Benzinga | Aug 11, 2021 07:19AM EDT

Clene Reports 2 New Leases To Materially Expand Manufacturing Capacity Of Its CNM-Au8

Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology to treat energetic failure, today announced the completion of two lease agreements that will more than quadruple the company's manufacturing capacity for its lead asset, CNM-Au8(r), a gold nanocrystal suspension.

The first of these agreements is a ten (10) year lease for a manufacturing space located at 100 Chesapeake Boulevard, Elkton, Maryland. The 74,210 sq. ft. building will be redeveloped to support Clene's proprietary electrochemical processes for manufacturing CNM-Au8 and will materially increase its manufacturing capacity in advance of the expected H1 2022 data release from its Phase 3 registration trial evaluating CNM-Au8 as a treatment for amyotrophic lateral sclerosis (ALS). Clene expects redevelopment to commence within weeks and plans on partial occupancy with a few months and Phase 1 of production to be underway in the first half of 2022.

Simultaneously, Clene entered into a seven (7) year lease to further expand its existing manufacturing capacity at its site located at 500 Principio Parkway West, North East, Maryland to a total of 32,229 sq. ft. This expansion enables additional R&D and manufacturing capacity for CNM-Au8 and further positions Clene to address its potential long-term needs in its efforts to treat the neurodegenerative diseases of ALS, multiple sclerosis and Parkinson's disease.

Rob Etherington, Chief Executive Officer and President of Clene commented, "All emerging pharmaceutical companies face the delicate balance of striving to align manufacturing capacity with the rigors of regulatory approvals and ultimately patient needs. As we move towards a readout from our registration trial in patients with ALS, we concluded this was the most appropriate time to undertake this expansion of our manufacturing capabilities. This will help enable that we are well prepared to meet the urgent unmet needs of ALS patients should CNM-Au8 receive regulatory approval."

Mr. Etherington continued, "Clene is greatly appreciative of all the efforts behind the scenes by many parties to help facilitate this critical step in Clene's evolution in an expeditious and efficient manner. We would like to thank them for helping us advance towards our goal of transforming the treatment of neurodegenerative disease."

Mark Mortenson, Chief Science Officer of Clene commented, "Completion of these lease agreements could not have been accomplished without the tireless work of our landlord, the Town of Elkton, Cecil County and the State of Maryland. The foresight, professionalism and commitment by the leadership teams in the town, the county and the state were wonderful to experience and are a perfect example of the teamwork that abounds in the State of Maryland."

On July 27, 2021, Governor Larry Hogan and Commerce Secretary Kelly Schulz visited Clene's current manufacturing site and joined a helicopter ride to view Clene's new Elkton, Maryland manufacturing site from the air.