Longeveron reported an EPS of -$0.23 for March 17, 2026, beating the estimated EPS of -$0.37, indicating a better-than-expected financial performance.The company's revenue reached $365,000, significantly exceeding the estimated revenue of $110,330, showcasing its ability to generate higher sales than anticipated.Longeveron is advancing its pivotal Phase 2b clinical trial, ELPIS II, for treating Hypoplastic Left Heart Syndrome (HLHS), with results expected in the third quarter of 2026, which could be a major ...

Financial Data and Key Metrics Changes - Revenues for the year ended December 31, 2025, were $1.2 million, a decrease of $1.2 million or 50% compared to $2.4 million in 2024, primarily due to lower participant demand for clinical trials and reduced contract manufacturing services [10][11] - General and administrative expenses increased to approximately $12 million in 2025 from $10.3 million in 2024, reflecting a 17% increase mainly due to higher personnel costs and a one-time severance cost [11] - Research and development expenses rose to approximately $12 million in 2025 from $8.1 million in 2024, marking a 48% increase driven by personnel costs and CMC costs [12][13] - The net loss increased to approximately $22.7 million in 2025 from $16 million in 2024, a rise of 41% [13] - Cash and cash equivalents as of December 31, 2025, were $4.7 million, with approximately $1.4 million in working capital [14] Business Line Data and Key Metrics Changes - Clinical trial revenue for 2025 was $1 million, down from $1.4 million in 2024, while contract manufacturing revenue decreased from $0.5 million to $0.2 million [10][11] Company Strategy and Development Direction - The company is focused on securing financial resources and efficient capital allocation, having secured $15 million in new capital and the potential for an additional $15 million [2][3] - Strategic partnerships are being pursued to accelerate time to market and leverage resources from larger organizations [3][4] - The company aims to prepare for its first Biologics License Application (BLA) with the U.S. FDA following the results of the ELPIS-II clinical trial [3][4] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's position in the stem cell field and the potential for laromestrocel to address significant unmet medical needs [2][15] - The anticipated pivotal data for HLHS and the strengthening of the balance sheet are seen as critical milestones for future growth [17] Other Important Information - The HLHS program has been granted rare pediatric disease designation by the FDA, making it eligible for priority review vouchers (PRVs) upon BLA approval [6] - The company plans to pursue a sale of any PRV received for HLHS, with investors entitled to 50% of the proceeds [6] Q&A Session Summary Question: What are the commercial perspectives regarding scaled-up manufacturing for laromestrocel? - The company is prioritizing manufacturing and CMC, engaging with a CDMO for future manufacturing needs [21][22] Question: What non-dilutive sources of capital could be accessed for Alzheimer's disease and age-related frailty? - The company plans to seek licensing partners for both indications, with preliminary conversations already set up [23] Question: How soon can the BLA for HLHS be filed if data is positive? - The company is potentially eligible for a rolling submission and aims to initiate the regulatory process as quickly as possible after data readout [27][30] Question: What is the timeline for the pediatric dilated cardiomyopathy (PDCM) program? - The goal is to initiate the trial in 2027, with a focus on reducing heart transplant needs through a hierarchical composite endpoint [34][39] Question: What is the strategy for the recently patented use of laromestrocel in female sexual dysfunction? - The company sees this as a high unmet need and is likely to pursue partnerships for development rather than going it alone [45][49]

Financial Data and Key Metrics Changes - Revenues for the year ended December 31, 2025, were $1.2 million, a decrease of $1.2 million or 50% compared to $2.4 million in 2024, primarily due to lower participant demand for clinical trials and reduced contract manufacturing services [11][12] - General and administrative expenses increased to approximately $12 million in 2025 from $10.3 million in 2024, reflecting a 17% rise due to increased personnel costs [12] - Research and development expenses rose to approximately $12 million in 2025 from $8.1 million in 2024, marking a 48% increase driven by personnel costs and technology transfer expenses [13][14] - The net loss increased to approximately $22.7 million in 2025 from $16 million in 2024, a rise of 41% [14] Business Line Data and Key Metrics Changes - Clinical trial revenue for 2025 was $1 million, down from $1.4 million in 2024, while contract manufacturing revenue decreased from $0.5 million to $0.2 million [11][12] Market Data and Key Metrics Changes - The company has secured $15 million in new capital from institutional investors, with a potential second tranche of $15 million contingent on meeting certain milestones [3][4] - The HLHS program has been granted rare pediatric disease designation by the FDA, making it eligible for priority review vouchers (PRVs) upon approval of a BLA [7] Company Strategy and Development Direction - The company aims to pursue a robust partnering strategy across all development programs to accelerate time to market and leverage resources from larger organizations [4][5] - The focus is on the HLHS program with a near-term pathway to potential approval, and the company plans to initiate a pivotal phase 2 registrational study for pediatric dilated cardiomyopathy (PDCM) [8][10] - The company is also exploring opportunities in Alzheimer's disease and age-related frailty, with plans to seek licensing partners for these initiatives [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming pivotal data for HLHS and the strengthening of the balance sheet, indicating a potentially exciting time for the company [18] - The CEO highlighted the importance of strategic partnerships and the potential for significant financial outcomes from PRVs [7][18] Other Important Information - The company anticipates that existing cash and cash equivalents will fund operations into Q4 of 2026 following a recent private placement [15] - The company is actively engaged in clinical trials and has made significant progress in stem cell research, with multiple patents issued globally [16][17] Q&A Session Summary Question: Commercial perspectives for laromestrocel manufacturing - Management confirmed the potential for a separate PRV for PDCM and emphasized the priority of manufacturing and CMC for future growth [22][23] Question: Non-dilutive capital sources for Alzheimer's disease - Management indicated that seeking licensing partners for Alzheimer's disease and age-related frailty is a priority, with preliminary conversations already set up [24] Question: Timeline for BLA filing for HLHS - Management stated that if data is positive in Q3 2026, they would aim for a rolling submission for the BLA, targeting submission in 2027 [28][31] Question: Pediatric dilated cardiomyopathy program details - Management outlined plans for a hierarchical composite endpoint in the PDCM trial, aiming to reduce heart transplant needs and hospitalization [40][42] Question: Strategy for laromestrocel in female sexual dysfunction - Management sees this indication as a ripe opportunity for partnerships, addressing a significant unmet need in women's health [46][50]

Stephen Willard Stephen Willard, Chief Executive Officer, Longeveron Inc. (LGVN) On track for third quarter 2026 top-line trial results from anticipated 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 may serve as foundation for a Biologics License Application (BLA) submission for full approval for HLHS, if results demonstrate sufficient evidence of efficacyClosed a private pl ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 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 Oth ...

Core Viewpoint - Longeveron shares have experienced a significant increase, driven by a recent private placement deal and upcoming earnings expectations, despite a projected decline in revenue compared to the previous year [2][3]. Group 1: Earnings and Financial Performance - Analysts anticipate an EPS loss of 38 cents for Longeveron, with estimated revenue of $106,200, marking a substantial decrease from $603,000 reported in the same quarter last year [2]. - The recent stock price surge follows a $30 million private placement deal announced on March 10, which has positively influenced investor sentiment [2]. Group 2: Financing and Future Prospects - The financing led by Coastlands Capital is structured in two tranches, with the first $15 million aimed at advancing laromestrocel, the company's lead candidate for rare pediatric conditions [3]. - This capital infusion extends Longeveron's cash runway into the fourth quarter of 2026, ensuring funding through the critical Phase 2b ELPIS II trial data readout for Hypoplastic Left Heart Syndrome (HLHS), expected in the third quarter [3]. Group 3: Stock Performance and Market Sentiment - Longeveron shares rose by 9.01% to $0.97 during Tuesday's trading session, reflecting positive market sentiment [5]. - The stock's Relative Strength Index (RSI) has recently surged into the Overbought territory above 70, indicating strong buying pressure following a year of high volatility [4].

A Regenerative Medicine Company Stem cell therapies addressing life threatening conditions in the most vulnerable populations - children and the elderly Investor Presentation Nasdaq (LGVN) │ March 2026 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 f ...

Core Viewpoint - Longeveron Inc. is set to report its 2025 full year financial results and provide a business update on March 17, 2026, after U.S. financial markets 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]. - The company is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease (AD), Pediatric Dilated Cardiomyopathy (PDCM), and Aging-related Frailty [3]. - Laromestrocel has received five important 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 AD program [3].

Core Viewpoint - Longeveron Inc. has successfully closed a private placement for approximately $30 million, with initial proceeds of $15 million expected to fund operations into Q4 2026, beyond the anticipated pivotal Phase 2b ELPIS II clinical trial data readout in Q3 2026 [1][8]. Financing Details - The private placement was led by Coastlands Capital, with participation from Janus Henderson Investors, Logos Capital, and Kalehua Capital, resulting in total gross proceeds of approximately $15 million at the initial closing [2][8]. - At the initial closing, the company issued 6,013,384 shares of Class A common stock at a price of $0.52 per share, along with Series A Non-Voting Convertible Preferred Stock convertible into 22,832,770 shares of Class A common stock at a conversion price of $0.52 per share [3][8]. - The company is eligible to receive an additional approximately $15 million in gross proceeds, contingent on achieving certain milestones related to the Phase 2b ELPIS II clinical trial and share price [3][8]. Use of Proceeds - The net proceeds from the financing will be used for the ongoing clinical and regulatory development of laromestrocel, working capital, and other general corporate purposes, with expectations to fund operations into Q4 2026 [5][8]. Additional Agreements - The company agreed to sell investors an interest in 50% of proceeds from a potential future sale of a Rare Pediatric Disease Priority Review Voucher from the U.S. FDA related to the laromestrocel program for HLHS [4][8]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines, with its lead product being laromestrocel, an allogeneic mesenchymal stem cell therapy [9]. - The company is pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease (AD), and Pediatric Dilated Cardiomyopathy (DCM), with multiple FDA designations for its programs [9].

Core Viewpoint - Longeveron (LGVN) stock experienced a significant increase following the announcement of a private placement that raised approximately $30 million, which is expected to support the company's operations and clinical trials [1][4]. Group 1: Financing and Operational Impact - The private placement consists of an initial $15 million tranche, with the potential for an additional $15 million contingent on achieving specific milestones related to the Phase 2b ELPIS II clinical trial [1][4]. - The initial funding secures operations until the final quarter of 2026, allowing the company to reach critical milestones, particularly the topline data readout for the Phase 2b ELPIS II trial expected in Q3 [4]. Group 2: Market Confidence and Strategic Positioning - The second tranche of funding is tied to trial milestones, indicating investor confidence in the clinical success of Longeveron's lead candidate, laromestrocel, for Hypoplastic Left Heart Syndrome [5]. - High-profile participation from firms like Janus Henderson in the private placement provides a significant endorsement for Longeveron, which has faced challenges related to cash burn [5]. Group 3: Broader Investment Potential - Longeveron shares are currently valued primarily on the company's HLHS program, offering investors additional value from the rest of its pipeline, including laromestrocel for Alzheimer's Disease and promising data in Aging-Related Frailty [6]. - With a new CEO and a strengthened balance sheet, Longeveron is positioned as a well-funded clinical contender with multiple avenues for re-rating [7]. Group 4: Analyst Sentiment - Wall Street analysts maintain a strong bullish outlook on Longeveron, with a consensus rating of "Strong Buy" and a mean target price of approximately $6.86, suggesting over six times potential upside from current levels [10].