Clene Inc reported full year 2025 financial results and recent operating highlights, showing a narrower net loss and strategic clinical progress for its experimental therapy CNM‑Au8, according to the company. The late clinical‑stage biopharmaceutical firm recorded a net loss of $26.2 million for 2025, or $2.65 per share, reduced from a $39.4 million loss the prior year as research and development and general and administrative expenses declined. Total revenues remained minimal at $200,000, reflecting the company’s focus on clinical programs rather than commercial products. Cash and cash equivalents stood at $5.2 million as of December 31, 2025, compared to $12.2 million at the end of 2024, with funding supplemented by an oversubscribed registered direct offering exceeding $28 million that is expected to support operations into 2027.
Clene highlighted ongoing work to advance its lead asset CNM‑Au8, an investigational therapy intended to improve mitochondrial health and protect neuronal function in neurodegenerative diseases such as amyotrophic lateral sclerosis and multiple sclerosis. The company expects an in‑person Type C meeting with the U.S. Food and Drug Administration by the end of the first quarter of 2026 to review recent biomarker and survival data and anticipates filing a new drug application for CNM‑Au8 under an accelerated approval pathway by the end of June 2026. Biomarker analyses completed in December 2025 showed statistically significant reductions in neurodegeneration markers linked to improved survival, and safety data across more than 1,100 patient‑years showed no significant safety concerns.
Clene also noted plans to initiate a confirmatory Phase 3 trial in ALS and pursue further Phase 3 studies in multiple sclerosis, positioning its clinical programs for key regulatory milestones in 2026.
