secwatch.observer — SEC 8-K summary
======================================

Issuer:     BIOVIE INC. (BIVI)
CIK:        0001580149
Form:       8-K
Filed at:   2022-09-07T23:59:59+00:00
Accession:  0001520138-22-000390
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioVie NE3107 Phase 2 trial: 82% of mild AD patients improved ADAS-Cog12 by 2.6 pts (p=0.0046); Phase 3 50% enrolled
--------------------------------------------------------------------------------

- 23-patient open-label Phase 2: 82% of mild AD patients (MMSE>=20) showed mean 2.6-point ADAS-Cog12 improvement (p=0.0046); no drug-related adverse events.
- Reduction in TNF alpha significantly correlated with cognitive improvement (R=0.70, p=0.0077).
- Phase 3 AD trial (NCT04669028) 50% enrolled of 316 target; DSMB review later in 2022 may adjust sample size up to 400; topline expected mid-2023.
- Phase 2 Parkinson's trial (NCT05083260) enrolling 40 patients; data readout by end of 2022; no drug-related AEs seen yet.
- Phase 2b BIV201 trial in refractory ascites enrollment delayed by COVID; data readout now anticipated by mid-2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1580149/000152013822000390/0001520138-22-000390-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1580149/000152013822000390/bivi-20220907_8k.htm
  HTML page:      https://secwatch.observer/filing/0001520138-22-000390

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