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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) reported promising interim Phase 2 data for its drug CNM-Au8, suggesting potential neurological improvements in multiple sclerosis (MS) patients. The company secured a grant from the Michael J. Fox Foundation to expedite CNM-Au8's development for Parkinson's disease. Clene holds $48 million in cash as of March 31, 2021, sufficient to cover operations into mid-2022. However, the company reported a net loss of $39.8 million for Q1 2021, a significant increase from the previous year, largely due to unrealized losses and rising R&D expenses.
Clene Inc. (NASDAQ: CLNN) has received Notices of Allowance from the U.S. Patent and Trademark Office for two patent applications related to its clean-surfaced nanocrystal therapeutic technology. This expands its patent portfolio to over 160, enhancing protection for its lead drug candidate, CNM-Au8. Currently undergoing evaluation in seven clinical studies targeting ALS, MS, and Parkinson’s disease, CNM-Au8 is pivotal for Clene's future, with Phase 3 trial results expected in H1 2022. Rob Etherington, CEO, emphasized the value of their growing intellectual property as the clinical pipeline advances.
Clene Inc. (NASDAQ: CLNN) reported its full-year 2020 results, highlighting progress in its clinical trials for CNM-Au8, a neuroprotective nanocatalyst aimed at treating ALS, MS, and Parkinson's disease. Interim Phase 2 data showed over 40% improvement in motor neuron function in ALS patients. Clene has $59.3M in cash as of December 31, 2020, expected to fund operations into mid-2022. The company anticipates topline data from key trials in 2021, including the HEALEY ALS Platform trial and studies in MS and PD.
Clene Inc. (NASDAQ: CLNN), a clinical-stage biopharmaceutical company, has showcased its corporate presentation on M-Vest.com and announced participation in the Maxim Group LLC Inaugural 2021 Emerging Growth Virtual Conference from March 17-19, 2021. At the conference, Clene will present on-demand and engage in a live fireside chat on March 19 at 11:00 am ET. The company's lead drug, CNM-Au8, aims to treat neurodegenerative diseases and is currently in advanced clinical trials for ALS, multiple sclerosis, and Parkinson’s disease. For more information, visit Clene’s investor website.
Clene Inc. (NASDAQ: CLNN) announced that over 50% of participants have been enrolled in the HEALEY ALS Platform Trial, the first registration trial for amyotrophic lateral sclerosis (ALS). This trial, led by Mass General Hospital, aims to evaluate the safety and efficacy of multiple investigational products, including Clene's candidate, CNM-Au8. The study includes up to 54 expert ALS clinical trial sites across the U.S. and is supported by philanthropic funding. Full enrollment targets 160 patients, with results potentially impacting ALS treatment strategies.
Clene Inc. (NASDAQ: CLNN) announced that its subsidiary, Clene Nanomedicine, will present at key investor conferences. The H.C. Wainwright Global Life Sciences Conference will feature a pre-recorded presentation available on-demand from March 9, 2021. A Fireside Chat is scheduled for the 33rd Annual Roth Conference on March 15, 2021, at 5:30 p.m. ET. Additionally, a live corporate presentation will occur at the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021, at 4:30 p.m. ET. Webcasts will be accessible on Clene's website.
Clene Inc. (NASDAQ: CLNN) announced promising interim data from its Phase 2 study of CNM-Au8, a nanocatalyst aimed at treating Parkinson's disease (PD). The data indicate significant improvements in CNS bioenergetic metabolites among PD patients. The company was awarded a grant from The Michael J. Fox Foundation to further develop CNM-Au8, with a Phase 2 proof-of-concept trial expected to start in 2021. Findings suggest CNM-Au8 may slow PD progression by enhancing neuronal survival and reducing oxidative stress.
Clene Inc. (NASDAQ: CLNN) announced positive interim data from its studies, VISIONARY-MS and REPAIR-MS, presented at the ACTRIMS Forum 2021. Interim results demonstrate CNM-Au8's potential in improving neurological functions in multiple sclerosis (MS) patients. The VISIONARY-MS trial showed significant enhancements in MS Functional Composite (MSFC) scores compared to baseline (p<0.0001). The REPAIR-MS study indicated notable metabolic improvements in CNS markers, suggesting a homeostatic effect of CNM-Au8. Unblinded topline data for both studies are expected in 2022.
Clene Inc. (NASDAQ: CLNN) will present updated interim data from its REPAIR-MS and VISIONARY-MS studies at the ACTRIMS Forum 2021, from February 25-27. The REPAIR-MS study examines the safety and efficacy of CNM-Au8 in patients diagnosed with MS, while the VISIONARY-MS trial focuses on its effects on chronic visual impairment in stable relapsing MS patients. Key endpoints of VISIONARY-MS include improvements in low contrast letter acuity and other functional tests after treatment. The results may highlight CNM-Au8’s potential in treating neurodegenerative diseases.
Clene Inc. (NASDAQ: CLNN) announced that its subsidiary Clene Nanomedicine received ANVISA approval to conduct a Phase 2 clinical study in Brazil. The trial will assess the efficacy and safety of CNM-ZnAg in treating acutely symptomatic, non-hospitalized COVID-19 patients. It aims to enroll approximately 276 patients, focusing on reducing hospitalizations at 28 days. While vaccines are available, the need for COVID-19 therapeutics persists. Results are expected in the second half of 2021, showcasing the company's dedication to advancing therapeutic solutions.
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