Zura Bio (ZURA) investor relations material

Differentiated therapeutic approach for autoimmune diseases

• Lead candidate tibulizumab is a first-in-class bispecific antibody targeting both IL-17 and BAFF pathways, designed to address complex immune disorders inadequately treated by single-pathway therapies.

• Dual inhibition aims to modulate both B-cell and T-cell driven pathobiology, with initial focus on hidradenitis suppurativa (HS) and systemic sclerosis (SSc).

• Phase 1/1b studies showed potent target engagement, low immunogenicity, and a safety profile consistent with known pathway inhibitors.

• Phase 2 trials (TibuSHIELD for HS and TibuSURE for SSc) are ongoing, with topline data expected in Q4 2026 and 1H 2027, respectively.

• Company is well-capitalized, with funding expected to last through at least the end of 2028.

Scientific and clinical rationale

• Autoimmune diseases like HS and SSc involve multiple intersecting immune pathways, limiting the efficacy of monotherapies.

• Tibulizumab fuses a BAFF-binding antibody (tabalumab) with an IL-17A-binding fragment (from ixekizumab), enabling dual-pathway modulation in a single agent.

• BAFF is central to B-cell survival and is elevated in both HS and SSc, while IL-17A is a validated inflammatory pathway implicated in these diseases.

• Clinical benchmarks for IL-17 inhibition (ixekizumab) and BAFF inhibition (belimumab) support the rationale for dual targeting.

Market opportunity and competitive landscape

• HS and SSc represent significant unmet needs, with estimated total addressable markets of ~$8B and ~$4B by the mid-2030s, respectively.

• HS is a chronic, relapsing disease with complex immune drivers, and SSc is a rare, multisystem autoimmune disorder with limited effective treatments.

• Multiple approved and late-stage therapies exist for HS, but ongoing need for differentiation remains; tibulizumab is the only agent targeting both BAFF and IL-17.