Clene Announces Peer-Reviewed Publication Describing CNM-Au8 Brain Target Engagement In Neurodegenerative Diseases

• Journal of Nanobiotechnology publication describes results from the successful Phase 2 REPAIR clinical studies that measured changes in brain energy metabolites in multiple sclerosis and Parkinson’s disease with CNM-Au8® treatment
• Data show significant increase in brain NAD+/NADH ratio from baseline, the studies’ primary endpoint, following 12 weeks of daily oral dosing of CNM-Au8
• CNM-Au8 treatment resulted in favorable modulation of additional brain energy metabolites that have been shown to be dysregulated in neurodegenerative diseases

SALT LAKE CITY, Dec. 14, 2023 (GLOBE NEWSWIRE) —  Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) 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), Parkinson’s disease and multiple sclerosis (MS), today announced the publication of a peer-reviewed article describing brain target engagement by CNM-Au8®, the company’s lead drug candidate. CNM-Au8 is an orally-delivered suspension of clean-surfaced, catalytically-active gold nanocrystals shown to have neuroprotective and neuroreparative properties in multiple preclinical models of neurodegenerative disease.

The paper, entitled, “Evidence of Brain Target Engagement in Parkinson’s Disease and Multiple Sclerosis by the Investigational Nanomedicine, CNM-Au8, in the REPAIR Phase 2 Clinical Trials,” was published in the Journal of Nanobiotechnology, a Springer Nature journal that communicates significant advances in the fields of medicine and biology with an emphasis in their interface with nanoscale sciences. The article is available via Open Access at: https://jnanobiotechnology.biomedcentral.com/articles/10.1186/s12951-023-02236-z.

Co-authored by physician scientists from the University of Texas Southwestern (UTSW) Medical Center and Clene, the publication describes results from two Phase 2a clinical trials, REPAIR-PD and REPAIR-MS. Key brain metabolites, such as NAD+ and NADH, that are involved in neuronal energy production, utilization, and maintenance, were measured for changes from baseline with daily, oral treatment of CNM-Au8 over 12 weeks. The studies’ primary endpoint, the change in brain ratio of the metabolites NAD+ to NADH from baseline, was met with statistical significance (p < 0.05) by a demonstrated 10.4% increase. Statistically significant treatment effects were also observed for secondary and exploratory imaging outcomes, including favorable effects on brain ATP (adenosine triphosphate) levels and phosphorylation potential across both cohorts.

Dr. Benjamin Greenberg, Head of Medical at Clene, said, “We believe the 10.4% increase in brain NAD+/NADH ratio to be clinically significant. Other groups have shown significant deficits in brain energy metabolites associated with neurodegenerative disease. For example, brain levels of NAD are deficient in Parkinson’s disease, and deficits in brain ATP levels correlate with the Expanded Disability Status clinical scale for multiple sclerosis. Even in healthy aging, the human brain’s NAD+/NADH decreases at a rate of loss of approximately half a percent per decade. Elevation of brain NAD+/NADH levels to many times the rate of loss observed in healthy aging is a significant and very promising effect.”

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 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 or follow us on Twitter and LinkedIn.

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, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. 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. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. 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. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. 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.