Clene reports MS patient improvements with CNM-Au8 treatment

SALT LAKE CITY - Clene Inc. (NASDAQ:CLNN), a clinical-stage biopharmaceutical company with a market capitalization of $22.84 million and currently trading near its 52-week low, announced significant findings from their VISIONARY-MS Trial long-term extension study today. According to InvestingPro analysis, the company appears undervalued despite challenging market conditions. The study observed anatomical and physiological improvements in multiple sclerosis (MS) patients treated with CNM-Au8, a gold nanocrystal oral suspension. These improvements suggest remyelination and neuronal repair.

The post hoc analyses of the VISIONARY-MS trial presented at the AAN 2025 Annual Meeting in San Diego showcased notable enhancements in cognition and visual function in MS patients. These improvements correlated with objective biomarkers from advanced MRI Diffusion Tensor Imaging (DTI) and multi-focal Visual Evoked Potential (mf-VEP) assessments.

Key findings from the trial extension indicated that MRI DTI metrics, which are structural markers associated with neuronal repair and remyelination, confirmed improvements in the brain's neuronal structure among MS participants receiving CNM-Au8. Additionally, mf-VEP metrics, functional markers associated with remyelination and neuronal repair, confirmed improvements in the visual system.

Clinical improvements were also observed in low contrast letter acuity (LCLA) and symbol digit modality test (SDMT), measures of vision-specific quality of life and cognitive processing speed, respectively. Notably, 96% of participants who showed visual improvement also demonstrated improvement in MRI DTI metrics, while 91% exhibited mf-VEP improvements. Furthermore, 98% of those with enhanced cognition had corresponding improvements in MRI DTI metrics.

The results affirm the potential of CNM-Au8 to support critical repair processes within neurons and oligodendrocytes, leading to improved neurological function and remyelination. These findings contrast with previous MS clinical trials of other repair candidate drugs, which have shown little success in consistent clinical benefits. While the clinical results are promising, InvestingPro data shows the company faces financial challenges with negative earnings of -$39.4 million in the last twelve months and rapidly depleting cash reserves.

Ben Greenberg, MS expert and Head of Medical for Clene, highlighted the significance of the trial results and expressed optimism about confirming the data in a forthcoming global Phase 3 trial.

This announcement is based on a press release statement from Clene Inc., a company focused on developing treatments for neurodegenerative diseases. Clene's investigational therapy, CNM-Au8, is designed to improve central nervous system cells' survival and function by targeting mitochondrial function and reducing oxidative stress. While Clene has not provided details on the expected timeline for the Phase 3 trial, analyst price targets ranging from $20 to $84 suggest significant upside potential if the treatment proves successful. Unlock more valuable insights and 12 additional ProTips about CLNN with InvestingPro, your comprehensive solution for in-depth financial analysis and investment research.

In other recent news, Clene Inc. reported its fourth-quarter and full-year financial results for 2024, revealing earnings per share of ($1.61) for the fourth quarter and ($5.67) for the year, which fell short of analyst expectations. The company ended the year with a cash position of $12.2 million, expected to sustain operations until the second quarter of 2025. Clene has settled an outstanding $125,000 debt by issuing 35,311 shares of common stock at $3.54 per share, as detailed in a recent SEC filing. This strategic move allows Clene to manage its financial obligations without additional cash expenditures. H.C. Wainwright maintained a Buy rating and a $31 price target on Clene stock, citing confidence in Clene's prospects. The company recently released new survival data from the HEALEY ALS Platform Trial, showing that its drug candidate CNM-Au8 may extend the survival of ALS patients. Clene's collaboration with APST Research aims to analyze the long-term effects of CNM-Au8 on ALS patients, focusing on neurofilament light chain biomarkers. These efforts are part of Clene's ongoing discussions with the FDA for a potential accelerated approval pathway for CNM-Au8.

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