Zenas BioPharma (ZBIO) Corporate presentation summary

Strategic vision and corporate positioning

• Aims to become a global, multi-franchise, fully integrated commercial-stage biopharma company with a cash runway into 2029 and a pipeline targeting autoimmune and inflammatory diseases.

• Plans for potential approval of three best-in-class franchise molecules across five indications by 2031, targeting markets exceeding $50B.

• Experienced executive team with a track record of 70+ IND filings, 30+ BLA/NDA filings, and 30+ commercial launches.

Pipeline and clinical milestones

• Obexelimab: BLA submitted to FDA and MAA submission to EMA for IgG4-RD; U.S. and EU launches expected in 2027 pending approval.

• Orelabrutinib: Phase 3 trials initiated for naSPMS and PPMS; addresses high unmet need in progressive MS with FDA-cleared protocols.

• ZB021 (oral IL-17 inhibitor): Phase 1 PK and safety results expected by year-end 2026; patient data in 2027.

• ZB022 (brain-penetrant TYK2 inhibitor) and ZB014 (half-life extended CD19/FcyRllb mAb): IND-enabling studies ongoing, with clinical data expected in 2027.

Obexelimab for IgG4-RD: clinical and commercial highlights

• INDIGO Phase 3 trial met primary and all key secondary endpoints, showing a 56% reduction in disease flare risk and significant reductions in glucocorticoid use and toxicity.

• Safety profile consistent with placebo, with fewer serious and high-grade adverse events.

• Market research indicates strong physician preference for obexelimab as a first-line therapy, with 47% biologic share and preference for subcutaneous administration.

• U.S. IgG4-RD market estimated at $3B, with 10-12K addressable patients and significant growth potential.

• Commercial launch team and supply chain in place for 2027 launch, with autoinjector expected within a year of launch.