Clene Inc. (NASDAQ: CLNN) to Present CNM-Au8(R) Updates at 37th Annual Roth Conference

• The 37th Annual Roth Conference, to be held March 16-18 in Dana Point, California, will showcase the broadest group of companies in the event’s history, with senior executives from approximately 500 companies across various industries, including business services, consumer, healthcare, insurance, sustainability and technology, media and entertainment.
• Clene’s management will participate in a virtual fireside chat at 9:20 a.m. PST on March 18, as well as one-on-one investor meetings during the event.
• During the fireside chat and in investor meetings, the company will detail recent achievements and next steps for lead drug candidate CNM-Au8 for ALS and MS.

Clene Inc. (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, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), will attend the 37th Annual Roth Conference, according to a company news release (https://ibn.fm/odbPx).

Clene’s management will participate in a virtual fireside chat on March 18, at 9:20 a.m. PST, as well as one-on-one investor meetings, to discuss the company’s latest achievements and the next steps for lead drug candidate CNM-Au8. Investors interested in participating can register online at https://ibn.fm/laAfp. After the event, the presentation will be available on Clene’s website, in the Events section (https://ibn.fm/MrZEK).

The 37th Annual Roth Conference will be held March 16-18, at The Laguna Cliffs Marriott, located in Dana Point, California. This premier event aims to provide a robust platform for institutional investors to connect with executive management from an array of public and private growth companies.

Clene’s CNM-Au8 is an oral suspension of gold nanocrystals designed to improve cellular energy production and utilization, which is critical for maintaining neuronal health. The drug candidate has been shown to improve central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the nicotinamide adenine dinucleotide (“NAD”) pathway while reducing oxidative stress. By targeting mitochondrial dysfunction, CNM-Au8 can provide neuroprotection and promote remyelination, potentially altering the course of neurodegenerative conditions.

Following encouraging clinical trial results, Clene is seeking to bring CNM-Au8 to market as soon as possible. In two Phase 2 clinical trials, RESCUE-ALS and HEALEY ALS Platform Trials, participants who were administered CNM-Au8 saw significant improvement in survival rates, delayed clinical worsening, and improvements in a combined assessment of function and survival. The company is now organizing a confirmatory Phase 3 trial (“RESTORE-ALS”) to evaluate the survival benefit of CNM-Au8, while preparing for a potential accelerated approval pathway for the drug candidate as per the additional written guidance received from the U.S. Food and Drug Administration (“FDA”) in late 2024.

Clene is preparing a New Drug Application (“NDA”) to submit to the FDA in the second half of 2025 to secure accelerated approval for CNM-Au8 for ALS. Clene is currently conducting further analyses recommended by the FDA regarding neurofilament light chain (“NfL”) data, a key biomarker for ALS, in its NIH-sponsored Expanded Access Program (“EAP”). To strengthen this analysis, the company signed an agreement with APST Research GmbH (“APST”) to leverage its extensive dataset to compare NfL levels in NIH-sponsored EAP participants treated with CNM-Au8 against matched historical ALS controls. The goal is to determine if CNM-Au8 treatment reduces NfL decline, and to demonstrate that the rate of NfL change is associated with survival in the NIH-sponsored EAP ALS population.

For more information, visit the company’s website at 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

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