Zenas BioPharma, Inc. Common Stock

Zenas BioPharma is a clinical-stage global biopharmaceutical company developing therapies for autoimmune and inflammatory diseases. It in-licenses and acquires product candidates rather than relying on internal discovery.

Its lead candidate is obexelimab, a self-administered subcutaneous bifunctional monoclonal antibody. It binds CD19 and FcγRIIb to inhibit B-cell activity without depleting the cells. Status by indication:
- IgG4-Related Disease: an FDA BLA has been accepted, with a PDUFA date of May 27, 2027, and an EMA MAA has been validated.
- Systemic lupus erythematosus: in Phase 2 (SunStone).
- Relapsing MS: previously studied in the Phase 2 MoonStone trial.

Its second late-stage asset is orelabrutinib, a CNS-penetrant oral BTK inhibitor licensed from InnoCare. Orelabrutinib is in Phase 3 trials in primary progressive MS (PriMroSe) and non-active secondary progressive MS (Monarch). InnoCare markets it for B-cell malignancies in mainland China and Singapore.

Earlier-stage programs include:
- ZB021, an oral IL-17AA/AF inhibitor in Phase 1, licensed worldwide excluding greater China and Southeast Asia.
- ZB022, a brain-penetrant oral TYK2 inhibitor.
- ZB014, a half-life extended anti-CD19/FcγRIIb antibody designed for once-monthly dosing.

The company generates license and collaboration revenue, including milestones from Bristol-Myers Squibb. It funds operations through equity, convertible senior notes, a Pharmakon term loan and a Royalty Pharma royalty arrangement. Zenas is building pre-commercial infrastructure ahead of a potential obexelimab launch. Updated Nov 5, 2026