secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2025-03-12T23:59:59+00:00
Accession:  0001437749-25-007120
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene reports CNM-Au8 survival benefit in ALS: median survival up 198 days vs control
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- Median survival 951 days for CNM-Au8 30 mg vs 753 days for Regimen A comparator, a 198-day (6.5-month) gain.
- Covariate-adjusted RMST improvement of 124 days (p=0.045); sensitivity analyses including NfL and TRICALS confirm robustness.
- In moderate-to-severe ALS (NfL>33, TRICALS -6.5 to -2.5), median survival gain 11.9 months; mortality risk reduced 44% (p=0.006).
- RESTORE-ALS-eligible subset: median survival 1079 vs 628 days (451-day gain, 14.8 mo), mortality risk reduced 49% (p=0.006).
- Clene to discuss findings with FDA; Phase 3 RESTORE-ALS study launch targeted for mid-2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774925007120/0001437749-25-007120-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774925007120/clnn20250311_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-007120

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