Zura Bio (ZURA) Guggenheim Inaugural Global Healthcare Innovation Conference summary

Company overview and asset pipeline

• Founded in 2022, IPO in April 2023 with $80M raised; in-licensed three bispecific antibody assets.

• Lead asset, tibulizumab (BAFF/IL-17), targets systemic sclerosis (SSc) and hidradenitis suppurativa (HS); trial initiations pending for both indications.

• Additional assets include IL-7 and IL-33 pathway antibodies, with development contingent on external readouts and internal validation.

• Financially, $190M cash on hand funds Phase II studies through 2027.

Clinical development strategy and trial design

• SSc trial to initiate Q4 2024, enrolling 80 subjects across three regions, with completion targeted by end of 2026.

• SSc study uses a single dose (Q4W) vs. placebo, focusing on skin (mRSS) and lung (HRCT) endpoints, with open-label extension.

• HS trial to start in H1 2025, designed as a 16-week study with two dose arms and placebo, aiming for competitive HiSCR75 results.

• HS study expected to read out about a quarter before SSc, both pivotal data anticipated in 2026.

Scientific rationale and competitive landscape

• SSc and HS prioritized due to strong scientific and clinical validation for IL-17 and BAFF pathways.

• BAFF's role in HS supported by in vitro, in silico, and recent clinical data, including BTK inhibitor studies.

• Lead asset differentiated by combining IL-17 and BAFF inhibition, aiming to surpass efficacy of current therapies.

• Ongoing monitoring of competitor data (e.g., Novartis, Q32, OSE, Roche, Sanofi/Regeneron) to inform development decisions.