secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2024-06-18T23:59:59+00:00
Accession:  0001437749-24-020589
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene: CNM-Au8 shows 60% reduced death risk (HR 0.431, p=0.0002) and 28% NfL reduction in ALS trial OLE
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- Survival analysis of CNM-Au8 30 mg vs matched PRO-ACT controls up to 3.5 years: HR 0.431 (95% CI 0.276-0.672, p=0.0002).
- NfL responder subset (n=55) showed average 28% NfL reduction at Week 76 (GMR 0.72, p<0.0001), indicating decreased axonal loss.
- More than 650 patient-years of CNM-Au8 treatment exposure with no identified safety signals.
- Data presented at 2024 ENCALS meeting; includes up to 42 months survival follow-up and 76 weeks biomarker results.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774924020589/0001437749-24-020589-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774924020589/clnn20240611_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-020589

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