Clene Inc.
For the period ended Aug 10, 2026. Filed Aug 10, 2026.
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Aug 10, 2026 · Filed Aug 10, 2026
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Contents
EX-99.2 · Safety and Tolerability Profile
Safety and Tolerability Profile
CNM-Au8 has demonstrated a consistent safety and tolerability profile across its clinical trial and expanded access programs, now totaling more than 1,280 collective participant-years of treatment as of July 31, 2026, including more than 1,100 participant-years in ALS, with the longest continuous treatment duration for ALS exceeding 6.8 years. As of August 10, 2026, no serious adverse events have been assessed as related to CNM-Au8, and no safety signals have been associated with long-term use. The safety-tolerability profile of CNM-Au8 is directly relevant to the benefit-risk assessment the FDA will conduct in reviewing the NDA.
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