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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 announced plans to submit a briefing book to the FDA by July 13, 2024, ahead of a Type C interaction scheduled for Q3 2024. The aim is to gain feedback on the accelerated approval pathway for CNM-Au8®, intended to treat ALS. The briefing book includes post-hoc analyses from completed clinical studies, focusing on neurofilament light (NfL) biomarker reduction, matured survival data, and evidence of CNM-Au8’s mechanism of action. These analyses address prior FDA comments and aim to demonstrate CNM-Au8’s potential for accelerated approval. Further data insights will be shared publicly later in 2024, and Clene will announce the FDA's feedback after the Type C interaction.
Clene (Nasdaq: CLNN), a biopharmaceutical company developing treatments for neurodegenerative diseases like ALS and MS, announced a 1-for-20 reverse stock split effective July 11, 2024. The split aims to comply with Nasdaq's $1.00 minimum closing bid price requirement. Clene's common stock will trade under the new CUSIP number 185634201, but the trading symbol 'CLNN' remains unchanged. Authorized by stockholders in May 2024, the reverse split reduces the total outstanding shares from approximately 128.7 million to 6.4 million, while maintaining each stockholder's ownership percentage. Equiniti Trust Company will manage the exchange and provide details to stockholders. Additional information is available in Clene's SEC filings and on their website.
Clene, a clinical-stage biopharmaceutical company, will present at H.C. Wainwright’s 5th Annual Neuro Perspectives Virtual Conference. The event, scheduled for June 27, 2024, will feature a fireside chat format and 1x1 investor meetings. Clene focuses on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). The webcast of the presentation will be available on Clene's website.
Clene presented preliminary data on June 19, 2024, at the International Rett Syndrome Foundation Annual Meeting, showcasing CNM-Au8® as a potential treatment for Rett Syndrome. This rare pediatric neurological disease, primarily affecting females, results in severe developmental impairments. CNM-Au8 demonstrated significant neuroprotective effects and mitochondrial function improvements in in vitro models. Clene aims to extend CNM-Au8’s applications beyond ALS and MS, leveraging its catalytic ability to enhance neuronal survival and remyelination. The study, in collaboration with Dr. Kathrin Meyer and researchers, highlights CNM-Au8's promise in treating multiple nervous system disorders.
Clene presented extended survival data and new neurofilament light (NfL) responder results for CNM-Au8 30 mg treatment from the HEALEY ALS Platform Trial open label extension at the 2024 ENCALS meeting.
The data showed a significant improvement in survival rates, with a hazard ratio of 0.431 (p=0.0002), demonstrating a 60% decreased risk of death up to 3.5 years post-baseline compared to matched PRO-ACT controls.
The trial included 59 participants originally randomized to CNM-Au8 30 mg treatment and 11 ex-placebo participants. Additionally, NfL responder analysis indicated an average 28% reduction in NfL levels (p<0.0001), suggesting decreased axonal loss. CNM-Au8 was found to be safe and well-tolerated with no identified safety signals over 650 patient years of exposure.
These results support CNM-Au8 as a potential treatment for ALS.
Clene (Nasdaq: CLNN), a clinical-stage biopharmaceutical company specializing in mitochondrial health and neuronal protection for neurodegenerative diseases, announced its participation in the Emerging Growth Conference.
The virtual presentation will take place on June 12, 2024, at 2:20 p.m. EDT and includes a corporate presentation with a Q&A session. The webcast will be accessible on Clene's website and a replay will be available on the Emerging Growth YouTube Channel.
The Emerging Growth Conference offers public companies a platform to present their innovations to a broad investor audience, including individual and institutional investors, as well as investment advisors and analysts.
Clene has announced updates for its NIH-funded Expanded Access Program (ACT-EAP) for CNM-Au8 in ALS. The first patient visit is planned for early June 2024. Enrollment has increased by 80%, now accommodating up to 180 participants. The program aims to collect 'real-world' data on drug efficacy, safety, survival, and disease progression. The initiative, supported by a four-year NIH grant, is designed in collaboration with Columbia University and Synapticure. The expanded access aims to improve the understanding of ALS and provide more treatment options for patients.
Clene (Nasdaq: CLNN) and its subsidiary Clene Nanomedicine, a late clinical-stage biopharmaceutical company, will be participating in three major investor conferences in May 2024.
The conferences include the Mizuho Neuroscience Summit on May 20-21, the Benchmark 2024 Healthcare House Call Virtual Conference on May 21-22, and the Virtual A.G.P. Healthcare Conference on May 22.
Clene focuses on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases like ALS, Parkinson's disease, and multiple sclerosis. Its investigational therapy, CNM-Au8®, aims to enhance central nervous system cell survival by targeting mitochondrial function and reducing oxidative stress.
Clene Inc. (Nasdaq: CLNN) reported its first quarter 2024 financial results and operating highlights, showcasing significant data from the Phase 2 VISIONARY-MS clinical trial of CNM-Au8® demonstrating repair and remyelination. The company also received a $7.3 million NIH grant for the ALS Expanded Access Program and had $27.9 million in cash and marketable securities as of March 31, 2024. Clene continues to advance its FDA discussions in ALS and aims to file a New Drug Application in 2024.
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