Clene Inc. Reports 83% Revenue Decline in Q3 2025, Faces Financial Challenges

Clene Inc. reported its financial results for the third quarter of 2025, revealing a total revenue of $15,000, a significant decrease of 83% compared to $87,000 in the same period last year. For the nine months ending September 30, 2025, the company generated $123,000 in revenue, down 51% from $251,000 in the prior year. The decline in revenue was attributed to a drop in product sales and royalty income, primarily from its dietary supplement products, which are marketed through its subsidiary, dOrbital, Inc., and under a license agreement with 4Life Research LLC.

Operating expenses for the third quarter were $5.7 million, a 28% reduction from $7.9 million in the same quarter of 2024. The decrease was driven by lower research and development costs, which fell by 21% to $3.5 million, and a 37% reduction in general and administrative expenses to $2.2 million. For the nine-month period, total operating expenses were $15.7 million, down 36% from $24.7 million in the previous year. Despite these reductions, Clene reported a net loss of $8.8 million for the quarter, compared to a loss of $8.0 million in the same quarter of 2024, and a net loss of $16.9 million for the nine months, down from $25.9 million in the prior year.

In terms of operational developments, Clene's accumulated deficit increased to $299.1 million as of September 30, 2025, up from $282.1 million at the end of 2024. The company had cash and cash equivalents of $7.9 million, a decrease from $12.2 million at the end of the previous year. Clene's net cash used in operating activities was $13.7 million for the nine months ended September 30, 2025, compared to $16.5 million for the same period in 2024. The company has indicated that it will need to secure additional financing to sustain its operations and continue its clinical development programs.

Strategically, Clene is focused on advancing its clinical-stage drug candidates, particularly CNM-Au8, which is being developed for the treatment of neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). The company has received guidance from the FDA regarding an accelerated approval pathway for CNM-Au8 in ALS and plans to submit a New Drug Application (NDA) in early 2026. Clene is also preparing for a confirmatory Phase 3 trial, RESTORE-ALS, contingent on funding. The company has implemented cost-saving measures, including reducing employee compensation and delaying certain research and development programs, to manage its financial position.

Looking ahead, Clene Inc. anticipates that it will continue to incur losses as it advances its clinical programs and seeks regulatory approvals. The company is exploring various funding options, including equity financing and collaboration arrangements, to meet its financial needs. However, there is substantial doubt about its ability to continue as a going concern without securing additional financing in the near term.