SALT LAKE CITY - Clene Inc. (NASDAQ:CLNN) announced new data supporting the efficacy of its investigational drug CNM-Au8 in treating amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. The data, submitted to the U.S. Food and Drug Administration (FDA), includes results from post hoc analyses of Phase 2 clinical trials.
Patients treated with CNM-Au8 who exhibited substantial reductions in neurofilament light (NfL) levels, a biomarker associated with ALS progression, showed significant improvements in survival and functional status compared to those with less or no reduction in NfL levels. Specifically, CNM-Au8 NfL Responders saw a 28% mean reduction in NfL levels and demonstrated improved survival rates and slower decline in the ALS Functional Rating Scale (ALSFRS-R), a measure of patient function.
Moreover, all participants treated with a 30mg dose of CNM-Au8 experienced significant survival benefits in long-term extension studies when compared to matched controls from natural history databases.
Merit Cudkowicz, M.D., Principal Investigator of the HEALEY ALS Platform Trial, highlighted the strong safety profile of CNM-Au8 and its link to survival evidence, advocating for a confirmatory Phase 3 clinical trial and discussions on regulatory approval pathways.
Clene's CEO, Rob Etherington, expressed optimism about the new data's potential to accelerate discussions with the FDA and bring CNM-Au8 to ALS patients sooner. Over 650 patient years of safety data have revealed no significant concerns or trends related to the drug's safety.
Clene Inc. has announced a 1-for-20 reverse stock split, a move aimed at maintaining compliance with Nasdaq's minimum bid price requirement for continued listing. The decision, authorized by Clene's stockholders and the company's Board of Directors, will reduce the outstanding common stock from approximately 128.7 million shares to about 6.4 million shares.
In parallel developments, Clene Inc. disclosed promising preclinical data for its product, CNM-Au8, a potential treatment for Rett Syndrome. The findings, presented at the 2024 International Rett Syndrome Foundation Annual Meeting, revealed that CNM-Au8 could improve mitochondrial respiration and support neuroprotection in vitro. The preclinical stages showed significant improvements in neuron health, neuron survival, and neurite lengths.
H.C. Wainwright has reiterated a Buy rating for Clene Inc., reflecting the firm's confidence in the potential of CNM-Au8 to become a significant treatment option for Rett Syndrome. This reaffirmation comes in the wake of the company's ongoing efforts to explore new indications for CNM-Au8.
InvestingPro Insights
As Clene Inc. (NASDAQ:CLNN) continues to show promise with its investigational ALS treatment CNM-Au8, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, Clene's market capitalization stands at $25.74 million, reflecting the size of the company in the current market landscape. Despite the potential breakthroughs in the medical field, the company's financial metrics demonstrate significant challenges. The Price to Earnings (P/E) ratio is currently negative at -0.52, indicating that the company is not generating profits relative to its share price.
InvestingPro Tips suggest that Clene's stock is in oversold territory, which could mean that the stock is undervalued compared to its potential. However, analysts are not optimistic about profitability in the near term, as there is an anticipation of a sales decline in the current year. Additionally, the stock has experienced a considerable decline over the past week, month, and year, with a one-year price total return of -71.95%. The company's stock is also trading near its 52-week low, which might attract investors looking for potential bargains.
For those interested in diving deeper into Clene Inc.'s financials and stock performance, InvestingPro offers a comprehensive set of metrics and tips. There are a total of 15 additional InvestingPro Tips available for investors seeking more detailed analysis, which can be found at https://www.investing.com/pro/CLNN. These tips could provide valuable insights for making informed investment decisions regarding Clene Inc.
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