Longeveron(LGVN)2025-03-01 00:04Financial Data and Key Metrics Changes - Revenues for 2024 were 1.7 million or 237% compared to 2023, primarily due to increased participant demand for clinical trials and new contract manufacturing revenue [23] - Net loss decreased 25% to approximately 21.4 million for 2023 [26] - Total operating expenses for the year declined 13% year-over-year, with G&A expenses decreasing to approximately 12.2 million in 2023 [24] Business Line Data and Key Metrics Changes - Contract manufacturing revenue for 2024 was 0.5 million from manufacturing lease services and another 0.5 million from manufacturing services contracts [23] - R&D expenses for 2024 decreased approximately 1 million or 10% to approximately 5 billion for Alzheimer's disease, 1 billion for HLHS [7] Company Strategy and Development Direction - The HLHS program is a key strategic priority, with high probability of success and the shortest path to potential regulatory approval and commercialization [8] - The company plans to initiate a rolling submission of a BLA with the FDA in 2026 if the current ELPIS II trial is successful [10][27] - The international non-proprietary name for Lomecel-B was approved by the WHO, marking an important step in its development and potential commercialization [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2025 being a transformative year, with clarity on the Alzheimer's development pathway and completion of enrollment for the HLHS Phase II trial [11] - The company is focused on seeking additional financing and non-dilutive funding options to support increased operating expenses and capital investments in 2025 [28] Other Important Information - The company has received multiple FDA designations for its programs, including orphan-drug designation and fast track designation for HLHS, and RMAT designation for Alzheimer's disease [14][15] Q&A Session Summary Question: What is causing the enrollment delay in ELPIS II? - Management noted that HLHS is a rare disease, making it difficult to predict enrollment timelines, with surgery dates being a key factor [36][38] Question: Will the FDA consider a composite endpoint for ELPIS II? - Management confirmed that they are working with the FDA to propose a composite endpoint that includes additional factors beyond RVEF [50][52] Question: What are the prospects for receiving a pediatric disease priority review voucher for Lomecel-B? - Management indicated that they believe they will have an extension for the PRV, pending agreement with the agency at the pre-BLA meeting [60] Question: How many patients remain to be enrolled in ELPIS II? - Management confirmed that 35 out of 38 patients have been enrolled, with the possibility of over-enrollment if additional eligible patients are identified [65][66] Question: What is the potential commercial scenario for Lomecel-B in HLHS? - Management stated that commercialization would require minimal infrastructure, targeting approximately 50 treating physicians in the U.S. [78][80] Question: What are the plans for international regulatory discussions regarding Alzheimer's disease? - Management plans to engage with international regulatory authorities after hiring a full-time regulatory person to lead these discussions [83][85]