Generalized pustular psoriasis disease overview

GPP is a systemic, life-threatening inflammatory disease characterized by widespread pustules

• Associated with unregulated IL-36 signaling
• Patients have a high fever and elevated levels of serum CRP and inflammatory cytokines (e.g., IL-8)
• Severe GPP patients can die from cardio-pulmonary failure, exhaustion, toxicity and infection

GPP ICD-10 diagnostic code analysis by IQVIA assessed US prevalence during 2017-2019 timeframe

• ~37,000 unique patients diagnosed at least once
• ~15,000 unique patients diagnosed two or more times

FDA has granted ODD for treatment of GPP

GEMINI-1 Phase 3 trial and top-line results

(Acute Flare) through week 4

Enrolled 45 patients across 3 arms (1:1:1)

53% who received single dose of 750mg IV imsidolimab responded:

• Achieved GPPPGA score of 0/1 (clear or almost clear) at Week 4 primary endpoint

Compared to:

• 13% responded on placebo (p=0.0131)
• 53% responded if received single dose of 300mg IV imsidolimab

GEMINI-2 Phase 3 trial and top-line results

(Maintenance/Prevention) through at least 24 weeks

All 8 responding patients from GEMINI-1 who re-randomized to monthly 200mg SC imsidolimab maintained GPPPGA score of 0/1

• None of these patients experienced a GPP flare

Compared to responding patients from GEMINI-1 that were re-randomized to placebo:

• Only 25% maintained GPPPGA 0/1 response
• 63% flared after being re-randomized to placebo

Safety and Tolerability

GEMINI-1 and GEMINI-2 trials demonstrated consistent, favorable safety and tolerability profile

• No treatment-related serious adverse events (SAEs) or SAEs that lead to discontinuation in imsidolimab-treated patients
• Low incidence and no elevation of infections vs. placebo
• No cases reported of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or Guillain-Barre syndrome (GBS)
• No infusion reactions reported
• Overall incidence of anti-drug antibodies (ADA) was low and, when detected, were determined to be non-neutralizing