- Clene Inc. plans to submit a New Drug Application (“NDA”) for lead candidate CNM-Au8® in ALS by year-end 2025.
- FDA meetings scheduled in Q3 2025 will address ALS survival benefit data and MS development plans.
- Neurofilament light biomarker data analysis from the NIH-sponsored EAP program is expected in early Q4 2025.
- The company reported $7.3 million in cash and cash equivalents as of June 30, 2025, together with recent financing extending the company’s cash runway into Q1 2026.
Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), released its second quarter 2025 financial results and provided an update on its clinical programs. The company emphasized progress toward an NDA submission for its lead asset CNM-Au8 in ALS, expected in the fourth quarter of 2025 (https://ibn.fm/PiKqu).
CNM-Au8 is an oral suspension of gold nanocrystals designed to restore neuronal health by improving energy metabolism. Clene recently held a Type C meeting with the U.S. Food and Drug Administration (“FDA”) to align on statistical methodology for analyzing neurofilament light (“NfL”) biomarker changes…
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN
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