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 plans to lease a 75,000 sq. ft. facility in Elkton, Maryland, to enhance its manufacturing capabilities ahead of positive data expected in H1 2022 from its Phase 3 trial for CNM-Au8, targeting amyotrophic lateral sclerosis (ALS). The company secured a Loan Agreement providing up to $30 million and a private placement (PIPE) to raise $9.25 million through the sale of common stock. Together, these initiatives are projected to increase Clene's cash position significantly to support its clinical and manufacturing expansion.
Clene Inc. (NASDAQ: CLNN) has appointed David J. Matlin as Chairman of the Board, succeeding Shalom Jacobovitz, who will remain on the Board. Matlin, who has been a Director since 2020, brings significant experience as the CEO of MatlinPatterson Global Advisers and a background in financial markets. Under Matlin's leadership, Clene aims to advance its clinical pipeline, notably a registration trial for ALS, with topline results expected in H1 2022. Clene focuses on treating neurodegenerative diseases through its innovative drug candidate, CNM-Au8.
Clene Inc. (NASDAQ: CLNN) received a Healthy Longevity Catalyst Award from the U.S. National Academy of Medicine for its bioenergetic nanocatalyst, CNM-Au8, aimed at treating aging-related neuronal deficits and Alzheimer's disease. Clene will utilize the award to fund preclinical studies, exploring CNM-Au8's potential in additional neurodegenerative diseases. Currently, CNM-Au8 is undergoing multiple clinical trials for amyotrophic lateral sclerosis, Parkinson’s, and multiple sclerosis, showcasing promise in enhancing neuroprotection and energy in neuronal cells.
Clene Inc. (NASDAQ: CLNN) announced promising preliminary blinded efficacy data from its ongoing Phase 2 RESCUE-ALS clinical trial, which evaluates CNM-Au8 in early symptomatic ALS patients. Data presented at the ENCALS 2021 meeting show that 34%, 26%, and 18% of participants demonstrated improvement in motor neuron function at Weeks 12, 24, and 36, respectively, differing from expected declines in prior studies. Correlation analyses indicate that these improvements are linked to less clinical worsening. Unblinded topline results are anticipated in the second half of 2021.
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.
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