Zura Bio (ZURA) investor relations material

Strategic vision and pipeline overview

• Focus on developing multifunctional antibodies for autoimmune and inflammatory diseases, with three in-licensed programs from pharma, each targeting multiple pathways for greater efficacy.

• Lead asset tibulizumab, a bispecific antibody targeting IL-17 and BAFF, is positioned for multiple indications, with upcoming data readouts in hidradenitis suppurativa (HS) and systemic sclerosis.

• Additional pipeline assets include an IL-7 receptor antibody (crebankitug) and an IL-33 program, both with external validation and potential for differentiated development paths.

• Recent expansion of tibulizumab's clinical program to include polymyalgia rheumatica, reflecting confidence in the asset's versatility.

• Strategic approach emphasizes independent, high-quality shots on goal across distinct indications, minimizing correlation between programs.

Tibulizumab clinical development and trial design

• TibuSHIELD, the phase II HS trial, is a three-arm, placebo-controlled study with 247 participants, powered for HiSCR 75 as the primary endpoint, and includes an open-label extension.

• The trial tracks both clinical and biomarker endpoints, including B-cell counts and immunoglobulin levels, to assess the contribution of BAFF and IL-17 pathways.

• Over-enrollment and rigorous investigator training aim to minimize placebo response noise and ensure robust, interpretable data.

• The trial excludes prior IL-17 inhibitor-exposed patients but plans to study this group in future phases.

• A 20 percentage point delta on HiSCR 75 versus placebo is considered a strong efficacy benchmark, with broader data context also important for decision-making.

Scientific rationale and competitive positioning

• Multifunctional approach addresses efficacy ceilings seen with single-pathway modulators, aiming for deeper and more durable responses.

• Tibulizumab's dual targeting of IL-17 and BAFF is supported by evidence of both pathways' roles in HS, with BAFF levels correlating with disease severity and non-response to standard therapies.

• BAFF inhibition reduces B-cell counts without full depletion, aligning with external data showing benefit from B-cell modulation in HS.

• Immunogenicity rates for tibulizumab have been low (<5%), comparing favorably to other agents, and not impacting pharmacokinetics.

• The approach is differentiated by being the first to explore two mechanisms in one molecule for HS, potentially setting a new standard if data are strong.