Slide 1: ALKIVIA Study Topline Results
ALKIVIA Study Topline Results August 17, 2026
Slide 2: Forward-Looking Statements
Forward-Looking Statements Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or represe
Slide 3: An Important Win for the Autoimmune Myositis Community
An Important Win for the Autoimmune Myositis Community Patients FcRn Science Rheumatology Delivering transformative outcomes Sixth first-in-class dataset First phase 3 data in rheumatology 3
Slide 4: A win for both IMNM and DM - met primary endpoint
A win for both IMNM and DM - met primary endpoint on combined population (p=0.0011), with early and sustained improvements across primary and secondary endpoints Consistent benefit across skin and muscle, with comparable magnitude of treatment effect in both subtypes Safety profile was consistent wi
Slide 5: Addressing Substantial Unmet Need in Autoimmune Myositis
Addressing Substantial Unmet Need in Autoimmune Myositis Internal argenx data IMNM patients can become wheelchair bound within 3-6 months Persistent muscle weakness as hallmark symptom Systemic manifestations beyond skin and muscle can lead to hospitalization "Time is muscle" – uncontrolled disease
Slide 6: Pioneering FcRn Biology with VYVGART Shaping the Treatment Paradigm
Pioneering FcRn Biology with VYVGART Shaping the Treatment Paradigm Signature efficacy profile: rapid, deep, sustained responses Broadest product presentation, empowering patient choice ~25K patient safety years Creating the FcRn Roadmap 6 First-in-Class Phase 3 Data Sets 6
Slide 7: Bringing our Proven Approach to Rheumatology
Bringing our Proven Approach to Rheumatology NEUROLOGY Established Leadership RHEUMATOLOGY Next Frontier Built deep partnerships with physicians, researchers and patients Leverage argenx playbook to build long-term leadership SSc SjD Important entry point and bridge into rheumatology 7 IMNM DM MG CI
Slide 8: This is an invisible disease
This is an invisible disease. You think you’re the only one, but once you start talking to people with similar experiences it’s amazing. Melissa, living with autoimmune myositis “ 8
Slide 9: ALKIVIA Phase 2/3 Adaptive Basket Study
ALKIVIA Phase 2/3 Adaptive Basket Study 89 patients (24 weeks) SCREENING 175 patients (52 weeks) steroid taper wk16 wk44 Open Label Extension - OR PHASE 2 ANALYSIS SCREENING PHASE 2 PHASE 3 Data supported continued enrollment across subtypes in Phase 3 Safety Follow Up Enrollment reflects unmet need
Slide 10: Rapid, Significant and Sustained Response Through Weeks
Rapid, Significant and Sustained Response Through 52 Weeks Consistent across primary and secondary endpoints Consistent across core TIS measures with benefit in both muscle and skin domains Consistent with the VYVGART signature: rapid and sustained response Consistent Treatment Effect Mean TIS Impro
Slide 11: Consistent Response Across IMNM and DM
Consistent Response Across IMNM and DM Baseline Characteristics Mean TIS Evaluated at 52 Weeks IMNM DM Active Placebo Delta p-value 45.05 30.24 14.81 p=0.0048 Active Placebo Delta p-value 51.51 36.96 14.54 p=0.1093 IMNM + DM Combined Population Active Placebo Delta p-value 47.95 32.56 15.39 p=0.0011
Slide 12: ALKIVIA Phase Safety Profile
ALKIVIA Phase 3 Safety Profile Efgartigimod PH20 SC (N=86; PYFU=75.8) Placebo PH20 SC (N=89; PYFU=71.7) n (%) n (%) ≥1 AE 80 (93.0) 78 (87.6) ≥1 SAE 18 (20.9) 12 (13.5) ≥1 grade ≥3 AE 23 (26.7) 13 (14.6) ≥1 AE leading to study drug discontinuation 6 (7.0) 12 (13.5) ≥1 AESI (infection) 51 (59.3) 43 (
Slide 13: Path Forward to Bringing Innovation to Patients
13 Path Forward to Bringing Innovation to Patients Moving with urgency toward regulatory filing Additional data to be shared at future medical congress Preparing commercial organization for launch
Slide 14: Accelerating Toward Vision 2030 – and Beyond
50k 10 5 patients on treatment labeled indications new molecules in Phase 3 Vision 2030 Today’s announcement 14 Accelerating Toward Vision 2030 – and Beyond
Slide 15: Delivering Long-Term Growth Across Immunology Pipeline
Delivering Long-Term Growth Across Immunology Pipeline gMG 2021 CIDP 2024 ITP (Japan) 2024 PFS (MG, CIDP) 2025 Seronegative MG 2026 MYOSITIS Ocular MG 2027** Positive Topline Results This is just the beginning… efgartigimod empasiprubart ARGX-121 ARGX-124 ARGX-125 ARGX-213 TSP-101* FB-102** ARGX-118