Zenas BioPharma (ZBIO) Guggenheim SMID Cap Biotech Conference summary

Company overview and strategy

• Focused on building an immunology and inflammation franchise around obexelimab, a novel B cell inhibitor in multiple global phase II and III trials.

• Obexelimab inhibits rather than depletes B cells, offering potential safety and convenience advantages, including a weekly autoinjection for at-home use.

• The molecule targets CD19 and Fc gamma RIIb, engaging a broad B cell lineage and impacting autoantibody and cytokine production.

• Prior clinical trials, including in rheumatoid arthritis and IgG4-related disease, support efficacy and informed ongoing development.

• The experienced team is leveraging prior global drug development and launch expertise.

Clinical development milestones

• Phase III INDIGO trial in IgG4-related disease completed enrollment in November; top-line results expected by year-end.

• Global phase II multiple sclerosis trial will report primary endpoint in Q3, using MRI endpoints to benchmark efficacy.

• SLE (lupus) study will complete enrollment this year, with data expected in the first half of next year.

• All ongoing trials are powered to demonstrate efficacy, with optimized dosing regimens for target engagement.

• $350 million in capital is sufficient to fund all endpoints through lupus readout.

Differentiation and competitive positioning

• Inhibition approach allows reversible B cell suppression, potentially improving safety and patient management versus depleting agents.

• Weekly autoinjection under Part D offers economic and convenience benefits over infusion-based Part B drugs.

• Continuous inhibition may provide superior efficacy by maintaining disease control and reducing relapse compared to six-month depleting regimens.

• Opportunity to prospectively include PIRA (progression independent of relapse activity) as a key endpoint in MS, potentially differentiating from current CD20 agents.

• Commercial strategy leverages orphan drug status and established market access infrastructure in the US, Europe, and Japan.