Longeveron (LGVN) Q3 2024 earnings summary

Executive summary

• Achieved significant milestones in clinical development, including over 80% enrollment in the pivotal ELPIS II trial for HLHS and positive Phase 2a results for Lomecel-B in Alzheimer's, with multiple FDA designations and further regulatory meetings planned.

• Focused on expense control and resource optimization, supporting advancement of the clinical pipeline and maintaining cash runway through Q4 2025.

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

• Accumulated deficit of $105.5 million as of September 30, 2024, with continued operating losses expected.

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

Financial highlights

• Revenue for the first nine months of 2024 was $1.8 million, up 177% year-over-year, driven by increased demand in the Bahamas Registry Trial and contract manufacturing; Q3 2024 revenue was $0.8 million, up 415% year-over-year.

• Gross profit for the nine months ended September 30, 2024 was $1.3 million, up 506% year-over-year.

• Total operating expenses declined 14% year-over-year; G&A expenses down 16% to $7.4 million, R&D expenses down 11% to $6.1 million.

• Net loss for the nine months ended September 30, 2024 was $11.9 million, a 23% improvement from $15.3 million in 2023; Q3 2024 net loss was $4.4 million, a 13% improvement year-over-year.

• 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.

• Anticipates meeting with FDA in Q1 2025 to discuss Alzheimer's program strategy.

• Cash runway expected through Q4 2025, but additional financing or non-dilutive funding may be needed as BLA-enabling activities ramp up.