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Clene Inc. (NASDAQ: CLNN) Announces Key Operational Highlights as part of First Quarter 2024 Financial Results

  • Clene presented clinical data at the 2024 American Academy of Neurology (“AAN”) Annual Meeting, demonstrating that long-term CNM-Au8® treatment resulted in significant evidence of repair and remyelination across multiple paraclinical endpoints
  • Clene entered into a sub-award grant agreement with Columbia University under the previously announced National Institute of Health (“NIH”) Grant
  • Clene announced the publication of “Protein Corona Composition of Gold Nanocatalysts” in the ACS Pharmacology & Translational Science journal

Clene (NASDAQ: CLNN), a late-stage clinical biopharmaceutical company dedicated to revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), along with its wholly-owned subsidiary Clene Nanomedicine, Inc., recently announced its first quarter 2024 financial results and provided an important update on the CNM-Au8 clinical program for MS (https://nnw.fm/snDmR).

In April, Clene presented clinical data at the 2024 AAN Annual Meeting, demonstrating that long-term CNM-Au8 treatment resulted in significant evidence of repair and remyelination across multiple paraclinical endpoints. Those participants initially randomized to CNM-Au8 treatment showed continued significant improvement in vision, as measured by low-contrast letter acuity.

More than half of the participants improved by ten or more letters on a low-contrast Sloan eye chart, with increases of up to 38 letters (vs. original baseline, measured by mixed model repeat measures analysis, or MMRM; p < 0.001). Additionally, participants treated with CNM-Au8 experienced up to 29 points (max score = 110) of significant improvement in cognition and working memory, as measured by the Symbol Digit Modality Test (“SDMT”) (vs. original baseline by MMRM analysis, p < 0.001). The study also demonstrated functional and structural evidence of repair and remyelination. The results of the Visionary-MS long-term extension study, presented at the 2024 AAN Annual Meeting, are available for review.

Corporate updates provided by the company included:

  • Sub-Award Grant Agreement with Columbia University: In April, Clene entered into a sub-award grant agreement with Columbia University under the previously announced NIH Grant. The sub-award includes reimbursement of company expenses for the NIH Expanded Access Program for CNM-Au8 in ALS (ACT-EAP) of up to $7.3 million from September 25, 2023, to August 31, 2024.
  • NIH Grant Collaboration: In October 2023, Clene announced a four-year, $45.1 million grant from the NIH in collaboration with Columbia University and Synapticure, a neurology specialty health clinic. This grant is intended to support a ACT-EAP for CNM-Au8 treatment of ALS, with funds disbursed to Clene based on invoice submissions for reimbursement on a monthly or quarterly basis.
  • Research Publication: In March, Clene announced the publication of “Protein Corona Composition of Gold Nanocatalysts” in the ACS Pharmacology & Translational Science journal. This publication, in the American Chemical Society journal, highlights innovative and impactful research with translational relevance across a broad spectrum of biological sciences. The protein corona is a feature of CNM-Au8’s neuroprotective mechanism of action, enabling the drug’s longevity in circulation without provoking an inflammatory response and aiding in the drug’s transport across the blood brain barrier.

The full publication can be found at https://nnw.fm/k3A6h.

Rob Etherington, President and CEO of Clene, underscored that the company is working diligently to advance FDA discussions in ALS while continuing to generate more data supporting the neurological benefits and mechanism of action of CNM-Au8. “We look forward to a productive and collaborative FDA meeting by mid-2024 and laying the groundwork towards filing of a New Drug Application in the second half of the year,” Etherington said. “Additionally, we are very pleased to see the recent data from our long-term extension of the VISIONARY-MS study. These data represent significant evidence of repair and remyelination across multiple paraclinical endpoints and provide us with greater support for the continued clinical evaluation of CNM-Au8 for this important indication.”

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://nnw.fm/CLNN

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