Leadership Changes - Longeveron Inc. appointed Than Powell as interim Chief Executive Officer, succeeding Wa'el Hashad who left to pursue other opportunities [1][6] - Dr. Joshua Hare, the founder and Chief Science Officer, has been appointed as Executive Chairman of the Board [1][6] - The Board plans to conduct a national search for a permanent CEO [1][6] Pipeline and Clinical Trials - Longeveron has a robust pipeline centered on laromestrocel, a stem cell therapy, with positive initial outcomes in five clinical trials across three indications [2] - The pivotal Phase 2b clinical trial for laromestrocel as a treatment for hypoplastic left heart syndrome (HLHS) has achieved full enrollment, with top-line results expected in 2026 [2] - The company has expanded its pipeline to include pediatric dilated cardiomyopathy, advancing three unique programs to pivotal clinical trial stage [2][7] Regulatory Designations - Laromestrocel has received five important FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for the HLHS program, and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the Alzheimer's disease program [7]

Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs [2] - 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 [2] - Laromestrocel has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects, with applications across various disease areas [2] Pipeline and FDA Designations - Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [2] - The HLHS program has received three important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation [2] - The Alzheimer's disease program has received two FDA designations: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [2] Upcoming Events - Longeveron will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City [1] - The company's presentation is scheduled for September 8, 2025, from 4:00 to 4:30 p.m. ET, with a webcast available on the company's website [1]

Financial Data and Key Metrics Changes - Revenues for the six months ended June 30, 2025, were $700,000, a decrease of $300,000 or 31% compared to $1,000,000 for the same period in 2024, primarily due to decreased participant demand for the Bahamas registry trial and reduced demand for contract manufacturing services [25][26] - Clinical trial revenue for the same period was $600,000, a decrease of $200,000 or 31% compared to $800,000 in 2024 [26] - General and administrative expenses increased to approximately $5,500,000, up from $4,300,000, representing a 28% increase [27] - Research and development expenses rose to approximately $5,500,000, a 39% increase from $3,900,000 in 2024 [27] - Net loss increased to approximately $10,000,000 for the six months ended June 30, 2025, compared to a net loss of $7,500,000 for the same period in 2024 [27][28] Business Line Data and Key Metrics Changes - The company is focused on three primary operational goals for 2025: advancing the pivotal Phase 2b study for SLHS, SLHS BLA preparedness, and pursuing strategic collaboration for the Alzheimer's disease program [6][30] - The SLHS program is considered a key strategic priority with a high probability of success and a shorter path to potential regulatory approval [6][30] Market Data and Key Metrics Changes - The U.S. market opportunities for the company's three initial indications are approximately $5 billion for Alzheimer's disease, over $4 billion for aging-related frailty, and up to $1 billion for hypoplastic left heart syndrome (HLHS) [5][6] - The prevalence of pediatric dilated cardiomyopathy is estimated to be around 2,000 to 3,000 patients in the U.S., while HLHS affects about 1,000 newborns [37] Company Strategy and Development Direction - The company is expanding its pipeline to include pediatric dilated cardiomyopathy and has licensed additional stem cell technology from the University of Miami [21][30] - The strategy focuses on excellent science, lower required investments, speed to market, and addressing important unmet medical needs [21] - The company plans to initiate a pivotal Phase 2 clinical trial for pediatric dilated cardiomyopathy in 2026 [18][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential BLA submission for SLHS in late 2026, contingent on positive trial results [28][30] - The company is focused on prudent capital allocation strategies to advance development programs, which are considered highly cost-efficient [28][29] - Management highlighted the importance of FDA interactions and the collaborative approach taken by the agency [8][56] Other Important Information - The company completed a public offering in August, raising approximately $5 million in gross proceeds [28] - The FDA has approved the IND application for evaluating laramestrocel as a treatment for pediatric dilated cardiomyopathy, allowing the company to move directly to a pivotal Phase 2 trial [17][18] Q&A Session Summary Question: Are the target patient populations and addressable markets for HLHS and pediatric dilated cardiomyopathy similar? - The markets are similar but not identical; HLHS has a one-time use administration while pediatric dilated cardiomyopathy involves continuous use [35][36] Question: Will a favorable approval decision in HLHS impact the regulatory outlook for pediatric dilated cardiomyopathy? - A positive outcome from the HLHS trial would support the regulatory review process for pediatric dilated cardiomyopathy, but the FDA will still require study results specific to that indication [41][42] Question: What is the estimated budget for the pediatric dilated cardiomyopathy trial? - Preliminary budget estimates for the entire trial range from $15 million to $20 million, with annual costs around $3 million [43][44] Question: Will the company retain the pediatric designation and associated benefits if the PRB sunsets? - The company is cautiously optimistic about the renewal of the PRB and has mechanisms in place for rolling submissions [51][53] Question: What gave the FDA confidence to allow the company to move directly to pivotal Phase 2 for pediatric dilated cardiomyopathy? - The FDA was confident due to the design of clinically meaningful endpoints and the company's robust safety data set from previous studies [67][72]

Exhibit 99.1 Longeveron® Announces Second Quarter 2025 Financial Results and Provides Business Update MIAMI, August 13, 2025 -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today reported financial results for the quarter ended June 30, 2025 and provided a business update. "Our differentiated approach to stem cell therapy continues to yield positive results ...

Core Viewpoint - Longeveron Inc. is advancing its clinical-stage regenerative medicine programs, particularly focusing on laromestrocel for treating rare pediatric and chronic conditions, with significant developments in clinical trials and regulatory interactions with the FDA [2][8]. Financial Results - Revenues for the six months ended June 30, 2025, were $0.7 million, a decrease of 31% compared to $1.0 million in 2024, primarily due to reduced participant demand for the Bahamas Registry Trial and contract manufacturing services [14]. - General and administrative expenses increased to approximately $5.5 million in 2025, up 28% from $4.3 million in 2024, mainly due to higher personnel costs [14]. - Research and development expenses rose to approximately $5.5 million, a 39% increase from $3.9 million in 2024, driven by increased personnel costs and patent amortization [14]. - The net loss for the six months ended June 30, 2025, was approximately $10.0 million, an increase of 34% from a net loss of $7.5 million in 2024 [14]. Development Programs Update - Laromestrocel (Lomecel-B) is being evaluated for multiple indications, including Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's disease, and Pediatric Dilated Cardiomyopathy (DCM) [3][4][5]. - The pivotal Phase 2b clinical trial (ELPIS II) for HLHS has achieved full enrollment of 40 pediatric patients, with top-line results expected in Q3 2026 [9]. - The FDA has granted laromestrocel Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS, and a similar pathway is being pursued for Alzheimer's disease [9][11]. Corporate Updates - The company completed a public offering, raising approximately $5.0 million, with potential additional proceeds of up to $12.5 million from short-term warrants [9]. - In July 2025, the FDA approved the IND application for laromestrocel as a potential treatment for pediatric dilated cardiomyopathy, allowing the company to move directly to a pivotal Phase 2 trial [9]. - The company is actively seeking strategic collaborations and partnerships to advance its Alzheimer's disease program and is focused on BLA readiness for HLHS [9][14].

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 June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-40060 Longeveron Inc. (Exact name of registrant as specified in its charter) | Delaware | 47-2174146 | | --- | --- | | (State or Other Ju ...

A Regenerative Medicine Company Cellular therapies for life-threatening and chronic aging-related conditions Investor Presentation Nasdaq (LGVN) │ August 2025 Forward Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management's current expectations, assumptions, and estimates of future operations, performance and economic ...

Core Points - Longeveron Inc. has closed a public offering of 5,882,354 shares of Class A common stock at a price of $0.85 per share, with potential additional gross proceeds of up to $12.5 million from short-term warrants [1][3] - The company intends to use the net proceeds for ongoing clinical and regulatory development of laromestrocel, targeting conditions such as HLHS, Alzheimer's disease, and pediatric DCM, as well as for general corporate purposes [3][6] - H.C. Wainwright & Co. acted as the exclusive placement agent for this offering [2] Financial Details - The gross proceeds from the offering were approximately $5.0 million before deducting fees and expenses [3] - The short-term warrants have an exercise price of $0.85 per share and are immediately exercisable for a period of twenty-four months [1][3] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines, with its lead product being laromestrocel, an allogeneic mesenchymal stem cell therapy [6] - The company is pursuing four pipeline indications: HLHS, Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [6] - Laromestrocel has received multiple FDA designations, including Orphan Drug and Fast Track designations for HLHS, and Regenerative Medicine Advanced Therapy designation for Alzheimer's disease [6]

Group 1 - Longeveron Inc. announced a public offering of 5,882,354 shares of Class A common stock at a price of $0.85 per share, with potential additional gross proceeds of up to $12.5 million from short-term warrants [1][3] - The offering is expected to close on or about August 11, 2025, subject to customary closing conditions [1] - The company intends to use the net proceeds for ongoing clinical and regulatory development of laromestrocel, including funding for various disease states such as HLHS, Alzheimer's disease, and pediatric DCM [3][6] Group 2 - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The securities are being offered under a registration statement filed with the SEC, which became effective on August 8, 2025 [4] Group 3 - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines, with its lead product being laromestrocel, an allogeneic mesenchymal stem cell therapy [6] - The company is pursuing four pipeline indications: HLHS, Alzheimer's disease, Pediatric DCM, and Aging-related Frailty, and has received multiple FDA designations for its development programs [6]

Core Viewpoint - Longeveron Inc. is set to report its second quarter 2025 financial results and provide a business update on August 13, 2025, after 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] - Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [3] Regulatory Designations - Laromestrocel development programs have received five significant FDA designations: - For the HLHS program: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation - For the Alzheimer's disease program: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [3]