Longeveron(US:LGVN)2025-03-01 00:04Financial Data and Key Metrics Changes - Revenues for 2024 were $2.4 million, up $1.7 million or 237% compared to 2023, primarily due to increased participant demand for clinical trials and new contract manufacturing revenue [23] - Total operating expenses for the year declined 13% year-over-year, with G&A expenses decreasing to approximately $10.3 million from $12.2 million in 2023, a decrease of approximately $1.9 million or 16% [24] - Net loss decreased 25% to approximately $16 million for 2024 from a net loss of $21.4 million for 2023 [26] Business Line Data and Key Metrics Changes - Contract manufacturing revenue for 2024 was $1 million, consisting of $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 $8.1 million, primarily due to reductions in expenses related to completed clinical trials [25] Market Data and Key Metrics Changes - The U.S. market opportunity for the company's three initial indications is approximately $5 billion for Alzheimer's disease, $4 billion for aging-related frailty, and up to $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] - The company aims to focus on partnerships for the Alzheimer's disease program to avoid dilution of efforts while pursuing global opportunities [85] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for a transformative year in 2025, with clarity on the Alzheimer's development pathway and completion of enrollment for the HLHS Phase II trial [11] - The company is ramping up activities for the BLA submission, which will increase operating expenses and capital expenditure requirements in 2025 [27] Other Important Information - The international non-proprietary name for the company's cellular therapy, Lomecel-B, was approved by the WHO, marking an important step in its development and potential commercialization [12] - The company is currently conducting a Phase IIb clinical trial, ELPIS II, which has achieved over 90% enrollment and is expected to complete enrollment by the second quarter of 2025 [16] 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 accurately, with surgery dates being a key factor [36][38] Question: Will the FDA consider a composite endpoint for ELPIS II? - Management confirmed discussions with the FDA regarding the acceptance of composite endpoints, including hospitalization and survival rates [51][53] 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 3 patients remain to be enrolled, with the possibility of over-enrollment if additional eligible patients are identified [65][66] Question: What is the commercialization strategy for Lomecel-B in HLHS? - Management stated that a minimal commercial infrastructure would be needed, as there are only about 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][84]