Slide 1: Key Inclusion Criteria
Key Inclusion Criteria · Fulfill at least 4 of the criteria for SLE defined by the ACR. · Receiving stable SLE treatment. · Seropositive for ANA or anti-dsDNA antibodies. Key Exclusion Criteria · Severe vasculitis, CNS lupus, lupus nephritis. · Anemia, neutropenia, or thrombocytopenia. · Malignancy
Slide 2: Kaplan Meier Analysis of Time to First Severe Flare
Kaplan Meier Analysis of Time to First Severe Flare (SLE Flare Index) Decrease in Proteinuria Subgroup: baseline proteinuria=1-6 g/24h
Slide 3: i Hazard
i Hazard p°0.22 5 | 8a Sony & ah, \ 28 L esentin Zz |—Pooled Placebo N=34/269 S75 |—200m8 QW bisibimod, N=3782 ' Placebo 200mg aw, N=1292 0 6 (08D 280 360 Time (days) Average duration of ‘Therapy
Slide 4: SRI Responses in mITT Population
SRI Responses in mITT Population Placebo Blisibimod Pooled 200mg Q4W 100mg QW 200mg QW Pooled 200mg Q4W 100mg QW 200mg QW ∆SRI Endpoint N=269 N=89 N=88 N=92 N=277 N=92 N=93 N=92 200mg QW 35.3% 34.8% 36.4% 34.8% 37.2% 35.9% 32.3% 43.5% 8.7% SRI-5 *p=0.635 *p=0.925 *p=0.603 *p=0.154 #p=0.884 #p=0.561
Slide 5: Increases in SRI Response in Subjects with Baseline SELENA-SLEDAI > 10 and Receiving Steroid
Increases in SRI Response in Subjects with Baseline SELENA-SLEDAI > 10 and Receiving Steroid
Slide 6: SRI Responses in Subjects with SELENA-SLEDAI > 10, Receiving Steroid
SRI Responses in Subjects with SELENA-SLEDAI > 10, Receiving Steroid Placebo Blisibimod Pooled 200mg Q4W 100mg QW 200mg QW Pooled 200mg Q4W 100mg QW 200mg QW ∆SRI Endpoint N=138 N=44 N=47 N=47 N=140 N=42 N=50 N=48 200mg QW 47.1% 47.7% 53.2% 40.4% 45.7% 50.0% 34.0% 54.2% 13.8% SRI-5 *p=0.682 *p=0.819
Slide 7: Summary of Adverse Events
Clinical Improvement meets SRI-8 criteria without counting low complement, increased DNA binding, thrombocytopenia, leukopenia Summary of Adverse Events Pooled Placebo N=266 Pooled Blisibimod N=280 200mg QW Blisibimod N=92 Overview (% incidence) AE 85.0 82.5 83.7 Serious AE 15.8 11.1 7.6 AEs related