secwatch.observer — SEC 8-K summary
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Issuer:     Entera Bio Ltd. (ENTXW)
CIK:        0001638097
Form:       8-K
Filed at:   2023-03-31T23:59:59+00:00
Accession:  0001178913-23-001271
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Entera Bio posts 2022 net loss of $13.1M; cash runway into Q3 2024; FDA accepts Type D meeting for EB613
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- Net loss $13.1M ($0.45/share) vs $12.2M ($0.47/share) in 2021; revenues $134K, down from $571K.
- Cash and equivalents $12.3M; expects runway into Q3 2024, excluding Phase 3 EB613 funding.
- FDA accepted Type D meeting to confirm placebo-controlled Phase 3 design with TH BMD endpoint for EB613.
- EB613 (oral teriparatide) positioned as first daily tablet anabolic therapy for osteoporosis; Phase 2 results positive.
- New formulation EB612 (PTH(1-34) for hypoparathyroidism) entering Phase 1 PK study, targeting Phase 2 in 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1638097/000117891323001271/0001178913-23-001271-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1638097/000117891323001271/form8k.htm
  HTML page:      https://secwatch.observer/filing/0001178913-23-001271

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