Company Overview - Longeveron is a regenerative medicine company focused on cellular therapies for life-threatening and chronic aging-related conditions[1] - The company's lead product is Laromestrocel (Lomecel-B), an allogeneic mesenchymal stem cell (MSC) therapy derived from healthy young adult bone marrow[9] - Longeveron is targeting large U S markets with significant unmet medical needs, including Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's Disease (AD), and Aging-related Frailty (AF)[6] Clinical Pipeline and Regulatory Pathway - The company has positive initial results from 5 clinical trials across 3 indications and a well-established safety profile[6] - Laromestrocel has received 5 important FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease for HLHS, and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track for AD[6] - A positive FDA Type C meeting for HLHS and an ongoing pivotal trial suggest a clear regulatory pathway to Biologics License Application (BLA)[6] - A positive FDA Type B meeting for AD and a planned single, pivotal Phase 2/3 clinical trial also indicate a potential BLA pathway[6] Market Opportunity - The U S market potential for HLHS is approximately $1 billion, for AD it is over $5 billion, and for Aging-related Frailty it is over $4 billion[6] - Alzheimer's Disease (AD) affects 6.9 million people in the U S [12] - Aging-related Frailty affects 8.1 million people in the U S [12] Financial Status - As of March 31, 2025, Longeveron had $14.3 million in cash and cash equivalents[57] - As of May 1, 2025, there were approximately 15.0 million shares of common stock outstanding, with approximately 6.8 million shares exercisable under outstanding warrants[58]

Exhibit 99.1 Longeveron® Announces First Quarter 2025 Financial Results and Provides Business Update MIAMI, May 8, 2025 -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today reported financial results for the quarter ended March 31, 2025 and provided a business update. "In the first quarter, we made notable progress advancing the development of our stem cell therapy, larom ...

Core Viewpoint - Longeveron Inc. is making significant progress in the development of its stem cell therapy, laromestrocel, with a focus on advancing clinical trials for Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer's disease, while preparing for potential regulatory submissions in the coming years [2][8]. Financial Results Summary - Revenues for Q1 2025 were $0.4 million, a decrease of 30% from $0.5 million in Q1 2024, primarily due to reduced participant demand for the Bahamas Registry Trial [9]. - Clinical trial revenue from the Bahamas Registry Trial decreased by 50% to $0.3 million in Q1 2025 from $0.5 million in Q1 2024 [9]. - Contract manufacturing revenue increased by approximately 270% to $0.1 million in Q1 2025 from $33,000 in Q1 2024 [9]. - General and administrative expenses rose by 34% to approximately $2.9 million in Q1 2025 compared to $2.2 million in Q1 2024 [9]. - Research and development expenses increased by 13% to approximately $2.5 million in Q1 2025 from $2.2 million in Q1 2024 [9]. - Net loss for Q1 2025 was approximately $5.0 million, an increase of 23% from $4.0 million in Q1 2024 [16]. Development Programs Update - The pivotal Phase 2b clinical trial (ELPIS II) for laromestrocel in HLHS has reached approximately 95% enrollment and is expected to complete enrollment in Q2 2025 [8][9]. - A potential Biologics License Application (BLA) submission for HLHS is anticipated in 2026, contingent on the success of ELPIS II [9]. - Results from the Phase 2a clinical trial (CLEAR MIND) for Alzheimer's disease were published in Nature Medicine, supporting further clinical development [9]. - The FDA has granted laromestrocel multiple designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease for HLHS, and RMAT and Fast Track for Alzheimer's disease [11]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines, with laromestrocel (Lomecel-B™) as its lead investigational product [11]. - The company is pursuing treatments for HLHS, Alzheimer's disease, and aging-related frailty, leveraging the therapeutic potential of its allogeneic mesenchymal stem cell therapy [11].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Longeveron Inc. (Exact name of registrant as specified in its charter) | Delaware | 47-2174146 | | --- | --- | | (State or Other Jurisdiction | (IRS Employer | | of Incorporation) | Identification No.) | | th 1951 NW 7 Avenue, Suite 520, Miami, Florida | 33136 | | (Address of principal executi ...

Core Viewpoint - Longeveron Inc. is set to report its first quarter 2025 financial results and provide a business update on May 8, 2025, after U.S. market close, followed by a conference call and webcast [1] Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to meet unmet medical needs [3] - The company's lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [3] - Laromestrocel has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects, with applications across various disease areas [3] Pipeline and FDA Designations - Longeveron is pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease (AD), and aging-related frailty [3] - The HLHS program has received three FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation [3] - The AD program has received two important FDA designations: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [3]

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].

Core Insights - Longeveron Inc. announced a positive outcome from a Type B meeting with the FDA regarding laromestrocel (Lomecel-B) as a potential treatment for Alzheimer's disease [2][3] - The FDA and the company aligned on the study design for a pivotal Phase 2/3 clinical trial, which may lead to a Biological License Application (BLA) based on interim results [3][9] - Laromestrocel has received both RMAT and Fast Track designations from the FDA, facilitating closer interactions during its development [7][9] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with laromestrocel as its lead investigational product [14] - The company is pursuing multiple indications, including hypoplastic left heart syndrome, Alzheimer's disease, and aging-related frailty [14] Clinical Trial Details - The planned pivotal Phase 2/3 clinical trial is expected to start in the second half of 2026, contingent on securing additional funding or partnerships [6][9] - Previous clinical trials, including a Phase 1 study and a Phase 2a trial (CLEAR-MIND), demonstrated a favorable safety profile and potential clinical efficacy in patients with mild Alzheimer's disease [4][5] Mechanism of Action - Laromestrocel is derived from mesenchymal stem cells (MSCs) and is believed to have multiple mechanisms of action that may address inflammatory responses associated with Alzheimer's disease [10][13] - The therapy aims to tackle the underlying pathology of Alzheimer's without the limitations of existing treatments [6] Alzheimer's Disease Context - Alzheimer's disease is a leading cause of dementia, significantly impacting patients and society, with costs in the U.S. reaching hundreds of billions annually [11] - Neuroinflammation is a key feature of Alzheimer's, contributing to the disease's progression and associated cognitive decline [12]

Core Insights - Longeveron Inc. announced a positive outcome from a Type B meeting with the FDA regarding laromestrocel (Lomecel-B™) as a potential treatment for Alzheimer's disease [1][2] - The FDA and the company aligned on the study design for a pivotal Phase 2/3 clinical trial, which includes patient population, placebo control, dosing, trial duration, and endpoints [2][8] - The FDA granted laromestrocel both RMAT and Fast Track designations, facilitating closer interaction during development [6][8] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines for unmet medical needs, with laromestrocel as its lead investigational product [12] - The company is pursuing multiple indications, including Alzheimer's disease, hypoplastic left heart syndrome, and aging-related frailty [12] Clinical Trial Details - The planned pivotal Phase 2/3 clinical trial is expected to begin in the second half of 2026, contingent on securing non-dilutive funding or partnerships [5][8] - Previous clinical trials, including a Phase 1 study and a Phase 2a trial (CLEAR-MIND), demonstrated a favorable safety profile and potential clinical efficacy in patients with mild Alzheimer's disease [3][4] Mechanism of Action - Laromestrocel is derived from mesenchymal stem cells (MSCs) and is believed to have multiple mechanisms of action that may address inflammatory responses associated with Alzheimer's disease [7][11] - The therapy aims to tackle the underlying pathology of Alzheimer's without the limitations of existing treatments [5] Alzheimer's Disease Context - Alzheimer's disease is a leading cause of dementia, significantly impacting patients, families, and society, with substantial economic costs [9] - Neuroinflammation is a key feature of Alzheimer's, contributing to the disease's progression and associated cognitive decline [10]

Core Insights - Longeveron Inc. announced the publication of results from the CLEAR MIND Phase 2a clinical trial for laromestrocel (Lomecel-B™) as a potential treatment for mild Alzheimer's disease, reinforcing its safety and efficacy [2][3] - The trial involved 48 patients aged 60-85, with results indicating improvements in cognitive function, quality of life, and brain volume [5][11] - Laromestrocel (Lomecel-B™) is the first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer's disease [5][7] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with laromestrocel (Lomecel-B™) as its lead investigational product [9] - The company is pursuing multiple indications, including hypoplastic left heart syndrome, Alzheimer's disease, and aging-related frailty [9] Clinical Trial Details - The CLEAR MIND trial was randomized and placebo-controlled, achieving primary safety and secondary efficacy endpoints [3][6] - Key findings showed laromestrocel (Lomecel-B™) improved cognitive function and minimized brain volume loss associated with Alzheimer's disease [11] - Safety evaluations indicated that laromestrocel (Lomecel-B™) was well tolerated, with no significant adverse effects reported [6][11] Mechanism of Action - Laromestrocel (Lomecel-B™) is derived from mesenchymal stem cells (MSCs) and is believed to have multiple mechanisms of action, including anti-inflammatory and pro-vascular effects [8][9] - The therapy aims to address the underlying pathology of Alzheimer's disease without the limitations of previous treatments [3][5] Regulatory Status - The FDA has granted laromestrocel (Lomecel-B™) both RMAT and Fast Track designations, facilitating greater access to the FDA during its development [7][9] - The company plans to meet with the FDA to discuss future development paths for laromestrocel (Lomecel-B™) in Alzheimer's disease [7]

Core Insights - Longeveron Inc. announced the publication of results from the CLEAR MIND Phase 2a clinical trial for laromestrocel (Lomecel-B™) as a potential treatment for mild Alzheimer's disease, reinforcing its safety and efficacy [1][2] Clinical Trial Details - The Phase 2a trial involved 48 patients aged 60-85 with mild Alzheimer's disease, where 36 received laromestrocel and 12 received a placebo [2][3] - The trial achieved its primary safety and secondary efficacy endpoints, with results published in Nature Medicine [2][3] Key Findings - Laromestrocel (Lomecel-B™) improved cognitive function, quality of life, and brain volume in patients with mild Alzheimer's disease [3] - The treatment demonstrated safety and tolerability, with no significant adverse effects reported [4] - Statistically significant improvements were observed in cognitive assessments and brain volume preservation compared to placebo [4] Mechanism of Action - Laromestrocel is a mesenchymal stem cell therapy that may address inflammatory responses in the brain, offering a new strategy for treating Alzheimer's disease [2][6] - The therapy has multiple potential mechanisms, including pro-vascular and immunomodulatory effects [6][7] Regulatory Designations - Laromestrocel (Lomecel-B™) has received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for the treatment of mild Alzheimer's disease [5][7] Future Development - The company plans to meet with the FDA to discuss the data and future development paths for laromestrocel in Alzheimer's disease [5]