Longeveron Inc., a clinical-stage biotechnology company focused on developing regenerative medicines, reported significant financial developments in its recent 10-K filing for the fiscal year ending December 31, 2024. The company generated revenues of $2.4 million, a substantial increase of 237% compared to $709,000 in the previous year. This growth was primarily driven by heightened participant demand for its Bahamas Registry Trial and the introduction of a manufacturing services contract, which contributed $1 million to the total revenue. The gross profit for the year was approximately $1.9 million, reflecting a 752% increase from the prior year's gross profit of $221,000.

Despite the revenue growth, Longeveron continues to face challenges with operating expenses. Total operating expenses decreased to $18.4 million from $21.3 million in 2023, largely due to reductions in general and administrative costs and research and development expenses. The company reported a net loss of $16 million for 2024, down from a net loss of $21.4 million in the previous year, indicating a 25% improvement in its financial performance. The decrease in losses was attributed to lower personnel expenses and reduced costs associated with clinical trials, particularly the completed CLEAR MIND Alzheimer’s disease trial.

Strategically, Longeveron is advancing its lead investigational product, Lomecel-B™, which is being developed for three indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer’s disease (AD), and aging-related frailty. The company has made significant progress in its clinical trials, including the completion of a Phase 2a trial for AD and the ongoing Phase 2b trial for HLHS, which is expected to provide pivotal data for regulatory approval. The FDA has granted Lomecel-B™ several designations, including Rare Pediatric Disease Designation and Fast Track Designation for HLHS, and Regenerative Medicine Advanced Therapy Designation for AD, which may expedite its development and approval process.

Operationally, Longeveron has focused on expanding its manufacturing capabilities to support clinical and potential commercial needs. The company operates a cGMP-compliant manufacturing facility in Miami, Florida, and has established contracts with multiple suppliers for bone marrow, which is critical for producing Lomecel-B™. As of December 31, 2024, Longeveron had 25 full-time employees, with plans to increase its workforce to support ongoing and future clinical trials.

Looking ahead, Longeveron anticipates that its cash and cash equivalents, totaling $19.2 million as of December 31, 2024, will fund operations into the fourth quarter of 2025. However, the company acknowledges the need for additional capital to support its accelerated activities related to the Biologics License Application (BLA) for Lomecel-B™. The company plans to seek further financing through equity offerings, grants, and collaborations to ensure it can continue its development programs and achieve its commercialization goals.

About Longeveron Inc.

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