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]

Core Viewpoint - Longeveron Inc. has licensed a US patent for a novel stem cell technology that could significantly enhance its regenerative medicine pipeline, particularly in treating cardiovascular diseases and rare pediatric conditions [1][7]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with its lead product being laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy [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]. Patent and Technology - The licensed patent (12,168,028 B2) protects a method for deriving GHRH-Receptor+ cardiomyogenic cells from pluripotent stem cells, which may provide a safer alternative for generating cardiac muscle cells [1][7]. - This technology addresses a significant barrier in the use of induced pluripotent stem cells (iPS) for cardiovascular applications by selecting cells that are destined to become cardiomyocytes, thus avoiding complications like malignant ventricular arrhythmias [2][3]. Clinical and Regulatory Progress - Longeveron has made significant advancements in clinical and regulatory aspects for conditions such as HLHS and Alzheimer's disease, including recent IND approval for pediatric dilated cardiomyopathy [2]. - The new stem cell technology is expected to complement existing therapies and expand the company's pipeline in cardiovascular and rare pediatric disease areas [2][4].

Core Insights - Longeveron Inc. has received FDA approval for its IND application for laromestrocel, a stem cell therapy aimed at treating pediatric dilated cardiomyopathy (DCM) [2][4] - The approval allows the company to proceed directly to a Phase 2 pivotal registration clinical trial, anticipated to begin in the first half of 2026 [8] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with laromestrocel being its lead investigational product [6] - Laromestrocel is derived from mesenchymal stem cells (MSCs) and has multiple potential mechanisms of action, including anti-inflammatory and pro-vascular regenerative responses [3][6] Disease Context - DCM is the most common form of cardiomyopathy in children, with 50-60% of pediatric cardiomyopathy cases diagnosed as dilated [5] - Nearly 40% of children diagnosed with DCM may require a heart transplant or may die within two years of diagnosis, highlighting the urgent need for effective treatments [3][8] Clinical Development - The IND approval marks a significant milestone in pediatric cardiovascular treatment, as current therapies primarily manage symptoms rather than address underlying causes [4] - The development program for laromestrocel reinforces Longeveron's commitment to innovative stem cell therapies for rare diseases, particularly in the cardiovascular space [3][4] Market Potential - Pediatric cardiomyopathies affect at least 100,000 children globally, indicating a substantial market opportunity for effective treatment options [8] - The innovative approach of using stem cells to repair damaged heart tissue could represent a groundbreaking development in treating cardiovascular diseases in children [4]

Core Insights - Longeveron Inc. has appointed Than Powell as Chief Business Officer to lead its business strategy and international efforts, particularly in Alzheimer's disease and hypoplastic left heart syndrome (HLHS) programs [1][2][4] - The company has recently completed enrollment for its pivotal Phase 2 trial of laromestorcel for HLHS, with top-line data expected in approximately 13 months, which could support the first Biological License Application (BLA) submission [2][6] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines for life-threatening and chronic aging-related conditions [6] - The lead investigational product, laromestrocel (Lomecel-B™), is an allogeneic mesenchymal stem cell therapy derived from young, healthy adult donors, with potential applications across various disease areas [6] - The company is pursuing three pipeline indications: HLHS, Alzheimer's disease, and aging-related frailty, and has received multiple FDA designations for its programs [6] Leadership Background - Than Powell brings over 25 years of experience in the pharmaceutical and biotech industries, having held leadership roles at organizations such as GSK and Eli Lilly [4][5] - Prior to joining Longeveron, Powell led Corporate Development & Strategy for Surescripts, culminating in the company's acquisition by TPG [4]

Core Insights - Longeveron Inc. has completed full enrollment of the Phase 2b clinical trial (ELPIS II) for laromestrocel, targeting Hypoplastic Left Heart Syndrome (HLHS) [1][2] - The trial aims to evaluate laromestrocel as a potential adjunct treatment for HLHS, with top-line results expected in Q3 2026 [1][5] - Laromestrocel has received multiple FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations, indicating its potential significance in addressing unmet medical needs [4][5] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines, with laromestrocel as its lead investigational product [9] - The company is pursuing treatments for HLHS, Alzheimer's disease, and aging-related frailty, with laromestrocel being an allogeneic mesenchymal stem cell therapy [9] Clinical Trial Details - ELPIS II enrolled 40 pediatric patients across twelve leading treatment institutions, with primary endpoints including survival at 12 months and changes in right ventricular ejection fraction [2][3] - The trial builds on the success of ELPIS I, which reported 100% transplant-free survival at five years for patients treated with laromestrocel [3][6] Market Potential - The U.S. market potential for laromestrocel in treating HLHS is estimated to be up to $1 billion, highlighting the significant unmet medical need in this area [5] - If successful, the company could be eligible for a Priority Review Voucher (PRV), which can expedite the review process for future drug applications [7] Regulatory Status - The FDA has confirmed that ELPIS II is a pivotal trial, and positive results could lead to a Biological License Application (BLA) submission for full approval [4][5] - The Rare Pediatric Disease PRV program is currently facing uncertainty, but recent legislative efforts may extend its availability [7]

Financial Data and Key Metrics Changes - The company held its fourth annual meeting of stockholders on June 13, 2025, with a quorum established based on the voting shares represented [8][9] - The financial statements for the year ending December 31, 2024, were certified by independent auditors CBIZ, and the annual report was made available to stockholders [5][14] Business Line Data and Key Metrics Changes - The meeting included proposals for the election of a director and amendments to the incentive award plan, indicating ongoing corporate governance and compensation strategies [9][11] Market Data and Key Metrics Changes - No specific market data or key metrics were discussed during the meeting, focusing instead on internal governance matters [9][11] Company Strategy and Development Direction and Industry Competition - The company is focused on enhancing its incentive award plan by increasing the number of shares available for issuance, which may indicate a strategy to attract and retain talent [11][14] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting, as the focus was primarily on procedural matters and voting [9][15] Other Important Information - The results of the voting on the proposals will be reported on Form 8-K to be filed with the SEC within four business days of the meeting [14] Q&A Session Summary - No questions were raised during the meeting regarding the proposals, indicating either satisfaction with the agenda or a lack of engagement from stockholders [11][15]