Clene (CLNN) Emerging Growth Conference 88 summary

Company overview and strategy

• Focuses on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, particularly ALS.

• Engaged in ongoing discussions with the FDA regarding biomarker data for accelerated approval of lead asset CNM-Au8.

• Pursuing a multi-pronged approach to validate biomarker data, including new data from the Healey Harvard program.

• Preparing a comprehensive dossier for FDA review in the first quarter.

Biomarker data and regulatory pathway

• Biomarkers neurofilament light chain and GFAP are being used to demonstrate neuronal damage and treatment efficacy.

• Statistically significant reductions in both biomarkers observed with CNM-Au8 treatment.

• Correlation established between neurofilament light chain levels and survival outcomes.

• FDA has outlined a path for accelerated approval based on biomarker endpoints.

Next steps and timeline

• Meeting with the FDA scheduled for the first quarter to discuss the data and next steps.

• New Drug Application (NDA) preparation underway, targeting submission in the first half of the year.

• Potential for commercialization decision in late 2026 or early 2027, pending FDA alignment.

• Confirmatory phase 3 study to commence in 2026, focusing on survival as the primary endpoint.