secwatch.observer — SEC 8-K summary
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Issuer:     Hepion Pharmaceuticals, Inc. (HEPA)
CIK:        0001583771
Form:       8-K
Filed at:   2022-01-10T23:59:59+00:00
Accession:  0001104659-22-002406
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Hepion provides pipeline update: Rencofilstat Phase 2a NASH trial positive; Phase 2b and HCC trials underway
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- Phase 2a NASH trial (AMBITION) met safety endpoints; showed ALT and Pro-C3 reductions over 28 days.
- Cash $98.7M as of Sept 30, 2021; 76.2M shares outstanding.
- Phase 2b NASH trial (ASCEND-NASH) to randomize 336 subjects across 75, 150, 225 mg doses for 12 months.
- Phase 2a HCC trial (HEPA-RENCOFILSTAT-209) launched with Simon 2-stage design; primary endpoint disease control rate.
- AI-POWR platform predicts responders; transcriptomics misclassification error <5% in Phase 2a analysis.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1583771/000110465922002406/0001104659-22-002406-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1583771/000110465922002406/tm222379d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-22-002406

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