In a Feb. 3 research note, analyst Elemer Piros reported that ROTH Capital Partners initiated coverage on Clene Inc. (CLNN:NASDAQ) with a Buy rating and a 12-month price target of $24 per share; its current share price is $10.94.
Piros explained that the biopharma, based in Salt Lake City, Utah, develops therapeutics for neurodegenerative diseases. Its lead drug is CNM-Au8, a concentrated suspension of gold nanoparticles. Clene is developing the compound to "simultaneously address the bioenergetics deficit, oxidative stress and protein aggregation." In other words, the ultimate goal is to repair damaged neurons that result from neurodegenerative diseases.
The analyst provided the factors behind ROTH's Buy recommendation on Clene.
For one, CNM-Au8 catalyzes not just one but several functions. They include the production of energy-carrying adenosine triphosphate (ATP), "the reduction of harmful reactive oxygen species and elimination of toxic protein aggregates," Piros wrote.
Also, CNM-Au8 has potential in at least three disorders: Parkinson's disease and amyotrophic lateral sclerosis (ALS), in which it was shown to lower or eliminate protein aggregation in animal models, and multiple sclerosis, in which it was shown to reverse demyelination. In humans, CNM-Au8 has been shown to facilitate ATP production in the brain.
"In an early ALS and multiple sclerosis trial, signs of activity were seen indicating potential functional improvement and reversal of the course of disease," noted Piros, referencing a study in humans.
Finally, CNM-Au8 could be what Piros called a blockbuster or megablockbuster therapeutic.
"CNM-Au8 could achieve sales in excess of $1 billion in ALS and greater than $10 billion in a much larger multiple sclerosis indication, in our calculation," he wrote.
He indicated that Clene has other products in development, including CNM-AgZn17, a silver and zinc ion compound for infectious diseases and wound healing, and NM-PtAu7, a gold-platinum treatment for tumors.
With many shots on goal, Clene has numerous potential stock-boosting events happening this year and next, Piros pointed out, since it has four different Phase 2 clinical trials and one pivotal study now in progress. Those catalysts include topline data from the RepairPD imaging Phase 2 trial expected in H1/21 and from the RepairMS imaging Phase 2 trial anticipated in H2/21. Also this year, Clene should provide an update on the COVID-19 clinical program with CNM-AgZn17 in Brazil.[NLINSERT]
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Disclosures from ROTH Capital Partners, Clene Inc., Company Note, February 3, 2021
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
ROTH makes a market in shares of Clene, Inc. and Apellis Pharmaceuticals, Inc. and as such, buys and sells from customers on a principal basis.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.