24 weeks with a four-week follow-up in patients with active dermatomyositis and reduced muscle strength. The top-line results are expected in the first half of 25. As a reminder, with the same molecule, we also start an SLE study which should result also the second half of 25. In oncology, as I explained last time at the meeting, we are very much focused on our point of care network for CAR-T. And this slide shows how we changed the paradigm of CAR-T treatment by the way of decentralizing production with a cocoon platform, which we brought in to Galapagos with the acquisition of CellPoint. In collaboration with CellPoint, we are now developing these new products. The decentralized has the benefit to give a short seven-day vein-to-vein time. We at the moment run this production in the hospitals with a very high success rate as we are running now two kilocontrials and soon three. On the next slide, you see the cocoon. On the left side, you see the cartridge. the whole cocoon in its environment, and then you see also the future where we can put many cocoons on the stack in order to reduce GMP unit space. This is complemented with the development of a digital and data system which collects and registers all the data, allowing us to do at the same time the quality control, quality release, allowing the seven days vein to vein. As I said, very consistent production over the centers, and we have close to 100% delivery of two patients here. The next slide shows you the data which I talked about in CLL, the study design at least. Three dose levels are being studied in a phase one two dose finding study in CLL in the point of care. With encouraging data, we presented at the EBMT EHA conference in February. Data on two dose levels are available. The third dose level is currently being tested. Important here is that we include Richter's transformation patients, which typically is not the case in CLL trials, and we see very good results. I'll come back to that in a minute. We aim for the top-line results of the three dose levels of mid-23 and the data will be presented at ASH later in the year. Here the next slide shows you the first data and shows that we have an overall response rate in six out of the seven patients, seven out of seven patients, with six out of seven having a complete response. And on the right side of the slide you see a patient with Richter's where after 28 days the patient is in complete remission and no disease is detected anymore with biomarkers in the body of the patient. The swimming plot of the patient shows you that in the two different levels, all the responders, overall responders, and all the complete responders, with one patient relapsing after five months with CD19 escape. What is very encouraging here is that all the patients with Richter's transformation had a complete response. We are further recruiting into these studies, and as I said, an update will be given later in mid this year, and the data will be published as we go on the large conference. We continue on the safety side to prove the safety of the product. Also, again, remarkable, we don't see a grade three or four CRS in any of the patients in the two dose levels we tested so far, and also no neurotoxicity icons as we have observed in the whole study. So overall, high efficacy, very complicated patients, and very good safety profile. At this moment, I would like to transition to Bart. It's an important meeting. It's Bart's last call, as you probably have heard in the press earlier this week, because Bart is going to leave us. I want to thank Bart for his contribution over nine years to the company. He has been the leader of introducing us on Nasdaq. He was instrumental in getting the Gilead deal done. He built the European commercial organization and so much more. Very important was that Bart was on my side to transition into Galapagos, and we have had a very productive collaboration over the last 14 months. So Bart, I give it to you.