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Clene Inc. (Nasdaq: CLNN) is a clinical-stage biopharmaceutical company leading the forefront of innovative treatments for neurodegenerative diseases. Utilizing their patented clean-surfaced nanotechnology (CSN), Clene has developed a groundbreaking electro-crystal-chemistry drug development platform, which produces stable, clean-surfaced nanocrystal suspensions. This cutting-edge technology allows for the creation of therapeutic nanoparticles designed to treat conditions such as amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple sclerosis (MS).
Headquartered in Salt Lake City, Utah, Clene operates with additional research and development facilities in Maryland. Their flagship product, CNM-Au8®, is a first-in-class investigational therapy that enhances mitochondrial health, thus protecting neuronal function. CNM-Au8® targets the central nervous system, facilitating improved cellular survival and function through mechanisms involving the NAD pathway and reduction of oxidative stress.
Recent significant achievements include:
- VISIONARY-MS Trial: Clene reported sustained improvement in vision and cognitive function in patients with stable relapsing MS during the long-term extension phase of the trial, demonstrating the potential of CNM-Au8® to improve neurological outcomes.
- ALS Expanded Access Program (EAP): Clene's EAP has shown promising survival benefits for individuals with advanced ALS, highlighting the robust efficacy and safety of CNM-Au8®.
- NIH Funding: Clene secured a substantial four-year grant from the National Institutes of Health to support an expanded access program for ALS, emphasizing the recognition and support from the broader medical and scientific community.
- Financial Position: As of the end of 2023, Clene reported $35 million in cash and equivalents, ensuring sufficient funding to advance their operations through 2024.
Clene continues to build on its promising clinical data, aiming to move CNM-Au8® into Phase 3 trials and potentially bring new hope to patients suffering from neurodegenerative diseases. For more information, visit Clene's website or follow them on social media platforms such as X (formerly Twitter) and LinkedIn.
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Clene Inc. and its subsidiary Clene Nanomedicine Inc. reported the publication of a study on the protein corona formed by CNM-Au8 gold nanocrystals. The corona aids in blood-brain barrier penetration, enhancing the drug's neuroprotective mechanism. The study revealed that the protein corona prevents aggregation, promotes colloidal stability, and prolongs circulation time in the blood. CNM-Au8's unique composition, enriched with apolipoproteins, facilitates brain delivery and has shown positive results in preclinical and clinical studies, with plans for a Phase 3 trial for ALS treatment in 2024.
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Clene Inc. (CLNN) announced discussions with FDA for accelerated approval of CNM-Au8® for ALS treatment. Long-term data showed significant reductions in plasma neurofilament levels and survival benefits. Financially, the company reported $35.0 million in cash as of Dec 31, 2023, with a grant of $45.1 million for an EAP in ALS.
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Clene Inc. and its subsidiary Clene Nanomedicine Inc. will participate in the 36th Annual ROTH Conference to discuss their focus on improving mitochondrial health and treating neurodegenerative diseases like ALS and MS. The presentation will be held on March 18, 2024, at The Ritz Carlton Laguna Niguel in California.
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Clene Inc. (CLNN) presents positive long-term clinical results for CNM-Au8 in treating multiple sclerosis at the ACTRIMS Forum. CNM-Au8 shows significant vision and cognition improvement over 35 months, well-tolerated with no serious adverse events.
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Clene Inc. reports significant survival benefits in ALS patients treated with CNM-Au8 in Expanded Access Programs. The treatment showed a 68% and 57% decreased risk of all-cause mortality compared to controls. The therapy was well-tolerated with no serious adverse events.
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Clene Inc. (Nasdaq: CLNN) reported positive long-term results for CNM-Au8® in the treatment of multiple sclerosis (MS) in the VISIONARY-MS trial. The treatment demonstrated significant improvement in vision and cognition through 35 months from randomization, with no significant safety concerns reported.
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Clene Inc. (Nasdaq: CLNN) reported new data from the 12-month long-term open label extension (OLE) of the CNM-Au8® treatment arm in the HEALEY ALS Platform Trial, showing significantly reduced plasma neurofilament light chain (NfL) levels at 76 weeks relative to placebo, a 60% decreased risk of long-term all-cause mortality, and greater overall treatment effect in delaying the time to morbidity events in the highest risk participants based on baseline NfL levels.
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Clene Inc. (Nasdaq: CLNN) provided an ALS regulatory update from its recent meeting with the U.S. Food and Drug Administration (FDA) regarding CNM-Au8® for the treatment of ALS. The FDA determined that the initial findings on biomarker NfL reduction from the Phase 2 programs were insufficient to support accelerated approval at this time. Clene plans to provide supplemental data for further engagement with the FDA, including additional long-term clinical evidence and biomarker results in the first half of 2024. The company also supports ongoing CNM-Au8 compassionate use programs and plans to launch a Phase 3 ALS confirmatory study in 2024.
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Clene Inc. (Nasdaq: CLNN) and its subsidiary Clene Nanomedicine Inc. announce the successful Phase 2 REPAIR clinical studies for CNM-Au8® in treating neurodegenerative diseases. The studies show significant increase in brain NAD+/NADH ratio, ATP levels, and phosphorylation potential, indicating favorable modulation of brain energy metabolites. The results are published in the Journal of Nanobiotechnology, signaling a significant advancement in the treatment of Parkinson’s disease and multiple sclerosis.
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Clene Inc. (Nasdaq: CLNN) reported statistically significant improved survival benefit of 19.3 months and significantly delayed clinical worsening in patients treated with CNM-Au8® in the RESCUE ALS open-label extension trial. The company also announced a statistically significant long-term survival benefit of 70% decreased risk of death associated with CNM-Au8 treatment in the HEALEY ALS Platform Trial. Additionally, they were awarded a $45.1 million NINDS grant to support research and expanded access of CNM-Au8 in people living with ALS and announced a peer-reviewed publication characterizing CNM-Au8 neuroprotective mechanism of action in a nanotechnology-focused journal. Clene's cash and cash equivalents totaled $42.1 million as of September 30, 2023, and they expect their resources to be sufficient to fund operations into the third quarter of 2024.
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FAQ
What is the current stock price of Clene (CLNN)?
The current stock price of Clene (CLNN) is $4.17 as of November 22, 2024.
What is the market cap of Clene (CLNN)?
The market cap of Clene (CLNN) is approximately 32.1M.
What does Clene Inc. specialize in?
Clene Inc. specializes in developing and commercializing clean-surfaced nanotechnology (CSN) therapeutics aimed at treating neurodegenerative diseases like ALS, Parkinson's, and MS.
What is CNM-Au8®?
CNM-Au8® is Clene's investigational therapy composed of gold nanocrystals designed to improve mitochondrial health and neuronal function by targeting the NAD pathway and reducing oxidative stress.
Where is Clene Inc. located?
Clene Inc. is headquartered in Salt Lake City, Utah, with additional research and development and manufacturing operations in Maryland.
What recent achievements has Clene Inc. reported?
Recent achievements include significant improvements in MS patient outcomes from the VISIONARY-MS trial, survival benefits in ALS from expanded access programs, and securing a major NIH grant.
What is the significance of the NIH funding for Clene?
The NIH funding supports an expanded access program for ALS, acknowledging Clene's innovative approaches and providing resources to treat more patients with CNM-Au8®.
How stable is Clene Inc.'s financial status?
As of the end of 2023, Clene reported $35 million in cash and equivalents, ensuring sufficient funding for operations through 2024.
What is unique about Clene's clean-surfaced nanotechnology?
Clene's clean-surfaced nanotechnology creates high-purity nanocrystal suspensions that improve therapeutic outcomes by enhancing mitochondrial function and reducing oxidative stress.
How has CNM-Au8® performed in clinical trials?
In clinical trials, CNM-Au8® has shown improvements in vision, cognitive function, and overall neurological health in patients with MS and ALS, with consistent safety and tolerability.
What are Clene’s future plans for CNM-Au8®?
Clene plans to advance CNM-Au8® into Phase 3 clinical trials to further validate its efficacy and safety, with the aim of obtaining regulatory approval for broader clinical use.
Where can I get more information about Clene Inc.?
More information about Clene Inc. can be found on their website at www.clene.com, as well as their social media profiles on X (formerly Twitter) and LinkedIn.
Clene Inc.
Nasdaq:CLNN
CLNN Rankings
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32.08M
5.68M
28.28%
12.91%
1.6%
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United States of America
SALT LAKE CITY