Clene (CLNN) investor relations material

Regulatory and clinical development updates

• Received FDA post-meeting minutes indicating data may support NDA submission for CNM-Au8 targeting ALS.

• 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 NDA submission with the goal of receiving a PDUFA date and potential approval next year.

Financial and operational outlook

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

• Upon receiving a PDUFA date, an additional $7 million in funding will be executed, extending operational runway.

• Current cash position supports ongoing regulatory activities and preparation for potential approval.

Pipeline and future plans

• Engaged in discussions with the FDA regarding a multiple sclerosis indication; early approval is not possible, requiring a phase III study.

• Phase III MS study will focus on cognition in patients already on MS drugs, aiming to address progressive MS.

• Collaborating with advisors and Division of Neurology 1 to design and potentially execute the MS phase III study next year.