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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) announced positive topline results from the Phase 2 VISIONARY-MS trial of CNM-Au8, an investigational treatment for relapsing multiple sclerosis (RRMS). The trial met its primary endpoint, showing significant improvements in Low Contrast Letter Acuity (LCLA) and the modified Multiple Sclerosis Functional Composite (mMSFC) over 48 weeks compared to placebo. CNM-Au8 was well-tolerated, with no significant safety issues noted. These results support advancing CNM-Au8 into Phase 3 development, addressing critical needs in MS treatment.
Clene Inc. (Nasdaq: CLNN) reported positive topline results from its Phase 2 VISIONARY-MS trial with CNM-Au8®, showing significant improvements in Low Contrast Letter Acuity (LCLA) and modified Multiple Sclerosis Functional Composite (mMSFC) over 48 weeks. In addition, open-label results from the RESCUE-ALS trial indicated a significant reduction in mortality (5 CNM-Au8 deaths vs. 14 placebo deaths). As of June 30, 2022, cash reserves were $26.3 million. Clene has also received European Orphan Drug Designation for CNM-Au8 in ALS, with further clinical data expected this quarter.
Clene Inc. (NASDAQ: CLNN) will present results from its Phase 2 VISIONARY-MS trial on August 15, 2022, at 7:30 a.m. EDT. The trial focuses on CNM-Au8, an oral suspension aimed at improving neuronal health in neurodegenerative diseases. Interested investors can join via conference call at 1 (888) 770-7152 using Conference ID: 5318408, or access a live audio webcast on the company's website for further insights into the clinical outcomes and implications for treatment.
Clene Inc. (Nasdaq: CLNN) has received a positive opinion from the European Medicines Agency for Orphan Drug Designation for CNM-Au8® aimed at treating amyotrophic lateral sclerosis (ALS). This designation, granted for serious conditions affecting fewer than 5 in 10,000 individuals, will provide Clene with regulatory benefits, including reduced fees and market exclusivity. The decision was based on data from the Phase 2 RESCUE-ALS trial, showing a statistically significant survival benefit. The company plans to expedite CNM-Au8's availability to ALS patients.
Clene Inc. (Nasdaq: CLNN) has reported promising results from its RESCUE-ALS trial, showing that patients treated with CNM-Au8 experienced significantly improved survival rates compared to those receiving a placebo. The trial indicated a 70% reduction in the risk of death for the CNM-Au8 group, based on Kaplan-Meier survival analysis (HR=0.301, p=0.0143). The treatment was also well-tolerated with no major safety issues noted. Clene anticipates releasing further data from the larger HEALEY ALS Platform Trial, aiming to confirm and expand on these promising findings.
Clene (NASDAQ: CLNN) announced that President and CEO Rob Etherington will join a virtual panel on ALS treatments, hosted by Maxim Group on June 28 at 11 a.m. EDT. The discussion will address the urgent need for new therapies for amyotrophic lateral sclerosis (ALS), as current options are limited. Clene's lead candidate, CNM-Au8®, is in late-stage trials, with topline data expected in Q3 from a Phase 2/3 study. This drug aims to restore neuronal health with gold nanocrystals, enhancing energy production and offering neuroprotection.
Clene Inc. (NASDAQ: CLNN) has announced its support for Lou Gehrig Day, marking the occasion by broadcasting a message on the Nasdaq MarketSite tower in Times Square. This initiative enhances awareness for ALS, a disease that Gehrig famously battled. Former Yankees outfielder Chris Dickerson will feature in the message, emphasizing commitment to ALS research and treatment. Clene is focused on new therapies and anticipates topline results from its Phase 2/3 clinical trial for its lead drug candidate, CNM-Au8, in the upcoming quarter.
Clene presented new interim survival data from its Phase 2 RESCUE-ALS study, showing that early treatment with CNM-Au8 reduced mortality risk by 62% compared to delayed treatment (HR 0.38; p = 0.06) and by 64% against the ENCALS predicted median survival (HR 0.36; p=0.008). The data suggest significant neuroprotection and improved quality of life for ALS patients. The ongoing study has been extended indefinitely, highlighting CNM-Au8’s potential as a disease-modifying treatment for ALS.
Clene Inc. (NASDAQ: CLNN) has secured a $3 million loan from Maryland’s Neighborhood BusinessWorks program to facilitate capital equipment purchases for a new 75,000-square-foot manufacturing facility in Elkton, Maryland. This facility will support the production of CNM-Au8®, Clene's lead drug candidate aimed at treating ALS. This non-dilutive funding aims to bolster Clene’s manufacturing capabilities in anticipation of potential commercialization, with topline data expected from a Phase 2/3 registrational study in Q3 2022.
Clene Inc. (NASDAQ: CLNN) will participate in several upcoming investor conferences, showcasing its commitment to revolutionizing the treatment of neurodegenerative diseases. The company will present at the H.C. Wainwright Global Investment Conference on May 25, 2022, at 2 p.m. ET, followed by participation in the Benchmark Healthcare House Call Virtual 1x1 Conference on June 2, 2022, and the JMP Securities Life Sciences Conference on June 15, 2022, also at 2 p.m. ET. Clene focuses on addressing energetic failure, a key factor in many neurological conditions.
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