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MissionIRNewsBreaks – Clene Inc. (NASDAQ: CLNN) Advances Toward NDA Submission for ALS Therapy

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, recently released second quarter 2025 financial results and provided an update on clinical programs. “The company emphasized progress toward an NDA submission for its lead asset CNM-Au8® in ALS, expected in the fourth quarter of 2025,” reads an article discussing this.

“We look forward to engaging with the FDA in our upcoming meeting this quarter focused on the extensive survival data that CNM-Au8® has generated in ALS patients,” said CEO Rob Etherington. “These meetings and biomarker analyses represent the final steps to our potential submission of an NDA under the accelerated approval pathway for ALS by the end of 2025. Our commitment to the ALS community remains unwavering as we endeavor to develop an impactful therapeutic agent for this devastating disease.”

To view the full article, visit https://ibn.fm/u9ulP

About Clene Inc.

Clene (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. CNM-Au8® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN

About MissionIR

MissionIR (“MIR”) is a specialized communications platform with a focus on assisting IR firms with syndicated content to enhance the visibility of private and public companies within the investment community. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, MIR is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, MIR brings its clients unparalleled recognition and brand awareness.

MIR is where breaking news, insightful content and actionable information converge.

For more information, please visit www.MissionIR.com

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