Clene Inc. (NASDAQ: CLNN) and Its Promising ALS Drug CNM-Au8®: An Investor's FAQ

What is Clene Inc.’s lead drug candidate and what does it treat?

Clene Inc.’s lead drug candidate is CNM-Au8®, an oral treatment designed for Amyotrophic Lateral Sclerosis (ALS), focusing on improving mitochondrial health and protecting neuronal function.

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

CNM-Au8® targets mitochondrial dysfunction, a unique mechanism of action that aims to enhance mitochondrial function and protect neurons, addressing a significant unmet need in neurodegenerative diseases.

When is Clene Inc. expecting FDA accelerated approval for CNM-Au8®?

Clene Inc. is progressing toward a potential FDA accelerated approval for CNM-Au8® in 2026, with key FDA meetings in 2025 serving as major valuation catalysts.

What is the expected market size for ALS treatments by 2034?

The ALS treatment market is expected to reach $1.3 billion by 2034, highlighting the significant potential for CNM-Au8® in addressing this unmet need.

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

Clene Inc. will rely on biomarker and survival data from over 150 patients, with important NfL data expected in the fourth quarter of 2025, to support its regulatory case.

What are Clene Inc.’s plans for a Phase 3 ALS trial?

Clene Inc. is preparing to initiate a confirmatory Phase 3 ALS trial in the first half of 2026, further advancing the development of CNM-Au8®.

Does Clene Inc. have any other programs in development?

Yes, Clene Inc. has a separate multiple sclerosis (MS) program in late-stage development, expanding its focus on neurodegenerative diseases.

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

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

What makes Clene Inc. a compelling investment opportunity?

Clene Inc. offers a compelling investment opportunity due to its differentiated mechanism of action, potential FDA accelerated approval for CNM-Au8®, and the significant unmet need in the growing ALS treatment market.