Longeveron(LGVN) - 2025 Q3 - Quarterly Results

Financial Performance - Revenues for the nine months ended September 30, 2025, were $0.8 million, a decrease of $1.0 million, or 53%, compared to $1.8 million in 2024, primarily due to decreased participant demand for the Bahamas Registry Trial and reduced contract manufacturing services[13] - Clinical trial revenue from the Bahamas Registry Trial decreased by $0.3 million, or 36%, to $0.7 million for the nine months ended September 30, 2025, compared to $1.0 million in 2024[13] - Net loss increased to approximately $17.3 million for the nine months ended September 30, 2025, up $5.4 million, or 45%, from a net loss of $11.9 million in the same period in 2024[13] - Total revenues for the three months ended September 30, 2025, were $137,000, a decrease of 82.3% compared to $773,000 for the same period in 2024[21] - The net loss for the three months ended September 30, 2025, was $7,221,000, compared to a net loss of $4,419,000 in the same period of 2024, indicating a 63.5% increase in losses[21] - Basic and diluted net loss per share for the three months ended September 30, 2025, was $(0.39), compared to $(0.34) for the same period in 2024[21] Expenses - Research and development expenses rose to approximately $9.3 million for the nine months ended September 30, 2025, an increase of $3.2 million, or 52%, compared to $6.1 million in 2024[13] - General and administrative expenses increased to approximately $9.1 million for the nine months ended September 30, 2025, up $1.7 million, or 22%, from $7.4 million in 2024[13] - Operating expenses increased to $7,435,000 for the three months ended September 30, 2025, compared to $5,331,000 for the same period in 2024, representing a 39.5% increase[21] Cash and Assets - Cash and cash equivalents as of September 30, 2025, were $9.2 million, expected to fund operations into the first quarter of 2026[13] - Cash and cash equivalents decreased to $9,244,000 as of September 30, 2025, from $19,232,000 as of December 31, 2024, a decline of 52.1%[19] - Total assets decreased to $15,557,000 as of September 30, 2025, down from $25,558,000 as of December 31, 2024, representing a 39.1% reduction[19] Liabilities and Deficit - Total current liabilities increased to $4,940,000 as of September 30, 2025, compared to $2,582,000 as of December 31, 2024, a rise of 91.3%[19] - The accumulated deficit increased to $(126,867,000) as of September 30, 2025, from $(109,607,000) as of December 31, 2024[19] Clinical Trials and Future Plans - The pivotal Phase 2b clinical trial (ELPIS II) for laromestrocel is fully enrolled with 40 pediatric patients, and top-line results are expected in the third quarter of 2026[6] - Laromestrocel has received multiple FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for the treatment of HLHS[6] - The company plans to initiate a pivotal Phase 2 clinical trial for pediatric dilated cardiomyopathy (DCM) in 2026, subject to financing[10] Funding Activities - The company completed a public offering in August 2025, raising approximately $5.0 million, with potential additional proceeds of up to $12.5 million from short-term warrants[10] Share Information - The number of basic and diluted weighted average common shares outstanding increased to 18,373,198 as of September 30, 2025, from 13,627,793 in the same period of 2024[21]