Zenas BioPharma (ZBIO) H.C. Wainwright 28th Annual Global Investment Conference summary

Pipeline and upcoming milestones

• BLA for obexelimab in IgG4-related disease is under FDA review, with a PDUFA date at the end of May and launch preparations underway.

• Key upcoming data includes open label extension and flare protection results, vaccine sub-study data, and SunStone Lupus phase IIb top-line results in Q4.

• Two phase III trials for orelabrutinib in progressive MS are ongoing, and ZB021 (IL-17 inhibitor) is advancing through phase I with phase II proof-of-concept planned for next year.

• ZB014 (extended half-life molecule) and ZB022 (brain-penetrant TYK2 inhibitor) are progressing toward clinical studies, with initial data expected next year.

Strategic advantages and market opportunities

• Obexelimab offers B-cell inhibition without depletion, providing a reversible, safer approach for older patients or those with comorbidities.

• IgG4-RD is a newly recognized disease with significant unmet need; current treatments are limited, and access to effective therapies like rituximab is challenging.

• The inhibitory approach is seen as a potential frontline option, especially for patients at risk from irreversible immune suppression.

• U.S. and European IgG4-RD markets are similar in size, with a target addressable market of about 12,000 patients each; pricing in the U.S. is around $300,000 annually.

Commercial and regulatory plans

• An investor event is scheduled for September 29th to discuss commercial planning and clinical data.

• MAA submission to the EMA is planned for the second half of the year, with the auto-injector pen format included.

• U.S. launch will begin with prefilled syringes, followed by a supplemental BLA for the auto-injector pen, expected within a year of initial approval.