Revenue: As of FY2026 Q2, the actual value is USD 90 K, beating the estimate of USD 48.8 K.

EPS: As of FY2026 Q2, the actual value is USD -1.08, missing the estimate of USD -0.368.

EBIT: As of FY2026 Q2, the actual value is USD -12.78 M.

Outlook and Guidance

Clene Inc. expects to submit a New Drug Application (NDA) for CNM-Au8 in ALS under the accelerated approval pathway in early fourth quarter of 2026. The company believes the evidence connecting the magnitude of NfL reduction to clinical benefit data will be critical for a successful review. Clene Inc. anticipates its resources as of June 30, 2026, will provide an operating runway through late fourth quarter 2026.

Cash Flow and Liquidity

As of June 30, 2026, Clene Inc.’s cash and cash equivalents totaled $9.7 million, an increase from $5.2 million as of December 31, 2025. Net cash used in operating activities was - $7.1 million for the six months ended June 30, 2026, an improvement compared to - $9.8 million for the same period in 2025.

Revenue (in thousands)

• Three Months Ended June 30, 2026:
  • Product revenue was $74.
  • Royalty revenue was $16.
  • Total revenue was $90, up from $27 in the same period of 2025.
• Six Months Ended June 30, 2026:
  • Product revenue was $75.
  • Royalty revenue was $30.
  • Total revenue was $105, compared to $108 in the same period of 2025.

Operating Expenses (in thousands)

• Three Months Ended June 30, 2026:
  • Cost of revenue was $36.
  • Research and development expenses were $3,471, a slight decrease from $3,514 in the prior year period.
  • General and administrative expenses were $1,930, down from $2,377 in the prior year period.
  • Total operating expenses were $5,437, compared to $5,891 in the same period of 2025.
• Six Months Ended June 30, 2026:
  • Cost of revenue was $36.
  • Research and development expenses were $3,800, down from $4,995 in the prior year period.
  • General and administrative expenses were $3,677, down from $5,033 in the prior year period.
  • Total operating expenses were $7,513, compared to $10,048 in the same period of 2025.

Loss from Operations (in thousands)

Loss from operations was - $5,347 for the three months ended June 30, 2026, an improvement from - $5,864 in the same period of 2025. For the six months ended June 30, 2026, loss from operations was - $7,408, an improvement from - $9,940 in the same period of 2025.

Other Income (Expense), Net (in thousands)

• Three Months Ended June 30, 2026:
  • Total other expense, net, was - $8,077, significantly higher than - $1,555 in the same period of 2025.
  • This increase was primarily due to a - $4,132 change in fair value of common stock warrant liabilities and a - $3,333 change in fair value of derivative liabilities.
• Six Months Ended June 30, 2026:
  • Total other expense, net, was - $14,107, compared to $1,770 in the same period of 2025.
  • This was largely driven by a - $5,192 change in fair value of common stock warrant liabilities, a - $2,620 change in fair value of derivative liabilities, and a - $4,582 loss on initial issuance of equity.

Net Loss (in thousands)

Clene Inc. reported a net loss of - $13,424 for the three months ended June 30, 2026, compared to a net loss of - $7,419 for the same period in 2025. The net loss for the six months ended June 30, 2026, was - $21,515, compared to - $8,170 for the same period in 2025.

Balance Sheet Highlights (in thousands)

Total assets were $23,041 as of June 30, 2026, up from $18,131 as of December 31, 2025. Total liabilities increased to $47,818 as of June 30, 2026, from $35,723 as of December 31, 2025. Total stockholders’ deficit was - $24,777 as of June 30, 2026, compared to - $17,592 as of December 31, 2025.