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Clene Inc. - CLNN STOCK NEWS

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.

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) received a Healthy Longevity Catalyst Award from the U.S. National Academy of Medicine for its bioenergetic nanocatalyst, CNM-Au8, aimed at treating aging-related neuronal deficits and Alzheimer's disease. Clene will utilize the award to fund preclinical studies, exploring CNM-Au8's potential in additional neurodegenerative diseases. Currently, CNM-Au8 is undergoing multiple clinical trials for amyotrophic lateral sclerosis, Parkinson’s, and multiple sclerosis, showcasing promise in enhancing neuroprotection and energy in neuronal cells.

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Clene Inc. (NASDAQ: CLNN) announced promising preliminary blinded efficacy data from its ongoing Phase 2 RESCUE-ALS clinical trial, which evaluates CNM-Au8 in early symptomatic ALS patients. Data presented at the ENCALS 2021 meeting show that 34%, 26%, and 18% of participants demonstrated improvement in motor neuron function at Weeks 12, 24, and 36, respectively, differing from expected declines in prior studies. Correlation analyses indicate that these improvements are linked to less clinical worsening. Unblinded topline results are anticipated in the second half of 2021.

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Clene Inc. (NASDAQ: CLNN) reported promising interim Phase 2 data for its drug CNM-Au8, suggesting potential neurological improvements in multiple sclerosis (MS) patients. The company secured a grant from the Michael J. Fox Foundation to expedite CNM-Au8's development for Parkinson's disease. Clene holds $48 million in cash as of March 31, 2021, sufficient to cover operations into mid-2022. However, the company reported a net loss of $39.8 million for Q1 2021, a significant increase from the previous year, largely due to unrealized losses and rising R&D expenses.

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Clene Inc. (NASDAQ: CLNN) has received Notices of Allowance from the U.S. Patent and Trademark Office for two patent applications related to its clean-surfaced nanocrystal therapeutic technology. This expands its patent portfolio to over 160, enhancing protection for its lead drug candidate, CNM-Au8. Currently undergoing evaluation in seven clinical studies targeting ALS, MS, and Parkinson’s disease, CNM-Au8 is pivotal for Clene's future, with Phase 3 trial results expected in H1 2022. Rob Etherington, CEO, emphasized the value of their growing intellectual property as the clinical pipeline advances.

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Clene Inc. (NASDAQ: CLNN) reported its full-year 2020 results, highlighting progress in its clinical trials for CNM-Au8, a neuroprotective nanocatalyst aimed at treating ALS, MS, and Parkinson's disease. Interim Phase 2 data showed over 40% improvement in motor neuron function in ALS patients. Clene has $59.3M in cash as of December 31, 2020, expected to fund operations into mid-2022. The company anticipates topline data from key trials in 2021, including the HEALEY ALS Platform trial and studies in MS and PD.

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Clene Inc. (NASDAQ: CLNN), a clinical-stage biopharmaceutical company, has showcased its corporate presentation on M-Vest.com and announced participation in the Maxim Group LLC Inaugural 2021 Emerging Growth Virtual Conference from March 17-19, 2021. At the conference, Clene will present on-demand and engage in a live fireside chat on March 19 at 11:00 am ET. The company's lead drug, CNM-Au8, aims to treat neurodegenerative diseases and is currently in advanced clinical trials for ALS, multiple sclerosis, and Parkinson’s disease. For more information, visit Clene’s investor website.

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Clene Inc. (NASDAQ: CLNN) announced that over 50% of participants have been enrolled in the HEALEY ALS Platform Trial, the first registration trial for amyotrophic lateral sclerosis (ALS). This trial, led by Mass General Hospital, aims to evaluate the safety and efficacy of multiple investigational products, including Clene's candidate, CNM-Au8. The study includes up to 54 expert ALS clinical trial sites across the U.S. and is supported by philanthropic funding. Full enrollment targets 160 patients, with results potentially impacting ALS treatment strategies.

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Clene Inc. (NASDAQ: CLNN) announced that its subsidiary, Clene Nanomedicine, will present at key investor conferences. The H.C. Wainwright Global Life Sciences Conference will feature a pre-recorded presentation available on-demand from March 9, 2021. A Fireside Chat is scheduled for the 33rd Annual Roth Conference on March 15, 2021, at 5:30 p.m. ET. Additionally, a live corporate presentation will occur at the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021, at 4:30 p.m. ET. Webcasts will be accessible on Clene's website.

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Clene Inc. (NASDAQ: CLNN) announced promising interim data from its Phase 2 study of CNM-Au8, a nanocatalyst aimed at treating Parkinson's disease (PD). The data indicate significant improvements in CNS bioenergetic metabolites among PD patients. The company was awarded a grant from The Michael J. Fox Foundation to further develop CNM-Au8, with a Phase 2 proof-of-concept trial expected to start in 2021. Findings suggest CNM-Au8 may slow PD progression by enhancing neuronal survival and reducing oxidative stress.

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Clene Inc. (NASDAQ: CLNN) announced positive interim data from its studies, VISIONARY-MS and REPAIR-MS, presented at the ACTRIMS Forum 2021. Interim results demonstrate CNM-Au8's potential in improving neurological functions in multiple sclerosis (MS) patients. The VISIONARY-MS trial showed significant enhancements in MS Functional Composite (MSFC) scores compared to baseline (p<0.0001). The REPAIR-MS study indicated notable metabolic improvements in CNS markers, suggesting a homeostatic effect of CNM-Au8. Unblinded topline data for both studies are expected in 2022.

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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

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