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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.
Clene Inc. (NASDAQ: CLNN) reported promising interim results from the RESCUE-ALS trial at the 2022 MDA Clinical & Scientific Conference. The trial indicated a 70% decreased risk of death for participants who entered the long-term open-label extension compared to predictions from the ENCALS risk model. The CNM-Au8 treatment showed significant benefits in slowing ALS disease progression, with improvements in quality of life metrics. Clene aims to validate these findings during ongoing larger clinical studies.
Clene Inc. (Nasdaq: CLNN) reported a full year 2021 net loss of $9.7 million, or $0.16 per share, improving from a loss of $19.3 million, or $1.10 per share, in 2020. As of December 31, 2021, cash and restricted cash totaled $50.3 million. Clene anticipates funding will last into Q2 2023. Key clinical milestones in 2022 include data from the HEALEY ALS Platform Trial and the VISIONARY-MS Trial, with results expected in the second half of 2022. The company also received two European patents regarding its nanotherapeutic drugs and a $1 million grant for a new manufacturing facility.
Clene Inc. (NASDAQ: CLNN), a biopharmaceutical company focused on treating neurodegenerative diseases, announced its participation in several upcoming healthcare conferences. Key events include the Roth 34th Annual Healthcare Conference on March 14, 2022, and the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, with respective presentation times of 3:00 PM ET and 8:40 AM ET. Webcasts will be available for on-demand viewing on the company's website. Clene aims to revolutionize treatments targeting energetic failure in neurological diseases.
Clene Inc. (NASDAQ: CLNN) announced promising interim data from its VISIONARY-MS Phase 2 trial and positive results from the REPAIR-MS trial, showcasing its lead drug candidate, CNM-Au8®, for treating Multiple Sclerosis (MS). The VISIONARY-MS trial shows significant improvements in the modified MS Functional Composite scores after 48 weeks of treatment, indicating potential neurological benefits. The REPAIR-MS trial demonstrated a notable increase in brain energy metabolism, with a 14.3% improvement in NAD+/NADH ratios. Clene aims to share unblinded data by late 2022.
Clene Inc. (NASDAQ: CLNN) announced it will present updated blinded data from its VISIONARY-MS study and results from the REPAIR-MS trial for stable relapsing MS at the ACTRIMS Forum 2022, held from Feb. 24-26 in West Palm Beach, FL. The presentations will include insights on CNM-Au8, a treatment targeting chronic optic neuropathy, and improvements in brain energy metabolism for MS patients. Both posters will be available on demand at the conference portal and on Clene's website starting Feb. 24, 2022.
Clene Inc. (NASDAQ: CLNN) announced key updates regarding its clinical programs, particularly for its lead candidate CNM-Au8 for treating neurodegenerative diseases. The HEALEY ALS Platform Trial has completed enrollment, with top-line data expected in the second half of 2022. Promising survival benefits from the RESCUE-ALS trial will be presented at a conference in March 2022. Meanwhile, the VISIONARY-MS trial is concluding early due to COVID-19 challenges, with unblinded data expected in the same timeframe. Clene is also moving forward with its COVID-19 trial in Brazil.
Clene Inc. (NASDAQ: CLNN) has appointed Morgan Brown as Chief Financial Officer effective February 1, 2022. Brown is a seasoned healthcare executive with extensive experience in financial leadership, particularly in the biopharmaceutical sector. He has previously raised over $1 billion in equity and debt financing and managed significant out-licensing transactions. His leadership comes during a critical phase in Clene's growth as they approach the potential commercialization of their lead drug candidate, CNM-Au8, in ALS.
Clene Inc. (NASDAQ: CLNN) has enrolled over 50% of participants in its Phase 2 study evaluating CNM-ZnAg, a zinc-silver ionic solution, for treating COVID-19 in Brazil. The study, with 276 planned participants, aims to determine the drug's efficacy in preventing hospitalization and achieving symptom resolution. Topline results are anticipated in 1H 2022. Clene's President emphasized the need for new therapeutic options due to ongoing virus mutations, highlighting CNM-ZnAg's potential if proven effective.
Clene Inc. (NASDAQ: CLNN) announced the validation of key patents from the European Patent Office that protect its innovative processes for treating neurodegenerative diseases. The patents enhance the company's lead candidate, CNM-Au8, a gold nanocrystal suspension aimed at treating amyotrophic lateral sclerosis (ALS). This significant development supports a Phase 3 registration study expected to reveal topline results in H2 2022. The patents offer extensive coverage for Clene's manufacturing methods and treatment approaches, bolstering its position in major global healthcare markets.
Clene Nanomedicine, a clinical-stage biopharmaceutical company, has received a $1 million grant from the Maryland Department of Housing and Community Development to support redeveloping its manufacturing facility in Elkton, MD. This expansion aims to boost manufacturing capacity for the anticipated commercialization of its lead drug candidate, CNM-Au8, targeting amyotrophic lateral sclerosis (ALS). Clene expresses gratitude for the state's support and emphasizes its commitment to community infrastructure growth.
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