secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2024-08-07T23:59:59+00:00
Accession:  0001437749-24-025020
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene Q2 net loss narrows to $6.8M; ALS survival data shows 60% risk reduction vs controls
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- Net loss of $6.8M ($1.06 per share) vs $25.1M ($5.84) in Q2 2023; cash and equivalents $21.7M.
- R&D expenses fell to $4.2M from $6.6M, partly due to NIH grant reimbursement for ALS expanded access program.
- CNM-Au8 30mg showed ~60% decreased risk of death vs matched PRO-ACT controls up to 3.5 years (HR 0.431, p=0.0002).
- Submitted briefing book to FDA for Type C meeting in Q3 2024 to discuss accelerated approval pathway for CNM-Au8 in ALS.
- Completed 1-for-20 reverse stock split to regain Nasdaq $1.00 minimum bid price compliance.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774924025020/0001437749-24-025020-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774924025020/clnn20240522_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-025020

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