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Longeveron(LGVN) - 2025 Q2 - Earnings Call Transcript
2025-08-13 21:30
Financial Data and Key Metrics Changes - Revenues for the six months ended June 30, 2025, were $700,000, a decrease of $300,000 or 31% compared to $1,000,000 for the same period in 2024, primarily due to decreased participant demand for the Bahamas registry trial and reduced demand for contract manufacturing services [25][26] - Clinical trial revenue for the same period was $600,000, a decrease of $200,000 or 31% compared to $800,000 in 2024 [26] - General and administrative expenses increased to approximately $5,500,000, up from $4,300,000, representing a 28% increase [27] - Research and development expenses rose to approximately $5,500,000, a 39% increase from $3,900,000 in 2024 [27] - Net loss increased to approximately $10,000,000 for the six months ended June 30, 2025, compared to a net loss of $7,500,000 for the same period in 2024 [27][28] Business Line Data and Key Metrics Changes - The company is focused on three primary operational goals for 2025: advancing the pivotal Phase 2b study for SLHS, SLHS BLA preparedness, and pursuing strategic collaboration for the Alzheimer's disease program [6][30] - The SLHS program is considered a key strategic priority with a high probability of success and a shorter path to potential regulatory approval [6][30] Market Data and Key Metrics Changes - The U.S. market opportunities for the company's three initial indications are approximately $5 billion for Alzheimer's disease, over $4 billion for aging-related frailty, and up to $1 billion for hypoplastic left heart syndrome (HLHS) [5][6] - The prevalence of pediatric dilated cardiomyopathy is estimated to be around 2,000 to 3,000 patients in the U.S., while HLHS affects about 1,000 newborns [37] Company Strategy and Development Direction - The company is expanding its pipeline to include pediatric dilated cardiomyopathy and has licensed additional stem cell technology from the University of Miami [21][30] - The strategy focuses on excellent science, lower required investments, speed to market, and addressing important unmet medical needs [21] - The company plans to initiate a pivotal Phase 2 clinical trial for pediatric dilated cardiomyopathy in 2026 [18][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential BLA submission for SLHS in late 2026, contingent on positive trial results [28][30] - The company is focused on prudent capital allocation strategies to advance development programs, which are considered highly cost-efficient [28][29] - Management highlighted the importance of FDA interactions and the collaborative approach taken by the agency [8][56] Other Important Information - The company completed a public offering in August, raising approximately $5 million in gross proceeds [28] - The FDA has approved the IND application for evaluating laramestrocel as a treatment for pediatric dilated cardiomyopathy, allowing the company to move directly to a pivotal Phase 2 trial [17][18] Q&A Session Summary Question: Are the target patient populations and addressable markets for HLHS and pediatric dilated cardiomyopathy similar? - The markets are similar but not identical; HLHS has a one-time use administration while pediatric dilated cardiomyopathy involves continuous use [35][36] Question: Will a favorable approval decision in HLHS impact the regulatory outlook for pediatric dilated cardiomyopathy? - A positive outcome from the HLHS trial would support the regulatory review process for pediatric dilated cardiomyopathy, but the FDA will still require study results specific to that indication [41][42] Question: What is the estimated budget for the pediatric dilated cardiomyopathy trial? - Preliminary budget estimates for the entire trial range from $15 million to $20 million, with annual costs around $3 million [43][44] Question: Will the company retain the pediatric designation and associated benefits if the PRB sunsets? - The company is cautiously optimistic about the renewal of the PRB and has mechanisms in place for rolling submissions [51][53] Question: What gave the FDA confidence to allow the company to move directly to pivotal Phase 2 for pediatric dilated cardiomyopathy? - The FDA was confident due to the design of clinically meaningful endpoints and the company's robust safety data set from previous studies [67][72]