Clene narrows losses 34% but cash falls to $5.2M; NDA submission pushed to June 2026

Filed March 17, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 24, 2025 · ~2 min read

Key Changes

• high

  Cash declined 57% to $5.2M at year-end 2025 vs $12.2M prior year, with operating burn of $18.5M annually giving less than four months runway without new financing. Company raised $6M in January 2026 equity offering and secured $8M NIH grant subaward.

  MD&A: Liquidity verify on EDGAR →
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  NDA submission for CNM-Au8 in ALS delayed to June 2026 from prior target of second half 2025, following Type C FDA meeting expected Q1 2026. Biomarker analyses completed December 2025 showed statistically significant NfL declines (p=0.0373) and 73-77% mortality risk reduction.

  MD&A: Clinical Development verify on EDGAR →
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  R&D spending cut 30% to $14.0M in 2025 from $20.1M prior year, driven by program delays, headcount reductions, and new employee compensation cuts. Net loss improved 34% to $26.2M from $39.4M.

  MD&A: Operating Expenses verify on EDGAR →