Longeveron Inc. Q2 FY2024 earnings call

• Science and Team: Strong science foundation, experienced team, and focus on patients impacted by target diseases.
• HLHS Program: Phase 1 ELPIS I showed 100% transplant-free survival up to 5 years. Phase 2 ELPIS II is enrolling, with 70% of 38 patients enrolled and targeting enrollment completion by end of 2024. FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS. Anticipate feedback from Type C meeting with FDA end year and ELPIS I five-year post-treatment data in Q3 2024.
• Alzheimer's Program: CLEAR MIND Phase 2a data showed Lomecel-B treated patients had overall slowing or prevention of disease worsening. Received RMAT and Fast Track designations. Plan to meet FDA end year to review future clinical and regulatory strategies. Seeking partnerships and non-dilutive funding for further development.
• Manufacturing: Expanding GMP facility in Miami with 3,000 sq ft cleanroom space. Generated over $200k in contract manufacturing revenue, with potential to reach $4-5 million annual revenue from contract services.
• Board Additions: Added three industry veterans to the board, including Dr. Roger Hajjar, Rich Kender, and Neha Motwani, who will add value to the board and company.

For the first half of 2024, revenues were $1 million, up $0.5 million (105%) compared to the first half of 2023, driven by increased participant demand for the Frailty and Cognitive Impairment registry trial in the Bahamas and new contract manufacturing revenue. Contract manufacturing revenue for the six months ended June 30, 2024, was $0.2 million from the first manufacturing services contract with Secretome Therapeutics. The company's total operating expenses for the first half of 2024 declined 22% year-over-year, with G&A expenses decreasing to approximately $4.3 million and R&D expenses to approximately $3.9 million.

• HLHS: Targeted enrollment completion for ELPIS II by end of 2024. Top-line data from ELPIS II expected in first quarter of 2026.
• Alzheimer's: Plan to meet FDA end year to review future clinical and regulatory strategies for the Alzheimer's program.
• Contract Services: Anticipate reaching $4-5 million in annual contract manufacturing revenue within 1-2 years as the contract manufacturing operation expands and matures.

• Uncertainties in clinical trial enrollments and timelines for ELPIS II and other programs.
• Regulatory approval processes for HLHS and Alzheimer's disease can be unpredictable and subject to delays.
• Dependence on securing non-dilutive funding and partnerships for continued development of Lomecel-B in various programs.

Q: Granularity on ELPIS II enrollment, timeline, and top-line data.

A: Currently, 27 out of 38 patients are enrolled in ELPIS II, with 11 remaining. Targeting enrollment completion by end of 2024. Top-line data from ELPIS II is expected in the first quarter of 2026.

Q: Details on ELPIS I long-term follow-up data.

A: We are collecting long-term data from 10 patients in ELPIS I. Full five-year follow-up after the Glenn procedure (Stage 2 procedure) will be available end of August 2024, which will support the Biologics License Application (BLA) submission with transplant-free survival and other key endpoints.

Q: Regulatory outlook, Alzheimer's funding, and contract services timeline.

A: Planning a Type B meeting with the FDA end of 2024 for both HLHS and Alzheimer's programs. Exploring non-dilutive funding sources, including grants and partnerships, for Alzheimer's research. Contract manufacturing services are expected to reach $4-5 million in annual revenue within 1-2 years as the operation scales up and expands its capabilities.