secwatch.observer — SEC 8-K summary
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Issuer:     PRECISION BIOSCIENCES INC (DTIL)
CIK:        0001357874
Form:       8-K
Filed at:   2025-11-10T23:59:59+00:00
Accession:  0001628280-25-051168
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Precision BioSciences reports positive Phase 1 PBGENE-HBV data; first human biopsy evidence of viral gene editing
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- Phase 1 ELIMINATE-B trial: 9 patients across 0.2, 0.4, 0.8 mg/kg doses (22 total administrations); no dose-limiting toxicities observed.
- All patients showed HBsAg reductions; Cohort 3 (0.8 mg/kg) had steep early declines with cumulative effect – one patient achieved 64% decrease.
- Paired liver biopsy from Cohort 2 confirmed ARCUS-mediated indel edits in HBV DNA – first direct human evidence of viral gene editing.
- Transient infusion reactions and asymptomatic platelet fluctuations; one reversible Grade 3 AST elevation resolved within 3 days.
- Cohort 3 dosing to complete Q1 2026; next step: Part 2 expansion with optimized regimen and mandatory paired biopsies.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1357874/000162828025051168/0001628280-25-051168-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1357874/000162828025051168/dtil-20251110.htm
  HTML page:      https://secwatch.observer/filing/0001628280-25-051168

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