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. (CLNN) reported promising outcomes for its CNM-Au8® in the Healey ALS Platform Trial, showcasing a >90% reduction in mortality risk at 24 weeks. The Phase 2 VISIONARY-MS trial also reported positive results, meeting both primary and secondary endpoints regarding neurological improvement. As of September 30, 2022, Clene had cash and equivalents of $16.2 million, following a $10.8 million stock offering. However, the company posted a net loss of $11.0 million in Q3 2022, down from a net income of $28.9 million the previous year, influenced by contingent earn-out liabilities.
Clene Inc. (CLNN) announced a registered direct offering of 10,723,926 shares at $1.01 each, expected to close around November 2, 2022, raising approximately $10.8 million. The funds will support general corporate purposes and the clinical development of CNM-Au8. Additionally, Clene secured a $5 million Loan Facility from the Maryland DHCD, contingent on matching this with $5 million in new equity capital, which the offering will fulfill. These financings aim to strengthen Clene's balance sheet and advance therapies for ALS and other neurodegenerative diseases.
Clene Inc. (Nasdaq: CLNN) announced topline results from the Healey ALS Platform trial, revealing that while the primary endpoint was not met, the 30 mg dose of CNM-Au8 showed a greater than 90% reduction in the risk of death at 24 weeks. The study failed to meet secondary endpoints of function and respiratory capacity, but survival results were consistent with earlier Phase 2 trials. Clene plans to continue the open-label extension of CNM-Au8 and is discussing an Expanded Access Protocol for eligible participants.
Clene Inc. (NASDAQ: CLNN) is set to announce topline results for its CNM-Au8® regimen in the HEALEY ALS Platform Trial on October 3, 2022. Following the release, Clene's management will host a conference call and webcast at 8:30 a.m. EDT to discuss findings. CNM-Au8®, an oral suspension of gold nanocrystals, aims to enhance neuronal health by facilitating energy production, targeting conditions like multiple sclerosis and amyotrophic lateral sclerosis. Investors can access the webcast through the company’s website.
Clene Inc. (Nasdaq: CLNN) announced significant findings from the Phase 2 RESCUE-ALS trial, indicating that treatment with CNM-Au8 reduced the risk of mortality by approximately 70% compared to placebo. The updated analyses, presented at the 2022 AANEM Conference, revealed that the treatment was well-tolerated with no significant safety concerns. These results support CNM-Au8's potential as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS). Clene also aims to advance CNM-Au8's development in other neurodegenerative diseases.
SALT LAKE CITY, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) announced its participation in two upcoming investor conferences in September 2022. The first is Citi’s 17th Annual BioPharma Conference on September 8, 2022, in Boston, followed by H.C. Wainwright's 24th Annual Global Investment Conference on September 12-13, 2022, in New York. Clene's lead asset, CNM-Au8, is a treatment for multiple sclerosis and amyotrophic lateral sclerosis that enhances neuronal health through gold nanocrystals. More information can be found on their website.
Clene Inc. (Nasdaq: CLNN) announced positive topline results from the Phase 2 VISIONARY-MS trial of CNM-Au8, an investigational treatment for relapsing multiple sclerosis (RRMS). The trial met its primary endpoint, showing significant improvements in Low Contrast Letter Acuity (LCLA) and the modified Multiple Sclerosis Functional Composite (mMSFC) over 48 weeks compared to placebo. CNM-Au8 was well-tolerated, with no significant safety issues noted. These results support advancing CNM-Au8 into Phase 3 development, addressing critical needs in MS treatment.
Clene Inc. (Nasdaq: CLNN) reported positive topline results from its Phase 2 VISIONARY-MS trial with CNM-Au8®, showing significant improvements in Low Contrast Letter Acuity (LCLA) and modified Multiple Sclerosis Functional Composite (mMSFC) over 48 weeks. In addition, open-label results from the RESCUE-ALS trial indicated a significant reduction in mortality (5 CNM-Au8 deaths vs. 14 placebo deaths). As of June 30, 2022, cash reserves were $26.3 million. Clene has also received European Orphan Drug Designation for CNM-Au8 in ALS, with further clinical data expected this quarter.
Clene Inc. (NASDAQ: CLNN) will present results from its Phase 2 VISIONARY-MS trial on August 15, 2022, at 7:30 a.m. EDT. The trial focuses on CNM-Au8, an oral suspension aimed at improving neuronal health in neurodegenerative diseases. Interested investors can join via conference call at 1 (888) 770-7152 using Conference ID: 5318408, or access a live audio webcast on the company's website for further insights into the clinical outcomes and implications for treatment.
Clene Inc. (Nasdaq: CLNN) has received a positive opinion from the European Medicines Agency for Orphan Drug Designation for CNM-Au8® aimed at treating amyotrophic lateral sclerosis (ALS). This designation, granted for serious conditions affecting fewer than 5 in 10,000 individuals, will provide Clene with regulatory benefits, including reduced fees and market exclusivity. The decision was based on data from the Phase 2 RESCUE-ALS trial, showing a statistically significant survival benefit. The company plans to expedite CNM-Au8's availability to ALS patients.
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