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SALT LAKE CITY - Clene Inc. (NASDAQ:CLNN), a biopharmaceutical company with a market capitalization of $33.5 million, has announced a collaboration with APST Research GmbH to analyze longitudinal neurofilament light (NfL) biomarker data from amyotrophic lateral sclerosis (ALS) patients. This effort aims to support the potential accelerated approval of Clene’s investigational drug CNM-Au8 for ALS treatment. According to InvestingPro data, the company is currently burning through cash rapidly, with negative free cash flow of $23.7 million in the last twelve months.
The partnership will utilize APST’s extensive ALS patient database, which includes serum NfL data from over 4,300 patients, to compare with findings from Clene’s ongoing Expanded Access Protocols (EAPs) sponsored by the National Institutes of Health (NIH). Clene’s EAP programs have involved nearly 500 ALS patients and have not identified any significant safety concerns or adverse events related to CNM-Au8 treatment. The announcement comes as the company’s stock has experienced a significant decline, down 50.8% over the past year. InvestingPro analysis suggests the stock is currently undervalued based on its Fair Value model.
Clene intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2025, with the analyses of NfL reduction in EAP participants expected to form part of the supportive evidence for CNM-Au8’s effect on NfL decline. The objective is to demonstrate that the rate of NfL change is associated with survival in ALS patients.
Clene’s CEO, Rob Etherington, expressed the company’s commitment to the ALS community and its goal to provide additional evidence for FDA review. APST’s founder and CEO, Thomas Meyer, highlighted the importance of their robust data collection in advancing clinical research and understanding ALS progression.
CNM-Au8 is an oral suspension of gold nanocrystals designed to improve mitochondrial health and protect neuronal function. The drug is currently under investigation for its potential to treat neurodegenerative diseases, including ALS, Parkinson’s disease, and multiple sclerosis. Investors should note that Clene’s next earnings report is scheduled for March 11, 2025. InvestingPro subscribers have access to additional insights, including 8 more ProTips and detailed financial metrics that could help evaluate the company’s progress in drug development and commercialization efforts.
This announcement is based on a press release statement from Clene Inc. and does not endorse the claims made. The information provided is intended for informational purposes only and does not constitute financial advice.
In other recent news, Clene Inc. has secured up to $8 million in additional funding for its amyotrophic lateral sclerosis (ALS) treatment program. This funding comes as part of an amended grant subaward with Columbia University, extending financial support from September 1, 2024, to August 31, 2025. The amendment is linked to the National Institute of Health’s $45.1 million grant under the Accelerating Access to Critical Therapies for ALS Act. Clene Inc. collaborates with Columbia University and Synapticure on the Expanded Access Program for CNM-Au8, a treatment for ALS. The recent amendment, disclosed in an SEC filing, focuses on financial details while leaving other terms unchanged. This development is significant for Clene Inc.’s ongoing efforts in ALS treatment, ensuring the continuation of the program. Investors can find the full text of the amendment in Exhibit 10.1 of the SEC filing for more detailed information.
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