Clene Inc. Provides Update on Corporate Presentation and ALS Clinical Trials

Clene Inc. (NASDAQ: CLNN), a company focused on developing novel nanotechnology-based therapeutics, recently released updates regarding its corporate presentation and clinical trials related to amyotrophic lateral sclerosis (ALS). On December 10, 2024, the company announced that it had presented additional data from its clinical trials and expanded access programs during poster sessions at the 35th International Symposium on ALS/MND.

The information presented included data on long-term survival with CNM-Au8 30 mg treatment and biomarkers of neurodegeneration, astrogliosis, and inflammation in ALS patients. Copies of the posters presented at the event have been furnished as Exhibit 99.2 and 99.3 in Clene’s recent filing with the Securities and Exchange Commission.

Furthermore, Clene disclosed that the U.S. Food and Drug Administration (FDA) has outlined a potential pathway for an accelerated approval of its drug, CNM-Au8, for the treatment of ALS. This potential accelerated approval would be subject to the submission of additional biomarker data related to CNM-Au8. The press release detailing the FDA’s feedback has been included as Exhibit 99.4 in Clene’s filing.

As part of the regulatory disclosures, Clene made public an updated corporate presentation, available on its website for investors. The company intends to use its website, invest.clene.com, to disseminate future updates to the Corporate Presentation, without necessarily filing additional Form 8-K reports for each update.

While the information shared in these disclosures is important for investors and stakeholders, it is essential to highlight that the details provided in these exhibits are not classified as “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934. Investors are advised to review these materials with caution and consider the context provided by Clene Inc. regarding this new regulatory update.

Investors and industry observers are eagerly awaiting further developments from Clene Inc. as it progresses with its clinical programs and regulatory interactions in the field of ALS therapeutics. For more information regarding this update, interested parties can refer to Clene Inc.’s recent filings with the Securities and Exchange Commission.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Clene’s 8K filing here.

Clene Company Profile

Clene Inc, a clinical-stage pharmaceutical company, focuses on the discovery, development, and commercialization of novel clean-surfaced nanotechnology (CSN) therapeutics. Its lead drug candidate is CNM-Au8, which is being studied in various clinical trials, including a completed Phase 2 platform trial to evaluate the safety and efficacy of CNM-Au8 in patients with amyotrophic lateral sclerosis (ALS); completed Phase 2 proof of concept clinical trial in patients with early symptomatic ALS; completed two open-label investigator blinded Phase 2 clinical trials on the brain's energy metabolites; completed Phase 2 clinical trial for the treatment of visual pathway deficits in chronic optic neuropathy for remyelination in stable relapsing Multiple Sclerosis; and a second Phase 2 clinical trial for the treatment of patients with Parkinson's Diseases.