
Maryland offers loan to Clene despite ALS trial bumps
Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.
The Maryland Board of Public Works has finalized a $3 million, 60-month 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 loan will be going toward equipment purchases that will support the expansion of Clene’s operations in Cecil County, MD. Clene’s new 75,000-square-foot commercial manufacturing facility will produce its lead drug candidate, CNM-Au8, a gold nanocrystal suspension meant to treat ALS. The purchased capital equipment will secure the loan.
The company anticipates the potential commercialization of CNM-Au8and, their candidate in ALS patients, to present topline data in the third quarter of 2022 from a Phase II/III study.
However, Clene has put stock in its candidate before, with not-so-positive results. Clene reported Phase II as its candidate, saying the compound did not reach statistical significance on the primary or secondary endpoints. And though Clene claimed to see positive signals in exploratory endpoints that could support an NDA, experts at the time were not bullish on Clene’s prospects.
Despite this, the state government is still supporting Clene’s facility as in December of last year, when they received a $1 million grant award from the Maryland Department of Housing and Community Development (DHCD) to further support the redevelopment of their facility. Maryland Gov. Larry Hogan took a tour of the facility and according to the local newspaper the Cecil Whig. CSO Mark Mortenson said in the governor’s tour that they would begin selling the drug in 2024 if they clear all the FDA hurdles and spark the need for more manufacturing facilities.
Although Maryland’s support did help Clene’s stock $CLNN increase today by over 14%, they still have a huge hill to climb as their price has been down almost 50% over the past six months.