Longeveron's Q2 2025 Earnings: Unpacking Key Contradictions in Manufacturing, Regulatory Support, and Clinical Benchmarks

Manufacturing strategy and partnering, PRV program impact on laromestrocel approval, budget and duration for the PBC Phase 2 study, regulatory support and FDA interactions, efficacy benchmarks for the HLHS ELPIS II trial are the key contradictions discussed in Longeveron's latest 2025Q2 earnings call.



Clinical Trial Advancements:
- Longeveron completed enrollment for the pivotal Phase 2b ELPIS II study in HLHS, with 40 patients enrolled.
- This milestone was achieved due to the unmet need in the area and commitment to supporting patients suffering from HLHS.

Regulatory Support and Interactions:
- Longeveron received support from the FDA, which enhances the regulatory pathway for laromestrocel in HLHS and other indications.
- The company has had 3 important interactions with the FDA in the past year, clarifying the regulatory path and supporting the development of new programs.

Financial Performance and Challenges:
- Longeveron's revenue for the first half of 2025 was $0.7 million, down 31% from the previous year.
- This decrease was primarily attributed to reduced participant demand for the Bahamas registry trial and reduced contract manufacturing services.

Research and Development Investments:
- Research and development expenses increased to approximately $5.5 million in the first half of 2025, up 39% from the previous year.
- The increase was driven by investments in CMC and manufacturing readiness activities to support BLA-enabling efforts.