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 three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, 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 - Wa'el Hashad, CEO of Longeveron, will present at the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference on June 16-17, 2025 [1] - The conference presentation will be accessible via a webcast, with a replay available on the company's website for 90 days following the event [1]

Core Viewpoint - Longeveron Inc. is actively pursuing partnerships for its Alzheimer's disease program, which has shown promising results in clinical trials, particularly with its lead candidate, laromestrocel [2][5]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with laromestrocel as its lead investigational product [7]. - Laromestrocel is an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors, with potential applications across various disease areas [7]. Clinical Trial Results - The Phase 2a clinical trial (CLEAR MIND) demonstrated that laromestrocel treated patients experienced an overall slowing or prevention of disease worsening compared to placebo, achieving primary safety and secondary efficacy endpoints [3][4]. - Statistically significant improvements were observed in pre-specified clinical and biomarker endpoints for specific laromestrocel groups compared to placebo [3]. Regulatory Designations - The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer's disease, facilitating greater access to FDA interactions during its development [5]. - Laromestrocel is noted as the first cellular therapeutic candidate to receive FDA RMAT designation for Alzheimer's disease [5]. Upcoming Events - Longeveron will participate in the BIO International Convention from June 16-19, 2025, to explore potential partnerships and strategic opportunities for its Alzheimer's disease program [1][2].

Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing cellular therapies for life-threatening and chronic aging-related conditions [6] - 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 [6] - Laromestrocel has potential applications across various disease areas, including hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty [6] Recent Developments - Longeveron has been selected as a Semi-Finalist Team in the XPRIZE Healthspan competition, receiving a $250,000 Milestone 1 Award [1][2] - The XPRIZE Healthspan competition is a 7-year, $101 million global initiative aimed at revolutionizing the approach to human aging [4] - The competition evaluates teams based on their scientific merit and the feasibility of their therapeutic approaches to restore or preserve functions lost to age-related degradation [2][4] Clinical Trials and FDA Designations - Laromestrocel has shown positive initial results in five clinical trials across three indications: Alzheimer's Disease, aging-related frailty, and HLHS [2] - The development programs for laromestrocel have received five significant U.S. FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS, and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for Alzheimer's Disease [2][6] Competition Goals - The XPRIZE Healthspan competition aims to develop therapeutics that can restore muscle, cognitive, and immune function by at least 10 years, with an ambitious goal of extending healthy life by 20 years [2][4] - The competition's top 100 teams were selected from over 600 applicants across 58 countries, with the potential for a grand prize of between $61 million and $81 million for the winning team [2][4]

Financial Data and Key Metrics Changes - Revenues for Q1 2025 were $400,000, a decrease of $100,000 or 30% compared to $500,000 in Q1 2024, primarily due to decreased participant demand for the Bahamas registry trial [23][24] - Net loss for the quarter increased to approximately $5,000,000 from $4,000,000 for the same period in 2024 [25] - Cash and cash equivalents as of March 31, 2025, were $14,300,000, expected to fund operations into Q3 2025 [25][26] Business Line Data and Key Metrics Changes - Clinical trial revenue from the Bahamas registry trial decreased to $300,000 in Q1 2025 from $500,000 in Q1 2024 [24] - Contract manufacturing revenue increased to $100,000 in Q1 2025 from $33,000 in Q1 2024, reflecting increased activity [24] Market Data and Key Metrics Changes - The U.S. market opportunity for HLHS is approximately $1 billion, with an estimated 1,000 babies born with HLHS each year [9][35] - The company anticipates a market penetration of about 65%, representing a potential revenue opportunity of over $500 million in the U.S. alone [35] Company Strategy and Development Direction - The company is focused on advancing stem cell therapy with its lead product, Laromestrocel, targeting multiple chronic indications [4][5] - Key strategic priorities include completing the Phase 2b study for HLHS, preparing for BLA submission, and pursuing strategic collaborations for the Alzheimer's disease program [9][10] - The company aims for a potential BLA submission in 2026 if the current HLHS trial is successful [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the upcoming transformational milestones over the next 12 to 18 months, including potential BLA submissions and partnerships [6][14] - The management team emphasized the importance of rigorous trial design and the supportive relationship with the FDA [39][40] Other Important Information - The company has received multiple FDA designations for its development programs, including orphan drug and fast track designations for HLHS [16] - The company is ramping up BLA enabling activities and anticipates increased operating expenses and capital requirements throughout 2025 [25][26] Q&A Session Summary Question: Clarification on HLHS market and enrollment challenges - Management noted that they have successfully enrolled approximately 95% of the trial population, which is a significant achievement for an orphan disease [32][33] Question: Impact of FDA leadership changes on BLA filing - Management stated that recent interactions with the FDA have been supportive and collaborative, with no indications that leadership changes would impact the BLA [39][40] Question: Current manufacturing capacity and plans for scaling operations - The company believes its current capacity can produce at least 1,500 doses of Laromestrocel, with plans to enhance GMP systems and potentially partner with a CDMO for commercial capabilities [43][44] Question: Value-based pricing applicability for Laromestrocel - Management indicated that they are considering value-based pricing and referenced a similar product priced at approximately $1.5 million for treatment, suggesting a potential for substantial revenue generation [52][53] Question: Salesforce requirements for HLHS and commercial strategy - Management highlighted that the 12 centers involved in the clinical trials conduct nearly 80% of the surgeries, indicating a focused commercial strategy with a small salesforce [60][61]

Financial Data and Key Metrics Changes - Revenues for Q1 2025 were $400,000, a decrease of $100,000 or 30% compared to $500,000 in Q1 2024, primarily due to decreased participant demand for the Bahamas registry trial [24][25] - Net loss for the quarter increased to approximately $5,000,000 from $4,000,000 for the same period in 2024 [26] - Cash and cash equivalents as of March 31, 2025, were $14,300,000, expected to fund operating expenses into Q3 2025 [26] Business Line Data and Key Metrics Changes - Clinical trial revenue from the Bahamas registry trial decreased to $300,000 in Q1 2025 from $500,000 in Q1 2024 [25] - Contract manufacturing revenue increased to $100,000 in Q1 2025 from $33,000 in Q1 2024, reflecting increased activity [25] Market Data and Key Metrics Changes - The U.S. market opportunity for HLHS is approximately $1 billion, with an estimated 1,000 babies born with HLHS each year [10][37] - The company anticipates a market penetration of about 65% for laromastrocel, representing a potential revenue of over $500 million in the U.S. alone [39] Company Strategy and Development Direction - The strategic plan focuses on the efficient execution of the development program for laromastrocel, with key priorities including HLHS BLA preparedness and seeking partnerships for the Alzheimer's disease program [10][11] - The company aims for a potential BLA submission in 2026, contingent on positive results from ongoing clinical trials [26][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming 12 to 18 months, highlighting multiple critical milestones that could be transformational for the company [6][15] - The management team emphasized the importance of rigorous trial design and the supportive relationship with the FDA, indicating confidence in the regulatory pathway [41][42] Other Important Information - The company has received five FDA designations for its lead product, laromastrocel, including orphan drug and fast track designations [17] - The enrollment for the Phase 2b clinical trial for HLHS is nearing completion, with approximately 95% enrollment expected to finish in Q2 2025 [11][20] Q&A Session Summary Question: Clarification on HLHS market and laromastrocel eligibility - Management confirmed that the majority of children who undergo stage two surgery will be considered for laromastrocel treatment once approved, with minimal exclusion criteria [34][36] Question: Impact of FDA leadership changes on BLA - Management stated that recent interactions with the FDA have been supportive and collaborative, with no indications that leadership changes would impact the BLA submission [41][42] Question: Manufacturing capacity and scaling plans - The company believes its current manufacturing capacity can produce at least 1,500 doses of laromastrocel, with plans to ramp up GMP systems and potentially partner with a CDMO for commercial capabilities [45][46] Question: Value-based pricing applicability - Management indicated that value-based pricing is applicable, with potential benchmarks from recent drug launches in the rare disease space, suggesting a premium pricing strategy for laromastrocel [51][56] Question: Salesforce requirements for HLHS - Management noted that the 12 centers involved in the ELPIS two study conduct the majority of surgeries, indicating a focused sales strategy with a small team [61][62] Question: Adaptive protocol for Alzheimer's study - The adaptive design will allow for a seamless transition from Phase 2 to Phase 3, with an interim analysis planned to assess efficacy before full approval [68][70]

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]