Clene receives $3 million loan

$3 million, 60-month loan to support the purchase of capital equipment at a new 75,000 square foot facility in Elkton, Maryland to manufacture Clene’s lead drug candidate, CNM-Au8®, for the treatment of ALS

SALT LAKE CITY, May 19, 2022 (GLOBE NEWSWIRE) — Clene Inc. (CLNN) together with its subsidiaries “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the… Treatment of Neurodegenerative Diseases, announced today that the Maryland Board of Public Works has closed a $3 million loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

This non-dilutive capital equipment purchase loan will support the expansion of Clene’s Cecil County, Maryland operations into a new commercial manufacturing facility for the production of its lead drug candidate, CNM-Au8®, a gold nanocrystal suspension. The purchased capital goods secure the loan. This extension is consistent with Clene’s anticipation of the potential commercialization of CNM-Au8 as a treatment for amyotrophic lateral sclerosis (ALS). Clene expects top-line data from a pivotal Phase 2/3 study, the HEALEY ALS Platform study, evaluating CNM-Au8 in ALS patients in Q3 2022.

“These funds allow Clene to accelerate the build-out of our infrastructure without the need for dilutive capital as we work toward commercial-scale manufacturing of CNM-Au8,” said Mark Mortenson, Founder and Chief Scientific Officer of Clene Nanomedicine. “We appreciate the continued financial support from the State of Maryland, the City of Elkton and Cecil County. This loan is another great example of public-private partnerships supporting continued investment in activities that create high-quality pharmaceutical manufacturing jobs, specifically the manufacture of nanotherapeutics at Clene, which have the potential to transform the lives of people living with neurodegenerative diseases to enhance.”

When fully developed and operational, Clene’s 75,000 square foot facility is expected to create hundreds of new jobs in Cecil County in a federally qualified opportunity zone in Elkton, Maryland.

About CNM-Au8®, a gold nanocrystal suspension
CNM-Au8 is an oral suspension of gold nanocrystals designed to restore neuron health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy-producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-related stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.

About Clene
Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah with R&D and manufacturing facilities in Maryland. For more information, please visit https://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 governed by the “safe haven” provisions created by those acts became. Clene’s forward-looking statements include, but are not limited to, statements about our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding our future business. In addition, all statements relating to forecasts, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements represent our views as of the date of this press release and involve a number of estimates, risks and uncertainties. We anticipate that subsequent events and developments will change our views. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date they are made, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Accordingly, forward-looking statements should not be relied upon as reflecting our views as of a later date. Our actual results or performance could differ materially from those expressed or implied in these forward-looking statements due to a number of known and unknown risks and uncertainties. Factors that could cause actual results to differ include our significant reliance on the successful commercialization of our drug candidates, should they be approved in the future; 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 by regulators; our ability to achieve commercial success for our drug candidates, if approved; our ability to obtain additional funds for operations; the impact of inflation; the impact of staff and material shortages; the possibility that we may be adversely affected by other economic, business and/or competitive factors; and other risks and uncertainties discussed under “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 say “we believe” and similar statements reflect our beliefs and opinions on the subject at hand. These statements are based on information available to us as of the date of this press release and while we believe such information provides a reasonable basis for such statements, such information may be limited or incomplete and our statements should not be read as such , suggesting that we have conducted an extensive investigation or review of all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to place undue reliance on these statements. All information in this press release is as of the date of this press release. The information contained on any website referenced herein is not a part of this press release and should not be considered a part of this press release.

The information contained on any website referenced herein is not a part of this press release and should not be considered a part of this press release.

investor contact
John Woolford
Managing Director Westwicke
[email protected]
+1-443-213-0506

media contact
Erica Fiorini, Ph.D., or David Schull
Russo Partners, LLC
[email protected]
[email protected]
+1-212-845-4253

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