Summary of Clene (CLNN) Conference Call - August 20, 2025 Company Overview - Clene Inc. (CLNN) is a late clinical stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases [1][5] Core Points and Arguments Clinical Development - Clene is pioneering catalytic nanotherapeutic suspensions for potential treatments of multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) [5][6] - The company has completed five phase two proof of concept studies, including two for ALS [5][6] - Clene is currently discussing the next stage for its MS program with the FDA, aiming for phase three [6][21] Drug Mechanism and Safety - The drug CNMAU8 is orally administered and targets energy metabolism by enhancing mitochondrial function [7][8] - Over 1,000 participant years of exposure to CNMAU8 have shown no serious adverse events attributed to the drug, with only mild side effects like nausea and headaches reported [9][10][36] Clinical Study Results - Two phase two studies (RESCUE and Healy) missed their primary endpoints but showed interesting secondary outcomes, including survival benefits and clinical worsening improvements [11][12][13] - In the Healy study, a 74% improvement in clinical worsening was observed, and a 71% improvement was noted in the RESCUE study [13] - Neurofilament levels, a biomarker for neuron death, were significantly reduced in patients taking CNMAU8, correlating with survival benefits [14][15][17] Regulatory Pathway - Clene plans to file a new drug application (NDA) by the end of the year based on neurofilament biomarker data and survival benefits [19][43] - The company is also exploring the possibility of accelerated approval with the FDA [19][42] Financial Position - As of June 30, Clene reported a cash position of $7.3 million, with additional funding raised post-reporting, bringing the pro forma cash balance to nearly $11 million [25][26] - This funding is expected to support operations through the first quarter of the following year, including FDA interactions and data analysis [26] Additional Important Content - Clene is actively engaging with potential partners for its MS program and has had numerous meetings to discuss collaboration [40][41] - The company emphasizes the devastating impact of ALS and expresses gratitude for the support from patients and investors [45][46] Upcoming Milestones - An important FDA meeting is scheduled for the upcoming quarter to discuss survival benefits and neurofilament data [30][31] - The company anticipates significant developments in the next few months regarding its regulatory pathway and clinical data analysis [31][32]