Clene to Submit Briefing Book to FDA for Accelerated Approval of CNM-Au8® in ALS

SALT LAKE CITY, July 11, 2024 – Clene Inc. (Nasdaq: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a biopharmaceutical firm at the clinical stage, have announced their intention to submit a briefing book to the U.S. Food and Drug Administration (FDA) by July 13. This submission is in preparation for a granted Type C interaction scheduled for the third quarter of 2024. The primary objective of this interaction is to gain insights from the FDA on the potential pathway for the submission of a new drug application (NDA) for CNM-Au8® as a treatment for amyotrophic lateral sclerosis (ALS) through the accelerated approval pathway.

The briefing book that Clene is preparing includes new post-hoc analyses of data from previously completed clinical studies. This document is crafted to address comments from the FDA during a prior meeting in December 2023, where Clene received initial feedback on the likelihood of accelerated approval. The briefing book consists of additional analyses focusing on the reduction of neurofilament light (NfL) biomarkers, a more comprehensive set of survival and functional benefit data, and further evidence supporting CNM-Au8’s potential mechanism of action. Clene is confident that these analyses collectively bolster the case for accelerated approval, leveraging NfL reduction as a surrogate endpoint.

Furthermore, Clene's document responds to the FDA’s request for additional information concerning the correlation between CNM-Au8’s proposed mechanism of action and the reduction in NfL. It also includes data on the relationship between observed NfL reductions and improved clinical outcomes among ALS patients, particularly in terms of survival. These new data analyses are slated for public presentation later in 2024.

Following the Type C interaction, Clene plans to publicly disclose the topline feedback from the FDA.

About Clene:
Clene Inc. (Nasdaq: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc. are focused on enhancing mitochondrial health and preserving neuronal function to treat neurodegenerative diseases such as ALS, Parkinson’s disease, and multiple sclerosis. CNM-Au8® is an investigational, first-of-its-kind therapy designed to enhance the survival and function of central nervous system cells by targeting mitochondrial function and the NAD pathway while mitigating oxidative stress. CNM-Au8 is a registered trademark of Clene Nanomedicine, Inc., based in Salt Lake City, Utah, with research and development and manufacturing operations in Maryland.