secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2024-02-22T23:59:59+00:00
Accession:  0001437749-24-005132
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene reports significant survival benefit with CNM-Au8 in ALS compassionate use programs
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- 68% decreased risk of all-cause mortality vs PRO-ACT matched controls (HR=0.320, p=0.0001).
- 57% decreased risk of all-cause mortality vs ALS Natural History Consortium matched controls (HR=0.433, p=0.0001).
- Data from 256 EAP participants (220 matched); no serious adverse events attributed to CNM-Au8.
- Results support advancing CNM-Au8 to Phase 3 testing in ALS; $45.1M NIH grant for third EAP.
- CNM-Au8 30 mg well-tolerated with up to 4 years of dosing; EAP enrollment in H1 2024 planned.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774924005132/0001437749-24-005132-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774924005132/clnn20240221_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-005132

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