Clene Inc. Advances CNM-Au8 NDA Submission for ALS Treatment with Extended Financial Runway

Clene Inc. (NASDAQ: CLNN) has reported its second quarter 2025 financial results while advancing preparations for a New Drug Application submission for its lead candidate CNM-Au8 in amyotrophic lateral sclerosis treatment. The company plans to submit the NDA by year-end 2025, marking a significant milestone in addressing the unmet medical needs of ALS patients. This development is particularly important given the limited treatment options currently available for this progressive neurodegenerative disease.

The company has scheduled FDA meetings in the third quarter of 2025 to discuss ALS survival benefit data and multiple sclerosis development plans. These regulatory interactions are crucial for aligning on the path forward and ensuring the drug's potential benefits are properly evaluated. Additionally, neurofilament light biomarker data analysis from the NIH-sponsored Expanded Access Program is expected in early fourth quarter 2025, which could provide further evidence of CNM-Au8's therapeutic effects.

Financially, Clene reported $7.3 million in cash and cash equivalents as of June 30, 2025, with recent financing extending the company's cash runway into the first quarter of 2026. This financial stability is essential for supporting the NDA submission process and ongoing clinical development activities. The extended runway provides the company with sufficient resources to navigate the regulatory pathway without immediate funding concerns.

CNM-Au8 represents an innovative approach to treating neurodegenerative diseases by targeting mitochondrial health and neuronal function. As an oral suspension of gold nanocrystals, the drug is designed to restore neuronal health through improved energy metabolism. The recent Type C meeting with the FDA focused on statistical methodology for analyzing neurofilament light biomarker changes, which could serve as important validation of the treatment's mechanism of action.

The progress toward NDA submission and the extended financial runway position Clene to potentially bring a new treatment option to ALS patients, addressing a significant unmet medical need in the neurodegenerative disease space.