Clene (CLNN) Emerging Growth Conference 92 summary

Regulatory progress and clinical data

• Received FDA post-meeting minutes indicating data may support NDA submission and review.

• Survival data is strong but not sufficient for accelerated approval; neurofilament light reduction is the surrogate endpoint being pursued.

• Achieved approximately 10% statistically significant reduction in neurofilament light in two separate studies, supporting the surrogate endpoint.

• Multiple lines of evidence, including survival, functional outcomes, and biomarker concordance, are being submitted to demonstrate clinical benefit.

• Preparing a comprehensive NDA package for FDA review, aiming for a PDUFA date and potential approval next year.

Financial and operational updates

• Recent data announcement led to increased trading activity and attracted a new investor, resulting in additional funding.

• Anticipates nearly $7 million in further funding upon receipt of a PDUFA date, providing runway through the regulatory process.

Pipeline and future plans

• Engaged in ongoing discussions with the FDA regarding a multiple sclerosis indication; early approval is not possible without a phase III study.

• Phase III MS study will focus on cognition in patients already on MS drugs, with planning underway for execution next year.