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]

Summary of Clene (CLNN) Conference Call - July 17, 2025 Company Overview - Clene Inc. (CLNN) is a late-stage clinical biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases [1] Core Industry Insights - The company is primarily involved in the development of treatments for neurodegenerative diseases, specifically Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) [1][2] - Clene's drug, CNMAU8, is being evaluated for its ability to reduce neurofilament levels in ALS patients, which serves as a biomarker for neuronal damage [3][4] Key Developments - Clene met with the FDA in June 2025 to discuss the evaluation of neurofilament as a biomarker for ALS treatment [2] - The company received $45 million in funding from the NIH to support a study involving 180 ALS patients, with data collection starting next month and continuing until September [4][5] - Clene aims to submit data to the FDA for a new drug application (NDA) by the end of 2025, with a decision expected in the first quarter of 2026 [8][6] Clinical Trial Plans - A confirmatory Phase 3 clinical trial is planned to commence later in 2025, focusing on survival as the primary endpoint [10][11] - The trial will compare the survival rates of patients taking CNMAU8 against a placebo group [10] Biomarker Insights - Neurofilament levels can indicate the onset of ALS symptoms before clinical presentation [12] - Clene is the only company in a Phase II double-blind placebo-controlled study that has shown a reduction in neurofilament levels [13] Future Directions - Clene is also exploring the potential of CNMAU8 for other neurodegenerative diseases, including MS, Parkinson's, Huntington's, and frontotemporal dementia [16][17] - The company is in discussions with the FDA regarding its MS program, which uses the same drug and dosage as in the ALS program [15][16] Additional Considerations - The company is focused on the energetic support of mitochondria, which is crucial for neuronal function [16] - Clene has presented data suggesting remyelination of damaged neurons in MS, although similar conclusions for ALS are still pending [14] This summary encapsulates the critical points discussed during the Clene conference call, highlighting the company's focus on neurodegenerative diseases, ongoing clinical trials, and future research directions.