Zenas BioPharma to file Obexelimab BLA this quarter; cash runway to 2029
Zenas BioPharma reported Q1 2026 financial results and provided corporate updates, highlighting significant progress in its clinical pipeline and a strengthened balance sheet. The company expects to submit Obexelimab marketing applications for IgG4-RD to the FDA this quarter and the EMA in H2 2026, with Phase 3 INDIGO trial results accepted for oral presentation at EULAR 2026. Enrollment for the Phase 2 SunStone SLE trial is complete, with topline results anticipated in Q4 2026. Zenas also completed public offerings and debt financing, raising $419.0 million, extending its cash runway into Q2 2029. The net loss for Q1 2026 increased to $81.0 million from $33.6 million in Q1 2025, primarily due to increased R&D and G&A expenses.
Key Highlights
- Obexelimab BLA submission to FDA this quarter, MAA to EMA in H2 2026.
- Obexelimab Phase 3 INDIGO results accepted for oral presentation at EULAR 2026.
- Obexelimab Phase 2 SunStone SLE trial enrollment complete; topline results Q4 2026.
- Raised $419.0M gross proceeds from public offerings and debt financing.
- Cash, cash equivalents, and investments of $718.5M as of March 31, 2026.
- Cash runway extended into Q2 2029, including potential $150M milestones.
- Q1 2026 net loss of $81.0M, compared to $33.6M in Q1 2025.
- R&D expenses increased to $60.4M in Q1 2026 from $34.9M in Q1 2025.