Longeveron Inc. Q3 FY2025 earnings call

• Than Powell emphasized focusing on delivering ELPIS II results (pivotal Phase IIb study in HLHS), securing financial resources, and HLHS BLA preparedness. - Nataliya Agafonova discussed the HLHS Phase IIb trial ELPIS II, which completed enrollment in June 2025 and is on track for results in Q3 2026. Also mentioned Alzheimer's Phase IIa results and potential partnerships. - Devin Blass spoke about CMC readiness, including pursuing commercial manufacturing via a third-party CMO, technology transfer, and potential contract manufacturing services for third parties. - Joshua Hare highlighted FDA designations for Longeveron's programs, including Orphan Drug, Fast Track, Rare Pediatric Disease, Regenerative Medicine Advanced Therapy, and Fast Track designations.

For the 9 months ended September 30, 2025: Clinical trial revenue was $0.7 million (a 36% decrease from $1.0 million in 2024). Contract manufacturing revenue was $0.2 million (a 76% decrease from $0.8 million in 2024). General and administrative expenses increased to $9.1 million from $7.4 million. Research and development expenses increased to $9.3 million from $6.1 million. Net loss was $17.3 million compared to $11.9 million in the same period in 2024. Cash and cash equivalents as of September 30, 2025, were $9.2 million.

• BLA for HLHS is now anticipated in 2027 rather than late 2026 due to operational decisions to extend cash runway. - Existing cash and cash equivalents are expected to fund operating expenses and capital expenditures into late Q1 2026. - The company intends to seek additional financing through capital raises, nondilutive funding options (grants, strategic partnerships), and will explore partnering opportunities across all indications.

• Uncertainty regarding future financing, which could require materially revising operational plans. - Risks associated with clinical trial outcomes not meeting expectations and potential delays or complications in regulatory approvals.

Q: Raghuram Selvaraju asked about the advisability of identifying potential partners for commercialization in rare conditions like HLHS and the format such partnerships might take.

A: Than Powell responded that they are exploring partnerships, considering both domestic and international options, and that the value proposition of laromestrocel in rare pediatric diseases is a key factor.

Q: Boobalan Pachaiyappan inquired about the postponement of the BLA to 2027 and ways to increase M&A appeal.

A: Than Powell explained that operational decisions to extend cash runway led to the BLA postponement, and he mentioned that the value proposition of the company's products and pipeline in rare diseases makes it appealing for potential M&A.

Q: Michael Okunewitch asked about HLHS value, payer conversations, and expediting the BLA pathway.

A: Than Powell discussed how HLHS's value proposition and long-term follow-up data from ELPIS I will be relevant in payer conversations, and emphasized the importance of ongoing conversations with the FDA to expedite the BLA pathway, including leveraging existing designations and potential initiatives like the Commissioner's National Priority Voucher program.