Clene Reports Second Quarter 2025 Financial Results and Recent Operating Highlights

Core Insights - Clene Inc. reported its second quarter 2025 financial results, highlighting progress in its CNM-Au8 programs for treating neurodegenerative diseases, particularly ALS and MS, and confirmed sufficient cash runway into Q1 2026 [1][6]. Financial Performance - Cash and cash equivalents as of June 30, 2025, totaled $7.3 million, down from $12.2 million as of December 31, 2024 [8]. - Research and development expenses for Q2 2025 were $3.5 million, a decrease from $4.2 million in Q2 2024, attributed to cost-saving initiatives and reduced personnel expenses [9]. - General and administrative expenses were $2.4 million for Q2 2025, down from $3.3 million in Q2 2024, primarily due to decreased personnel and legal fees [10]. - Clene reported a net loss of $7.4 million, or $0.78 per share, for Q2 2025, compared to a net loss of $6.8 million, or $1.06 per share, for the same period in 2024 [12]. Clinical Development Updates - Clene is preparing for a Type C meeting with the FDA to discuss survival data from CNM-Au8 in ALS patients, with a New Drug Application (NDA) submission planned by the end of 2025 [2][4]. - The company plans to analyze neurofilament light biomarker data from its NIH-sponsored expanded access program in Q4 2025, which is crucial for supporting its NDA submission [3][6]. - Clene presented evidence of remyelination and neuronal repair in MS patients treated with CNM-Au8 at the AAN 2025 Annual Meeting, indicating significant improvements in cognition and visual function [5]. Future Plans - A second Type C meeting with the FDA is scheduled for Q3 2025 to review long-term survival benefits associated with CNM-Au8 treatment [4][6]. - Clene plans to hold an end-of-Phase 2 Type B meeting with the FDA in Q3 2025 to discuss the MS clinical development program [7].