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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) has reported promising results from its RESCUE-ALS trial, showing that patients treated with CNM-Au8 experienced significantly improved survival rates compared to those receiving a placebo. The trial indicated a 70% reduction in the risk of death for the CNM-Au8 group, based on Kaplan-Meier survival analysis (HR=0.301, p=0.0143). The treatment was also well-tolerated with no major safety issues noted. Clene anticipates releasing further data from the larger HEALEY ALS Platform Trial, aiming to confirm and expand on these promising findings.
Clene (NASDAQ: CLNN) announced that President and CEO Rob Etherington will join a virtual panel on ALS treatments, hosted by Maxim Group on June 28 at 11 a.m. EDT. The discussion will address the urgent need for new therapies for amyotrophic lateral sclerosis (ALS), as current options are limited. Clene's lead candidate, CNM-Au8®, is in late-stage trials, with topline data expected in Q3 from a Phase 2/3 study. This drug aims to restore neuronal health with gold nanocrystals, enhancing energy production and offering neuroprotection.
Clene Inc. (NASDAQ: CLNN) has announced its support for Lou Gehrig Day, marking the occasion by broadcasting a message on the Nasdaq MarketSite tower in Times Square. This initiative enhances awareness for ALS, a disease that Gehrig famously battled. Former Yankees outfielder Chris Dickerson will feature in the message, emphasizing commitment to ALS research and treatment. Clene is focused on new therapies and anticipates topline results from its Phase 2/3 clinical trial for its lead drug candidate, CNM-Au8, in the upcoming quarter.
Clene presented new interim survival data from its Phase 2 RESCUE-ALS study, showing that early treatment with CNM-Au8 reduced mortality risk by 62% compared to delayed treatment (HR 0.38; p = 0.06) and by 64% against the ENCALS predicted median survival (HR 0.36; p=0.008). The data suggest significant neuroprotection and improved quality of life for ALS patients. The ongoing study has been extended indefinitely, highlighting CNM-Au8’s potential as a disease-modifying treatment for ALS.
Clene Inc. (NASDAQ: CLNN) has secured a $3 million loan from Maryland’s Neighborhood BusinessWorks program to facilitate capital equipment purchases for a new 75,000-square-foot manufacturing facility in Elkton, Maryland. This facility will support the production of CNM-Au8®, Clene's lead drug candidate aimed at treating ALS. This non-dilutive funding aims to bolster Clene’s manufacturing capabilities in anticipation of potential commercialization, with topline data expected from a Phase 2/3 registrational study in Q3 2022.
Clene Inc. (NASDAQ: CLNN) will participate in several upcoming investor conferences, showcasing its commitment to revolutionizing the treatment of neurodegenerative diseases. The company will present at the H.C. Wainwright Global Investment Conference on May 25, 2022, at 2 p.m. ET, followed by participation in the Benchmark Healthcare House Call Virtual 1x1 Conference on June 2, 2022, and the JMP Securities Life Sciences Conference on June 15, 2022, also at 2 p.m. ET. Clene focuses on addressing energetic failure, a key factor in many neurological conditions.
Clene Inc. (Nasdaq: CLNN) reported its Q1 2022 results, revealing cash, cash equivalents, and marketable securities of $36.6 million. The company anticipates data readouts for its lead asset, CNM-Au8®, for ALS and MS in Q3 2022. Key results from the RESCUE-ALS trial showed a 70% survival benefit for patients in an open-label extension. Operating expenses rose, with R&D at $8.6 million, while net loss improved to $13.4 million, down from $39.8 million year-over-year. Clene expects funding will last into Q2 2023.
Clene Inc. (NASDAQ: CLNN) has announced promising new data from the open-label extension of its RESCUE-ALS study, revealing a significant 70% survival benefit for ALS patients treated with CNM-Au8®. The interim analysis showed a hazard ratio of 0.3 (p=0.006), indicating a lower mortality risk compared to the ENCALS prediction model. The Phase 2 study also highlighted benefits in slowing disease progression and enhancing life quality. CEO Rob Etherington expresses optimism for future trials and the potential to change treatment paradigms for ALS.
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.
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