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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) reported its Q2 2024 financial results and updates on CNM-Au8® programs. Key highlights:
1. Improved survival in CNM-Au8 30 mg treated ALS patients compared to controls.
2. Significant clinical improvements in CNM-Au8 NfL Responders.
3. Neuroprotective effects demonstrated in Rett Syndrome model.
4. First ALS patient enrolled in NIH-funded Expanded Access Program.
5. Regained Nasdaq listing compliance.
6. FDA Type C interaction scheduled for Q3 2024.
Financial results: Cash and equivalents of $21.7M as of June 30, 2024. Q2 net loss of $6.8M ($1.06 per share), compared to $25.1M ($5.84 per share) in Q2 2023. R&D expenses decreased to $4.2M from $6.6M year-over-year.
Clene Inc. (Nasdaq: CLNN) has submitted new CNM-Au8 biomarker and clinical efficacy data to the FDA for ALS treatment. Key findings include:
1. CNM-Au8 NfL Responders showed significant improvements in survival, functional status, and combined function and survival.
2. Long-term CNM-Au8 treatment demonstrated substantial survival benefits compared to matched controls.
3. NAD and glutathione improvements were consistent with CNM-Au8 treatment, supporting its dual mechanism of action.
4. Safety profile remains strong with no significant concerns identified over 650 patient years of data.
These results aim to support discussions with the FDA for an accelerated approval pathway for CNM-Au8 in ALS treatment.
Clene Inc. (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focusing on neurodegenerative diseases, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase. The event is scheduled for August 13, 2024, with Clene's presentation set for 11:30 am EST.
Clene specializes in improving mitochondrial health and protecting neuronal function to treat conditions such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). The company's management will deliver a presentation and host one-on-one investor meetings during the conference.
Interested parties can access a webcast of the presentation through Clene's website in the 'Events' section or via a provided registration link.
Clene (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, such as ALS and MS, will present at the Emerging Growth Conference. The virtual presentation is scheduled for July 18, 2024, at 4:45 p.m. EDT and will include a corporate update and Q&A session. The webcast will be available on Clene's website and the Emerging Growth YouTube Channel. The Emerging Growth Conference is designed to connect public companies with investors, featuring companies from various growth sectors. Clene's investigational therapy, CNM-Au8®, targets mitochondrial function to improve cell survival and reduce oxidative stress. Based in Salt Lake City, Clene also has R&D and manufacturing operations in Maryland.
Clene announced plans to submit a briefing book to the FDA by July 13, 2024, ahead of a Type C interaction scheduled for Q3 2024. The aim is to gain feedback on the accelerated approval pathway for CNM-Au8®, intended to treat ALS. The briefing book includes post-hoc analyses from completed clinical studies, focusing on neurofilament light (NfL) biomarker reduction, matured survival data, and evidence of CNM-Au8’s mechanism of action. These analyses address prior FDA comments and aim to demonstrate CNM-Au8’s potential for accelerated approval. Further data insights will be shared publicly later in 2024, and Clene will announce the FDA's feedback after the Type C interaction.
Clene (Nasdaq: CLNN), a biopharmaceutical company developing treatments for neurodegenerative diseases like ALS and MS, announced a 1-for-20 reverse stock split effective July 11, 2024. The split aims to comply with Nasdaq's $1.00 minimum closing bid price requirement. Clene's common stock will trade under the new CUSIP number 185634201, but the trading symbol 'CLNN' remains unchanged. Authorized by stockholders in May 2024, the reverse split reduces the total outstanding shares from approximately 128.7 million to 6.4 million, while maintaining each stockholder's ownership percentage. Equiniti Trust Company will manage the exchange and provide details to stockholders. Additional information is available in Clene's SEC filings and on their website.
Clene, a clinical-stage biopharmaceutical company, will present at H.C. Wainwright’s 5th Annual Neuro Perspectives Virtual Conference. The event, scheduled for June 27, 2024, will feature a fireside chat format and 1x1 investor meetings. Clene focuses on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). The webcast of the presentation will be available on Clene's website.
Clene presented preliminary data on June 19, 2024, at the International Rett Syndrome Foundation Annual Meeting, showcasing CNM-Au8® as a potential treatment for Rett Syndrome. This rare pediatric neurological disease, primarily affecting females, results in severe developmental impairments. CNM-Au8 demonstrated significant neuroprotective effects and mitochondrial function improvements in in vitro models. Clene aims to extend CNM-Au8’s applications beyond ALS and MS, leveraging its catalytic ability to enhance neuronal survival and remyelination. The study, in collaboration with Dr. Kathrin Meyer and researchers, highlights CNM-Au8's promise in treating multiple nervous system disorders.
Clene presented extended survival data and new neurofilament light (NfL) responder results for CNM-Au8 30 mg treatment from the HEALEY ALS Platform Trial open label extension at the 2024 ENCALS meeting.
The data showed a significant improvement in survival rates, with a hazard ratio of 0.431 (p=0.0002), demonstrating a 60% decreased risk of death up to 3.5 years post-baseline compared to matched PRO-ACT controls.
The trial included 59 participants originally randomized to CNM-Au8 30 mg treatment and 11 ex-placebo participants. Additionally, NfL responder analysis indicated an average 28% reduction in NfL levels (p<0.0001), suggesting decreased axonal loss. CNM-Au8 was found to be safe and well-tolerated with no identified safety signals over 650 patient years of exposure.
These results support CNM-Au8 as a potential treatment for ALS.
Clene (Nasdaq: CLNN), a clinical-stage biopharmaceutical company specializing in mitochondrial health and neuronal protection for neurodegenerative diseases, announced its participation in the Emerging Growth Conference.
The virtual presentation will take place on June 12, 2024, at 2:20 p.m. EDT and includes a corporate presentation with a Q&A session. The webcast will be accessible on Clene's website and a replay will be available on the Emerging Growth YouTube Channel.
The Emerging Growth Conference offers public companies a platform to present their innovations to a broad investor audience, including individual and institutional investors, as well as investment advisors and analysts.
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