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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) recently announced promising results from the HEALEY ALS Platform Trial, highlighting the efficacy of its treatment CNM-Au8 in delaying clinical progression in amyotrophic lateral sclerosis (ALS) patients. Key findings include a 74% reduced risk of overall clinical worsening (p=0.035) and a 98% reduction in the risk of death or permanent assisted ventilation (p=0.028). The treatment was well-tolerated, presenting no significant safety concerns. Clene plans to meet with the FDA to discuss these results and seek a regulatory pathway for CNM-Au8. A live webcast to review these findings is scheduled for today at 7:30 a.m. EST.
Clene Inc. (Nasdaq: CLNN) will host a live audio webcast on March 9, 2023, at 7:30 a.m. ET to discuss new clinical results from the Healey ALS Platform Trial regarding its investigational product CNM-Au8. This trial is a multi-center, double-blind, placebo-controlled study assessing the safety and efficacy of CNM-Au8 for treating ALS. The primary outcome focuses on changes in disease severity over 24 weeks, with secondary endpoints including respiratory function and overall survival. Archived webcasts will be available shortly after the event on the company’s website.
Clene Inc. (Nasdaq: CLNN) has announced its participation in significant events, including Roth's 35th Annual Healthcare Conference from March 12th-14th and Renmark Financial's Virtual Non-Deal Roadshow Series on March 7th and 22nd. At the Roth Conference, Clene will present on March 13 at 3:30 p.m. EDT, accessible via a webcast link. Additionally, the Renmark events will feature a live Q&A with CEO Rob Etherington and CFO Morgan Brown. Interested individuals can register for both events through provided links. Clene aims to advance treatments for neurodegenerative diseases, highlighting their innovative work in this domain.
Clene Inc. (Nasdaq: CLNN) announced positive results from the open-label extension (OLE) of its Phase 2 RESCUE-ALS trial for its treatment CNM-Au8® in patients with early amyotrophic lateral sclerosis (ALS). Key findings include a significant preservation of function measured by the ALSFRS-R with a p-value of 0.0159 over 48 weeks, and an overall 52% reduction in the risk of ALS clinical worsening across 120 weeks (HR: 0.478, p=0.0494). The treatment was well-tolerated without long-term safety concerns. These results suggest that early treatment with CNM-Au8 may improve patient functionality and slow disease progression in ALS.
Clene Inc. (Nasdaq: CLNN) reported updated results from the VISIONARY-MS Phase 2 trial at the ACTRIMS Forum 2023, demonstrating positive clinical outcomes for CNM-Au8 in treating stable relapsing MS patients. Key findings include:
- Visual Evoked Potential (VEP) results showed improved signaling from the eye to the brain.
- MRI analysis indicated significant improvements in brain structure integrity.
- CNM-Au8 treatment was well-tolerated with no major safety concerns.
These results support further investigation into CNM-Au8, addressing the significant unmet needs in MS therapeutics.
Clene Inc. (Nasdaq: CLNN) announced promising results from the VISIONARY-MS trial investigating CNM-Au8 in stable relapsing multiple sclerosis (MS) patients. Updated MRI results showed significant improvements in brain neuronal structural integrity and myelin health, independent of immunomodulatory effects. Among the 68 participants with advanced MRI data, key metrics indicated robust enhancements in white matter integrity. These findings support previous clinical results demonstrating global neurological function improvements. Clene plans to initiate a Phase 3 study to further explore CNM-Au8's potential in addressing unmet needs in MS treatment.
Clene Inc. (Nasdaq: CLNN) will participate in Renmark Financial Communications’ Virtual Non-Deal Roadshow Series on January 18 and 23, 2023. The company invites investors and stakeholders to attend these free live events, featuring presentations from CEO Rob Etherington and CFO Morgan Brown, followed by a Q&A session. Registration is recommended as attendance may be limited, but replays will be available on the company's Investor website afterward. Clene focuses on developing treatments for neurodegenerative diseases.
Clene Inc. (Nasdaq: CLNN) announced that its Phase 2 trial of CNM-ZnAg, designed for treating non-hospitalized COVID-19 patients, did not meet its primary endpoint of substantial symptom resolution. Conducted in Brazil, the trial involved 288 participants and compared low and high doses of CNM-ZnAg to a placebo. Although the treatment showed a positive safety profile, with no adverse effects noted, the company decided to cease further development for COVID-19. Clene will refocus on its lead asset, CNM-Au8, for neurodegenerative diseases.
Clene Inc. (Nasdaq: CLNN) has secured a $5 million debt facility from the Maryland Department of Housing and Community Development. This loan, sourced through the State Small Business Credit Initiative, carries a 6% interest rate, maturing in 60 months. The funding will support Clene's efforts to advance CMN-Au8, a treatment for neurodegenerative diseases like ALS, while promoting pharmaceutical manufacturing jobs in Maryland. Clene's management highlights the loan as a successful public-private partnership aimed at creating value in the biopharmaceutical sector.
Clene Inc. (Nasdaq: CLNN) presented positive results from the VISIONARY-MS trial at the 14th Annual PACTRIMS Congress. The trial evaluated CNM-Au8 in stable multiple sclerosis (MS) patients. Key findings showed significant improvements in low contrast vision and global neurological function, as measured by the mMSFC, compared to placebo. Notably, CNM-Au8 was well-tolerated with no significant safety issues. Despite the trial being prematurely stopped due to COVID-19, these results may address an unmet need in MS treatment, prompting plans for a Phase 3 study.
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