A Pivotal Year for Clene’s Neurological Treatment Pipeline

Clene Inc. finds itself at a critical juncture. The biotechnology firm is approaching major regulatory milestones for its lead drug candidate, CNM-Au8, just as its financial runway shows signs of tightening.

Financial Position and Strategic Cost Management

The company’s mid-August earnings release for the second quarter of 2025 presented a dual narrative. While the net loss expanded to $7.4 million, or $0.78 per share, from $6.8 million in the same quarter last year, Clene demonstrated significant operational discipline. A strategic review led to a notable reduction in expenditures:

• Research and development costs decreased to $3.5 million from $4.2 million
• General and administrative expenses were lowered to $2.4 million from $3.3 million

These cuts were achieved through the discontinuation of certain study programs and workforce adjustments. Despite this fiscal prudence, liquidity remains a primary concern. As of the end of June, cash and equivalents stood at a modest $7.3 million. However, subsequent capital-raising efforts secured an additional $3.4 million, extending the company’s financial runway into the first quarter of 2026. This timing is crucial, as it aligns with anticipated key regulatory decisions.

The Regulatory Path for ALS Treatment

The core investment thesis hinges on upcoming regulatory events. Clene is targeting a New Drug Application (NDA) submission for CNM-Au8 as a treatment for amyotrophic lateral sclerosis (ALS) by the end of 2025. The path to this submission will be shaped by two critical meetings with the U.S. Food and Drug Administration (FDA) scheduled for the third quarter:

Should investors sell immediately? Or is it worth buying Clene?

• A Type C meeting to review survival data from the HEALEY-ALS pivotal study
• A Type B meeting to discuss the development pathway for multiple sclerosis (MS)

A separate biomarker analysis of neurofilament data, expected in the fourth quarter, could prove decisive. The FDA’s reception of this data is likely to determine the company’s future trajectory.

Progress in Multiple Sclerosis Indication

Beyond ALS, Clene’s drug candidate has shown promise in treating multiple sclerosis. Data presented at the American Academy of Neurology (AAN) annual meeting from the VISIONARY-MS study indicated potential signals of neuronal repair and remyelination. Improvements in cognitive and visual function among patients treated with CNM-Au8 provide the foundation for a planned Phase 3 clinical program.

The upcoming Type B meeting with regulators will be instrumental in determining whether cognitive improvement can serve as the primary endpoint in this crucial late-stage trial.

This year represents the most significant period in Clene’s corporate history. The company’s ability to achieve a regulatory breakthrough in either ALS or MS is paramount. A successful NDA filing remains the immediate and primary objective; any other outcome would pose a substantial setback for the company’s already delicate financial position.