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.

Summary of Clene (CLNN) Conference Call - June 10, 2025 Company Overview - Clene (CLNN) is focused on improving mitochondrial health and protecting neuron function, targeting neurodegenerative diseases such as ALS, MS, and Parkinson's through catalytic nanotherapeutics [10][11][34] Core Points and Arguments - **Therapeutic Focus**: Clene is pioneering treatments for neurodegenerative diseases, emphasizing the need for breakthroughs in this area [10] - **Clinical Programs**: The company has completed several Phase II programs, including studies named Visionary (MS), Healy (ALS), and Rescue (ALS), with ongoing regulatory discussions [11][16] - **Safety Profile**: Clene reports a clean safety profile with no serious adverse events related to their drug AU8, despite some mild side effects like headache and nausea [14][34] - **Regulatory Interactions**: Clene has had multiple interactions with the FDA and plans to submit a New Drug Application (NDA) by the end of the year, contingent on positive data from ongoing studies [15][32][36] - **Clinical Efficacy**: Although primary endpoints were missed in some studies, significant secondary endpoints were achieved, including survival benefits and clinical worsening improvements [16][18][24] - **Neurofilament as a Biomarker**: The company is utilizing neurofilament light levels as a predictive biomarker for disease progression and treatment efficacy, showing significant risk reduction in patients with high neurofilament levels [19][21][22] Important but Overlooked Content - **Expanded Access Protocols**: Clene has several expanded access protocols in place, which have shown significant survival benefits compared to natural history controls [22][23] - **Financial Position**: Clene ended the first quarter with nearly $10 million in cash, sufficient to support operations through October, while exploring additional funding options [35] - **Future Plans**: The company is planning further discussions with the FDA regarding both ALS and MS, with a focus on cognitive improvements in MS patients as a significant market opportunity [32][33] This summary encapsulates the key points from the Clene conference call, highlighting the company's focus on neurodegenerative diseases, clinical progress, regulatory strategies, and financial outlook.