Longeveron Inc. Q4 FY2024 earnings call

• Wa'el Hashad highlighted 2024 as a productive year and discussed progress in Lomecel-B clinical trials for Alzheimer's, aging-related frailty, and HLHS. The HLHS Phase IIb study ELPIS II is over 90% enrolled and on track for BLA submission in 2026 if successful. - Nataliya Agafonova detailed the clinical programs, noting the HLHS program's focus and Alzheimer's CLEAR MIND Phase IIa results were positive with FDA designations. - Lisa Locklear reviewed financial results, noting revenue growth, expense management, and cash position.

Revenues for 2024 were $2.4 million, up $1.7 million or 237% compared to 2023. Contract manufacturing revenue for 2024 was $1 million, consisting of $0.5 million from manufacturing lease services and $0.5 million from manufacturing services contract. Total operating expenses for 2024 declined 13% year-over-year. G&A expenses decreased to approximately $10.3 million from $12.2 million in 2023. R&D expenses decreased approximately $1 million or 10% to approximately $8.1 million. Net loss decreased 25% to approximately $16 million for 2024 from a net loss of $21.4 million for 2023. Cash and cash equivalents as of December 31, 2024, were $19.2 million.

• Anticipate a rolling BLA submission with the FDA in 2026 if the ELPIS II trial is successful. - Operating expenses and capital expenditure requirements are expected to accelerate in 2025 due to BLA preparation activities. - The company intends to seek additional financing and non-dilutive funding options to support activities.

• HLHS is a rare disease, and enrollment delays can occur due to surgery timing. - Need for FDA alignment on composite endpoints and BLA preparation. - Uncertainties around PRV renewal and pre-BLA meetings with the FDA.

Q: What's causing the enrollment delay in ELPIS II?

A: HLHS is rare, surgery timing can cause delays, but the team is pushing to finish enrollment with over 90% enrolled.

Q: Will the FDA consider composite endpoints for ELPIS II?

A: Had discussions with FDA, and they are open to composite endpoints including hospitalization and other events.

Q: How many patients remain to be enrolled in ELPIS II?

A: The trial is for 38 patients, 35 enrolled, waiting on 3 more.

Q: How would Lomecel-B be commercialized in HLHS?

A: Treating physicians are limited (about 50 in US), minimal sales and marketing infrastructure needed.

Q: Any interactions with non-US regulators for Alzheimer's?

A: No current interactions, but planning to engage with international regulators and focus on partnerships.

Q: Manufacturing revenue outlook for 2025?

A: Remain open to other opportunities, but CMC readiness is a major focus, with potential small work from Secretome.