BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Unveils Progress on CNM-Au8(R), Eyes Potential Fast-Track FDA Approval

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”), is actively advancing its lead drug candidate, CNM-Au8®. The company presented its progress at two key investor events this month, including the Q1 Virtual Investor Summit and the 37th Annual Roth Conference. At both events, Clene’s management discussed the latest achievements with CNM-Au8, a gold nanocrystal-based oral suspension that targets mitochondrial dysfunction and promotes neuronal health. The drug has shown promising results in Phase 2 trials, including significant survival benefits and delayed clinical worsening in ALS patients. Clene is now preparing to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in the second half of 2025, aiming for potential accelerated approval.

As part of its ongoing efforts, Clene is conducting further analyses recommended by the FDA regarding neurofilament light chain (“NfL”) data, a key biomarker for ALS, in its NIH-sponsored Expanded Access Program (“EAP”). The company is collaborating with APST Research GmbH to compare NfL levels in treated ALS patients to historical controls. This analysis aims to determine whether CNM-Au8 can reduce NfL decline and to demonstrate that the rate of NfL change is associated with survival in the NIH-sponsored EAP ALS population, which would further strengthen Clene’s case for regulatory approval.

To view the full articles, visit https://ibn.fm/VZfZB and https://ibn.fm/gwrCB

About Clene Inc.
Clene (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. CNM-Au8® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8 is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN