FAQ: Clene Inc. Q2 2025 Results and CNM-Au8® NDA Submission Plans

What is the main focus of Clene Inc.’s Q2 2025 report?

The report focuses on Clene’s financial results, progress toward submitting a New Drug Application (NDA) for CNM-Au8® in ALS by year-end 2025, and extending the company’s cash runway into Q1 2026.

When does Clene plan to submit the NDA for CNM-Au8® in ALS?

Clene plans to submit the NDA for CNM-Au8® in ALS by the end of 2025.

What are the key upcoming milestones mentioned for Clene?

Key milestones include FDA meetings in Q3 2025 to discuss ALS survival benefit data and MS development plans, and neurofilament light biomarker data analysis from the NIH-sponsored EAP program expected in early Q4 2025.

What is CNM-Au8® and how does it work?

CNM-Au8® is an oral suspension of gold nanocrystals designed to restore neuronal health by improving energy metabolism for treating neurodegenerative diseases like ALS and MS.

What was Clene’s financial position as of June 30, 2025?

As of June 30, 2025, Clene reported $7.3 million in cash and cash equivalents, with recent financing extending the company’s cash runway into Q1 2026.

What neurodegenerative diseases is Clene targeting with CNM-Au8®?

Clene is targeting amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS) with CNM-Au8®.

Where can investors find more information about Clene Inc.?

Investors can find the latest news and updates in the company’s newsroom at https://ibn.fm/CLNN.

What recent regulatory interaction did Clene have with the FDA?

Clene recently held a Type C meeting with the FDA to align on statistical methodology for analyzing neurofilament light (NfL) biomarker changes.