Longeveron Inc. Q2 FY2025 earnings call

• Wa’el Hashad highlighted progress in stem cell research across multiple indications, including HLHS, Alzheimer's, and pediatric dilated cardiomyopathy. - Nataliya Agafonova discussed completion of enrollment in HLHS Phase 2b trial, positive results in Alzheimer's, and FDA approval of IND for pediatric dilated cardiomyopathy. - Devin Blass spoke about CMC readiness for potential BLA submission. - Josh Hare mentioned licensing new stem cell technology from the University of Miami. - Lisa Locklear reviewed financials, funding needs, and BLA plans for HLHS.

For the 6 months ended June 30, 2025, revenues were $0.7 million compared to $1 million in 2024, a decrease of $0.3 million or 31%. Clinical trial revenue was $0.6 million in 2025, down $0.2 million or 31% from $0.8 million in 2024, driven by decreased participant demand. Contract manufacturing revenue was $0.1 million in 2025, down $0.1 million or 35% from $0.2 million in 2024. General and administrative expenses increased to $5.5 million in 2025 from $4.3 million in 2024. Research and development expenses rose to $5.5 million in 2025 from $3.9 million in 2024. Net loss was $10 million in 2025 compared to $7.5 million in 2024. Cash and cash equivalents as of June 30, 2025, were $10.3 million.

• Anticipate BLA filing with FDA in late 2026 if HLHS Phase 2b trial is successful. - Current cash expected to fund operations into Q1 2026; seeking additional financing. - Focus on partnership opportunities and nondilutive funding for Alzheimer's disease program.

• Uncertainty of securing future financing at favorable terms or at all, which could require revising operational plans. - Regulatory changes at the FDA that could impact development timelines and approval processes.

Q: Regarding HLHS and pediatric dilated cardiomyopathy, are the target markets similar and what's the regulatory outlook for PBC based on HLHS?

A: Markets are similar but not identical. HLHS has 1,000 patients, pediatric DCM has ~600 new cases. Positive HLHS results would support PBC regulatory review but FDA still needs PBC study results.

Q: Any updates on 5-year survival in HLHS?

A: Study was set for 5-year survival after Glenn procedure, no 6-year data available.

Q: Pros and cons of self-manufacturing vs CDMO for laromestrocel?

A: CDMO option offers faster timeline, lower costs, and reduced risk compared to renovating existing facility.

Q: Differentiation of iPSC platform technology?

A: New technology avoids arrhythmia risk by identifying subpopulation of cells that form heart muscle cells without electrical instability, unlike some current iPSC approaches.