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) will participate in Renmark Financial Communications’ Virtual Non-Deal Roadshow Series on January 18 and 23, 2023. The company invites investors and stakeholders to attend these free live events, featuring presentations from CEO Rob Etherington and CFO Morgan Brown, followed by a Q&A session. Registration is recommended as attendance may be limited, but replays will be available on the company's Investor website afterward. Clene focuses on developing treatments for neurodegenerative diseases.
Clene Inc. (Nasdaq: CLNN) announced that its Phase 2 trial of CNM-ZnAg, designed for treating non-hospitalized COVID-19 patients, did not meet its primary endpoint of substantial symptom resolution. Conducted in Brazil, the trial involved 288 participants and compared low and high doses of CNM-ZnAg to a placebo. Although the treatment showed a positive safety profile, with no adverse effects noted, the company decided to cease further development for COVID-19. Clene will refocus on its lead asset, CNM-Au8, for neurodegenerative diseases.
Clene Inc. (Nasdaq: CLNN) has secured a $5 million debt facility from the Maryland Department of Housing and Community Development. This loan, sourced through the State Small Business Credit Initiative, carries a 6% interest rate, maturing in 60 months. The funding will support Clene's efforts to advance CMN-Au8, a treatment for neurodegenerative diseases like ALS, while promoting pharmaceutical manufacturing jobs in Maryland. Clene's management highlights the loan as a successful public-private partnership aimed at creating value in the biopharmaceutical sector.
Clene Inc. (Nasdaq: CLNN) presented positive results from the VISIONARY-MS trial at the 14th Annual PACTRIMS Congress. The trial evaluated CNM-Au8 in stable multiple sclerosis (MS) patients. Key findings showed significant improvements in low contrast vision and global neurological function, as measured by the mMSFC, compared to placebo. Notably, CNM-Au8 was well-tolerated with no significant safety issues. Despite the trial being prematurely stopped due to COVID-19, these results may address an unmet need in MS treatment, prompting plans for a Phase 3 study.
Clene Inc. (CLNN) reported promising outcomes for its CNM-Au8® in the Healey ALS Platform Trial, showcasing a >90% reduction in mortality risk at 24 weeks. The Phase 2 VISIONARY-MS trial also reported positive results, meeting both primary and secondary endpoints regarding neurological improvement. As of September 30, 2022, Clene had cash and equivalents of $16.2 million, following a $10.8 million stock offering. However, the company posted a net loss of $11.0 million in Q3 2022, down from a net income of $28.9 million the previous year, influenced by contingent earn-out liabilities.
Clene Inc. (CLNN) announced a registered direct offering of 10,723,926 shares at $1.01 each, expected to close around November 2, 2022, raising approximately $10.8 million. The funds will support general corporate purposes and the clinical development of CNM-Au8. Additionally, Clene secured a $5 million Loan Facility from the Maryland DHCD, contingent on matching this with $5 million in new equity capital, which the offering will fulfill. These financings aim to strengthen Clene's balance sheet and advance therapies for ALS and other neurodegenerative diseases.
Clene Inc. (Nasdaq: CLNN) announced topline results from the Healey ALS Platform trial, revealing that while the primary endpoint was not met, the 30 mg dose of CNM-Au8 showed a greater than 90% reduction in the risk of death at 24 weeks. The study failed to meet secondary endpoints of function and respiratory capacity, but survival results were consistent with earlier Phase 2 trials. Clene plans to continue the open-label extension of CNM-Au8 and is discussing an Expanded Access Protocol for eligible participants.
Clene Inc. (NASDAQ: CLNN) is set to announce topline results for its CNM-Au8® regimen in the HEALEY ALS Platform Trial on October 3, 2022. Following the release, Clene's management will host a conference call and webcast at 8:30 a.m. EDT to discuss findings. CNM-Au8®, an oral suspension of gold nanocrystals, aims to enhance neuronal health by facilitating energy production, targeting conditions like multiple sclerosis and amyotrophic lateral sclerosis. Investors can access the webcast through the company’s website.
Clene Inc. (Nasdaq: CLNN) announced significant findings from the Phase 2 RESCUE-ALS trial, indicating that treatment with CNM-Au8 reduced the risk of mortality by approximately 70% compared to placebo. The updated analyses, presented at the 2022 AANEM Conference, revealed that the treatment was well-tolerated with no significant safety concerns. These results support CNM-Au8's potential as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS). Clene also aims to advance CNM-Au8's development in other neurodegenerative diseases.
SALT LAKE CITY, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) announced its participation in two upcoming investor conferences in September 2022. The first is Citi’s 17th Annual BioPharma Conference on September 8, 2022, in Boston, followed by H.C. Wainwright's 24th Annual Global Investment Conference on September 12-13, 2022, in New York. Clene's lead asset, CNM-Au8, is a treatment for multiple sclerosis and amyotrophic lateral sclerosis that enhances neuronal health through gold nanocrystals. More information can be found on their website.
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