secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2026-05-14T12:02:05+00:00
Accession:  0001437749-26-016881
Event type: earnings
Sentiment:  positive
Materiality: 0.85
Item codes: 1.01, 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene plans Q3 2026 NDA submission for CNM-Au8 ALS; Q1 net loss $8.1M, cash $5.9M
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- FDA Type C meeting confirmed data may support NDA under accelerated approval for ALS; submission planned Q3 2026.
- May 2026: Amended $10M convertible debt; maturity extended to Aug 2027, monthly payments cancelled.
- Q1 2026 net loss $8.1M ($0.69/share) vs $0.8M loss in Q1 2025; R&D down, other expense up from financing.
- Cash $5.9M at Mar 31; with $7M May offering and $7M warrant exercises, runway expected into 2027.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774926016881/0001437749-26-016881-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774926016881/clnn20260116_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-016881

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