Completion of ELPIS II Phase 2b Enrollment
Longeveron completed enrollment for the pivotal ELPIS II Phase 2b study, evaluating laromestrocel as a treatment for HLHS, a significant step towards regulatory approval.
Positive Regulatory Progress
The FDA's determination that ELPIS II is pivotal accelerates the regulatory path for laromestrocel, with a potential rolling BLA submission in late 2026.
Strong Pipeline Expansion
Introduction of pediatric dilated cardiomyopathy to the pipeline, with an IND approval from the FDA for a Phase 2 pivotal trial, showing confidence in the program.
Strategic Manufacturing Partner
Decision to use a third-party CDMO for commercial manufacturing to leverage scale and experience, facilitating the strategic plan for BLA readiness.
Positive Financial Outlook
Completion of a public offering raising approximately $5 million with potential for an additional $12.5 million, ensuring funding into the first quarter of 2026.