Longeveron® Issues Letter to Shareholders Highlighting Corporate Strategy, Recent Progress and Key Priorities and Goals for 2025

Core Viewpoint - Longeveron Inc. has made significant progress in developing cellular therapies for life-threatening and chronic aging-related conditions, with a focus on advancing its lead product, laromestrocel (Lomecel-B™), towards a potential Biological License Application (BLA) submission in 2026 [1][22]. Strategic Overview and 2024 Progress - The field of stem cell therapy has evolved significantly over the past decade, transitioning from a theoretical concept to one that delivers tangible clinical outcomes, highlighting its potential in regenerative medicine [3]. - Longeveron is at the forefront of this evolution, with laromestrocel derived from mesenchymal stem cells (MSCs) showing promise in treating aging-related conditions and rare cardiovascular diseases [4]. Clinical Development and Market Opportunities - Laromestrocel has shown positive results in multiple clinical trials, including Phase 1 & 2 trials for Alzheimer's disease, aging-related frailty, and Hypoplastic Left Heart Syndrome (HLHS), with estimated market opportunities of over $5 billion for Alzheimer's, $4 billion for aging-related frailty, and up to $1 billion for HLHS [5]. - The World Health Organization approved "laromestrocel" as the non-proprietary name for Lomecel-B™, marking a key milestone for future commercialization [5]. HLHS Program - HLHS is a rare pediatric disease with a high mortality rate, where Longeveron's program aims to improve heart function in affected infants, achieving 100% transplant-free survival in a Phase I trial compared to a historical 20% mortality rate [7][8]. - The company is nearing completion of enrollment for the pivotal Phase 2b trial (ELPIS II), with nearly 95% enrollment expected to finish in Q2 2025 [9]. - A Type C meeting with the FDA confirmed that ELPIS II could be pivotal for BLA submission, with potential eligibility for a Priority Review Voucher (PRV) upon approval [10]. Alzheimer's Disease Program - The Alzheimer's disease program has received recognition, with positive results from the CLEAR MIND Phase 2a trial indicating safety and potential efficacy in slowing disease progression [11][12]. - A Type B meeting with the FDA established a clear regulatory pathway for a potential BLA submission based on positive interim results from a proposed seamless adaptive Phase 2/3 trial [13]. Financial Position and Capital Strategy - Longeveron anticipates needing additional capital to support its strategic objectives, with existing cash expected to fund operations into Q4 2025 [19]. - The company aims to manage expenses effectively, having reduced total operating expenses by 13% in 2024 while advancing development programs [22]. 2025 Goals and Priorities - Key objectives for 2025 include completing enrollment for ELPIS II, achieving BLA preparedness for HLHS, and seeking strategic partnerships for the Alzheimer's disease program [23]. - The company is focused on efficient execution of its strategic plan, with multiple transformational milestones anticipated over the next 12 months [20].