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.
Clene Inc. reports developments as a late clinical-stage biopharmaceutical company developing clean-surfaced nanotechnology therapeutics for neurodegenerative diseases. Through Clene Nanomedicine Inc., the company focuses on improving mitochondrial health and protecting neuronal function in amyotrophic lateral sclerosis, multiple sclerosis and Parkinson’s disease.
Recurring news centers on CNM-Au8®, an investigational nanocrystal suspension designed to target mitochondrial function and the NAD pathway while reducing oxidative stress. Company updates include ALS biomarker and expanded-access data, FDA meeting and regulatory communications, operating and financial results, registered direct financing activity, shareholder communications, voting matters and investor-conference presentations.
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) 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 (p0.0001). 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.