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]

As filed with the Securities and Exchange Commission on August 8, 2025 Registration No. 333-289210 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Delaware 2834 47-2174146 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 1951 NW 7 Avenue, Suite 520 Miami, Florida 33136 Telephone: (305) 909-0840 ...

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]

As filed with the Securities and Exchange Commission on August 4, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 47-2174146 (I.R.S. Employer Identification No.) 1951 NW 7 Avenue, Suite 520 Miami, Florida 33136 Telephone: (305) 909-0840 (Address, including zip code, and telephone number, including area code, of registrant's p ...

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]

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]