Zenas BioPharma (ZBIO) investor relations material

Strategic vision and corporate positioning

• Aims to become a global, fully integrated, commercial-stage biopharmaceutical company with multi-franchise capabilities in immunology and inflammation (I&I) by 2031.

• Cash runway extends into 2029, supporting commercialization and pipeline advancement.

• Executive team has deep experience with 70+ IND filings, 30+ BLA/NDA filings, and 30+ commercial launches.

Pipeline and clinical milestones

• Portfolio includes late-stage and early-stage programs targeting IgG4-RD, SLE, RMS, PPMS, naSPMS, and psoriasis.

• Obexelimab: BLA accepted by FDA for IgG4-RD, MAA submission to EMA planned, with U.S. and EU launches expected in 2027.

• Orelabrutinib: Phase 3 trials initiated for naSPMS and PPMS; protocols cleared by FDA and EMA.

• ZB021 (oral IL-17 inhibitor) and ZB022 (brain-penetrant TYK2 inhibitor) in early clinical development, with data expected in 2026–2027.

Obexelimab clinical data and market positioning

• INDIGO Phase 3 trial in IgG4-RD met primary and all key secondary endpoints, reducing flare risk by 56% and showing superior remission rates and reduced steroid use.

• Safety profile comparable to 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 high patient/physician preference for subcutaneous administration.

• U.S. IgG4-RD market estimated at $3B, with significant growth potential and only one approved therapy currently.