secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2025-08-14T23:59:59+00:00
Accession:  0001437749-25-026690
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 1.01, 2.02, 2.03, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene reports Q2 net loss $7.4M, cash $7.3M, plans NDA submission for CNM-Au8 in ALS by end of 2025
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- Net loss of $7.4M ($0.78 per share) vs $6.8M ($1.06) in Q2 2024; R&D expenses $3.5M, G&A $2.4M.
- Cash and equivalents $7.3M as of June 30, 2025; post-quarter $1.9M equity and $1.5M convertible debt funding provides runway into Q1 2026.
- FDA meetings scheduled: Type C for survival data in Q3 2025, and analysis of NfL biomarker from NIH EAP early Q4 2025.
- Plans to submit NDA for CNM-Au8 in ALS under accelerated approval by end of 2025.
- End-of-Phase 2 Type B meeting with FDA for MS program planned in Q3 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774925026690/0001437749-25-026690-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774925026690/clnn20250611_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-026690

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