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) reported its Q1 2022 results, revealing cash, cash equivalents, and marketable securities of $36.6 million. The company anticipates data readouts for its lead asset, CNM-Au8®, for ALS and MS in Q3 2022. Key results from the RESCUE-ALS trial showed a 70% survival benefit for patients in an open-label extension. Operating expenses rose, with R&D at $8.6 million, while net loss improved to $13.4 million, down from $39.8 million year-over-year. Clene expects funding will last into Q2 2023.
Clene Inc. (NASDAQ: CLNN) has announced promising new data from the open-label extension of its RESCUE-ALS study, revealing a significant 70% survival benefit for ALS patients treated with CNM-Au8®. The interim analysis showed a hazard ratio of 0.3 (p=0.006), indicating a lower mortality risk compared to the ENCALS prediction model. The Phase 2 study also highlighted benefits in slowing disease progression and enhancing life quality. CEO Rob Etherington expresses optimism for future trials and the potential to change treatment paradigms for ALS.
Clene Inc. (NASDAQ: CLNN) reported promising interim results from the RESCUE-ALS trial at the 2022 MDA Clinical & Scientific Conference. The trial indicated a 70% decreased risk of death for participants who entered the long-term open-label extension compared to predictions from the ENCALS risk model. The CNM-Au8 treatment showed significant benefits in slowing ALS disease progression, with improvements in quality of life metrics. Clene aims to validate these findings during ongoing larger clinical studies.
Clene Inc. (Nasdaq: CLNN) reported a full year 2021 net loss of $9.7 million, or $0.16 per share, improving from a loss of $19.3 million, or $1.10 per share, in 2020. As of December 31, 2021, cash and restricted cash totaled $50.3 million. Clene anticipates funding will last into Q2 2023. Key clinical milestones in 2022 include data from the HEALEY ALS Platform Trial and the VISIONARY-MS Trial, with results expected in the second half of 2022. The company also received two European patents regarding its nanotherapeutic drugs and a $1 million grant for a new manufacturing facility.
Clene Inc. (NASDAQ: CLNN), a biopharmaceutical company focused on treating neurodegenerative diseases, announced its participation in several upcoming healthcare conferences. Key events include the Roth 34th Annual Healthcare Conference on March 14, 2022, and the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, with respective presentation times of 3:00 PM ET and 8:40 AM ET. Webcasts will be available for on-demand viewing on the company's website. Clene aims to revolutionize treatments targeting energetic failure in neurological diseases.
Clene Inc. (NASDAQ: CLNN) announced promising interim data from its VISIONARY-MS Phase 2 trial and positive results from the REPAIR-MS trial, showcasing its lead drug candidate, CNM-Au8®, for treating Multiple Sclerosis (MS). The VISIONARY-MS trial shows significant improvements in the modified MS Functional Composite scores after 48 weeks of treatment, indicating potential neurological benefits. The REPAIR-MS trial demonstrated a notable increase in brain energy metabolism, with a 14.3% improvement in NAD+/NADH ratios. Clene aims to share unblinded data by late 2022.
Clene Inc. (NASDAQ: CLNN) announced it will present updated blinded data from its VISIONARY-MS study and results from the REPAIR-MS trial for stable relapsing MS at the ACTRIMS Forum 2022, held from Feb. 24-26 in West Palm Beach, FL. The presentations will include insights on CNM-Au8, a treatment targeting chronic optic neuropathy, and improvements in brain energy metabolism for MS patients. Both posters will be available on demand at the conference portal and on Clene's website starting Feb. 24, 2022.
Clene Inc. (NASDAQ: CLNN) announced key updates regarding its clinical programs, particularly for its lead candidate CNM-Au8 for treating neurodegenerative diseases. The HEALEY ALS Platform Trial has completed enrollment, with top-line data expected in the second half of 2022. Promising survival benefits from the RESCUE-ALS trial will be presented at a conference in March 2022. Meanwhile, the VISIONARY-MS trial is concluding early due to COVID-19 challenges, with unblinded data expected in the same timeframe. Clene is also moving forward with its COVID-19 trial in Brazil.
Clene Inc. (NASDAQ: CLNN) has appointed Morgan Brown as Chief Financial Officer effective February 1, 2022. Brown is a seasoned healthcare executive with extensive experience in financial leadership, particularly in the biopharmaceutical sector. He has previously raised over $1 billion in equity and debt financing and managed significant out-licensing transactions. His leadership comes during a critical phase in Clene's growth as they approach the potential commercialization of their lead drug candidate, CNM-Au8, in ALS.
Clene Inc. (NASDAQ: CLNN) has enrolled over 50% of participants in its Phase 2 study evaluating CNM-ZnAg, a zinc-silver ionic solution, for treating COVID-19 in Brazil. The study, with 276 planned participants, aims to determine the drug's efficacy in preventing hospitalization and achieving symptom resolution. Topline results are anticipated in 1H 2022. Clene's President emphasized the need for new therapeutic options due to ongoing virus mutations, highlighting CNM-ZnAg's potential if proven effective.
FAQ
What is the current stock price of Clene (CLNN)?
What is the market cap of Clene (CLNN)?
What is Clene Inc.'s core technology?
What diseases is Clene targeting?
What is CNM-Au8®?
What sets Clene apart from competitors?
How does Clene generate revenue?
What is Clene’s regulatory strategy?
What are Clene’s safety findings for CNM-Au8®?
Who are Clene’s key collaborators?
What is the potential market impact of CNM-Au8®?
How does Clene contribute to real-world evidence in ALS?
