Slide 1: LUMUS Phase 2b Topline Results
LUMUS Phase 2b Topline Results September 1, 2026 Transform Therapies. Reimagine Lives.
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward looking statements within the meaning of federal securities laws, including the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based upon current plans, estimates and expec
Slide 3: LUMUS Trial Topline Results
LUMUS Trial Topline Results 01 Opening Remarks Martin Babler, President & CEO 02 LUMUS Trial Design and Topline Results Jörn Drappa, CMO 03 Closing Remarks and Q&A Martin Babler, President & CEO 3
Slide 4: LUMUS Topline Results Summary
LUMUS Topline Results Summary Envudeucitinib in Moderate-to-Severe Systemic Lupus Erythematosus (SLE) Trial did not meet primary and secondary Robust clinical responses observed in prespecified subgroup of endpoints in overall trial population patients with high interferon gene signature (IFNGS-high
Slide 5: LUMUS Phase 2b Clinical Trial Design
LUMUS Phase 2b Clinical Trial Design Part A Part B Phase 2b Trial Open Label Extension (OLE) Trial Envu 20 mg QD Envu 20 mg BID R Envu 40 mg BID Envu 40 mg BID 408* Placebo Randomization 1:1:1:1 » Exit Part A: Complete Baseline Primary EP Day 1 BICLA at Week 48 28-day follow-up period » Primary endp
Slide 6: Key Topline Efficacy Endpoints
Key Topline Efficacy Endpoints 20mg QD 20mg BID 40mg BID Placebo (N=103) (N=99) (N=102) (N=101) Response Rate 40.0 (30.6, 50.3) 42.2 (32.1, 52.9) 41.0 (31.7, 50.9) 35.7 (26.7, 45.9) (95% CI) BICLA Delta vs. placebo* Week 48 (95% CI) 4.7 (-9.1, 18.6) 6.9 (-7.4, 21.1) 6.2 (-7.5, 19.9) P-value** 0.5018
Slide 7: LUMUS Topline Safety Summary
LUMUS Topline Safety Summary Envudeucitinib was well-tolerated with no new safety signals observed Overall, incidence rates were lower on active treatment compared with placebo for: • TEAEs, grade ≥3 TEAEs, study drug related TEAEs, and TEAEs leading to study drug discontinuation • Serious Adverse E
Slide 8: Pharmacodynamic Dose Response with Maximal Inhibition at the Highest Dose
Pharmacodynamic Dose Response with Maximal Inhibition at the Highest Dose LUMUS blood based RNA-seq analysis of all available subjects. Normalized gene expression values. Median values with interquartile ranges. Type 1 IFN 4 gene signatures calculated as median normalized expression of the following
Slide 9: Type I Interferon Gene Signature High Subgroup is Well-defined and Represents the Majority
Type I Interferon Gene Signature High Subgroup is Well-defined and Represents the Majority of Moderate-to-Severe Patients with SLE • Well established bimodal type I IFN pathway activity distribution seen in SLE population, with clustering of patients into two biologically distinct "IFNGS-high" and
Slide 10: Baseline Demographics and Disease Characteristics
Baseline Demographics and Disease Characteristics • Baseline demographics were generally well balanced across groups • Baseline disease characteristics – Lower than expected proportion of interferon gene signature high – Lower than expected proportion of patients with severe disease 20mg QD 20mg BID
Slide 11: Primary and Key Secondary Efficacy Endpoints at Week 48: by Baseline IFNGS Score
Primary and Key Secondary Efficacy Endpoints at Week 48: by Baseline IFNGS Score Baseline IFNGS-high Baseline IFNGS-low 20mg 20mg 40mg 20mg 20mg 40mg Endpoint QD BID BID Placebo QD BID BID Placebo (N=64) (N=62) (N=60) (N=63) (N=39) (N=37) (N=42) (N=38) BICLA Response rate (%) 40.7 49.5 52.6 28.6 39.
Slide 12: BICLA by Visit: Baseline IFNGS Score (High vs Low)
BICLA by Visit : Baseline IFNGS Score (High vs Low) Baseline: IFNGS-high Baseline: IFNGS-low Envudeucitinib is an investigational therapy not reviewed or approved by any regulatory agency. 12
Slide 13: BICLA Response in IFNGS-high Patients
BICLA Response in IFNGS-high Patients LUMUS, PAISLEY and TULIP-1/2 Studies BICLA response rate, IFNGS-high: placebo vs active arm 60 +24.0 +26.7 +20.9 +18.2 50 52.6 BICLA response rate, % +12.1 49.5 51.3 +14.5 47.6 40 +2.8 40.7 39.1 30 28.6 28.6 28.6 29.4 27.4 20 24.6 24.6 24.6 10 0 Envu Envu Envu D
Slide 14: BICLA Response in IFNGS-low Patients
BICLA Response in IFNGS-low Patients LUMUS, PAISLEY and TULIP-1/2 Studies BICLA response rate, IFNGS-low: placebo vs active arm +37.0 60 −1.3 65.0 +9.3 −8.5 −17.5 −23.1 50 46.8 BICLA response rate, % 47.5 39.0 47.5 47.5 40 30.0 −3.0 37.5 30 26.7 24.4 25.0 28.0 28.0 28.0 20 10 0 Envu Envu Envu Deucra
Slide 15: SRI-4 Response in IFNGS-high Patients
SRI-4 Response in IFNGS-high Patients LUMUS, PAISLEY and TULIP-1/2 Studies SRI-4 response rate, IFNGS-high: placebo vs active arm +34.6 70 +27.8 +28.2 +24.7 67.7 +14.7 60 +15.6 +18.4 60.9 60.5 SRI-4 response rate, % 57.8 50 53.7 50.7 47.9 40 39.0 30 33.1 33.1 33.1 32.3 32.3 32.3 20 10 0 Envu Envu En
Slide 16: SRI-4 Response in IFNGS-low Patients
SRI-4 Response in IFNGS-low Patients LUMUS, PAISLEY and TULIP-1/2 Studies SRI-4 response rate, IFNGS-low: placebo vs active arm 70 +6.7 −2.8 −9.9 −11.6 +15.0 60 55.0 SRI-4 response rate, % 49.7 −15.0 −0.2 50 46.7 45.2 52.5 52.5 42.6 52.5 40.9 40 45.3 40.0 40.0 40.0 30 25.0 20 10 0 Envu Envu Envu Deu
Slide 17: Primary and Key Secondary Endpoints: Robust Response Plus Clear Separation from Placebo
Primary and Key Secondary Endpoints: Robust Response Plus Clear Separation from Placebo IFNGS-high response rates for LUMUS and TULIP-1/2 studies IFNGS-high response rates (%) — active arms vs their placebo Anifrolumab 300 mg TULIP placebo Envudeucitinib 20 mg QD Envudeucitinib 20 mg BID Envudeucit
Slide 18: Key Next Steps
Key Next Steps • Preparing for End of Phase 2 meetings with FDA and EMA to discuss: • Benefit observed in IFNGS-high patients in LUMUS across doses, and primary and key secondary endpoints • Phase 3 design and sizing • Confirm Phase 3 dose, define enrollment criteria related to desired IFNGS status
Slide 19: Key Achievements and Anticipated Milestones
Key Achievements and Anticipated Milestones 1Q26 Envu – Psoriasis Phase 3 Topline Data for 16- and 24-week Endpoints 1Q26 Envu – Psoriasis Phase 3 Additional Data Presented at AAD 1H26 Lonigutamab – Completion of Strategic Review TYK2 Franchise Development Strategy (Envu and A-005) – 2Q26 Evaluation
Slide 20: Thank You
Thank You Q&A Transform Therapies. Reimagine Lives.