secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2023-11-07T23:59:59+00:00
Accession:  0001437749-23-030493
Event type: earnings
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene Q3 net loss narrows to $2.4M; ALS drug shows survival benefit, receives $45.1M NIH grant
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- Net loss $2.4M ($0.02/sh) vs $11.0M ($0.17/sh) in Q3 2022; R&D expense $6.0M.
- Cash $42.1M as of Sep 30, 2023, expected to fund operations into Q3 2024.
- CNM-Au8 in ALS: 19.3-month median survival benefit in RESCUE-ALS OLE; 49% decreased death risk in HEALEY vs PRO-ACT historical controls.
- Awarded $45.1M NINDS/NIH grant for expanded access of CNM-Au8 in ALS.
- FDA regulatory discussion planned for Q4 2023 to accelerate ALS submission path.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774923030493/0001437749-23-030493-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774923030493/clnn20230829_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-23-030493

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