Clene Secures $10 Million Debt Facility to Advance ALS Drug Development

Clene Inc. (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, has secured a $10 million debt facility to advance the development of its lead drug candidate CNM-Au8 for the treatment of amyotrophic lateral sclerosis (ALS). This financial move is significant as it provides Clene with the necessary resources to generate additional data required by the U.S. Food and Drug Administration (FDA) to support a potential new drug application through an accelerated regulatory pathway.

The new debt facility serves multiple purposes for Clene. It allows the company to pay off an existing higher interest rate loan and finance operations to collect crucial data from expanded access programs. This data will complement existing clinical study results, strengthening Clene's position as it seeks approval for CNM-Au8 in ALS treatment.

Rob Etherington, CEO and President of Clene, emphasized the importance of this financial arrangement, stating that it provides the company with an extended cash runway to meet the FDA's data requirements. The extended interest-only period associated with the new debt facility offers Clene additional financial flexibility during this critical phase of drug development.

CNM-Au8, Clene's investigational first-in-class therapy, targets mitochondrial function and the NAD pathway while reducing oxidative stress. The company's focus on improving mitochondrial health and protecting neuronal function positions it at the forefront of neurodegenerative disease research, including ALS, Parkinson's disease, and multiple sclerosis.

This development is particularly significant for the ALS community and investors in the biotechnology sector. ALS, a progressive neurodegenerative disease, currently has limited treatment options. The potential for an accelerated approval pathway for CNM-Au8 could bring a new therapeutic option to patients more quickly. For investors, this news underscores Clene's progress in its clinical pipeline and its ability to secure funding for critical research and development activities.

As Clene advances its efforts to gather additional data and pursue regulatory approval for CNM-Au8, the biotechnology industry will be watching closely. The outcome of this process could have far-reaching implications for ALS treatment and set a precedent for future drug developments in the neurodegenerative disease space.