On Wednesday, H.C. Wainwright maintained a Buy rating on Clene Inc. (NASDAQ:CLNN) and significantly raised the shares target to $31.00 from the previous $7.00.
This adjustment follows Clene's announcement on Tuesday of promising new biomarker data and additional long-term survival analyses which indicate the clinical efficacy of their drug CNM-Au8 in treating patients with ALS (Amyotrophic Lateral Sclerosis).
The recent findings are part of a briefing book submitted to the FDA, in preparation for a Type C meeting scheduled for the third quarter of 2024. This meeting is intended to discuss CNM-Au8's regulatory path.
The new data highlights that ALS patients treated with CNM-Au8 who showed substantial declines in neurofilament light chain (NfL) levels—a key biomarker of disease progression and mortality risk in ALS—also demonstrated improved survival rates and better scores on the ALS Functional Rating Scale (ALSFRS-R).
In the open label extension (OLE) phase of the HEALEY ALS Platform Trial, patients classified as NfL responders, meaning those with consistent and sustained reductions in NfL, were observed to have a 28% mean reduction in NfL levels compared to baseline, lasting up to 19 months.
Conversely, NfL levels continued to increase in patients who did not respond to CNM-Au8 treatment. The geometric mean ratio (GMR) difference at week 76 post-baseline was reported at 0.57 with a 95% confidence interval of 0.50-0.64, and a significance level of p
InvestingPro Insights
As Clene Inc. (NASDAQ:CLNN) continues to show clinical promise with its ALS treatment, CNM-Au8, the company's financial health and stock performance also warrant attention. The market has reacted with a significant return over the last week, as indicated by a 29.23% increase in price total return. However, it's important to note that the company has been quickly burning through cash and analysts do not anticipate profitability this year, which could be a concern for potential investors. Clene's stock has also fared poorly over the last month, experiencing a 15.69% decrease in price total return.
InvestingPro data shows Clene with a market cap of approximately $37.84 million USD and a high Price / Book ratio of 8.87 as of Q1 2024, suggesting a premium valuation relative to the company's book value. Despite a 12.73% revenue growth in the last twelve months as of Q1 2024, the company operates with a moderate level of debt and has not been profitable over the same period.
For investors considering Clene's potential, the InvestingPro platform offers additional insights and metrics. There are 10 more InvestingPro Tips available, which can provide a deeper analysis of Clene's financials and market performance. For more detailed guidance, visit https://www.investing.com/pro/CLNN.
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