Roth Capital Partners resumed coverage on Monday on Clene Inc (Clene Inc Stock Quote, Charts, News, Analysts, Financials NASDAQ:CLNN), a clinical stage biopharmaceutical company focused on neurodegenerative diseases. Roth analyst Jonathan Aschoff issued a “Buy” rating on CLNN, saying an upcoming FDA advisory committee decision on Biogen’s ALS drug Tofersen could be a positive inflection point for Clene’s valuation.
Salt Lake City-based Clene, with R&D and manufacturing operations in Maryland, is developing treatments targeting energetic failure and has clinical trials for its pure gold nanocrystals called CNM-Au8 for ALS and for MS. Clene says its research is based, as per its name, on the cleanliness of the gold nanocrystals compared to other elemental gold therapies, allowing CNM-Au8 to effectively catalyze energy reactions.
As Aschoff described in his report, the pure gold nanocrystals are administered as an oral liquid suspension and are intended to catalyze the production of energy and thus raise ATP levels and generally counter the reduction in energy that comes with normal aging.
“The primary evidence for the mechanism comes from the clinical observation (from the REPAIR- PD and REPAIR-MS trials) that the ratio of NAD+ to NADH increases upon at least 12 weeks of once-daily dosing (mean change of 10.4 per cent; p=0.0371; n=24),” Aschoff said.
“Efficacy from lead asset CNM-Au8 comes from observing that brain energy decreases with age, evidenced by a lower NAD redox potential, and that CNM-Au8’s ability to increase NAD, ATP, and proteostasis, while reducing reactive oxygen species, will produce more energy while wasting less,” he wrote.
The company reported with its third quarter financials in November, 2022, that it had positive results from a pre-specified secondary endpoint in its HEALEY ALS Platform trial, showing a statistically significant reduction in mortality at six months. For its Phase 2 VISIONARY MS trial, it reported meeting primary and secondary endpoints for 15 mg and 30 mg once-daily CNM-Au8 versus placebo over 48 weeks of treatment in stable RRMS patients with chronic optic neuropathy and taking background disease modifying treatments. Clene said it will be advancing its MS program once a strategic partner has been found.
On Biogen’s competing ALS drug, Aschoff said a positive FDA recommendation for Tofersen would show a willingness to approve an ALS drug that missed its primary endpoint (in its ALSFRS-R at 24 weeks as a Phase 3 VALOR trial) as well as secondary endpoints but achieved those secondary endpoints in the trial’s open-label extension.
Aschoff pointed to the similarities, where CNM-Au8 also missed primary and secondary endpoints in its ALS trial but nonetheless showed a decreased mortality risk in its open-label expansion.
“We note that a positive Tofersen advisory committee and PDUFA in April would strongly incline CLNN to file its NDA by YE23, thus setting the company up for a potential mid-2024 approval. Should that not occur, we believe that the requirement for a Phase 3 trial would push potential approval in ALS out to early 2027,” Aschoff wrote.
With his “Buy” rating, Aschoff asserted a 12-month target price of $10.00, representing at press time a projected return of 529 per cent.