Zenas BioPharma (ZBIO) Citi's 2024 Global Healthcare Conference summary

Platform overview and pipeline development

• Focus on immunology and autoimmune diseases, leveraging a global clinical operations team with experience in multiple drug approvals.

• Obexelimab is the lead asset, with completed phase 3 enrollment for IgG4-related disease and ongoing phase 2 trials in multiple sclerosis (MS) and lupus.

• Pipeline expansion is driven by business development, with two major funding rounds raising over $450 million in 2023.

• Five clinical trials are ongoing across 220 sites in 31 countries, with over 300 patients enrolled.

• Management team expanded to support execution and milestone delivery.

Clinical trial progress and timelines

• IgG4-RD phase 3 (INDIGO) completed enrollment in November 2023; top-line results expected by year-end 2025.

• MS phase 2 trial will report top-line data in Q3 2025; lupus phase 2 will finish enrollment in 2024 and report in H1 2026.

• Interim results from a wAIHA proof-of-mechanism study showed positive hemoglobin and biomarker changes.

• Obexelimab demonstrated rapid and sustained B-cell inhibition without depletion, differentiating it from other therapies.

• Weekly subcutaneous dosing maintains high drug levels, allowing continuous B-cell suppression and flexibility for patient management.

Mechanism of action and differentiation

• Obexelimab targets CD19 and co-engages Fc gamma RIIb (CD32B), providing potent B-cell inhibition without antibody-dependent cell-mediated cytotoxicity (ADCC).

• Non-clinical and clinical data support its mechanism, showing efficacy in rheumatoid arthritis, IgG4-RD, and lupus.

• Unlike depleting antibodies, B-cell activity returns within weeks after pausing treatment, enabling vaccination and infection management.

• Subcutaneous autoinjector offers convenience over IV infusions, with lower hypersensitivity risk compared to competitors.