Zura Bio (ZURA) Piper Sandler 36th Annual Healthcare Conference summary

Pipeline strategy and upcoming catalysts

• Focus on three assets with multiple pipeline opportunities, prioritizing ZB-106 for systemic sclerosis (SSc) and hidradenitis suppurativa (HS).

• Indirect catalysts expected from Q32 data in atopic dermatitis (AD) and alopecia areata (AA), with preparedness to launch own programs based on results.

• Key 2025 readouts include Novartis's BAFF data in HS and two phase 3 COPD readouts for IL-33 pathway assets.

• Enrollment for SSc study expected to complete in Q1 2026, with data readout by end of 2026; HS study readout anticipated in Q3 2026.

• Limited at-risk capital is allocated to non-lead assets, with further investment contingent on clinical validation.

Clinical trial design and differentiation

• SSc trial incorporates learnings from past failures: validated targets, experienced CRO, certified assessors, early disease patients, and stable background therapy.

• SSc study powered to detect a clinically meaningful mRSS change (MCID 3–5), with exploratory endpoints for lung and quality of life.

• HS trial will use higher dosing based on safety and exposure models, with two active arms, one placebo, and at least one loading dose arm.

• Dosing strategies informed by receptor occupancy, pSTAT5 inhibition, and PopPK modeling, emphasizing skin exposure.

• IL-33 asset (torudokimab) offers broader pathway inhibition (IL-33 and RAGE) and higher potency compared to competitors.

Mechanistic rationale and competitive landscape

• Bispecific approaches target both type 1 and type 2 inflammation, addressing unmet needs in AD, AA, SSc, and HS.

• BAFF and IL-17 validated in SSc and HS; dual targeting may offer additive benefits, especially in heterogeneous diseases.

• Clinical and mechanistic data support B cell involvement in HS, with BAFF presence in lesions and supporting literature.

• Competitive readouts in 2025 (Novartis BAFF, Roche and Sanofi IL-33 assets) are key for external validation and strategic decisions.

• Regulatory path for SSc leverages orphan status, with single phase 3 studies of ~300 patients and evolving endpoints.