Longeveron (NASDAQ:LGVN) executives used the company’s full-year 2025 earnings call to highlight a recently completed private placement, provide timelines for key clinical readouts, and discuss how management is prioritizing partnering and manufacturing readiness as it advances laromestrocel across multiple programs.
Leadership outlines near-term priorities and financing runway
Chief Executive Officer Stephen Willard, who recently joined the company, said his immediate focus has been on (1) securing capital and allocating it efficiently, (2) advancing the hypoplastic left heart syndrome (HLHS) program toward a potential first Biologics License Application (BLA), and (3) pursuing strategic partnering across the pipeline.
HLHS program positioned for pivotal data and potential BLA preparation
Chief Medical Officer Dr. Nataliya Agafonova said HLHS is the company’s primary clinical focus and described the ongoing Phase 2b ELPIS II trial as nearing completion. Enrollment of 40 patients was completed in June 2025, and management said it anticipates top-line results in the third quarter of 2026.
Agafonova cited FDA feedback received in August 2024 indicating ELPIS II “may be considered a pivotal study,” depending on results. If supported by the data, management said it plans to initiate preparation for a potential BLA submission, which would be the company’s first.
In the question-and-answer session, executives also discussed regulatory mechanics that could affect the pace of a filing. Co-founder and Chief Science Officer Joshua Hare said the company is potentially eligible for rolling submission and would take advantage of it if allowed by the FDA, adding that the next major milestone is the data readout, which would be followed by an end-of-phase meeting with the FDA to determine timing. Hare also said he believes the company is eligible for priority review based on its designations, “data permitting.” Agafonova added that, assuming positive data, the company would like to take advantage of rolling submission but noted that readiness includes both clinical modules and chemistry, manufacturing, and controls (CMC). She said the company is targeting BLA submission “sometime in 2027.”
PRV strategy and partnering plans
Willard emphasized the potential value of priority review vouchers (PRVs), noting that the HLHS program has rare pediatric disease designation, which makes it eligible to receive a PRV upon approval of a BLA. He said a similar PRV opportunity may exist for the pediatric dilated cardiomyopathy (PDCM) program and that the company expects to pursue that designation “very shortly.”
Willard also discussed the economic terms associated with the HLHS PRV under the recent financing, stating that the company agreed to pursue a sale of a PRV received for HLHS if granted, and that investors would be entitled to 50% of the proceeds from a potential sale of the HLHS PRV. In response to an analyst question, Willard pointed to recent PRV sales and said he expects prices to remain strong as 2029 approaches, while noting the inherent uncertainty in forecasting that far out.
Beyond PRVs, Willard said the company intends to seek licensing partners for Alzheimer’s disease and age-related frailty, describing partnering as a priority and referencing preliminary conversations. He also pointed to a recently published paper in Cell Stem Cell related to age-related frailty and said the company has received inbound licensing interest connected to that work.
PDCM trial planning: IND effective, global study concept, and endpoints
Agafonova said the company’s investigational new drug (IND) application for laromestrocel in PDCM became effective in July 2025. She said the IND allows the company to advance directly into a single pivotal Phase 2 registrational clinical trial, reflecting the seriousness of the rare pediatric disease and unmet need.
Management laid out a planning and initiation timeline for the PDCM program, with Agafonova stating the company anticipates planning and preparation in 2026 and potential study initiation in 2027. During Q&A, she added the company plans to conduct a feasibility assessment and hopes to begin opening sites in 2027.
Agafonova also provided study design elements, including a hierarchical composite endpoint similar to HLHS and inclusion of transplant listing and hospitalization measures. She said the study is planned as a one-year trial with administration every three months and a target enrollment of 70 patients, with an intent to run the trial globally rather than only in the U.S.
Hare said the company is enthusiastic about the possibility of a disease-modifying effect in pediatric dilated cardiomyopathy, while stressing that a curative outcome remains a hypothesis that will require clinical validation. He said the planned trial is designed to detect the ability to reverse disease and potentially reduce the need for transplant.
2025 financial results: revenue decline and higher operating expenses
Locklear reported 2025 revenue of $1.2 million, consisting of $1.0 million in clinical trial revenue and $0.2 million in contract manufacturing revenue. For 2024, revenue was $2.4 million, consisting of $1.4 million in clinical trial revenue, $0.5 million of contract manufacturing lease revenue, and $0.5 million of contract manufacturing revenue. She said the 50% year-over-year decrease was driven by lower participant demand for the Bahamas registry trial and reduced demand for contract manufacturing services from third-party clients.
On expenses, Locklear said general and administrative costs rose to approximately $12.0 million in 2025 from $10.3 million in 2024, primarily due to higher personnel costs from increased headcount and a one-time accrued severance cost for the former CEO. Research and development expense increased to approximately $12.0 million from $8.1 million, driven by increased personnel costs (including equity-based compensation), higher CMC costs associated with technology transfer and non-clinical manufacturing batches aimed at BLA readiness, and higher amortization related to patent costs.
Net loss widened to approximately $22.7 million in 2025 from $16.0 million in 2024. The company ended 2025 with $4.7 million in cash and cash equivalents and approximately $1.4 million in working capital, prior to the March 2026 financing.
On operational readiness, Willard also addressed manufacturing and CMC for laromestrocel, saying it is a priority and that the company is engaged with a contract development and manufacturing organization (CDMO) to handle manufacturing going forward, which would free internal laboratory space for other projects.
About Longeveron (NASDAQ:LGVN)
Longeveron Inc is a clinical-stage biotechnology company focused on the development and commercialization of allogeneic cellular therapies designed to address aging-related and inflammatory conditions. The company’s primary therapeutic candidate, Lomecel-B, is an off-the-shelf mesenchymal stem cell product derived from bone marrow. Through its proprietary manufacturing process, Longeveron aims to produce a consistent, scalable cell therapy platform with potential applications in multiple disease areas.
Longeveron’s pipeline encompasses several ongoing and completed clinical studies.
