Coverage Initiated on Nanomedicine Firm, Upside ‘Potentially Significant’ With Upcoming Trial Results

Source: Streetwise Reports   10/01/2021

“With Clene’s potential to realize several multibillion-dollar revenue opportunities, we see its roughly $480 million enterprise value as offering attractive risk-reward,” an Oppenheimer report noted.

In a Sept. 28 research note, analyst Leland Gershell reported that
Oppenheimer initiated coverage on Clene Inc. (CLNN:NASDAQ) given
its “potential to realize several multibillion dollar revenue opportunities.”

“With the company trading at just around $480 million of enterprise value and a cash balance of $63 million, we see potentially substantial upside for Clene.”

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Oppenheimer initiated with an Outperform rating and a $20 per share target price on Clene. Its current share price, in comparison, is $7.

Gershell explained what investors should know about this company. It is developing bioenergetic nanotherapeutics for treatment of neurodegenerative and other diseases in which bioenergetic failure, or dysfunction of intracellular energy metabolism, is a feature.

Clene’s lead candidate is gold-based CNM-Au8, which “consists of gold nanoparticles whose surfaces act as highly active redox catalysts and through that mechanism are able to improve cellular bioenergetics,” Gershell indicated.

He added, “We see mechanistic rationale for the improvement of mitochondrial dysfunction in the treatment of neurodegenerative conditions.”

Clene is advancing CNM-Au8 in three indications: amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple sclerosis.

Preclinical and clinical results to date are encouraging, proving CNM-Au8’s mechanism of action. In the three indications, CNM-Au8 has been shown in animal models to enhance remyelination and neuroprotection. The therapeutic crosses the blood-brain barrier and then acts in three ways, Gershell explained. It supports energy transfer in stressed, diseased and damaged cells. It “reduces harmful reactive oxygen species and promotes proteome integrity through heat shock factor-1 pathway activation,”

Early indicators from Phase 2 studies are that the therapeutic has potential to modify disease and has a solid safety profile. After 12 weeks of receiving CNM-Au8, study participants showed improvement in key biomarkers of brain energy production and utilization along with signs of improved energy efficiency.

Data on motor nerve function are expected in Q4/21 followed in Q2/22 by topline results from the in-progress Phase 3 Healey ALS Platform Trial in which two doses of CNM-Au8 are being evaluated.

“With the company trading at just around $480 million of enterprise value and a cash balance of $63 million, we see potentially substantial upside for Clene as its trials read out in the next six to 12 months,” Gershell commented.

The analyst highlighted that Clene’s therapeutics are neither small molecules nor biologics. Rather, they are “orally administered suspensions of ‘clean-surfaced’ transition metal nanocrystals, distinguished by unusually efficient electron exchange ability and scalable, consistent manufacture.”

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Disclosures from Oppenheimer & Co. Inc., Clene Nanomedicine Inc., Sept. 28, 2021.

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