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. reports developments as a late clinical-stage biopharmaceutical company developing clean-surfaced nanotechnology therapeutics for neurodegenerative diseases. Through Clene Nanomedicine Inc., the company focuses on improving mitochondrial health and protecting neuronal function in amyotrophic lateral sclerosis, multiple sclerosis and Parkinson’s disease.
Recurring news centers on CNM-Au8®, an investigational nanocrystal suspension designed to target mitochondrial function and the NAD pathway while reducing oxidative stress. Company updates include ALS biomarker and expanded-access data, FDA meeting and regulatory communications, operating and financial results, registered direct financing activity, shareholder communications, voting matters and investor-conference presentations.
Clene Inc. (CLNN) reported significant clinical advancements for its treatment CNM-Au8 in two key trials targeting amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). In the HEALEY ALS Platform Trial, CNM-Au8 showed a 74% reduced risk of ALS clinical worsening at six months, while the RESCUE-ALS Trial confirmed preserved physical function at 48 weeks. In MS, the VISIONARY-MS trial highlighted improvements in neurological function and brain structure. Financially, Clene ended 2022 with $23.3 million in cash, but reported a net loss of $29.9 million, up from $9.7 million in 2021. The company is focusing on advancing regulatory discussions with the FDA for both indications in 2023.
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.