Zenas BioPharma (ZBIO) investor relations material

Strategic vision and positioning

• Aims to become a global, fully integrated, commercial-stage biopharma with multi-franchise capabilities in immune-mediated diseases, targeting markets exceeding $50B by 2031.

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

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

Pipeline and clinical milestones

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

• Obexelimab: Phase 3 INDIGO trial in IgG4-RD met all primary and key secondary endpoints; BLA submission to FDA planned for Q2 2026, with U.S. and EU launches expected in 2027.

• Orelabrutinib: Phase 3 trials initiated for naSPMS and PPMS; FDA-cleared protocols with risk mitigation for liver safety.

• ZB021 (oral IL-17 inhibitor) and ZB022 (brain-penetrant TYK2 inhibitor) advancing through IND-enabling and early clinical studies, with data expected 2026–2027.

Obexelimab clinical and commercial highlights

• Demonstrated 56% risk reduction in IgG4-RD flares and superior remission rates versus placebo; well-tolerated safety profile.

• Preferred by physicians for first-line use in IgG4-RD, with strong patient and physician preference for weekly subcutaneous administration.

• U.S. IgG4-RD market opportunity estimated at $3B, with similar prevalence and opportunity in Europe.

• Commercial launch teams and supply chain in place for 2027 launches, including autoinjector availability.