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SALT LAKE CITY - Clene Inc. (NASDAQ:CLNN), a micro-cap biotech company with a market capitalization of $33.78 million, announced today it has received supportive feedback from the U.S. Food and Drug Administration on its proposed statistical analysis plan for neurofilament light (NfL) biomarker data from its ongoing NIH-sponsored Expanded Access Program for amyotrophic lateral sclerosis (ALS). According to InvestingPro analysis, the stock appears undervalued based on its Fair Value model.
The biotech company plans to conduct the NfL biomarker analyses early in the fourth quarter of 2025. These analyses will compare data from nearly 200 ALS patients receiving CNM-Au8 under compassionate use to matched controls. The primary analysis will assess NfL changes after 9 months of treatment, with a supportive analysis at 6 months. While the stock has seen an 8.29% decline over the past week, analyst price targets range from $20 to $33, suggesting significant upside potential from current levels.
Clene has resubmitted its revised statistical analysis plan incorporating the FDA’s requested revisions, with final acceptance expected this summer.
The company also confirmed two additional FDA meetings scheduled for the third quarter of 2025. One meeting will review long-term survival data from CNM-Au8 treatment compared to controls from the Healey ALS Platform Trial. The second meeting will discuss results from the Phase 2 VISIONARY-MS trial and plans for a Phase 3 study focused on cognitive improvement.
"We are encouraged by the FDA’s collaborative approach and their constructive feedback on our NfL biomarker analysis plan," said Benjamin Greenberg, Head of Medical at Clene, in the press release.
Clene stated it remains on track for potential submission of a new drug application for ALS under the accelerated approval pathway in the fourth quarter of 2025, pending positive results from the NfL analyses.
CNM-Au8 is an oral suspension of gold nanocrystals designed to restore neuronal health by increasing energy production and utilization, according to the company. InvestingPro data reveals the company’s challenging financial position, with a weak overall financial health score and rapid cash burn rate. InvestingPro subscribers have access to 8 additional key insights about Clene’s financial outlook and market position.
In other recent news, Clene Inc. has entered into an Equity Distribution Agreement with Canaccord Genuity LLC, allowing the company to offer and sell up to $25 million of its common stock. The sales will be conducted under Clene Inc.’s previously filed registration statement, with Canaccord Genuity acting as the placement agent and receiving a 3.0% commission on gross proceeds. This move aims to potentially raise capital for Clene Inc.’s operations through the equity markets. Additionally, Clene Inc. announced findings from their VISIONARY-MS Trial long-term extension study, highlighting improvements in multiple sclerosis (MS) patients treated with their CNM-Au8 treatment. The study showed anatomical and physiological improvements, suggesting remyelination and neuronal repair, with enhancements in cognition and visual function. These results were presented at the AAN 2025 Annual Meeting, demonstrating the potential of CNM-Au8 to support critical repair processes within neurons. Ben Greenberg, Head of Medical for Clene, noted the significance of these findings and the company’s optimism for a forthcoming global Phase 3 trial.
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