Clene Reports First Quarter 2025 Financial Results and Recent Operating Highlights

Core Viewpoint - Clene Inc. is focused on advancing its CNM-Au8 programs for treating neurodegenerative diseases, particularly ALS and MS, with plans for potential NDA submissions and ongoing clinical evaluations [2][3][6]. Financial Results - As of March 31, 2025, Clene reported cash and cash equivalents of $9.8 million, down from $12.2 million as of December 31, 2024, indicating a cash runway into the third quarter of 2025 [8]. - Research and development expenses for Q1 2025 were $1.5 million, significantly lower than $5.9 million for the same period in 2024, primarily due to grant revenue from the NIH-funded ALS EAP [9]. - General and administrative expenses decreased to $2.7 million in Q1 2025 from $3.4 million in Q1 2024, attributed to lower public relations and personnel costs [10]. - Clene reported a net loss of $0.8 million, or $0.09 per share, for Q1 2025, a substantial improvement from a net loss of $11.1 million, or $1.73 per share, in Q1 2024 [12]. CNM-Au8 Program Updates - Clene is preparing for a meeting with the FDA in Q2 2025 to finalize its statistical analysis plan for NfL biomarker data, with analysis scheduled for Q3 2025 to support the NDA submission for ALS [3][6]. - New analyses from the HEALEY ALS Platform Trial indicated a survival improvement of 4.1 months for patients receiving CNM-Au8 compared to a control group, with significant benefits observed in patients with severe ALS [4]. - Clene presented evidence of remyelination and neuronal repair associated with CNM-Au8 treatment at the AAN 2025 Annual Meeting, highlighting improvements in cognition and visual function [5][7]. Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company focused on treating neurodegenerative diseases through its investigational therapy CNM-Au8, which targets mitochondrial function and reduces oxidative stress [13][14].