Zenas BioPharma (ZBIO) Corporate presentation summary

Strategic vision and growth trajectory

• Aims to become a global, multi-franchise, fully integrated commercial-stage biopharma focused on immune-mediated diseases, with plans for global marketing submissions and launches across major markets by 2027.

• Expects potential approval of three best-in-class franchise molecules across five indications by 2031, targeting markets exceeding $50B.

• Well-capitalized with up to $250M in non-dilutive funding from Pharmakon, supporting operations through key milestones.

• Commercial launch teams and supply chain infrastructure are in place, ready to scale for anticipated product launches.

Pipeline and clinical milestones

• Portfolio includes late-stage programs for obexelimab (IgG4-RD, SLE, RMS), orelabrutinib (PPMS, naSPMS), and early-stage assets ZB021, ZB022, and ZB014.

• Obexelimab met primary and all key secondary endpoints in Phase 3 INDIGO trial for IgG4-RD, with regulatory submissions planned for 2026.

• Orelabrutinib demonstrated rapid and sustained efficacy in RRMS and is advancing to Phase 3 trials in PPMS and naSPMS, with FDA-cleared protocols.

• ZB021 (oral IL-17 inhibitor) and ZB022 (brain-penetrant TYK2 inhibitor) are advancing through IND-enabling studies, with clinical data expected in 2027.

Product differentiation and market opportunity

• Obexelimab offers a novel bifunctional mechanism targeting CD19 and FcyRIIb, providing B cell inhibition without depletion, and is positioned as a front-line therapy for IgG4-RD.

• Physician and patient surveys indicate strong preference for obexelimab due to its efficacy, safety, subcutaneous administration, and ability to pause therapy for vaccinations.

• IgG4-RD and SLE represent significant commercial opportunities, with U.S. markets estimated at $3B and $12B respectively.

• Orelabrutinib is positioned as a best-in-class BTKi for progressive MS, addressing high unmet needs in naSPMS and PPMS, with a U.S. market opportunity exceeding $12B.

• ZB021 and ZB022 target multi-billion dollar markets in autoimmune and neuroinflammatory diseases, leveraging oral and brain-penetrant modalities.