Clene (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., today released its third quarter 2023 financial results and provided recent operating highlights for its ALS clinical program. Among the highlights, the company reported statistically significant improved survival benefit of 19.3 months and significantly delayed clinical worsening in patients treated with CNM-Au8(R) in the RESCUE ALS open-label extension trial. “We are pleased to be approaching a meaningful regulatory discussion with the U.S. Food and Drug Administration (‘FDA’) later in the fourth quarter to elucidate key next steps in our ALS regulatory submission of CNM-Au8,” said Rob Etherington, president and CEO of Clene. “We are hopeful that the consistent survival, delayed time to clinical worsening and strong safety profile with CNM-Au8 treatment from two phase 2 independent trials is sufficiently compelling for FDA to consider an accelerated path forward. The unmet need remains high for treatments to improve and extend life for patients living with this highly debilitating and rapidly progressive condition.”
To view the full press release, visit https://ibn.fm/h2nuN
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(R) 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(R) 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
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