Welcome to our dedicated page for Clene news (Ticker: CLNN), a resource for investors and traders seeking the latest updates and insights on Clene stock.
About Clene Inc. (Nasdaq: CLNN)
Clene Inc. is a late clinical-stage biopharmaceutical company dedicated to revolutionizing treatment options for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease. Headquartered in Salt Lake City, Utah, with research and development facilities in Maryland, Clene is at the forefront of leveraging nanotechnology to address critical unmet medical needs. The company’s patented Clean-Surface Nanocrystal (CSN) Technology enables the production of high-purity nanocrystals that enhance cellular energy metabolism and reduce oxidative stress, key contributors to neurodegeneration.
Core Technology and Innovation
Clene’s proprietary CSN platform represents a paradigm shift in pharmaceutical development, moving beyond traditional small-molecule drugs and biologics. By utilizing high-purity metallic nanocrystals, the technology targets mitochondrial function, the NAD pathway, and oxidative stress, enhancing the survival and functionality of central nervous system cells. This approach is exemplified by Clene’s lead candidate, CNM-Au8®, an oral suspension of gold nanocrystals designed to restore neuronal health and function.
Focus on Neurodegenerative Diseases
Clene is primarily focused on addressing neurodegenerative diseases with limited treatment options. Its flagship product, CNM-Au8®, is being developed for ALS, MS, and Parkinson’s disease. By improving mitochondrial health and reducing biomarkers like neurofilament light (NfL), CNM-Au8® has demonstrated potential in delaying disease progression and improving survival rates in clinical trials. Clene is also exploring the application of CNM-Au8® in rare diseases such as Rett Syndrome, further expanding its therapeutic scope.
Clinical Pipeline and Regulatory Progress
Clene’s clinical pipeline includes multiple Phase 2 and Phase 3 trials for CNM-Au8®. The company has garnered support from the National Institutes of Health (NIH) and other organizations to advance its research. Notably, Clene’s Expanded Access Programs (EAPs) provide real-world evidence of CNM-Au8®’s efficacy, particularly in ALS. These programs, combined with biomarker analyses and survival data, are integral to Clene’s pursuit of an accelerated approval pathway with the U.S. Food and Drug Administration (FDA).
Strategic Partnerships and Market Position
Clene collaborates with leading institutions, including Columbia University and Massachusetts General Hospital, to advance its clinical programs. The company recently partnered with APST Research GmbH to leverage one of the largest ALS biomarker datasets for regulatory submissions. By focusing on mitochondrial health and oxidative stress, Clene differentiates itself from competitors in the neurodegenerative disease space, such as Biogen and Amylyx Pharmaceuticals.
Commitment to Patients and Future Outlook
Clene’s mission is deeply rooted in improving patient outcomes. With over 800 participant-years of safety data and a robust clinical pipeline, the company is well-positioned to address the urgent needs of patients with neurodegenerative diseases. As Clene progresses toward regulatory milestones, its innovative approach to nanomedicine holds promise for transforming the treatment landscape.
Clene Inc. (NASDAQ: CLNN) announced the completion of the final patient visit in its Phase 2 RESCUE-ALS study, with close-out activities now underway. The trial involved 45 ALS patients and aimed to evaluate the efficacy and safety of CNM-Au8, a gold nanocrystal suspension. Interim results demonstrated improvements in neurophysiology endpoints, contrasting prior worsening in ALS data sets. Notably, 90% of eligible participants have chosen to continue treatment under a long-term extension of the study. Unblinded topline data are expected in Q4 2021.
Clene Inc. (NASDAQ: CLNN) announced its participation in several investor conferences in September 2021. The events include the Citi’s 16th Annual BioPharma Virtual Conference from September 8-10, the H.C. Wainwright 23rd Annual Global Investment Conference on September 13 with a pre-recorded corporate presentation, the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21 for a live presentation, and the 2021 Cantor Virtual Global Healthcare Conference on September 27. Webcasts of the presentations will be available on Clene's website.
Clene Inc. (NASDAQ: CLNN) has finalized lease agreements that will more than quadruple its manufacturing capacity for CNM-Au8, a leading treatment for neurodegenerative diseases. The first lease is for a 74,210 sq. ft. facility in Elkton, Maryland, set to be redeveloped within weeks, with partial occupancy anticipated in months. Additionally, a seven-year lease will expand existing capacity at another Maryland site to 32,229 sq. ft. This expansion responds to the upcoming Phase 3 trial data for ALS, enhancing Clene's readiness for potential commercialization.
Clene Inc. (NASDAQ: CLNN) reported positive Phase 2 REPAIR trial results, indicating that its nanotherapy, CNM-Au8, significantly enhances brain energy metabolism in patients with neurodegenerative diseases. CNM-Au8 showed 10.4% improvement in the NAD+/NADH ratio in MS and PD patients. The RESCUE-ALS trial is on track for top-line data in H2 2021, suggesting neuro-reparative potential in ALS. As of June 30, 2021, the company had $63 million in cash and expects sufficient funds for over 12 months. The company incurred a net loss of $3.4 million for the quarter, an improvement from the previous year.
Clene Inc. (NASDAQ: CLNN) has appointed Dr. Vallerie V. McLaughlin to its board as the seventh independent director. Dr. McLaughlin, a renowned cardiovascular expert from the University of Michigan, has significant experience in rare diseases, particularly pulmonary arterial hypertension. Her addition is expected to strengthen Clene's leadership as it approaches the commercialization phase of its lead candidate, CNM-Au8, for ALS treatment. This move reflects Clene's strategy to enhance its clinical pipeline with medical leadership.
Clene Inc. (NASDAQ: CLNN) announced positive top-line results from its Phase 2 REPAIR clinical trials for the energy-enhancing nanotherapeutic CNM-Au8 in patients with Parkinson's disease (PD) and multiple sclerosis (MS). The primary endpoint showed a statistically significant increase in the brain NAD+/NADH ratio by 10.4% after 12 weeks of treatment (p=0.037). The trials demonstrated consistent brain target engagement, enhancing the potential for meaningful neurological improvements in neurodegenerative disorders. Furthermore, CNM-Au8 was well tolerated, with no serious adverse events reported.
Clene Inc. (NASDAQ: CLNN) announced its participation in Canaccord Genuity's 41st Annual Growth Conference, scheduled for August 11, 2021, at 3:30 p.m. EDT. The virtual presentation will focus on Clene's innovative efforts in treating neurodegenerative diseases using nanotechnology. Their lead candidate, CNM-Au8, aims to enhance cellular energy to support neurorepair, currently being evaluated through multiple clinical trials for conditions such as amyotrophic lateral sclerosis and multiple sclerosis. More information is available on Clene's official website.
Clene Inc. (NASDAQ: CLNN) will host a webinar on July 14, 2021, at 4:30 p.m. ET, focusing on 'Cellular Energetic Failure' related to ALS and MS. Expert speakers include Professors Matthew Kiernan and Benjamin Greenberg, who will discuss current treatment options and unmet needs in these conditions. Clene's management will present their lead candidate, CNM-Au8, a gold nanocrystal suspension aimed at improving neuroprotection and energy in cells. The webinar will also cover milestone expectations, including data from the Phase 2 RESCUE-ALS trial.
Clene Inc. (NASDAQ: CLNN) announced its inclusion in the U.S. small-cap Russell 2000® and all-cap Russell 3000® Indexes effective June 28, 2021. This membership is based on the company's market capitalization as of May 7, 2021, and will last for one year.
Rob Etherington, President and CEO, stated that this recognition will enhance the visibility of Clene's stock and attract more institutional investors. The firm aims to achieve key milestones, such as announcing topline data from its Phase 2 RESCUE-ALS trial later this year, which may increase shareholder value.
Clene Inc. (NASDAQ: CLNN) announced that Rob Etherington, President and CEO, will present at the Raymond James Human Health Innovation Conference on June 22, 2021, at 11:20 a.m. ET. A webcast of the presentation will be available on Clene's website. Clene is a clinical-stage biopharmaceutical company focused on neurodegenerative diseases, utilizing nanotechnology to address bioenergetic failure. Their lead drug candidate, CNM-Au8, is in Phase 3 trials for ALS and Phase 2 trials for multiple sclerosis and Parkinson’s disease.
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