CLENE INC C/WTS 30/12/2025 (TO PUR COM) | 8-K: FY2025 Q3 Revenue: USD 15 K

Revenue: As of FY2025 Q3, the actual value is USD 15 K.

EPS: As of FY2025 Q3, the actual value is USD -0.85.

EBIT: As of FY2025 Q3, the actual value is USD -5.039 M.

Cash Flow

• Cash and cash equivalents totaled $7.9 million as of September 30, 2025, compared to $12.2 million as of December 31, 2024. Clene expects its cash and cash equivalents, together with $1.2 million raised subsequent to September 30, 2025, will be sufficient to fund operations into the second quarter of 2026.

Operating Expenses

• Research and development expenses were $3.5 million for the quarter ended September 30, 2025, compared to $4.5 million for the same period in 2024. The decrease was primarily due to cost-saving initiatives and reduced manufacturing expenses.
• General and administrative expenses were $2.2 million for the quarter ended September 30, 2025, compared to $3.4 million for the same period in 2024, mainly due to decreases in legal fees, public and investor relations expenses, and personnel expenses.

Net Loss

• Clene reported a net loss of $8.8 million, or $0.85 per share, for the quarter ended September 30, 2025, compared to a net loss of $8.0 million, or $1.22 per share, for the same period in 2024.

Other Expenses

• Total other expense was $3.1 million for the quarter ended September 30, 2025, compared to $0.2 million for the same period in 2024. The increase was primarily related to losses from changes in fair value of common stock warrant liabilities and derivative liabilities.

Outlook / Guidance

• Clene plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathway and expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026.