FAQ on Clene Inc.'s Progress in the ALS Market and FDA Milestones for CNM-Au8®

What is Clene Inc.’s lead drug candidate and its target market?

Clene Inc.’s lead drug candidate is CNM-Au8®, targeting the ALS (Amyotrophic Lateral Sclerosis) market, which is expected to reach $1.3 billion by 2034.

Why is CNM-Au8® considered a novel approach to treating neurodegenerative diseases?

CNM-Au8® targets mitochondrial dysfunction, a unique mechanism aimed at improving mitochondrial health and protecting neuronal function in diseases like ALS and MS.

When does Clene Inc. expect potential FDA accelerated approval for CNM-Au8®?

Clene Inc. is progressing toward a potential FDA accelerated approval for CNM-Au8® in 2026.

What are the upcoming milestones for Clene Inc. in 2025?

Key FDA meetings in 2025 and important NfL data expected in the fourth quarter of 2025 are major upcoming milestones for Clene Inc.

How does Clene Inc. plan to support its regulatory case for CNM-Au8®?

Biomarker and survival data from over 150 patients will be critical to Clene Inc.’s regulatory case for CNM-Au8®.

What is the significance of the ALS market for investors?

The ALS market represents a significant unmet need with a projected value of $1.3 billion by 2034, offering investors a compelling entry point through Clene Inc.’s innovative treatment.

Where can investors find the latest news and updates about Clene Inc.?

The latest news and updates relating to Clene Inc. (NASDAQ: CLNN) are available in the company’s newsroom at https://ibn.fm/CLNN.

What other programs is Clene Inc. developing besides CNM-Au8® for ALS?

Clene Inc. is also developing a separate MS (multiple sclerosis) program in late-stage development, alongside its ALS treatment.