Clene reports Q1 EPS (9c), consensus (78c)

Reports Q1 revenue $81,000, consensus $61,000. “Prolonging survival for people living with ALS is the critical mission for Clene (CLNN). Additionally, we continue to collect NfL biomarker data from our ongoing NIH-sponsored EAP in ALS patients, which we still plan to analyze in the third quarter of 2025, in alignment with FDA’s proposal, as announced in December 2024,” said Rob Etherington, President and CEO of Clene. “Using this data, alongside our data showing CNM-Au8 improved survival over time, we are in active preparations to potentially submit an NDA under the Accelerated Approval pathway for ALS in the fourth quarter of 2025. To discuss this possibility, we remain in active dialogue with the Division of Neurology at the FDA, who we believe also prioritizes alleviating the burden of neurodegenerative diseases for patients and their families.”