secwatch.observer — SEC 8-K summary
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Issuer:     Zenas BioPharma, Inc. (ZBIO)
CIK:        0001953926
Form:       8-K
Filed at:   2025-06-04T23:59:59+00:00
Accession:  0001104659-25-056215
Event type: other_material
Sentiment:  neutral
Materiality: 0.55
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Zenas BioPharma updates pipeline timelines; obexelimab Phase 3 IgG4-RD data due year-end 2025
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- Phase 3 INDIGO trial (IgG4-RD) topline results expected year-end 2025; over 190 patients enrolled.
- Phase 2 MoonStone (RMS) primary endpoint (12-week new T1 Gd+ lesions) data expected early Q4 2025.
- Phase 2 SunStone (SLE) primary endpoint (24-week BICLA) data expected mid-2026.
- Q1 2025 cash of ~$314M; management expects cash runway into Q4 2026.
- Prior Phase 2 IgG4-RD showed 93% ongoing response; SLE optimized exposure effect size 35% vs placebo.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1953926/000110465925056215/0001104659-25-056215-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1953926/000110465925056215/tm2517068d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-056215

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer