secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2022-11-07T23:59:59+00:00
Accession:  0000950170-22-022334
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene reports Q3 net loss $11.0M; ALS survival benefit >90% and MS trial meet endpoints
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- Net loss of $11.0M ($0.17/share) vs net income $28.9M in Q3 2021; R&D $6.4M, G&A $3.6M.
- Cash & securities $16.2M at Sep 30; subsequent $10.8M equity raise and $5.0M loan commitment.
- ALS Healey trial: CNM-Au8 30 mg showed >90% reduction in risk of death at 24 weeks (p=0.028-0.075).
- VISIONARY-MS Phase 2 met primary LCLA endpoint (p=0.056) and secondary mMSFC (p=0.0207).
- Received EU Orphan Drug Designation for CNM-Au8 in ALS; ZnAg COVID trial topline Q4 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000095017022022334/0000950170-22-022334-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000095017022022334/clnn-20221107.htm
  HTML page:      https://secwatch.observer/filing/0000950170-22-022334

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