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.
Clene Inc. (NASDAQ: CLNN) has finalized lease agreements that will more than quadruple its manufacturing capacity for CNM-Au8, a leading treatment for neurodegenerative diseases. The first lease is for a 74,210 sq. ft. facility in Elkton, Maryland, set to be redeveloped within weeks, with partial occupancy anticipated in months. Additionally, a seven-year lease will expand existing capacity at another Maryland site to 32,229 sq. ft. This expansion responds to the upcoming Phase 3 trial data for ALS, enhancing Clene's readiness for potential commercialization.
Clene Inc. (NASDAQ: CLNN) reported positive Phase 2 REPAIR trial results, indicating that its nanotherapy, CNM-Au8, significantly enhances brain energy metabolism in patients with neurodegenerative diseases. CNM-Au8 showed 10.4% improvement in the NAD+/NADH ratio in MS and PD patients. The RESCUE-ALS trial is on track for top-line data in H2 2021, suggesting neuro-reparative potential in ALS. As of June 30, 2021, the company had $63 million in cash and expects sufficient funds for over 12 months. The company incurred a net loss of $3.4 million for the quarter, an improvement from the previous year.
Clene Inc. (NASDAQ: CLNN) has appointed Dr. Vallerie V. McLaughlin to its board as the seventh independent director. Dr. McLaughlin, a renowned cardiovascular expert from the University of Michigan, has significant experience in rare diseases, particularly pulmonary arterial hypertension. Her addition is expected to strengthen Clene's leadership as it approaches the commercialization phase of its lead candidate, CNM-Au8, for ALS treatment. This move reflects Clene's strategy to enhance its clinical pipeline with medical leadership.
Clene Inc. (NASDAQ: CLNN) announced positive top-line results from its Phase 2 REPAIR clinical trials for the energy-enhancing nanotherapeutic CNM-Au8 in patients with Parkinson's disease (PD) and multiple sclerosis (MS). The primary endpoint showed a statistically significant increase in the brain NAD+/NADH ratio by 10.4% after 12 weeks of treatment (p=0.037). The trials demonstrated consistent brain target engagement, enhancing the potential for meaningful neurological improvements in neurodegenerative disorders. Furthermore, CNM-Au8 was well tolerated, with no serious adverse events reported.
Clene Inc. (NASDAQ: CLNN) announced its participation in Canaccord Genuity's 41st Annual Growth Conference, scheduled for August 11, 2021, at 3:30 p.m. EDT. The virtual presentation will focus on Clene's innovative efforts in treating neurodegenerative diseases using nanotechnology. Their lead candidate, CNM-Au8, aims to enhance cellular energy to support neurorepair, currently being evaluated through multiple clinical trials for conditions such as amyotrophic lateral sclerosis and multiple sclerosis. More information is available on Clene's official website.
Clene Inc. (NASDAQ: CLNN) will host a webinar on July 14, 2021, at 4:30 p.m. ET, focusing on 'Cellular Energetic Failure' related to ALS and MS. Expert speakers include Professors Matthew Kiernan and Benjamin Greenberg, who will discuss current treatment options and unmet needs in these conditions. Clene's management will present their lead candidate, CNM-Au8, a gold nanocrystal suspension aimed at improving neuroprotection and energy in cells. The webinar will also cover milestone expectations, including data from the Phase 2 RESCUE-ALS trial.
Clene Inc. (NASDAQ: CLNN) announced its inclusion in the U.S. small-cap Russell 2000® and all-cap Russell 3000® Indexes effective June 28, 2021. This membership is based on the company's market capitalization as of May 7, 2021, and will last for one year.
Rob Etherington, President and CEO, stated that this recognition will enhance the visibility of Clene's stock and attract more institutional investors. The firm aims to achieve key milestones, such as announcing topline data from its Phase 2 RESCUE-ALS trial later this year, which may increase shareholder value.
Clene Inc. (NASDAQ: CLNN) announced that Rob Etherington, President and CEO, will present at the Raymond James Human Health Innovation Conference on June 22, 2021, at 11:20 a.m. ET. A webcast of the presentation will be available on Clene's website. Clene is a clinical-stage biopharmaceutical company focused on neurodegenerative diseases, utilizing nanotechnology to address bioenergetic failure. Their lead drug candidate, CNM-Au8, is in Phase 3 trials for ALS and Phase 2 trials for multiple sclerosis and Parkinson’s disease.
Clene Inc. (NASDAQ: CLNN) announced plans to lease a 75,000 sq. ft. facility in Elkton, Maryland, to enhance its manufacturing capabilities ahead of positive data expected in H1 2022 from its Phase 3 trial for CNM-Au8, targeting amyotrophic lateral sclerosis (ALS). The company secured a Loan Agreement providing up to $30 million and a private placement (PIPE) to raise $9.25 million through the sale of common stock. Together, these initiatives are projected to increase Clene's cash position significantly to support its clinical and manufacturing expansion.
Clene Inc. (NASDAQ: CLNN) has appointed David J. Matlin as Chairman of the Board, succeeding Shalom Jacobovitz, who will remain on the Board. Matlin, who has been a Director since 2020, brings significant experience as the CEO of MatlinPatterson Global Advisers and a background in financial markets. Under Matlin's leadership, Clene aims to advance its clinical pipeline, notably a registration trial for ALS, with topline results expected in H1 2022. Clene focuses on treating neurodegenerative diseases through its innovative drug candidate, CNM-Au8.
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