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Edge31 Oct 2025
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Clene (CLNN) investor relations material
Clene Emerging Growth Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Emerging Growth Conference summary23 Oct, 2025
Clinical and regulatory progress
Recent FDA engagement has provided a path forward for expanded access protocols, adding new clinical data to existing results.
Phase II ALS studies (Healy and Rescue) missed primary endpoints but showed significant survival and clinical worsening benefits, with neural filament light as a key biomarker.
Over 500 ALS patients have received compassionate use treatment, with some on therapy for over six years, indicating notable long-term safety and survival.
Statistically significant reductions in neural filament light levels are linked to survival benefits, with up to 91% risk reduction in certain patient groups.
Ongoing analysis of new expanded access protocol data may provide a second proof source for neural filament and survival benefits.
Commercialization and financial outlook
If new data aligns with previous findings, a new drug application could be filed by year-end, with commercialization preparations in 2026.
Sufficient cash is available to reach key milestones, including data readouts, FDA meetings, and potential NDA submission.
Additional fundraising may be considered following successful outcomes, but current resources are adequate for near-term needs.
Key inflection points are expected within the next 60 days, including neural filament results and an FDA meeting in December.
The company anticipates sharing neural filament data and further updates with the market in the coming weeks.
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Q3 202512 Nov, 2025
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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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