Zenas BioPharma (ZBIO) Q4 2025 earnings summary

Executive summary

• Positive Phase 3 INDIGO trial results for obexelimab in IgG4-RD, with significant reduction in disease flare risk and all key secondary endpoints met.

• Marketing applications for obexelimab in IgG4-RD planned for FDA in Q2 2026 and EMA in H2 2026.

• Multiple pipeline programs advancing, including orelabrutinib for MS and new candidates ZB014, ZB021, and ZB022.

• Secured up to $250 million non-dilutive debt financing from Pharmakon to support commercialization and pipeline development.

Financial highlights

• Revenue for 2025 was $10.0 million, up from $5.0 million in 2024, driven by a one-time license payment.

• R&D expenses rose to $168.1 million in 2025 from $139.1 million in 2024, reflecting increased personnel and clinical costs.

• G&A expenses increased to $53.3 million in 2025 from $29.7 million in 2024, due to higher personnel, pre-commercialization, and professional fees.

• Acquired in-process R&D expenses were $171.7 million in 2025, related to the InnoCare license agreement.

• Net loss for 2025 was $377.7 million, compared to $157.0 million in 2024.

• Cash, cash equivalents, and investments totaled $360.5 million as of December 31, 2025.

Outlook and guidance

• Cash and financing expected to fund operations into Q2 2027, and potentially into Q4 2027 with additional milestone payments.

• Topline results for the Phase 2 SunStone trial in SLE expected in Q4 2026.

• Phase 1 trial for ZB021 to begin in Q2 2026, with initial data by year-end 2026.

• Orelabrutinib Monarch Phase 3 trial for non-active SPMS to initiate in Q1 2026.