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Clene
Clene (CLNN) investor relations material
Clene Emerging Growth Conference 89 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Emerging Growth Conference 89 summary21 Jan, 2026
Regulatory progress and clinical data
Granted an in-person Type C FDA meeting this quarter to discuss biomarker and survival data for ALS treatment.
Biomarker analyses showed significant reductions in neurofilament and GFAP, both linked to longer survival in ALS patients.
Survival benefit consistently demonstrated across multiple data sets, despite missing the ALSFRS functional endpoint in the HEALEY study.
Data package includes three key biomarkers: neurofilament, GFAP, and IGFBP, all showing concordant responses and association with survival.
Plan to file a New Drug Application for accelerated approval if FDA concurs, targeting submission in Q2 and potential commercialization early next year.
Accelerated approval pathway and next steps
Accelerated approval pathway pursued using biomarker as surrogate endpoint, following precedent set by Biogen's Tofersen.
Confirmatory phase III study planned, focusing on survival as the primary endpoint.
FDA meeting scheduled for later this quarter, with outcome determining NDA filing timeline.
If NDA is accepted, potential FDA decision and commercialization could occur by early next year.
Financial update and investor participation
Recent tranche financing raised $6 million at $6.50 per share, extending cash runway by an additional quarter.
Additional tranches could raise $7 million at $7 and $15 million at $12.50, triggered by regulatory milestones.
Three major healthcare investors participated: Vivo, Castellan, and Boxer Capital.
Funding now supports operations through potential approval in a positive scenario.
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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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