- The company will present at the Jones Las Vegas Technology and Innovation Conference on April 8-9, to update investors on its lead drug candidate.
- The conference will provide one-on-one meetings and networking opportunities for institutional investors and executives.
- Clene recently received FDA guidance on a potential accelerated approval pathway for CNM-Au8 in ALS treatment.
- New analyses suggest CNM-Au8 improves survival for ALS patients, with a 4.1-month increase in restricted mean survival time.
- Clene plans to begin enrollment for a Phase 3 confirmatory trial (RESTORE-ALS) in mid-2025.
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”) and multiple sclerosis (“MS”), will participate in the upcoming Jones Las Vegas Technology and Innovation Conference at The Venetian Resort. The April 8-9 event, organized by JonesTrading and supported by B2i Digital, provides a platform for direct engagement between innovative companies and institutional investors (https://ibn.fm/fIKDc).
“We look forward to participating in the Jones Conference, which provides an opportunity to share our progress and connect directly with investors in a setting that fosters productive conversations,” said Rob Etherington, CEO and President of Clene.
The conference will feature keynote addresses from Dr. Charity Dean, CEO of PHC Global, and Eric F. Trump, Executive Vice President of The Trump Organization, along with a Jones-hosted Golf Event and Cocktail Reception.
Commenting on the event, Alan Hill, CEO of JonesTrading, underlined that his firm and the conference are focused on creating a forum where public companies can communicate directly with the investment community, while B2i Digital, Inc. CEO David Shapiro underlined his company’s commitment to ensuring that companies participating in the Jones Conference have a platform to reach investors who are actively seeking new ideas and opportunities.
Clene’s presence at the Jones Conference offers investors a chance to engage with the company at a pivotal moment in its regulatory journey. At the event, the company will provide key updates about its lead drug candidate CNM-Au8 and its path to regulatory approval. CNM-Au8 is an oral suspension of gold nanocrystals designed to improve cellular energy production and utilization, which is critical for maintaining neuronal health. In several clinical trials, the drug candidate has been shown to improve survival rates in ALS patients, a finding supported by preclinical evidence that the drug works by improving central nervous system cells’ survival and function. The company recently received FDA guidance on using biomarker data to support an accelerated approval pathway for the drug.
Following a November 2024 meeting with the FDA’s Division of Neurology 1 (“DN1”), Clene was advised to analyze additional data from ongoing Expanded Access Programs (“EAPs”) to evaluate CNM-Au8’s impact on neurofilament light chain (“NfL”), a potential surrogate endpoint for ALS treatment. No significant safety concerns have emerged in over 800 patient years of CNM-Au8 use, and no serious adverse events (“SAEs”) have been linked to the treatment.
Clene expects to finalize a statistical analysis plan with the FDA in Q2 2025 before collecting and analyzing NfL biomarker data in Q3 2025, supporting a potential NDA submission in the second half of 2025.
New survival analyses compared CNM-Au8 (30 mg, Regimen C) against a concurrent control group (Regimen A) in the HEALEY ALS Platform Trial. Findings include:
- A 4.1-month improvement in restricted mean survival time (“RMST”) (p=0.045).
- Enhanced survival in severe ALS cases, with median survival extended by 11.9 months.
- A 44% decrease in mortality risk for patients with high baseline NfL levels (p=0.006).
To further evaluate CNM-Au8’s efficacy, Clene will launch the Phase 3 RESTORE-ALS trial in mid-2025. The study will assess overall survival as a primary endpoint and delayed ALS clinical worsening events as a secondary endpoint.
“We expect further regulatory guidance in 2025 on the critical next steps required to advance our CNM-Au8 NDA submission for the treatment of ALS under the accelerated approval pathway,” said Etherington. The company also continues to evaluate CNM-Au8’s impact on vision and cognition in multiple sclerosis patients, he added. “As always, we are incredibly motivated by our mission to help people suffering from ALS and other neurodegenerative diseases prolong their lifespan and improve their quality of life.”
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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