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Zenas BioPharma (ZBIO) guidance and outlook

Zenas BioPharma's 10-Q filed Nov 5, 2026 makes 51 forward-looking statements.

Guidance and outlook

Forward-looking statements, 10-Q filed Nov 5, 2026

• With the evolving understanding of the pathogenesis of autoimmune diseases, along with the expansion of promising immunology-based pharmacologic targets, we are building an immunology and inflammation (“I&I”) focused biopharmaceutical company.
• Based on existing clinical data generated to date, we believe that targeting B cell lineage via CD19 and FcγRIIb can inhibit B cells and has been shown to be well-tolerated.
• We are conducting clinical trials in IgG4-RD through a registration-directed Phase 3 trial which reported topline data in January 2026, relapsing multiple sclerosis (“RMS”) through an ongoing Phase 2, double-blind, randomized, placebo-controlled trial which reported topline data in October 2025 (the “MoonStone” trial) and systemic lupus erythematosus (“SLE”) through an ongoing Phase 2, double-blind, randomized,…
• In August 2026, the FDA accepted our BLA and assigned a Prescription Drug User Fee Act (“PDUFA”) target date of May 27, 2027.
• We intend to submit a supplemental application to obexelimab’s IgG4-RD BLA, if approved, and included the bioequivalence data in the European MAA submission.
• In April 2026, we completed enrollment in the SunStone trial and expect to report topline results, including biomarker data, in the fourth quarter of 2026.
• As we continue to evaluate the MoonStone data and consider next steps for clinical development in this indication, we will consider, among other items, the evolving treatment landscape in RMS, including existing therapies, current pivotal trial endpoints and prioritization of capital.
• Subject to the results of IND-enabling studies, we expect to initiate a Phase 1 clinical study in 2027.
• We expect to continue to incur significant and increasing losses for the foreseeable future.
• We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:
• We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for a product candidate, and we cannot assure investors that we will ever generate significant revenue or profits.
• In addition, if we obtain regulatory approval for a product candidate and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities.

Zenas BioPharma's latest quarter

Questions

What does Zenas BioPharma expect?

With the evolving understanding of the pathogenesis of autoimmune diseases, along with the expansion of promising immunology-based pharmacologic targets, we are building an immunology and inflammation (“I&I”) focused biopharmaceutical company. Based on existing clinical data generated to date, we believe that targeting B cell lineage via CD19 and FcγRIIb can inhibit B cells and has been shown to be well-tolerated. We are conducting clinical trials in IgG4-RD through a registration-directed Phase 3 trial which reported topline data in January 2026, relapsing multiple sclerosis (“RMS”) through a

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Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.