argenx SE

earlier today with our full year financial results and recent business updates. This can be found on our website along with the presentation for today's webcast. Before we begin, I'd like to remind you on slide two that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. Actual results may differ materially from those indicated by these statements. Argemix is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Tinvan Haramiran, Chief Executive Officer, Carl Gubitz, Chief Financial Officer, and Karen Massey, Chief Operating Officer.

I will now turn the call over to Tin.

Thank you, Beth, and welcome, everyone. I'll begin on slide three. It has been an overview of incredible execution by the Argenis team, setting us up to build on this momentum for the year ahead. At the core of everything we do is our mission to transform the lives of patients suffering from autoimmune diseases. And today, we are in a better position than ever to deliver on this mission, reaching more patients globally with our first-in-class innovation and bringing hope to the autoimmune community on what a novel treatment can offer. We see multiple opportunities to expand our patient impact this year and are investing across our business to do so. These innovation horizons serve as a roadmap for how we will build long-term value by expanding the safeguard opportunity, advancing our pipeline, and bringing the next wave of IND candidates into the clinics. On today's call, I would like to highlight recent use and walk through upcoming milestones in the context of these horizons. Slide four. Let's start with a bit about opportunity. We had an incredible second year of launch driven by the ambitious strategies and seamless execution of our commercial and medical teams. And we are still at the beginning of what we hope to achieve. First and foremost, The long trajectory demonstrates the significant unmet needs that still exist with GMG and the opportunity for an innovation like VivGuard to deliver differentiated outcomes for patients. As a part of our commitment to the broader MG community, we will initiate a registration trial in seronegative patients this year, which, if positive, could allow us to reach the 15% of GMG patients who are not served by our current labels. Beyond MG, we continue to demonstrate the breadth of possibility for SCRN across autoimmune indications, and we have launch preparations underway ahead of anticipated regulatory decisions in ITP in Japan in March and in CIDP in the US in June. We will be ready to tackle these anticipated opportunities as we leverage our key learnings from our launch playbook to best position ourselves for success Slide five. CLIVGAP continues to make headway in the clinic. The phase three TED study is ready to start this quarter, and will be the first to utilize our pre-filled syringe from the onset. We are expecting relapse from five phase two studies, including insurance, post-COVID POTS, and three subtypes of myositis. And we expect to provide an update on our plans in Bull of Pensacola later this year, once the team has had the opportunity to analyze the data from patients who are involved in pilot stage 8. This is part of our commitment as a learning organization and our ongoing work to double-click on the clinical feasibility of current and future Abkhazigamot studies based on team science from Advanced SC and ADDRESS. This will be another year where we learn more about the broad potential of FCRN through our next wave of indications, advancing our leadership of the class, and unraveling important findings about the underlying biology of these autoimmune diseases. Today, we will focus on our expectations of success around children, as that will be the first of the five. The rule study has a target enrollment of 30 moderate to severe patients, randomized to one. The study is not powered for efficacy, So we will rely on the depth of data we will gather from each patient, looking at various endpoints, including CRESS, SDI, SPRE, and biomarkers across patients. We have a few objectives with the signal-finding study. First, to confirm the role of IgG autoantibodies in mediating disease in children. Second, to evaluate a combination of efficacy and biomarker data to gain sufficient confidence to move forward in this indication. And third, to inform potential patient selection and endpoints to design a winning registrational trial to amplify any signal we observe in phase two. We plan to employ a similar approach in our evaluation of POPs, looking at the depth of data across the enrolled patients to make an evidence-based decision to move into a phase three study. With mysitis, We have a seamless phase 2-3 design, which will expedite the transition from the first 30 patients of each subset into a registration study of one or more of the subsets where proof-of-concept has been established. Wrapping up on abgratigamot, I'm very proud of all that we have accomplished in pioneering this new class of medicines. Proof-of-concept has now been demonstrated in nine out of nine indications across SCRN, and we believe this is still just the beginning of the broader opportunity. Slide six. Turning attention to our next horizon of innovation, I want to briefly touch on our pipeline progress. EMPA is our second pipeline in a product opportunity from which we have showed compelling MMM data from the first patient cohort earlier this year. This is a program that emerged from our IIP and perfectly demonstrates how we like to build opportunity from our discovery engine into our pipeline and now towards a registration trial in its first indication. In collaboration with Professor Eric Hacks, we built what we believe is the first in class and best in class sweeping antibody against C2 and have conducted translational work to highlight where targeting C2 could have the most impact. Out of this, we identified that complement activation in NMM happens upstream in the complement cascade. We designed an innovative trial, and in the first cohort, we demonstrated a 91% reduction in the need for IVIG rescue compared to placebo. We are now awaiting the results of the second cohort to inform the final design of the registration trial and look forward to sharing the full Phase II data set this year. The MMM opportunity fits perfectly within our expanding capabilities in neurology, as does Argenix 119, our third pipeline program. This molecule will come more into focus this year as we move beyond healthy volunteers into CMS and ALS patient studies. Of note, we recently initiated natural history studies in both CMS and MMM to engage each of their respective patient communities. This falls in line with our strategy to better understand the real-world experience of patients and will help us identify potential participants in upcoming studies. Slide seven. Finally, and core to our sustainable growth, is our third innovation horizon, our Immunology Innovation Program. The track record of success of our IIT goes well beyond FGAT-DIGEMOD and EMPA, with nine programs tested in humans since inception. We demonstrated the efficiency of this pipeline engine by nominating four new molecules last year. All are on track to be filed as IMDs by the end of 2025. We will continue to invest in our internal discovery engine and technical capabilities, combining our antibody engineering and clinical development expertise with the knowledge of leading scientific collaborators as we advance our next wave of molecules. I will now turn the call over to Carol.