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On Thursday, H.C. Wainwright reaffirmed its confidence in Clene Inc. (NASDAQ:CLNN) by maintaining a Buy rating and a price target of $31.00. Currently trading at $4.40, the stock sits well below analyst targets ranging from $20 to $84, according to InvestingPro data. The company’s market capitalization stands at approximately $37 million. The endorsement comes after Clene revealed new long-term survival data on Sunday related to its CNM-Au8 treatment, which is part of the HEALEY ALS Platform Trial. The data compares CNM-Au8 (Regimen C) with zilucoplan (Regimen A), a treatment developed by UCB, which is not rated by the firm. InvestingPro analysis indicates the company faces financial challenges, with a weak overall financial health score and rapidly depleting cash reserves.
The latest findings suggest that CNM-Au8 has continued to show survival benefits, a trend consistent with previous reports from various study periods such as the HEALEY’s 24-week double-blind phase, the Phase 2 RESCUE-ALS OLE period, and the EAP studies. This new information is expected to contribute to ongoing discussions with the FDA regarding potential accelerated approval for CNM-Au8.
Zilucoplan, which was one of the initial treatments examined in the HEALEY trial starting in July 2020, was discontinued in March 2022 due to futility, as it seemed unlikely to significantly slow the progression of the disease compared to a placebo. This decision was based on a recommendation from the Data Safety Monitoring Board (DSMB) after a majority of participants had completed a 24-week assessment.
The long-term survival data, which includes information from clinical sites and public records, indicated no significant difference between the treatment and placebo groups within Regimen A. This supports the comparison with the survival data of participants from Regimen C. The analyst at H.C. Wainwright cites these results as reinforcing the potential of CNM-Au8 and justifies the reiterated Buy rating and price target for Clene Inc. Clene is also preparing to launch the confirmatory Phase 3 RESTORE-ALS study, which is expected to begin in mid-2025. With revenue of just $0.42 million in the last twelve months and significant cash burn, investors should note that analysts don’t expect profitability this year. Get deeper insights and access to over 10 additional key metrics with InvestingPro.
In other recent news, Clene Inc. has reported significant findings from a post hoc analysis of their HEALEY ALS Platform Trial, revealing that their drug candidate CNM-Au8® 30 mg may extend the survival of patients with amyotrophic lateral sclerosis (ALS). The study highlighted a median survival increase of 198 days for patients treated with CNM-Au8 compared to the control group. These results are set to be part of discussions with the FDA as Clene prepares for the Phase 3 RESTORE-ALS study. Additionally, Clene has secured up to $8 million in additional funding from the National Institute of Health for its ALS treatment program, extending support through August 2025. The company has also partnered with APST Research to analyze neurofilament light (NfL) biomarker data, aiming to support the accelerated approval of CNM-Au8. H.C. Wainwright has maintained a Buy rating on Clene’s stock, citing optimism about the drug’s efficacy based on this collaboration. The partnership with APST Research is expected to bolster Clene’s New Drug Application submission to the FDA in the second half of 2025. Clene’s efforts focus on demonstrating CNM-Au8’s potential to reduce NfL levels and improve patient survival rates.
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