secwatch.observer — SEC 8-K summary
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Issuer:     Zenas BioPharma, Inc. (ZBIO)
CIK:        0001953926
Form:       8-K
Filed at:   2026-08-13T11:05:49+00:00
Accession:  0001104659-26-095437
Event type: earnings
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 5.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Zenas Q2 net loss $111.5M; FDA accepts obexelimab BLA, PDUFA May 27, 2027
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- Q2 2026 net loss $111.5M vs $52.2M; revenue $1.0M from Tenacia milestone; R&D $62.9M, G&A $15.7M, AIPR&D $30.0M.
- Cash $673.9M at June 30; runway through Q2 2029 assuming $75M Royalty Pharma milestone and $75M Pharmakon draw.
- FDA accepted obexelimab BLA for IgG4-RD; PDUFA May 27, 2027; MAA to EMA expected H2 2026.
- Phase 3 INDIGO: 56% flare risk reduction (HR 0.44, p=0.0005); 73.2% flare-free vs 45.4% placebo.
- CFO Jennifer Fox to become Strategic Advisor to Board Chair Sept 30; Joe Farmer named Principal Financial Officer.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1953926/000110465926095437/0001104659-26-095437-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1953926/000110465926095437/tm2622871d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-095437

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