Longeveron (LGVN) Q3 2024 earnings summary

Executive summary

• Achieved significant progress in clinical and regulatory milestones, with Lomecel-B advancing for HLHS and Alzheimer's, supported by strong clinical data and multiple FDA designations.

• Over 80% enrollment in pivotal ELPIS II Phase IIb trial for HLHS; FDA confirmed trial as pivotal for potential BLA submission.

• Positive Phase IIa results for Alzheimer's program, earning RMAT and Fast Track designations, with further regulatory engagement planned for 2025.

• Celebrated 10th anniversary, highlighting a decade of innovation and administration of Lomecel-B to over 540 patients.

• No FDA-approved products yet; revenue generated from grants, Bahamas Registry Trials, and contract manufacturing.

Financial highlights

• Revenue for the first nine months of 2024 was $1.8 million, up 177% year-over-year, driven by contract manufacturing and Bahamas Registry Trial demand.

• Gross profit for the nine months was $1.3 million, up 506% year-over-year.

• Net loss for the nine months ended September 30, 2024, was $11.9 million, a 23% improvement from 2023.

• Cash and cash equivalents stood at $22.8 million as of September 30, 2024, expected to fund operations through Q4 2025.

• Raised $15.4 million in capital in July and September 2024.

Outlook and guidance

• ELPIS II enrollment expected to complete by end of 2024 or early 2025, with potential for rolling BLA submission in 2026 if results are positive.

• Plans to meet with FDA in Q1 2025 to discuss next steps for the Alzheimer's program.

• Anticipates increased capital needs in 2025 due to ramp-up of BLA-enabling activities and manufacturing readiness; seeking additional financing and non-dilutive funding.