Clene Inc. is making significant strides in its neurological disease treatment efforts, with promising developments for its CNM-Au8 therapy targeting amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). The company plans to submit a New Drug Application (NDA) under the FDA's Accelerated Approval pathway in the fourth quarter of 2025, backed by compelling survival data and upcoming biomarker analysis.
Recent research has demonstrated that CNM-Au8 significantly improved survival rates among patients with more severe ALS, offering potential hope for a patient population with limited treatment options. Additionally, the company presented Phase 2 extension results for MS that showcase promising neuronal repair and remyelination capabilities.
Financially, Clene reported a modest net loss of $0.8 million for the first quarter, reflecting reduced operational expenses. The company maintains $9.8 million in cash reserves, which is expected to fund operations through the third quarter of 2025.
The potential approval of CNM-Au8 represents a critical advancement in neurodegenerative disease treatment. By targeting mitochondrial function and the NAD pathway while reducing oxidative stress, the investigational therapy could offer a novel approach to improving neuronal cell survival and function.
