MIAMI, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today announced that it will report third quarter 2025 financial results and provide a business update on Tuesday, November 4, 2025 after the U.S. financial markets close. The Company will host a conference call and webcast the same day at 4:30 p.m. ET. Conference Call and Webcast Details: Co ...

Laromestrocel is a proprietary, scalable, allogeneic cellular therapy being evaluated to improve the clinical outcomes of children with HLHSFull enrollment achieved for pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated indicationELPIS II top-line trial results are anticipated in the third quarter of 2026 MIAMI, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechn ...

MIAMI, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today announced that it will participate in the 4th Annual ROTH Healthcare Opportunities Conference. Longeveron management will host one-on-one meetings with investors at the conference to be held October 9, 2025 in New York. About Longeveron Inc. Longeveron is a clinical stage biotechnology co ...

Core Insights - Longeveron Inc. has elected Dr. George Paletta, Jr. to its Board of Directors, bringing extensive experience in medicine and entrepreneurship to the company [2][3] - The company is focused on developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, with a promising pipeline of stem cell therapies [2][6] Company Overview - Longeveron is a clinical stage biotechnology company that develops regenerative medicines to address unmet medical needs, with its lead product being laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy [6] - The company is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [6] - Laromestrocel has received five important FDA designations, including Orphan Drug designation and Fast Track designation for the HLHS program [6] Leadership and Expertise - Dr. Paletta is a recognized orthopedic surgeon and has significant experience in developing ambulatory surgical centers, having participated in the sale of two ASCs valued at nearly $1 billion [2][3] - He holds multiple patents in orthopedic and cardiovascular fields and has been involved in various start-up ventures, providing advisory roles [3][4] - Dr. Paletta's educational background includes a Doctor of Medicine from Johns Hopkins University and an MBA from Washington University in St. Louis [4]

Core Insights - Longeveron Inc. is participating in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa from October 6-8, 2025, to explore partnerships for its Alzheimer's disease stem cell therapy program [1][2] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions [1][5] - The lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [5] - The company is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [5] Alzheimer's Disease Program - Laromestrocel has shown promising results in a completed Phase 2a clinical trial (CLEAR MIND) for mild Alzheimer's disease, demonstrating an overall slowing of disease progression compared to placebo [3][6] - The trial met primary safety and secondary efficacy endpoints, with statistically significant improvements in clinical and biomarker outcomes for specific laromestrocel groups [3][7] - Full results from the CLEAR MIND study were presented at the 2024 Alzheimer's Association International Conference [4] Regulatory Designations - Laromestrocel has received multiple FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the HLHS program; and Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the Alzheimer's disease program [5][6] Clinical Development Pathway - A positive Type B meeting with the FDA in March 2025 established a clear regulatory pathway for a Biologics License Application (BLA) submission for laromestrocel in Alzheimer's disease [7] - The FDA has granted laromestrocel both RMAT and Fast Track designations, facilitating its development [6][7]

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]

Company Overview and Business Update [Introduction and CEO Statement](index=1&type=section&id=Introduction%20and%20CEO%20Statement) Longeveron Inc. reported Q2 2025 financial results and business updates, with CEO Wa'el Hashad highlighting positive stem cell therapy progress, productive FDA communications for HLHS and Alzheimer's, and IND approval for pediatric DCM, preparing for HLHS BLA submission by late 2026 - Longeveron Inc. is a clinical-stage regenerative medicine biotechnology company focused on developing cell therapies for life-threatening rare pediatric and chronic aging-related diseases[2](index=2&type=chunk) - CEO Wa'el Hashad stated that its stem cell therapy, Laromestrocel, showed positive preliminary results across five clinical trials for three indications[3](index=3&type=chunk) - The company held positive, clear-path meetings with the FDA for HLHS and Alzheimer's development programs and received IND approval for pediatric dilated cardiomyopathy, allowing direct entry into pivotal clinical trials[3](index=3&type=chunk) - The pivotal Phase 2b clinical trial for HLHS has completed patient enrollment, with top-line results expected in 2026 and a BLA submission planned for late 2026[3](index=3&type=chunk) [Development Programs Update](index=1&type=section&id=Development%20Programs%20Update) Longeveron's Laromestrocel (Lomecel-B) is being evaluated across multiple indications, with HLHS Phase 2b enrollment complete and BLA planned for late 2026, Alzheimer's showing potential with FDA agreement on Phase 2/3 design, and pediatric DCM receiving IND approval for a pivotal Phase 2 trial expected to start in H1 2026 - Longeveron's investigational therapeutic candidate is Laromestrocel (Lomecel-B), a proprietary, scalable, allogeneic cell therapy[4](index=4&type=chunk) [Hypoplastic Left Heart Syndrome (HLHS)](index=1&type=section&id=Hypoplastic%20Left%20Heart%20Syndrome%20%28HLHS%29) The HLHS program has completed enrollment for its pivotal Phase 2b clinical trial, with top-line results expected in Q3 2026 and a BLA submission planned for late 2026 if results are positive - The pivotal Phase 2b clinical trial for HLHS (ELPIS II) completed enrollment of all **40 pediatric patients** in June 2025[5](index=5&type=chunk)[6](index=6&type=chunk) - Top-line results from ELPIS II are anticipated in the **third quarter of 2026**[5](index=5&type=chunk)[6](index=6&type=chunk) - If ELPIS II results are positive, a Biologics License Application (BLA) for Laromestrocel in HLHS is expected to be submitted in **late 2026**[5](index=5&type=chunk)[6](index=6&type=chunk) - The FDA confirmed ELPIS II as a pivotal trial, potentially supporting a BLA submission for HLHS if sufficient evidence of efficacy is demonstrated[6](index=6&type=chunk) [Alzheimer's Disease (AD)](index=2&type=section&id=Alzheimer's%20Disease%20%28AD%29) The Alzheimer's disease program showed therapeutic potential in Phase 2a, with FDA agreement on a pivotal Phase 2/3 trial design, and the company is seeking strategic partnerships - Results from the Phase 2a clinical trial (CLEAR MIND) were published in Nature Medicine in March 2025, supporting Laromestrocel's therapeutic potential in treating mild Alzheimer's disease[10](index=10&type=chunk) - A positive Type B meeting was held with the FDA in March 2025 regarding the Alzheimer's BLA submission pathway, with agreement on the design, population, and endpoints for a proposed single pivotal Phase 2/3 clinical trial[10](index=10&type=chunk) - The FDA granted Laromestrocel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the treatment of mild Alzheimer's disease[10](index=10&type=chunk) - The company is seeking strategic collaborations and/or partnerships to advance Laromestrocel in treating AD[10](index=10&type=chunk) [Pediatric Dilated Cardiomyopathy (DCM)](index=2&type=section&id=Pediatric%20Dilated%20Cardiomyopathy%20%28DCM%29) The pediatric DCM program received FDA IND approval for direct entry into a pivotal Phase 2 clinical trial, anticipated to start in H1 2026 pending financing - In July 2025, the FDA approved Longeveron's IND application for its stem cell therapy, Laromestrocel, as a potential treatment for pediatric dilated cardiomyopathy (DCM)[10](index=10&type=chunk) - The approved IND application allows direct entry into a single pivotal Phase 2 registrational clinical trial[10](index=10&type=chunk) - The company currently anticipates initiating the pivotal Phase 2 clinical trial in the **first half of 2026**, subject to securing necessary financing[10](index=10&type=chunk) [Corporate Milestones and Strategic Initiatives](index=2&type=section&id=Corporate%20Milestones%20and%20Strategic%20Initiatives) Longeveron achieved significant regulatory milestones, including multiple FDA designations for HLHS and RMAT/Fast Track for AD, while actively seeking AD strategic collaborations, securing an XPRIZE Healthspan award, appointing a Chief Business Officer, licensing new stem cell technology, and raising approximately **$5 million** through a public offering with potential additional funds from warrant exercises - ELPIS II builds upon positive clinical results from ELPIS I, where children treated with Laromestrocel achieved **100% transplant-free survival** before five years of age[10](index=10&type=chunk) - The FDA granted Laromestrocel Orphan Drug, Fast Track, and Rare Pediatric Disease designations for the treatment of HLHS[10](index=10&type=chunk) - The company was selected as a semifinalist team for the XPRIZE Healthspan competition and received a **$250,000 Milestone 1 award**[10](index=10&type=chunk) - Than Powell was appointed Chief Business Officer, responsible for overall corporate business strategy, Alzheimer's program partnerships, and international strategy for the HLHS program[10](index=10&type=chunk) - The company licensed a new, composition-of-matter patented stem cell technology from the University of Miami with broad cardiac indications[10](index=10&type=chunk) - The company raised approximately **$5 million** through a public offering, with potential for an additional **$12.5 million** in gross proceeds from the full exercise of short-term warrants[10](index=10&type=chunk) Second Quarter 2025 Financial Results [Summary Financial Performance (Six Months Ended June 30, 2025)](index=3&type=section&id=Summary%20Financial%20Performance%20%28Six%20Months%20Ended%20June%2030%2C%202025%29) For the six months ended June 30, 2025, Longeveron's total revenue decreased by **31%** to **$0.7 million**, gross profit fell by **37%** to **$0.4 million**, while G&A and R&D expenses significantly increased by **28%** and **39%** respectively, leading to a **34%** expansion in net loss to **$10.0 million**, partially offset by a **$0.5 million** increase in other income Summary Financial Performance (Six Months Ended June 30, 2025) | Metric | Six Months Ended June 30, 2025 (million dollars) | Six Months Ended June 30, 2024 (million dollars) | Change (million dollars) | Change (%) | | :----------------------- | :--------------------------------- | :--------------------------------- | :---------------- | :------- | | **Revenue** | 0.7 | 1.0 | (0.3) | -31% | | **Cost of Revenue** | 0.3 | 0.3 | 0.0 | 0% | | **Gross Profit** | 0.4 | 0.7 | (0.3) | -37% | | **General and Administrative Expenses** | 5.5 | 4.3 | 1.2 | 28% | | **Research and Development Expenses** | 5.5 | 3.9 | 1.6 | 39% | | **Other Income, Net** | 0.5 | 0.1 | 0.4 | 400% | | **Net Loss** | (10.0) | (7.5) | (2.5) | 34% | - The decrease in revenue was primarily due to reduced demand from Bahamian registered trial participants and lower demand for contract manufacturing services from third-party customers[11](index=11&type=chunk) - The increase in general and administrative expenses was mainly associated with higher personnel and related costs, including equity-based compensation, in 2025[11](index=11&type=chunk) - The increase in research and development expenses was primarily due to higher personnel and related costs, including equity-based compensation, to support CMC and manufacturing readiness activities, and increased patent cost amortization in 2025, partially offset by reduced clinical trial expenses due to the discontinuation of aging-related frailty clinical trial activities[11](index=11&type=chunk) [Balance Sheet Highlights](index=6&type=section&id=Balance%20Sheet%20Highlights) As of June 30, 2025, Longeveron's total assets decreased to **$16,749 thousand** from **$25,558 thousand** at December 31, 2024, with cash and cash equivalents falling to **$10,334 thousand**, while total liabilities slightly increased to **$4,093 thousand**, and total stockholders' equity declined to **$12,656 thousand** primarily due to increased accumulated deficit Balance Sheet Highlights | Metric (thousand dollars) | June 30, 2025 | December 31, 2024 | Change (thousand dollars) | | :-------------------- | :------------- | :------------- | :------------- | | **Assets:** | | | | | Cash and Cash Equivalents | 10,334 | 19,232 | (8,898) | | Total Current Assets | 11,269 | 19,624 | (8,355) | | Total Assets | 16,749 | 25,558 | (8,809) | | **Liabilities:** | | | | | Total Current Liabilities | 3,284 | 2,582 | 702 | | Total Long-Term Liabilities | 809 | 1,089 | (280) | | Total Liabilities | 4,093 | 3,671 | 422 | | **Stockholders' Equity:** | | | | | Accumulated Deficit | (119,646) | (109,607) | (10,039) | | Total Stockholders' Equity | 12,656 | 21,887 | (9,231) | - As of June 30, 2025, cash and cash equivalents significantly decreased to **$10.334 million** from **$19.232 million** at December 31, 2024[19](index=19&type=chunk) - As of June 30, 2025, total assets decreased to **$16.749 million** from **$25.558 million** at December 31, 2024[19](index=19&type=chunk) - As of June 30, 2025, the accumulated deficit increased to **$119.646 million** from **$109.607 million** at December 31, 2024[19](index=19&type=chunk) [Statements of Operations Highlights](index=7&type=section&id=Statements%20of%20Operations%20Highlights) For the three months ended June 30, 2025, total revenue was **$316 thousand** with a net loss of **$5,028 thousand**, while for the six months, total revenue decreased to **$697 thousand** and net loss expanded to **$10,039 thousand**, though basic and diluted net loss per share decreased to **($0.67)** due to a significant increase in weighted average common shares outstanding Statements of Operations Highlights | Metric (thousand dollars) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :-------------------- | :-------------------- | :-------------------- | :-------------------- | | **Total Revenue** | 316 | 468 | 697 | 1,016 | | **Gross Profit** | 146 | 344 | 421 | 673 | | **Total Operating Expenses** | 5,543 | 3,844 | 10,999 | 8,263 | | **Operating Loss** | (5,397) | (3,500) | (10,578) | (7,590) | | **Other Income, Net** | 369 | 87 | 539 | 119 | | **Net Loss** | (5,028) | (3,413) | (10,039) | (7,471) | | **Basic and Diluted Net Loss Per Share** | (0.33) | (1.83) | (0.67) | (3.54) | | **Weighted Average Common Shares Outstanding** | 15,013,072 | 6,509,881 | 14,982,075 | 4,511,734 | - For the six months ended June 30, 2025, clinical trial revenue decreased from **$0.802 million** to **$0.557 million**, contract manufacturing lease revenue decreased from **$0.191 million** to **$0.012 million**, and contract manufacturing revenue increased from **$0.023 million** to **$0.128 million**[21](index=21&type=chunk) - For the six months ended June 30, 2025, operating loss expanded from **$7.59 million** to **$10.578 million**[21](index=21&type=chunk) - Basic and diluted net loss per share decreased from **($3.54)** to **($0.67)** for the six-month period, despite an increased net loss, due to a significant increase in weighted average common shares outstanding from **4,511,734** to **14,982,075**[21](index=21&type=chunk) [Cash Position and Financial Outlook](index=4&type=section&id=Cash%20Position%20and%20Financial%20Outlook) As of June 30, 2025, the company held **$10.3 million** in cash and cash equivalents, with recent financing expected to support operations until Q1 2026, anticipating increased operating and capital expenditures for HLHS BLA preparation, and planning to seek additional financing, including non-dilutive funds and partnerships for the Alzheimer's program - As of June 30, 2025, cash and cash equivalents totaled **$10.3 million**[12](index=12&type=chunk) - The company anticipates that existing cash and cash equivalents will support operating expenses and capital expenditures through the **first quarter of 2026**[12](index=12&type=chunk) - Operating expenses and capital expenditures are projected to increase for the remainder of 2025 and throughout 2026, primarily for CMC (Chemistry, Manufacturing, and Controls) and manufacturing readiness to support the HLHS BLA submission[12](index=12&type=chunk) - The company plans to pursue additional financing opportunities, equity financing, and non-dilutive funding, with a focus on seeking collaboration opportunities and/or non-dilutive funding for the Alzheimer's disease program[12](index=12&type=chunk) Additional Information [Conference Call Details](index=4&type=section&id=Conference%20Call%20Details) Longeveron Inc. hosted a conference call and webcast on August 13, 2025, at 4:30 PM ET to discuss financial results and business updates, with details provided for dial-in, conference ID, webcast link, and an archived replay Conference Call Details | Item | Details | | :-------------------- | :-------------------- | | **Conference Call Number** | 1.877.407.0789 | | **Conference ID** | 13754295 | | **Webcast** | Accessible via link | - An archived replay of the webcast will be available in the "Events & Presentations" section of the company's website[13](index=13&type=chunk) [About Longeveron Inc.](index=4&type=section&id=About%20Longeveron%20Inc.) Longeveron is a clinical-stage biotechnology company developing regenerative medicine products, with its lead candidate Laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy, demonstrating multiple potential mechanisms of action across four pipeline indications (HLHS, Alzheimer's, pediatric DCM, and aging-related frailty) and holding five key FDA designations - Longeveron is a clinical-stage biotechnology company developing regenerative medicine products to address unmet medical needs[14](index=14&type=chunk) - The company's lead investigational product is Laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors[14](index=14&type=chunk) - Laromestrocel possesses multiple potential mechanisms of action, including pro-angiogenic, pro-regenerative, anti-inflammatory, and tissue repair and healing effects[14](index=14&type=chunk) - The company is currently advancing four pipeline indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's disease, pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty[14](index=14&type=chunk) - The Laromestrocel development program has received five important 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 AD[14](index=14&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995, reflecting management's current expectations and estimates regarding future operations, performance, and economic conditions, which involve known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially, and the company disclaims any obligation to update them - 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[15](index=15&type=chunk) - Forward-looking statements involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from expectations[15](index=15&type=chunk) - Factors that could cause actual results to differ materially from forward-looking statements include, but are not limited to: cash position and the need to raise additional capital, difficulties in financing, dilutive effects on investors, financial performance, ability to continue as a going concern, the period over which existing cash and cash equivalents will be sufficient to fund future operating expenses and capital expenditure requirements, the ability of clinical trials to demonstrate the safety and efficacy of product candidates, the timing and focus of clinical trials, the size of the market opportunity, the ability to scale manufacturing and commercialization, the success of competing therapies, the characteristics, safety, and efficacy of product candidates, the ability to obtain and maintain regulatory approvals, further development plans for product candidates, intellectual property protection, and the ability to recruit and retain personnel[15](index=15&type=chunk) - The company undertakes no obligation to update or revise any forward-looking statements, except as required by law[16](index=16&type=chunk)

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].