Clene (CLNN) investor relations material

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.