How are energy investors positioned?
Tuesday, Clene Inc. (NASDAQ:CLNN) shares maintained a Buy rating and a $31.00 price target from H.C. Wainwright following the announcement of its fourth-quarter and full-year financial results for 2024. The biopharmaceutical company, currently valued at $32.64 million, reported earnings per share (EPS) of ($1.61) for the fourth quarter and ($5.67) for the year, which did not meet the expectations set by analysts. According to InvestingPro data, the stock is trading near its 52-week low of $3.82, having declined over 54% in the past year.
Clene closed the year with a cash position of $12.2 million, which the company’s management anticipates will be sufficient to support its operations until the second quarter of 2025. InvestingPro analysis indicates the company is quickly burning through cash, with a weak overall financial health score of 1.53 out of 5. Subscribers to InvestingPro can access 5 additional key insights about Clene’s financial position and future prospects. The company’s primary focus remains on the development of CNM-Au8 for the treatment of Amyotrophic Lateral Sclerosis (ALS).
In the past year, Clene met with the U.S. Food and Drug Administration (FDA) to discuss a possible accelerated approval pathway for CNM-Au8. The FDA requested additional data from ongoing Expanded Access Protocols (EAPs) and the HEALEY ALS Platform Trial to demonstrate the drug’s impact on neurofilament light chain (NfL) biomarkers, a potential indicator of treatment effectiveness.
Clene plans to meet with the FDA again in the second quarter of 2025 to finalize its statistical analysis plan for the EAP NfL biomarker data. The company aims to gather and analyze this data in the third quarter of 2024, which will be crucial for the New Drug Application (NDA) Clene expects to submit in the second half of 2025.
Additionally, Clene recently presented long-term survival data from post-hoc analyses of the HEALEY ALS Platform Trial, comparing CNM-Au8 with zilucoplan. The results appear to bolster CNM-Au8’s progression into the Phase 3 RESTORE-ALS study, which is set to start enrolling participants in mid-2025. This study will further investigate CNM-Au8’s potential to extend survival and delay the progression of ALS symptoms.
In summary, H.C. Wainwright reiterated its Buy rating and $31 price target on Clene stock, expressing continued support for the company’s prospects in developing treatments for ALS. The current analyst consensus shows strong optimism, with targets ranging from $20 to $84, suggesting significant potential upside from current levels. InvestingPro’s Fair Value analysis suggests the stock is currently slightly undervalued, though investors should note the company’s challenging financial metrics and negative earnings yield of -120%.
In other recent news, Clene Inc. announced new survival data from its HEALEY ALS Platform Trial, revealing that its drug candidate CNM-Au8 may significantly extend the survival of ALS patients. The study showed a median survival increase of 198 days compared to the control group, with a notable 44% decrease in mortality risk for patients with moderate to severe ALS. Clene plans to discuss these findings with the FDA as it prepares for the Phase 3 RESTORE-ALS study, set to launch in mid-2025. Meanwhile, H.C. Wainwright has reaffirmed its Buy rating for Clene, maintaining a $31 price target, citing the potential of CNM-Au8. Clene has also partnered with APST Research to analyze neurofilament light chain data, aiming to support the drug’s regulatory approval. Additionally, Clene secured up to $8 million in NIH grant funds to continue its ALS treatment program in collaboration with Columbia University. This funding is part of a larger $45.1 million grant under the Accelerating Access to Critical Therapies for ALS Act. These developments highlight Clene’s ongoing efforts to advance its ALS treatment and secure regulatory approval.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.