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Clene
Clene (CLNN) investor relations material
Clene Emerging Growth Virtual Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Emerging Growth Virtual Conference summary25 Feb, 2026
Company overview and mission
Focused on developing therapies to improve mitochondrial health and protect neuronal function for neurodegenerative diseases, with a primary emphasis on ALS and ongoing interest in MS.
Lead asset CNM-Au8 is a nanotherapeutic suspension designed to cross the blood-brain barrier and support neuronal housekeeping.
Over 800 patients have been treated, including more than 500 through expanded access protocols.
Clinical data and regulatory engagement
CNM-Au8 demonstrated statistically significant reductions in neurofilament and GFAP biomarkers, both linked to improved survival in ALS.
Survival benefit observed in multiple studies, including a 94% risk reduction in the HEALEY study and durable effects out to 36 months.
FDA provided three options for further evidence, leading to extensive biomarker and survival data submission.
The agency is considering whether biomarker changes are reasonably likely to predict clinical benefit and may serve as confirmatory evidence for accelerated approval.
Upcoming milestones and timelines
Type C FDA meeting expected by end of Q1, with meeting minutes anticipated early Q2.
NDA filing targeted for end of Q2, with potential PDUFA date in Q3 and possible commercialization in early 2027.
Confirmatory Phase III trial is planned, with the goal of providing patient access to CNM-Au8 as early as next year.
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Next Clene earnings date
Q4 202513 Mar, 2026
Clene
Next Clene earnings date
Q4 202513 Mar, 2026
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Frequently asked questions
Clene Inc. is a biopharmaceutical company focused on developing nanotechnology-based therapies for neurodegenerative diseases. The company specializes in therapeutic candidates targeting conditions such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease. Its lead programs utilize proprietary nanocrystal technology to enhance cellular energy production and neuroprotection. The company is headquartered in Salt Lake City, Utah, and its shares are listed on the NASDAQ.
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