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SALT LAKE CITY - Clene Inc. (NASDAQ:CLNN), a clinical-stage biopharmaceutical company with a market capitalization of $37.8 million, announced new survival data from a post hoc analysis involving participants in the HEALEY ALS Platform Trial. According to InvestingPro analysis, the company currently shows weak financial health metrics, reflecting the typical profile of early-stage biotech firms. The analysis indicated that their drug candidate CNM-Au8® 30 mg may extend the survival of patients with amyotrophic lateral sclerosis (ALS).
The study compared the effectiveness of CNM-Au8 30 mg with a control regimen from the same trial. Notably, the median survival for patients treated with CNM-Au8 was 951 days, compared to 753 days for the control group, translating to a 198-day increase. Adjusted analyses also showed a restricted mean survival time benefit of 124 days. InvestingPro data reveals the company is quickly burning through cash, with negative EBITDA of $32.71 million in the last twelve months, highlighting the importance of positive clinical results for future funding.
The results were particularly significant in patients with moderate to severe ALS, where the median survival jumped from 589 to 951 days, and the mortality risk decreased by 44%. A subset of participants who met the criteria for the planned Phase 3 RESTORE-ALS Trial saw an even greater median survival improvement of 451 days.
These findings support the potential of CNM-Au8 to improve outcomes for ALS patients and will be part of the discussions with the FDA as Clene prepares for the launch of the Phase 3 RESTORE-ALS study, slated for mid-2025. The RESTORE-ALS trial aims to confirm the efficacy and safety of CNM-Au8 in a larger patient population.
The data builds on previous research that suggested survival benefits during the 24-week double-blind period of the HEALEY ALS Platform Trial, the open-label extension of the Phase 2 RESCUE-ALS trial, and analyses of Expanded Access Programs.
Clene’s focus is on neurodegenerative diseases such as ALS, Parkinson’s disease, and multiple sclerosis, aiming to improve mitochondrial health and protect neuronal function. CNM-Au8 is designed to restore neuronal health by enhancing cellular energy production.
The company is headquartered in Salt Lake City, Utah, with additional operations in Maryland. Investors should note that Clene’s next earnings report is scheduled for March 18, with analyst price targets ranging from $20 to $84, suggesting significant potential upside if clinical trials succeed. The information presented in this article is based on a press release statement from Clene Inc. For comprehensive financial analysis and additional insights, including 8 more key ProTips, visit InvestingPro.
In other recent news, Clene Inc. has announced a collaboration with APST Research GmbH to analyze neurofilament light (NfL) biomarker data from patients with amyotrophic lateral sclerosis (ALS). This effort is part of the company’s strategy to support the potential accelerated approval of its investigational drug CNM-Au8. The partnership will leverage APST’s extensive ALS patient database to compare findings with Clene’s Expanded Access Protocols, which have involved nearly 500 patients without significant safety concerns. Clene plans to submit a New Drug Application to the FDA in the second half of 2025, with the analyses of NfL reduction expected to be pivotal evidence. Additionally, Clene has secured up to $8 million in additional funding for its ALS treatment program from the National Institutes of Health, extending financial support through August 2025. This funding is part of the NIH’s $45.1 million grant under the Accelerating Access to Critical Therapies for ALS Act. Moreover, H.C. Wainwright has maintained a Buy rating on Clene’s stock with a $31 target, highlighting the company’s recent collaboration and optimistic outlook for regulatory approval. These developments are part of Clene’s ongoing efforts to advance its ALS treatment program and provide further evidence for FDA review.
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