Clene to Announce New CNM-Au8® Data From the Healey ALS Platform Trial

Rhea-AI Summary

Clene Inc. (Nasdaq: CLNN) will host a live audio webcast on March 9, 2023, at 7:30 a.m. ET to discuss new clinical results from the Healey ALS Platform Trial regarding its investigational product CNM-Au8. This trial is a multi-center, double-blind, placebo-controlled study assessing the safety and efficacy of CNM-Au8 for treating ALS. The primary outcome focuses on changes in disease severity over 24 weeks, with secondary endpoints including respiratory function and overall survival. Archived webcasts will be available shortly after the event on the company’s website.

Positive

• Hosting a live audio webcast to present new clinical results indicates active engagement with investors.
• CNM-Au8 is part of the Healey ALS Platform Trial, a significant study with a structured methodology evaluating multiple investigational products.

Negative

• Results of the CNM-Au8 trial remain unknown until the webcast, presenting uncertainty in investor outlook.

Webcast set for 7:30 a.m. ET on March 9

SALT LAKE CITY, March 08, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, announced today that it will host a live audio webcast at 7:30 a.m. ET tomorrow, Thursday, March 9, to review new clinical results from the CNM-Au8^® arm of the Healey ALS Platform Trial. The Healey ALS Platform Trial was a multi-center, double-blind, placebo-controlled study to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of CNM-Au8 in treating ALS. The webcast is accessible via the link below or the Investors section of the Company’s website located at www.clene.com.

Webcast Information:
Title: Clene’s Healey ALS Platform Trial Data Update
Presenters: Clene & Merit Cudkowicz, M.D., Chief Neurology Department, Director, Sean M Healey & AMG Center for ALS, and the Principal Investigator of the Healey ALS Platform Trial
Date: March 9, 2023
Start Time: 7:30 a.m. ET
Webcast link: https://edge.media-server.com/mmc/p/e8xezoye

The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

About the Healey ALS Platform Trial

The HEALEY ALS Platform Trial is a perpetual multi-center, randomized, double-blind, placebo-controlled program designed to evaluate the efficacy and safety of multiple investigational products utilizing a shared placebo group in people living with amyotrophic lateral sclerosis (ALS). In the CNM-Au8 regimen, 161 participants were randomized to 30 mg CNM-Au8, 60 mg CNM-Au8, or placebo as adjunct to standard of care for a 24-week treatment period. Active drug was offered to all participants who were eligible and elected to continue into the open-label extension. The primary outcome of the trial was the change in disease severity over time as measured by ALSFRS-R through 24 weeks accounting for mortality (analyzed using a Bayesian shared parameter model). Prespecified secondary efficacy endpoints included the Combined Assessment of Function and Survival joint rank test (CAFS), change in respiratory function as measured by slow vital capacity (SVC), and overall survival. For more information, please see ClinicalTrials.gov Identifier: NCT04297683.

About CNM-Au8
CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8 is a federally registered trademark of Clene Nanomedicine, Inc.

About Clene
Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter, LinkedIn and Facebook.

Media Contact Ignacio Guerrero-Ros, Ph.D., or David Schull Russo Partners, LLC Ignacio.guerrero-ros@russopartnersllc.com David.schull@russopartnersllc.com (858) 717-2310

Investor Contact Kevin Gardner LifeSci Advisors kgardner@lifesciadvisors.com 617-283-2856

FAQ

What is the date and time of Clene's webcast regarding CNM-Au8 results?

The webcast is scheduled for March 9, 2023, at 7:30 a.m. ET.

How can I access the webcast for Clene's clinical results?

The webcast can be accessed through Clene's website or via the provided link in the press release.

What is the focus of the Healey ALS Platform Trial involving CNM-Au8?

The trial assesses the safety and efficacy of CNM-Au8 in treating ALS, with a primary focus on changes in disease severity over 24 weeks.

How many participants were involved in the CNM-Au8 trial?

The trial involved 161 participants.

What are the primary and secondary endpoints of the Healey ALS Platform Trial?

The primary endpoint is the change in disease severity over time, while secondary endpoints include respiratory function and overall survival.