Clene Reports Third Quarter 2025 Financial Results and Recent Operating Highlights

Core Insights - Clene Inc. reported its third quarter 2025 financial results and updates on its CNM-Au8 programs, focusing on treatments for neurodegenerative diseases such as ALS and MS [1] Financial Performance - Cash and cash equivalents as of September 30, 2025, totaled $7.9 million, down from $12.2 million as of December 31, 2024 [11] - Research and development expenses for the quarter were $3.5 million, a decrease from $4.5 million in the same period in 2024, attributed to cost-saving initiatives and reduced manufacturing expenses [12] - General and administrative expenses were $2.2 million for the quarter, down from $3.4 million in the same period in 2024, primarily due to lower legal fees and personnel expenses [13] - The company reported a net loss of $8.8 million, or $0.85 per share, compared to a net loss of $8.0 million, or $1.22 per share, for the same period in 2024 [15] CNM-Au8 Development for ALS - Clene held a second Type C meeting with the FDA to discuss the long-term survival benefit of CNM-Au8 treatment for ALS, with a focus on ALS disease-specific biomarkers [3] - The FDA recommended three potential biomarker paths to enhance the persuasiveness of the company's ALS data, including NfL analysis from ongoing studies [4][5] - Clene plans to submit a New Drug Application (NDA) under an accelerated approval pathway in the first quarter of 2026, pending favorable data analyses [5][8] CNM-Au8 Development for MS - In September 2025, Clene held a Type B end-of-Phase 2 meeting with the FDA to review results from the Phase 2 VISIONARY-MS trial, focusing on cognition improvement as a potential primary endpoint for the planned Phase 3 study [7] - The FDA acknowledged the limitations of the Expanded Disability Status Scale and expressed openness to considering cognition as a primary endpoint [7] CNM-Au8 Development for Parkinson's Disease - New preclinical data showed that CNM-Au8 improved key measures of cellular health in a novel dopaminergic neuron model of Parkinson's disease, supporting its continued development as a treatment for PD [10] Upcoming Milestones - Clene anticipates the first patient will be dosed in its confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026 [6][8]