Zenas BioPharma (ZBIO) Corporate presentation summary

Strategic positioning and milestones

• Two late-stage programs span four inflammation and immunology indications; early-stage assets are positioned for best-in-class potential.

• Obexelimab’s FDA BLA was accepted; PDUFA date is May 27, 2027, with an EMA marketing application planned for 2H 2026.

• Three potential franchise molecules across five indications are targeted by 2031; estimated markets exceed $30B across IgG4-RD, SLE, PPMS and naSPMS.

• Cash runway is projected into 2029, supporting launch preparation and pipeline advancement.

Obexelimab in IgG4-RD

• In the 194-patient INDIGO trial, obexelimab reduced flare risk 56% vs. placebo through Week 52 (HR 0.443; p=0.0005); 26.8% vs. 54.6% experienced flares.

• All four key secondary endpoints were met: complete remission 37.1% vs. 19.6%; annualized flare rate 0.34 vs. 0.70; rescue glucocorticoid use 329.5 mg vs. 929.8 mg.

• Obexelimab was generally well tolerated; serious AEs were 10.3% vs. 18.6% and Grade ≥3 AEs 11.3% vs. 23.7% for placebo, while discontinuations were 9.3% vs. 3.1%.

• CD19/FcγRIIb co-engagement is designed to inhibit B cells without effector-cell-dependent depletion; circulating B cells remained above the lower limit of normal in INDIGO.

• U.S. IgG4-RD estimates include 30–40K prevalent cases, ~25K diagnosed and treated patients, ~12.5K eligible for maintenance therapy, and a $4B commercial opportunity.

Launch and commercial opportunity

• Physician research indicated 64% were extremely likely to prescribe obexelimab in three years; projected biologics share was 47%.

• Launch planning targets ~7,100 HCPs; 45 field reps are intended to cover >90% of patient opportunity at target accounts.

• Planned support includes 45 field sales professionals, 14 market-access staff, six nurse educators and six strategic-engagement roles.

• Obexelimab’s weekly self-administered subcutaneous formulation and potential treatment flexibility are key planned differentiators for chronic IgG4-RD management.