Clene Inc. (NASDAQ: CLNN) Presents Lead Candidate CNM-Au8(R) Updates, Latest Achievements at Top Investor Conferences

• Clene gave a fireside presentation and held one-on-one investor meetings at the 2024 Maxim Healthcare Virtual Summit on October 15.
• On October 30, Clene will give a presentation and participate in one-on-one meetings at The ThinkEquity Conference 2024 at the Mandarin Oriental Hotel in New York.
• Clene’s lead drug candidate, CNM-Au8^® has been shown to restore and protect neurological function, offering new hope for patients with ALS and other neurodegenerative conditions.
• Clene is seeking an accelerated approval pathway for CNM-Au8 for ALS and is scheduled to have a meeting with the FDA leadership in November.

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, including amyotrophic lateral sclerosis (“ALS”) multiple sclerosis (“MS”) and Parkinson’s Disease (“PD”), is participating in two top investor conferences this month to present its latest achievements and key updates on its lead drug candidate, CNM-Au8 (https://ibn.fm/BDqtM).

On October 15, the company gave a fireside presentation at the 2024 Maxim Healthcare Virtual Summit. The October 15-17 event included presentations and interactive discussions with CEOs and key executives from a wide range of biotechnology, diagnostic, medical device, and healthcare information technology companies, along with several topical industry panels. Clene was also scheduled to take part in several one-on-one investor meetings with participants.

The company will also give a presentation and take part in one-on-one meetings at The ThinkEquity Conference 2024 at the Mandarin Oriental Hotel in New York on October 30, at 3:30 p.m. E.T. Those interested in attending can register at https://ibn.fm/Eycfv. This year’s ThinkEquity Conference will feature a diverse group of attendees, including U.S. public and private companies, Canadian and international listed companies, investors, and other industry professionals. Presentations at the event will cover investment topics across various sectors, including AI, biotechnology, metals and mining, oil and gas, and technology.

Developed as an oral suspension of gold nanocrystals, CNM-Au8 works by improving cellular energy production and utilization, which is critical for maintaining neuronal health. In both clinical trials and compassionate use programs, CNM-Au8 has already 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 aims to provide neuroprotection and promote remyelination, potentially altering the course of neurodegenerative conditions.

Clene’s lead drug candidate has obtained encouraging results in ALS patients in Phase 2 clinical trials RESCUE-ALS and HEALEY ALS Platform Trials, where participants who were administered CNM-Au8 saw significant improvement in survival rates and combined assessment of function and survival. In both trials CNM-Au8 treatment also delayed clinical worsening in ALS participants. Overall there is now more than 700 cumulative patient-years of safety data that show no significant safety concerns or safety trends identified as related to CNM-Au8 treatment.

The company is seeking to file a New Drug Application (“NDA”) using the accelerated approval regulatory pathway for CNM-Au8 for ALS and has already submitted biomarker and clinical efficacy data to the Food and Drug Administration. A meeting with the FDA leadership to discuss this request will be held in November. If this accelerated pathway is approved, the next steps will be to file an NDA by the end of the year and to launch a confirmatory global Phase 3 study in ALS.

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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