H.C. Wainwright maintains $31 target on Clene stock with Buy rating

On Wednesday, H.C. Wainwright reaffirmed a Buy rating on Clene Inc. (NASDAQ:CLNN) stock, maintaining a $31.00 price target. According to InvestingPro data, analyst targets for CLNN range from $20 to $84, with the stock currently trading at $4.27, down nearly 50% over the past year. The company’s shares have experienced significant volatility, having declined about 20% year-to-date. The firm’s analyst highlighted Clene’s recent collaboration with APST Research, a German digital research platform, to analyze the long-term effects of its drug CNM-Au8™ on patients with Amyotrophic Lateral Sclerosis (ALS). With a market capitalization of $34.36 million, Clene faces financial challenges, as InvestingPro analysis indicates the company is quickly burning through cash with short-term obligations exceeding liquid assets.

Clene announced on February 25 that the partnership with APST Research is set to facilitate the Expanded Access Protocol (EAP) analyses recommended by the FDA. This protocol will examine the impact of CNM-Au8™ on the decline of neurofilament light chain (NfL), a biomarker for ALS. APST Research operates one of the largest ALS data repositories, which includes a wide array of patient data and over 4,300 serum NfL records, providing a comprehensive perspective on the progression of ALS and the natural history of changes in NfL.

The NfL dataset being assessed by Clene contains results from more than 1,625 ALS patients. It aligns NfL biomarker data with clinical assessments and events, such as the need for ventilation support and nutrition intervention. The aim is to support previous evidence that CNM-Au8™ can reduce NfL levels over the long term and improve patient survival rates.

The collaboration is expected to bolster the potential approval of CNM-Au8™ through an accelerated regulatory pathway. According to H.C. Wainwright’s analyst, both the firm and Clene’s management are optimistic that the EAP NfL comparisons to the matched-controls from APST will substantiate the drug’s efficacy. The anticipated New Drug Application (NDA) submission for CNM-Au8™ is on track for the second half of 2025. With a gross profit margin of 78.62% but significant ongoing losses, investors should note that analysts don’t expect profitability this year. For deeper insights into Clene’s financial health and additional analysis, including 8 more key ProTips, check out InvestingPro.

In other recent news, Clene Inc. announced a collaboration with APST Research GmbH to analyze biomarker data from amyotrophic lateral sclerosis (ALS) patients. This initiative aims to support the potential accelerated approval of Clene’s investigational drug CNM-Au8 for ALS treatment. Clene plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of 2025, with the analyses expected to form part of the supportive evidence for CNM-Au8’s effect on neurofilament light decline. In another development, Clene Inc. has secured up to $8 million in additional funding through a grant subaward with Columbia University for its ALS treatment program. This funding is part of the National Institute of Health’s $45.1 million grant under the Accelerating Access to Critical Therapies for ALS Act. The financial support is set to extend the program from September 2024 to August 2025. Clene collaborates with Columbia University and Synapticure on this Expanded Access Program for CNM-Au8. These developments reflect Clene’s ongoing efforts in advancing its ALS treatment initiatives.

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