Clene Announces Peer-Reviewed Publication Describing CNM-Au8 Catalytic Neuroprotective Mechanism of Action

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Novel catalytic mechanism of CNM-Au8 reveals its promise as a versatile new treatment to address multiple assaults on neuronal health in neurodegenerative diseases

SALT LAKE CITY, Sept. 28, 2023 (GLOBE NEWSWIRE) — Clene Inc. (Nasdaq: CLNN) through its wholly owned subsidiary Clene Nanomedicine Inc. (collectively, “Clene”), today announced the publication of a scientific paper describing the catalytic mechanism of action of its investigational drug CNM-Au8® in the journal Small, a top nanotechnology-focused journal at the interface of materials science, chemistry, physics, engineering, medicine, and biology. The publication, titled “A Mechanism Underpinning the Bioenergetic Metabolism-Regulating Function of Gold Nanocatalysts,” is co-authored by lead investigators at the University of South Carolina and Clene.

This study demonstrates that the robust neuroprotective properties of CNM-Au8 can be attributed to its therapeutic catalytic activity. When neurons were exposed to toxins that induce neuronal death, CNM-Au8 treatment promoted the survival of cells and preservation of neurite networks. To unravel the mechanisms underpinning the neuroprotective function of CNM-Au8, Professor Hui Wang, Ph.D., and his graduate students at the University of South Carolina conducted detailed studies focused on characterizing CNM-Au8-mediated catalytic reactions to determine how CNM-Au8 effectively regulates cellular health and metabolism. Neuronal deficiencies have been associated with cell death in multiple types of neurodegenerative disease, as documented by a growing body of scientific literature. Because of the unique mechanism of CNM-Au8 and the wide applicability of its neuroprotective activities, Clene’s lead asset is being investigated in the clinic as a potential first-in-class drug for the treatment of multiple neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS) and Parkinson’s disease (PD).

“The insights gained from this research provide, for the first time, important guiding principles for the rational design of a new class of gold-based catalytic therapeutic agents with energy metabolism-regulating and neuroprotective functions,” said Professor Wang, Ph.D., Department of Chemistry and Biochemistry, University of South Carolina and a senior co-author of the paper.

Karen S. Ho, Ph.D., VP of Translational Medicine at Clene and senior co-author, added, “CNM-Au8 represents a new way to address the multiple assaults on neuronal health that occur during the course of neurodegenerative diseases. Its catalytic activity strikes at a core metabolic deficiency and enables neurons to survive and function in a challenging environment that would otherwise lead to cell death. The remarkable promise of CNM-Au8 to address multiple different neurodegenerative diseases using this catalytic mechanism is truly exciting.”

The publication is available via Open Access at https://onlinelibrary.wiley.com/doi/10.1002/smll.202304082.

About Clene
Clene Inc. (Nasdaq: CLNN) (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 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 or follow us on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created by those laws. Clene’s forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, beliefs, intentions or strategies regarding our future operations. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

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Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
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LifeSci Advisors
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