 Biologics License Application for efgartigimod in generalized myasthenia gravis on track to be submitted to U.S. Food and Drug Administration by end of year Full data from ADAPT trial to be presented at upcoming medical meeting in 2020 Cusatuzumab development strategy aligned with evolving AML treatment landscape to focus on combination with venetoclax and azacitidine 1.9 billion in cash and cash equivalents and current financial assets strongly support commercial launch preparation of efgartigimod Management to host conference call today at 2:30 pm CEST 8:30 am ET July 30, 2020 Breda, the Netherlands Ghent, Belgium argenx Euronext Nasdaq: ARGX, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced its half year 2020 financial results and provided a second quarter business update and outlook for the remainder of the year.We are proud of the progress we have made during the first half of 2020 to advance our immunology pipeline and validate our first-in-class FcRn antagonist, efgartigimod. We announced positive topline results from the Phase 3 ADAPT trial, furthering our conviction that efgartigimod has the potential to significantly improve the standard of care for people with gMG as well as several other autoantibody-driven diseases. We are focused on our planned 2021 U.S. commercial launch of efgartigimod to bring this therapy to patients as quickly as possible and to advance on our argenx 2021 vision, said Tim Van Hauwermeiren, CEO of argenx.We also remain committed to advancing our robust pipeline, including our late-stage efgartigimod trials in additional autoimmune indications and our early-stage candidates from our Immunology Innovation Program. Regarding cusatuzumab, which we are currently developing in a global collaboration with Janssen, as clinical trial sites re-open, we are taking the opportunity to evaluate the most appropriate development strategy given the rapidly evolving treatment landscape, continued Mr. Van Hauwermeiren. SECOND QUARTER 2020 AND RECENT BUSINESS UPDATEargenx continues to execute on its argenx 2021 vision to become a fully integrated, global immunology company. The company continues to implement measures across the organization and in the operations of globally run clinical trials to minimize the impact of COVID-19 on employees, patients and their communities, physicians and ongoing business priorities. Commercial preparations underway to support potential approval and launch of argenxs first-in-class FcRn antagonist, efgartigimod, in its first indication, generalized myasthenia gravis gMG. Biologics License Application BLA on track to be filed with the U.S. Food and Drug Administration FDA by the end of 2020 with an expected U.S. commercial launch in 2021 Japanese Marketing Authorization Application J-MAA expected to be filed with the Pharmaceuticals and Medical Devices Agency PMDA in the first half of 2021 with an expected efgartigimod launch in gMG in Japan following the U.S. commercial launch Commercial infrastructure readiness activities, including with global supply chain, are on track for launch timeline in the U.S. and Japan In May, argenx reported positive topline data from the Phase 3 ADAPT trial showing efgartigimod was well-tolerated and able to drive responses that support plans to offer individualized dosing to gMG patients. ADAPT met its primary endpoint showing 67.7 of acetylcholine receptor-antibody positive AChR-Ab gMG patients were responders on the Myasthenia Gravis Activities of Daily Living MG-ADL score compared with 29.7 on placebo p0.0001 63.1 of AChR-Ab gMG patients responded to efgartigimod compared with 14.1 on placebo on the Quantitative Myasthenia Gravis QMG score p0.0001 40.0 of efgartigimod-treated AChR-Ab patients achieved minimal symptom expression defined as MG-ADL scores of 0 symptom free or 1, compared to 11.1 treated with placebo In AChR-Ab patients who met the primary endpoint, the majority showed a sustained response, including 88.6 who achieved a response for at least six weeks, 56.8 for at least eight weeks and 34.1 for at least 12 weeks Safety profile of efgartigimod was comparable to placebo Detailed data set to be presented at upcoming medical meeting in 2020 argenx plans to meet with FDA in fourth quarter of 2020 to discuss bridging strategy for subcutaneous SC efgartigimod Positive ADAPT data support continued progress of efgartigimod in additional severe autoimmune indications within key commercial franchises. Primary immune thrombocytopenia ITP registrational program includes ongoing ADVANCE trial evaluating 10mgkg IV efgartigimod in up to 156 patients Enrollment delays in the program have been observed due to COVID-19 Discussions ongoing with FDA on how to bring forward SC components of program to meet COVID-19 enrollment challenges Chronic inflammatory demyelinating polyneuropathy CIDP Phase 2 ADHERE trial ongoing evaluating SC efgartigimod Due to COVID-19 enrollment delays, potential decision to expand trial up to 130 patients now expected in 2021 Pemphigus vulgaris PV registrational trial to start in second half of 2020 following proof-of-concept data from adaptive Phase 2 trial that showed fast onset of disease control and deep responses with potential for steroid sparing Fifth indication to be announced by end of 2020 Cusatuzumab development strategy aligned with evolving treatment landscape and anticipated global adoption of venetoclax in acute myeloid leukemia AML clinical practice. Development plan, in collaboration with Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson Johnson, to now focus on cusatuzumab in combination with venetoclax, including in the Phase 1b ELEVATE combination trial of cusatuzumab with venetoclax and azacitidine in newly diagnosed, elderly patients with AML who are ineligible for intensive chemotherapy Trial enrolling again after pause due to COVID-19 Maturing data from Phase 2 CULMINATE trial of cusatuzumab in combination with azacitidine in newly diagnosed, elderly patients with AML who are ineligible for intensive chemotherapy suggest that complete response rates are not likely to exceed those from the VIALE-A trial of venetoclax in combination with azacitidine presented at the European Hematology Association EHA Annual Congress in June 2020 Based on enrollment to date, dose selected to be 20mgkg CULMINATE trial will continue to evaluate responses and durability for existing patients but will not enroll new patients Topline data to be reported in early 2021 Registration strategy to be determined following evaluation of maturing data across cusatuzumab program and AML treatment landscape Phase 1 trial of cusatuzumab in combination with azacitidine trial in Japan evaluating newly diagnosed, elderly AML patients who are ineligible for intensive chemotherapy remains ongoing Phase 2 BEACON trial of cusatuzumab in combination with azacitidine versus azacitidine alone in higher-risk patients with myelodysplastic syndromes MDS who are ineligible for intensive chemotherapy remains paused for enrollment Part 1 dose escalation of Phase 1 study of cusatuzumab in combination with azacitidine in newly diagnosed, elderly patients with AML who are ineligible for intensive chemotherapy, published in Nature Medicine argenx continues to advance its early-stage pipeline of first-in-class antibodies against immunologic targets. 