---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-007543"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2024-03-13T23:59:59+00:00"
generated_at: "2026-06-04T22:29:25.250549+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Clene posts FY2023 net loss $49.5M; FDA discussions for CNM-Au8 accelerated approval ongoing

## Summary
- Net loss $49.5M ($0.47/share) vs $29.9M ($0.46/share) in FY2022; cash $35.0M, expected to fund ops into Q4 2024.
- R&D expenses $26.7M (down from $31.9M); G&A $14.4M (down from $16.9M).
- FDA Q4 2023 meeting: initial NfL biomarker data insufficient for accelerated approval; planning supplemental data submission in 2024, potential NDA.
- HEALEY ALS OLE: CNM-Au8 reduced plasma NfL at 76 wks (p=0.023) and 60% decreased risk of all-cause mortality (>18 months, p=0.0167).
- EAP survival: 68% and 57% reduced mortality risk vs historical controls (p=0.0001); MS trial showed vision and cognition improvements through 35 months.

## SEC filing metadata
- accession: 0001437749-24-007543
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2024-03-13T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774924007543/0001437749-24-007543-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774924007543/clnn20231022_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-007543
- JSON: https://secwatch.observer/filing/0001437749-24-007543.json
- Plain text: https://secwatch.observer/filing/0001437749-24-007543.txt

## Key facts
- Earnings Releases
  Clene Inc. reported financial results for the year ended December 31, 2023.
  - Period: the year ended December 31, 2023
  - Result: reported results
  source text: On March 13, 2024, Clene Inc. (the “Company”) issued a press release announcing its full year operating and financial results for its year ended December 31, 2023.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1822791/000143774924007543/0001437749-24-007543-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.