• Clene’s recently released 2023 financial and operational updates highlight the company’s developments for the treatment of amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis
• CNM-Au8(R) functions as a neuroprotective and remyelinating therapy in neurodegenerative diseases
• Recent data from the randomized, double-blind, placebo-controlled HEALEY-ALS Platform Trial and its open-label extension, reported by Clene in December 2023, revealed encouraging outcomes on survival and delayed clinical worsening
• Clene recently provided perspectives on its achievements and the development path for CNM-Au8(R) during its participation in the 36th Annual ROTH Conference, which was held March 18-19, 2024

Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a 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”), recently announced its 2023 operational highlights for its lead candidate, along with future goals. Clene’s lead candidate, CNM-Au8(R), is a gold nanocrystal suspension that has emerged as a promising candidate for the treatment of both ALS and MS (https://ibn.fm/bzDSB).

The unique catalytic mechanism of CNM-Au8 is believed to function as a neuroprotective and remyelinating therapy in neurodegenerative diseases by: (1) driving, supporting, and maintaining beneficial metabolic and energetic cellular reactions within diseased, stressed, or damaged cells, (2) directly catalyzing the reduction of harmful reactive oxygen species (“ROS”), and (3) promoting protein homeostasis through activation of the heat shock factor-1 pathway. This pathway is known to mitigate the cytotoxic effects of misfolded and denatured proteins, which are prevalent in neurodegenerative diseases.

Clene, in collaboration with Columbia University and Synapticure, secured a substantial grant from the NIH in October 2023 to offer an Expanded Access Program (“EAP”) to people living with ALS who do not qualify for clinical trials. Additionally, recent data from the HEALEY-ALS Platform Trial and its open-label extension, reported by Clene in December 2023, revealed encouraging outcomes: CNM-Au8 30 mg treatment was associated with a substantial decrease in the long-term risk of all-cause mortality compared to placebo, a result corroborated by a notable reduction in a plasma NfL levels. Survival benefit with CNM-Au8 treatment has now been reported as a result of the open label extension of the RESCUE-ALS Phase 2 Trial, the HEALEY-ALS platform trial Regimen C, its open-label extension, and in propensity-matched control analyses of two EAPs in ALS.

Despite the FDA’s decision in late 2023 against allowing Clene to move forward with an accelerated approval pathway based on initial biomarker data, Clene is diligently preparing supplemental data to provide additional supportive biomarker, survival, and mechanistic data, to advance discussions for accelerated approval and a new drug application (“NDA”) in 2024.

CNM-Au8’s therapeutic potential extends to MS, as indicated by Clene’s January 2024 report on substantial clinical and functional improvements observed in the long-term VISIONARY-MS trial, including sustained enhancements in vision and cognition over 35 months, alongside a favorable safety profile. These advancements align with recent publications explaining CNM-Au8’s mechanism of action and brain target engagement, further establishing its credibility as a therapeutic agent.

Rob Etherington, President and CEO of Clene, said, the company will continue to advance regulatory discussions with FDA this year, talks that will include new data on biomarkers, as well as additional clinical function and survival data in people living with ALS. “Having held our initial discussion with the FDA in the fourth quarter of last year, we have a clear understanding of the additional data required to support an accelerated approval pathway filing for CNM-Au8,” Etherington explained. “We believe that we can provide additional supportive evidence to advance discussions with the FDA with the potential to file an NDA later this year.”

In addition to Clene’s updates, the company recently participated in the 36th Annual ROTH Conference, which was held March 18-19, 2024. The conference was held at The Ritz Carlton Laguna Niguel in Dana Point, California. A webcast of Clene’s presentation is available in the “Events” section of the Clene website.

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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