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Clene (CLNN) investor relations material
Clene H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Key presentations and clinical updates
Highlighted ongoing development of CNM-Au8, a nanotherapeutic for ALS and MS, with a focus on mitochondrial function and safety profile.
Completed multiple Phase II studies (HEALEY, RESCUE-ALS, VISIONARY-MS) with primary endpoint misses but demonstrated secondary benefits in survival, clinical worsening, and neural filament biomarkers.
Achieved significant survival and biomarker improvements, including a 94% risk reduction in time to death or PAV and notable neural filament reductions, especially in patients with high baseline levels.
Ongoing Expanded Access Program funded by NIH is collecting additional neural filament data to support potential accelerated approval filings.
VISIONARY-MS trial showed sustained improvements in vision and cognition over three years, leading to FDA discussions for a Phase III trial focused on cognition in MS.
Regulatory and strategic outlook
Engaged in active discussions with the FDA regarding New Drug Application filings based on neural filament and survival data, with decisions expected by early next year.
Planning to leverage both neural filament and survival as potential surrogate endpoints for accelerated approval of CNM-Au8.
Anticipates possible commercialization of CNM-Au8 for ALS and MS by late 2026, pending regulatory outcomes.
Financial position and forward plans
Reported $7.3 million in cash at June-end, with an additional $1.9 million raised post-quarter and a $1.5 million increase in debt facility, totaling nearly $11 million.
Current cash runway extends into the first quarter, covering upcoming FDA interactions, data readouts, and potential NDA filings.
Expressed gratitude to investors and patients, emphasizing the importance of continued support for advancing neurodegenerative disease therapies.
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