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 ...

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. 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].