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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. (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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Clene Inc. receives a $45.1 million grant from NINDS to support an Expanded Access Protocol for its investigational drug, CNM-Au8, in ALS.
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Clene Inc. announces the publication of a scientific paper describing the catalytic mechanism of action of its drug CNM-Au8 in neurodegenerative diseases. CNM-Au8 treatment promotes cell survival and preservation of neurite networks. The drug is being investigated as a potential first-in-class treatment for ALS, MS, and PD.
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Clene Inc. (CLNN) to participate in Cantor Fitzgerald Annual Global Healthcare Conference.
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Clene Inc. announces long-term follow-up data for patients treated with CNM-Au8 30mg in the HEALEY ALS Platform Trial, showing improved survival with a 49% decreased risk of death compared to PRO-ACT placebo (p=0.046). Pooled analysis with RESCUE-ALS Trial shows a 59% decreased risk of death (p=0.004). No safety signals observed with over 500 patient years of CNM-Au8 treatment exposure.
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Clene Inc. (Nasdaq: CLNN) to participate in investor conferences in September.
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Clene Inc. announces significant survival benefit and decreased risk of ALS worsening events with CNM-Au8 treatment
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Clene Inc. (CLNN) announced significant reductions in plasma neurofilament light chain levels compared to placebo in patients treated with CNM-Au8 in the HEALEY ALS Platform trial. The company also reported results of the Phase 2 RESCUE ALS study and its open-label extension, as well as a grant from the National Multiple Sclerosis Society to fund Cohort 2 of REPAIR-MS, a Phase 2 clinical study. Clene expects multiple near-term data announcements to support the benefit and safety of CNM-Au8 in ALS patients. The company's cash, cash equivalents, and marketable securities total $49.2 million as of June 30, 2023, including gross proceeds of $40 million from a recent public offering.
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FAQ
What is the current stock price of Clene (CLNN)?
The current stock price of Clene (CLNN) is $5 as of December 24, 2024.
What is the market cap of Clene (CLNN)?
The market cap of Clene (CLNN) is approximately 39.9M.
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
CLNN Stock Data
39.90M
5.68M
28.28%
12.91%
1.6%
Packaged Foods
Pharmaceutical Preparations
United States of America
SALT LAKE CITY