Longeveron Inc. Q4 FY2025 earnings call

Stephen Willard mentioned securing $15 million in new capital with potential for a second tranche, runway into Q4 2026, completing and delivering ELPAS-2 results, pursuing strategic partnering across development programs. Natalia Agafanova discussed HLHS program near-term pivotal data, LPS2 trial nearing completion, PDCM program IND effective, planning for study. Lisa Locklear touched on financial results highlights. Joshua Hare spoke about pivotal data in HLHS, progress in stem cell research. Stephen Willard also emphasized key areas of focus like securing capital, clinical trial progress, partnering.

Revenues for the year ended December 31st, 2025 were $1.2 million consisting of $1 million of clinical trial revenue and $0.2 million of contract manufacturing revenue. Revenues for the year ended December 31st, 2024 were $2.4 million consisting of $1.4 million of clinical trial revenue, $0.5 million of contract manufacturing lease revenue and $0.5 million of contract manufacturing revenue. 2025 revenues decreased $1.2 million or 50% compared to 2024. General and administrative expenses for 2025 increased to approximately $12 million compared to $10.3 million in 2024. Research and development expenses for 2025 increased to approximately $12 million from $8.1 million in 2024. Net loss increased to approximately $22.7 million in 2025 from $16 million in 2024. Cash and cash equivalents as of December 31st, 2025 were $4.7 million with approximately $1.4 million in working capital.

Secured $15 million in new capital with potential for a second tranche. Initial capital provides runway into Q4 2026. Anticipate reporting ELPAS-2 results in Q3 2026. Plan to pursue strategic partnering across development programs. Potential to close second tranche of $15 million upon meeting milestones. Existing cash and cash equivalents enable funding into Q4 2026 based on current budget and forecast.

Q: About commercial perspectives as these pertain to scaled-up manufacturing and CMC for laramestrocell, and potential non-dilutive sources of capital for Alzheimer's and age-related frailty.

A: Steve mentioned priority for manufacturing, engaged with CDMO; Stephen said priority to seek licensing partners for Alzheimer's and age-related frailty.

Q: About HLHS program BLA filing, PRV monetization, PDCM program.

A: Josh said potentially eligible for rolling submission, PRV prices likely strong, Natalia said PDCM trial planning to initiate in 2027 with hierarchical composite endpoint.

Q: About LARO's use in sexual dysfunction in females.

A: Josh said indication ripe for partnership.