Longeveron Inc.

We are a clinical stage biotechnology company developing regenerative medicines. Our main investigational product is laromestrocel, also known as Lomecel-B®. Laromestrocel is a proprietary, scalable, allogeneic cellular therapy designed to promote tissue repair and healing through pro-vascular, pro-regenerative, and anti-inflammatory mechanisms. This therapy has broad potential applications across various disease areas. Our mission is to advance laromestrocel's development and regulatory approval to make it available to patients. Since our founding in 2014, we have focused on organizing and staffing our company, building and equipping a current good manufacturing practice (cGMP) manufacturing facility with research and development labs, business planning, raising capital, establishing and maintaining our intellectual property portfolio, generating clinical safety and efficacy data in selected disease conditions and indications, and developing and expanding our manufacturing processes and capabilities for internal and external development programs. We manufacture our own investigational product candidates for early-phase clinical trials and have begun enhancing our Chemistry, Manufacturing and Controls (CMC) infrastructure to support potential future Biologics License Application (BLA) submissions, including planning for process and analytical method validation and commercial production readiness. For a potential BLA submission for laromestrocel for Hypoplastic Left Heart Syndrome (HLHS), we have decided to pursue commercial manufacturing through a third-party contract development and manufacturing organization (CDMO) instead of renovating our Miami facility for commercial-scale production. This decision was based on cost, timeline feasibility, and scalability, aiming for a more cost-effective and timely path for potential BLA submission and commercial launch.